MEMANTINE HYDROCHLORIDE tablet

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Preferred Pharmaceuticals Inc.

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Memantine hydrochloride USP 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. Risk Summary There are no adequate data on the developmental risk associated with the use of memantine hydrochloride 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 hydrochloride [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 unknown. Data A

ملخص المنتج:

10 mg Tablet: Gray color, capsule shape, film-coated tablet, debossed with “CL28” on one side and plain on the other side. Bottle of 30                                        NDC # 68788-7165-3 Bottle of 60                                        NDC # 68788-7165-6 Bottle of 90                                        NDC # 68788-7165-9 Store memantine hydrochloride tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

MEMANTINE HYDROCHLORIDE- MEMANTINE HYDROCHLORIDE TABLET
PREFERRED PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
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 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
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
Memantine hydrochlorideis contraindicated in patients with known
hypersensitivity to memantine
hydrochloride or to any excipients used in the formulation. (4) (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 MACLEODS PHARMA USA, INC. AT 1-888-943-3210 OR FDA AT
1-800-FDA-1088 OR
WWW.FDA.GOV/MEDWATCH
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 7/2021
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS & USAGE
2 DOSAGE & ADMINISTRATION
3 DOSAGE FORMS & 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
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)
Tablets: 5 mg and 10 mg (3)
7.1 Drugs that Make