MEMANTINE HYDROCHLORIDE tablet, film coated MEMANTINE HYDROCHLORIDE tablet, film coated

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:

POLYGEN PHARMACEUTICALS INC.

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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. 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 a

Tóm tắt sản phẩm:

5 mg Tablet: Orange, capsule-shaped, biconvex, film-coated tablet debossed with “P” on one side and “71” on the other side. Bottle of 30                 NDC #52605-071-13 Bottle of 90                 NDC #52605-071-19 Bottle of 1000             NDC #52605-071-10 10 mg Tablet: Grey, capsule-shaped, biconvex, film-coated tablet debossed with “P” on one side and “72” on the other side. Bottle of 30                 NDC #52605-072-13 Bottle of 90                 NDC #52605-072-19 Bottle of 1000             NDC #52605-072-10 Store memantine hydrochloride tablets, USP at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

MEMANTINE HYDROCHLORIDE - MEMANTINE HYDROCHLORIDE TABLET, FILM COATED
MEMANTINE HYDROCHLORIDE - MEMANTINE HYDROCHLORIDE TABLET, FILM COATED
POLYGEN 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 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)
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 , (6)
headache, confusion and constipation. (6.1) (6)
(6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT POLYGEN PHARMACEUTICALS
INC. AT 1-888-
291-7337 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. (6)
(6)
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING. (6)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
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 Experience
7 DRUG INTERACTIONS
7.1 Drugs that Make the Urine Alkaline
7.2 Use with Other N-methyl-D-aspartate (NMDA) Antagonists
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
8.7 Hepatic Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL