Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
DEXTROAMPHETAMINE SULFATE (UNII: JJ768O327N) (DEXTROAMPHETAMINE - UNII:TZ47U051FI)
Zydus Pharmaceuticals (USA) Inc.
DEXTROAMPHETAMINE SULFATE
DEXTROAMPHETAMINE SULFATE 5 mg
ORAL
PRESCRIPTION DRUG
Dextroamphetamine Sulfate Tablets USP are 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 pediatric patients (ages 3 to 16 years) with a 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 this 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 may not be warranted. Advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympath
HOW SUPPLIED Dextroamphetamine Sulfate Tablets USP are available as: 5 mg: Peach, round, flat-faced, bevel edged, scored tablet, debossed "N" score "941" on one side and plain on the other side. NDC 68382-941-01……….Bottles of 100 Tablets 10 mg: Pink, round, flat-faced, bevel edged, scored tablet, debossed "N" score "942" on one side and plain on the other side. NDC 68382-942-01……….Bottles of 100 Tablets Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. DEA Order Form Required. Manufactured By: Nesher Pharmaceuticals USA LLC St. Louis, MO 63044 Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 P10138-4 12/2021
Abbreviated New Drug Application
DEXTROAMPHETAMINE SULFATE- dextroamphetamine sulfate tablet Zydus Pharmaceuticals (USA) Inc. ---------- MEDICATION GUIDE DEXTROAMPHETAMINE SULFATE TABLETS USP, CII (DEX-troe-am-FET-uh-meen SULL-fate) Read the Medication Guide that comes with Dextroamphetamine Sulfate Tablets before you or your child starts taking them 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 Sulfate Tablets. What is the most important information I should know about Dextroamphetamine Sulfate Tablets? The following have been reported with use of Dextroamphetamine 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 Sulfate Tablets. Your doctor should check your or your child's blood pressure and heart rate regularly during treatment with Dextroamphetamine Sulfate Tablets. 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 Tablets. 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, or about a family history of suicide, bipolar illness, or depression. Call your doctor right away if you or your child have any new or worsening mental symp Lesen Sie das vollständige Dokument
DEXTROAMPHETAMINE SULFATE- DEXTROAMPHETAMINE SULFATE TABLET ZYDUS PHARMACEUTICALS (USA) INC. ---------- DEXTROAMPHETAMINE SULFATE - DEXTROAMPHETAMINE SULFATE TABLET 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, USP 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, USP as the neutral sulfate. The structural formula is as follows: (C9H13N)2∙H2SO4 M.W. 368.49 INACTIVE INGREDIENTS Calcium sulfate, colloidal silicon dioxide, compressible sugar, corn starch, magnesium stearate, and microcrystalline cellulose. The 5 mg also contains D&C yellow no. 10 aluminum lake and FD&C red no. 40 aluminum lake. The 10 mg also contains FD&C red no. 40 aluminum lake and FD&C yellow no. 6 aluminum lake. 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. There is neither specific evidence which clearly establishes the mechanism whereby amphetamines produce mental and behavioral effects in children, nor conclusive evidence regarding how these effects relate to the condition of the central nervous system. PHARMACOKINETICS The pharmacokinetics of the tablet and sustained-release capsule were compared in 12 healthy subjects. The extent of bioavailability of the sustained-release capsule was similar compared to t Lesen Sie das vollständige Dokument