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Pronunciation:

(fen dye ME tra zeen)

U.S. Brand Names:

Bontril PDM®; Bontril® Slow-Release; Melfiat®; Obezine® [DSC]; Prelu-2® [DSC]

Synonyms:

Phendimetrazine Tartrate

Generic Available:

Yes

Canadian Brand Names:

Bontril®; Plegine®; Statobex®

Use:

Appetite suppressant during the first few weeks of dieting to help establish new eating habits; its effectiveness lasts only for short periods (3-12 weeks)

Restrictions:

C-III

Pregnancy Risk Factor:

Lactation:

Excretion in breast milk unknown/not recommended

Contraindications:

Hypersensitivity to phendimetrazine or any component of the formulation

Warnings/Precautions:

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 been found to occur with increased frequency in patients receiving anorexigens. There have been reports of PPH and valvular irregularities in users of phendimetrazine tartrate tablets. Stimulants may unmask tics in individuals with coexisting Tourette's syndrome.

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 (ie, a few weeks). Serious, potentially life-threatening toxicities may occur when thyroid hormones (at dosages above usual daily hormonal requirements) are used in combination with sympathomimetic amines to induce weight loss. Treatment of obesity is not an approved use for thyroid hormone.

Adverse Reactions:

Frequency not defined.

Cardiovascular: Hypertension, tachycardia, arrhythmia

Central nervous system: Euphoria, nervousness, insomnia, confusion, mental depression, restlessness, headache

Dermatologic: Alopecia

Endocrine & metabolic: Changes in libido

Gastrointestinal: Nausea, vomiting, constipation, diarrhea, abdominal cramps

Genitourinary: Dysuria

Hematologic: Blood dyscrasias

Neuromuscular & skeletal: Tremor, myalgia

Ocular: Blurred vision

Renal: Polyuria

Respiratory: Dyspnea

Miscellaneous: Diaphoresis (increased)

Dosage:

Adults: Oral:

Tablet: 35 mg 2 or 3 times daily, 1 hour before meals

Capsule, timed release: 105 mg once daily in the morning before breakfast

Patient Education:

Take with a full glass of water 1 hour before meals (unless your physician directs otherwise). Tell your physician about unusual or allergic reactions you have had to any medications, especially to phendimetrazine or other appetite suppressants (such as benzphetamine, phenmetrazine, diethylpropion, fenfluramine, mazindol, and phentermine) or to epinephrine, norepinephrine, ephedrine, amphetamines, dextroamphetamine, phenylephrine, phenylpropanolamine, pseudoephedrine, albuterol, metaproterenol, or terbutaline. Before having surgery or other medical or dental treatment, tell your physician or dentist you are taking this drug. Phendimetrazine is related to amphetamine and may be habit-forming when taken for long periods of time (both physical and psychological dependence can occur). You should not increase the dosage of this medication or take it for longer than 12 weeks without first consulting your physician. It is also important that you not stop taking this medication abruptly - fatigue, sleep disorders, mental depression, nausea, vomiting, or stomach cramps or pain could occur. Your physician may, therefore, want to decrease your dosage gradually. Be sure to tell your physician if you are pregnant. Although studies of phendimetrazine in humans have not been conducted, some of the appetite suppressants have been shown to cause side effects in the fetuses of animals that received large doses during pregnancy. Also, tell your physician if you are breast-feeding an infant. It is not known whether this medication passes into breast milk.

Dental Health: Effects on Dental Treatment:

No significant effects or complications reported

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

Use vasoconstrictor with caution in patients taking phendimetrazine. Phendimetrazine can enhance the sympathomimetic response to epinephrine leading to potential hypertension and cardiotoxicity.

Dosage Forms:

[DSC] = Discontinued product

Capsule, slow release, as tartrate (Bontril® Slow Release, Prelu-2® [DSC]): 105 mg

Capsule, sustained release, as tartrate (Melfiat®): 105 mg

Tablet, as tartrate (Bontril PDM®, Obezine® [DSC]): 35 mg

International Brand Names:

Anoran® (BE); Bontril® (CA); Obesan® (ZA); Obex-LA® (ZA); Plegine® (CA); Statobex® (CA)

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