THERAPEUTIC INDICATIONS

It is indicated as an adjunct in the treatment of exogenous obesity, associated with a hypocaloric diet and exercise.

CLINICAL PHARMACOLOGY

Amfepramone is rapidly absorbed from the gastrointestinal tract after oral administration and is extensively metabolized through a complex pathway of biotransformation involving N-dealkylation and reduction, many of their metabolites are biologically active and may participate in the therapeutic action of IFA Norex.

Studies have reported that amfepramone and its metabolites can cross the blood brain barrier and placenta.

Amfepramone and its metabolites are excreted primarily by renal excretion, has been reported that 75% of the dose was recovered in the urine within 24 hours after dosing, plasma half-life of its metabolites is estimated between 4 and 6 hours.

CONTRAINDICATIONS

IFA Norex not be administered concurrently or 14 days after administration of monoamine oxidase, since it can result in hypertensive crisis should not be given to patients hypersensitive to amfepramone or idiosyncrasy to sympathomimetic amines, states of agitation or emotionally unstable individuals who are susceptible or history of drug or alcohol abuse.

It is contraindicated in patients with glaucoma, hyperthyroidism, advanced arteriosclerosis or severe hypertension, severe kidney disease, children under 12 years, pregnancy and lactation.

GENERAL PRECAUTIONS

- Must not exceed the recommended dose, however, the drug should be discontinued when the patient stops losing weight.

- Must be used with a high degree of caution in severe hypertension and cardiovascular disease including arrhythmias.

- It has been reported that amfepramone crisis may increase seizures in some epileptic patients, so these patients should be carefully monitored to adjust the dose or stopping the medication.

- Prolonged use can induce dependence with withdrawal syndrome on discontinuation of therapy.

Drug abuse and dependence: Compounds chemically related to amphetamines and other stimulant drugs have a potential addict. There have been reports of individuals who reported being psychologically dependent amfepramone. Rarely hallucinations have occurred after taking relatively high doses.

There have been several cases of toxic psychosis excessive use straight amfepramone. In a very small number of cases was observed toxic psychosis despite apparently did not exceed the recommended dose.

The psychosis was temporary and disappeared after stopping the drug. Most of these subjects had abused other drugs such as amphetamine and fermetrazinc, and many are described with unstable personality.

In a few cases was administered intravenously amfepramone The addicts said they felt relatively little euphoria being dissatisfied therefore, even in patients who took the amfepramone abusers orally had an undesirable degree of anxiety and agitation faded as the effects of the drug.

Other reports amfepramone expressed by abusers was that after having taken it for 24 to 72 hours, additional doses did not produce euphoria, but rather anxiety. If tolerance develops, the recommended dose should not be exceeded in an attempt to increase the effect, preferably the drug should be discontinued.

Amfepramone may decrease the ability of patients who are using their concentration in dangerous activities such as machinery or driving vehicles. It is important to warn patients about these conditions.

Please consult your personal physician before taking any medication.