Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
AMPHETAMINE SULFATE (UNII: 6DPV8NK46S) (AMPHETAMINE - UNII:CK833KGX7E)
Ascend Laboratories, LLC
ORAL
PRESCRIPTION DRUG
Amphetamine sulfate tablet is indicated for: - Narcolepsy - Attention Deficit Disorder with Hyperactivity as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability , and impulsivity. The diagnosis of the syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or not be warranted. - Exogenous Obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction for patients refractory to alternative therapy, e.g., repeated diets, group programs, and other
Amphetamine sulfate tablets, USP are supplied as follows: 5 mg: White, round, biconvex tablet, debossed “AS” on one side and ‘’5’’ with a functional score on other side in bottles of 100 tablets, NDC 67877-710-01. 10 mg: Blue, round biconvex tablet, debossed “AS” on one side and “10” with a functional double score on the other side in bottles of 100 tablets, NDC 67877-711-01. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a well closed container, as defined in the USP. Manufactured by: Alkem Laboratories Fenton, MO. 63026 Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 Revised: December, 2021
Abbreviated New Drug Application
AMPHETAMINE SULFATE - AMPHETAMINE SULFATE TABLET Ascend Laboratories, LLC ---------- MEDICATION GUIDE Amphetamine Sulfate (am fet' a meen sul' fate) Tablets, USP CII Read this Medication Guide before you or your child starts taking amphetamine sulfate tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about you or your child's treatment. What is the most important information I should know about amphetamine sulfate tablets? Amphetamine sulfate tablets are a stimulant medicine. Some people have had the following problems when taking stimulant medicines such as amphetamine sulfate tablets: 1. Heart-related problems : • sudden death in people 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 has 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 amphetamine sulfate tablets. Your doctor should check you or your child's blood pressure and heart rate regularly during treatment with amphetamine sulfate tablets. Call your doctor right away if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting while taking amphetamine sulfate tablets. 2. Mental (Psychiatric) problems including: In children, teenagers, and adults: • new or worse behavior and thought problems • new or worse bipolar illness • new or worse aggressive behavior or hostility In Children and Teenagers who have psychiatric problems, new psychotic symptoms such as: • hearing voices • seeing things that are not real • believing things that are not true • being suspicious • new manic symptoms Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression. Call your doctor right away if you or your child Lees het volledige document
AMPHETAMINE SULFATE - AMPHETAMINE SULFATE TABLET ASCEND LABORATORIES, LLC ---------- 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 Amphetamine Sulfate, USP is a sympathomimetic amino of the amphetamine group. It is a white to off-white odourless crystalline powder. It has a slightly bitter taste. Its solutions are acid to litmus, having a pH of 5.0 to 6.0. It is freely soluble in water and slightly soluble in alcohol. Each tablet, for oral administration contains 5 mg or 10 mg of amphetamine sulfate, USP. Each tablet also contains the following inactive ingredients: crospovidone, silicified microcrystalline cellulose and magnesium stearate. The 10 mg tablet also contains FD&C Blue #1 aluminum lake. Structural Formula: CLINICAL PHARMACOLOGY Amphetamines are non-catecholamine, sympathomimetic amines with CNS stimulant activity. Peripheral actions include elevations of systolic and diastolic blood pressures, and weak bronchodilator, and respiratory stimulant action. Amphetamine, as the racemic form, differs from dextroamphetamine in a number of ways. The l-isomer is more potent than the d-isomer in cardiovascular activity, but much less potent in causing CNS excitatory effects. The racemic mixture also is less effective as an appetite suppressant when compared to dextroamphetamine. There is neither specific evidence which clearly establishes the mechanism whereby amphetamines produce mental and behavioral effects in children, nor conclusive evidence regarding how those effects relate to the condition of the central nervous system. Drugs in this class used in obesity are commonly known as "anorectics" or " Lees het volledige document