MEMANTINE HYDROCHLORIDE tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

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Active ingredient:

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

Available from:

Alembic Pharmaceuticals Inc.

INN (International Name):

MEMANTINE HYDROCHLORIDE

Composition:

MEMANTINE HYDROCHLORIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Memantine hydrochloride is indiacted 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 to 4% and 15 to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data

Product summary:

Memantine Hydrochloride Tablets USP, 5 mg are supplied as orange colored, capsule shaped, film coated tablets, debossed with ‘211’ on one side and plain on other side. NDC 62332-075-20    bottle of 20 tablets NDC 62332-075-30    bottle of 30 tablets NDC 62332-075-60    bottle of 60 tablets NDC 62332-075-31    bottle of 100 tablets NDC 62332-075-91    bottle of 1000 tablets NDC 62332-075-42    bottle of 3000 tablets NDC 62332-075-10    10 x 10 Unit dose Memantine Hydrochloride Tablets USP, 10 mg are supplied as light gray colored, capsule shaped, film coated tablets, debossed with ‘L212’ on one side and plain on other side. NDC 62332-076-20    bottle of 20 tablets NDC 62332-076-30    bottle of 30 tablets NDC 62332-076-60    bottle of 60 tablets NDC 62332-076-31    bottle of 100 tablets NDC 62332-076-71    bottle of 500 tablets NDC 62332-076-42    bottle of 3000 tablets NDC 62332-076-10    10 x 10 Unit dose Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].  Call your doctor for medical advice about side effects. You may report side effects to Alembic Pharmaceuticals Limited at 1-866-210-9797 or FDA at 1-800-FDA-1088.  GLUCOVANCE® is a registered trademark of Merck Santé S.A.S., an associate of Merck KGaA of Darmstadt, Germany. Licensed to Bristol-Myers Squibb Company.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

                                MEMANTINE HYDROCHLORIDE - MEMANTINE HYDROCHLORIDE TABLET, COATED
ALEMBIC 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 ALEMBIC PHARMACEUTICALS
LIMITED AT 1-
866-210-9797 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 10/2021
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 DRUG INTERACTIONS
7.1 Drugs that Make th
                                
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