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Desoxyn®
(methamphetamine hydrochloride) Tablets for Oral Administration

DESCRIPTION

DESOXYN® (methamphetamine hydrochloride tablets, USP), chemically known as (S)-N,α-dimethylbenzene ethanamine hydrochloride, is a member of the amphetamine group of sympathomimetic amines.
Desoxyn (methamphetamine hydrochloride tablets, USP) Structural Formula Illustration
DESOXYN tablets contain 5 mg of methamphetamine hydrochloride for oral administration.

Inactive Ingredients
Corn starch, lactose, sodium para aminobenzoate, stearic acid and talc.

INDICATIONS

Attention Deficit Disorder With Hyperactivity
DESOXYN tablets are indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children over 6 years of age with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only 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 (i.e., a few weeks) adjunct in a regimen of weight reduction based on caloric restriction, for patients in whom obesity is refractory to alternative therapy, e.g., repeated diets, group programs, and other drugs.

The limited usefulness of DESOXYN tablets (see CLINICAL PHARMACOLOGY) should be weighed against possible risks inherent in use of the drug,

DOSAGE AND ADMINISTRATION

DESOXYN tablets are given orally.

Methamphetamine should be administered at the lowest effective dosage, and dosage should be individually adjusted. Late evening medication should be avoided because of the resulting insomnia.

Attention Deficit Disorder With Hyperactivity
For treatment of children 6 years or older with a behavioral syndrome characterized by moderate to severe distractibility, short attention span, hyperactivity, emotional lability and impulsivity: an initial dose of 5 mg DESOXYN once or twice a day is recommended. Daily dosage may be raised in increments of 5 mg at weekly intervals until an optimum clinical response is achieved. The usual effective dose is 20 to 25 mg daily. The total daily dose may be given in two divided doses daily.

Where possible, drug administration should be interrupted occasionally to determine if there is a recurrence of behavioral symptoms sufficient to require continued therapy.

For Obesity
One 5 mg tablet should be taken one-half hour before each meal. Treatment should not exceed a few weeks in duration. Methamphetamine is not recommended for use as an anorectic agent in children under 12 years of age.

HOW SUPPLIED

DESOXYN (methamphetamine hydrochloride tablets, USP) is supplied as white tablets imprinted with the letters OV on one side and the number 12 on the opposite side, containing 5 mg methamphetamine hydrochloride in bottles of 100 (NDC 55292-102-01).

Recommended Storage: Store below 86°F (30°C).

Dispense in a USP tight, light resistant container.

SIDE EFFECTS

The following are adverse reactions in decreasing order of severity within each category that have been reported:

Cardiovascular
Elevation of blood pressure, tachycardia and palpitation. Fatal cardiorespiratory arrest has been reported, mostly in the context of abuse/misuse.

Central Nervous System
Psychotic episodes have been rarely reported at recommended doses. Dizziness, dysphoria, overstimulation, euphoria, insomnia, tremor, restlessness and headache. Exacerbation of motor and phonic tics and Tourette’s syndrome.

Gastrointestinal
Diarrhea, constipation, dryness of mouth, unpleasant taste and other gastrointestinal disturbances.

Hypersensitivity
Urticaria.

Endocrine
Impotence and changes in libido; frequent or prolonged erections.

Musculoskeletal
Rhabdomyolysis.

Miscellaneous
Suppression of growth has been reported with the long-term use of stimulants in children