Phendimetrazine Tartrate Tablets (Bontril PDM)
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Phendimetrazine Tartrate Tablets (Bontril PDM)

BONTRIL® PDM
(phendimetrazine tartrate) Tablets, USP 35 mg

DRUG DESCRIPTION

Phendimetrazine tartrate, as the dextro isomer, has the chemical name of (2S,3S)-3,4-Dimethyl-2-phenylmorpholine L-(+)-tartrate (1:1).

The structural formula is:

BONTRIL® (Phendimetrazine tartrate) Structural Formula Illustration

C12H17NO•C4H6O6..........................M.W. 341.36

Phendimetrazine tartrate is a white, odorless crystaline powder. It is freely soluble in water; sparingly soluble in warm alcohol, insoluble in chloroform, acetone, ether and benzene.

In addition, the following inactive ingredients are present: Compressible Sugar, Confectioner's Sugar, D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6, Isopropyl Alcohol, Lactose Anhydrous, Magnesium Stearate, Microcrystalline Cellulose, Povidone, Purified Water, Sodium Starch Glycolate.

What are the possible side effects of phendimetrazine (Adipost, Bontril PDM, Bontril Slow Release, Melfiat)?

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

Stop using phendimetrazine and call your doctor at once if you have a serious side effect such as:

  • feeling short of breath, even with mild exertion;
  • chest pain, feeling like you might pass out;
  • swelling in your ankles or feet;
  • pounding heartbeats or fluttering in your chest;
  • confusion or irritability, unusual thoughts or...

Read All Potential Side Effects and See Pictures of Bontril PDM »

What are the precautions when taking phendimetrazine tartrate tablets (Bontril PDM)?

Before taking phendimetrazine, tell your doctor or pharmacist if you are allergic to it; or to any other sympathomimetic amines (e.g., decongestants such as pseudoephedrine, stimulants such as amphetamine, appetite suppressants such as phentermine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using phendimetrazine, consult your doctor or pharmacist if you have: uncontrolled high blood pressure, glaucoma, history of alcohol/drug abuse, vascular heart disease (e.g., chest pain, heart attack), mental/mood problems (e.g., severe anxiety, bipolar disorder, psychosis,...

Read All Potential Precautions of Bontril PDM »

Last reviewed on RxList: 3/25/2009
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Bontril® PDM (phendimetrazine tartrate) is indicatedin the management of exogenous obesity as a short term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m2 or higher who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight,in kilograms (kg), divided bythe patient's height,inmeters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters.

BODY MASS INDEX (BMI), kg/m2
Height (feet, inches)

Weight (pounds) 5'0” 5'3” 5'6” 5'9” 6'0” 6'3”
140 27 25 23 21 19 18
150 29 27 24 22 20 19
160 31 28 26 24 22 20
170 33 30 28 25 23 21
180 35 32 29 27 25 23
190 37 34 31 28 26 24
200 39 36 32 30 27 25
210 41 37 34 31 29 26
220 43 39 36 33 30 28
230 45 41 37 34 31 29
240 47 43 39 36 33 30
250 49 44 40 37 34 31

Phendimetrazine tartrate is indicated for use as monotherapy only.

DOSAGE AND ADMINISTRATION

Usual Adult Dosage: 1 tablet (35 mg) twice a day or three times a day one hour before meals.

Dosage should be individualized to obtain an adequate response with the lowest effective dosage. In some cases, 1/2 tablet (17.5 mg) per dose may be adequate. Dosage should not exceed 2 tablets three times a day.

HOW SUPPLIED

Three-layered green, white and yellow tablet with “B 35” on the scored side and the letter “V” on the other. Bontril® PDM tablets containing 35 mg of phendimetrazine tartrate are available in bottles of 100 (NDC 0187-0497-01) and 1000 (NDC 0187-0497-02).

Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F).

DEA Order Form Required.

Distributed by: Valeant Pharmaceuticals North America. One Enterprise, Aliso Viejo, CA 92656 USA. Manufactured by: Mallinckrodt, Inc. Hobart, NY 13788.

Last reviewed on RxList: 3/25/2009
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Cardiovascular: Palpitation, tachycardia, elevated blood pressure, ischemic events.

Valvular heart disease associated with the use of some anorectic agents such as fenfluramine and dexfenfluramine, both independently and especially when used in combination with other anorectic drugs, have been reported. However, no case of this valvulopathy has been reported when phendimetrazine tartrate has been used alone.

Central Nervous System: Overstimulation, restlessness, insomnia, agitation, flushing, tremor, sweating, dizziness, headache, psychotic state, blurring of vision.

Gastrointestinal: Dryness of the mouth, nausea, diarrhea, constipation, stomach pain.

Genitourinary: Urinary frequency, dysuria, changes in libido.

Drug Abuse And Dependence

Controlled Substance: Bontril® PDM (phendimetrazine tartrate) is a Schedule lll controlled substance.

Dependence: Phendimetrazine tartrate is related chemically and pharmacologically to the amphetamines. Amphetamines and related stimulant drugs have been extensively abused, and the possibility of abuse of phendimetrazine should be kept in mind when evaluating the desirability of including a drug as part of a weight reduction program. Abuse of amphetamines and related drugs may be associated with intense psychological dependence and severe social dysfunction. There are reports of patients who have increased the dosage to many times that recommended. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity and personality changes. The most severe manifestation of chronic intoxications is psychosis, often clinically indistinguishable from schizophrenia.

Read the Bontril PDM (phendimetrazine tartrate tablets) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

Efficacy of phendimetrazine tartrate with other anorectic agents has not been studied and the combined use may have the potential for serious cardiac problems.

Last reviewed on RxList: 3/25/2009
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Phendimetrazine tartrate should not be used in combination with other anorectic agents, including prescribed drugs, over-the-counter preparations and herbal products.

In a case-control epidemiological study, the use of anorectic agents, including phendimetrazine tartrate, was associated with an increased risk of developing pulmonary hypertension, a rare, but often fatal disorder. The use of anorectic agents for longer than three months was associated with a 23-fold increase in the risk of developing pulmonary hypertension. Increased risk of pulmonary hypertension with repeated courses of therapy cannot be excluded.

The onset or aggravation of exertional dyspnea, or unexplained symptoms of angina pectoris, syncope, or lower extremity edema suggest the possibility of occurrence of pulmonary hypertension. Under these circumstances, phendimetrazine tartrate should be immediately discontinued, and the patient should be evaluated for the possible presence of pulmonary hypertension.

Valvular heart disease associated with the use of some anorectic agents such as fenfluramine and dexfenfluramine has been reported. Possible contributing factors include use for extended periods of time, higher than recommended dose, and/or use in combination with other anorectic drugs. However, no cases of this valvulopathy have been reported when phendimetrazine tartrate has been used alone.

The potential risk of possible serious adverse effects such as valvular heart disease and pulmonary hypertension should be assessed carefully against the potential benefit of weight loss. Baseline cardiac evaluation should be considered to detect pre-existing valvular heart diseases or pulmonary hypertension prior to initiation of phendimetrazine treatment. Phendimetrazine tartrate is not recommended in patients with known heart murmur or valvular heart disease. Echocardiogram during and after treatment could be useful for detecting any valvular disorders which may occur. To limit unwarranted exposure and risks, treatment with phendimetrazine tartrate should be continued only if the patient has satisfactory weight loss within the first 4 weeks of treatment (i.e., weight loss of at least 4 pounds, or as determined by the physician and patient).

Tolerance to the anorectic effect of phendimetrazine develops within a few weeks. When this occurs, its use should be discontinued; the maximum recommended dose should not be exceeded.

Use of phendimetrazine tartrate within 14 days following the administration of monoamine oxidase inhibitors may result in a hypertensive crisis.

Abrupt cessation of administration following prolonged high dosage results in extreme fatigue and depression. Because of the effect on the central nervous system, phendimetrazine tartrate may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; the patient should therefore be cautioned accordingly.

Phendimetrazine tartrate is not recommended for patients who used any anorectic agents within the prior year.

PRECAUTIONS

Caution is to be exercised in prescribing phendimetrazine for patients with even mild hypertension.

Insulin requirements in diabetes mellitus may be altered in association with the use of phendimetrazine tartrate and the concomitant dietary regimen.

Phendimetrazine tartrate may decrease the hypotensive effect of guanethidine. The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies with Phendimetrazine Tartrate have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.

Pregancy: Pregnancy Category C

Animal reproduction studies have not been conducted with phendimetrazine tartrate. It is also not known whether phendimetrazine tartrate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Usage in Pregnancy

Safe use in pregnancy has not been established. Until more information is available, phendimetrazine tartrate should not be taken by women who are or may become pregnant unless, in the opinion of the physician, the potential benefits outweigh the possible hazards.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, phendimetrazine tartrate should not be taken by women who are nursing unless, in the opinion of the physician, the potential benefits outweigh the possible hazards.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Last reviewed on RxList: 3/25/2009
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

Acute overdosage with phendimetrazine tartrate may manifest itself by the following signs and symptoms: unusual restlessness, confusion, belligerence, hallucinations, and panic states. Fatigue and depression usually follow the central stimulation. Cardiovascular effects include arrhythmias, hypertension, or hypotension and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea, and abdominal cramps. Poisoning may result in convulsions, coma, and death.

The management of overdosage is largely symptomatic. It includes sedation with a barbiturate. If hypertension is marked, the use of a nitrate or rapid-acting alpha receptor-blocking agent should be considered. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendations for its use.

CONTRAINDICATIONS

Known hypersensitivity or idiosyncratic reactions to sympathomimetics.

Advanced arteriosclerosis, symptomatic cardiovascular disease, moderate and severe hypertension, hyperthyroidism, and glaucoma.

Highly nervous or agitated patients.

Patients with a history of drug abuse.

Patients taking other CNS stimulants, including monoamine oxidase inhibitors.

Last reviewed on RxList: 3/25/2009
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Phendimetrazine tartrate is a sympathomimetic amine with pharmacological activity similar to the prototype drugs of this class used in obesity, the amphetamines. Actions include central nervous system stimulation and elevation of blood pressure. Tachyphylaxis and tolerance have been demonstrated with all drugs of this class in which these phenomena have been looked for.

Drugs of this class used in obesity are commonly known as “anorectics” or “anorexigenics”. It has not been established, however, that the action of such drugs in treating obesity is primarily one of appetite suppression. Other central nervous system actions or metabolic effects, may be involved for example.

Adult obese subjects instructed in dietary management and treated with anorectic drugs, lose more weight on the average than those treated with placebo and diet, as determined in relatively short term clinical trials.

The magnitude of increased weight loss of drug-treated patients over placebo-treated patients is only a fraction of a pound a week. The rate of weight loss is greatest in the first weeks of therapy for both drug and placebo subjects and tends to decrease in succeeding weeks. The possible origin of the increased weight loss due to the various drug effects is not established. The amount of weight loss associated with the use of an anorectic drug varies from trial to trial, and the increased weight loss appears to be related in part to variables other than the drug prescribed, such as the physician investigator, the population treated, and the diet prescribed. Studies do not permit conclusions as to the relative importance of the drug and non-drug factors on weight loss.

The natural history of obesity is measured in years, whereas the studies cited are restricted to a few weeks duration; thus, the total impact of drug-induced weight loss over that of diet alone must be considered clinically limited.

The major route of elimination is via the kidneys where most of the drug and metabolites are excreted. Some of the drug is metabolized to phenmetrazine and also phendimetrazine-N-oxide. The average half-life of elimination when studied under controlled conditions is about 3.7 hours for both the extended-release and immediate release forms. The absorption half-life of the drug from the immediate release 35 mg phendimetrazine tablets is appreciably more rapid than the absorption rate of the drug from the extended-release formulation.

Last reviewed on RxList: 3/25/2009
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 3/25/2009
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 3/25/2009
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Bontril PDM Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

PHENDIMETRAZINE - ORAL

(FEN-dye-meh-TRA-zeen)

USES: Phendimetrazine is used along with a doctor-approved, reduced-calorie diet, exercise, and behavior change program to help you lose weight. It is used in people who are significantly overweight (obese) and have not been able to lose enough weight with diet and exercise alone. Losing weight and keeping it off can reduce the many health risks that come with obesity, including heart disease, diabetes, high blood pressure, and a shorter life.

It is not known how this medication helps people to lose weight. It may work by decreasing your appetite, increasing the amount of energy used by your body, or by affecting certain parts of the brain. This medication is an appetite suppressant and belongs to a class of drugs called sympathomimetic amines.

HOW TO USE: Take the immediate-release form of this medication by mouth, usually 2 to 3 times a day 1 hour before meals or as directed by your doctor. Taking this medication late in the day may cause trouble sleeping (insomnia).

The sustained-release form of phendimetrazine is usually taken once a day 30 - 60 minutes before the morning meal. Swallow this medication whole. Do not crush, chew, or break the capsules. Doing so can destroy the long action of the drug and may increase side effects.

The dosage is based on your medical condition and response to therapy. Your doctor will adjust the dose to find the best dose for you. Use this medication regularly and exactly as prescribed in order to get the most benefit from it. To help you remember, take it at the same time(s) each day.

Phendimetrazine is usually taken for only a few weeks at a time. It should not be taken with other appetite suppressants (see also Drug Interactions section). The possibility of serious side effects increases with longer use of this medication and use of this drug along with certain other diet drugs.

This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as depression, severe tiredness) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.

Rarely, abnormal drug-seeking behavior (addiction) is possible with this medication. Do not increase your dose, take it more frequently, or use it for a longer time than prescribed. Properly stop the medication when so directed.

This medication may stop working well after you have been taking it for a while. Talk with your doctor if this medication stops working well. Do not increase the dose unless directed by your doctor. Your doctor may direct you to stop taking this medication.

Disclaimer

Bontril PDM Consumer (continued)

SIDE EFFECTS: Dizziness, dry mouth, difficulty sleeping, irritability, nausea, vomiting, diarrhea, or constipation may occur. If these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fast/irregular/pounding heartbeat, mental/mood changes (e.g., agitation, uncontrolled anger, hallucinations, nervousness), uncontrolled muscle movements, change in sexual ability/interest.

Stop taking this medication and seek immediate medical attention if any of these rare but very serious side effects occur: severe headache, slurred speech, seizure, weakness on one side of the body, vision changes (e.g., blurred vision).

This drug may infrequently cause serious (sometimes fatal) lung or heart problems (pulmonary hypertension, heart valve problems). The risk increases with longer use of this medication and use of this drug along with other appetite-suppressant drugs/herbal products. If you notice any of the following unlikely but very serious side effects, stop taking this medication and consult your doctor or pharmacist immediately: chest pain, difficulty breathing with exercise, decreased ability to exercise, fainting, swelling of the legs/ankles/feet.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Bontril PDM (phendimetrazine tartrate tablets) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before taking phendimetrazine, tell your doctor or pharmacist if you are allergic to it; or to any other sympathomimetic amines (e.g., decongestants such as pseudoephedrine, stimulants such as amphetamine, appetite suppressants such as phentermine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using phendimetrazine, consult your doctor or pharmacist if you have: uncontrolled high blood pressure, glaucoma, history of alcohol/drug abuse, vascular heart disease (e.g., chest pain, heart attack), mental/mood problems (e.g., severe anxiety, bipolar disorder, psychosis, schizophrenia), high blood pressure in the lungs (pulmonary hypertension), other heart problems (e.g., heart murmur, fast/irregular heartbeat, heart valve problems), stroke, overactive thyroid (hyperthyroidism).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, controlled high blood pressure, kidney disease, seizure problem.

This drug may make you dizzy or (rarely) drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Before having surgery, tell your doctor or dentist that you are using this medication.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at greater risk for dizziness and high blood pressure while using this drug.

This medication must not be used during pregnancy. Weight loss offers no potential benefit to a pregnant woman and may harm an unborn baby. If you become pregnant or think you may be pregnant, tell your doctor immediately.

It is unknown if this drug passes into breast-milk. However, similar drugs pass into breast milk. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Disclaimer

Bontril PDM Consumer (continued)

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

This drug should not be used with certain medications because very serious interactions may occur. If you are taking or have taken other appetite-suppressant drugs in the past year (e.g., phentermine, sibutramine, ephedra/ma huang), tell your doctor or pharmacist before starting this medication.

Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) within 2 weeks before, during, and after treatment with phendimetrazine. In some cases a serious (possibly fatal) drug interaction may occur.

If you are currently using any of these medications, tell your doctor or pharmacist before starting this medication.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially: drugs for depression (e.g., TCAs such as imipramine, SSRIs and SNRIs such as paroxetine, fluoxetine, venlafaxine, duloxetine), drugs for diabetes (e.g., insulin, sulfonylureas such as glipizide), high blood pressure medicine (e.g., guanethidine, methyldopa), phenothiazines (e.g., prochlorperazine, promethazine, chlorpromazine), other stimulants (e.g., amphetamines, methylphenidate, street drugs such as cocaine or MDMA/"ecstasy").

Tell your doctor or pharmacist if you also take drugs that cause dizziness or drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., risperidone, amitriptyline, trazodone).

Also report the use of drugs which might increase seizure risk when combined with this medication such as isoniazid (INH), phenothiazines (e.g., thioridazine), theophylline, or tricyclic antidepressants (e.g., amitriptyline), among others.

Check the labels on all your medicines/herbal products (e.g., cough-and-cold products containing decongestants such as pseudoephedrine, diet aids such as phenylpropanolamine, ephedra/ma huang) because they may contain ingredients that could increase your heart rate or blood pressure. Ask your pharmacist about using those products safely.

Caffeine can increase the side effects of this medication. Avoid drinking large amounts of beverages containing caffeine (coffee, tea, colas) or eating large amounts of chocolate.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: rapid breathing, unusual restlessness, fast/slow/irregular heartbeat, chest pain, hallucinations, seizures, loss of consciousness.

NOTES: Appetite suppressants should not be used in place of proper diet. For best results, this drug must be used along with a doctor-approved diet and exercise program.

Do not share this medication with others. It is against the law.

Laboratory and/or medical tests (e.g., blood pressure, heart tests, kidney tests) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose or late in the evening, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store the slow release form of this medication at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Store the immediate release form of this medication at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised April 2012. Copyright(c) 2012 First Databank, Inc.

Bontril PDM Patient Information Including Side Effects

Brand Names: Adipost, Bontril PDM, Bontril Slow Release, Melfiat

Generic Name: phendimetrazine (Pronunciation: fen di MEH tra zeen)

What is phendimetrazine (Bontril PDM)?

Phendimetrazine is similar to an amphetamine. Phendimetrazine stimulates the central nervous system (nerves and brain), which increases your heart rate and blood pressure and decreases your appetite.

Phendimetrazine is used as a short-term supplement to diet and exercise in the treatment of obesity.

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

Bontril PDM

round, green/yellow, imprinted with B 35, V

Bontril Slow Release 105 mg-AMA

green/yellow, imprinted with A, 047

Bontril

green/yellow, imprinted with C, 8647

What are the possible side effects of phendimetrazine (Bontril PDM)?

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

Stop using phendimetrazine and call your doctor at once if you have a serious side effect such as:

  • feeling short of breath, even with mild exertion;
  • chest pain, feeling like you might pass out;
  • swelling in your ankles or feet;
  • pounding heartbeats or fluttering in your chest;
  • confusion or irritability, unusual thoughts or behavior;
  • feelings of extreme happiness or sadness; 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:

  • feeling restless or hyperactive;
  • headache, dizziness, tremors;
  • sleep problems (insomnia);
  • flushing (warmth, redness, or tingly feeling);
  • dry mouth;
  • diarrhea or constipation, upset stomach; or
  • increased or decreased interest in sex, impotence.

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.

Read the Bontril PDM (phendimetrazine tartrate tablets) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about phendimetrazine (Bontril PDM)?

Phendimetrazine may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Phendimetrazine may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it.

Do not stop using phendimetrazine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using phendimetrazine.

Do not crush, chew, break, or open the extended-release capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

Bontril PDM Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking phendimetrazine (Bontril PDM)?

Do not use phendimetrazine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

You should not use this medication if you are allergic to phendimetrazine, or if you have:

  • coronary artery disease (hardening of the arteries);
  • heart disease;
  • severe or uncontrolled high blood pressure;
  • heart murmur or heart valve disorder;
  • pulmonary arterial hypertension (PAH);
  • overactive thyroid;
  • glaucoma;
  • severe agitation or nervousness;
  • if you have a history of drug or alcohol abuse; or
  • if you are allergic to other diet pills, amphetamines, stimulants, or cold medications.

To make sure you can safely take phendimetrazine, tell your doctor if you have any of these other conditions:

  • high blood pressure;
  • diabetes;
  • an anxiety disorder;
  • epilepsy or seizure disorder; or
  • if you have used other diet pills in the past year (prescription, over-the-counter, or herbal products).

It is not known whether phendimetrazine will harm an unborn baby. Do not take phendimetrazine without first talking to your doctor if you are pregnant.

It is also not known whether phendimetrazine passes into breast milk. Do not take phendimetrazine without first talking to your doctor if you are breast-feeding a baby.

How should I take phendimetrazine (Bontril PDM)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Phendimetrazine should be taken only for a short time, such as a few weeks.

Phendimetrazine is usually taken once daily. Follow your doctor's instructions.

Take phendimetrazine on an empty stomach, 30 to 60 minutes before your morning meal.

Do not crush, chew, break, or open the extended-release capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

You should lose at least 4 pounds during the first 4 weeks of taking phendimetrazine and eating a low calorie diet. Tell your doctor if you do not lose at least 4 pounds after taking the medication for 4 weeks.

Do not stop using phendimetrazine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using phendimetrazine.

Never take more of this medication than is prescribed for you. Too much phendimetrazine could be very dangerous to your health. Talk with your doctor if you have increased hunger or if you otherwise think the medication is not working properly. Taking more of this medication will not make it more effective and can cause serious, life-threatening side effects.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Bontril PDM Patient Information including If I Miss a Dose

What happens if I miss a dose (Bontril PDM)?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

A dose taken too late in the day will cause insomnia.

What happens if I overdose (Bontril PDM)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of phendimetrazine can be fatal.

Overdose symptoms of a phendimetrazine overdose include nausea, vomiting, diarrhea, stomach cramps, confusion, panic, hallucinations, extreme restlessness, feeling tired or depressed, ringing in your ears, chest pain, slow heart rate, weak pulse, fainting, seizure, or slow breathing (breathing may stop).

What should I avoid while taking phendimetrazine (Bontril PDM)?

Phendimetrazine may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

What other drugs will affect phendimetrazine (Bontril PDM)?

Tell your doctor about all other medicines you use, especially:

  • insulin; or
  • any other diet pills.

This list is not complete and other drugs may interact with phendimetrazine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about phendimetrazine.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 6.01. Revision date: 5/10/2011.

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