MEMANTINE HYDROCHLORIDE tablet MEMANTINE HYDROCHLORIDE- memantine hydrochloride tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Ajanta Pharma USA Inc.

INN (International Name):

MEMANTINE HYDROCHLORIDE

Composition:

MEMANTINE HYDROCHLORIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

5 mg Tablets: Orange, capsule shaped, biconvex, film-coated tablets with “m5” engraved on one side and plain on other side. Bottles of 60 with child-resistant closure, NDC # 27241-070-06 Bottle of 500, NDC # 27241-070-05 10 mg Tablets: Grey, capsule shaped, biconvex, film-coated tablets with “m10” engraved on one side and plain on other side. Bottle of 60 with child-resistant closure, NDC # 27241-071-06 Bottle of 500, NDC # 27241-071-05 Store memantine hydrochloride tablets at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight container.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MEMANTINE HYDROCHLORIDE - MEMANTINE HYDROCHLORIDE TABLET
MEMANTINE HYDROCHLORIDE - MEMANTINE HYDROCHLORIDE TABLET
AJANTA PHARMA USA 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 USP 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 AJANTA PHARMA USA INC.
AT 855-664-
7744 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 12/2021
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