Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
DEXTROAMPHETAMINE SACCHARATE (UNII: G83415V073) (DEXTROAMPHETAMINE - UNII:TZ47U051FI), AMPHETAMINE ASPARTATE MONOHYDRATE (UNII: O1ZPV620O4) (AMPHETAMINE - UNII:CK833KGX7E), DEXTROAMPHETAMINE SULFATE (UNII: JJ768O327N) (DEXTROAMPHETAMINE - UNII:TZ47U051FI), AMPHETAMINE SULFATE (UNII: 6DPV8NK46S) (AMPHETAMINE - UNII:CK833KGX7E)
NorthStar RxLLC
ORAL
PRESCRIPTION DRUG
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. Attention Deficit Hyperactivity Disorder (ADHD) 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 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 to follow through on tasks; poor organization; avoids tasks requiring sustained mental eff
Dextroamphetamine Saccharate, amphetamine aspartate monohydrate, Dextroamphetamine sulfate and amphetamine sulfate tablets are supplied as: 5 mg Tablets - Light blue to blue colored, mottled, round, flat-faced, beveled edge tablets debossed with ‘U25’ on one side and quadrisect on other side. Bottles of 100 16714-948-01 7.5 mg Tablets - Light blue to blue colored, mottled, round, convex tablets debossed with ‘U26’ on one side and quadrisect on other side. Bottles of 100 16714-949-01 10 mg Tablets - Light blue to blue colored, mottled, round, convex tablets debossed with ‘U27’ on one side and quadrisect on other side. Bottles of 100 16714-950-01 12.5 mg Tablets - Light orange to orange colored, mottled, round, flat-faced, beveled edge tablets debossed with ‘U28’ on one side and quadrisect on other side. Bottles of 100 16714-951-01 15 mg Tablets - Light orange to orange colored, mottled, round, convex tablets debossed with ‘U29’ on one side and quadrisect on other side. Bottles of 100 16714-952-01 20 mg Tablets - Light orange to orange colored, mottled, round, convex tablets debossed with ‘U30’ on one side and quadrisect on other side. Bottles of 100 16714-953-01 30 mg Tablets - are light orange to orange colored, mottled, round, flat-faced, beveled edge tablets debossed with ‘U31’ on one side and quadrisect on other side. Bottles of 100 16714-954-01 Dispense in a tight, light-resistant container as described in the USP. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense with Medication Guide available at www.northstarrxllc.com/products or call 1-800-206-7821 Manufactured for: Northstar Rx LLC, Memphis, TN 38141. Manufactured by: Corepharma LLC, Middlesex, NJ 08846 Issued: 08/2022
Abbreviated New Drug Application
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE - DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET NorthStar RxLLC ---------- MEDICATION GUIDE Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets CII Rx only Read the Medication Guide that comes with Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets and 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 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets and Amphetamine Sulfate Tablets. What is the most important information I should know about Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets? The following have been reported with use of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets and other stimulant medicines. 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 Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets. Your doctor should check your or your child's blood pressure and heart rate regularly during treatment with Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets Call your doctor right away if you or your child have any Leggi il documento completo
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE - DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET NORTHSTAR RXLLC ---------- DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS CII RX ONLY BOXED 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 AMPHETAMINE MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS DESCRIPTION A single-entity amphetamine product combining the neutral sulfate salts of Dextroamphetamine and amphetamine, with the Dextro isomer of amphetamine Saccharate and d, 1-amphetamine aspartate monohydrate. EACH TABLET CONTAINS 5 MG 7.5 MG 10 MG 12.5 MG 15 MG20 MG30 MG Dextroamphetamine Saccharate 1.25 mg 1.875 mg 2.5 mg 3.125 mg 3.75 mg 5 mg 7.5 mg Amphetamine Aspartate Monohydrate 1.25 mg 1.875 mg 2.5 mg 3.125 mg 3.75 mg 5 mg 7.5 mg Dextroamphetamine Sulfate, USP 1.25 mg 1.875 mg 2.5 mg 3.125 mg 3.75 mg 5 mg 7.5 mg Amphetamine Sulfate, USP 1.25 mg 1.875 mg 2.5 mg 3.125 mg 3.75 mg 5 mg 7.5 mg Total Amphetamine Base Equivalence 3.13 mg 4.7 mg 6.3 mg 7.8 mg 9.4 mg 12.6 mg 18.8 mg INACTIVE INGREDIENTS In addition, each tablet contains: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch. COLORS The 5 mg, 7.5 mg, and 10 mg tablets contain the color additive FD&C Blue #1 Aluminum Lake. The 12.5 mg, 15 mg, 20 mg, and 30 mg tablets contain the color additive FD&C Yellow #6 Aluminum Lake. CLINICAL PHARMACOLOGY PHARMACODYNAMICS Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The mode of therapeutic action in A Leggi il documento completo