Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
DEXTROAMPHETAMINE SULFATE (UNII: JJ768O327N) (DEXTROAMPHETAMINE - UNII:TZ47U051FI)
Mayne Pharma Inc.
DEXTROAMPHETAMINE SULFATE
DEXTROAMPHETAMINE SULFATE 5 mg
ORAL
PRESCRIPTION DRUG
Dextroamphetamine sulfate extended-release capsules are 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 the 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 organ
Dextroamphetamine Sulfate Extended-Release Capsules are available as follows: 5 mg - Capsules with a light brown opaque cap and body are printed with and 0303 on both cap and body in black ink and contain 5 mg of dextroamphetamine sulfate, USP. Capsules are supplied in bottles of 90 (NDC 51862-344-90). 10 mg - Capsules with a light brown opaque cap and light orange transparent body are printed with and 0304 on both cap and body in black ink and contain 10 mg of dextroamphetamine sulfate, USP. Capsules are supplied in bottles of 90 (NDC 51862-345-90). 15 mg - Capsules with a light brown opaque cap and light orange transparent body are printed with and 0305 on both cap and body in black ink and contain 15 mg of dextroamphetamine sulfate, USP. Capsules are supplied in bottles of 90 (NDC 51862-346-90). Store at controlled room temperature between 20° and 25°C (68° and 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA Distributed by: Mayne Pharma Greenville, NC 27834 Rev. A 3/2019
Abbreviated New Drug Application
DEXTROAMPHETAMINE SULFATE- DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE Mayne Pharma Inc. ---------- MEDICATION GUIDE Dextroamphetamine Sulfate (dex'' troe am fet' a meen sul' fate) Extended-Release Capsules CII 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. What is the most important information I should know about dextroamphetamine sulfate extended- release capsules? The following have been reported with use of dextroamphetamine sulfate extended-release capsules and other stimulant medicines. 1. Heart-related problems: • Sudden death in patients who have heart problems or heart defects • Stroke and heart attack in adults • Increased blood pressure and heart rate Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems. Your doctor should check you or your child carefully for heart problems before starting dextroamphetamine sulfate extended-release capsules. Your doctor should check your or your child's blood pressure and heart rate regularly during treatment with dextroamphetamine sulfate extended-release capsules. Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking dextroamphetamine sulfate extended-release capsules. 2. Mental (Psychiatric) problems: All Patients • new or worse behavior and thought problems • new or worse bipolar illness • new or worse aggressive behavior or hostility Children and Teenagers • new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms. Tell your doctor about any mental problems you or your child have, or about Preberite celoten dokument
DEXTROAMPHETAMINE SULFATE- DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE MAYNE PHARMA INC. ---------- DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE CAPSULES CII RX ONLY 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 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 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 sulfate extended-release as the neutral sulfate. Structural formula: 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 5 mg capsule, with a light brown opaque cap and body, contains 5 mg of dextroamphetamine sulfate, USP. The 5 mg capsule is printed with and 0303 on both cap and body in black ink. Each 10 mg capsule, with a light brown opaque cap and light orange transparent body, contains 10 mg of dextroamphetamine sulfate, USP. The 10 mg capsule is printed with and 0304 on both cap and body in black ink. Each 15 mg capsule, with a light brown opaque cap and light orange transparent body, contains 15 mg of dextroamphetamine sulfate, USP. The 15 mg capsule is printed with and 0305 on both cap and body in black ink. Inactive ingredients: denatured alcohol, ammonium hydroxide, ethylcellulose, gelatin, hydroxypropyl cellulose, hypromellose, medium chain triglycerides, oleic acid, polyethylene glycol and sugar spheres (which contain sucrose and corn starch). The capsule shells of the 5 mg, 10 mg and 15 mg contain black ir Preberite celoten dokument