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Norex IFA Amfepramone Hydrochloride 50 mg 30 tabs

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Therapeutic Indications

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

Norex is a drug for the treatment of obesity. Weight reduction occurs by suppressing appetite. The active ingredient releases norepinephrine, which blocks the signals of hunger.
The drug is prescribed as adjuvant therapy in conjunction with diet and exercise. Short-term use is recommended until the first tangible results are obtained.

The active substance, amfepramone, belongs to the amphetamine group. It is available in tablet form with a dose of the main component of 50 mg.

Clinical Pharmacology

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

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

Amfepramone and its metabolites are excreted primarily by renal excretion, with 75% of the dose reported to be excreted in the urine within 24 hours of administration; the half-life of its metabolites from plasma is estimated to be between 4 and 6 hours.

Norex is classified as an anorexigenic drug. It is distinguished by its psychostimulant effects. Continuous use excites the satiety center in the brain and inhibits the hunger center. It stimulates the cerebral cortex of the large hemispheres of the brain. Does not have peripheral adrenostimulatory action. Slightly increases metabolism.

Rapidly absorbed from the gastrointestinal tract. The action occurs 30-60 minutes after intake and lasts for 8 hours. 75% of the dose is excreted in the urine within 24 hours. The half-life of metabolites is 4-6 hours.

Drug regimen

You can start taking the drug only after a full examination by a doctor. The duration of treatment is determined individually, taking into account tolerance and effect. The drug willn’t give results if you don’t change your lifestyle. Comprehensive therapy includes periodic physical activity and dietary intake.

Norex is prescribed to patients without concomitant pathologies. The body mass index is taken into account. The drug can be introduced into the treatment regimen in the absence of comorbidities and a body mass index of 30 kg/m². If the patient belongs to a risk group, the body mass index must be at least 27 kg/m².

Norex is prescribed in a dose of 25 mg 3-4 times a day. It should be taken 30-60 minutes before meals. If the effect of the initial dose is insufficient, it is increased to 100 mg. The duration of treatment is determined individually. On average, it takes 6-10 weeks to get the effect. Longer use of the drug is not recommended.

Norex is prescribed to patients from 16 years old. Categorically prohibited for children under 12 years of age.

Side effects

- Increased pressure.
- Dry mouth.
- Sleep disorders.
- Gastrointestinal disorders.
- Dizziness.
- Abnormal heart rhythm.
- Psychosis.
- Hallucinations.
- Anxiety.


Norex shouldn’t be administered simultaneously or 14 days after taking monoamine oxidase as it may cause a hypertensive crisis; patients with hypersensitivity to amfepramone or idiosyncrasy to sympathomimetic amines, states of agitation, or emotionally unstable individuals with a tendency or abuse of drugs or alcohol should not be treated.

Contraindicated in patients with glaucoma, hyperthyroidism, advanced atherosclerosis or severe hypertension, severe kidney disease, children under 12 years of age, pregnancy, and lactation.

General precautions

- The recommended dose should not be exceeded, but the drug should be discontinued if the patient stops losing weight.

- Use with great caution in severe hypertension and cardiovascular disease, including arrhythmias.

- It has been reported that amfepramone crises may increase seizures in some epileptic patients, so such patients should be closely monitored to adjust the dose or discontinue the drug.

- Prolonged use may cause dependence with a withdrawal syndrome when therapy is discontinued.

Drug abuse and dependence: Compounds chemically related to amphetamines and other stimulant drugs are potentially addictive. There are reports of people who have reported psychological dependence on amfepramone. In rare cases, hallucinations have occurred after relatively high doses.

There have been a few cases of toxic psychosis from overuse of amfepramone. In a very small number of cases toxic psychosis was observed, even though the recommended dose did not seem to be exceeded.

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

In a few cases, amfepramone was administered intravenously Addicts said they experienced relatively little euphoria while unsatisfied, so even patients who took amfepramone orally had an unwanted degree of anxiety and agitation that subsided as the drug's effects waned.

Other reports from amfepramone abusers were that after taking the drug for 24-72 hours, additional doses caused anxiety rather than euphoria. If tolerance develops, the recommended dose should not be exceeded in an attempt to increase the effects; it is better to discontinue the drug.

Amfepramone may impair the ability to concentrate in patients engaged in hazardous activities such as operating machinery or driving vehicles. It is important to warn patients about these conditions.

Please consult your personal physician before taking any medication.

Specific Uses

When taking Norex, the dose shouldn’t be increased on its own. Patients with a history of hypertension, cardiovascular disorders should not use without a physician's supervision. Monitor blood pressure during treatment. The main component of the drug may aggravate seizures in patients with epilepsy.

Norex shouldn’t be taken by patients with a history of drug addiction. When taken in high doses, the drug causes a slight euphoria. The compound belongs to the group of amphetamines, so in rare cases, it may cause drug dependence in healthy patients with uncontrolled long-term treatment. Withdrawal syndrome occurs when the intake is stopped abruptly, so the dose should be reduced gradually.

Affects concentration. After taking the drug, it is better not to drive vehicles and not to engage in activities that require high concentration.

The drug reduces the hypotensive effect of guanethidine and the hypoglycemic effect of insulin. Simultaneous use of these drugs is not recommended. Combination with MAO inhibitors increases the risk of hypertensive crisis.

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