DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE CAPSULES CII

/DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE CAPSULES CII
DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE CAPSULES CII2018-09-06T09:12:40+00:00

Prescription Drug Name:

DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE CAPSULES CII

ID:

a713d3ed-0eb3-4dcc-be8e-d03a954a8d95

Code:

34391-3

DESCRIPTION


id: b496c02f-fbc0-4cf4-b5dd-912f4dc92b69
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Dextroamphetamine sulfate, USP is the dextro isomer of the compound d,l -amphetamine sulfate, a sympathomimetic amine of the amphetamine group. Chemically, dextroamphetamine is d-alpha-methylphenethylamine, and is present in all forms of dextroamphetamine as the neutral sulfate. The structural formula is as follows: (C9H13N)2 • H2SO4 M.W. 368.49 Each extended-release capsule is so prepared that an initial dose is released promptly and the remaining medication is released gradually over a prolonged period. Each capsule contains dextroamphetamine sulfate, USP, and has the following inactive ingredients: colloidal silicon dioxide, dibutyl sebacate, ethylcellulose aqueous dispersion, methylcellulose, povidone, propylene glycol, sugar spheres and talc. The capsule shell ingredients in the 5 mg are D&C red no. 33, FD&C blue no. 1, FD&C yellow no. 6, gelatin, and titanium dioxide. The capsule shell ingredients in the 10 mg are black iron oxide, gelatin, red iron oxide, titanium dioxide, and yellow iron oxide. The capsule shell ingredients in the 15 mg are black iron oxide, gelatin, red iron oxide, titanium dioxide, and yellow iron oxide. The imprinting ingredients are D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, pharmaceutical glaze, propylene glycol, and synthetic black iron oxide.

CLINICAL PHARMACOLOGY


id: b2e7948b-e161-4f60-b079-1a1c41a4386e
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1

Amphetamines are noncatecholamine, sympathomimetic amines with CNS stimulant activity. Peripheral actions include elevations of systolic and diastolic blood pressures and weak bronchodilator and respiratory stimulant action. There is neither specific evidence that clearly establishes the mechanism whereby amphetamines produce mental and behavioral effects in children, nor conclusive evidence regarding how these effects relate to the condition of the central nervous system. Dextroamphetamine sulfate extended-release capsules are formulated to release the active drug substance in vivo in a more gradual fashion than the standard formulation, as demonstrated by blood levels. The formulation has not been shown superior in effectiveness over the same dosage of the standard, noncontrolled-release formulations given in divided doses.

INDICATIONS AND USAGE


id: d45fb6c4-7774-43f1-88db-58b763aa40a6
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Dextroamphetamine Sulfate Extended-Release Capsules are indicated in:

CONTRAINDICATIONS


id: 44f4a138-c00c-4336-a662-0237e0cfe2fb
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, glaucoma. Agitated states. Patients with a history of drug abuse. During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result).

DRUG ABUSE AND DEPENDENCE


id: adabac15-4e55-4dfa-a2f5-4ea2b08a44e2
displayName: DRUG ABUSE AND DEPENDENCE SECTION
FDA Article Code: 42227-9

Dextroamphetamine sulfate is a Schedule II controlled substance. Amphetamines have been extensively abused. Tolerance, extreme psychological dependence and severe social disability have occurred. There are reports of patients who have increased the dosage to many times that recommended. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. Manifestations of chronic intoxication with amphetamines include severe dermatoses, marked insomnia, irritability, hyperactivity, and personality changes. The most severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia. This is rare with oral amphetamines.

OVERDOSAGE


id: 71edfe5c-8407-402a-b7bc-8cea5dc25050
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

Individual patient response to amphetamines varies widely. While toxic symptoms occasionally occur as an idiosyncrasy at doses as low as 2 mg, they are rare with doses of less than 15 mg; 30 mg can produce severe reactions, yet doses of 400 to 500 mg are not necessarily fatal. In rats, the oral LD50 of dextroamphetamine sulfate is 96.8 mg/kg. Manifestations of acute overdosage with amphetamines include restlessness, tremor, hyperreflexia, rhabdomyolysis, rapid respiration, hyperpyrexia, confusion, assaultiveness, hallucinations, panic states. Fatigue and depression usually follow the central stimulation. Cardiovascular effects include arrhythmias, hypertension or hypotension, and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea, and abdominal cramps. Fatal poisoning is usually preceded by convulsions and coma.

DOSAGE AND ADMINISTRATION


id: eff3aafb-7d67-4a90-ade8-d17a34e113bb
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

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.

HOW SUPPLIED


id: 80f333d1-e903-4d2e-9ff4-7780b403c4fd
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Dextroamphetamine Sulfate Extended-Release Capsules are available as: 5 mg: Two-piece hard gelatin capsules with beige opaque cap and beige opaque body filled with white to off-white pellets. Imprinted in black ink stylized barr 954. Available in bottles of 100 (NDC 0555-0954-02). 10 mg: Two-piece hard gelatin capsules with brown opaque cap and colorless, clear body filled with white to off-white pellets. Imprinted in black ink stylized barr 955. Available in bottles of 100 (NDC 0555-0955-02). 15 mg: Two-piece hard gelatin capsules with dark brown opaque cap and colorless, clear body filled with white to off-white pellets. Imprinted in black ink stylized barr 956. Available in bottles of 100 (NDC 0555-0956-02). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Rev. D 4/2015

MEDICATION GUIDE


id: 491c6152-3ae9-47fa-9cd3-a2cc57fcacac
displayName: SPL MEDGUIDE SECTION
FDA Article Code: 42231-1

DEXTROAMPHETAMINE SULFATE
(DEX-troe-am-FET-uh-meen SULL-fate)
EXTENDED-RELEASE CAPSULES CII
Read the Medication Guide that comes with dextroamphetamine sulfate extended-release capsules before you or your child starts taking them and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your or your child’s treatment with dextroamphetamine sulfate extended-release capsules.

Package/Label Display Panel


id: 467914f7-3b02-4d35-b417-c805e61cb4ec
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Package/Label Display Panel


id: 581ebcf4-c272-4b49-973f-918c8f2df1bf
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Package/Label Display Panel


id: 99f90d7d-ff5b-46fa-a240-71fce5c2a3ec
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4