MEMANTINE HYDROCHLORIDE- memantine tablet

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Mylan Institutional Inc.

INN (इंटरनेशनल नाम):

MEMANTINE HYDROCHLORIDE

रचना:

MEMANTINE HYDROCHLORIDE 5 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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/m 2 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 continui

उत्पाद समीक्षा:

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 42292-005-06 – Unit dose blister packages of 50 (5 cards of 10 tablets each). 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 42292-006-06 – Unit dose blister packages of 50 (5 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] PHARMACIST: Dispense the Patient Information Leaflet with each prescription.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

MEMANTINE HYDROCHLORIDE- MEMANTINE TABLET
MYLAN INSTITUTIONAL 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
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)
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg and 10 mg ( 3)
CONTRAINDICATIONS
Memantine hydrochloride tablets are contraindicated in patients with
known hypersensitivity to memantine
hydrochloride or to any excipients used in the formulation. ( 4)
WARNINGS AND PRECAUTIONS
Conditions that raise urine pH may decrease the urinary elimination of
memantine, resulting in increased plasma levels
of memantine. ( 5.1, 7.1)
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: 7/2015
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 INTERACTI