AMPHETAMINE SULFATE 10 mg/1
amphetamine sulfate · TABLET · Bryant Ranch Prepack
AMPHETAMINE SULFATE is a tablet containing amphetamine sulfate at 10 mg/1, taken oral. Manufactured by Bryant Ranch Prepack.
Key Facts
- Brand Name
- AMPHETAMINE SULFATE
- Generic Name
- amphetamine sulfate
- NDC Code (Product)
72162-1088- Manufacturer
- Bryant Ranch Prepack
- Strength
- 10 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule II (Controlled)
- Application #
- ANDA212901
- Marketing Start
- 05/25/2020
Recall History
Teva Pharmaceuticals USA
Some bottles may contain mixed strengths of the product.
Actavis Elizabeth LLC
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Actavis Elizabeth LLC
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Amerisource Health Services
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Amerisource Health Services
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Amerisource Health Services
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Amerisource Health Services
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Granules Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications:
Teva Pharmaceuticals USA
Some bottles may contain mixed strengths of the product.
Teva Pharmaceuticals USA
Some bottles may contain mixed strengths of the product.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Amphetamine sulfate tablets are indicated for: Narcolepsy Attention Deficit Disorder with Hyperactivity as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of the syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or not be warranted. Exogenous Obesity as a short-term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction for patients refractory to alternative therapy, e.g., repeated diets, group programs, and other drugs. The limited usefulness of amphetamines ( see CLINICAL PHARMACOLOGY ) should be weighed against possible risks inherent in use of the drug, such as those desc…
Dosage & Administration
DOSAGE AND ADMINISTRATION Regardless of indication, amphetamine should be administered at the lowest effective dosage and dosage should be individually adjusted. Late evening doses should be avoided because of resulting insomnia. Narcolepsy Usual dose is 5 to 60 milligrams per day in divided doses depending on the individual patient response. Narcolepsy seldom occurs in children under 12 years of age; however, when it does, amphetamine sulfate tablets may be used. The suggested initial dose for patients aged 6 to 12 is 5 mg daily; daily dose may be raised in increments of 5 mg at weekly intervals until optimal response obtained. In patients 12 years of age and older, start with 10 mg daily; daily dosage may be raised in increments of 10 mg at weekly intervals until optimal response is obtained. If bothersome adverse reactions appear (e.g., insomnia or anorexia) dosage should be reduced. Give the first dose on awakening; additional doses (5 or 10 mg) at intervals of 4 to 6 hours. Attention Deficit Disorder with Hyperactivity Not recommended for children under 3 years of age. In children from 3 to 5 years of age, start with 2.5 mg daily; daily dosage may be raised in increments of 2.…
Warnings
WARNINGS Abuse, Misuse, and Addiction Amphetamine sulfate tablets have a high potential for abuse and misuse. The use of amphetamine sulfate tablets exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Amphetamine sulfate can be diverted for non-medical use into illicit channels or distribution ( see DRUG ABUSE AND DEPENDENCE ). Misuse and abuse of CNS stimulants, including amphetamine sulfate tablets, can result in overdose and death ( see OVERDOSAGE ), and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing amphetamine sulfate tablets, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks and proper disposal of any unused drug. Advise patients to store amphetamine sulfate in a safe place, preferably locked, and instruct patients to not give amphetamine sulfate tablets to anyone else. Throughout amphetamine sulfate tablets treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, an…
Contraindications
CONTRAINDICATIONS Known hypersensitivity to amphetamine products. During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result) ( see WARNINGS ).
Drug Interactions
Drug Interactions MAO inhibitors - MAOI antidepressants, as well as a metabolic of furazolidone, slow amphetamine metabolism. This slowing potentiates amphetamines, increasing their effect on the release of norepinephrine and other monoamines from adrenergic nerve endings; this can cause headaches and other signs of hypertensive crisis. A variety of neurological toxic effects and malignant hyperpyrexia can occur, sometimes with fatal results. Serotonergic drugs - The concomitant use of amphetamine sulfate tablets and serotonergic drugs increases the risk of serotonin syndrome. Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during amphetamine sulfate tablets initiation or dosage increase. If serotonin syndrome occurs, discontinue amphetamine sulfate tablets and the concomitant serotonergic drug(s) ( see WARNINGS and PRECAUTIONS ). CYP2D6 inhibitors - The concomitant use of amphetamine sulfate tablets and CYP2D6 inhibitors may increase the exposure of amphetamine sulfate tablets compared to the use of the drug alone and increase the risk of serotonin syndrome. Initiate with lower doses and monitor patients for signs and sympt…
Adverse Reactions
ADVERSE REACTIONS 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 verbal tics and Tourette's syndrome. Gastrointestinal Dryness of the mouth, unpleasant taste, diarrhea, constipation, intestinal ischemia and other gastrointestinal disturbances. Anorexia and weight loss may occur as undesirable effects when amphetamines are used for other than the anorectic effect. Allergic Urticaria Endocrine Impotence, changes in libido, and frequent or prolonged erections. Musculoskeletal Rhabdomyolysis
Frequently Asked Questions
What is AMPHETAMINE SULFATE used for?
AMPHETAMINE SULFATE contains amphetamine sulfate. It is a tablet taken oral. Consult your doctor for specific uses.
Is AMPHETAMINE SULFATE a controlled substance?
Yes, AMPHETAMINE SULFATE is classified as CII under the DEA Controlled Substances Act.
What is the generic name for AMPHETAMINE SULFATE?
The generic name for AMPHETAMINE SULFATE is amphetamine sulfate. There are 8 other brand versions of amphetamine sulfate.
What is the NDC code for AMPHETAMINE SULFATE 10 mg/1?
The NDC (National Drug Code) for AMPHETAMINE SULFATE 10 mg/1 is 72162-1088, listed by Bryant Ranch Prepack.