Okay - those of you who have been here for awhile will know where this came from. I hope I have copied this information correctly. Soccermom, you did very well - there are a couple of corrections to the info on the website you cited. I have spent a half an hour cutting and pasting - I apologize if I goofed in anyway. I've done my best. Disclaimer: I do not in any way pretend to be an expert in this subject.
Phendimetrazine comes in 35mg immediate release tablets & capsules & 105 mg slow release capsules.
Bontril PDM® is a 35 mg tablet. Bontril-SR® is a 105mg Slow Release capsule.
Amarin Pharma manufactures Bontril. That other website says Carnrick Labs. That other website lists a bunch of errors under, “Bontril-SR Disclosures / Information Page.” The info they list is general copied info from 50 million other sites about all the anorectic drugs. The info they list is not specifically for phendimetrazine or Bontril!
Plegine® was a 35mg tablet. This tablet was manufactured by Wyeth-Ayerst. It has been withdrawn from the market.
Wyeth-Ayerst made Pondimin®. Shortly after Wyeth-Ayerst withdrew Pondimin from the market, they withdrew Plegine. Hmmmmmm … I wonder why??? Notice how they don’t mention that they were the maker of Pondimin in that FDA letter?
That other website list this, “US FDA Class 4 Medication” under Bontril-SR®. This is wrong!!!
Bontril is an FDA Schedule C-III controlled substance.
Phendimetrazine or Bontril should not be considered less effective than phentermine.
Doctors usually prescribe the Bontril PDM® or phendimetrazine 35mg (not the Bontril-SR® like the other website talks about) with phentermine.
Soccermom said – “Phendimetrazine is also known as Bontril. Some Physicians prescribe Bontril with Phen, the FDA has issued a WARNING against this practice.”
The FDA has not issued a warning against this practice. This is known as “off-label” prescribing and doctors are allowed to do this.
The same thing could be said about prescribing phentermine with Prozac.
Here is the famous “Dear Doctor” letter that was sent out by Medeva after the big fen/phen ordeal …
Dear Doctor or Health Care Professional:
The recent actions taken by Wyeth-Ayerst to withdraw their weight loss medications, Pondimin (fenfluramine hydrochloride) Tablets C-IV and Redux (dexfenfluramine hydrochloride) Capsules C-IV from the market have raised numerous questions and concerns about the status of other medications indicated in the treatment of exogenous obesity. Medeva Pharmaceuticals, Inc. would like to provide the medical community with important information about our product, IONAMIN (phentermine resin) Capsules C-IV.
This voluntary market withdrawal decision does NOT affect the availability of IONAMIN Capsules.
The decision to withdraw Pondimin and Redux was based on emerging information regarding significant adverse effects associated with these products. This information concerned abnormal heart valve findings which were determined to present an unacceptable risk to patients. The cases of valvular heart disease have reportedly involved patients taking fenfluramine in combination with phentermine; fenfluramine alone; dexfenfluramine alone; or dexfenfluramine in combination with phentermine. There have been no reported cases to date of this valvular condition occurring with the use of phentermine alone.
Primary pulmonary hypertension (PPH) is another significant adverse effect which has been reported to occur with increased frequency in patient using certain appetite suppressants (mainly fenfluramine or dexfenfluramine)1. Medeva is aware of only a few isolated case reports of PPH possibly associated with phentermine monotherapy over the last 38 years. Although present data do not support an association between PPH and phentermine monotherapy, the possibility cannot be ruled out.
For patients with a history of fenfluramine or dexfenfluramine use, alone or in combination with phentermine, a thorough cardiac evaluation may be appropriate prior to embarking on a new therapeutic regimen for the treatment of obesity. The safety and efficacy of IONAMIN Capsules in patients with existing valvular dysfunction and/or heart murmur, in whom the influence of increased sympathomimetic activity may be undesirable, have not been established, and its use in such patients cannot be recommended.
IONAMIN (phentermine resin) Capsules C-IV are indicated in the management of exogenous obesity as a short-term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction. In addition to dietary adjustments, comprehensive weight loss programs also include behavioral modifications and increased physical activity, at a sufficient level to produce health benefits toward the improvement of obesity-related medical conditions.
IONAMIN Capsules are indicated as monotherapy only. There are no data to support the safety and/or efficacy of combination therapy with phentermine and any other drug products for the treatment of obesity, including serotonin reuptake inhibitors (e.g., fluoxetine, sertraline, paroxetine). The coadministration of these agents is not recommended.
At the present time, the long-term safety and efficacy of IONAMIN Capsules have not been systematically evaluated, and long-term use of IONAMIN Capsules is not recommended.
Use of pharmacotherapy for weight loss should not be instituted for cosmetic purposes, but rather, should be reserved for those individuals with a body mass index (BMI) of greater than or equal to 30 kg/m2, or for those with a BMI or greater than or equal to 27 kg/m2 in the presence of other risk factors (e.g., hypertension, diabetes, hyperlipidemia), in whom non-pharmacologic interventions have been unsuccessful.
Further information regarding the withdrawal of Pondimin and Redux and valvular heart disease can be obtained from the FDA's Internet Website at
http://www.fda.gov/cder/news/fenphenqa2.htm. If you would like additional information about IONAMIN Capsules, the only phentermine resin product available, please contact Medeva's Medical Services Department at (800) 234-5535.
Sincerely,
Terrance C. Coyne, M.D.
Vice President, Medical Affairs
Phendimetrazine
Bontril®, Plegine® | Adipost® | Bock-Arate™ | Bontril® | Bontril® PDM | Cam-Metrazine™ | Kraft-Pleg™ | Kraft-Stat 35™ | Melfiat® | Obezine® | Phenazine® | Phendiet™ | Phenzene™ | Plegine® | Prelu-2® | Rapdone™ | Spec-Tabs™ | Statobex™ | X-Trozine® LA
Classification:
• Adrenergic agonists
• Autonomic Agents
• Psychostimulants
• Psychotropic Agents
• Sympathomimetics
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Indications:
•obesity
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Comments:
NOTE: Phendimetratizine is a schedule C-III controlled substance.
Description: Phendimetrazine is an oral, indirect-acting, nonamphetamine sympathomimetic amine. It is used as an anoretic agent for short-term (8 to 12 weeks) adjunct in the treatment of exogenous obesity. Phendimetrazine is only indicated for use as monotherapy only. This class of agents has a high potential for abuse and addiction. This drug was approved by the FDA in 1961.
Mechanism of Action: Appetite-suppression activity is believed to occur through direct stimulation of the satiety center in the hypothalamic and limbic region.
Contraindications/Precautions: Advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, glaucoma, agitated states, history of alcoholism or drug abuse, during or within 14 days of administration of an MAO inhibitor.
Children: Safety and efficacy have not been established in children.
Combination antiobesity therapy: Concurrent use of phendimetrazine with other anorectic agents is contraindicated. Phendimetrazine is not recommended for patients who used any anorectic agent within the prior year.
Pulmonary hypertension: In a case-control epidemiological study, the use of anorectic agents, including phendimetrazone, was associated with an increased risk of developing pulmonary hypertension, a rare, but often fatal disorder. The use of anorectic agents for longer than 3 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, phendimetrazone should be immediately discontinued, and the patient should be evaluated for the possible presence of pulmonary hypertension.
Valvulopathy: 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. Valvulopathy has not been reported with phendimetrazone monotherapy. 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 preexisting valvular heart diseases or pulmonary hypertension prior to initiation of phendimetrazone treatment. Phendimetrazone 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.
Drug Interactions:
Guanethidine: Anorexiants can decrease the antihypertensive effect of guanethidine.
Monoamine oxidase inhibitors: Can increase the pressor response to anorexiants. Do not administer phendimetrazine within 14 days of an MAOI drug.
Tricyclic antidepressants: Can decrease the effects of anorexiants.
Adverse Reactions: Anorexigens have been reported to be associated with the occurrence of serious regurgitant cardiac valvular disease, including disease of the mitral, aortic, and/or tricuspid valves. Primary pulmonary hypertension (PPH), a rare, frequently fatal disease of the lungs, has also been found to occur with increased frequency in patients receiving anorexigens. There have been reports of PPH and valvular irregularities in patients receiving phendimetrazine, all of which had a history of using at least one other anorexigen. No case of valvulopathy has been reported when phendimetrazine was used alone. Other adverse reactions that may occur with phendimetrazine include nausea/vomiting, diarrhea, sinus tachycardia, hypertension, overstimulation, restlessness, dizziness, insomnia, dyskinesia, euphoria, dysphoria, xerostomia, mydriasis, ocular irritation, blurred vision, anorexia, weight loss, impotence.
Available as:
Capsules or Tablets
phendimetrazine 35 mg
Available generically.
Extended-release Capsules or Tablets
phendimetrazine 105 mg
Available generically.
Dosage:
NOTE: The safety and effectiveness of the combined use of phendimetrazine with other anorexigens in the treatment of obesity have not been established, and there is no approved use of these products together in the treatment of obesity. Phendimetrazine is approved only as a single agent for short-term use (i.e., a few weeks).
For 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 and who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone:
Oral dosage:
Adults: 35 mg PO 2—3 times per day, 1 hour before meals.
NOTE: To limit unwarranted exposure and risks, treatment with phendimetrazine should be continued only if the patient has satisfactory weight loss within the first 4 weeks of treatment (e.g., weight loss of at least 4 lbs, or as determined by the physician and patient).
[ Revised 8/25/99 ]
PDR® entry for
Bontril Slow-Release Capsules (Amarin)
DESCRIPTION
Phendimetrazine tartrate, as the dextro isomer, has the chemical name of (+)-3,4-Dimethyl-2-phenylmorpholine Tartrate.
The structural formula is as follows:
Phendimetrazine tartrate is a white, odorless powder with a bitter taste. It is soluble in water, methanol and ethanol.
Bontril Slow-Release capsules contain FD&C Yellow No. 6 as a color additive.
ACTIONS
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.
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 active drug 105 mg of phendimetrazine tartrate in each capsule of this special slow-release dosage form approximates the action of three 35 mg non-time release doses taken at 4 hours intervals.
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 1.9 hours for the non-time and 9.8 hours for the slow-release dosage form. The absorption half-life of the drug from conventional non-time 35 mg phendimetrazine tartrate tablets is approximately the same. These data indicate that the slow-release product has a similar onset of action to the conventional non-time-release product and, in addition, has a prolonged therapeutic effect.
INDICATIONS
Phendimetrazine tartrate is indicated in the management of exogenous obesity as a short term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction. The limited usefulness of agents of this class (see ACTIONS ) should be measured against possible risk factors inherent in their use such as those described below.
CONTRAINDICATIONS
Advanced arteriosclerosis, symptomatic cardiovascular disease, moderate and severe hypertension, hyperthyroidism, known hypersensitivity, or idiosyncrasy to the sympathomimetic amines, glaucoma. Agitated states. Patients with a history of drug abuse. Use in patients taking other CNS stimulants including monoamine oxidase inhibitors.
WARNINGS
Tolerance to the anorectic effect usually develops within a few weeks. When this occurs, the recommended dose should not be exceeded in an attempt to increase the effect; rather, the drug should be discontinued.
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.
PRECAUTIONS
Caution is to be exercised in prescribing phendimetrazine tartrate 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.
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.
Usage in Children: Phendimetrazine tartrate is not recommended for use in children under 12 years of age.
ADVERSE REACTIONS
Cardiovascular: Palpitation, tachycardia, elevation of blood pressure.
Central Nervous System: Overstimulation, restlessness, dizziness, insomnia, tremor, headache; rarely psychotic episodes at recommended doses, agitation, flushing, sweating, blurring of vision.
Gastrointestinal: Dryness of the mouth, diarrhea, constipation, nausea, stomach pain.
Genitourinary: Changes in libido, urinary frequency, dysuria.
DRUG ABUSE AND DEPENDENCE
Controlled Substance: Phendimetrazine tartrate is a Schedule III 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.
OVERDOSAGE
Manifestations of acute overdosage may include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, 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.
Management of acute intoxication is largely symptomatic and includes lavage and sedation with a barbiturate. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendation in this regard.
Acidification of the urine increases phendimetrazine tartrate excretion.
Intravenous phentolamine (Regitine) has been suggested for possible acute, severe hypertension, if this complicates overdosage.
DOSAGE AND ADMINISTRATION
One Slow-Release Capsule (105 mg) in the morning, taken 30-60 minutes before the morning meal.
Phendimetrazine Tartrate is not recommended for use in children under twelve years of age.
HOW SUPPLIED
Phendimetrazine Tartrate Slow-Release Capsules, 105 mg is supplied in bottles of 100 opaque green and clear yellow capsules, imprinted with the letter "A" and 047. NDC # 65234-047-10.
Store at controlled room temperature, 15°- 30°C(59°-86°F).
CAUTION
** only
Manufactured for Amarin Pharmaceuticals Inc.
PHEEEEEEEEW!! I'm exhausted!
Gosh I hope I did this right.
[ February 22, 2002: Message edited by: nal ]
[ February 22, 2002: Message edited by: nal ]