Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
DEXTROAMPHETAMINE SULFATE (UNII: JJ768O327N) (DEXTROAMPHETAMINE - UNII:TZ47U051FI)
Mikart, LLC
DEXTROAMPHETAMINE SULFATE
DEXTROAMPHETAMINE SULFATE 5 mg in 5 mL
ORAL
PRESCRIPTION DRUG
Dextroamphetamine Sulfate Oral Solution is indicated in: Narcolepsy Attention Deficit Disorder with Hyperactivity: As an integral part of a total treatment program that typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 years to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: Moderate to severe distractibility, short attention span, hyperactivity, emotionally 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 sympa
Dextroamphetamine Sulfate Oral Solution 5 mg/5 mL is a colorless, bubblegum flavored oral solution, available in containers of 16 fluid ounces, NDC 46672-646-16. Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Dispense in a tight, light resistant container. Manufactured by: Mikart, Inc. Atlanta, Georgia 30318 Manufactured for: Outlook Pharmaceuticals Inc. Cincinnati, OH 45209 Code 983Z00 Rev. 09/16
Abbreviated New Drug Application
DEXTROAMPHETAMINE SULFATE- DEXTROAMPHETAMINE SULFATE SOLUTION Mikart, LLC ---------- MEDICATION GUIDE D extroamphetamine Sulfate Oral Solution, 5 mg/5 mL CII (DEX-troe-am-FET-uh-meen SULL-fate) Read the Medication Guide that comes with Dextroamphetamine Sulfate Oral Solution 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 your or your child’s treatment with Dextroamphetamine Sulfate Oral Solution. What is the most important information I should know about Dextroamphetamine Sulfate Oral Solution? The following have been reported with use of Dextroamphetamine Sulfate Oral Solution 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 Oral Solution. Your doctor should check your or your child’s blood pressure and heart rate regularly during treatment with Dextroamphetamine Sulfate Oral Solution. 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 Oral Solution. 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 chil Pročitajte cijeli dokument
DEXTROAMPHETAMINE SULFATE- DEXTROAMPHETAMINE SULFATE SOLUTION MIKART, LLC ---------- PRESCRIBING INFORMATION DEXTROAMPHETAMINE SULFATE ORAL SOLUTION, 5 MG/5 ML CII 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 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 as the neutral sulfate. Structural Formula: Dextroamphetamine Sulfate Oral Solution is a colorless, bubblegum flavored oral solution. Each teaspoonful (5 mL) of Dextroamphetamine Sulfate Oral Solution contains 5 mg of dextroamphetamine sulfate. Inactive ingredients consist of benzoic acid, citric acid anhydrous, purified water, sodium citrate hydrous, sodium saccharin, sorbitol solution, and artificial bubble gum flavor. CLINICAL PHARMACOLOGY Amphetamines are noncatecholamine, sympathomimetic amines with CNS stimulant activity. Peripheral actions include elevations of systolic and diastolic blood pressures and weak bronchdilator and respiratory stimulant action. There is neither specific evidence that 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 Ingestion of 10 mg of dextroamphetamine sulfate in oral solution form by healthy volunteers produced an average peak dextroamphetamine blood level of 33.2 ng/mL. The half-life was 11.75 hours. The average urinary r Pročitajte cijeli dokument