Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
MEMANTINE HYDROCHLORIDE (UNII: JY0WD0UA60) (MEMANTINE - UNII:W8O17SJF3T)
Bryant Ranch Prepack
ORAL
PRESCRIPTION DRUG
Memantine hydrochloride extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer's type. Memantine hydrochloride extended-release capsules are contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation. Risk Summary There are no adequate data on the developmental risk associated with the use of memantine hydrochloride extended-release capsules in pregnant women. Adverse developmental effects (decreased body weight and skeletal ossification) were observed in the offspring of rats administered memantine during pregnancy at doses associated with minimal maternal toxicity. These doses are higher than those used in humans at the maximum recommended daily dose of memantine hydrochloride extended-release capsules [see Data]. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The ba
Memantine hydrochloride extended-release capsules 28 mg, are pink opaque cap and white opaque body, hard gelatin capsules, printed “28MG” on cap and “A266” on the body and are supplied as: Bottles of 90 NDC 63629-2142-1 Store memantine hydrochloride extended-release capsules at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.
Abbreviated New Drug Application
MEMANTINE HYDROCHLORIDE- MEMANTINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE BRYANT RANCH PREPACK ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE MEMANTINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MEMANTINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. MEMANTINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, FOR ORAL USE INITIAL U.S. APPROVAL: 2003 INDICATIONS AND USAGE Memantine hydrochloride extended-release capsules are a N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. (1) DOSAGE AND ADMINISTRATION • • DOSAGE FORMS AND STRENGTHS Memantine hydrochloride extended-release capsules are available as an extended-release capsule in the following strengths: 7 mg, 14 mg, 21 mg, 28 mg (3) CONTRAINDICATIONS • WARNINGS AND PRECAUTIONS • ADVERSE REACTIONS The most commonly observed adverse reactions occurring at a frequency of at least 5% and greater than placebo with administration of memantine hydrochloride extended-release capsules 28 mg/day were headache, diarrhea and dizziness. (6.1) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ANI PHARMACEUTICALS, INC. AT 1-800-308- 6755 OR FDA AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH._ SEE 17 FOR PATIENT COUNSELING INFORMATION. REVISED: 3/2022 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosing 2.2 Switching from Memantine Hydrochloride Tablets to Memantine Hydrochloride Extended-Release Capsules 2.3 Dosing in Patients with Renal Impairment The recommended starting dose of memantine hydrochloride extended-release capsules is 7 mg once daily; the dose should be increased in 7 mg increments to the recommended maintenance dose of 28 mg once daily; the minimum recommended interval between dose increases is one week. (2.1) Patients with severe renal impairment: the recommended maintenance dose of memantine hydrochlori Belgenin tamamını okuyun