Pronunciation(fen dye ME tra zeen)
U.S. Brand NamesBontril PDM®; Bontril® Slow-Release; Melfiat®; Obezine® [DSC]; Prelu-2® [DSC]
SynonymsPhendimetrazine Tartrate
Generic AvailableYes
Canadian Brand NamesBontril®; Plegine®; Statobex®
UseAppetite suppressant during the first few weeks of dieting to help establish new eating habits; its effectiveness lasts only for short periods (3-12 weeks)
RestrictionsC-III
Pregnancy Risk FactorC
LactationExcretion in breast milk unknown/not recommended
ContraindicationsHypersensitivity to phendimetrazine or any component of the formulation
Warnings/PrecautionsAnorexigens 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 ReactionsFrequency 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)
DosageAdults: 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 EducationTake 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 TreatmentNo significant effects or complications reported
Dental Health: Vasoconstrictor/Local Anesthetic PrecautionsUse 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 productCapsule, 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 NamesAnoran® (BE); Bontril® (CA); Obesan® (ZA); Obex-LA® (ZA); Plegine® (CA); Statobex® (CA)
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