MEMANTINE HYDROCHLORIDE tablet

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Macleods Pharmaceuticals Limited

INN (Међународно име):

MEMANTINE HYDROCHLORIDE

Састав:

MEMANTINE HYDROCHLORIDE 5 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Memantine hydrochloride USP is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. Memantine hydrochloride is 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 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 [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 background risk of major birth defects and miscarriage for the indicated population is unknown. Data A

Резиме производа:

Memantine hydrochloride tablet USP, 5 mg: Peach color, capsule shape, film-coated tablet, debossed with “CL27” on one side and plain on the other side. Bottle of 60                                       NDC # 33342-297-09 Bottle of 500                                     NDC # 33342-297-15 Carton of 100 (10 x 10 unit dose)      NDC # 33342-297-12   Memantine hydrochloride tablet USP, 10 mg: Gray color, capsule shape, film-coated tablet, debossed with “CL28” on one side and plain on the other side. Bottle of 60                                        NDC # 33342-298-09 Bottle of 500                                      NDC # 33342-298-15 Carton of 100 (10 x 10 unit dose)       NDC # 33342-298-12 Store memantine hydrochloride tablets 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]. Prevent from light and moisture.Preserve in tight containers.

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

MEMANTINE HYDROCHLORIDE - MEMANTINE HYDROCHLORIDE TABLET
MACLEODS PHARMACEUTICALS LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
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, FOR ORAL USE
INITIAL U.S. APPROVAL: 2003
INDICATIONS AND USAGE
Memantine hydrochloride is 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 hydrochlorideis contraindicated in patients with known
hypersensitivity to memantine
hydrochloride or to any excipients used in the formulation. (4) (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 MACLEODS PHARMA USA,
INC. AT 1-888-
943-3210 OR 1-855-926-3384 OR FDA AT 1-800-FDA-1088 OR
WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 12/2022
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS & USAGE
2 DOSAGE & ADMINISTRATION
3 DOSAGE FORMS & STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Genitourinary Conditions
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experien