Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
DEXTROAMPHETAMINE SULFATE (UNII: JJ768O327N) (DEXTROAMPHETAMINE - UNII:TZ47U051FI)
SpecGx LLC
DEXTROAMPHETAMINE SULFATE
DEXTROAMPHETAMINE SULFATE 5 mg
ORAL
PRESCRIPTION DRUG
Dextroamphetamine sulfate tablets 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. Known hypersensitivity to amphetamine products. During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result). Dex
Each Dextroamphetamine Sulfate Tablet USP (5 mg) contains dextroamphetamine sulfate 5 mg. It is available as triangle shaped, white to off white tablet debossed with a number “5” and a bisect on one side and an “M” in a box on the other. Bottles of 100 ........................NDC 0406-8958-01 Each Dextroamphetamine Sulfate Tablet USP (10 mg) contains dextroamphetamine sulfate 10 mg. It is available as diamond shaped, white to off white tablet debossed with a number “10” and a partial quadrisect on one side and an “M” in a box on the other. Bottles of 100 ........................NDC 0406-8959-01 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in well-closed containers with a child-resistant closure as defined in the USP. Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. © 2023 Mallinckrodt. SpecGx LLC Webster Groves, MO 63119 USA Rev 09/2023 Mallinckrodt™ Pharmaceuticals An electronic copy of this medication guide can be obtained from www.mallinckrodt.com/Medguide/L20D10.pdf or by calling 1-800-778-7898 for alternate delivery options.
Abbreviated New Drug Application
SpecGx LLC ---------- MEDICATION GUIDE Dextroamphetamine Sulfate Tablets USP, CII (DEX-troe-am-FET-uh-meen SULL-fate) What is the most important information I should know about Dextroamphetamine Sulfate Tablets? Dextroamphetamine sulfate tablets may cause serious side effects, including: • Abuse misuse, and addiction. Dextroamphetamine sulfate tablets have a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of dextroamphetamine sulfate tablets, other amphetamine containing medicines, and methylphenidate containing medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of dextroamphetamine sulfate tablets or when it is used in ways that are not approved, such as snorting or injection. • Your healthcare provider should check you or your child’s risk for abuse, misuse, and addiction before starting treatment with dextroamphetamine sulfate tablets and will monitor you or your child during treatment. • Dextroamphetamine sulfate tablets may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider. • Do not give dextroamphetamine sulfate tablets to anyone else. See “What are dextroamphetamine sulfate tablets?” for more information. • Keep dextroamphetamine sulfate tablets in a safe place and properly dispose of any unused medicine. See “How should I store dextroamphetamine sulfate tablets?” for more information. • Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs. • Risks for people with serious heart disease: Sudden death has happened in people who have heart defects or other serious heart disease. Your healthcare provider should check you or your child carefully for heart problems before starting treatment with dextroamphetamine sulfate tablets. Tell your healthcare provider if you or your child have any heart problems, heart disease, or heart defects. C Belgenin tamamını okuyun
DEXTROAMPHETAMINE SULFATE- DEXTROAMPHETAMINE SULFATE TABLET SPECGX LLC ---------- DEXTROAMPHETAMINE SULFATE TABLETS USP 5 MG AND 10 MG RX ONLY CII WARNING: ABUSE, MISUSE, AND ADDICTION DEXTROAMPHETAMINE SULFATE TABLETS HAVE A HIGH POTENTIAL FOR ABUSE AND MISUSE, WHICH CAN LEAD TO THE DEVELOPMENT OF A SUBSTANCE USE DISORDER, INCLUDING ADDICTION. MISUSE AND ABUSE OF CNS STIMULANTS, INCLUDING DEXTROAMPHETAMINE SULFATE TABLETS, CAN RESULT IN OVERDOSE AND DEATH (_SEE _OVERDOSAGE), AND THIS RISK IS INCREASED WITH HIGHER DOSES OR UNAPPROVED METHODS OF ADMINISTRATION, SUCH AS SNORTING OR INJECTION. BEFORE PRESCRIBING DEXTROAMPHETAMINE SULFATE TABLETS, ASSESS EACH PATIENT’S RISK FOR ABUSE, MISUSE, AND ADDICTION. EDUCATE PATIENTS AND THEIR FAMILIES ABOUT THESE RISKS, PROPER STORAGE OF THE DRUG, AND PROPER DISPOSAL OF ANY UNUSED DRUG. THROUGHOUT DEXTROAMPHETAMINE SULFATE TABLETS TREATMENT, REASSESS EACH PATIENT’S RISK OF ABUSE, MISUSE, AND ADDICTION AND FREQUENTLY MONITOR FOR SIGNS AND SYMPTOMS OF ABUSE, MISUSE, AND ADDICTION (_SEE _WARNINGS, DRUG ABUSE AND DEPENDENCE). 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. The structural formula is as follows: Each tablet, for oral administration, contains dextroamphetamine sulfate USP, 5 mg or 10 mg. Each tablet also contains the following inactive ingredients: microcrystalline cellulose, povidone, silicon dioxide, and stearic acid. 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 concl Belgenin tamamını okuyun