DESOXYN® (methamphetamine hydrochloride tablets, USP)

///DESOXYN® (methamphetamine hydrochloride tablets, USP)

DESOXYN® (methamphetamine hydrochloride tablets, USP)

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Description

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Desoxyn 5 mg Methamphetamine hydrochloride tablets, USP), chemically known as (S)-N,?-dimethylbenzeneethanamine hydrochloride, is a member of the amphetamine group of sympathomimetic amines.

DESOXYN tablets contain 5 mg of methamphetamine hydrochloride for oral administration.

DESOXYN tablets contain 5 mg of methamphetamine hydrochloride for oral administration.

INACTIVE INGREDIENTS

Corn starch, lactose, sodium paraminobenzoate, stearic acid and talc.

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 (NDC55292-102-01).

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

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