Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
DEXTROAMPHETAMINE SACCHARATE (UNII: G83415V073) (DEXTROAMPHETAMINE - UNII:TZ47U051FI), AMPHETAMINE ASPARTATE (UNII: H527KAP6L5) (AMPHETAMINE - UNII:CK833KGX7E), DEXTROAMPHETAMINE SULFATE (UNII: JJ768O327N) (DEXTROAMPHETAMINE - UNII:TZ47U051FI), AMPHETAMINE SULFATE (UNII: 6DPV8NK46S) (AMPHETAMINE - UNII:CK833KGX7E)
STAT RX USA LLC
DEXTROAMPHETAMINE SACCHARATE
DEXTROAMPHETAMINE SACCHARATE 7.5 mg
ORAL
PRESCRIPTION DRUG
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. 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 effort; loses things; easily distracted; forgetful.
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets are available as: 5 mg: Blue, oval, biconvex tablet with two partial bisects on one side debossed with stylized b over 971 and four partial bisects on the other side debossed with 5 . Available in bottles of: 7.5 mg: Blue, round, flat-faced, beveled-edge tablet debossed with stylized b over 775 on one side and two partial bisects and a full score on the other side debossed with 7│½ . Available in bottles of: 10 mg: Blue, oval, flat-faced, beveled-edge tablet with two partial bisects on one side debossed with stylized b over 972 and two partial bisects and a full score on the other side debossed with 1│0 . Available in bottles of: 12.5 mg: Peach, oval, biconvex tablet debossed with stylized b over 776 separated by a full score on one side and four partial bisects on the other side debossed with 12│½. Available in bottles of: 15 mg: Peach, round, flat-faced, beveled-edge tablet debossed with stylized b over 777 on one side and two partial bisects and a full score on the other side debossed with 1│5 . Available in bottles of: 20 mg: Peach, oval, flat-faced, beveled-edge tablet with two partial bisects on one side debossed with stylized b over 973 and two partial bisects and a full score on the other side debossed with 2│0 . Available in bottles of: 30 mg: Peach, oval, biconvex tablet with two partial bisects on one side debossed with stylized b over 974 and two partial bisects and a full score on the other side debossed with 3│0 . Available in bottles of: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Abbreviated New Drug Application
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SUFLATE - DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SUFLATE TABLET STAT RX USA LLC ---------- MEDICATION GUIDE DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS Rx only Read the Medication Guide that comes with dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets 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. 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. 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 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 signs of heart problems such as Baca dokumen lengkapnya
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SUFLATE - DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SUFLATE TABLET STAT RX USA LLC ---------- DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS CII (THREE MEDICATION GUIDES ATTACHED) ISS. 10/2009 11001546 RX ONLY 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, l-amphetamine aspartate. EACH TABLET CONTAINS 5 MG 7.5 MG 10 MG 12.5 MG 15 MG 20 MG 30 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 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 In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, compressible sugar, corn starch, magnesium stearate, microcrystalline cellulose and saccharin sodium. The 5, 7.5 and 10 mg also contain FD&C blue no.1 aluminum lake. The 12.5, 15, 20 and 30 mg also contain FD&C yellow no. 6 aluminum lake. CLINICAL PHARMACOLOGY PHARMACODYNAMICS Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The mode of therapeutic action in Attention De Baca dokumen lengkapnya