Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
DEXTROAMPHETAMINE SULFATE (UNII: JJ768O327N) (DEXTROAMPHETAMINE - UNII:TZ47U051FI), DEXTROAMPHETAMINE SACCHARATE (UNII: G83415V073) (DEXTROAMPHETAMINE - UNII:TZ47U051FI), AMPHETAMINE SULFATE (UNII: 6DPV8NK46S) (AMPHETAMINE - UNII:CK833KGX7E), AMPHETAMINE ASPARTATE MONOHYDRATE (UNII: O1ZPV620O4) (AMPHETAMINE - UNII:CK833KGX7E)
Global Pharmaceuticals, Division of Impax Laboratories Inc.
DEXTROAMPHETAMINE SULFATE
DEXTROAMPHETAMINE SULFATE 1.25 mg
ORAL
PRESCRIPTION DRUG
MAS-ER Capsules® are indicated for the treatment of attention deficit hyperactivity disorder (ADHD). The efficacy of MAS-ER Capsules in the treatment of ADHD was established on the basis of two controlled trials in children aged 6 to 12, one controlled trial in adolescents aged 13 to 17, and one controlled trial in adults who met DSM-IV® criteria for ADHD [see CLINICAL STUDIES (14)]. A diagnosis of 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 two 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 six 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 t
MAS-ER Capsules are available as: 5 mg- Clear/blue (imprinted M. Amphet Salts 5 mg), bottles of 100, NDC 0115-1328-01 10 mg- Blue/blue (imprinted M. Amphet Salts 10 mg), bottles of 100, NDC 0115-1329-01 15 mg- Blue/white (imprinted M. Amphet Salts 15 mg), bottles of 100, NDC 0115-1330-01 20 mg- Orange/orange (imprinted M. Amphet Salts 20 mg), bottles of 100, NDC 0115-1331-01 25 mg- Orange/white (imprinted M. Amphet Salts 25 mg), bottles of 100, NDC 0115-1332-01 30 mg- Natural/orange (imprinted M. Amphet Salts 30 mg), bottles of 100, NDC 0115-1333-01 Dispense in a tight, light-resistant container as defined in the USP. Store at 25° C (77° F). Excursions permitted to 15-30° C (59-86° F) [see USP Controlled Room Temperature]
New Drug Application Authorized Generic
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE- DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE Global Pharmaceuticals, Division of Impax Laboratories Inc. ---------- MEDICATION GUIDE Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules (mixed salts of a single-entity amphetamine product) CII Read the Medication Guide that comes with MAS-ER 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 you or your child's treatment with MAS-ER Capsules. What is the most important information I should know about MAS-ER Capsules? MAS-ER Capsules are a stimulant medicine. The following have been reported with use of 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 MAS-ER Capsules. Your doctor should check you or your child's blood pressure and heart rate regularly during treatment with MAS-ER 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 MAS-ER 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 Прочитайте повний документ
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE- DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE EXTENDED- RELEASE CAPSULES (MAS-ER) SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MAS-ER CAPSULES. DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE EXTENDED-RELEASE CAPSULES (MIXED SALTS OF A SINGLE-ENTITY AMPHETAMINE PRODUCT), CII INITIAL U.S. APPROVAL: 2001 WARNING: POTENTIAL FOR ABUSE _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_ Amphetamines have a high potential for abuse; prolonged administration may lead to dependence. (9) Misuse of amphetamines may cause sudden death and serious cardiovascular adverse reactions. RECENT MAJOR CHANGES Warnings and Precautions (5.5) 6/2013 INDICATIONS AND USAGE Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules (MAS-ER Capsules), a CNS stimulant, is indicated for the treatment of attention deficit hyperactivity disorder (ADHD). (1) Children (ages 6-12): Efficacy was established in one 3-week outpatient, controlled trial and one analogue classroom, controlled trial in children with ADHD. (14) Adolescents (ages 13-17): Efficacy was established in one 4-week controlled trial in adolescents with ADHD. (14) Adults: Efficacy was established in one 4-week controlled trial in adults with ADHD. (14) DOSAGE AND ADMINISTRATION Pediatric patients (ages 6-17): 10 mg once daily in the morning. The maximum dose for children 6-12 is 30 mg once daily. (2.1, 2.2, 2.3) Adults: 20 mg once daily in Прочитайте повний документ