MEMANTINE HYDROCHLORIDE tablet, film coated

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Contract Pharmacy Services-PA

INN (الاسم الدولي):

MEMANTINE HYDROCHLORIDE

تركيب:

MEMANTINE HYDROCHLORIDE 10 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Memantine hydrochloride tablets 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. 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/m 2 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

ملخص المنتج:

10 mg Tablet: Gray, capsule-shaped, film-coated tablets, debossed with "322" on one side and plain on the other side. NDC 67046-458-07 blisterpacks of 7 NDC 67046-458-14 blisterpacks of 14 NDC 67046-458-15 blisterpacks of 15 NDC 67046-458-20 blisterpacks of 20 NDC 67046-458-21 blisterpacks of 21 NDC 67046-458-28 blisterpacks of 28 NDC 67046-458-30 blisterpacks of 30 NDC 67046-458-60 blisterpacks of 60 Store memantine hydrochloride tablets at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Dispense in a tightly closed container as described in the USP.

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

MEMANTINE HYDROCHLORIDE- MEMANTINE HYDROCHLORIDE TABLET, FILM COATED
CONTRACT PHARMACY SERVICES-PA
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HIGHLIGHTS OF PRESCRIBING INFORMATION
458 MEMANTINE 10 MG
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 tablets are 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 SUN PHARMACEUTICAL
INDUSTRIES, INC. AT 1-800-818-4555
OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 9/2017
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 Experie