Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
DEXTROAMPHETAMINE SULFATE (UNII: JJ768O327N) (DEXTROAMPHETAMINE - UNII:TZ47U051FI)
SpecGx LLC
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;
Dextroamphetamine Sulfate Extended-Release Capsules Each capsule, with white opaque cap and white opaque body, contains dextroamphetamine sulfate. The 5 mg capsule is imprinted with an ® on the cap and is imprinted 8960 5 mg on the body in black. The 10 mg capsule is imprinted with an ® on the cap and is imprinted 8961 10 mg on the body in blue. The 15 mg capsule is imprinted with an ® on the cap and is imprinted 8962 15 mg on the body in pink. 5 mg Bottles of 100……………….NDC 0406-8960-01 10 mg Bottles of 100……………….NDC 0406-8961-01 15 mg Bottles of 100……………….NDC 0406-8962-01 Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure. Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and are trademarks of a Mallinckrodt company. © 2022 Mallinckrodt. SpecGx LLC Webster Groves, MO 63119 USA Rev 02/2022 Mallinckrodt™ Pharmaceuticals An electronic copy of this medication guide can be obtained from www.mallinckrodt.com/Medguide/L20D09.pdf or by calling 1-800-778-7898 for alternate delivery options.
Abbreviated New Drug Application
DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE- DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE SpecGx LLC ---------- MEDICATION GUIDE 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. 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, Perskaitykite visą dokumentą
DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE- DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE SPECGX LLC ---------- 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 extended-release capsule 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 capsules as the neutral sulfate. Structural formula: DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE CAPSULES 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, with white opaque cap and white opaque body, contains dextroamphetamine sulfate USP. The 5 mg capsule is imprinted with an on the cap and is imprinted 8960 5 mg on the body in black. The 10 mg capsule is imprinted with an on the cap and is imprinted 8961 10 mg on the body in blue. The 15 mg capsule is imprinted with an on the cap and is imprinted 8962 15 mg on the body in pink. ® ® ® Inactive ingredients consist of sugar spheres, titanium dioxide, gelatin, shellac glaze- 45%, SD-45 alcohol, iron oxide black, propylene glycol, FD&C Blue #2/Indigo Carmine Lake, FD&C Red #40/Allura Red AC Lake, FD&C Blue #1/Brilliant Blue FCF Lake, D&C Yellow #10 Lake, SD3A alcohol, shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, strong ammonia solution, FD&C Blue #2 Aluminum Lak Perskaitykite visą dokumentą