Dextroamphetamine Sulfate Extended-Release 10 mg/1
dextroamphetamine sulfate · CAPSULE, EXTENDED RELEASE · SpecGx LLC
Dextroamphetamine Sulfate Extended-Release is a capsule, extended release containing dextroamphetamine sulfate at 10 mg/1, taken oral. Manufactured by SpecGx LLC.
Key Facts
- Brand Name
- Dextroamphetamine Sulfate Extended-Release
- Generic Name
- dextroamphetamine sulfate
- NDC Code (Product)
0406-8961- Manufacturer
- SpecGx LLC
- Strength
- 10 mg/1
- Dosage Form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule II (Controlled)
- Application #
- ANDA076353
- Marketing Start
- 05/06/2003
Recall History
Actavis Inc
Failed Dissolution Specifications
Actavis Elizabeth LLC
Failed Dissolution Specifications
Amedra Pharmaceuticals LLC
Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
Amedra Pharmaceuticals LLC
Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
Amedra Pharmaceuticals LLC
Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Dextroamphetamine sulfate 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, social) for patients (ages 6 years to 16 years) with this syndrome. A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in 2 or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least 6 of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least 6 of the following symptoms must have p…
Dosage & Administration
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 is 5 to 60 mg 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, dextroamphetamine sulfate 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 an optimal response is 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 an optimal response is obtained. If bothersome adverse reactions appear (e.g., insomnia or anorexia), dosage should be reduced. Extended-release capsules may be used for once-a-day dosage wherever appropriate. Attention Deficit Disorder with Hyperactivity The extended-release capsule formulation is not recommended for pediatric patients younger than 6 years of age. In pediatric patients 6 years of age and older, start with 5 mg once or twice da…
Warnings
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 in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems. Although some serious heart problems alone carry an increased risk of sudden death, stimulant products generally should not be used in children or adolescents with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug. Adults Sudden deaths, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses for ADHD. Although the role of stimulants in these adult cases is also unknown, adults have a greater likelihood than children of having serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems. Adults with such abnormaliti…
Contraindications
CONTRAINDICATIONS 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. 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 ].
Drug Interactions
Drug Interactions Acidifying Agents Lower blood levels and efficacy of amphetamines. Increase dose based on clinical response. Examples of acidifying agents include gastrointestinal acidifying agents (e.g., guanethidine, reserpine, glutamic acid hydrochloride, ascorbic acid) and urinary acidifying agents (e.g., ammonium chloride, sodium acid phosphate, methenamine salts). Adrenergic Blockers Adrenergic blockers are inhibited by amphetamines. Alkalinizing Agents Increase blood levels and potentiate the action of amphetamine. Co-administration of dextroamphetamine sulfate and gastrointestinal alkalinizing agents should be avoided. Examples of alkalinizing agents include gastrointestinal alkalinizing agents (e.g., sodium bicarbonate) and urinary alkalinizing agents (e.g. acetazolamide, some thiazides). Tricyclic Antidepressants May enhance the activity of tricyclic or sympathomimetic agents causing striking and sustained increases in the concentration of d-amphetamine in the brain; cardiovascular effects can be potentiated. Monitor frequently and adjust or use alternative therapy based on clinical response. Examples of tricyclic antidepressants include desipramine, protriptyline. CYP2…
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 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. To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Frequently Asked Questions
What is Dextroamphetamine Sulfate Extended-Release used for?
Dextroamphetamine Sulfate Extended-Release contains dextroamphetamine sulfate. It is a capsule, extended release taken oral. Consult your doctor for specific uses.
Is Dextroamphetamine Sulfate Extended-Release a controlled substance?
Yes, Dextroamphetamine Sulfate Extended-Release is classified as CII under the DEA Controlled Substances Act.
What is the generic name for Dextroamphetamine Sulfate Extended-Release?
The generic name for Dextroamphetamine Sulfate Extended-Release is dextroamphetamine sulfate. There are 10 other brand versions of dextroamphetamine sulfate.
What is the NDC code for Dextroamphetamine Sulfate Extended-Release 10 mg/1?
The NDC (National Drug Code) for Dextroamphetamine Sulfate Extended-Release 10 mg/1 is 0406-8961, listed by SpecGx LLC.
Other Dextroamphetamine Sulfate Extended-Release Dosages
Other Dextroamphetamine Brands
See all →- DEXTROAMPHETAMINE SULFATE10 mg/172162-1234
- Dextroamphetamine Sulfate10 mg/172162-2350
- DEXTROAMPHETAMINE SULFATE5 mg/10406-8958
- Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate1.25 mg/10527-0790
- Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate7.5 mg/10527-0795
- Dextroamphetamine Sulfate20 mg/175826-125
- Zenzedi10 mg/124338-853
- Dextroamphetamine Sulfate10 mg/127808-090
- dextroamphetamine sulfate5 mg/145963-303
- MYDAYIS3.125 mg/154092-468
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)