Ponderax

Ponderax HCl is indicated in the management of exogenous obesity as a short-term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction.

Drugs of this class used in obesity are commonly known as "anorectics" or "anorexigenics." It has not been established, however, that the action of such drugs in treating obesity is primarily one of appetite suppression. Other central nervous system actions or metabolic effects may be involved.

Adult obese subjects instructed in dietary management and treated with "anorectic" drugs, lose more weight on the average than those treated with placebo and diet, as determined in relatively short-term trials.

The average magnitude of increased weight loss of drug-treated patients over placebo-treated is only a fraction of a pound a week. The rate of weight loss is greatest in the first weeks of therapy for both drug and placebo subjects and tends to decrease in succeeding weeks. The possible origins of the increased weight loss due to the various drug effects are not established. The average amount of weight loss associated with the use of an "anorectic" drug varies from trial to trial, and the increased weight loss appears to be related in proof to variables other than the drug prescribed such as the physician-investigator, the population treated and the diet prescribed. Studies do not permit conclusions as to the relative importance of the drug and non-drug factors on weight loss.

The natural history of obesity is measured in years, whereas the studies cited are restricted to a few weeks duration; thus, the total impact of drug-induced weight loss over that of diet alone must be considered clinically limited.

The usual dose is one 20 mg tablet three times daily before meals. Depending on the degree of effectiveness and side effects, the dosage may be increased at weekly intervals by one tablet (20 mg) daily until a maximum dosage of two tablets three times daily is attained. Total dosage of Ponderax should not exceed 120 mg per day.

How supplied

Ponderax (Ponderax - removed from us market) is available in 20 mg orange, scored, compressed tablets monogrammed AHR and 6447, in bottles of 100 and 500.

Tablet, Uncoated -

Oral - 20 mg

Store at controlled room temperature, between 15°C and 30°C (59°F and 86°F).

Dispense in well-closed container.

Ponderax is contraindicated in patients with glaucoma or with hypersensitivity to Ponderax or other sympathomimetic amines. Do not administer Ponderax during or within 14 days following the administration of monoamine oxidase inhibitors, since hypertensive crises may result. Patients with a history of drug abuse should not receive this drug.

Do not administer Ponderax to patients with alcoholism since psychiatric symptoms (paranoia, depression, psychosis) have been reported in a few such patients who had been administered this drug.

Ponderax should also generally be avoided in patients with psychotic illness. There have been reports of schizophrenic patients who have become agitated, delusional, and assaultive.

A fatal cardiac arrest has been reported shortly after the induction of anesthesia in a patient who had been taking Ponderax prior to surgery. Ponderax may have a catecholamine-depleting effect when administered for prolonged periods of time; therefore, potent anesthetic agents should be administered with caution to patients taking Ponderax. If general anesthesia cannot be avoided, full cardiac monitoring and facilities for instant resuscitative measures are a minimum necessity.

Ponderax is used for short term therapy to reduce weight in the management of exogenous obesity (obesity caused by overeating).

Ponderax may increase slightly the effect of antihypertensive drugs, e.g., guanethidine, methyldopa, reserpine.

Other CNS depressant drugs should be used with caution in patients taking Ponderax, since the effects may be additive.

The most common adverse reactions of Ponderax are drowsiness, diarrhea, and dry mouth. Less frequent adverse reactions reported in association with Ponderax are:

Central nervous system: Dizziness; confusion; incoordination; headache; elevated mood; depression; anxiety, nervousness, or tension; insomnia; weakness or fatigue; increased or decreased libido; agitation, dysarthria.

Gastrointestinal: Constipation; abdominal pain; nausea.

Autonomic: Sweating; chills; blurred vision.

Genitourinary: Dysuria; urinary frequency.

Cardiovascular: Palpitation; hypotension; hypertension; fainting; pulmonary hypertension.

Skin: Rash; urticaria; burning sensation.

Miscellaneous: Eye irritation; myalgia; fever; chest pain; bad taste.

Drug Abuse and Dependence

Ponderax (Ponderax hydrochloride) is a controlled substance in Schedule IV. Ponderax is related chemically to the amphetamines, although it differs somewhat pharmacologically. The amphetamines and related stimulant drugs have been extensively abused and can produce tolerance and severe psychological dependence, as well as other adverse organic and mental changes. In this regard, there has been a report of abuse of Ponderax by subjects with a history of abuse of other drugs. Abuse of 80 to 400 milligrams of the drug has been reported to be associated with euphoria, derealization, and perceptual changes. Ponderax did not produce signs of dependence in animals and appears to produce sedation more often than CNS stimulation at therapeutic doses. Its abuse potential appears qualitatively different from that of amphetamines. The possibility that Ponderax may induce dependence should be kept in mind when evaluating the desirability of including the drug in the weight reduction programs of individual patients.