Phendimetrazine Tartrate (Page 2 of 3)

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies with phendimetrazine tartrate sustained release have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.

Pregnancy

Pregnancy Category X

Phendimetrazine tartrate is contraindicated during pregnancy because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm. A minimum weight gain, and no weight loss, is currently recommended for all pregnant women, including those who are already overweight or obese, due to obligatory weight gain that occurs in maternal tissues during pregnancy. Phendimetrazine tartrate, a phenylalkylamine sympathomimetic amine has pharmacological activity similar to amphetamines (see CLINICAL PHARMACOLOGY). Animal reproduction studies have not been conducted in phendimetrazine tartrate. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.

Nursing Mothers

It is not known if phendimetrazine tartrate is excreted in human milk. Phendimetrazine tartrate, a phenylalkylamine sympathomimetic amine, has pharmacological activity similar to the amphetamines (see CLINICAL PHARMACOLOGY), and other amphetamines are present in human milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Drug Interactions

Monoamine Oxidase Inhibitors

Use of phendimetrazine tartrate is contraindicated during or within 14 days following the administration of monoamine oxidase inhibitors because of the risk of hypertensive crisis.

Alcohol

Concomitant use of alcohol with phendimetrazine tartrate may result in an adverse drug reaction.

Insulin and Oral Hypoglycemic Medications

Requirements may be altered

Adrenergic Neuron Blocking Drugs

phendimetrazine tartrate may decrease the hypotensive effect of adrenergic neuron blocking drugs.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Because pediatric obesity is a chronic condition requiring long-term treatment, the use of phendimetrazine tartrate ER approved for short-term therapy, is not recommended in patients less that 17 years of age.

Renal Impairment

Phendimetrazine tartrate extended-release capsules were not studied in patients with renal impairment. As phendimetrazine tartrate is excreted in urine, exposure increases can be expected in patients with renal impairment. Use caution when administering phendimetrazine tartrate to patients with renal impairment.

Geriatric Use

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

The major route of elimination is via the kidney where most of the drug and metabolites are excreted. The risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

ADVERSE REACTIONS

The following adverse reactions are described, or described in greater detail, in other sections:

– Primary pulmonary hypertension (see Warnings)

– Valvular heart disease (see Warnings)

-Effect on the ability to engage in potentially hazardous tasks (see Warnings)

-Withdrawal effects following prolonged high dosage administration (see Drug Abuse and Dependence)

The following adverse reactions to phendimetrazine have been identified:

Cardiovascular

Primary pulmonary hypertension and/or regurgitant cardiac valvular disease, palpitation, tachycardia, elevated blood pressure, ischemic events.

Central Nervous System

Overstimulation, restlessness, insomnia, agitation, flushing, tremor, sweating, dizziness, headache, psychotic state, blurring of vision.

Gastrointestinal

Dryness of the mouth, nausea, stomach pain, diarrhea, constipation,

Genitourinary

Urinary frequency, dysuria, changes in libido.

DRUG ABUSE AND DEPENDENCE

Controlled Substance

Phendimetrazine tartrate extended-release capsules are defined by the Drug Enforcement Administration as a Schedule III controlled substance.

Abuse

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.

Dependence

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

The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.

Acute Overdosage

Acute overdosage with phendimetrazine tartrate may manifest itself by the following signs and symptoms: unusual restlessness, confusion, belligerence, hallucinations, and panic states. Fatigue and depression usually follow the central stimulation. Cardiovascular effects include tachycardia, arrhythmias, hypertension, or hypotension and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea, and abdominal cramps. Poisoning may result in convulsions, coma, and death.

The management of acute overdosage is largely symptomatic. It includes lavage and sedation with a barbiturate. If hypertension is marked, the use of a nitrate or rapid-acting alpha receptor-blocking agent should be considered. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendations for its use.

Chronic Intoxication

Manifestations of chronic intoxication with anorectic drugs include sever dermatoses, marked insomnia, irritability, hyperactivity and personality changes. The most server manifestation of chronic intoxications is psychosis, often clinically indistinguishable from schizophrenia. See Drug Abuse and Dependence.

DOSAGE AND ADMINISTRATION

Extended-release capsule

Since the product is an extended-release dosage form, limit to one extended-release capsule (105 mg phendimetrazine tartrate) in the morning (30 to 60 minutes before morning meal).

Each extended-release capsule contains 105 mg phendimetrazine tartrate in a Brown/Clear capsule imprinted E 5254.

HOW SUPPLIED

Product: 63629-3051

NDC: 63629-3051-1 28 CAPSULE, EXTENDED RELEASE in a BOTTLE

NDC: 63629-3051-2 30 CAPSULE, EXTENDED RELEASE in a BOTTLE

NDC: 63629-3051-6 7 CAPSULE, EXTENDED RELEASE in a BOTTLE

NDC: 63629-3051-7 14 CAPSULE, EXTENDED RELEASE in a BOTTLE

NDC: 63629-3051-5 2 CAPSULE, EXTENDED RELEASE in a BOTTLE

NDC: 63629-3051-3 60 CAPSULE, EXTENDED RELEASE in a BOTTLE

NDC: 63629-3051-4 100 CAPSULE, EXTENDED RELEASE in a BOTTLE

NDC: 63629-3051-8 21 CAPSULE, EXTENDED RELEASE in a BOTTLE

NDC: 63629-3051-9 45 CAPSULE, EXTENDED RELEASE in a BOTTLE

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