Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
AMPHETAMINE SULFATE (UNII: 6DPV8NK46S) (AMPHETAMINE - UNII:CK833KGX7E), AMPHETAMINE ASPARTATE MONOHYDRATE (UNII: O1ZPV620O4) (AMPHETAMINE - UNII:CK833KGX7E), DEXTROAMPHETAMINE SULFATE (UNII: JJ768O327N) (DEXTROAMPHETAMINE - UNII:TZ47U051FI), DEXTROAMPHETAMINE SACCHARATE (UNII: G83415V073) (DEXTROAMPHETAMINE - UNII:TZ47U051FI)
ANI Pharmaceuticals, Inc.
ORAL
PRESCRIPTION DRUG
Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules are indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsule administration is contraindicated in patients: Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/clinical-and-research- programs/pregnancyregistry/othermedications/ . Risk Summary
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules 5 mg are hard gelatin capsules, green opaque cap and clear body, printed “AMG” on cap and “277” on body, which are supplied as follows: Bottles of 100 NDC 43975-277-10 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules 10 mg are hard gelatin capsules, green opaque cap and body, printed “AMG” on cap and “278” on body, which are supplied as follows: Bottles of 100 NDC 43975-278-10 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules 15 mg are hard gelatin capsules, green opaque cap and white opaque body, printed “AMG” on cap and “279” on body, which are supplied as follows: Bottles of 100 NDC 43975-279-10 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules 20 mg are hard gelatin capsules, pink opaque cap and body, printed “AMG” on cap and “280” on body, which are supplied as follows: Bottles of 100 NDC 43975-280-10 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules 25 mg are hard gelatin capsules, pink opaque cap and white opaque body, printed “AMG” on cap and “281” on body, which are supplied as follows: Bottles of 100 NDC 43975-281-10 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules 30 mg are hard gelatin capsules, pink opaque cap and clear body, printed “AMG” on cap and “282” on body, which are supplied as follows: Bottles of 100 NDC 43975-282-10 Dispense in a tight, light-resistant container as defined in the USP. Store at room temperature, 20°C to 25°C (68°F to 77°F). [see USP CONTROLLED ROOM TEMPERATURE].
Abbreviated New Drug Application
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE- DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE ANI Pharmaceuticals, Inc. ---------- MEDICATION GUIDE Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules CII (DEX-troe-am-FET-a-meen sak-uh-reyt, am-fet-uh-meen ah-spahr-teyt mon-uh-hahy-dreyt, DEX-troe- am-FET-a-meen suhl-feyt, and am-fet-uh-meen suhl-feyt extended-release capsules) What is the most important information I should know about Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules? Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules may cause serious side effects, including: • Abuse, misuse, and addiction. Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules have a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules, 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 Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules or when it is used in ways that are not approved, such as snorting or injection. o Your healthcare provider should check you or your child’s risk for abuse, misuse, and addiction before starting treatment with Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Exte Prečítajte si celý dokument
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE- DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE ANI PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE EXTENDED-RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE EXTENDED- RELEASE CAPSULES. DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE (MIXED SALTS OF A SINGLE-ENTITY AMPHETAMINE PRODUCT) EXTENDED-RELEASE CAPSULES, FOR ORAL USE, CII INITIAL U.S. APPROVAL: 2001 WARNING: ABUSE, MISUSE, AND ADDICTION _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_ DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE EXTENDED-RELEASE CAPSULES 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 SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE EXTENDED-RELEASE CAPSULES, CAN RESULT IN OVERDOSE AND DEATH (5.1, 9.2, 10) • • • RECENT MAJOR CHANGES Boxed Warning 10/2023 Indications and Usage (1) 10/2023 Dosage and Administration (2.1, 2.2, 2.7) 10/2023 Contraindications (4) 10/2023 Warnings and Precautions (5.1, 5.2, 5.3, 5.4, 5.5, 5.7, 5.9) 10/2023 INDICATIONS AND USAGE Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules, a CNS stimulant, is indicated for the treatment of Prečítajte si celý dokument