WARNING
id: 75e3b368-4b21-43f9-ae3c-6602261aeb3e
displayName: BOXED WARNING SECTION
FDA Article Code: 34066-1
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 BE PAID TO THE POSSIBILITY OF SUBJECTS OBTAINING AMPHETAMINES FOR NON-THERAPEUTIC USE OR DISTRIBUTION TO OTHERS, AND THE DRUGS SHOULD BE PRESCRIBED OR DISPENSED SPARINGLY.
MISUSE OF AMPHETAMINES MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS.
DESCRIPTION
id: b6cf6a9c-bbcc-4b6b-8be8-a09287676eba
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.
Structural formula:
Each dextroamphetamine sulfate 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: corn starch, dibutyl sebacate, ethylcellulose, hypromellose, magnesium stearate, polyethylene glycol, sucrose, sodium lauryl sulfate, and talc. Each capsule shell contains the following ingredients: D&C Red #28, D&C Yellow #10, FD&C Blue #1, gelatin and titanium dioxide. The imprinting inks contain: iron oxide black, iron oxide red, iron oxide yellow, povidone, propylene glycol, shellac, sodium hydroxide, and titanium dioxide. Each capsule has a clear body and a brown cap with the following imprints: the 5 mg capsule is imprinted with “5 mg” on the cap and “V2674” on the body; the 10 mg capsule is imprinted with “10 mg” on the cap and “V2675” on the body; the 15 mg capsule is imprinted with “15 mg” on the cap and “V2676” on the body.
CLINICAL PHARMACOLOGY
id: 63b63490-500b-4a6e-ba45-7c534f069010
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: 5fe49622-b892-43d4-a82c-7446ba347d89
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Dextroamphetamine sulfate extended-release capsules are indicated in:
CONTRAINDICATIONS
id: f77f65f7-150c-4e60-ab85-665b811648d7
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.
Known hypersensitivity or idiosyncrasy to amphetamine.
In patients known to be hypersensitive to amphetamine, or other components of dextroamphetamine sulfate extended-release capsules. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products [see
ADVERSE REACTIONS
].
Patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis [see
WARNINGS
and
Drug Interactions
].
ADVERSE REACTIONS
id: a479a561-cd87-4c9b-9201-5a9a8678b5dc
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
Cardiovascular
Palpitations, tachycardia, elevation of blood pressure. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use.
Central Nervous System
Psychotic episodes at recommended doses (rare), overstimulation, restlessness, dizziness, insomnia, euphoria, dyskinesia, dysphoria, tremor, headache, exacerbation of motor and phonic tics, and Tourette’s syndrome.
Gastrointestinal
Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances. Anorexia and weight loss may occur as undesirable effects.
Allergic
Urticaria.
Endocrine
Impotence, changes in libido, frequent or prolonged erections.
Musculoskeletal
Rhabdomyolysis.
Skin and Subcutaneous Tissue Disorders
Alopecia.
DRUG ABUSE AND DEPENDENCE
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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: ae28ae25-0e58-4e0f-9370-5d0f15f30ad1
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
Manifestations of amphetamine overdose include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, panic states, hyperpyrexia and rhabdomyolysis. Fatigue and depression usually follow the central nervous system stimulation. Serotonin syndrome has also been reported. 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.
Treatment
Consult with a Certified Poison Control Center for up to date guidance and advice.
TREATMENT
id: b718b7a5-87ad-41c3-9c30-8bf3530cb26f
displayName: SPL UNCLASSIFIED SECTION
FDA Article Code: 42229-5
Consult with a Certified Poison Control Center for up-to-date guidance and advice. Management of acute amphetamine intoxication is largely symptomatic and includes gastric lavage, administration of activated charcoal, administration of a cathartic, and sedation. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendation in this regard. Acidification of the urine increases amphetamine excretion, but is believed to increase risk of acute renal failure if myoglobinuria is present. If acute, severe hypertension complicates amphetamine overdosage, administration of intravenous phentolamine (Bedford Laboratories) has been suggested. However, a gradual drop in blood pressure will usually result when sufficient sedation has been achieved.
Chlorpromazine antagonizes the central stimulant effects of amphetamines and can be used to treat amphetamine intoxication.
Since much of the dextroamphetamine sulfate extended-release capsule medication is coated for gradual release, therapy directed at reversing the effects of the ingested drug and at supporting the patient should be continued for as long as overdosage symptoms remain. Saline cathartics are useful for hastening the evacuation of pellets that have not already released medication.
DOSAGE AND ADMINISTRATION
id: 5ee5a45a-05a7-44e9-9f69-ea46c6fd33ca
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: 313df098-2262-4926-af6a-6738203edc1e
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Dextroamphetamine sulfate extended-release capsules contain polymer coated extended-release pellets of dextroamphetamine sulfate, USP and are available in three dose strengths.
Dextroamphetamine Sulfate Extended-Release Capsules, 5 mg, are size 4, with a clear body printed with “V2674” in brown ink and a dark brown opaque cap printed with “5 mg” in white ink. They are supplied as follows:
NDC 0603-2674-21: bottles containing 100 capsules
Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg, are size 4, with a clear body printed with “V2675” in brown ink and a dark brown opaque cap printed with “10 mg” in white ink. They are supplied as follows:
NDC 0603-2675-21: bottles containing 100 capsules
Dextroamphetamine Sulfate Extended-Release Capsules, 15 mg, are size 3, with a clear body printed with “V2676” in brown ink and a dark brown opaque cap printed with “15 mg” in white ink. They are supplied as follows:
NDC 0603-2676-21: bottles containing 100 capsules
Medication Guide
id: 3394246e-9dd1-44b1-b5f2-357ed306f6be
displayName: SPL MEDGUIDE SECTION
FDA Article Code: 42231-1
Dextroamphetamine Sulfate Extended-Release Capsules CII
(DEX-troe-am-FET-uh-meen SULL-fate)
Read the Medication Guide that comes with dextroamphetamine sulfate extended-release capsules before you or your child starts taking it 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.
PRINCIPAL DISPLAY PANEL – 5 mg
id: 003cc23b-9ef1-46d3-be4a-2d0c879e3dce
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
PRINCIPAL DISPLAY PANEL – 10 mg
id: 1fd2c803-0ab5-4f8a-8d62-12de5431eb28
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
PRINCIPAL DISPLAY PANEL – 15 mg
id: 9a156db3-6da1-415a-a197-a624455f42cf
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
