Trihibit

Generic Name: diphtheria, haemophilus influenzae, pertussis, and tetanus vaccine (dif THEER ee a, hem OFF il us in floo ENZ uh per TUS is , and TET a nus)

Brand Names: Trihibit

What is Trihibit (diphtheria, haemophilus influenzae, pertussis, and tetanus vaccine)?

Diphtheria, haemophilus influenzae, pertussis, and tetanus are serious diseases caused by bacteria.

Diphtheria causes a thick coating in the nose, throat, and airway. It can lead to breathing problems, paralysis, heart failure, or death.

Haemophilus influenzae can cause minor flu symptoms or it can cause more serious symptoms such as swelling around the throat, making it hard to swallow or breathe. Haemophilus influenzae can also cause swelling of the membranes around the brain and spinal cord (meningitis).

Pertussis (whooping cough) causes coughing so severe that it interferes with eating, drinking, or breathing. These spells can last for weeks and can lead to pneumonia, seizures (convulsions), brain damage, and death.

Tetanus (lockjaw) causes painful tightening of the muscles, usually all over the body. It can lead to "locking" of the jaw so the victim cannot open the mouth or swallow. Tetanus leads to death in about 1 out of 10 cases.

Diphtheria, haemophilus influenzae, and pertussis are spread from person to person. Tetanus enters the body through a cut or wound.

The diphtheria, haemophilus influenzae, pertussis, and tetanus vaccine is used to help prevent these diseases in people who are ages 2 months to 5 years old.

This vaccine works by exposing your child to a small dose of the bacteria or a protein from the bacteria, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.

Like any vaccine, the diphtheria, haemophilus influenzae, pertussis, and tetanus vaccine may not provide protection from disease in every person.

What is the most important information I should know about this vaccine?

The diphtheria, haemophilus influenzae, pertussis, and tetanus vaccine is given in a series of shots. The first shot is usually given when the child is 2 months old. The booster shots are then given at 4 months, 6 months, and 12 to 15 months of age. Your child's individual booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by the health department of the state you live in.

Be sure your child receives all recommended doses of this vaccine. If your child does not receive the full series of vaccines, he or she may not be fully protected against the disease.

Your child can still receive a vaccine if he or she has a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until the child gets better before receiving this vaccine.

Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with diphtheria, haemophilus influenzae, pertussis, or tetanus is much more dangerous to your child's health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

What should I discuss with my healthcare provider before receiving this vaccine?

Your child should not receive this vaccine if he or she has ever had a life-threatening allergic reaction to any vaccine containing diphtheria, haemophilus, pertussis, or tetanus. Your child should not receive this vaccine if the child has:

• 
  

  severe or uncontrolled epilepsy or other seizure disorder; or

  
  


• 
  

  if the child has received cancer chemotherapy or radiation treatment in the past 3 months.

  
  

Your child may not be able to receive this vaccine if he or she has ever received a similar vaccine that caused any of the following:

• 
  

  a very high fever (over 104 degrees);

  
  


• 
  

  a neurologic disorder or disease affecting the brain;

  
  


• 
  

  excessive crying for 3 hours or longer;

  
  


• 
  

  fainting or going into shock;

  
  


• 
  

  seizure (convulsions); or

  
  


• 
  

  Guillain-Barré syndrome (within 6 weeks after receiving a vaccine containing tetanus).

  
  

Before receiving this vaccine, tell the doctor if your child has:

• 
  

  a bleeding or blood clotting disorder such as hemophilia or easy bruising;

  
  


• 
  

  a history of seizures;

  
  


• 
  

  a neurologic disorder or disease affecting the brain (or if this was a reaction to a previous vaccine);

  
  


• 
  

  an allergy to latex rubber;

  
  


• 
  

  a weak immune system caused by disease, bone marrow transplant, or by using certain medicines or receiving cancer treatments; or

  
  


• 
  

  if the child is taking a blood thinner such as warfarin (Coumadin).

  
  

Your child can still receive a vaccine if he or she has a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until the child gets better before receiving this vaccine.

How is this vaccine given?

This vaccine is given as an injection into a muscle. Your child will receive this injection in a doctor's office or other clinic setting.

The diphtheria, haemophilus influenzae, pertussis, and tetanus vaccine is given in a series of shots. The first shot is usually given when the child is 2 months old. The booster shots are then given at 4 months, 6 months, and 12 to 15 months of age. Your child's individual booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by the health department of the state you live in.

Your doctor may recommend treating fever and pain with an aspirin-free pain reliever such as acetaminophen (Tylenol) or ibuprofen (Motrin, Advil, and others) when the shot is given and for the next 24 hours. Follow the label directions or your doctor's instructions about how much of this medicine to give your child.

It is especially important to prevent fever from occurring in a child who has a seizure disorder such as epilepsy.

What happens if I miss a dose?

Contact your doctor if you will miss a booster dose or if you get behind schedule. The next dose should be given as soon as possible. There is no need to start over.

Be sure your child receives all recommended doses of this vaccine. If your child does not receive the full series of vaccines, he or she may not be fully protected against the disease.

What happens if I overdose?

An overdose of this vaccine is unlikely to occur.

What should I avoid before or after receiving this vaccine?

Follow your doctor's instructions about any restrictions on food, beverages, or activity after receiving the vaccine.

This vaccine side effects

Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot. Keep track of any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with diphtheria, haemophilus influenzae, pertussis, or tetanus is much more dangerous to your child's health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if the child has any of these serious side effects:

• 
  

  extreme drowsiness, fainting;

  
  


• 
  

  fussiness, irritability, crying for an hour or longer;

  
  


• 
  

  seizure (black-out or convulsions); or

  
  


• 
  

  high fever.

  
  

Less serious side effects may include:

• 
  

  redness, pain, tenderness, or swelling where the shot was given;

  
  


• 
  

  low fever;

  
  


• 
  

  mild fussiness or crying;

  
  


• 
  

  headache or tiredness;

  
  


• 
  

  joint pain, body aches;

  
  


• 
  

  loss of appetite; or

  
  


• 
  

  mild nausea, diarrhea, or vomiting.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Trihibit (diphtheria, haemophilus influenzae, pertussis, and tetanus vaccine)?

Before receiving this vaccine, tell the doctor about all other vaccines your child has recently received.

Also tell the doctor if your child has received drugs or treatments in the past 2 weeks that can weaken the immune system, including:

• 
  

  an oral, nasal, inhaled, or injectable steroid medicine;

  
  


• 
  

  medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, such as azathioprine (Imuran), efalizumab (Raptiva), etanercept (Enbrel), leflunomide (Arava), and others; or

  
  


• 
  

  medicines to treat or prevent organ transplant rejection, such as basiliximab (Simulect), cyclosporine (Sandimmune, Neoral, Gengraf), muromonab-CD3 (Orthoclone), mycophenolate mofetil (CellCept), sirolimus (Rapamune), or tacrolimus (Prograf).

  
  

If your child is using any of these drugs, he or she may not be able to receive the vaccine.

This list is not complete and there may be other drugs that can affect this vaccine. Tell your doctor about all the prescription and over-the-counter medications your child has received. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your child's doctor.

More Trihibit resources

• Trihibit Drug Interactions
• Trihibit Support Group
• 0 Reviews for Trihibit - Add your own review/rating

Compare Trihibit with other medications

• Diphtheria Prophylaxis
• Haemophilus influenzae Prophylaxis
• Pertussis Prophylaxis
• Tetanus

Where can I get more information?

• Your doctor or pharmacist may have information about this vaccine written for health professionals that you may read. You may also find additional information from your local health department or the Centers for Disease Control and Prevention.

Nexterone Solution

Pronunciation: A-mi-OH-da-rone
Generic Name: Amiodarone
Brand Name: Generic only. No brands available.

Nexterone Solution is used for:

Treating and preventing certain kinds of life-threatening heart rhythm problems in patients who cannot take the oral form of Nexterone Solution or who do not respond to other medicines. It may also be used for other conditions as determined by your doctor.

Nexterone Solution is an antiarrhythmic. It works by stabilizing the heart rhythm in conditions in which the heart is beating too fast or in an irregular rhythm. It is usually used in situations in which the abnormal heart rhythms, if not treated, could cause death.

Do NOT use Nexterone Solution if:

• you are allergic to any ingredient in Nexterone Solution, including iodine


• you have moderate to severe heart block (unless you have a pacemaker), very slow heartbeat, or shock due to serious heart problems


• you are taking cisapride, dofetilide, certain H₁ antagonists (eg, astemizole, terfenadine), nilotinib, certain phenothiazines (eg, thioridazine), a phosphodiesterase inhibitor (eg, vardenafil), ranolazine, St. John's wort, a streptogramin (eg, quinupristin, dalfopristin), tetrabenazine, or ziprasidone

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

Before using Nexterone Solution:

Some medical conditions may interact with Nexterone Solution. 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 abnormal liver function tests or a history of liver problems, lung or breathing problems, other heart problems, low blood pressure, thyroid problems, electrolyte problems (eg, low blood potassium or magnesium), eye or vision problems, a slow heartbeat, or heart block


• if you have recently had severe or persistent diarrhea


• if you will be having surgery, or if you have an implanted pacemaker or defibrillator

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

• Cisapride, dofetilide, certain H₁ antagonists (eg, astemizole, terfenadine), nilotinib , certain phenothiazines (eg, thioridazine), phosphodiesterase inhibitors (eg, vardenafil), ranolazine, St. John's wort, a streptogramin (eg, dalfopristin, quinupristin), tetrabenazine, or ziprasidone because the risk of worsening irregular heartbeat may be increased


• Many prescription and nonprescription medicines (eg, used for allergies, bacterial and fungal infections, blood thinning, cancer, cough, enlarged prostate, heartburn or reflux disease, heart problems, high blood pressure, high cholesterol, HIV infection, immune system suppression, inflammation, irregular heartbeat, local anesthesia, mental or mood problems, nausea and vomiting, pain, seizures), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo, St. John's wort) may interact with Nexterone Solution, increasing the risk of serious side effects. Check with your doctor to see if Nexterone Solution may interact with any other medicine that you are taking

This may not be a complete list of all interactions that may occur. Ask your health care provider if Nexterone Solution 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 Nexterone Solution:

Use Nexterone Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Nexterone Solution will be given by a qualified health care provider who is experienced in treating life-threatening irregular heartbeats. Nexterone Solution is usually given as an injection at your doctor's office, hospital, or clinic.


• Do not use Nexterone Solution if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.


• Do not eat grapefruit or drink grapefruit juice while you use Nexterone Solution.


• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.


• If you miss a dose of Nexterone Solution, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Nexterone Solution.

Important safety information:

• Nexterone Solution may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Nexterone Solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Nexterone Solution may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Nexterone Solution stays in your body for weeks or months even after you stop taking it. Use caution during treatment with Nexterone Solution and for several months after you stop taking it if you are taking any medicines that may interact with it.


• Limit alcoholic beverages while taking Nexterone Solution.


• Tell your doctor or dentist that you take Nexterone Solution before you receive any medical or dental care, emergency care, or surgery, including laser surgery on the eye.


• Tell your doctor if you have severe or persistent diarrhea while you are taking Nexterone Solution. You will need to take care not to become dehydrated.


• Worsening of irregular heartbeat, life-threatening lung disease, and serious liver problems may occur with Nexterone Solution. Therefore, it should only be given to patients with life-threatening heartbeats who cannot tolerate other medicines.


• Your doctor may want you to check your pulse rate every day while you take Nexterone Solution. Learn how to monitor your pulse.


• Carry an ID card at all times that says you take Nexterone Solution.


• Lab tests, including electrocardiogram (ECG), chest x-rays, lung, liver, thyroid, and eye exams, may be performed while you use Nexterone Solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Nexterone Solution with caution in the ELDERLY; they may be more sensitive to its effects, especially slow heartbeat.


• Nexterone Solution should not be used in CHILDREN; safety and effectiveness in children have not been confirmed. Nexterone Solution has benzyl alcohol in it. Do not use it in NEWBORNS and INFANTS. It may cause serious and sometimes fatal nervous system problems and other side effects.


• DEHP, a chemical found in plastic IV tubing, may cause harm in young CHILDREN (male reproductive system effects). Nexterone Solution can cause DEHP to leach out of the tubing. If Nexterone Solution is used in a child, discuss any questions or concerns with your doctor.


• PREGNANCY and BREAST-FEEDING: Nexterone Solution has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Nexterone Solution while you are pregnant. Nexterone Solution is found in breast milk. Do not breast-feed while taking Nexterone Solution.

Possible side effects of Nexterone Solution:

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:

Nausea.

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; unusual hoarseness); chest pain; confusion; coughing up blood; dark urine; decreased urination; fainting; feeling of being unusually cold; fever, chills, or persistent sore throat; joint pain; mental or mood changes; muscle pain, tenderness, or weakness (especially with fever or unusual tiredness); numbness of an arm or leg; red, swollen, blistered, or peeling skin; severe dizziness; severe stomach pain; shortness of breath; slow heartbeat; sudden, unexplained weight change; swelling of the hands or feet; symptoms of thyroid problems (eg, feeling of being unusually hot or cold, increased sweating, mental or mood changes, unusual weight changes, numbness or tingling of the hands or feet, menstrual changes); unusual bruising or bleeding; unusual cough; vision changes (eg, seeing halos, blurred vision, loss of vision); wheezing; worsening of irregular heartbeat; yellowing of the skin or eyes.

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: Nexterone 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. Symptoms may include fainting; light-headedness, especially when standing; severe dizziness; slow or irregular heartbeat; weakness; yellowing of the skin or eyes.

Proper storage of Nexterone Solution:

Nexterone Solution is usually handled and stored by a health care provider. If you are using Nexterone Solution at home, store Nexterone Solution as directed by your pharmacist or health care provider. Keep Nexterone Solution out of the reach of children and away from pets.

General information:

• If you have any questions about Nexterone Solution, please talk with your doctor, pharmacist, or other health care provider.


• Nexterone Solution 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 Nexterone Solution. 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 Nexterone resources

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

Compare Nexterone with other medications

• Arrhythmia
• Supraventricular Tachycardia
• Ventricular Fibrillation
• Ventricular Tachycardia

Kenalog Spray

Generic Name: triamcinolone acetonide

Dosage Form: topical aerosol spray
KENALOG® SPRAY

Triamcinolone Acetonide Topical Aerosol, USP

(0.147 mg/g)

Rx only

For dermatologic use only

Not for ophthalmic use

Kenalog Spray Description

The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone acetonide is designated chemically as 9-fluoro-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with acetone. The structural formula is:

C24H31FO6, MW 434.50

A two-second application, which covers an area approximately the size of the hand, delivers an amount of triamcinolone acetonide not exceeding 0.2 mg. After spraying, the nonvolatile vehicle remaining on the skin contains approximately 0.2% triamcinolone acetonide. Each gram of spray provides 0.147 mg triamcinolone acetonide in a vehicle of isopropyl palmitate, dehydrated alcohol (10.3%), and isobutane propellant.

Kenalog Spray - Clinical Pharmacology

Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions.

The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.

Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption.

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

Indications and Usage for Kenalog Spray

Kenalog Spray (Triamcinolone Acetonide Topical Aerosol, USP) is indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Contraindications

Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

Precautions

General

Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.

Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings.

Therefore, patients receiving a large dose of any potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests, and for impairment of thermal homeostasis. If HPA axis suppression or elevation of the body temperature occurs, an attempt should be made to withdraw the drug, to reduce the frequency of application, substitute a less potent steroid, or use a sequential approach.

Recovery of HPA axis function and thermal homeostasis are generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see PRECAUTIONS, Pediatric Use).

If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.

In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

Information for the Patient

Patients using Kenalog Spray should receive the following information and instructions:

1. This medication is to be used as directed by the physician. It is for external use only; avoid contact with the eyes and inhalation of the spray.


2. Patients should be advised not to use this medication for any disorder other than for which it was prescribed.


3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.


4. Patients should report any signs of local adverse reactions.


5. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.


6. Do not use Kenalog Spray on the underarms or groin areas unless directed by your physician.


7. If no improvement is seen within 2 weeks, contact your physician.


8. Do not use other corticosteroid-containing products while using Kenalog Spray without first consulting your physician.


9. Kenalog Spray is flammable. Avoid heat, flames or smoking when applying Kenalog Spray.

Laboratory Tests

A urinary free cortisol test and ACTH stimulation test may be helpful in evaluating HPA axis suppression.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.

Studies to determine mutagenicity with prednisolone and hydrocortisone showed negative results.

Pregnancy: Teratogenic Effects

Category C. Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

Nursing Mothers

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

Pediatric Use

Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface area to body weight ratio.

HPA axis suppression, Cushing’s syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.

Adverse Reactions

The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings (reactions are listed in an approximate decreasing order of occurrence): burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.

Overdosage

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS, General).

Kenalog Spray Dosage and Administration

Directions for use of the spray can are provided on the label. The preparation may be applied to any area of the body, but when it is sprayed about the face, care should be taken to see that the eyes are covered, and that inhalation of the spray is avoided.

Spray is flammable; avoid heat, flame or smoking when using this product.

Three or four applications daily of Kenalog Spray (Triamcinolone Acetonide Topical Aerosol) are generally adequate.

How is Kenalog Spray Supplied

Kenalog Spray (Triamcinolone Acetonide Topical Aerosol, USP)

63 g (NDC 10631-093-62) aerosol can.

100 g (NDC 10631-093-07) aerosol can.

Storage and Handling

Store at room temperature; avoid excessive heat. Contents under pressure; do not puncture or incinerate. Keep out of reach of children.

To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

RANBAXY

Jacksonville, FL 32257 USA

Revised August 2011

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

100 g Carton

KENALOG  triamcinolone acetonide  aerosol, spray

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 10631-093 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE) TRIAMCINOLONE ACETONIDE 0.147 mg  in 1 g

Inactive Ingredients Ingredient Name Strength ISOPROPYL PALMITATE   ISOBUTANE   ALCOHOL

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 10631-093-62 63 g In 1 CAN None 2 10631-093-07 100 g In 1 CAN None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA012104	05/19/2009

Labeler - Ranbaxy Laboratories Inc. (169932519)

Registrant - Ranbaxy Laboratories Inc. (169932519)

Establishment
Name	Address	ID/FEI	Operations
Contract Pharmaceuticals Limited		248761249	manufacture

Revised: 08/2011Ranbaxy Laboratories Inc.

More Kenalog Spray resources

• Kenalog Spray Use in Pregnancy & Breastfeeding
• Kenalog Spray Drug Interactions
• Kenalog Spray Support Group
• 22 Reviews for Kenalog - Add your own review/rating

Compare Kenalog Spray with other medications

• Aphthous Ulcer
• Atopic Dermatitis
• Dermatitis
• Lichen Planus
• Psoriasis

Humulin 70/30 Pen

Generic Name: insulin isophane and insulin regular (IN su lin EYE soe fane and IN su lin REG ue lar)

Brand Names: HumuLIN 50/50, HumuLIN 70/30, HumuLIN 70/30 Pen, NovoLIN 70/30, NovoLIN 70/30 Innolet, NovoLIN 70/30 PenFill, Relion NovoLIN 70/30 Innolet, ReliOn/NovoLIN 70/30

What is Humulin 70/30 Pen (insulin isophane and insulin regular)?

Insulin isophane and insulin regular is a man-made form of a hormone that is produced in the body. It works by lowering levels of glucose (sugar) in the blood. Insulin isophane and insulin regular is a long-acting form of insulin that is slightly different from other forms of insulin that are not man-made.

Insulin isophane and insulin regular is used to treat diabetes.

Insulin isophane and insulin regular may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Humulin 70/30 Pen (insulin isophane and insulin regular)?

Take care to keep your blood sugar from getting too low, causing hypoglycemia. Symptoms of low blood sugar may include headache, nausea, hunger, confusion, drowsiness, weakness, dizziness, blurred vision, fast heartbeat, sweating, tremor, or trouble concentrating. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar. Also be sure your family and close friends know how to help you in an emergency.

Also watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, loss of appetite, increased urination, nausea, vomiting, drowsiness, dry skin, and dry mouth. Check your blood sugar levels and ask your doctor how to adjust your insulin doses if needed.

Never share an injection pen or cartridge with another person. Sharing injection pens or cartridges can allow disease such as hepatitis or HIV to pass from one person to another.

Insulin isophane and insulin regular is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

What should I discuss with my healthcare provider before using Humulin 70/30 Pen (insulin isophane and insulin regular)?

Do not use this medication if you are allergic to insulin, or if you are having an episode of hypoglycemia (low blood sugar).

Before using insulin isophane and insulin regular, tell your doctor if you have liver or kidney disease.

Tell your doctor about all other medications you use, including any oral (by mouth) diabetes medications.

Insulin isophane and insulin regular is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether insulin isophane and insulin regular passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use Humulin 70/30 Pen (insulin isophane and insulin regular)?

Use this medication exactly as it was prescribed for you. Do not use it in larger amounts or for longer than recommended by your doctor. Follow the directions on your prescription label.

Insulin isophane and insulin regular is given as an injection (shot) under your skin. Your doctor, nurse, or pharmacist will give you specific instructions on how and where to inject this medicine. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Choose a different place in your injection skin area each time you use this medication. Do not inject into the same place two times in a row.

Carefully shake or rotate the insulin vial (bottle) several times to thoroughly mix the insulin isophane and insulin regular before each use. Shake the mixture until it looks cloudy or milky. Do not use the mixture if has clumps or white particles in it after mixing, or if the white substance remains at the bottom of the vial. Call your doctor for a new prescription.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Some insulin needles can be used more than once, depending on needle brand and type. But a reused needle must be properly cleaned, recapped, and inspected for bending or breakage. Reusing needles also increases your risk of infection. Ask your doctor or pharmacist whether you are able to reuse your insulin needles.

Never share an injection pen or cartridge with another person. Sharing injection pens or cartridges can allow disease such as hepatitis or HIV to pass from one person to another.

Check your blood sugar carefully during a time of stress or illness, if you travel, exercise more than usual, or skip meals. These things can affect your glucose levels and your insulin dose needs may also change.

Watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, loss of appetite, increased urination, nausea, vomiting, drowsiness, dry skin, and dry mouth. Check your blood sugar levels and ask your doctor how to adjust your insulin doses if needed.

Ask your doctor how to adjust your insulin isophane and insulin regular dose if needed. Do not change your dose without first talking to your doctor. Carry an ID card or wear a medical alert bracelet stating that you have diabetes, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are diabetic. Storing unopened vials or injection pens: Keep in the carton and store in a refrigerator. Do not freeze. Throw away any insulin not used before the expiration date on the medicine label. Storing after your first use: Keep the "in-use" vials or injection pens at cool room temperature, away from heat and light, and use prior to the expiration date. Throw an in-use injection pen 10 days after the first use, even if there is still medicine left in it.

Do not freeze insulin isophane and insulin regular, and throw away the medication if it has become frozen.

What happens if I miss a dose?

Since insulin isophane and insulin regular is used before meals or snacks, you may not be on a timed dosing schedule. Whenever you use insulin isophane and insulin regular, be sure to eat a meal or snack within 30 to 60 minutes. Do not use extra insulin isophane and insulin regular to make up a missed dose.

It is important to keep insulin isophane and insulin regular on hand at all times. Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An insulin overdose can cause life-threatening hypoglycemia.

Symptoms of severe hypoglycemia include extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, seizure (convulsions), or coma.

What should I avoid while using Humulin 70/30 Pen (insulin isophane and insulin regular)?

Do not change the brand of insulin isophane and insulin regular or syringe you are using without first talking to your doctor or pharmacist. Avoid drinking alcohol. Your blood sugar may become dangerously low if you drink alcohol while using insulin isophane and insulin regular.

Humulin 70/30 Pen (insulin isophane and insulin regular) side effects

Get emergency medical help if you have any of these signs of insulin allergy: itching skin rash over the entire body, wheezing, trouble breathing, fast heart rate, sweating, or feeling like you might pass out.

Hypoglycemia, or low blood sugar, is the most common side effect of insulin isophane and insulin regular. Symptoms of low blood sugar may include headache, nausea, hunger, confusion, drowsiness, weakness, dizziness, blurred vision, fast heartbeat, sweating, tremor, trouble concentrating, confusion, or seizure (convulsions). Watch for signs of low blood sugar. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar.

Tell your doctor if you have itching, swelling, redness, or thickening of the skin where you inject insulin isophane and insulin regular.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Humulin 70/30 Pen (insulin isophane and insulin regular)?

Using certain medicines can make it harder for you to tell when you have low blood sugar. Tell your doctor if you use any of the following:

• 
  

  albuterol (Proventil, Ventolin);

  
  


• 
  

  clonidine (Catapres);

  
  


• 
  

  reserpine;

  
  


• 
  

  guanethidine (Ismelin); or

  
  


• 
  

  beta-blockers such as atenolol (Tenormin), bisoprolol (Zebeta), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), timolol (Blocadren), and others.

  
  

There are many other medicines that can increase or decrease the effects of insulin isophane and insulin regular on lowering your blood sugar. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

More Humulin 70/30 Pen resources

• Humulin 70/30 Pen Side Effects (in more detail)
• Humulin 70/30 Pen Use in Pregnancy & Breastfeeding
• Humulin 70/30 Pen Drug Interactions
• Humulin 70/30 Pen Support Group
• 0 Reviews for Humulin 70/30 Pen - Add your own review/rating

• Humulin 50/50 Pens MedFacts Consumer Leaflet (Wolters Kluwer)


• Humulin 50/50 Prescribing Information (FDA)


• Humulin 70/30 Prescribing Information (FDA)


• Novolin 70/30 Prescribing Information (FDA)


• Novolin 70/30 InnoLets MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Humulin 70/30 Pen with other medications

• Diabetes, Type 1
• Diabetes, Type 2
• Gestational Diabetes

Where can I get more information?

• Your pharmacist can provide more information about insulin isophane and insulin regular.

See also: Humulin 70/30 Pen side effects (in more detail)

Twynsta

Generic Name: telmisartan and amlodipine (Oral route)

tel-mi-SAR-tan, am-LOE-di-peen BES-i-late

Oral route(Tablet)

When pregnancy is detected, discontinue telmisartan/amlodipine besylate as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus .

Commonly used brand name(s)

In the U.S.

• Twynsta

Available Dosage Forms:

• Tablet

Therapeutic Class: Antihypertensive

Pharmacologic Class: Angiotensin II Receptor Antagonist

Chemical Class: Amlodipine

Uses For Twynsta

Telmisartan and amlodipine is a combination of medicines that may be used alone or with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

Telmisartan is an angiotensin II receptor blocker. It works by blocking a substance in the body that causes blood vessels to tighten. As a result, telmisartan relaxes blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart.

Amlodipine is a calcium channel blocker. It affects the movement of calcium into the cells of the heart and blood vessels. As a result, amlodipine relaxes blood vessels and increases the supply of blood and oxygen to the heart while reducing its workload.

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

Before Using Twynsta

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 telmisartan and amlodipine combination 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 telmisartan and amlodipine combination in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require starting at a lower dose in these patients.

Pregnancy

	Pregnancy Category	Explanation
1st Trimester	C	Animal 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.
2nd Trimester	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.
3rd Trimester	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

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 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.

• Amiodarone


• Atazanavir


• Benazepril


• Conivaptan


• Dantrolene


• Droperidol


• Enalapril


• Enalaprilat


• Lisinopril


• Moexipril


• Perindopril


• Quinapril


• Ramipril


• Simvastatin


• Telaprevir


• Trandolapril

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.

• Acebutolol


• Alprenolol


• Atenolol


• Betaxolol


• Bevantolol


• Bisoprolol


• Bromfenac


• Bucindolol


• Carteolol


• Carvedilol


• Celecoxib


• Celiprolol


• Clopidogrel


• Dalfopristin


• Diclofenac


• Diflunisal


• Digoxin


• Dilevalol


• Diltiazem


• Esmolol


• Etodolac


• Fenoprofen


• Fluconazole


• Flurbiprofen


• Ibuprofen


• Imatinib


• Indinavir


• Indomethacin


• Itraconazole


• Ketoconazole


• Ketoprofen


• Ketorolac


• Labetalol


• Levobunolol


• Lithium


• Magnesium Salicylate


• Meclofenamate


• Mefenamic Acid


• Meloxicam


• Mepindolol


• Metipranolol


• Metoprolol


• Nabumetone


• Nadolol


• Naproxen


• Nebivolol


• Nepafenac


• Oxaprozin


• Oxprenolol


• Penbutolol


• Pindolol


• Piroxicam


• Propranolol


• Quinupristin


• Rifapentine


• Ritonavir


• Salsalate


• Sotalol


• St John's Wort


• Sulindac


• Talinolol


• Tertatolol


• Timolol


• Tolmetin

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:

• Kidney Problems or


• Congestive heart failure—Use with caution. May make these conditions worse.

• Electrolyte imbalances (e.g., low levels of salt or sodium in the body) or


• Fluid imbalances (caused by dehydration, vomiting, or diarrhea) or


• Heart problems (e.g., aortic stenosis)—Use with caution. The blood pressure-lowering effects of this medicine may be increased.

• Heart or blood vessel disease (e.g., severe obstructive coronary artery disease)—Use with caution. May increase the risk of experiencing chest pain or heart attacks.

• Liver disease (including biliary obstructive disorders)—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of Twynsta

This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

In addition to the use of this medicine, treatment for your high blood pressure may include weight control and a change in the types of foods you eat, especially foods high in sodium (salt). Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that this medicine will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

You may take this medicine with or without food.

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 oral dosage form (tablets):
  
  • For high blood pressure:
    
    • Adults—At first, one tablet containing 40 milligrams (mg) or 80 mg of telmisartan and 5 mg of amlodipine once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 80 mg of telmisartan and 10 mg of amlodipine once a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

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.

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 Twynsta

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you think you have become pregnant while using this medicine, tell your doctor right away.

Dizziness, lightheadedness, or fainting may occur after the first dose of this medicine, especially if you have been taking a diuretic (water pill). Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert.

Check with your doctor right away if you experience dizziness, fainting, confusion, muscle pain, weakness, and/or a fast heartbeat. Use extra care if you exercise or if the weather is hot. Heavy sweating can cause dehydration (loss of too much water) or electrolyte imbalances (loss of sodium or potassium in the body).

Check with your doctor right away if you become sick while taking this medicine, especially with severe or continuing nausea, vomiting, or diarrhea. These conditions may cause you to lose too much water or salt which may cause low blood pressure.

Hyperkalemia (high potassium in the blood) may occur in certain people receiving this medicine. Check with your doctor right away if you have the following symptoms: abdominal or stomach pain; confusion; difficulty with breathing; irregular heartbeat; nausea or vomiting; nervousness; numbness or tingling in the hands, feet, or lips; shortness of breath; or weakness or heaviness of the legs.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Twynsta 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:

More common

• Bloating or swelling of the face, arms, hands, lower legs, or feet


• body aches or pain


• chills


• cough


• difficulty with breathing


• ear congestion


• fever


• headache


• loss of voice


• nasal congestion


• rapid weight gain


• runny nose


• sneezing


• sore throat


• tingling of the hands or feet


• unusual tiredness or weakness


• unusual weight gain or loss

Less common

• Bladder pain


• bloody or cloudy urine


• blurred vision


• chest pain


• diarrhea


• difficult, burning, or painful urination


• dizziness


• frequent urge to urinate


• general feeling of discomfort or illness


• joint pain


• loss of appetite


• lower back or side pain


• muscle aches and pains


• nausea


• nervousness


• pounding in the ears


• shivering


• slow or fast heartbeat


• sweating


• trouble with sleeping


• vomiting

Rare

• Abdominal or stomach pain


• arm, back, or jaw pain


• black, tarry stools


• bleeding gums


• blistering, peeling, or loosening of the skin


• blood in the urine or stools


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• chest tightness or heaviness


• cold sweats


• confusion


• constipation


• cough or hoarseness


• dark urine


• difficult or labored breathing


• difficulty with swallowing


• dilated neck veins


• dry mouth


• extreme fatigue


• fast, irregular, pounding, or racing heartbeat or pulse


• feeling of warmth


• flushed, dry skin


• fruit-like breath odor


• hives


• increased hunger


• increased sweating


• increased thirst


• increased volume of pale, dilute urine


• indigestion


• irregular heartbeat


• irritation in the mouth


• joint or muscle pain


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• lightheadedness, dizziness, or fainting


• loss of consciousness


• muscle cramps or stiffness


• pale, bluish-colored, or cold hands or feet


• pinpoint red spots on the skin


• rash


• redness and swelling of the gums


• redness, soreness, or itching skin


• severe or sudden headache


• sudden loss of coordination


• sudden slurring of speech


• swollen glands


• tightness in the chest


• trembling or shaking of the hands or feet


• troubled breathing


• unexplained weight loss


• unsteadiness, trembling, or other problems with muscle control or coordination


• unusual bleeding or bruising


• vomiting of blood


• waking to urinate at night


• weakness in the arms, hands, legs, or feet


• weight gain


• yellow eyes or skin

Incidence not known

• Decreased urine output


• nervousness


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• weakness or heaviness of the legs

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:

Less common

• Acid or sour stomach


• belching


• difficulty with moving


• heartburn


• indigestion


• pain or tenderness around the eyes and cheekbones


• sleepiness or unusual drowsiness

Rare

• Abnormal dreams


• abnormal ejaculation


• ankle, knee, or great toe joint pain


• anxiety


• bad, unusual, or unpleasant (after) taste


• bleeding after defecation


• blistering, crusting, irritation, itching, or reddening of the skin


• bloody nose


• burning feeling in the chest or stomach


• burning, dry, or itching eyes


• changes in vision


• cold and clammy skin


• continuing ringing or buzzing or other unexplained noise in the ears


• cough producing mucus


• cracked, dry, or scaly skin


• decreased sexual performance or desire


• depression


• discharge or excessive tearing


• dry mouth


• dryness of the eyes


• dryness of the skin


• earache


• excess air or gas in the stomach or intestines


• feeling of constant movement of self or surroundings


• feeling of unreality


• feeling of warmth


• full feeling


• hair loss or thinning of the hair


• headache, severe and throbbing


• hearing loss


• hives or welts


• hyperventilation


• inability to have or keep an erection


• increased appetite


• irritability


• lack of feeling or emotion


• lack or loss of strength


• loose stools


• loss of memory


• pinpoint red or purple spots on the skin


• redness of the face, neck, arms, and occasionally, upper chest


• redness of the skin


• redness or swelling in the ear


• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid


• restlessness


• tenderness in the stomach area


• toothache


• unable to sleep


• uncomfortable swelling around the anus

Incidence not known

• Decreased interest in sexual intercourse


• swelling of the breasts or breast soreness in both females and males

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: Twynsta 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 Twynsta resources

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

• Twynsta Prescribing Information (FDA)


• Twynsta MedFacts Consumer Leaflet (Wolters Kluwer)


• Twynsta Consumer Overview

Compare Twynsta with other medications

• High Blood Pressure

Trusopt Ocumeter

Generic Name: dorzolamide (Ophthalmic route)

dor-ZOLE-a-mide

Commonly used brand name(s)

In the U.S.

• Trusopt Ocumeter


• Trusopt Ocumeter Plus

Available Dosage Forms:

• Solution

Therapeutic Class: Antiglaucoma

Pharmacologic Class: Carbonic Anhydrase Inhibitor

Uses For Trusopt Ocumeter

Dorzolamide ophthalmic (eye) drops is used to treat increased pressure in the eye caused by open-angle glaucoma or a condition called hypertension of the eye. Both eye conditions are caused by high pressure in your eye and can lead to pain from pressure in your eye and then can eventually harm your vision. This medicine can help you keep your sight by reducing the pressure in your eye and stopping eye pain.

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

Before Using Trusopt Ocumeter

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 dorzolamide eye drops in children.

Geriatric

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

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal 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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Acute angle-closure glaucoma—Use of dorzolamide eye drops in these patients have not been studied. This condition may need other medicine or treatment besides dorzolamide.

• Allergy to sulfa drugs—Use with caution. May increase risk for more serious side effects.

• Bacterial eye infection (e.g., keratitis) or


• Cornea (part of the eye) problems, history of or


• Eye surgery, recent—Use with caution. May make these conditions worse.

• Kidney disease, severe or


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

Proper Use of dorzolamide

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

Your eye doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.

If you normally wear soft contact lenses, remove them before you use dorzolamide eye drops. Wait at least for 15 minutes before putting the contact lenses back in.

To use the eye drops:

• Wash your hands with soap and water.


• Before using this medicine for the first time, make sure that the safety strip on the bottle is unbroken.


• Tear off the safety strip to break the seal and open the bottle by unscrewing the cap by turning as indicated by the arrows on the top of the cap. Do not pull the cap directly up and away from the bottle.


• Tilt your head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the eyelid away from the eye to make a space. Drop the medicine into this space.


• Invert the bottle, and press lightly the "finger push area" using your thumb or index finger.


• Let go of the eyelid and gently close the eye. Do not blink. Keep the eye closed for 1 or 2 minutes to allow the medicine to cover the eye.


• If you think you did not get the drop of medicine into your eye properly, replace the cap on the bottle and tighten. Then, remove by turning the cap in the opposite direction as indicated by the arrows on the top of the cap and repeat the process with another drop.


• Replace the cap by turning until it is firmly touching the bottle. Do not overtighten or you may damage the bottle and cap.


• Wash your hands after using the eye drops to remove any medicine.


• Never touch the applicator tip to any surface, including the eye, and keep the container tightly closed. This will keep the medicine as germ-free as possible.

If your doctor ordered two different eye drops to be used together, wait at least 10 minutes between the times you apply the medicines. This will help to keep the second medicine from “washing out” the first one.

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 ophthalmic dosage form (eye drops):
  
  • For glaucoma or hypertension of the eye:
    
    • Adults and teenagers—Use one drop in the affected eye three times a day.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  

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.

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 Trusopt Ocumeter

It is very important that your doctor check the progress of you or your child at regular visits. Your doctor may want to do certain tests to see if the medicine is working properly or to see if certain side effects may be occurring without you or your child knowing it.

If itching, redness, swelling, or other signs of eye or eyelid irritation occur, check with your doctor. These signs may mean that you or your child are allergic to dorzolamide eye drops.

This medicine may cause some people to have blurred vision for a short time. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you cannot see properly. Also, since blurred vision may be a sign of a side effect that needs medical attention, check with your doctor if it continues.

Ophthalmic dorzolamide may cause your eyes to become more sensitive to light than they are normally. Wearing sunglasses and avoiding too much exposure to bright light may help lessen the discomfort. If the discomfort continues, check with your doctor.

If you hurt your eye, develop an eye infection, or need to have eye surgery, talk with your doctor right away. You or your child may need to get a new bottle of the eye drops to help prevent an eye infection or keep an infection from getting worse.

Serious allergic reactions may occur while using this medicine. Stop using this medicine and check with your doctor right away if you or your child have any of the following symptoms: black, tarry stools; blistering, peeling, or loosening of the skin; chills; dark urine; joint or muscle pain; rash; red skin lesions, often with a purple center; sores, ulcers, or white spots in the mouth or on the lips; unusual bleeding or bruising; unusual tiredness or weakness; or yellow eyes or skin.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Trusopt Ocumeter 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:

More common

• Burning, stinging, or discomfort when medicine is applied


• itching, redness, swelling, or other sign of the eye or eyelid irritation

Less common

• Burning, dry, or itching eyes


• discharge from the eye


• excessive tearing


• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

Rare

• Blood in the urine


• blurred vision


• nausea or vomiting


• pain in the side, back, or abdomen


• skin rash


• tearing

Incidence not known

• Blistering, burning, crusting, dryness, or flaking of the skin


• change in vision


• chills


• cough


• diarrhea


• difficult or labored breathing


• flashes of light


• floaters in vision


• hives or welts


• itching skin


• joint or muscle pain


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• noisy breathing


• redness of the skin


• shortness of breath


• sore throat


• sores, ulcers, or white spots in the mouth or on the lips


• tightness in the chest


• unusual tiredness or weakness


• wheezing

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

Symptoms of overdose

• Confusion


• irregular heartbeat


• muscle cramps or pain


• numbness, tingling, pain, or weakness in the hands or feet


• seizures


• trembling


• weakness and heaviness of the legs

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

• Bitter taste


• feeling of something in the eye

Less common

• Changes in color vision


• difficulty seeing at night


• dryness of the eyes


• eyelid reactions


• headache


• increased sensitivity of the eyes to sunlight

Incidence not known

• Bloody nose


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• change in distance vision


• difficulty in focusing the eyes


• dizziness


• dry mouth


• eyelid crusting


• lack or loss of strength


• scaling of the skin


• severe redness, soreness, or swelling 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: Trusopt Ocumeter 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 Trusopt Ocumeter resources

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

Compare Trusopt Ocumeter with other medications

• Glaucoma, Open Angle
• Intraocular Hypertension