Sunday, April 26, 2009

Pan-Amoxicillin




Pan-Amoxicillin may be available in the countries listed below.


Ingredient matches for Pan-Amoxicillin



Amoxicillin

Amoxicillin is reported as an ingredient of Pan-Amoxicillin in the following countries:


  • Lithuania

Amoxicillin sodium salt (a derivative of Amoxicillin) is reported as an ingredient of Pan-Amoxicillin in the following countries:


  • Latvia

International Drug Name Search

Friday, April 24, 2009

Carvol




Carvol may be available in the countries listed below.


Ingredient matches for Carvol



Carvedilol

Carvedilol is reported as an ingredient of Carvol in the following countries:


  • Hungary

International Drug Name Search

Friday, April 17, 2009

Oral B Anti-Cavity


Generic Name: fluoride topical (FLOR ide TOP i kal)

Brand Names: ACT Fluoride Rinse, ACT Kids Fluoride Rinse, ACT Restoring Mouthwash Cinnamon, ACT Restoring Mouthwash Mint, ACT Restoring Mouthwash Spearmint, ACT Restoring Mouthwash Vanilla Mint, Control Rx, Denta 5000 Plus, Dentagel, Ethedent, Fluoridex, Fluoridex Daily Defense, Fluoridex Daily Defense Enhanced Whitening, Fluorigard, Fluorinse, Gel-Kam, Gel-Kam Dental Therapy Pak, Gel-Kam Dentinbloc, Gel-Kam Sensitivity Therapy, NaFrinse Daily/Acidulated, NaFrinse Daily/Neutral, Nafrinse Solution, NaFrinse Weekly, Neutracare Gel, Neutragard, Neutragard Advanced, Neutral Sodium Fluoride Rinse, Omnii Gel, Omnii Gel Just For Kids, Oral B Anti-Cavity, Perfect Choice, Perio Med, Phos-Flur, Prevident, Prevident 500 Plus Boost, PreviDent 5000 Booster, Prevident 5000 Dry Mouth, Prevident 5000 Plus, Prevident 5000 Sensitive, Prevident Dental Rinse, SF, SF 5000 Plus, Stop, Thera-Flur-N


What is Oral B Anti-Cavity (fluoride topical)?

Fluoride is a substance that strengthens tooth enamel. This helps to prevent dental cavities.


Fluoride topical is used as a medication to prevent tooth decay in patients that have a low level of fluoride topical in their drinking water. Fluoride topical is also used to prevent tooth decay in patients who undergo radiation of the head and/or neck, which may cause dryness of the mouth and an increased incidence of tooth decay.


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


What is the most important information I should know about Oral B Anti-Cavity (fluoride topical)?


Fluoride topical should not be used if the level of fluoride in the drinking water is greater than 0.7 parts per million (ppm).

Before using fluoride topical, tell your dentist and doctor if you are on a low salt or a salt free diet. You may not be able to use fluoride topical, or you may need special tests while you are using it.


Do not eat, drink, or rinse your mouth for 30 minutes after using a fluoride topical. Do not swallow fluoride topical. Spit it out after use. Do not allow a child to swallow fluoride topical or serious overdose symptoms could result.

Overdose symptoms may result if you swallow large amounts of fluoride while using it.


What should I discuss with my healthcare provider before using Oral B Anti-Cavity (fluoride topical)?


Fluoride topical should not be used if the level of fluoride in the drinking water is greater than 0.7 parts per million (ppm).

Before using fluoride topical, tell your dentist and doctor if you are on a low salt or a salt free diet. You may not be able to use fluoride topical, or you may need special tests while you are using it.


If you have gum disease, some forms of fluoride topical may be irritating to your gums. Talk to your dentist or doctor if you have bothersome mouth irritation while using fluoride topical.


Talk to your doctor and dentist before using fluoride topical if you are pregnant. Talk to your doctor and dentist before using fluoride topical if you are breast-feeding. The use of fluoride is particularly important in children to protect against tooth decay. The American Dental Association's Council on Dental Therapeutics recommends the use of fluoride by children up to 13 years of age. The American Academy of Pediatrics recommends fluoride supplementation in children until the age of 16 years old. Do not allow a child to swallow fluoride topical or serious overdose symptoms could result.

How should I use Oral B Anti-Cavity (fluoride topical)?


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


Fluoride topical should be used immediately after brushing or flossing your teeth. For best results, use the medication just before bedtime, unless your doctor tells you otherwise.


Swish this medication in your mouth without swallowing. Then spit it out.


Do not eat, drink, or rinse your mouth for 30 minutes after using fluoride topical. Store fluoride topical at room temperature away from moisture and heat.

What happens if I miss a dose?


Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.


What happens if I overdose?


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

Overdose symptoms may include nausea, vomiting, stomach pain, diarrhea, drooling, numbness or tingling, loss of feeling anywhere in your body, muscle stiffness, or seizure (convulsions).


Overdose symptoms may result if you swallow large amounts of fluoride while using it.


What should I avoid while using Oral B Anti-Cavity (fluoride topical)?


Do not swallow fluoride topical. Spit it out after use.

Oral B Anti-Cavity (fluoride topical) 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 if you have any of the following side effects:

  • discolored teeth;




  • weakened tooth enamel; or




  • any changes in the appearance of your teeth.



Less serious side effects may include:



  • stomach upset;




  • headache; or




  • weakness.



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 Oral B Anti-Cavity (fluoride topical)?


It is not likely that other drugs you take orally or inject will have an effect on topically applied fluoride. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.



More Oral B Anti-Cavity resources


  • Oral B Anti-Cavity Side Effects (in more detail)
  • Oral B Anti-Cavity Use in Pregnancy & Breastfeeding
  • Oral B Anti-Cavity Support Group
  • 0 Reviews for Oral B Anti-Cavity - Add your own review/rating


  • APF Gel Advanced Consumer (Micromedex) - Includes Dosage Information

  • EtheDent Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Gel-Kam Rinse MedFacts Consumer Leaflet (Wolters Kluwer)

  • Phos-Flur Cream MedFacts Consumer Leaflet (Wolters Kluwer)

  • PreviDent 5000 Sensitive MedFacts Consumer Leaflet (Wolters Kluwer)

  • Prevident 5000 Booster Prescribing Information (FDA)

  • Prevident 5000 Dry Mouth Prescribing Information (FDA)

  • Prevident 5000 Enamel Protect Prescribing Information (FDA)

  • Prevident 5000 Sensitive Prescribing Information (FDA)



Compare Oral B Anti-Cavity with other medications


  • Prevention of Dental Caries


Where can I get more information?


  • Your pharmacist can provide more information about fluoride topical.

See also: Oral B Anti-Cavity side effects (in more detail)


Wednesday, April 15, 2009

Oxaliplatino Hospira




Oxaliplatino Hospira may be available in the countries listed below.


Ingredient matches for Oxaliplatino Hospira



Oxaliplatin

Oxaliplatin is reported as an ingredient of Oxaliplatino Hospira in the following countries:


  • Italy

International Drug Name Search

Monday, April 13, 2009

Belfix-CV




Belfix-CV may be available in the countries listed below.


Ingredient matches for Belfix-CV



Cefixime

Cefixime is reported as an ingredient of Belfix-CV in the following countries:


  • India

Clavulanate

Clavulanic Acid potassium (a derivative of Clavulanic Acid) is reported as an ingredient of Belfix-CV in the following countries:


  • India

International Drug Name Search

Saturday, April 11, 2009

Bio-Cox





Dosage Form: FOR ANIMAL USE ONLY
Bio-Cox®

60

Brand of salinomycin sodium

Type A Medicated Article


For use in broiler, roaster, replacement

(breeder and layer) chickens, and quail only



Active drug ingredient


Salinomycin equivalent to 60 grams salinomycin sodium activity per pound



For use in manufacturing medicated feeds only



Broiler, roaster and replacement (breeder and layer) chickens


Use Bio-Cox 60 to provide salinomycin sodium concentrations ranging from 40-60 g/ton (0.0044% to 0.0066%) for the prevention of coccidiosis in broiler, roaster and replacement chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti and E. mivati. The dosage should be adjusted to meet the severity of the coccidial challenge, which varies with environmental and management conditions.



Quail


Use Bio-Cox 60 to provide salinomycin sodium concentrations of 50 g/ton (0.0055%) for the prevention of coccidiosis in quail caused by Eimeria dispersa and E. lettyae.



Mixing directions


Thoroughly mix Bio-Cox 60 with non-medicated feed to provide the level of salinomycin sodium per ton as indicated in the table below.






















Salinomycin Sodium ActivityAmount of Bio-Cox 60 Type A Medicated Article (60 g/lb) Per Ton of Feed
(grams per ton)lbgrams
400.67304
450.75341
500.83377
550.92418
601.00454

Feeding directions


Feed continuously as the sole ration



Important


Must be thoroughly mixed in feeds before use. Not approved for use with pellet binders.



Caution


May be fatal if fed to adult turkeys or to horses.



Warning


Do not feed to laying hens producing eggs for human consumption. When mixing and handling Bio-Cox 60 premix, use protective clothing, impervious gloves, eye protection, and an approved dust respirator. Operators should wash thoroughly with soap and water after handling. If accidental eye contact occurs, immediately rinse thoroughly with water.



Store in a cool, dry place



NADA #128-686, Approved by FDA



Marketed by

Alpharma, LLC

Bridgewater, New Jersey 08807


Net wt 50 LB (22.68 kg)



Trademarks registered

by Alpharma LLC


Made in USA

400321 1008



PRINCIPAL DISPLAY PANEL - 22.68 kg Bag Label


Bio-Cox®

60


ALPHARMA


Brand of salinomycin sodium

Type A Medicated Article


Important: See back panel for use directions


Net wt 50 LB (22.68 kg)


ALPHARMA®


Bio-Cox®

60










Bio-Cox 
salinomycin  granule










Product Information
Product TypeOTC TYPE A MEDICATED ARTICLE ANIMAL DRUGNDC Product Code (Source)46573-532
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salinomycin (Salinomycin)Salinomycin60 g  in 0.45 kg





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
ColorWHITE (White to Tan)Score    
ShapeSize
FlavorImprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
146573-532-0022.68 kg In 1 BAGNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NADANADA12868601/01/2009


Labeler - Alpharma, LLC. (070954094)
Revised: 10/2010Alpharma, LLC.



Friday, April 10, 2009

Exiben




Exiben may be available in the countries listed below.


Ingredient matches for Exiben



Cefixime

Cefixime is reported as an ingredient of Exiben in the following countries:


  • Bangladesh

International Drug Name Search

Thursday, April 9, 2009

Virustat




Virustat may be available in the countries listed below.


Ingredient matches for Virustat



Acyclovir

Aciclovir is reported as an ingredient of Virustat in the following countries:


  • Oman

International Drug Name Search

Monday, April 6, 2009

Chemmart Nifedipine




Chemmart Nifedipine may be available in the countries listed below.


Ingredient matches for Chemmart Nifedipine



Nifedipine

Nifedipine is reported as an ingredient of Chemmart Nifedipine in the following countries:


  • Australia

International Drug Name Search

Glimepirid Alpharma




Glimepirid Alpharma may be available in the countries listed below.


Ingredient matches for Glimepirid Alpharma



Glimepiride

Glimepiride is reported as an ingredient of Glimepirid Alpharma in the following countries:


  • Finland

International Drug Name Search

Sunday, April 5, 2009

BiDil


Pronunciation: eye-soe-SOR-bide die-NYE-trate/hye-DRAL-a-zeen
Generic Name: Isosorbide Dinitrate/Hydralazine
Brand Name: BiDil


BiDil is used for:

Treating heart failure in certain patients. It may also be used for other conditions as determined by your doctor.


BiDil is a vasodilator combination. It works by relaxing and dilating (opening) the blood vessels in the body, allowing blood to flow through the vessels easier and at a lower pressure.


Do NOT use BiDil if:


  • you are allergic to nitrates or to any ingredient in BiDil

  • you are taking certain medicines for erectile or lung problems (eg, phosphodiesterase inhibitors [sildenafil, vardenafil, tadalafil])

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



Before using BiDil:


Some medical conditions may interact with BiDil. 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 blood problems (eg, anemia), dehydration problems, heart problems, low blood pressure, liver problems, lupus, or an overactive thyroid, or you have had a recent head injury or recent heart attack

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


  • Medicines that affect your blood vessels, medicines that treat high blood pressure, or other vasodilators because they may increase the risk of BiDil's side effects

  • Monoamine oxidase (MAO) inhibitors (eg, furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, selegiline, tranylcypromine) or phosphodiesterase inhibitors (sildenafil, tadalafil, vardenafil) because the risk of severe low blood pressure may be increased or because serious side effects may occur

  • Beta-blockers (eg propranolol) or lisinopril because the risk of their side effects may be increased by BiDil

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


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


  • Take BiDil by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.

  • Drinking extra fluids while you are taking BiDil is recommended. Check with your doctor for instructions.

  • Take BiDil on a regular schedule to get the most benefit from it. Taking BiDil at the same time each day will help you remember to take it.

  • Continue to take BiDil even if you feel well. Do not miss any doses.

  • If you miss a dose of BiDil, 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 BiDil.



Important safety information:


  • BiDil may cause dizziness or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use BiDil 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 BiDil; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

  • BiDil may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, fever, low fluid intake, excessive sweating, vomiting, or diarrhea can increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of dizziness, lightheadedness, or weakness. If fainting occurs, notify your doctor as soon as possible.

  • BiDil may cause a vitamin B6 deficiency. Talk with your doctor for more information.

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

  • Lab tests, including blood pressure checks, may be performed while you use BiDil. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Use BiDil with caution in the ELDERLY; they may be more sensitive to its effects.

  • BiDil should not be used 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 BiDil while you are pregnant. It is not known if BiDil is found in breast milk. If you are or will be breast-feeding while you use BiDil, check with your doctor. Discuss any possible risks to your baby.


Possible side effects of BiDil:


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:



Dizziness; headache; lightheadedness; nausea; 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); change in the amount of urine produced; chest pain; difficult urination; fainting; fast or irregular heartbeat; fever, chills, or sore throat; joint pain; numbness or tingling of the skin; persistent fatigue or weakness; runny nose; severe or persistent headache or dizziness; vision changes.



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: BiDil 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 chest pain; confusion; fast or irregular heartbeat; flushing; severe headache; shock.


Proper storage of BiDil:

Store BiDil at 77 degrees F (25 degrees C) in a tightly closed container. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep BiDil out of the reach of children and away from pets.


General information:


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

  • BiDil 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 BiDil. 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 BiDil resources


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


  • BiDil Prescribing Information (FDA)

  • BiDil Consumer Overview



Compare BiDil with other medications


  • Heart Failure

Thursday, April 2, 2009

Bontril


Generic Name: Phendimetrazine Tartrate
Class: Anorexigenic Agents and Respiratory and Cerebral Stimulants, Miscellaneous
VA Class: GA751
CAS Number: 50-58-8

Introduction

Amphetamine congener;c anorexigenic agent.a b c d f


Uses for Bontril


Exogenous Obesity


Adjunct to caloric restriction in the short-term management (a few weeks) of exogenous obesity.a b c d f


Use only for short-term monotherapy; not for use in combination with any other drug for weight loss.100 120 d


Bontril Dosage and Administration


General



  • Teach patient to curtail overeating and consume a suitable diet to help induce and maintain weight loss.c



Administration


Oral Administration


Administer conventional tablets orally 2 or 3 times daily, 1 hour before meals.b c f


Administer extended-release capsules orally once daily, 30–60 minutes before the morning meal.a c d


Dosage


Available as phendimetrazine tartrate; dosage expressed in terms of the salt.b d f


Pediatric Patients


Exogenous Obesity

Conventional Tablets

Oral

Children ≥12 years of age: 35 mg 2 or 3 times daily, given 1 hour before meals.b A dosage of 17.5 mg 2 or 3 times daily may be adequate for some patients.b


Extended-release Capsules

Oral

Children ≥12 years of age: 105 mg once daily, given 30–60 minutes before the morning meal.a


Adults


Exogenous Obesity

Conventional Tablets

Oral

35 mg 2 or 3 times daily, given 1 hour before meals.b c f A dosage of 17.5 mg 2 or 3 times daily may be adequate for some patients.b f


Extended-release Capsules

Oral

105 mg once daily, given 30–60 minutes before the morning meal.a c d


Prescribing Limits


Pediatric Patients


Exogenous Obesity

Oral

Children ≥12 years of age: Maximum 70 mg 3 times daily (as conventional tablets).b


Children ≥12 years of age: Maximum 105 mg once daily (as extended-release capsules).d


Adults


Exogenous Obesity

Oral

Maximum 70 mg 3 times daily (as conventional tablets).b c f


Maximum 105 mg once daily (as extended-release capsules).d


Cautions for Bontril


Contraindications



  • Symptomatic cardiovascular disease, hyperthyroidism, moderate to severe hypertension, pulmonary hypertension, glaucoma, or advanced arteriosclerosis.a b c d f




  • Highly nervous or agitated state or history of drug abuse.a b c d f




  • Concurrent therapy with other CNS stimulantsa b c d f or anorexigenic drugs.d




  • Within 14 days of MAO inhibitor therapy.c




  • Known hypersensitivity or idiosyncrasy to sympathomimetic amines.a b c d f



Warnings/Precautions


Warnings


Primary Pulmonary Hypertension

Risk of primary pulmonary hypertension (frequently fatal), particularly when used in combination with at least one other anorexigenic agent, or in those with a history of receiving at least one other anorexigenic agent.100 d Risk increased by 23-fold when anorexigenic agents are used for >3 months.d Increased risk following repeated courses of phendimetrazine cannot be ruled out.d


Discontinue immediately if new-onset or exacerbation of exertional dyspnea or unexplained symptoms of angina, syncope, or edema of the lower extremities occur, and evaluate for possible pulmonary hypertension.d


Valvular Heart Disease

Valvular heart disease reported following use of some anorexigenic agents (e.g., fenfluramine, dexfenfluramine [both no longer commercially available in the US]), particularly when used for extended periods of time, at higher than recommended dosages, and/or in combination with other anorexigenic agents.d


Abnormal heart valve findings have been reported in some patients receiving phendimetrazine.c 100 120 Weigh potential risks against benefits of therapy.d


Consider performing baseline cardiac evaluation to detect preexisting valvular heart diseases prior to initiation of therapy.d Use not recommended in patients with known heart murmur or valvular heart disease.d Echocardiogram during and after treatment may be useful for detecting any valvular disorders that may occur.d


To limit unwarranted exposure and risks, continue therapy only if patient has achieved satisfactory weight loss (e.g., ≥4 pounds [1.8 kg], or as determined by physician and patient) within first 4 weeks of therapy.d


Tolerance to Anorexigenic Effect

Tolerance to anorexigenic effect usually develops within a few weeks.a b d f When it does, discontinue therapy; do not attempt to increase effect by exceeding recommended dosage.a b d f


CNS Effects

Performance of activities requiring mental alertness or physical coordination may be impaired.a b c d f (See Advice to Patients.)


Abuse Potential

Potential for abuse; habituation or addiction reported with phendimetrazinec and similar drugs (e.g., amphetamines).a b d f


Manifestations of chronic intoxication may include psychosis resembling schizophrenia, severe dermatoses, marked insomnia, irritability, hyperactivity, and personality changes.a b d f


Abrupt discontinuance following prolonged high dosage may result in extreme fatigue, depression, and sleep EEG changes.a b d f


Sensitivity Reactions


Tartrazine Sensitivity

Some preparations (e.g., 35-mg conventional tablets manufactured by Sandoz) contain tartrazine (FD&C yellow No. 5), which may cause allergic reactions including bronchial asthma in susceptible individuals.f Incidence of tartrazine sensitivity is low, but it frequently occurs in patients who are sensitive to aspirin.f


General Precautions


Prescribe and dispense in the smallest feasible quantity to minimize possibility of overdosage.a b d f


Hypertension

Use with caution in patients with mild hypertension;a b c d f monitor BP closely.c Contraindicated in those with moderate or severe hypertension.a b c d f


Diabetes Mellitus

Use with caution in patients with diabetes mellitus; insulin requirements may decrease in association with phendimetrazine use and the concomitant dietary regimen and weight loss.c


Specific Populations


Pregnancy

Category C.d e


Whether potential benefits of anorexigenic agents outweigh risks is questionable; use of these agents during pregnancy (especially during the first trimester) probably should be considered a contraindication.c


Lactation

Not known whether phendimetrazine is distributed into milk;d however, because of its low molecular weight, the drug is expected to distribute into milk.e Caution if used in nursing women.d


Pediatric Use

Use not recommended in children <12 years of age.a b c f


Common Adverse Effects


Palpitation, tachycardia, increased BP, overstimulation, restlessness, dizziness, insomnia, agitation, flushing, tremor, sweating, headache, psychosis, blurred vision, dry mouth, diarrhea, constipation, nausea, stomach pain, changes in libido, urinary frequency, dysuria.a b c d f


Interactions for Bontril


Specific Drugs





















Drug



Interaction



Comments



Anorexigenic agents



Risk of serious cardiac problemsd



Avoid concomitant use (including with OTC drugs or herbal preparations) (see Contraindications under Cautions); phendimetrazine not recommended for patients who used any anorexigenic agents within prior yeard



CNS stimulants



Concomitant use contraindicateda b d f



Guanethidine (no longer commercially available in the US)



Decreased hypotensive effecta b c d



Insulin



Possible decrease in insulin requirements in patients with diabetes mellitusc



Use concomitantly with cautionc



MAO inhibitors



Potential for hypertensive crisisa b c d f



Phendimetrazine use during or within 14 days of MAO inhibitor use is contraindicatedc


Bontril Pharmacokinetics


Absorption


Bioavailability


Readily absorbed from the GI tract following oral administration.c


Duration


Effects persist for about 4 hours.c


Extended-release capsules produce prolonged therapeutic effect.a Effects achieved with one 105-mg extended-release capsule are similar to those achieved with three 35-mg conventional tablets administered at 4-hour intervals.a d


Distribution


Extent


Not known whether phendimetrazine is distributed into milk;d however, because of its low molecular weight, the drug is expected to distribute into milk.e


Elimination


Metabolism


Undergoes limited biotransformation.a d


Elimination Route


Excreted principally in urine.a d


Half-life


Conventional tablets: Approximately 1.9–3.7 hours.a d


Extended-release capsules: Approximately 3.7–9.8 hours.a d


Stability


Storage


Oral


Conventional Tablets and Extended-release Capsules

Tight, light-resistant containersf at 20–25°C.a b d f Protect from moisture.d f


ActionsActions



  • Produces anorexigenic effect and loss of weight.a b c d f




  • Like other amphetamine derivatives, has no primary effect on appetite;a b c d f anorexigenic action probably is secondary to CNS stimulation.c



Advice to Patients



  • Potential for drug to impair mental alertness or physical coordination; caution when driving or operating machinery until effects on individual are known.a b c d f




  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses (e.g., glaucoma, high BP, cardiac disease).a b d f




  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.a b d f




  • Importance of informing patients of other important precautionary information.a b d f (See Cautions.)



Preparations


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.


Subject to control under the Federal Controlled Substances Act of 1970 as a schedule III (C-III) drug.a b c d f


* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name




























Phendimetrazine Tartrate

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Capsules, extended-release



105 mg*



Bontril Slow Release (C-III)



Valeant



Phendimetrazine Tartrate Extended-release Capsules (C-III; with povidone)



Sandoz



Tablets



35 mg*



Bontril PDM (C-III; with isopropyl alcohol and povidone; scored)



Valeant



Phendimetrazine Tartrate Tablets (C-III; with povidone)



RLC, Sandoz



Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.


The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions February 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.




References


Only references cited for selected revisions after 1984 are available electronically.



100. Wyeth-Ayerst. Dear health care professional letter regarding valvular irregularities and primary pulmonary hypertension associated with the use of Plegine. Philadelphia, PA Wyeth-Ayerst; 1998 Jun 15.



101. Deitch MW. Dear health care provider letter: Pondimin and Redux to be voluntarily withdrawn. Philadelphia, PA: Wyeth-Ayerst; 1997 Sep 15.



102. Wyeth-Ayerst. Pondimin and Redux to be voluntarily withdrawn. Philadelphia, PA: 1997 Sep 15. Press release.



103. Lumpkin MM. FDA public health advisory: reports of valvular heart disease in patients receiving concomitant fenfluramine and phentermine. Rockville, MD: Food and Drug Administration; 1997 Jul 8.



104. Connolly HM, Crary JL, McGoon MD et al. Valvular heart disease associated with fenfluramine-phentermine. N Engl J Med. 1997; 337:581-8. [IDIS 391136] [PubMed 9271479]



105. Anon. FDA steps up campaign to discourage off-label “fen/phen” use with public health advisory; agency coordinates message with NEJM, Mayo clinic. FDC Rep. 1997; (Jul 14):4-5.



106. Anon. Knoll Meridia studies continue after Redux, Pondimin withdrawal: lawsuits call for Wyeth to fund medical monitoring of patients exposed to drugs. FDC Rep. 1997; (Sep 22):5.



107. US Food and Drug Administration. Questions and answers about Phen/fen and valvular heart disease. Rockville, MD; 1997 July 8.



108. Plutowski S (Mayo Foundation for Medical Education and Research). Valvular heart disease associated with commonly prescribed diet pills. Rochester, MN; 1997 Jul 8. Press release from website ().



109. Mayo Foundation for Medical Education and Research. Information for physicians regarding pharmacologic therapy for obesity. Rochester, MN; 1997 Jul 7. Press release from website ().



110. Mayo Foundation for Medical Education and Research. Heart valve disease and fen-phen: NEJM waives embargo for Mayo Clinic announcement. Rochester, MN; 1997 Jul 8. Press release from website ().



111. Anon. FDA fenfluramine/Redux epidemiological analysis of HMO records supports findings of valvulopathy in asymptomatic patients reported from five surveys. FDC Rep. 1997; (Sep 15):3-5.



112. Connolly HM, Crary JL, McGoon MD et al. for the Mayo Foundation for Medical Education and Research. Valvular heart disease associated with fenfluramine-phentermine. Rochester, MN; 1997 Jul 8.



113. Mayo Foundation for Medical Education and Research. Information and recommendations for people taking fenfluramine and phentermine. Rochester, MN; 1997 Jul 8.



114. Graham DJ, Green L. Further cases of valvular heart disease associated with fenfluramine-phentermine. N Engl J Med. 1997; 337:635. [IDIS 391141] [PubMed 9280830]



115. Centers for Disease Control and Prevention. Cardiac valvulopathy associated with exposure to fenfluramine or dexfenfluramine: U.S. Department of Health and Human Services interim public health recommendations, November 1997. MMWR Morb Mortal Wkly Rep. 1997; 46:1061-6. [IDIS 395477] [PubMed 9385873]



116. Medeva. Ionamin (C-IV) (phentermine resin capsules) prescribing information. Rochester, NY; 1997 Oct.



117. Coyne CT. Dear health care professional letter regarding labeling changes of Ionamin (phentermine resin capsules). Rochester, NY: Medeva; 1997 Aug 8.



118. Coyne CT. Dear doctor or health care professional letter regarding appropriate use of Ionamin (phentermine resin capsules). Rochester, NY: Medeva; 1997 Sep 18.



119. SoRelle R. Fen-phen and risk of valvular disease. Circulation. 1997; 96:1705-6. [PubMed 9323046]



120. Wyeth-Ayerst. Plegine (phendimetrazine tartrate tablets) prescribing information. In: Physicians’ desk reference. 52nd ed. Montvale, NJ: Medical Economics Company Inc; 1998(Suppl A):A304.



a. Valeant Pharmaceuticals International. Bontril (phendimetrazine tartrate) slow-release capsules prescribing information. Costa Mesa, CA; 2004 Sep.



b. Valeant Pharmaceuticals International. Bontril PDM (phendimetrazine tartrate) tablets prescribing information. Costa Mesa, CA; 2004 Sep.



c. AHFS Drug Information 2007. McEvoy GK, ed. Phendimetrazine tartrate. Bethesda, MD: American Society of Health-System Pharmacists; 2007:2496-7.



d. Sandoz Inc. Phendimetrazine tartrate extended-release capsules prescribing information. Princeton, NJ; 2006 Mar.



e. Phendimetrazine. In: Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation. 7th ed. Philadelphia, PA: Lippincott Williams & Wilkins, 2005:1276.



f. Sandoz Inc. Phendimetrazine tartrate tablets prescribing information. Princeton, NJ; 2006 Mar.



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Furosemide Farmacologico Milanese




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Furosemide

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