Yes

Anorexiant

An 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)

C-III

Known hypersensitivity to phendimetrazine

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. 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).

>10%:

Cardiovascular: Hypertension

Central nervous system: Euphoria, nervousness, insomnia

1% to 10%:

Central nervous system: Confusion, mental depression, restlessness

Gastrointestinal: Nausea, vomiting, constipation

Endocrine & metabolic: Changes in libido

Hematologic: Blood dyscrasias

Neuromuscular & skeletal: Tremor

Ocular: Blurred vision

<1%:

Cardiovascular: Tachycardia, arrhythmias

Central nervous system: Restlessness, headache

Dermatologic: Alopecia

Gastrointestinal: Diarrhea, abdominal cramps

Genitourinary: Dysuria

Neuromuscular & skeletal: Myalgia

Renal: Polyuria

Respiratory: Dyspnea

Miscellaneous: Diaphoresis (increased)

Adults: Oral:

Sustained release: 105 mg once daily in the morning before breakfast

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

Patients taking phendimetrazine may present with hypertension; monitor blood pressure

Take with a full glass of water one hour before meals (unless your doctor directs otherwise). Tell your doctor 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 doctor 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 doctor. 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 doctor may, therefore, want to decrease your dosage gradually. Be sure to tell your doctor 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 doctor if you are breast-feeding an infant. It is not known whether this medication passes into breast milk.

Capsule, as tartrate: 35 mg

Capsule, as tartrate, sustained release (Adipost®, Bontril® Slow-Release, Dital®, Dyrexan-OD®, Melfiat-105® Unicelles®, Prelu-2®; Rexigen Forte®): 105 mg

Tablet, as tartrate (Bontril PDM®, Plegine®): 35 mg