DEXEDRINE SPANSULE Extended-release capsule (2019)

Βιβλιογραφική αναφορά

Συγγραφείς

Amneal Pharmaceuticals LLC

Λέξεις κλειδιά

64896-673 64896-674 64896-675

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BOXED WARNING SECTION

WARNING AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG DEPENDENCE AND MUST BE AVOIDED. PARTICULAR ATTENTION SHOULD ...

1. Description

DEXEDRINE (dextroamphetamine sulfate) is the dextro isomer of the compound d,l-amphetamine sulfate, a sympathomimetic amine of the amphetamine group. Chemically, dextroamphetamine is ...

2. Clinical Pharmacology

Amphetamines are noncatecholamine, sympathomimetic amines with CNS stimulant activity. Peripheral actions include elevations of systolic and diastolic blood pressures and weak bronchodilator and respiratory ...

3. Indications and Usage

DEXEDRINE is indicated in: Narcolepsy Attention Deficit Disorder with Hyperactivity As an integral part of a total treatment program that typically includes other measures (psychological, educational, ...

4. Contraindications

Advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, glaucoma. Agitated ...

5. Warnings

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

6.1. General

The least amount feasible should be prescribed or dispensed at 1 time in order to minimize the possibility of overdosage.

6.2. Information for Patients

Amphetamines may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or vehicles; the patient should therefore be cautioned accordingly. Prescribers ...

6.5. Drug/Laboratory Test Interactions

Amphetamines can cause a significant elevation in plasma corticosteroid levels. This increase is greatest in the evening. Amphetamines may interfere with urinary steroid determinations.

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

Mutagenicity studies and long-term studies in animals to determine the carcinogenic potential of DEXEDRINE have not been performed.

6.7. Pregnancy

Teratogenic Effects DEXEDRINE has been shown to have embryotoxic and teratogenic effects when administered to A/Jax mice and C57BL mice in doses approximately 41 times the maximum human dose. Embryotoxic ...

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 amphetamines in pediatric patients have not been well established. DEXEDRINE is not recommended for use in pediatric patients younger than 6 years of age with Attention Deficit Disorder ...

7. Adverse Reactions

Cardiovascular: Palpitations, tachycardia, elevation of blood pressure. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use. Central Nervous System: ...

8. Drug Abuse and Dependence

Dextroamphetamine sulfate is a Schedule II controlled substance. Amphetamines have been extensively abused. Tolerance, extreme psychological dependence and severe social disability have occurred. There ...

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

Amphetamines should be administered at the lowest effective dosage and dosage should be individually adjusted. Late evening doses should be avoided because of the resulting insomnia. Narcolepsy Usual dose ...

11. How Supplied

DEXEDRINE SPANSULE capsules. Each capsule, with brown cap and natural body, contains dextroamphetamine sulfate. The 5-mg capsule is imprinted in white with IX and 5 mg on the brown cap and is imprinted ...

12. Storage and Handling

Store at controlled room temperature between 20° to 25°C (68° to 77°F) [see USP]. Dispense in a tight, light-resistant container.