MEMANTINE HYDROCHLORIDE tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

DirectRx

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Memantine hydrochloride tablets, USP 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. 8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of memantine 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 [see Data]. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknow

Dettagli prodotto:

Memantine Hydrochloride Tablets USP, 5 mg are white to off white, capsule shaped, biconvex film coated tablets debossed with 'ZF' on one side and '41' on other side and are supplied as below. NDC in bottle of 60 tablets NDC in bottle of 100 tablets NDC in bottle of 500 tablets NDC in bottle of 1000 tablets NDC in unit-dose blister carton of 100 (10 x 10) unit-dose tablets Memantine Hydrochloride Tablets USP, 10 mg are white to off white, capsule shaped, biconvex film coated tablets debossed with 'ZF 40' on one side and other side is plain and are supplied as below. NDC in bottle of 60 tablets NDC in bottle of 100 tablets NDC in bottle of 500 tablets NCD in bottle of 1000 tablets NDC 72578-004-77 in unit-dose blister carton of 100 (10 x 10) unit-dose tablets Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container. Call your doctor for medical advice about side effects. You may report side effects to Viona Pharmaceuticals Inc. at 1-888-304-5011 or FDA at 1-800-FDA-1088.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

MEMANTINE HYDROCHLORIDE- MEMANTINE HYDROCHLORIDE TABLET
DIRECTRX
----------
MEMANTINE HCL
Memantine hydrochloride tablets, USP are indicated for the treatment
of moderate to
severe dementia of the Alzheimer's type.
The recommended starting dose of memantine hydrochloride is 5 mg once
daily. The
dose should be increased in 5 mg increments to 10 mg/day (5 mg twice
daily), 15
mg/day (5 mg and 10 mg as separate doses), and 20 mg/day (10 mg twice
daily). The
minimum recommended interval between dose increases is one week. The
dosage
shown to be effective in controlled clinical trials is 20 mg/day.
Memantine hydrochloride tablets can be taken with or without food. If
a patient misses a
single dose of memantine hydrochloride tablets, that patient should
not double up on
the next dose. The next dose should be taken as scheduled.
If a patient fails to take memantine hydrochloridetablets for several
days, dosing may
need to be resumed at lower doses and retitrated as described above.
Specific Populations
Renal Impairment
A target dose of 5 mg twice daily is recommended in patients with
severe renal
impairment (creatinine clearance of 5 to 29 mL/min based on the
Cockcroft-Gault
equation).
Hepatic Impairment
Memantine hydrochloride tablets should be administered with caution to
patients with
severe hepatic impairment [see Clinical Pharmacology (12.3)].
Memantine Hydrochloride Tablets USP, 5 mg are white to off white,
capsule shaped,
biconvex film coated tablets debossed with 'ZF' on one side and '41'
on other side.
Memantine Hydrochloride Tablets USP, 10 mg are white to off white,
capsule shaped,
biconvex film coated tablets debossed with 'ZF 40' on one side and
other side is plain.
Memantine hydrochloride tablets are contraindicated in patients with
known
hypersensitivity to memantine hydrochloride or to any excipients used
in the
formulation.
5.1 Genitourinary Conditions
Conditions that raise urine pH may decrease the urinary elimination of
memantine
resulting in increased plasma levels of memantine [see Drug
Interactions