Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
DEXTROAMPHETAMINE SACCHARATE (UNII: G83415V073) (DEXTROAMPHETAMINE - UNII:TZ47U051FI), AMPHETAMINE ASPARTATE MONOHYDRATE (UNII: O1ZPV620O4) (AMPHETAMINE - UNII:CK833KGX7E), DEXTROAMPHETAMINE SULFATE (UNII: JJ768O327N) (DEXTROAMPHETAMINE - UNII:TZ47U051FI), AMPHETAMINE SULFATE (UNII: 6DPV8NK46S) (AMPHETAMINE - UNII:CK833KGX7E)
SpecGx LLC
DEXTROAMPHETAMINE SACCHARATE
DEXTROAMPHETAMINE SACCHARATE 1.25 mg
ORAL
PRESCRIPTION DRUG
Mixed Salts of a Single Entity Amphetamine Product are 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. For the Hyperactive-Impulsive Type, at least six of the fol
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) are supplied as follows: 5 mg: White to cream colored/mottled pillow shaped tablet, debossed with a “5” and a partial quadrisect on one side and a on the other side. Bottles of 100….NDC 0406-8891-01 7.5 mg: White to cream colored/mottled pillow shaped tablet, debossed with a “7.5” and a partial quadrisect on one side and a on the other side. Bottles of 100….NDC 0406-8884-01 10 mg: White to cream colored/mottled pillow shaped tablet, debossed with a “10” and a partial quadrisect on one side and a on the other side. Bottles of 100….NDC 0406-8892-01 12.5 mg: White to cream colored/mottled octagon shaped tablet, debossed with a “12.5” and a partial quadrisect on one side and a on the other side. Bottles of 100….NDC 0406-8886-01 15 mg: White to cream colored/mottled octagon shaped tablet, debossed with a “15” and a partial quadrisect on one side and a on the other side. Bottles of 100….NDC 0406-8885-01 20 mg: White to cream colored/mottled octagon shaped tablet, debossed with a “20” and a partial quadrisect on one side and a on the other side. Bottles of 100….NDC 0406-8893-01 30 mg: White to cream colored/mottled octagon shaped tablet, debossed with a “30” and a partial quadrisect on one side and a on the other side. Bottles of 100….NDC 0406-8894-01 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]. Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and are trademarks of a Mallinckrodt company. © 2023 Mallinckrodt. DSM-IV and Evekeo are trademarks of their respective owners. Manufactured by: SpecGx LLC Webster Groves, MO 63119 USA Rev 10/2023 Mallinckrodt™ Pharmaceuticals An electronic copy of this medication guide can be obtained from www.mallinckrodt.com/Medguide/L20D11.pdf or by calling 1-800-778-7898 for alternate delivery options.
Abbreviated New Drug Application
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE- DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET SpecGx LLC ---------- MEDICATION GUIDE MEDICATION GUIDE Dextroamphetamine Saccharate Amphetamine Aspartate Dextroamphetamine Sulfate Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product), CII (dex” troe am fet' a meen sac cha rate, am fet' a meen a spar' tate, dex” troe am fet' a meen sul' fate, am fet' a meen sul' fate) What is the most important information I should know about Mixed Salts of a Single Entity Amphetamine Product? Mixed Salts of a Single Entity Amphetamine Product may cause serious side effects, including: • Abuse, misuse, and addiction. Mixed Salts of a Single Entity Amphetamine Product has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of Mixed Salts of a Single Entity Amphetamine Product, 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 Mixed Salts of a Single Entity Amphetamine Product 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 Mixed Salts of a Single Entity Amphetamine Product and will monitor you or your child during treatment. • Mixed Salts of a Single Entity Amphetamine Product may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider. • Do not give Mixed Salts of a Single Entity Amphetamine Product to anyone else. See “What is Mixed Salts of a Single Entity Amphetamine Product?” for more information. • Keep Mixed Salts of a Single Entity Amphetamine Product in a safe place and properly dispose of any unused medicine. See “How should I store Mixed Salts of a Single Entity A Lees het volledige document
DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE- DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET SPECGX LLC ---------- DEXTROAMPHETAMINE SACCHARATE AMPHETAMINE ASPARTATE DEXTROAMPHETAMINE SULFATE AMPHETAMINE SULFATE TABLETS (MIXED SALTS OF A SINGLE ENTITY AMPHETAMINE PRODUCT), CII (5 MG, 7.5 MG, 10 MG, 12.5 MG, 15 MG, 20 MG, AND 30 MG) RX ONLY WARNING: ABUSE, MISUSE, AND ADDICTION Mixed Salts of a Single Entity Amphetamine Product has 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 Mixed Salts of a Single Entity Amphetamine Product, 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 Mixed Salts of a Single Entity Amphetamine Product, 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 Mixed Salts of a Single Entity Amphetamine Product 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_ and _DRUG ABUSE AND DEPENDENCE). 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 monohydrate. 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 Monohydrate 1.25 mg 1.875 mg 2.5 mg 3.125 mg 3.75 mg 5 mg 7.5 mg Dextroamphetamine1.25 1.875 mg 2.5 3.125 3.75 5 mg 7.5 mg Sulfate USP mg 1.875 mg mg mg mg 5 mg 7.5 mg Amphetamine Sulf Lees het volledige document