देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
MEMANTINE HYDROCHLORIDE (UNII: JY0WD0UA60) (MEMANTINE - UNII:W8O17SJF3T)
Mylan Pharmaceuticals Inc.
MEMANTINE HYDROCHLORIDE
MEMANTINE HYDROCHLORIDE 5 mg
ORAL
PRESCRIPTION DRUG
Memantine hydrochloride tablets, USP are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. Memantine hydrochloride tablets are contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation. There are no adequate and well-controlled studies of memantine in pregnant women. Memantine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Memantine given orally to pregnant rats and pregnant rabbits during the period of organogenesis was not teratogenic up to the highest doses tested (18 mg/kg/day in rats and 30 mg/kg/day in rabbits, which are 9 and 30 times, respectively, the maximum recommended human dose [MRHD] on a mg/m2 basis). Slight maternal toxicity, decreased pup weights and an increased incidence of non-ossified cervical vertebrae were seen at an oral dose of 18 mg/kg/day in a study in which rats were given oral memantine beginning pre-mating and continuin
Memantine Hydrochloride Tablets, USP are available containing 5 mg and 10 mg of memantine hydrochloride, USP. The 5 mg tablets are white, film-coated, round, unscored tablets debossed with M on one side of the tablet and 103 on the other side: NDC 0378-1103-91 bottles of 60 tablets NDC 0378-1103-05 bottles of 500 tablets The 10 mg tablets are white, film-coated, round, unscored tablets debossed with M on one side of the tablet and 104 on the other side: NDC 0378-1104-91 bottles of 60 tablets NDC 0378-1104-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense the Patient Information Leaflet with each prescription.
Abbreviated New Drug Application
MEMANTINE HYDROCHLORIDE- MEMANTINE TABLET MYLAN PHARMACEUTICALS INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE MEMANTINE HYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MEMANTINE HYDROCHLORIDE TABLETS. MEMANTINE HYDROCHLORIDE TABLETS USP, FOR ORAL USE INITIAL U.S. APPROVAL: 2003 INDICATIONS AND USAGE Memantine hydrochloride tablets, USP are an 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 • CONTRAINDICATIONS • WARNINGS AND PRECAUTIONS • ADVERSE REACTIONS Most common adverse reactions (≥ 5 % and greater than placebo) are dizziness, headache, confusion and constipation. (6.1) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN PHARMACEUTICALS INC. AT 1-877-446-3679 (1-877- 4-INFO-RX) OR FDA AT 1-800-FDA-1088 OR www.fda.gov/medwatch. SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT LABELING. REVISED: 9/2014 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Genitourinary Conditions 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 6.2 Postmarketing Experience 7 DRUG INTERACTIONS 7.1 Drugs that Make the Urine Alkaline May be taken with or without food (2) Initial dose is 5 mg once daily. Increase dose in 5 mg increments to a maintenance dose of 10 mg twice daily. A minimum of one week of treatment with the previous dose should be observed before increasing the dose. (2) Severe renal impairment: recommended dose is 5 mg twice daily. (2) Tablets: 5 mg and 10 mg (3) Memantine hydrochloride tablets are contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation. (4) Conditions that raise urine pH may decrease the urinary elimination of memantine, r पूरा दस्तावेज़ पढ़ें