MEMANTINE HYDROCHLORIDE tablet

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Silarx Pharmaceuticals, Inc.

INN (Tên quốc tế):

MEMANTINE HYDROCHLORIDE

Thành phần:

MEMANTINE HYDROCHLORIDE 5 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Memantine hydrochloride 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. Pregnancy Category B There are no adequate and well-controlled studies of memantine in pregnant women. Memantine hydrochloride 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 a

Tóm tắt sản phẩm:

Memantine Hydrochloride Tablets, USP are supplied as: 5 mg Tablet: Beige, capsule-shaped, film-coated tablets with “101” embossed on one side and “SI” on the other. Bottle of 60 NDC #54838-221-06 Bottle of 500 NDC #54838-221-52 Bottle of 1000 NDC #54838-221-13 10 mg Tablet: Gray, capsule-shaped, film-coated tablets with “102” embossed on one side and “SI” on the other. Bottle of 60 NDC #54838-222-06 Bottle of 500 NDC #54838-222-52 Bottle of 1000 NDC #54838-222-13 Store Memantine Hydrochloride tablets at 25°C (77°F); excursions permitted to 15° to 30°C (59° to ­86°F) [see USP Controlled Room Temperature].

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

MEMANTINE HYDROCHLORIDE- MEMANTINE HYDROCHLORIDE TABLET
SILARX 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, 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 Hydrochloride is 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 LANNETT COMPANY, INC.
AT 1-844-834-0530 OR FDA AT 1-
800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 5/2016
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 that Make the Urine Alkaline
7.2 Use with Other N-methyl-D-asp