MEMANTINE HYDROCHLORIDE tablet, coated

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Alembic Pharmaceuticals Limited

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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 a

Dettagli prodotto:

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 46708-451-20    bottle of 20 tablets NDC 46708-451-30    bottle of 30 tablets NDC 46708-451-60    bottle of 60 tablets NDC 46708-451-31    bottle of 100 tablets NDC 46708-451-91    bottle of 1000 tablets NDC 46708-451-42    bottle of 3000 tablets NDC 46708-451-10    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 46708-452-20    bottle of 20 tablets NDC 46708-452-30    bottle of 30 tablets NDC 46708-452-60    bottle of 60 tablets NDC 46708-452-31    bottle of 100 tablets NDC 46708-452-71    bottle of 500 tablets NDC 46708-452-42    bottle of 3000 tablets NDC 46708-452-10    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 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.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

MEMANTINE HYDROCHLORIDE - MEMANTINE HYDROCHLORIDE TABLET, COATED
ALEMBIC PHARMACEUTICALS LIMITED
----------
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 FDA AT 1-800-FDA-1088
OR
WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 1/2023
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 with Other N-methyl-D-aspartate (NMDA) Antagonists
8 USE IN SPECIF