MEMANTINE HYDROCHLORIDE tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aphena Pharma Solutions - Tennessee, LLC

INN (International Name):

MEMANTINE HYDROCHLORIDE

Composition:

MEMANTINE HYDROCHLORIDE 10 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. 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 an

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 62332-075-60    bottle of 60 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 62332-076-60    bottle of 60 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
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MEMANTINE HYDROCHLORIDE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MEMANTINE
HYDROCHLORIDE TABLETS.
MEMANTINE HYDROCHLORIDE TABLETS USP, 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.
REVISED: 3/2016
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 wit