MEMANTINE HYDROCHLORIDE- memantine tablet

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

MEMANTINE HYDROCHLORIDE (UNII: JY0WD0UA60) (MEMANTINE - UNII:W8O17SJF3T)

可用日期:

Mylan Pharmaceuticals Inc.

INN（国际名称）:

MEMANTINE HYDROCHLORIDE

组成:

MEMANTINE HYDROCHLORIDE 5 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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

產品總結:

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.

授权状态:

Abbreviated New Drug Application

产品特点

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