Monday, December 26, 2011

Mirtazapina Farmoz




Mirtazapina Farmoz may be available in the countries listed below.


Ingredient matches for Mirtazapina Farmoz



Mirtazapine

Mirtazapine is reported as an ingredient of Mirtazapina Farmoz in the following countries:


  • Portugal

International Drug Name Search

Monday, December 19, 2011

Rafocilina




Rafocilina may be available in the countries listed below.


Ingredient matches for Rafocilina



Ofloxacin

Ofloxacin is reported as an ingredient of Rafocilina in the following countries:


  • Argentina

International Drug Name Search

Sunday, December 18, 2011

Proterine




Proterine may be available in the countries listed below.


Ingredient matches for Proterine



Isoxsuprine

Isoxsuprine hydrochloride (a derivative of Isoxsuprine) is reported as an ingredient of Proterine in the following countries:


  • Indonesia

International Drug Name Search

Friday, December 9, 2011

Bumex Injection



Generic Name: bumetanide (Injection route)

bue-MET-a-nide

Injection route(Solution)

Bumetanide is a potent diuretic which, if given in excessive amounts, can lead to a profound diuresis with water and electrolyte depletion. Therefore, careful medical supervision is required, and dose and dosage schedule have to be adjusted to the individual patient's needs .



Commonly used brand name(s)

In the U.S.


  • Bumex

Available Dosage Forms:


  • Solution

Therapeutic Class: Cardiovascular Agent


Pharmacologic Class: Diuretic, Loop


Uses For Bumex


Bumetanide belongs to a group of medicines called loop diuretics or "water pills." Bumetanide is given to help treat fluid retention (edema) and swelling that is caused by congestive heart failure, liver disease, kidney disease, or other medical conditions. It works by acting on the kidneys to increase the flow of urine .


This medicine is available only with your doctor's prescription .


Before Using Bumex


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Appropriate studies have not been performed on the relationship of age to the effects of bumetanide injection in the pediatric population. Safety and efficacy have not been established .


Geriatric


Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of bumetanide injection in the elderly. However, elderly patients are more likely to have age-related liver, kidney or heart problems, which may require an adjustment of dosage in patients receiving bumetanide injection .


Pregnancy








Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding


There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Arsenic Trioxide

  • Bepridil

  • Digitoxin

  • Dofetilide

  • Droperidol

  • Ketanserin

  • Levomethadyl

  • Lithium

  • Metolazone

  • Sotalol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Alacepril

  • Apazone

  • Aspirin

  • Benazepril

  • Bromfenac

  • Captopril

  • Celecoxib

  • Cilazapril

  • Delapril

  • Dibekacin

  • Diclofenac

  • Diflunisal

  • Enalaprilat

  • Enalapril Maleate

  • Etodolac

  • Fenoprofen

  • Flurbiprofen

  • Fosinopril

  • Germanium

  • Ginseng

  • Gossypol

  • Ibuprofen

  • Ibuprofen Lysine

  • Imidapril

  • Indomethacin

  • Kanamycin

  • Ketoprofen

  • Ketorolac

  • Licorice

  • Lisinopril

  • Magnesium Salicylate

  • Meclofenamate

  • Mefenamic Acid

  • Meloxicam

  • Moexipril

  • Nabumetone

  • Naproxen

  • Neomycin

  • Nepafenac

  • Oxaprozin

  • Pentopril

  • Perindopril

  • Piroxicam

  • Quinapril

  • Ramipril

  • Salicylic Acid

  • Salsalate

  • Spirapril

  • Streptomycin

  • Sulindac

  • Temocapril

  • Tolmetin

  • Trandolapril

  • Zofenopril

Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Other Medical Problems


The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:


  • Anuria (not able to form urine) or

  • Liver disease, severe (e.g., hepatic coma)—Should not use in patients with these conditions .

  • Dehydration or

  • Gout or

  • Hearing problems or

  • Hyperuricemia (high uric acid in the blood) or

  • Hypocalcemia (low calcium in the blood) or

  • Hypokalemia (low potassium in the blood) or

  • Hypomagnesemia (low magnesium in the blood) or

  • Hypovolemia (low blood volume) or

  • Thrombocytopenia (low platelets in the blood)—Use with caution. This medicine may make these conditions worse .

  • Diabetes—This medicine may increase the amount of sugar in the blood .

  • Kidney disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body .

Proper Use of Bumex


A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed into one of your veins .


Precautions While Using Bumex


Your doctor will only give you a few doses of this medicine until your condition improves, and then you will be switched to another medicine that works the same way. If you have any concerns about this, talk to your doctor .


Bumex Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor or nurse immediately if any of the following side effects occur:


More common
  • Abdominal pain

  • blurred vision

  • confusion

  • decreased urine output

  • dizziness

  • drowsiness

  • dry mouth

  • fast or irregular heartbeat

  • flushed, dry skin

  • fruit-like breath odor

  • headache

  • increased hunger

  • increased thirst

  • increased urination

  • irritability

  • joint pain, stiffness, or swelling

  • loss of appetite

  • loss of mental alertness

  • lower back, side, or stomach pain

  • mood or mental changes

  • muscle pain or cramps

  • nausea or vomiting

  • numbness or tingling in the hands, feet, or lips

  • shortness of breath

  • sweating

  • swelling of face, hands, feet, ankles, or lower legs

  • troubled breathing

  • unexplained weight loss

  • unusual tiredness or weakness

  • weak pulse

Rare
  • Agitation

  • back pain

  • black, tarry stools

  • bleeding gums

  • blood in the urine or stools

  • chest pain

  • convulsions (seizures)

  • deep or fast breathing with dizziness

  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly

  • fever

  • hallucinations

  • hives

  • increase in heart rate

  • increased blood pressure

  • numbness of feet, hands, and around the mouth

  • pinpoint red spots on the skin

  • rapid breathing

  • stiff neck

  • sunken eyes

  • trembling, jerking of hands

  • unusual bleeding or bruising

  • weight gain

  • wrinkled skin

Get emergency help immediately if any of the following symptoms of overdose occur:


Symptoms of overdose
  • Difficulty breathing

  • pain in chest, groin, or legs, especially the calves

  • severe, sudden headache

  • slurred speech

  • sudden loss of coordination

  • sudden, severe weakness or numbness in the arm or leg

  • sudden, unexplained shortness of breath

  • tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over affected area

  • unusual drowsiness, dullness, or feeling of sluggishness

  • vision changes

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


Rare
  • Decreased interest in sexual intercourse

  • diarrhea

  • difficulty with moving

  • ear discomfort

  • feeling of constant movement of self or surroundings

  • inability to have or keep an erection

  • itching skin

  • loss in sexual ability, desire, drive, or performance

  • muscle or bone pain

  • muscle stiffness

  • nipple tenderness

  • pain, swelling, or redness in joints

  • rash

  • sensation of spinning

  • shorter than usual time to ejaculation of semen

  • trouble with hearing

  • upset stomach

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Bumex Injection side effects (in more detail)



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


More Bumex Injection resources


  • Bumex Injection Side Effects (in more detail)
  • Bumex Injection Use in Pregnancy & Breastfeeding
  • Drug Images
  • Bumex Injection Drug Interactions
  • Bumex Injection Support Group
  • 1 Review for Bumex Injection - Add your own review/rating


Compare Bumex Injection with other medications


  • Ascites
  • Edema
  • Pulmonary Edema

Thursday, December 8, 2011

rimabotulinumtoxinb Intramuscular


rim-a-bot-ue-LYE-num-tox-in-bee


Intramuscular route(Injectable)

The effects of rimabotulinumtoxinB and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults, particularly in those patients who have underlying conditions that would predispose them to these symptoms. Cases of spread of effect have occurred at doses comparable to those used to treat cervical dystonia and at lower doses .



Commonly used brand name(s)

In the U.S.


  • Myobloc

Available Dosage Forms:


  • Solution

Therapeutic Class: Cervical Agent


Pharmacologic Class: Neuromuscular Blocker, Non-Depolarizing


Uses For rimabotulinumtoxinb


RimabotulinumtoxinB is used to treat the abnormal head position and neck pain that result from cervical dystonia (severe muscle spasms of the neck). RimabotulinumtoxinB is a botulinum toxin B product. It works on the nervous system to relax the muscles.


RimabotulinumtoxinB is injected into the muscles that are affected. Depending on your condition, more than one treatment may be required.


rimabotulinumtoxinb is available only with your doctor's prescription and will be administered by your doctor.


Before Using rimabotulinumtoxinb


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For rimabotulinumtoxinb, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to rimabotulinumtoxinb or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Appropriate studies have not been performed on the relationship of age to the effects of rimabotulinumtoxinB in the pediatric population. Safety and efficacy have not been established.


Geriatric


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of rimabotulinumtoxinB in the elderly.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding


There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.


Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Other Medical Problems


The presence of other medical problems may affect the use of rimabotulinumtoxinb. Make sure you tell your doctor if you have any other medical problems, especially:


  • Amyotrophic lateral sclerosis (Lou Gehrig's disease) or

  • Lambert-Eaton syndrome (nerve-muscle disorder) or

  • Motor neuropathy (muscle or nerve problem) or

  • Myasthenia gravis (severe muscle weakness)—May cause side effects to become worse.

  • Breathing problems or

  • Dysarthria (trouble with speaking) or

  • Dysphagia (trouble with swallowing) or

  • Dysphonia (voice problem) or

  • Ptosis (droopy eyelid) or

  • Urinary incontinence (problems passing urine)—Use with caution. May make these conditions worse.

  • Infection at the injection site—Should not be used in patients with this condition.

Proper Use of rimabotulinumtoxinb


Your doctor will give you rimabotulinumtoxinb in a hospital or clinic. rimabotulinumtoxinb is given as a shot into one of your muscles.


Your doctor will only use rimabotulinumtoxinB (Myobloc®) to treat your condition. Other botulinum toxin products may not work the same way and require a different dose.


Precautions While Using rimabotulinumtoxinb


It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.


Serious muscle reactions have occurred within hours to weeks after receiving rimabotulinumtoxinb. If you start to have muscle weakness or trouble with swallowing, talking, or breathing, call your doctor right away. In some situations, these problems could be life-threatening and may require treatment in a hospital or clinic.


rimabotulinumtoxinb may make your muscles weak and cause vision problems. Avoid driving, using machines, or doing anything else that could be dangerous if you feel weak or are not able to see well.


One part of rimabotulinumtoxinb is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from medicines made of human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and testing during the manufacture of these medicines. Although the risk is low, talk with your doctor if you have concerns.


rimabotulinumtoxinb Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor or nurse immediately if any of the following side effects occur:


More common
  • Difficulty with swallowing

  • infection

  • neck pain

  • uncontrolled twisting movements of the neck

Rare
  • Difficulty with breathing or speaking

  • muscle weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


More common
  • Acid or sour stomach

  • back pain

  • belching

  • bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

  • cough

  • difficulty with moving

  • dizziness

  • dry mouth

  • flu-like syndrome

  • headache

  • heartburn or indigestion

  • lack or loss of strength or energy

  • muscle pain, stiffness, or weakness

  • nausea

  • pain, swelling, or redness in the joints

  • stomach discomfort, upset, or pain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


More rimabotulinumtoxinb Intramuscular resources


  • Rimabotulinumtoxinb Intramuscular Side Effects (in more detail)
  • Rimabotulinumtoxinb Intramuscular Use in Pregnancy & Breastfeeding
  • Rimabotulinumtoxinb Intramuscular Drug Interactions
  • Rimabotulinumtoxinb Intramuscular Support Group
  • 0 Reviews for Rimabotulinumtoxinb Intramuscular - Add your own review/rating


Compare rimabotulinumtoxinb Intramuscular with other medications


  • Cervical Dystonia
  • Dystonia
  • Facial Wrinkles
  • Hyperhidrosis

Monday, December 5, 2011

Neoclox




Neoclox may be available in the countries listed below.


In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Neoclox



Cloxacillin

Cloxacillin sodium salt (a derivative of Cloxacillin) is reported as an ingredient of Neoclox in the following countries:


  • Germany

Neomycin

Neomycin sulfate (a derivative of Neomycin) is reported as an ingredient of Neoclox in the following countries:


  • Germany

International Drug Name Search

Thursday, December 1, 2011

Biracin-E




Biracin-E may be available in the countries listed below.


Ingredient matches for Biracin-E



Tobramycin

Tobramycin is reported as an ingredient of Biracin-E in the following countries:


  • Vietnam

International Drug Name Search

Friday, November 25, 2011

Amisulpride CristerS




Amisulpride CristerS may be available in the countries listed below.


Ingredient matches for Amisulpride CristerS



Amisulpride

Amisulpride is reported as an ingredient of Amisulpride CristerS in the following countries:


  • France

International Drug Name Search

A-Lennon Fluoxetine




A-Lennon Fluoxetine may be available in the countries listed below.


Ingredient matches for A-Lennon Fluoxetine



Fluoxetine

Fluoxetine hydrochloride (a derivative of Fluoxetine) is reported as an ingredient of A-Lennon Fluoxetine in the following countries:


  • South Africa

International Drug Name Search

Saturday, November 12, 2011

Immunosin




Immunosin may be available in the countries listed below.


Ingredient matches for Immunosin



Inosine Pranobex

Inosine Pranobex is reported as an ingredient of Immunosin in the following countries:


  • Philippines

International Drug Name Search

Friday, November 4, 2011

Zondar




Zondar may be available in the countries listed below.


Ingredient matches for Zondar



Diacerein

Diacerein is reported as an ingredient of Zondar in the following countries:


  • France

International Drug Name Search

Wednesday, November 2, 2011

Vascace




Vascace may be available in the countries listed below.


UK matches:

  • Vascace Tablets (SPC)

Ingredient matches for Vascace



Cilazapril

Cilazapril is reported as an ingredient of Vascace in the following countries:


  • Greece

  • Ireland

  • Israel

  • Philippines

Cilazapril monohydrate (a derivative of Cilazapril) is reported as an ingredient of Vascace in the following countries:


  • United Kingdom

International Drug Name Search

Glossary

SPC Summary of Product Characteristics (UK)

Click for further information on drug naming conventions and International Nonproprietary Names.

Thursday, October 27, 2011

Spasmo Cibalgin




Spasmo Cibalgin may be available in the countries listed below.


Ingredient matches for Spasmo Cibalgin



Drofenine

Drofenine hydrochloride (a derivative of Drofenine) is reported as an ingredient of Spasmo Cibalgin in the following countries:


  • Oman

Propyphenazone

Propyphenazone is reported as an ingredient of Spasmo Cibalgin in the following countries:


  • Oman

International Drug Name Search

Wednesday, October 26, 2011

Vikela




Vikela may be available in the countries listed below.


Ingredient matches for Vikela



Levonorgestrel

Levonorgestrel is reported as an ingredient of Vikela in the following countries:


  • Austria

International Drug Name Search

Saturday, October 22, 2011

Ron-Acid Suspension


Pronunciation: MAG-al-drate
Generic Name: Magaldrate
Brand Name: Examples include Ri-Mag and Ron-Acid


Ron-Acid Suspension is used for:

Treating acid indigestion, heartburn, and sour stomach. It may also be used for other conditions as determined by your doctor.


Ron-Acid Suspension is an antacid. It works by neutralizing stomach acid and increasing the pH of the stomach.


Do NOT use Ron-Acid Suspension if:


  • you are allergic to any ingredient in Ron-Acid Suspension

  • you have a history of kidney problems

  • you are taking citrate salts (found in some calcium supplements, antacids, and laxatives)

Contact your doctor or health care provider right away if any of these apply to you.



Before using Ron-Acid Suspension:


Some medical conditions may interact with Ron-Acid Suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you have appendicitis, stomach pain, nausea, vomiting, diarrhea, blockage of the bowel, rectal bleeding of unknown cause, kidney problems, or you have had bowel surgery

Some MEDICINES MAY INTERACT with Ron-Acid Suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Oral blood thinners (eg, warfarin), citrate salts (found in some calcium supplements, antacids, and laxatives), or quinidine because their actions and side effects may be increased by Ron-Acid Suspension

  • Bisphosphonates (eg, alendronic acid), cation exchange resins (eg, sodium polystyrene sulfonate), cephalosporins (eg, cefaclor), imidazoles (eg, fluconazole), mycophenolate, penicillamine, quinolones (eg, ciprofloxacin), tetracyclines (eg, doxycycline), or thyroid hormones because their effectiveness may be decreased by Ron-Acid Suspension

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ron-Acid Suspension may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Ron-Acid Suspension:


Use Ron-Acid Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Ron-Acid Suspension may be taken with or without food.

  • Shake well before using.

  • If you miss a dose of Ron-Acid Suspension and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Ron-Acid Suspension.



Important safety information:


  • Do not exceed the recommended dose or use the maximum dose for more than 2 weeks without checking with your doctor.

  • Ron-Acid Suspension contains aluminum and magnesium. Before you begin taking any new prescription or over-the-counter medicine, read the ingredients to see if it also contains aluminum or magnesium. If it does or if you are uncertain, contact your doctor or pharmacist.

  • PREGNANCY and BREAST-FEEDING: It is unknown if Ron-Acid Suspension can cause harm to the fetus. If you become pregnant while taking Ron-Acid Suspension, discuss with your doctor the benefits and risks of using Ron-Acid Suspension during pregnancy. Ron-Acid Suspension is excreted in breast milk. If you are or will be breast-feeding while you are using Ron-Acid Suspension, check with your doctor or pharmacist to discuss the risks to your baby.


Possible side effects of Ron-Acid Suspension:


All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Constipation; diarrhea; intestinal pain.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; loss of appetite; muscle weakness; nausea; slow reflexes; vomiting; vomit that looks like coffee grounds.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


See also: Ron-Acid side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.


Proper storage of Ron-Acid Suspension:

Store Ron-Acid Suspension at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ron-Acid Suspension out of the reach of children and away from pets.


General information:


  • If you have any questions about Ron-Acid Suspension, please talk with your doctor, pharmacist, or other health care provider.

  • Ron-Acid Suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Ron-Acid Suspension. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Ron-Acid resources


  • Ron-Acid Side Effects (in more detail)
  • Ron-Acid Use in Pregnancy & Breastfeeding
  • Ron-Acid Drug Interactions
  • 0 Reviews for Ron-Acid - Add your own review/rating


Compare Ron-Acid with other medications


  • Indigestion

Friday, October 21, 2011

Vermifugo de Piperazina




Vermifugo de Piperazina may be available in the countries listed below.


In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Vermifugo de Piperazina



Piperazine

Piperazine hexahydrate (a derivative of Piperazine) is reported as an ingredient of Vermifugo de Piperazina in the following countries:


  • Portugal

International Drug Name Search

Wednesday, October 12, 2011

Dermtex-HC


Generic Name: hydrocortisone (Topical application route)

hye-droe-KOR-ti-sone

Commonly used brand name(s)

In the U.S.


  • Ala-Cort

  • Ala-Scalp HP

  • Anusol HC

  • Aquanil HC

  • Beta HC

  • Caldecort

  • Cetacort

  • Corta-Cap

  • Cortagel Extra Strength

  • Cortaid

  • CortAlo With Aloe

  • Corticaine

  • Corticool Maximum Strength

  • Cortizone-10

  • Cortizone-5

  • Cotacort

  • Delacort

  • Dermarest

  • Dermtex-HC

  • Foille Cort

  • Gly-Cort

  • Hydrozone Plus

  • Hytone

  • Instacort-10

  • Ivy Soothe

  • IvyStat

  • Keratol HC

  • Kericort 10

  • Lacticare-HC

  • Locoid

  • Locoid Lipocream

  • Medi-Cortisone Maximum Strength

  • Microcort

  • Mycin Scalp

  • Neutrogena T/Scalp

  • NuCort

  • Nupercainal HC

  • Nutracort

  • Pandel

  • Pediaderm HC Kit

  • Preparation H Hydrocortisone

  • Proctocream-HC

  • Recort Plus

  • Sarnol-HC Maximum Strength

  • Scalacort

  • Scalpcort

  • Summer's Eve Specialcare

  • Texacort

  • Therasoft Anti-Itch & Dermatitis

  • U-Cort

  • Westcort

In Canada


  • Barriere-Hc

  • Cortate

  • Cort-Eze

  • Cortoderm Mild Ointment

  • Cortoderm Regular Ointment

  • Emo-Cort

  • Emo-Cort Scalp Solution

  • Hydrocortisone Cream

  • Novo-Hydrocort

  • Novo-Hydrocort Cream

  • Prevex Hc

  • Sarna Hc

Available Dosage Forms:


  • Solution

  • Cream

  • Spray

  • Lotion

  • Ointment

  • Pad

  • Liquid

  • Gel/Jelly

  • Kit

  • Foam

  • Stick

  • Paste

Therapeutic Class: Corticosteroid, Weak


Pharmacologic Class: Adrenal Glucocorticoid


Uses For Dermtex-HC


Hydrocortisone topical is used to help relieve redness, itching, swelling, or other discomfort caused by skin conditions. This medicine is a corticosteroid (cortisone-like medicine or steroid).


This medicine is available both over-the-counter (OTC) and with your doctor's prescription.


Before Using Dermtex-HC


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of hydrocortisone topical in the pediatric population. However, because of this medicine's toxicity, it should be used with caution. Children may absorb large amounts through the skin, which can cause serious side effects. If your child is using this medicine, follow your doctor's instructions very carefully.


Geriatric


No information is available on the relationship of age to the effects of hydrocortisone topical in geriatric patients.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.


Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Other Medical Problems


The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:


  • Cushing's syndrome (adrenal gland disorder) or

  • Diabetes or

  • Hyperglycemia (high blood sugar) or

  • Intracranial hypertension (increased pressure in the head)—Use with caution. May make these conditions worse.

  • Infection of the skin at or near the place of application or

  • Large sores, broken skin, or severe skin injury at the place of application—The chance of side effects may be increased.

Proper Use of hydrocortisone

This section provides information on the proper use of a number of products that contain hydrocortisone. It may not be specific to Dermtex-HC. Please read with care.


It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.


This medicine is for use on the skin only. Do not get it in your eyes. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.


This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.


To use:


  • Wash your hands with soap and water before and after using this medicine.

  • Apply a thin layer of this medicine to the affected area of the skin. Rub it in gently.

  • With the lotion, shake it well before using.

  • Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.

  • If the medicine is applied to the diaper area of an infant, do not use tight-fitting diapers or plastic pants unless directed to do so by your doctor.

  • If your doctor ordered an occlusive dressing or airtight covering to be applied over the medicine, make sure you know how to apply it. Occlusive dressings increase the amount of medicine absorbed through your skin, so use them only as directed. If you have any questions about this, check with your doctor.

Dosing


The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For redness, itching, and swelling of the skin:
    • For topical dosage form (cream):
      • Adults—Apply to the affected area of the skin two or three times per day.

      • Children—Apply to the affected area of the skin two or three times per day.


    • For topical dosage form (lotion):
      • Adults—Apply to the affected area of the skin two to four times per day.

      • Children—Apply to the affected area of the skin two to four times per day.


    • For topical dosage form (ointment):
      • Adults—Apply to the affected area of the skin three or four times per day.

      • Children—Apply to the affected area of the skin three or four times per day.


    • For topical dosage form (solution):
      • Adults—Apply to the affected area of the skin three or four times per day.

      • Children—Apply to the affected area of the skin three or four times per day.



Missed Dose


If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Ask your healthcare professional how you should dispose of any medicine you do not use.


Precautions While Using Dermtex-HC


It is very important that your doctor check your or your child's progress at regular visits for any unwanted effects that may be caused by this medicine.


If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.


Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. The risk is greater for children and patients who use large amounts for a long time. Talk to your doctor right away if you or your child have more than one of these symptoms while you are using this medicine: blurred vision; dizziness or fainting; a fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.


Stop using this medicine and check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin.


Do not use cosmetics or other skin care products on the treated areas.


Dermtex-HC Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor immediately if any of the following side effects occur:


Incidence not known
  • Blistering, burning, crusting, dryness, or flaking of the skin

  • irritation

  • itching, scaling, severe redness, soreness, or swelling of the skin

  • redness and scaling around the mouth

  • thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (e.g. between the fingers)

  • thinning, weakness, or wasting away of the skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


Incidence not known
  • Acne or pimples

  • burning and itching of the skin with pinhead-sized red blisters

  • burning, itching, and pain in hairy areas, or pus at the root of the hair

  • increased hair growth on the forehead, back, arms, and legs

  • lightening of normal skin color

  • lightening of treated areas of dark skin

  • reddish purple lines on the arms, face, legs, trunk, or groin

  • softening of the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Dermtex-HC side effects (in more detail)



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


More Dermtex-HC resources


  • Dermtex-HC Side Effects (in more detail)
  • Dermtex-HC Use in Pregnancy & Breastfeeding
  • Dermtex-HC Drug Interactions
  • Dermtex-HC Support Group
  • 0 Reviews for Dermtex-HC - Add your own review/rating


Compare Dermtex-HC with other medications


  • Anal Itching
  • Aphthous Stomatitis, Recurrent
  • Atopic Dermatitis
  • Dermatitis
  • Eczema
  • Gingivitis
  • Proctitis
  • Pruritus
  • Psoriasis
  • Seborrheic Dermatitis
  • Skin Rash

Sunday, October 9, 2011

Disintyl




Disintyl may be available in the countries listed below.


Ingredient matches for Disintyl



Benzalkonium Chloride

Benzalkonium chloride (a derivative of Benzalkonium) is reported as an ingredient of Disintyl in the following countries:


  • Italy

International Drug Name Search

Wednesday, September 28, 2011

Chlortetracycline Bisulfate




In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Chlortetracycline Bisulfate



Chlortetracycline

Chlortetracycline bisulfate (a derivative of Chlortetracycline) is reported as an ingredient of Chlortetracycline Bisulfate in the following countries:


  • United States

International Drug Name Search

Monday, September 26, 2011

Fentizol




Fentizol may be available in the countries listed below.


Ingredient matches for Fentizol



Fenticonazole

Fenticonazole nitrate (a derivative of Fenticonazole) is reported as an ingredient of Fentizol in the following countries:


  • Brazil

International Drug Name Search

Sunday, September 18, 2011

Gaster D




Gaster D may be available in the countries listed below.


Ingredient matches for Gaster D



Famotidine

Famotidine is reported as an ingredient of Gaster D in the following countries:


  • Japan

International Drug Name Search

Monday, September 12, 2011

Serralex-NM




Serralex-NM may be available in the countries listed below.


Ingredient matches for Serralex-NM



Nimesulide

Nimesulide is reported as an ingredient of Serralex-NM in the following countries:


  • India

Serrapeptase

Serrapeptase is reported as an ingredient of Serralex-NM in the following countries:


  • India

International Drug Name Search

Wednesday, September 7, 2011

Razadyne IR


Generic Name: galantamine (Oral route)

ga-LAN-ta-meen

Commonly used brand name(s)

In the U.S.


  • Razadyne

  • Razadyne ER

  • Razadyne IR

Available Dosage Forms:


  • Tablet

  • Capsule, Extended Release

  • Solution

Therapeutic Class: Central Nervous System Agent


Pharmacologic Class: Cholinesterase Inhibitor, Centrally/Peripherally Acting


Uses For Razadyne IR


Galantamine is used to treat the symptoms of mild to moderate Alzheimer's disease. Galantamine will not cure Alzheimer's disease, and it will not stop the disease from getting worse. However, galantamine can improve thinking ability in some patients with Alzheimer's disease


In Alzheimer's disease, many chemical changes take place in the brain. One of the earliest and biggest changes is that there is less of a chemical called acetylcholine (ACh). ACh helps the brain to work properly. Galantamine slows the breakdown of ACh, so it can build up and have a greater effect. However, as Alzheimer's disease gets worse, there will be less and less ACh, so galantamine may not work as well.


This medicine is available only with your doctor's prescription.


Before Using Razadyne IR


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of galantamine in children with use in other age groups. Use in children is not recommended.


Geriatric


Galantamine levels are higher in older adults than in healthy young subjects.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersBAnimal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding


There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Amitriptyline

  • Fluoxetine

  • Fluvoxamine

  • Ketoconazole

  • Oxybutynin

  • Paroxetine

  • Quinidine

  • Tolterodine

Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Other Medical Problems


The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:


  • Asthma (or history of) or

  • Lung disease—May make breathing problems worse

  • Epilepsy or history of seizures—Galantamine may cause seizures

  • Heart problems, including slow heartbeat or heart block (slow and irregular heartbeat)—May make condition worse

  • Kidney problems or

  • Liver problems—Your doctor may need to adjust your dose. If the problems are severe, you should not take galantamine.

  • Mild cognitive impairment (memory problems)—Galantamine should not be used for this condition.

  • Stomach ulcer (or history of) or

  • Urinary tract blockage or difficult urination—Galantamine may make these conditions worse

Proper Use of galantamine

This section provides information on the proper use of a number of products that contain galantamine. It may not be specific to Razadyne IR. Please read with care.


Dosing


The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


If you are taking the tablets or oral solution: Take this medicine with your morning and evening meals.


If you are taking the extended-release capsules: Take this medicine with your morning meal.


Follow the instruction sheet for the proper dosing of the oral solution and ask your doctor or pharmacist if you have any questions.


Make sure that you are drinking plenty of fluids while you are taking this medicine.


  • For oral dosage forms (oral solution and tablets):
    • For treatment of Alzheimer's disease:
      • Adults—To start, take 4 mg (milligrams) two times a day. Your doctor may increase your dose gradually if you are doing well on this medicine.



  • For long acting oral dosage forms (extended-release capsules):
    • For treatment of Alzheimer's disease:
      • Adults—To start, take 8 mg one time a day. Your doctor may increase your dose gradually if you are doing well on this medicine.



Missed Dose


If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Do not take your morning and evening doses close together.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Ask your healthcare professional how you should dispose of any medicine you do not use.


Precautions While Using Razadyne IR


It is very important that your doctor check you at regular visits.


Tell your doctor if your symptoms get worse, or if you notice any new symptoms.


Do not take other medicines unless they have been discussed with your doctor. This especially includes nonprescription medicines, such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.


Galantamine causes a large number of patients to have problems with their stomachs and intestines. Tell your doctor about any nausea, vomiting, diarrhea, stomach pain or loss of appetite.


If you think you or someone else may have taken an overdose of galantamine, get emergency help at once. Taking an overdose of galantamine may lead to convulsions (seizures) or shock. Some signs of shock are large pupils, irregular breathing, and fast weak pulse. Other signs of an overdose are severe nausea and vomiting, increasing muscle weakness, greatly increased sweating, and greatly increased watering of the mouth.


Razadyne IR Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor as soon as possible if any of the following side effects occur:


Less common
  • Chest pain or discomfort

  • Shortness of breath

Incidence not known
  • Attack, assault, force

  • bloody or black, tarry stools

  • confusion

  • constipation

  • convulsions

  • decreased urination

  • dry mouth

  • increase in heart rate

  • increased thirst

  • irregular heartbeat

  • mood changes

  • muscle pain or cramps

  • numbness or tingling in hands, feet, or lips

  • rapid breathing

  • severe stomach pain

  • sunken eyes

  • vomiting of blood or material that looks like coffee grounds

  • wrinkled skin

Symptoms of overdose
  • Cramping

  • defecation or urination, uncontrolled

  • dizziness

  • drooling

  • fainting

  • increased sweating

  • low blood pressure

  • muscle weakness

  • seizures

  • slow heart beat

  • severe nausea or vomiting

  • slow or troubled breathing

  • tearing of the eyes

  • watering of the mouth

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


More common
  • Bladder pain

  • bloody or cloudy urine

  • diarrhea

  • difficult, burning, or painful urination

  • discouragement

  • feeling sad or empty

  • frequent urge to urinate

  • irritability

  • loss of appetite

  • loss of interest or pleasure

  • lower back or side pain

  • nausea

  • tiredness

  • trouble concentrating

  • vomiting

  • weight loss

Less common
  • Abdominal pain

  • pale skin

  • troubled breathing with activity

  • slow or irregular heartbeat (less than 50 beats per minute)

  • light-headedness

  • dizziness or fainting

  • unusual tiredness or weakness

  • indigestion

  • headache

  • blood in urine

  • lower back pain

  • pain or burning while urinating

  • trouble sleeping

  • unable to sleep

  • sleepiness

  • sleeplessness

  • stuffy nose

  • unusual bleeding or bruising

  • unusual drowsiness

  • high or low blood pressure

  • tremor

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Razadyne IR side effects (in more detail)



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


More Razadyne IR resources


  • Razadyne IR Side Effects (in more detail)
  • Razadyne IR Use in Pregnancy & Breastfeeding
  • Drug Images
  • Razadyne IR Drug Interactions
  • Razadyne IR Support Group
  • 0 Reviews for Razadyne IR - Add your own review/rating


Compare Razadyne IR with other medications


  • Alzheimer's Disease

Monday, September 5, 2011

Rantudil Kowa




Rantudil Kowa may be available in the countries listed below.


Ingredient matches for Rantudil Kowa



Acemetacin

Acemetacin is reported as an ingredient of Rantudil Kowa in the following countries:


  • Japan

International Drug Name Search

Thursday, September 1, 2011

Pronon




Pronon may be available in the countries listed below.


Ingredient matches for Pronon



Propafenone

Propafenone hydrochloride (a derivative of Propafenone) is reported as an ingredient of Pronon in the following countries:


  • Japan

International Drug Name Search

Saturday, August 27, 2011

Lattulosio Mylan




Lattulosio Mylan may be available in the countries listed below.


Ingredient matches for Lattulosio Mylan



Lactulose

Lactulose is reported as an ingredient of Lattulosio Mylan in the following countries:


  • Italy

International Drug Name Search

Wednesday, August 24, 2011

Mesalazine Pharmathen




Mesalazine Pharmathen may be available in the countries listed below.


Ingredient matches for Mesalazine Pharmathen



Mesalazine

Mesalazine is reported as an ingredient of Mesalazine Pharmathen in the following countries:


  • Greece

International Drug Name Search

Friday, August 12, 2011

Acimol




Acimol may be available in the countries listed below.


Ingredient matches for Acimol



Methionine

Methionine is reported as an ingredient of Acimol in the following countries:


  • Germany

International Drug Name Search

Wednesday, August 10, 2011

Ambroxol Sopharma




Ambroxol Sopharma may be available in the countries listed below.


Ingredient matches for Ambroxol Sopharma



Ambroxol

Ambroxol is reported as an ingredient of Ambroxol Sopharma in the following countries:


  • Bulgaria

International Drug Name Search

Saturday, August 6, 2011

Sorestin




Sorestin may be available in the countries listed below.


Ingredient matches for Sorestin



Erythromycin

Erythromycin stearate (a derivative of Erythromycin) is reported as an ingredient of Sorestin in the following countries:


  • Philippines

International Drug Name Search

Wednesday, July 20, 2011

Sanipirina




Sanipirina may be available in the countries listed below.


Ingredient matches for Sanipirina



Paracetamol

Paracetamol is reported as an ingredient of Sanipirina in the following countries:


  • Italy

International Drug Name Search

Quit-Itch




Quit-Itch may be available in the countries listed below.


In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Quit-Itch



Povidone Iodine

Povidone-Iodine is reported as an ingredient of Quit-Itch in the following countries:


  • Australia

International Drug Name Search

Tuesday, July 19, 2011

Premium Gamba




Premium Gamba may be available in the countries listed below.


In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Premium Gamba



Amprolium

Amprolium hydrochloride (a derivative of Amprolium) is reported as an ingredient of Premium Gamba in the following countries:


  • Germany

Azanidazole

Azanidazole is reported as an ingredient of Premium Gamba in the following countries:


  • Germany

International Drug Name Search

Sunday, July 17, 2011

Maxicrom




Maxicrom may be available in the countries listed below.


Ingredient matches for Maxicrom



Cromoglicic Acid

Cromoglicic Acid disodium salt (a derivative of Cromoglicic Acid) is reported as an ingredient of Maxicrom in the following countries:


  • Brazil

International Drug Name Search

Saturday, July 16, 2011

Meletin




Meletin may be available in the countries listed below.


Ingredient matches for Meletin



Mexiletine

Mexiletine hydrochloride (a derivative of Mexiletine) is reported as an ingredient of Meletin in the following countries:


  • Taiwan

International Drug Name Search

Tuesday, July 12, 2011

Trusil




Trusil may be available in the countries listed below.


Ingredient matches for Trusil



Tropicamide

Tropicamide is reported as an ingredient of Trusil in the following countries:


  • Bangladesh

International Drug Name Search

Saturday, July 9, 2011

Ulcoreks




Ulcoreks may be available in the countries listed below.


Ingredient matches for Ulcoreks



Pantoprazole

Pantoprazole sodium (a derivative of Pantoprazole) is reported as an ingredient of Ulcoreks in the following countries:


  • Turkey

International Drug Name Search

Tuesday, June 28, 2011

Ondansetron Oral Solution





Dosage Form: oral solution

Ondansetron Oral Solution Description




The active ingredient in Ondansetron Oral Solution, USP is ondansetron hydrochloride (HCl) as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula:



The molecular formula is C18H19N3O•HCl•2H2O, representing a molecular weight of 365.9. Ondansetron hydrochloride dihydrate USP is a white to off-white powder that is soluble in water and normal saline.

 

Each 5 mL of Ondansetron Oral Solution, USP contains 5 mg of ondansetron hydrochloride dihydrate USP equivalent to 4 mg of ondansetron. Ondansetron Oral Solution, USP contains the following inactive ingredients sucrose, glycerin, citric acid anhydrous, sodium citrate, sodium benzoate, edetate disodium, and liquid strawberry flavor.

Ondansetron Oral Solution - Clinical Pharmacology



Pharmacodynamics




Ondansetron is a selective 5-HT3 receptor antagonist. While its mechanism of action has not been fully characterized, ondansetron is not a dopamine-receptor antagonist. Serotonin receptors of the 5-HT3 type are present both peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone of the area postrema. It is not certain whether ondansetron’s antiemetic action is mediated centrally, peripherally, or in both sites. However, cytotoxic chemotherapy appears to be associated with release of serotonin from the enterochromaffin cells of the small intestine. In humans, urinary 5-HIAA (5-hydroxyindoleacetic acid) excretion increases after cisplatin administration in parallel with the onset of emesis. The released serotonin may stimulate the vagal afferents through the 5-HT3 receptors and initiate the vomiting reflex.

 

In animals, the emetic response to cisplatin can be prevented by pretreatment with an inhibitor of serotonin synthesis, bilateral abdominal vagotomy and greater splanchnic nerve section, or pretreatment with a serotonin 5-HT3 receptor antagonist.

 

In normal volunteers, single intravenous doses of 0.15 mg/kg of ondansetron had no effect on esophageal motility, gastric motility, lower esophageal sphincter pressure, or small intestinal transit time. Multiday administration of ondansetron has been shown to slow colonic transit in normal volunteers. Ondansetron has no effect on plasma prolactin concentrations.

 

Ondansetron does not alter the respiratory depressant effects produced by alfentanil or the degree of neuromuscular blockade produced by atracurium. Interactions with general or local anesthetics have not been studied.

Pharmacokinetics




Ondansetron is well absorbed from the gastrointestinal tract and undergoes some first-pass metabolism. Mean bioavailability in healthy subjects, following administration of a single 8 mg tablet, is approximately 56%.

 

Ondansetron systemic exposure does not increase proportionately to dose. AUC from a 16 mg tablet was 24% greater than predicted from an 8 mg tablet dose. This may reflect some reduction of first-pass metabolism at higher oral doses. Bioavailability is also slightly enhanced by the presence of food but unaffected by antacids.

 

Ondansetron is extensively metabolized in humans, with approximately 5% of a radiolabeled dose recovered as the parent compound from the urine. The primary metabolic pathway is hydroxylation on the indole ring followed by subsequent glucuronide or sulfate conjugation. Although some nonconjugated metabolites have pharmacologic activity, these are not found in plasma at concentrations likely to significantly contribute to the biological activity of ondansetron.


In vitro metabolism studies have shown that ondansetron is a substrate for human hepatic cytochrome P-450 enzymes, including CYP1A2, CYP2D6, and CYP3A4. In terms of overall ondansetron turnover, CYP3A4 played the predominant role. Because of the multiplicity of metabolic enzymes capable of metabolizing ondansetron, it is likely that inhibition or loss of one enzyme (e.g., CYP2D6 genetic deficiency) will be compensated by others and may result in little change in overall rates of ondansetron elimination. Ondansetron elimination may be affected by cytochrome P-450 inducers. In a pharmacokinetic study of 16 epileptic patients maintained chronically on CYP3A4 inducers, carbamazepine, or phenytoin, reduction in AUC, Cmax, and T½ of ondansetron was observed.1 This resulted in a significant increase in clearance. However, on the basis of available data, no dosage adjustment for ondansetron is recommended (see PRECAUTIONS: Drug Interactions).

 

In humans, carmustine, etoposide, and cisplatin do not affect the pharmacokinetics of ondansetron.

 

Gender differences were shown in the disposition of ondansetron given as a single dose. The extent and rate of ondansetron's absorption is greater in women than men. Slower clearance in women, a smaller apparent volume of distribution (adjusted for weight), and higher absolute bioavailability resulted in higher plasma ondansetron levels. These higher plasma levels may in part be explained by differences in body weight between men and women. It is not known whether these gender-related differences were clinically important. More detailed pharmacokinetic information is contained in Tables 1 and 2 taken from 2 studies. 

































Table 1. Pharmacokinetics in Normal Volunteers: Single 8 mg Ondansetron Hydrochloride Tablet Dose
Age-group

(years)
Mean

Weight (kg)
   n   Peak Plasma

Concentration

(ng/mL)
Time of

Peak Plasma

Concentration

(h)
Mean Elimination

Half-life (h)
Systemic Plasma

Clearance L/h/kg
Absolute

Bioavailability
   18-40 M 

              F
69

62.7
6

5
26.2

42.7
2

1.7
3.1

3.5
0.403

0.354
0.483

0.663
   61-74 M 

              F
77.5

60.2
6

6
24.1

52.4
2.1

1.9
4.1

4.9
0.384

0.255
0.585

0.643
      ≥75 M 

              F
78

67.6
5

6
37

46.1
2.2

2.1
4.5

6.2
0.277

0.249
0.619

0.747




















Table 2. Pharmacokinetics in Normal Volunteers: Single 24 mg Ondansetron Hydrochloride Tablet Dose
Age-group

(years)
Mean

Weight (kg)
   n    Peak Plasma

Concentration

(ng/mL)
Time of

Peak Plasma

Concentration

(h)
Mean Elimination

Half-life (h)
   18-43 M
84.1
8
125.8
1.9
4.7
              F
71.8
8
194.4
1.6
5.8



A reduction in clearance and increase in elimination half-life are seen in patients over 75 years of age. In clinical trials with cancer patients, safety and efficacy were similar in patients over 65 years of age and those under 65 years of age; there was an insufficient number of patients over 75 years of age to permit conclusions in that age-group. No dosage adjustment is recommended in the elderly.

 

In patients with mild-to-moderate hepatic impairment, clearance is reduced 2-fold and mean half-life is increased to 11.6 hours compared to 5.7 hours in normals. In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced 2-fold to 3-fold and apparent volume of distribution is increased with a resultant increase in half-life to 20 hours. In patients with severe hepatic impairment, a total daily dose of 8 mg should not be exceeded.

 

Due to the very small contribution (5%) of renal clearance to the overall clearance, renal impairment was not expected to significantly influence the total clearance of ondansetron. However, ondansetron oral mean plasma clearance was reduced by about 50% in patients with severe renal impairment (creatinine clearance <30 mL/min). This reduction in clearance is variable and was not consistent with an increase in half-life. No reduction in dose or dosing frequency in these patients is warranted.

 

Plasma protein binding of ondansetron as measured in vitro was 70% to 76% over the concentration range of 10 to 500 ng/mL. Circulating drug also distributes into erythrocytes.

 

Four and 8 mg doses of either Ondansetron Oral Solution or ondansetron orally disintegrating tablets are bioequivalent to corresponding doses of ondansetron hydrochloride tablets and may be used interchangeably. One 24 mg ondansetron hydrochloride tablet is bioequivalent to and interchangeable with three 8 mg ondansetron hydrochloride tablets.

Clinical Trials




Chemotherapy-Induced Nausea and Vomiting


Highly Emetogenic Chemotherapy

 

In 2 randomized, double-blind, monotherapy trials, a single 24 mg ondansetron hydrochloride tablet was superior to a relevant historical placebo control in the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥50 mg/m2. Steroid administration was excluded from these clinical trials. More than 90% of patients receiving a cisplatin dose ≥50 mg/m2in the historical placebo comparator experienced vomiting in the absence of antiemetic therapy.

 

The first trial compared oral doses of ondansetron 24 mg once a day, 8 mg twice a day, and 32 mg once a day in 357 adult cancer patients receiving chemotherapy regimens containing cisplatin ≥50 mg/m2. A total of 66% of patients in the ondansetron 24 mg once-a-day group, 55% in the ondansetron 8 mg twice-a-day group, and 55% in the ondansetron 32 mg once-a-day group completed the 24-hour study period with 0 emetic episodes and no rescue antiemetic medications, the primary endpoint of efficacy. Each of the 3 treatment groups was shown to be statistically significantly superior to a historical placebo control.

 

In the same trial, 56% of patients receiving oral ondansetron 24 mg once a day experienced no nausea during the 24-hour study period, compared with 36% of patients in the oral ondansetron 8 mg twice-a-day group (P = 0.001) and 50% in the oral ondansetron 32 mg once-a-day group.

 

In a second trial, efficacy of the oral ondansetron 24 mg once-a-day regimen in the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥50 mg/m2, was confirmed.


Moderately Emetogenic Chemotherapy

 

In 1 double-blind U.S. study in 67 patients, ondansetron hydrochloride tablets 8 mg administered twice a day were significantly more effective than placebo in preventing vomiting induced by cyclophosphamide-based chemotherapy containing doxorubicin. Treatment response is based on the total number of emetic episodes over the 3-day study period. The results of this study are summarized in Table 3:


































Table 3. Emetic Episodes: Treatment Response
Ondansetron

8 mg b.i.d.

Ondansetron Hydrochloride Tablets*
PlaceboP Value
* The first dose was administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. An 8 mg ondansetron hydrochloride tablet was administered twice a day for 2 days after completion of chemotherapy.

† Median undefined since at least 50% of the patients were withdrawn or had more than 2 emetic episodes.

‡ Median undefined since at least 50% of patients did not have any emetic episodes.
   Number of patients
33
34
   Treatment response
      0 Emetic episodes
20 (61%)
2 (6%)
<0.001
      1 to 2 Emetic episodes
6 (18%)
8 (24%)
      More than 2 emetic episodes/withdrawn
7 (21%)
24 (71%)
<0.001
   Median number of emetic episodes
0
Undefined†
   Median time to first emetic episode (h)
Undefined‡
6.5



In 1 double-blind U.S. study in 336 patients, ondansetron hydrochloride tablets 8 mg administered twice a day were as effective as ondansetron hydrochloride tablets 8 mg administered 3 times a day in preventing nausea and vomiting induced by cyclophosphamide-based chemotherapy containing either methotrexate or doxorubicin. Treatment response is based on the total number of emetic episodes over the 3-day study period. The results of this study are summarized in Table 4:






























Table 4. Emetic Episodes: Treatment Response
Ondansetron
8 mg b.i.d. Ondansetron Hydrochloride Tablets*8 mg t.i.d. Ondansetron Hydrochloride Tablets†
* The first dose was administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. An 8 mg ondansetron hydrochloride tablet was administered twice a day for 2 days after completion of chemotherapy.

† The first dose was administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. An 8 mg ondansetron hydrochloride tablet was administered 3 times a day for 2 days after completion of chemotherapy.

‡ Median undefined since at least 50% of patients did not have any emetic episodes.

§ Visual analog scale assessment: 0 = no nausea, 100 = nausea as bad as it can be.
   Number of patients
165
171
   Treatment response
      0 Emetic episodes
101 (61%)
99 (58%)
      1 to 2 Emetic episodes
16 (10%)
17 (10%)
      More than 2 emetic episodes/withdrawn
48 (29%)
55 (32%)
   Median number of emetic episodes
0
0
   Median time to first emetic episode (h)
Undefined‡
Undefined‡
   Median nausea scores (0 to 100)§
6
6


Re-treatment

 

In uncontrolled trials, 148 patients receiving cyclophosphamide-based chemotherapy were re-treated with ondansetron hydrochloride tablets 8 mg 3 times daily during subsequent chemotherapy for a total of 396 re-treatment courses. No emetic episodes occurred in 314 (79%) of the re-treatment courses, and only 1 to 2 emetic episodes occurred in 43 (11%) of the re-treatment courses.


Pediatric Studies

 

Three open-label, uncontrolled, foreign trials have been performed with 182 pediatric patients 4 to 18 years old with cancer who were given a variety of cisplatin or noncisplatin regimens. In these foreign trials, the initial dose of ondansetron hydrochloride injection ranged from 0.04 to 0.87 mg/kg for a total dose of 2.16 to 12 mg. This was followed by the administration of ondansetron hydrochloride tablets ranging from 4 to 24 mg daily for 3 days. In these studies, 58% of the 170 evaluable patients had a complete response (no emetic episodes) on day 1. Two studies showed the response rates for patients less than 12 years of age who received ondansetron hydrochloride tablets 4 mg 3 times a day to be similar to those in patients 12 to 18 years of age who received ondansetron hydrochloride tablets 8 mg 3 times daily. Thus, prevention of emesis in these pediatric patients was essentially the same as for patients older than 18 years of age. Overall, ondansetron hydrochloride tablets were well tolerated in these pediatric patients.

 

Radiation-Induced Nausea and Vomiting


Total Body Irradiation

 

In a randomized, double-blind study in 20 patients, ondansetron hydrochloride tablets (8 mg given 1.5 hours before each fraction of radiotherapy for 4 days) were significantly more effective than placebo in preventing vomiting induced by total body irradiation. Total body irradiation consisted of 11 fractions (120 cGy per fraction) over 4 days for a total of 1,320 cGy. Patients received 3 fractions for 3 days, then 2 fractions on day 4.


Single High-Dose Fraction Radiotherapy

 

Ondansetron was significantly more effective than metoclopramide with respect to complete control of emesis (0 emetic episodes) in a double-blind trial in 105 patients receiving single high-dose radiotherapy (800 to 1,000 cGy) over an anterior or posterior field size of ≥80 cm2 to the abdomen. Patients received the first dose of ondansetron hydrochloride tablets (8 mg) or metoclopramide (10 mg) 1 to 2 hours before radiotherapy. If radiotherapy was given in the morning, 2 additional doses of study treatment were given (1 tablet late afternoon and 1 tablet before bedtime). If radiotherapy was given in the afternoon, patients took only 1 further tablet that day before bedtime. Patients continued the oral medication on a 3 times a day basis for 3 days.

 

Daily Fractionated Radiotherapy

 

Ondansetron was significantly more effective than prochlorperazine with respect to complete control of emesis (0 emetic episodes) in a double-blind trial in 135 patients receiving a 1- to 4-week course of fractionated radiotherapy (180 cGy doses) over a field size of ≥100 cm2 to the abdomen. Patients received the first dose of ondansetron hydrochloride tablets (8 mg) or prochlorperazine (10 mg) 1 to 2 hours before the patient received the first daily radiotherapy fraction, with 2 subsequent doses on a 3 times a day basis. Patients continued the oral medication on a 3 times a day basis on each day of radiotherapy.

 

Postoperative Nausea and Vomiting

 

Surgical patients who received ondansetron 1 hour before the induction of general balanced anesthesia (barbiturate: thiopental, methohexital, or thiamylal; opioid: alfentanil, sufentanil, morphine, or fentanyl; nitrous oxide; neuromuscular blockade: succinylcholine/curare or gallamine and/or vecuronium, pancuronium, or atracurium; and supplemental isoflurane or enflurane) were evaluated in 2 double-blind studies (1 U.S. study, 1 foreign) involving 865 patients. Ondansetron hydrochloride tablets (16 mg) were significantly more effective than placebo in preventing postoperative nausea and vomiting.

 

The study populations in all trials thus far consisted of women undergoing inpatient surgical procedures. No studies have been performed in males. No controlled clinical study comparing ondansetron hydrochloride tablets to ondansetron hydrochloride injection has been performed.

Indications and Usage for Ondansetron Oral Solution


  1. Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥50 mg/m2.

  2. Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.

  3. Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.

  4. Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, Ondansetron Oral Solution, USP is recommended even where the incidence of postoperative nausea and/or vomiting is low.


Contraindications




The concomitant use of apomorphine with ondansetron is contraindicated based on reports of profound hypotension and loss of consciousness when apomorphine was administered with ondansetron.

 

Ondansetron Oral Solution is contraindicated for patients known to have hypersensitivity to the drug.

Warnings




Hypersensitivity reactions have been reported in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists.

 

ECG changes including QT interval prolongation has been seen in patients receiving ondansetron. In addition, postmarketing cases of Torsade de Pointes have been reported in patients using ondansetron. Avoid ondansetron in patients with congenital long QT syndrome. ECG monitoring is recommended in patients with electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart failure, bradyarrhythmias or patients taking other medicinal products that lead to QT prolongation.

Precautions



General




Ondansetron is not a drug that stimulates gastric or intestinal peristalsis. It should not be used instead of nasogastric suction. The use of ondansetron in patients following abdominal surgery or in patients with chemotherapy-induced nausea and vomiting may mask a progressive ileus and/or gastric distension.

Drug Interactions




Ondansetron does not itself appear to induce or inhibit the cytochrome P-450 drug-metabolizing enzyme system of the liver (see CLINICAL PHARMACOLOGY, Pharmacokinetics). Because ondansetron is metabolized by hepatic cytochrome P-450 drug-metabolizing enzymes (CYP3A4, CYP2D6, CYP1A2), inducers or inhibitors of these enzymes may change the clearance and, hence, the half-life of ondansetron. On the basis of available data, no dosage adjustment is recommended for patients on these drugs.


Apomorphine


Based on reports of profound hypotension and loss of consciousness when apomorphine was administered with ondansetron, concomitant use of apomorphine with ondansetron is contraindicated (see CONTRAINDICATIONS).

 

Phenytoin, Carbamazepine, and Rifampicin

 

In patients treated with potent inducers of CYP3A4 (i.e., phenytoin, carbamazepine, and rifampicin), the clearance of ondansetron was significantly increased and ondansetron blood concentrations were decreased. However, on the basis of available data, no dosage adjustment for ondansetron is recommended for patients on these drugs.1,3


Tramadol

 

Although no pharmacokinetic drug interaction between ondansetron and tramadol has been observed, data from 2 small studies indicate that ondansetron may be associated with an increase in patient controlled administration of tramadol.4,5


Chemotherapy

 

Tumor response to chemotherapy in the P-388 mouse leukemia model is not affected by ondansetron. In humans, carmustine, etoposide, and cisplatin do not affect the pharmacokinetics of ondansetron.

 

In a crossover study in 76 pediatric patients, I.V. ondansetron did not increase blood levels of high-dose methotrexate.


Use in Surgical Patients

 

The coadministration of ondansetron had no effect on the pharmacokinetics and pharmacodynamics of temazepam.

Carcinogenesis, Mutagenesis, Impairment of Fertility




Carcinogenic effects were not seen in 2-year studies in rats and mice with oral ondansetron doses up to 10 and 30 mg/kg/day, respectively. Ondansetron was not mutagenic in standard tests for mutagenicity. Oral administration of ondansetron up to 15 mg/kg/day did not affect fertility or general reproductive performance of male and female rats.

Pregnancy


Teratogenic effects

Pregnancy Category B.

 

Reproduction studies have been performed in pregnant rats and rabbits at daily oral doses up to 15 and 30 mg/kg/day, respectively, and have revealed no evidence of impaired fertility or harm to the fetus due to ondansetron. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers




Ondansetron is excreted in the breast milk of rats. It is not known whether ondansetron is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ondansetron is administered to a nursing woman.

Pediatric Use




Little information is available about dosage in pediatric patients 4 years of age or younger (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION sections for use in pediatric patients 4 to 18 years of age).

Geriatric Use




Of the total number of subjects enrolled in cancer chemotherapy-induced and postoperative nausea and vomiting in U.S.- and foreign-controlled clinical trials, for which there were subgroup analyses, 938 were 65 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Dosage adjustment is not needed in patients over the age of 65 (see CLINICAL PHARMACOLOGY).

Adverse Reactions




The following have been reported as adverse events in clinical trials of patients treated with ondansetron, the active ingredient of ondansetron hydrochloride. A causal relationship to therapy with ondansetron hydrochloride has been unclear in many cases.

 

Chemotherapy-Induced Nausea and Vomiting

 

The adverse events in Table 5 have been reported in ≥5% of adult patients receiving a single 24 mg ondansetron hydrochloride tablet in 2 trials. These patients were receiving concurrent highly emetogenic cisplatin-based chemotherapy regimens (cisplatin dose ≥ 50 mg/m2).













Table 5. Principal Adverse Events in U.S. Trials: Single Day Therapy With 24 mg Ondansetron Hydrochloride Tablets (Highly Emetogenic Chemotherapy)
EventOndansetron

24 mg q.d.

n = 300
Ondansetron

8 mg b.i.d.

n = 124
Ondansetron

32 mg q.d.

n = 117
   Headache
33 (11%)
16 (13%)
17 (15%)
   Diarrhea
13 (4%)
9 (7%)
3 (3%)


The adverse events in Table 6 have been reported in ≥5% of adults receiving either 8 mg of ondansetron hydrochloride tablets 2 or 3 times a day for 3 days or placebo in 4 trials. These patients were receiving concurrent moderately emetogenic chemotherapy, primarily cyclophosphamide-based regimens. 

























Table 6. Principal Adverse Events in U.S. Trials: 3 Days of Therapy With 8 mg Ondansetron Hydrochloride Tablets (Moderately Emetogenic Chemotherapy)
EventOndansetron

8 mg b.i.d.

n = 242
Ondansetron

8 mg t.i.d.

n = 415
Placebo

n = 262
   Headache
58 (24%)
113 (27%)
34 (13%)
   Malaise/fatigue
32 (13%)
37 (9%)
6 (2%)
   Constipation
22 (9%)
26 (6%)
1 (<1%)
   Diarrhea
15 (6%)
16 (4%)
10 (4%)
   Dizziness
13 (5%)
18 (4%)
12 (5%)


Central Nervous System

 

There have been rare reports consistent with, but not diagnostic of, extrapyramidal reactions in patients receiving ondansetron.


Hepatic

 

In 723 patients receiving cyclophosphamide-based chemotherapy in U.S. clinical trials, AST and/or ALT values have been reported to exceed twice the upper limit of normal in approximately 1% to 2% of patients receiving ondansetron hydrochloride tablets. The increases were transient and did not appear to be related to dose or duration of therapy. On repeat exposure, similar transient elevations in transaminase values occurred in some courses, but symptomatic hepatic disease did not occur. The role of cancer chemotherapy in these biochemical changes cannot be clearly determined.

 

There have been reports of liver failure and death in patients with cancer receiving concurrent medications including potentially hepatotoxic cytotoxic chemotherapy and antibiotics. The etiology of the liver failure is unclear.


Integumentary

 

Rash has occurred in approximately 1% of patients receiving ondansetron.


Other

 

Rare cases of anaphylaxis, bronchospasm, tachycardia, angina (chest pain), hypokalemia, electrocardiographic alterations, vascular occlusive events, and grand mal seizures have been reported. Except for bronchospasm and anaphylaxis, the relationship to ondansetron was unclear.

 

Radiation-Induced Nausea and Vomiting

 

The adverse events reported in patients receiving ondansetron hydrochloride tablets and concurrent radiotherapy were similar to those reported in patients receiving ondansetron hydrochloride tablets and concurrent chemotherapy. The most frequently reported adverse events were headache, constipation, and diarrhea.


Postoperative Nausea and Vomiting

 

The adverse events in Table 7 have been reported in ≥5% of patients receiving ondansetron hydrochloride tablets at a dosage of 16 mg orally in clinical trials. With the exception of headache, rates of these events were not significantly different in the ondansetron and placebo groups. These patients were receiving multiple concomitant perioperative and postoperative medications. 











































Table 7. Frequency of Adverse Events From Controlled Studies With Ondansetron Hydrochloride Tablets (Postoperative Nausea and Vomiting)
Adverse EventOndansetron 16 mg

(n = 550)
Placebo

(n = 531)
   Wound problem
152 (28%)
162 (31%)
   Drowsiness/sedation
112 (20%)
122 (23%)
   Headache
49 (9%)
27 (5%)
   Hypoxia
49 (9%)
35 (7%)
   Pyrexia
45 (8%)
34 (6%)
   Dizziness
36 (7%)
34 (6%)
   Gynecological disorder
36 (7%)
33 (6%)
   Anxiety/agitation
33 (6%)
29 (5%)
   Bradycardia
32 (6%)
30 (6%)
   Shiver(s)
28 (5%)
30 (6%)
   Urinary retention
28 (5%)
18 (3%)
   Hypotension
27 (5%)
32 (6%)
   Pruritus
27 (5%)
20 (4%)


Preliminary observations in a small number of subjects suggest a higher incidence of headache when ondansetron orally disintegrating tablets are taken with water, when compared to without water.


Observed During Clinical Practice

 

In addition to adverse events reported from clinical trials, the following events have been identified during post-approval use of oral formulations of ondansetron. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to ondansetron hydrochloride.


Cardiovascular:  Rarely and predominantly with intravenous ondansetron, transient ECG changes including QT interval prolongation have been reported.


General:  Flushing. Rare cases of hypersensitivity reactions, sometimes severe (e.g., anaphylaxis/anaphylactoid reactions, angioedema, bronchospasm, shortness of breath, hypotension, laryngeal edema, stridor) have also been reported. Laryngospasm, shock, and cardiopulmonary arrest have occurred during allergic reactions in patients receiving injectable ondansetron.


Hepatobiliary:  Liver enzyme abnormalities


Lower Respiratory:  Hiccups


Neurology:  Oculogyric crisis, appearing alone, as well as with other dystonic reactions


Skin: Urticaria


Special Senses: Eye Disorders: Cases of transient blindness, predominantly during intravenous administration, have been reported. These cases of transient blindness were reported to resolve within a few minutes up to 48 hours.

Drug Abuse and Dependence




Animal studies have shown that ondansetron is not discriminated as a benzodiazepine nor does it substitute for benzodiazepines in direct addiction studies.

Overdosage




There is no specific antidote for ondansetron overdose. Patients should be managed with appropriate supportive therapy. Individual intravenous doses as large as 150 mg and total daily intravenous doses as large as 252 mg have been inadvertently administered without significant adverse events. These doses are more than 10 times the recommended daily dose.

 

In addition to the adverse events listed above, the following events have been described in the setting of ondansetron overdose: “Sudden blindness” (amaurosis) of 2 to 3 minutes’ duration plus severe constipation occurred in 1 patient that was administered 72 mg of ondansetron intravenously as a single dose. Hypotension (and faintness) occurred in a patient that took 48 mg of ondansetron hydrochloride tablets. Following infusion of 32 mg over only a 4-minute period, a vasovagal episode with transient second-degree heart block was observed. In all instances, the events resolved completely.

Ondansetron Oral Solution Dosage and Administration




Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy

 

The recommended adult oral dosage of ondansetron is 24 mg given as three 8 mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.


Pediatric Use

 

There is no experience with the use of a 24 mg dosage in pediatric patients.


Geriatric Use

 

The dosage recommendation is the same as for the general population.


Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy

 

The recommended adult oral dosage is 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of Ondansetron Oral Solution given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours

after the first dose. 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of Ondansetron Oral Solution should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.


Pediatric Use


For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is 5 mL (1 teaspoonful equivalent to 4 mg of ondansetron) of Ondansetron Oral Solution given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. 5 mL (1 teaspoonful equivalent to 4 mg of ondansetron) of Ondansetron Oral Solution should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

 

Geriatric Use

 

The dosage is the same as for the general population.


Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen

 

The recommended oral dosage is 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of Ondansetron Oral Solution given 3 times a day.


For total body irradiation, 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of Ondansetron Oral Solution should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.


For single high-dose fraction radiotherapy to the abdomen, 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of Ondansetron Oral Solution should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.


For daily fractionated radiotherapy to the abdomen, 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of Ondansetron Oral Solution should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.


Pediatric Use

 

There is no experience with the use of Ondansetron Oral Solution in the prevention of radiation-induced nausea and vomiting in pediatric patients.


Geriatric Use

 

The dosage recommendation is the same as for the general population.


Postoperative Nausea and Vomiting

 

The recommended dosage is 20 mL (4 teaspoonfuls equivalent to 16 mg of ondansetron) of Ondansetron Oral Solution 1 hour before induction of anesthesia.


Pediatric Use

 

There is no experience with the use of Ondansetron Oral Solution in the prevention of postoperative nausea and vomiting in pediatric patients.


Geriatric Use

 

The dosage is the same as for the general population.


Dosage Adjustment for Patients With Impaired Renal Function

 

The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.


Dosage Adjustment for Patients With Impaired Hepatic Function

 

In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

How is Ondansetron Oral Solution Supplied




Ondansetron Oral Solution USP, a clear, colorless to light yellow Strawberry flavored liquid in 60 mL amber colored round Glass bottle with Child-resistant closure having expanded polyethylene wad (NDC 16714-671-01).


Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light. Store bottles upright in cartons.

REFERENCES


  1. Britto MR, Hussey EK, Mydlow P, et al. Effect of enzyme inducers on ondansetron (OND) metabolism in humans. Clin Pharmacol Ther. 1997;61:228.

  2. Pugh RNH, Murray-Lyon IM, Dawson JL, Pietroni MC, Williams R. Transection of the oesophagus for bleeding oesophageal varices. Brit J Surg. 1973;60:646-649.

  3. Villikka K, Kivisto KT, Neuvonen PJ. The effect of rifampin on the pharmacokinetics of oral and intravenous ondansetron. Clin Pharmacol Ther. 1999;65:377-381.

  4. De Witte JL, Schoenmaekers B, Sessler DI, et al. Anesth Analg. 2001;92:1319-1321.

  5. Arcioni R, della Roc