MEMANTINE HYDROCHLORIDE- memantine hydrochloride kit 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:

Vivimed Labs Limited

INN (International Name):

MEMANTINE HYDROCHLORIDE

Composition:

MEMANTINE HYDROCHLORIDE 5 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Memantine hydrochloride 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. 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 a

Product summary:

5 mg Tablet: Orange, film-coated, capsule shaped tablets debossed with 'W121' on one side and other side plain. Bottle of 30 tablets                                         NDC 64679-121-01 Bottle of 60 tablets                                         NDC 64679-121-03 Bottle of 100 tablets                                       NDC 64679-121-08 Bottle of 500 tablets                                       NDC 64679-121-02 24 x 12 Unit dose                                           NDC 64679-121-06 10 mg Tablet: Grey, film-coated, capsules shaped tablets debossed with 'W122' on one side and other side plain. Bottle of 30 tablets                                         NDC 64679-122-01 Bottle of 60 tablets                                         NDC 64679-122-03 Bottle of 100 tablets                                       NDC 64679-122-08 Bottle of 500 tablets                                       NDC 64679-122-02 24 x 12 Unit dose                                           NDC 64679-122-06 Titration Pack: The 5 mg capsule shaped, film-coated tablets are orange in color, with 'W121' debossed on one side and other side plain. The 10 mg capsule shaped, film coated tablets are grey in color, with 'W122'debossed on one side and other side plain. PVC/Aluminum Blister Package containing 49 tablets. 28 x 5 mg tablets and 21 x 10 mg tablets       NDC 64679-123-01 Store memantine hydrochloride tablets at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MEMANTINE HYDROCHLORIDE - MEMANTINE HYDROCHLORIDE
MEMANTINE HYDROCHLORIDE- MEMANTINE HYDROCHLORIDE TABLET
VIVIMED LABS LIMITED
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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.
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 WOCKHARDT USA LLC. AT
1-800-346-6854 OR FDA AT 1-
800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 5/2015
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 Mak