MEMANTINE HYDROCHLORIDE- memantine tablet, film coated

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

AvKARE, Inc.

INN:

MEMANTINE HYDROCHLORIDE

composition:

MEMANTINE HYDROCHLORIDE 5 mg

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

Memantine hydrochloride (HCl) tablets, USP are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. Memantine HCl tablets, USP are contraindicated in patients with known hypersensitivity to memantine hydrochloride, USP or to any excipients used in the formulation. Pregnancy Category B There are no adequate and well-controlled studies of memantine in pregnant women. Memantine HCl 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 be

leaflet_short:

Memantine HCl tablets USP, 5 mg, are supplied as orange colored, oblong, biconvex, film-coated tablets debossed “IP 173” on one side and plain on the other side. They are available as follows: Bottles of 60:  NDC  42291-551-60 Memantine HCl tablets USP, 10 mg, are supplied as gray colored, oblong, biconvex, film-coated tablets debossed “IP 174” on one side and plain on the other side. They are available as follows: Bottles of 60:  NDC  42291-552-60 Store memantine HCl tablets, USP 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].

authorization_status:

Abbreviated New Drug Application

SPC

MEMANTINE HYDROCHLORIDE- MEMANTINE TABLET, FILM COATED
AVKARE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
MEMANTINE HYDROCHLORIDE TABLETS, USP
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MEMANTINE HCL TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MEMANTINE HCL
TABLETS .
MEMANTINE HCL TABLETS USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 2003
INDICATIONS AND USAGE
Memantine HCl tablets, USPare 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 1 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 HCl tablets, USP are contraindicated in patients with known
hypersensitivity to memantine hydrochloride,
USP 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 AVKARE, INC. AT
1-855-361-3993; EMAIL
[e-mail]; OR FDA AT 1-800-FDA-1088 OR
WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 1/2016
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 T