Desoxyn®, CII (methamphetamine hydrochloride tablets, USP)

Indications and Usage

Attention Deficit Disorder with Hyperactivity: As an integral part of a total treatment program for a stabilizing effect in children over 6 years of age with behaviors characterized as moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. Diagnosis should not be made with finality when these symptoms are of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted.

Exogenous Obesity: As a short-term (few weeks) adjunct in a regimen of weight reduction based on caloric restriction, for patients in whom obesity is refractory to alternative therapy.


Important Safety Information

Methamphetamine has a high potential for abuse and should be tried only in weight reduction programs where alternative therapy has been ineffective. Administration of Methamphetamine for prolonged periods may lead to drug dependence. The drug should be prescribed or dispensed sparingly. Misuse may cause sudden death and serious cardiovascular adverse events.

 

DESOXYN® (methamphetamine hydrochloride tablets, USP) is contraindicated during or within 14 days after administration of MAOIs as hypertensive crisis may result, in patients with glaucoma, advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism or known hypersensitivity or idiosyncrasy to sympathomimetic amines, and should not be given to patients who are in an agitated state or who have a history of drug abuse.

 

Tolerance to the anorectic effect usually develops within a few weeks. When this occurs, the drug should be discontinued. DESOXYN generally should not be used in children and adolescents with known serious heart problems. They can cause an increase in average blood pressure and average heart rate, and patients should be monitored through physical exam and careful history. Care should be taken if administering stimulants to patients with psychosis, bipolar illness and aggression, either pre-existing or treatment-emergent. In the presence of seizures, the drug should be discontinued. Patients 7-10 years of age who are not growing or gaining height or weight as expected may need their treatment interrupted. Visual disturbance has been reported. DESOXYN should be used with caution in patients with even mild hypertension. Methamphetamine should not be used to combat fatigue or to replace rest in normal persons. DESOXYN should not be used during pregnancy or nursing unless benefit justifies risk to the fetus.

 

The following adverse reactions have been reported: elevated blood pressure, tachycardia, palpitation, fatal cardiorespiratory arrest, dizziness, dysphoria, overstimulation, euphoria, insomnia, tremor, restlessness, headache, exacerbation of tics, Tourette’s syndrome, diarrhea, constipation, mouth dryness, unpleasant taste, urticaria, impotence, libido changes, and growth suppression.


Desoxyn is a registered trademark of Recordati Rare Diseases, Inc.