Bontril Information
Bontril® (phendimetrazine tartrate tablets, USP 35mg), an anti-obesity product - The active ingredient in Bontril is Phendimetrazine, Not Phentermine. Not as popular as Phentermine, but is also a very effective weight loss drug. It has the least side effects of any of the appetite suppressant medications with virtually no insomnia or stimulation. Due to its short half life it is more effective in most people with twice-a-day dosage even though a once-a-day dosage is available
An oral appetite suppressant used for weight loss. Bontril is the trade
name for Phendimetrazine. As with all appetite suppressants, Meant to be used in conjunction with a reduced calorie diet and is readily absorbed from the GI tract and effects persist for about 4 hours after oral administration. Some other names for Phendimetrazine include: Adipost, Melfiat, Prelu-2, X-Troxine, Obezine, Bontril -SR, and Bontril-PDM. Manufactured for and Marketed by Amarin Pharmaceuticals Inc. Bontril -SR stands for Bontril
Slow-Release Capsules
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. 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. OVER DOSAGE
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 Bontril Slow-Release Capsule (105 mg) in the morning, taken 30-60 minutes before the morning meal. |
