DESOXYN Tablet (2019)

Βιβλιογραφική αναφορά

Συγγραφείς

RECORDATI RARE DISEASES, INC.

Λέξεις κλειδιά

55292-104 55292-102

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BOXED WARNING SECTION

Methamphetamine has a high potential for abuse. Particular attention should be paid to the possibility of subjects obtaining methamphetamine for non-therapeutic use or distribution to others, and the ...

1. Description

DESOXYN (methamphetamine hydrochloride tablets, USP), chemically known as (S)-N,α-dimethylbenzeneethanamine hydrochloride, is a member of the amphetamine group of sympathomimetic amines. It has the following ...

2. Clinical Pharmacology

Methamphetamine is a sympathomimetic amine with CNS stimulant activity. Peripheral actions include elevation of systolic and diastolic blood pressures and weak bronchodilator and respiratory stimulant ...

3. Indications and Usage

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, ...

4. Contraindications

In patients known to be hypersensitive to amphetamine, or other components of DESOXYN. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with ...

5. Warnings

Serious Cardiovascular Events Sudden Death and Pre-existing Structural Cardiac Abnormalities or Other Serious Heart Problems Children and Adolescents: Sudden death has been reported in association ...

6.1. General

DESOXYN tablets 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. Prescribing and dispensing ...

6.2. Information for Patients

The patient should be informed that methamphetamine may impair the ability to engage in potentially hazardous activities, such as, operating machinery or driving a motor vehicle. Circulation problems ...

6.4. Drug Interactions

Insulin requirements in diabetes mellitus may be altered in association with the use of methamphetamine and the concomitant dietary regimen. Methamphetamine may decrease the hypotensive effect of ...

6.5. Drug/Laboratory Test Interactions

Literature reports suggest that amphetamines may be associated with significant elevation of plasma corticosteroids. This should be considered if determination of plasma corticosteroid levels is desired ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

Data are not available on long-term potential for carcinogenicity, mutagenicity, or impairment of fertility.

6.7. Pregnancy

Teratogenic effects Pregnancy Category C. Methamphetamine has been shown to have teratogenic and embryocidal effects in mammals given high multiples of the human dose. There are no adequate and well-controlled ...

6.9. Nursing Mothers

Amphetamines are excreted in human milk. Mothers taking amphetamines should be advised to refrain from nursing.

6.10. Pediatric Use

Long-term effects of methamphetamine in children have not been established (see WARNINGS). Drug treatment is not indicated in all cases of the behavioral syndrome characterized by moderate to severe distractibility, ...

6.11. Geriatric Use

Clinical Studies of DESOXYN did not include sufficient numbers of subjects age 65 years and over to determine whether elderly subjects respond differently from younger subjects. Other reported clinical ...

7. Adverse Reactions

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 ...

8. Drug Abuse and Dependence

Controlled Substance: DESOXYN tablets are subject to control under DEA schedule II. Abuse: Methamphetamine has been extensively abused. Tolerance, extreme psychological dependence, and severe ...

9. Overdosage

Manifestations of amphetamine overdose include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, panic states, hyperpyrexia and rhabdomyolysis. Fatigue ...

10. 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 ...

11. How Supplied

DESOXYN (methamphetamine hydrochloride tablets, USP) is supplied as white tablets imprinted with the letter R on one side and the number 12 on the opposite side, containing 5 mg methamphetamine hydrochloride ...

12. Storage and Handling

Recommended Storage: Store at 20°C to 25°C (68°F to 77°F). See USP controlled room temperature.