Friday, March 23, 2012

Prevalite


Generic Name: cholestyramine (Oral route)

koe-le-STYE-ra-meen

Commonly used brand name(s)

In the U.S.


  • Prevalite

  • Questran

  • Questran Light

In Canada


  • Novo-Cholamine

  • Novo-Cholamine Light

Available Dosage Forms:


  • Powder for Suspension

  • Tablet

Therapeutic Class: Antihyperlipidemic


Pharmacologic Class: Bile Acid Sequestrant


Uses For Prevalite


Cholestyramine is used to lower high cholesterol levels in the blood. This may help prevent medical problems caused by cholesterol clogging the blood vessels. Cholestyramine is also used to remove substances called bile acids from your body. With some liver problems, there is too much bile acid in your body and this can cause severe itching.


Cholestyramine works by attaching to certain substances in the intestine. Since cholestyramine is not absorbed into the body, these substances also pass out of the body without being absorbed.


Cholestyramine may also be used for other conditions as determined by your doctor.


Cholestyramine is available only with your doctor's prescription.


Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, cholestyramine is used in certain patients with the following medical conditions:


  • Digitalis glycoside overdose

  • Excess oxalate in the urine

Before Using Prevalite


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


This medicine has been tested in a limited number of children. In effective doses, the medicine has not been shown to cause different side effects or problems than it does in adults.


Geriatric


Side effects may be more likely to occur in patients over 60 years of age, who are usually more sensitive to the effects of cholestyramine.


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


Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.


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.


  • Mycophenolate Mofetil

  • Mycophenolic Acid

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.


  • Amiodarone

  • Anisindione

  • Cephalexin

  • Cerivastatin

  • Deferasirox

  • Diclofenac

  • Dicumarol

  • Digitoxin

  • Digoxin

  • Ezetimibe

  • Furosemide

  • Hydrochlorothiazide

  • Leflunomide

  • Levothyroxine

  • Meloxicam

  • Metronidazole

  • Phenprocoumon

  • Valproic Acid

  • Warfarin

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:


  • Bleeding problems or

  • Constipation or

  • Gallstones or

  • Heart or blood vessel disease or

  • Hemorrhoids or

  • Stomach ulcer or other stomach problems or

  • Underactive thyroid—Cholestyramine may make these conditions worse

  • Kidney disease—There is an increased risk of developing electrolyte problems (problems in the blood)

  • Phenylketonuria—Phenylalanine in aspartame is included in the sugar-free brand of cholestyramine and should be avoided. Aspartame can cause problems in people with phenylketonuria. Therefore, it is best if you avoid using the sugar-free product.

Proper Use of cholestyramine

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


Take this medicine exactly as directed by your doctor. Try not to miss any doses and do not take more medicine than your doctor ordered.


This medicine should never be taken in its dry form, since it could cause you to choke. Instead, always mix as follows:


  • Place the medicine in 2 ounces of any beverage and mix thoroughly. Then add an additional 2 to 4 ounces of beverage and again mix thoroughly (it will not dissolve) before drinking. After drinking all the liquid containing the medicine, rinse the glass with a little more liquid and drink that also, to make sure you get all the medicine.

  • You may also mix this medicine with milk in hot or regular breakfast cereals, or in thin soups such as tomato or chicken noodle soup. Or you may add it to some pulpy fruits such as crushed pineapple, pears, peaches, or fruit cocktail.

For patients taking this medicine for high cholesterol :


  • Importance of diet—Before prescribing medicine for your condition, your doctor will probably try to control your condition by prescribing a personal diet for you. Such a diet may be low in fats, sugars, and/or cholesterol. Many people are able to control their condition by carefully following their doctor's orders for proper diet and exercise. Medicine is prescribed only when additional help is needed. Follow carefully the special diet your doctor gave you, since the medicine is effective only when a schedule of diet and exercise is properly followed.

  • Also, this medicine is less effective if you are greatly overweight. It may be very important for you to go on a reducing diet. However, check with your doctor before going on any diet.

  • Remember that this medicine will not cure your cholesterol problem but it will help control it. Therefore, you must continue to take it as directed if you expect to lower your cholesterol level.

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 (powder for oral suspension):
    • For high cholesterol or pruritus (itching) related to biliary obstruction:
      • Adults—At first, 4 grams one or two times a day before meals. Then, your doctor may increase your dose to 8 to 24 grams a day. This is divided into two to six doses.

      • Children—At first, 4 grams a day. This is divided into two doses and taken before meals. Then, your doctor may increase your dose to 8 to 24 grams a day. This is divided into two or more doses.



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.


Precautions While Using Prevalite


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 take it.


Do not take any other medicine unless prescribed by your doctor since cholestyramine may change the effect of other medicines.


Do not stop taking this medicine without first checking with your doctor. When you stop taking this medicine, your blood cholesterol levels may increase again. Your doctor may want you to follow a special diet to help prevent this from happening.


Prevalite Side Effects


In some animal studies, cholestyramine was found to cause tumors. It is not known whether cholestyramine causes tumors in humans.


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:


Rare
  • Black, tarry stools

  • stomach pain (severe) with nausea and vomiting

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


More common
  • Constipation

Rare
  • Loss of weight (sudden)

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
  • Heartburn or indigestion

  • nausea or vomiting

  • stomach pain

Less common
  • Belching

  • bloating

  • diarrhea

  • dizziness

  • headache

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: Prevalite 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 Prevalite resources


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


  • Prevalite Powder MedFacts Consumer Leaflet (Wolters Kluwer)

  • Prevalite Concise Consumer Information (Cerner Multum)

  • Prevalite Prescribing Information (FDA)

  • Cholestyramine Prescribing Information (FDA)

  • Cholestyramine Professional Patient Advice (Wolters Kluwer)

  • Cholestyramine Light Prescribing Information (FDA)

  • Cholestyramine Resin Monograph (AHFS DI)

  • Questran Prescribing Information (FDA)



Compare Prevalite with other medications


  • Crohn's Disease
  • Hyperlipoproteinemia
  • Hyperlipoproteinemia Type IIa, Elevated LDL
  • Hyperlipoproteinemia Type IIb, Elevated LDL VLDL
  • Irritable Bowel Syndrome
  • Pruritus of Partial Biliary Obstruction

Sunday, March 18, 2012

Ciclopirox Shampoo




CICLOPIROX

SHAMPOO, 1%

FOR TOPICAL USE ONLY.

NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE.

KEEP OUT OF REACH OF CHILDREN.



Ciclopirox Shampoo Description


Ciclopirox Shampoo, 1%, contains the synthetic antifungal agent, ciclopirox.


Each gram (equivalent to 0.96 mL) of Ciclopirox Shampoo, 1% contains 10 mg ciclopirox in a shampoo base consisting of purified water USP, sodium laureth sulfate, disodium laureth sulfosuccinate, sodium chloride USP, and laureth-2.


Ciclopirox Shampoo, 1% is a colorless, translucent solution. The chemical name for ciclopirox is 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridone, with the empirical formula C12H17NO2and a molecular weight of 207.27. The CAS Registry Number is [29342-05-0]. The chemical structure is:




Ciclopirox Shampoo - Clinical Pharmacology



Mechanism of Action


Ciclopirox is a hydroxypyridone antifungal agent although the relevance of this property for the indication of seborrheic dermatitis is not known. Ciclopirox acts by chelation of polyvalent cations (Fe3+or Al3+), resulting in the inhibition of the metal-dependent enzymes that are responsible for the degradation of peroxides within the fungal cell.



Pharmacokinetics and Pharmacodynamics


In a study in patients with seborrheic dermatitis of the scalp, application of 5 mL Ciclopirox Shampoo, 1% twice weekly for 4 weeks, with an exposure time of 3 minutes per application, resulted in detectable serum concentrations of ciclopirox in 6 out of 18 patients. The serum concentrations measured throughout the dosing interval on Days 1 and 29 ranged from 10.3 ng/mL to 13.2 ng/mL. Total urinary excretion of ciclopirox was less than 0.5 % of the administered dose.



Clinical Studies


In two randomized, double-blind clinical trials, patients 16 years and older with seborrheic dermatitis of the scalp applied Ciclopirox Shampoo, 1% or its vehicle two times per week for 4 weeks. Patients who were immunocompromised, those with psoriasis or atopic dermatitis, women of childbearing potential not using adequate contraception, and pregnant or lactating women were excluded from the clinical studies. An evaluation of the overall status of the seborrheic dermatitis, and the presence and severity of erythema or inflammation, and scaling, was made at week 4, using a scale of 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = pronounced, and 5 = severe. Effective treatment was defined as achieving a score of 0 (or a score of 1 if the baseline score was ≥3) simultaneously for status of the seborrheic dermatitis, erythema or inflammation, and scaling at Week 4. Ciclopirox Shampoo, 1% was shown to be statistically significantly more effective than vehicle in both studies. Efficacy results for the two studies are presented in the following table.












Effective Treatment Rates at Week 4 in Studies 1 and 2
Ciclopirox Shampoo, 1%Vehicle
Study 1220/380 (58%)60/192 (31%)
Study 262/250 (26%)32/249 (13%)

Efficacy for black patients was not demonstrated, although only 53 black patients were enrolled in the two pivotal studies.



Microbiology


Ciclopirox is fungicidalin vitroagainstMalassezia furfur (Pityrosporumspp.), P. ovale,andP. orbiculare.Ciclopirox acts by chelation of polyvalent cations (Fe3+or Al3+), resulting in the inhibition of the metal-dependent enzymes that are responsible for the degradation of peroxides within the fungal cell.


The clinical significance of antifungal activity in the treatment of seborrheic dermatitis is not known.



Indications and Usage for Ciclopirox Shampoo


Ciclopirox Shampoo, 1% is indicated for the topical treatment of seborrheic dermatitis of the scalp in adults.



Contraindications


Ciclopirox Shampoo, 1% is contraindicated in individuals who have shown hypersensitivity to any of its components.



Warnings


Ciclopirox Shampoo, 1% is not for ophthalmic, oral, or intravaginal use.


Keep out of reach of children.



Precautions



General


If a reaction suggesting sensitivity or irritation should occur with the use of Ciclopirox Shampoo, 1%, treatment should be discontinued and appropriate therapy instituted.


Contact of Ciclopirox Shampoo, 1% with the eyes should be avoided. If contact occurs, rinse thoroughly with water.


Seborrheic dermatitis may appear at puberty, however, no clinical studies have been done in patients younger than 16 years.


In patients with lighter hair color, hair discoloration has rarely been reported.


There is no relevant clinical experience with patients who have a history of immunosuppression (e.g., extensive, persistent, or unusual distribution of dermatomycoses, recent or recurring herpes zoster, or persistent herpes simplex), who are immunocompromised (e.g., HIV-infected patients and transplant patients), or who have a diabetic neuropathy.



Information for Patients


The patient should be instructed to:


  1. Use Ciclopirox Shampoo, 1% as directed by the physician. Avoid contact with the eyes and mucous membranes. If contact occurs, rinse thoroughly with water. Ciclopirox Shampoo, 1% is for external use on the scalp only. Do not swallow.

  2. Use the medication for seborrheic dermatitis for the full treatment time even though symptoms may have improved. Notify the physician if there is no improvement after 4 weeks.

  3. Inform the physician if the area of application shows signs of increased irritation (redness, itching, burning, blistering, swelling, or oozing) indicative of possible allergic reaction.

  4. Not use the medication for any disorder other than that for which it is prescribed.


Carcinogenesis, Mutagenesis, and Impairment of Fertility:


Long-term animal studies have not been performed to evaluate the carcinogenic potential of Ciclopirox Shampoo, 1% or ciclopirox.


The followingin vitrogenotoxicity tests have been conducted with ciclopirox: evaluation of gene mutation in the AmesSalmonellaandE. coliassays (negative); chromosome aberration assays in V79 Chinese hamster lung fibroblast cells, with and without metabolic activation (positive); chromosome aberration assays in V79 Chinese hamster lung fibroblast cells in the presence of supplemental Fe3+, with and without metabolic activation (negative); gene mutation assays in the HGPRT-test with V79 Chinese hamster lung fibroblast cells (negative); and a primary DNA damage assay (i.e., unscheduled DNA synthesis assay in A549 human cells) (negative). Anin vitrocell transformation assay in BALB/c 3T3 cells was negative for cell transformation. In anin vivoChinese hamster bone marrow cytogenetic assay, ciclopirox was negative for chromosome aberrations at a dosage of 5000 mg/kg body weight.


A combined oral fertility and embryofetal developmental study was conducted in rats with ciclopirox olamine. No effect on fertility or reproductive performance was noted at the highest dose tested of 3.85 mg/kg/day ciclopirox (approximately 1.3 times the maximum recommended human dose based on body surface area comparisons).



Pregnancy:


Teratogenic effects:

Pregnancy Category B


Oral embryofetal developmental studies were conducted in mice, rats, rabbits and monkeys. Ciclopirox or ciclopirox olamine was orally administered during the period of organogenesis. No maternal toxicity, embryotoxicity or teratogenicity were noted at the highest doses of 77, 125, 80 and 38.5 mg/kg/day ciclopirox in mice, rats, rabbits and monkeys, respectively (approximately 13, 42, 54 and 26 times the maximum recommended human dose based on body surface area comparisons, respectively).


Dermal embryofetal developmental studies were conducted in rats and rabbits with ciclopirox olamine dissolved in PEG 400. Ciclopirox olamine was topically administered during the period of organogenesis. No maternal toxicity, embryotoxicity or teratogenicity were noted at the highest doses of 92 mg/kg/day and 77 mg/kg/day ciclopirox in rats and rabbits, respectively (approximately 31 and 54 times the maximum recommended human dose based on body surface area comparisons, respectively).


There are no adequate or well-controlled studies of topically applied ciclopirox in pregnant women. Because animal reproduction studies are not always predictive of human response, Ciclopirox Shampoo, 1% should be used during pregnancy only if clearly needed.



Nursing Mothers:


It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Ciclopirox Shampoo, 1% is administered to a nursing woman.



Pediatric Use:


Seborrheic dermatitis may appear at puberty, however, no clinical studies have been done in patients younger than 16 years.



Geriatric Use:


In clinical studies, the safety and tolerability of Ciclopirox Shampoo, 1% in the population 65 years and older was comparable to that of younger subjects. Results of the efficacy analysis in those patients 65 years and older showed effectiveness in 25 of 85 (29%) patients treated with Ciclopirox Shampoo, 1%, and in 15 of 61 (25%) patients treated with the vehicle; due to the small sample size, a statistically significant difference was not demonstrated. Other reported clinical experience has not identified differences in responses between the elderly and younger subjects, but greater sensitivity to adverse effects in some older individuals cannot be ruled out.



Adverse Reactions


In 626 patients treated with Ciclopirox Shampoo, 1% twice weekly in the two pivotal clinical studies, the most frequent adverse events were increased itching in 1% of patients, and application site reactions, such as burning, erythema, and itching, also in 1% of patients. Other adverse events occurred in individual patients only.


Adverse events that led to early study medication termination in clinical trials occurred in 1.5% (26/1738) of patients treated with Ciclopirox Shampoo, 1% and 2.0% (12/661) of patients treated with shampoo vehicle. The most common adverse event leading to termination of study medication in either group was seborrhea. In the Ciclopirox Shampoo, 1% group, other adverse events included rash, pruritus, headache, ventricular tachycardia, and skin disorder. In the shampoo vehicle group, other adverse events included skin disorder and rash.



Ciclopirox Shampoo Dosage and Administration


Wet hair and apply approximately 1 teaspoon (5 mL) of Ciclopirox Shampoo, 1% to the scalp. Up to 2 teaspoons (10 mL) may be used for long hair. Lather and leave on hair and scalp for 3 minutes. A timer may be used. Avoid contact with eyes. Rinse off. Treatment should be repeated twice per week for 4 weeks, with a minimum of 3 days between applications.


If a patient with seborrheic dermatitis shows no clinical improvement after 4 weeks of treatment with Ciclopirox Shampoo, 1%, the diagnosis should be reviewed.



How is Ciclopirox Shampoo Supplied


Ciclopirox Shampoo, 1% is supplied in 120 mL plastic bottles (NDC 0574-2059-12). Discard unused product after initial treatment duration.



Store at 20 - 25 C (68 - 77 F) [see USP Controlled Room Temperature]



Paddock Laboratories, Inc.

Minneapolis, MN 55427

(10-08)



PRINCIPAL DISPLAY PANEL - 120 mL Label


NDC 0574-2059-12

CICLOPIROX

SHAMPOO, 1%


Rx ONLY


For topical use only.


Not for ophthalmic, oral, or

intravaginal use.


Keep out of reach of children.


This package is not child resistant.


NET CONTENTS

120 mL


Paddock

Laboratories, Inc.


2202135 (10-08)





PRINCIPAL DISPLAY PANEL - 120 mL Carton


NDC 0574-2059-12

CICLOPIROX

SHAMPOO, 1%


Rx ONLY


For topical use only.


Not for ophthalmic, oral, or

intravaginal use.


Keep out of reach of children.


This package is not child resistant.


120 mL BOTTLE


Paddock

Laboratories, Inc.










CICLOPIROX 
ciclopirox  shampoo










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0574-2059
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ciclopirox (Ciclopirox)Ciclopirox10 mg  in 0.96 mL












Inactive Ingredients
Ingredient NameStrength
Water 
Sodium Laureth Sulfate 
Disodium Laureth Sulfosuccinate 
Sodium Chloride 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
10574-2059-121 BOTTLE In 1 CARTONcontains a BOTTLE, PLASTIC
1120 mL In 1 BOTTLE, PLASTICThis package is contained within the CARTON (0574-2059-12)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09049011/24/200901/20/2014


Labeler - Paddock Laboratories, LLC (967694121)









Establishment
NameAddressID/FEIOperations
Paddock Laboratories, LLC967694121MANUFACTURE
Revised: 01/2012Paddock Laboratories, LLC

Saturday, March 17, 2012

Key-Pred SP


Generic Name: prednisolone (pred NIS oh lone)

Brand Names: Bubbli-Pred, Flo-Pred, Hydeltrasol, Key-Pred SP, Millipred, Orapred, Orapred ODT, Pediapred, Pred-Ject-50, Predacort 50, Predalone 50, Predate-50, Veripred 20


What is Key-Pred SP (prednisolone)?

Prednisolone is in a class of drugs called steroids. Prednisolone prevents the release of substances in the body that cause inflammation.


Prednisolone is used to treat many different conditions such as allergic disorders, skin conditions, ulcerative colitis, arthritis, lupus, psoriasis, or breathing disorders.


Prednisolone may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about Key-Pred SP (prednisolone)?


You should not use this medication if you are allergic to prednisolone, or if you have a fungal infection anywhere in your body.

Before taking prednisolone, tell your doctor about all of your medical conditions, and about all other medicines you are using. There are many other diseases that can be affected by steroid use, and many other medicines that can interact with steroids.


Your steroid medication needs may change if you have any unusual stress such as a serious illness, fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you during treatment.


Steroid medication can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have or have recently had. Tell your doctor about any illness or infection you have had within the past several weeks.


Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medication.


Do not receive a "live" vaccine while you are taking prednisolone. Vaccines may not work as well while you are taking a steroid.


Do not stop using prednisolone suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication. Carry an ID card or wear a medical alert bracelet stating that you are taking a steroid, in case of emergency.

What should I discuss with my healthcare provider before taking Key-Pred SP (prednisolone)?


You should not use this medication if you are allergic to prednisolone, or if you have a fungal infection anywhere in your body.

Steroid medication can weaken your immune system, making it easier for you to get an infection. Steroids can also worsen an infection you already have, or reactivate an infection you recently had. Before taking this medication, tell your doctor about any illness or infection you have had within the past several weeks.


If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:



  • liver disease (such as cirrhosis);




  • kidney disease;




  • a thyroid disorder;




  • diabetes;




  • a history of malaria;




  • tuberculosis;




  • osteoporosis;




  • a muscle disorder such as myasthenia gravis;




  • glaucoma or cataracts;




  • herpes infection of the eyes;




  • stomach ulcers, ulcerative colitis, or diverticulitis;




  • depression or mental illness;




  • congestive heart failure; or




  • high blood pressure




FDA pregnancy category C. It is not known whether prednisolone is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. Prednisolone can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Steroids can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication.

How should I take Key-Pred SP (prednisolone)?


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


Your doctor may occasionally change your dose to make sure you get the best results from this medication.


Your steroid medication needs may change if you have unusual stress such as a serious illness, fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you.


Measure the liquid form of prednisolone with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.


Keep the disintegrating tablet (Orapred ODT) in its blister pack until you are ready to take the medicine. Open the package using dry hands, and peel back the foil from the tablet blister (do not push the tablet through the foil). Remove the tablet and place it in your mouth.


Allow the disintegrating tablet to dissolve in your mouth without chewing. Swallow several times as the tablet dissolves. If desired, you may drink liquid to help swallow the dissolved tablet.


Steroids can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using prednisolone.


Do not stop using prednisolone suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication. Carry an ID card or wear a medical alert bracelet stating that you are taking a steroid, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are taking steroid medication. Store prednisolone at room temperature away from moisture and heat.

What happens if I miss a dose?


If you miss a dose or forget to take your medicine, contact your doctor or pharmacist for instructions.


What happens if I overdose?


Seek emergency medical attention if you think you have received too much of this medicine.

A single large dose of prednisolone is not expected to produce life-threatening symptoms. However, long-term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.


What should I avoid while taking Key-Pred SP (prednisolone)?


Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medication.


Do not receive a "live" vaccine while you are being treated with prednisolone. Vaccines may not work as well while you are taking a steroid.


Avoid drinking alcohol while you are taking prednisolone.

Key-Pred SP (prednisolone) side effects


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 you have any of these serious side effects:

  • problems with your vision;




  • swelling, rapid weight gain, feeling short of breath;




  • severe depression, unusual thoughts or behavior, seizure (convulsions);




  • bloody or tarry stools, coughing up blood;




  • pancreatitis (severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate);




  • low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling); or




  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).



Less serious side effects may include:



  • sleep problems (insomnia), mood changes;




  • acne, dry skin, thinning skin, bruising or discoloration;




  • slow wound healing;




  • increased sweating;




  • headache, dizziness, spinning sensation;




  • nausea, stomach pain, bloating; or




  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect Key-Pred SP (prednisolone)?


There are many other medicines that can interact with steroids. Below is only a partial list of these medicines:



  • aspirin (taken on a daily basis or at high doses);




  • a diuretic (water pill);




  • a blood thinner such as warfarin (Coumadin);




  • cyclosporine (Gengraf, Neoral, Sandimmune);




  • insulin or diabetes medications you take by mouth;




  • ketoconazole (Nizoral);




  • rifampin (Rifadin, Rifater, Rifamate, Rimactane); or




  • seizure medications such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton).



This list is not complete and there may be other drugs that can interact with prednisolone. 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.



More Key-Pred SP resources


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


  • Bubbli-Pred Advanced Consumer (Micromedex) - Includes Dosage Information

  • Flo-Pred Prescribing Information (FDA)

  • Flo-Pred Consumer Overview

  • Flo-Pred Suspension MedFacts Consumer Leaflet (Wolters Kluwer)

  • Millipred Prescribing Information (FDA)

  • Millipred DP MedFacts Consumer Leaflet (Wolters Kluwer)

  • Orapred Solution MedFacts Consumer Leaflet (Wolters Kluwer)

  • Orapred Prescribing Information (FDA)

  • Orapred Consumer Overview

  • Orapred ODT Prescribing Information (FDA)

  • Orapred ODT MedFacts Consumer Leaflet (Wolters Kluwer)

  • PediaPred Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

  • Prednisolone tablets Prescribing Information (FDA)

  • Prednisolone Monograph (AHFS DI)

  • Prednisolone MedFacts Consumer Leaflet (Wolters Kluwer)

  • Prednisolone Professional Patient Advice (Wolters Kluwer)

  • Prednisolone Acetate eent Monograph (AHFS DI)

  • Prelone Syrup MedFacts Consumer Leaflet (Wolters Kluwer)

  • Veripred 20 Prescribing Information (FDA)



Compare Key-Pred SP with other medications


  • Asthma, acute
  • Bronchopulmonary Dysplasia
  • Bullous Pemphigoid
  • Dermatitis
  • Immunosuppression
  • Inflammatory Conditions
  • Multiple Sclerosis
  • Nephrotic Syndrome
  • Pemphigoid
  • Pemphigus


Where can I get more information?


  • Your pharmacist can provide more information about prednisolone.

See also: Key-Pred SP side effects (in more detail)


Tricosal


Pronunciation: KOE-leen and mag-NEE-zee-um tri-sa-LI-si-lates
Generic Name: Choline and Magnesium Trisalicylates
Brand Name: Examples include Tricosal and Trilisate

Children and teenagers should not use aspirin, aspirin-containing, or aspirin-related medicines for flu symptoms or chickenpox without first consulting a doctor. A rare but serious illness known as Reye syndrome may occur. Tricosal contains an aspirin-related component.





Tricosal is used for:

Relieving signs and symptoms of rheumatoid arthritis, osteoarthritis, and acute shoulder pain. It may also be used to relieve mild to moderate pain and to reduce fever.


Tricosal is a salicylate. It works by reducing inflammation in the joints.


Do NOT use Tricosal if:


  • you are allergic to any ingredient in Tricosal or to nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen)

  • you have a blood-clotting disease (including von Willebrand disease), bleeding, or hemophilia

  • the patient is a child or teenager with flu symptoms or chickenpox

  • you are taking probenecid or sulfinpyrazone

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



Before using Tricosal:


Some medical conditions may interact with Tricosal. 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 stomach problems, ulcers, fever, nasal polyps, stroke, bleeding in the brain, vitamin K deficiency, chickenpox, blood-clotting problems, liver or kidney problems, or the flu

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


  • Carbonic anhydrase inhibitors (eg, acetazolamide), insulin, meglitinide antidiabetics (eg, repaglinide), methotrexate, steroids (eg, dexamethasone), or valproic acid because the risk of their side effects may be increased by Tricosal

  • Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), probenecid, or sulfinpyrazone because their the effectiveness may be decreased by Tricosal

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


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


  • Take Tricosal by mouth with or without food. If stomach upset occurs, take with food or a large glass of milk to reduce stomach irritation.

  • Take Tricosal with a full glass of water (8 oz/240 mL). Do not lie down for 30 minutes after taking Tricosal.

  • If you miss a dose of Tricosal 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 Tricosal.



Important safety information:


  • Tricosal may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Tricosal with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • Talk to your doctor before you take Tricosal if you drink more than 3 drinks with alcohol per day.

  • Tricosal may cause stomach bleeding. Your risk may be greater if you drink alcohol while you are using Tricosal.

  • Tricosal has a salicylate in it. Before you start any new medicine, check the label to see if it has a salicylate in it too. If it does or if you are not sure, check with your doctor or pharmacist.

  • Tell your doctor or dentist that you take Tricosal before you receive any medical or dental care, emergency care, or surgery.

  • Tricosal should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tricosal while you are pregnant. Tricosal is found in breast milk. If you are or will be breast-feeding while you use Tricosal, check with your doctor. Discuss any possible risks to your baby.


Possible side effects of Tricosal:


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; dizziness; drowsiness; headache; heartburn; indigestion; nausea; sweating; stomach pain; upset stomach; vomiting.



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 or tarry stools; blood in the stool; confusion; flushing; hallucinations; hearing loss; ringing in the ears; severe stomach pain; unusual bruising, bleeding, or black stools; vomit that looks like coffee grounds; yellowing of 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: Tricosal 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 bloody stools; disorientation; drowsiness; general body discomfort; hallucinations; loss of consciousness; nausea; ringing in the ears; seizures; stupor; upset stomach; vomiting; wheezing.


Proper storage of Tricosal:

Store Tricosal 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 Tricosal out of the reach of children and away from pets.


General information:


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

  • Tricosal 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 Tricosal. 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 Tricosal resources


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


  • Tricosal Concise Consumer Information (Cerner Multum)

  • Tricosal Advanced Consumer (Micromedex) - Includes Dosage Information



Compare Tricosal with other medications


  • Osteoarthritis
  • Pain

Friday, March 16, 2012

tetracaine Topical application


TE-tra-kane


Commonly used brand name(s)

In the U.S.


  • Cepacol Viractin

  • Pontocaine

In Canada


  • Supracaine

Available Dosage Forms:


  • Cream

  • Ointment

  • Gel/Jelly

  • Solution

Therapeutic Class: Anesthetic, Local


Chemical Class: Amino Ester


Uses For tetracaine


Tetracaine is used in different parts of the body to cause numbness or loss of feeling in some patients before having a medical test or procedure.


Tetracaine belongs to a group of medicines known as topical local anesthetics. It deadens the nerve endings in the skin. tetracaine does not cause unconsciousness as general anesthetics do when used for surgery.


tetracaine is available only with your doctor's prescription.


Before Using tetracaine


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 tetracaine, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to tetracaine 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


No information is available on the relationship of age to the effects of tetracaine in the pediatric population. Safety and efficacy have not been established.


Geriatric


No information is available on the relationship of age to the effects of tetracaine 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 tetracaine. Make sure you tell your doctor if you have any other medical problems, especially:


  • Brain or spinal problems or

  • Eye problems or

  • Heart and blood vessel problems—Use with caution. May make these conditions worse.

  • Infection at or near the place of application or

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

Proper Use of tetracaine


A nurse or other trained health professional will give you tetracaine. tetracaine is for use on the skin only.


Be careful not to get any of tetracaine in your nose, mouth, and especially in your eyes, because it can cause severe eye irritation. If any of the medicine does get into these areas especially the eyes, wash it with water and check with your doctor right away.


Precautions While Using tetracaine


It is very important that your doctor check you closely for any problems or unwanted effects that may be caused by tetracaine.


Stop using tetracaine and check with your doctor right away if you have a skin rash, burning, stinging, swelling, or irritation of your skin.


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


tetracaine 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:


Incidence not known
  • Blurred vision

  • chest pain or discomfort

  • confusion

  • dizziness

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

  • fainting

  • fast or irregular heartbeat

  • lightheadedness or fainting

  • no blood pressure or pulse

  • no breathing

  • numbness

  • seizures

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

  • shortness of breath

  • slow or irregular heartbeat

  • stopping of heart

  • sweating

  • trembling or shaking of the hands or feet

  • unconsciousness

  • unusual tiredness or 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:


Incidence not known
  • Continuing ringing or buzzing or other unexplained noise in the ears

  • fear or nervousness

  • hearing loss

  • restlessness

  • sleepiness

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.



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 tetracaine Topical application resources


  • Tetracaine Topical application Support Group
  • 1 Review for Tetracaine Topical application - Add your own review/rating


Compare tetracaine Topical application with other medications


  • Allergic Urticaria
  • Cold Sores
  • Local Anesthesia
  • Skin Rash
  • Urticaria

Tuesday, March 13, 2012

Colidrops Drops


Pronunciation: HYE-oh-SYE-a-meen
Generic Name: Hyoscyamine
Brand Name: Examples include Hyosyne and Colidrops


Colidrops Drops are used for:

Treating certain stomach, intestinal, and bladder conditions, including spasms. It is used to control stomach secretions and cramps. It is used to relieve the symptoms of colic, runny nose, and Parkinson-like problems. It is used to treat excessive sweating or saliva production. It may also be used for other conditions as determined by your doctor.


Colidrops Drops are an anticholinergic agent. It works by decreasing the motion of muscles in the stomach, intestines, and bladder. It also decreases the production of stomach acid.


Do NOT use Colidrops Drops if:


  • you are allergic to any ingredient in Colidrops Drops

  • you have severe esophagus problems (eg, irritation, narrowing); a blockage of the stomach, bowel, or bladder; bowel motility problems; or severe bowel problems (eg, severe ulcerative colitis, toxic megacolon)

  • you have glaucoma, myasthenia gravis, or heart problems caused by severe bleeding

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



Before using Colidrops Drops:


Some medical conditions may interact with Colidrops Drops. 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 nerve problems, prostate problems, esophagus problems (eg, reflux), stomach or bowel problems, heart or blood vessel problems (eg, fast or irregular heartbeat, heart failure, coronary heart disease), hiatal hernia, kidney problems, an overactive thyroid, high blood pressure, urinary problems, paralysis, or brain damage, or if you are at risk for glaucoma

  • if you have diarrhea or fever, have been very ill, or are in poor health

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


  • Amantadine, antihistamines (eg, diphenhydramine), haloperidol, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), other anticholinergics (eg, scopolamine), phenothiazines (eg, thioridazine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Colidrops Drops's side effects

  • Narcotic pain medicines (eg, codeine) or potassium chloride because the risk of their side effects may be increased by Colidrops Drops

  • Ketoconazole or metoclopramide because their effectiveness may be decreased by Colidrops Drops

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


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


  • Colidrops Drops are usually taken 30 to 60 minutes before a meal. Follow your doctor's instructions for taking Colidrops Drops.

  • Use the dropper that comes with Colidrops Drops to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.

  • If you also take antacids, take Colidrops Drops before meals and the antacid after meals, unless directed otherwise by your doctor.

  • If you miss a dose of Colidrops Drops, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Colidrops Drops.



Important safety information:


  • Colidrops Drops may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Colidrops Drops with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Colidrops Drops; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

  • Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.

  • Do not become overheated or dehydrated in hot weather or while you are being active; heatstroke may occur.

  • Drink plenty of fluids, maintain good oral hygiene, and suck on sugarless hard candy to relieve dry mouth.

  • Proper dental care is important while you are taking Colidrops Drops. Brush and floss your teeth and visit the dentist regularly.

  • Colidrops Drops may make your eyes more sensitive to sunlight. It may help to wear sunglasses.

  • Tell your doctor or dentist that you take Colidrops Drops before you receive any medical or dental care, emergency care, or surgery.

  • Use Colidrops Drops with caution in the ELDERLY; they may be more sensitive to its effects, especially constipation, trouble urinating, dry mouth, drowsiness, agitation, confusion, excitability, or memory problems.

  • Caution is advised when using Colidrops Drops in CHILDREN; they may be more sensitive to its effects, including excitability.

  • Colidrops Drops should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.

  • Colidrops Drops should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: It is not known if Colidrops Drops can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Colidrops Drops while you are pregnant. Colidrops Drops are found in breast milk. If you are or will be breast-feeding while taking Colidrops Drops, check with your doctor. Discuss any possible risks to your baby.


Possible side effects of Colidrops Drops:


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:



Bloated feeling; blurred vision; constipation; decreased sweating; dizziness; drowsiness; dry mouth; enlarged pupils; excitability; headache; nausea; nervousness; trouble sleeping; weakness.



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); agitation; behavior changes; confusion; decreased sexual ability; diarrhea; difficulty focusing eyes; disorientation; exaggerated sense of well-being; fast or irregular heartbeat; hallucinations; loss of consciousness; loss of coordination; memory loss; mental or mood changes; severe or persistent trouble sleeping; speech changes; taste changes or loss; trouble urinating; unusual tiredness or weakness; vision changes; vomiting.



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: Colidrops 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 disorientation; excessive thirst or excitability; fever; hot, dry skin; seizures; severe dry mouth; severe or persistent blurred vision, dizziness, headache, nausea, or vomiting; trouble breathing or swallowing.


Proper storage of Colidrops Drops:

Store Colidrops Drops 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 Colidrops Drops out of the reach of children and away from pets.


General information:


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

  • Colidrops Drops are 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 Colidrops Drops. 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 Colidrops resources


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


Compare Colidrops with other medications


  • Anesthesia
  • Crohn's Disease
  • Endoscopy or Radiology Premedication
  • Irritable Bowel Syndrome
  • Urinary Incontinence

Sunday, March 11, 2012

Twinrix


Generic Name: hepatitis A and hepatitis B vaccine (HEP a TYE tis)

Brand Names: Twinrix


What is Twinrix (hepatitis A and hepatitis B vaccine)?

Hepatitis A and B are serious diseases caused by virus.


Hepatitis A is spread through contact with the stool (bowel movements) of a person infected with the hepatitis A virus. This usually occurs by eating food or drinking water that has become contaminated as a result of handling by an infected person.


Hepatitis B is spread through blood or bodily fluids, sexual contact or sharing IV drug needles with an infected person, or during childbirth when a baby is born to a mother who is infected.


Hepatitis causes inflammation of the liver, vomiting, and jaundice (yellowing of the skin or eyes). Hepatitis can lead to liver cancer, cirrhosis, or death.


The hepatitis A and hepatitis B vaccine is used to help prevent these diseases. The vaccine works by exposing you to a small dose of the virus, 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.


Vaccination with hepatitis A and hepatitis B is recommended for all adults who are at risk of getting hepatitis A or B. Risk factors include: having more than one sex partner in 6 months; being a homosexual male; having sexual contact with infected people; having cirrhosis or chronic hepatitis C; using intravenous (IV) drugs; being on dialysis or receiving blood transfusions; working in healthcare or public safety and being exposed to infected blood or body fluids; being in the military or traveling to high-risk areas; and living with a person who has either hepatitis A or B infection.


Like any vaccine, the hepatitis A and hepatitis B vaccine may not provide protection from disease in every person.


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


You should not receive this vaccine if you are allergic to yeast or neomycin (Mycafradin, Neo-Fradin, Neo-Tab), or if you have ever had a life-threatening allergic reaction to any vaccine containing hepatitis A or hepatitis B.

Before receiving this vaccine, tell the doctor if you have multiple sclerosis, a bleeding or blood clotting disorder, seizures, a weak immune system, if you are taking a blood thinner, or if you are allergic to rubber.


Vaccination with hepatitis A and hepatitis B is recommended for all adults who are at risk of getting hepatitis A or B. Risk factors include: having more than one sex partner in 6 months; being a homosexual male; having sexual contact with infected people; having cirrhosis or chronic hepatitis C; using intravenous (IV) drugs; being on dialysis or receiving blood transfusions; working in healthcare or public safety and being exposed to infected blood or body fluids; being in the military or traveling to high-risk areas; and living with a person who has either hepatitis A or B infection.


Be sure you receive all recommended doses of this vaccine. If you do not receive the full series of vaccines, you may not be fully protected against the disease.


You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.

Hepatitis A and hepatitis B vaccine will not protect you against infection with hepatitis C or E, or other viruses that affect the liver. It will also not protect you from hepatitis if you are already infected with the virus, even if you do not yet show symptoms.


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


Becoming infected with hepatitis A or B is much more dangerous to your 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?


Hepatitis A and hepatitis B vaccine will not protect you against infection with hepatitis C or E, or other viruses that affect the liver. It will also not protect you from hepatitis A or B if you are already infected with the virus, even if you do not yet show symptoms.


You should not receive this vaccine if you are allergic to yeast or neomycin (Mycafradin, Neo-Fradin, Neo-Tab), or if you have ever had a life-threatening allergic reaction to any vaccine containing hepatitis A or hepatitis B.

Before receiving this vaccine, tell the doctor if you have:



  • multiple sclerosis;




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




  • a history of seizures;




  • 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 you are taking a blood thinner such as warfarin (Coumadin).



You can still receive a vaccine if you have a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.


FDA pregnancy category C. It is not known whether hepatitis A and hepatitis B vaccine is harmful to an unborn baby. Before receiving this vaccine, tell your doctor if you are pregnant. It is not known whether hepatitis A and hepatitis B vaccine passes into breast milk or if it could harm a nursing baby. Do not receive this vaccine without telling your doctor if you are breast-feeding a baby.

How is this vaccine given?


This vaccine is given as an injection (shot) into a muscle. You will receive this injection in a doctor's office or other clinic setting.


The hepatitis A and hepatitis B vaccine is given in a series of shots. The booster shots are sometimes given 1 month and 6 months after the first shot.


If you have a high risk of hepatitis infection, you may be given 3 shots within 30 days of each other, and a fourth shot 12 months after the first.


Your 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 take.


It is especially important to prevent fever from occurring if you have 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 you receive all recommended doses of this vaccine. If you do not receive the full series of vaccines, you 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.


This vaccine side effects


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

Becoming infected with hepatitis A or B is much more dangerous to your 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 you have any of these serious side effects:



  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;




  • fast or pounding heartbeats; or




  • easy bruising or bleeding.



Less serious side effects include:



  • redness, pain, tenderness, swelling, or a hard lump where the shot was given;




  • headache, tired feeling;




  • mild fever;




  • runny or stuffy nose, sore throat, other cold symptoms; or




  • nausea, vomiting, loss of appetite, diarrhea.



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.


What other drugs will affect Twinrix (hepatitis A and hepatitis B vaccine)?


Before receiving this vaccine, tell the doctor about all other vaccines you have recently received.

Also tell the doctor if you have 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).



This list is not complete and there may be other drugs that can interact with hepatitis A and hepatitis B vaccine. Tell your doctor about all the prescription and over-the-counter medications you have received. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.



More Twinrix resources


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


  • Twinrix Prescribing Information (FDA)

  • Twinrix Advanced Consumer (Micromedex) - Includes Dosage Information

  • Twinrix MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Twinrix with other medications


  • Hepatitis A Prophylaxis
  • Hepatitis B Prevention


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.

See also: Twinrix side effects (in more detail)