MEMANTINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Cardinal Health 107, LLC

INN (International Name):

MEMANTINE HYDROCHLORIDE

Composition:

MEMANTINE HYDROCHLORIDE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Memantine hydrochloride tablets are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.   Memantine hydrochloride tablets are 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 to 4% and 15 to 20%, respectively. The background risk of major birth defects and miscarriage for the indicat

Product summary:

Memantine hydrochloride tablets USP, 5 mg are orange colored, capsule shaped, biconvex, film coated tablets debossed with ‘RDY’ on one side and ‘596’ on other side. They are supplied in : Overbagged with 10 tablets per bag, NDC 55154-4151-0 Memantine hydrochloride tablets USP, 10 mg are grey colored, capsule shaped, biconvex, film coated tablets debossed with ‘RDY’ on one side and ‘597’ on other side. They are supplied in: Overbagged with 10 tablets per bag, NDC 55154-7637-0 Store at 20°-25°C (68°-77°F); [See USP Controlled Room Temperature.] 

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MEMANTINE- MEMANTINE TABLET
CARDINAL HEALTH 107, LLC
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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) (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) (3)
CONTRAINDICATIONS
Memantine hydrochloride tablets are 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) (5)
ADVERSE REACTIONS
Most common adverse reactions (≥ 5 % and greater than placebo) are
dizziness, headache, confusion
and constipation. (6.1) (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT DR. REDDY’S
LABORATORIES INC., AT 1-888-
375-3784 OR FDA AT 1-800-FDA-1088 ORWWW.FDA.GOV/MEDWATCH. (6)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 5/2022
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 w