NAMZARIC- memantine hydrochloride and donepezil hydrochloride capsule NAMZARIC- memantine hydrochloride and donepezil hydrochlo

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

memantine hydrochloride (UNII: JY0WD0UA60) (memantine - UNII:W8O17SJF3T), donepezil hydrochloride (UNII: 3O2T2PJ89D) (donepezil - UNII:8SSC91326P)

Sẵn có từ:

Allergan, Inc.

INN (Tên quốc tế):

memantine hydrochloride

Thành phần:

memantine hydrochloride 14 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

NAMZARIC is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily. NAMZARIC is contraindicated in patients with known hypersensitivity to memantine hydrochloride, donepezil hydrochloride, piperidine derivatives, or to any excipients used in the formulation. Risk Summary There are no adequate data on the developmental risk associated with the use of NAMZARIC or its active ingredients (memantine hydrochloride and donepezil hydrochloride) in pregnant women. Adverse developmental effects (mortality and decreased body weight and skeletal ossification) were observed in the offspring of rats administered memantine or donepezil during pregnancy at doses associated with minimal maternal toxicity. These doses are higher than those used in humans at the recommended daily dose of NAMZARIC [see Data ] . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recogni

Tóm tắt sản phẩm:

7 mg memantine hydrochloride and 10 mg donepezil hydrochloride: light green opaque body and an orange opaque cap with a black “FL 7/10” radial imprint. Bottle of 30:       NDC# 0456-1207-30 14 mg memantine hydrochloride and 10 mg donepezil hydrochloride: light green opaque capsules with a black “FL 14/10” radial imprint. Bottle of 30:       NDC# 0456-1214-30 Bottle of 90:       NDC# 0456-1214-90 Unit Dose carton (10x10):       NDC# 0456-1214-63 Unit Dose blister (10):       NDC# 0456-1214-11 21 mg memantine hydrochloride and 10 mg donepezil hydrochloride: white opaque body and an orange opaque cap with a black “FL 21/10” radial imprint. Bottle of 30:       NDC# 0456-1221-30 28 mg memantine hydrochloride and 10 mg donepezil hydrochloride: blue opaque capsules with a black “FL 28/10” radial imprint. Bottle of 30:       NDC# 0456-1228-30 Bottle of 90:       NDC# 0456-1228-90 Unit Dose carton (10x10):       NDC# 0456-1228-63 Unit Dose blister (10):       NDC# 0456-1228-11 Titration Pack NDC# 0456-1229-29 Contains 28 capsules (7 x 7mg/10 mg, 7 x 14 mg/10 mg, 7 x 21 mg/10 mg, 7 x 28 mg/10 mg) Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature] . Dispense in a tight, light-resistant container, as defined in the USP.

Tình trạng ủy quyền:

New Drug Application

Đặc tính sản phẩm

NAMZARIC- MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE CAPSULE
NAMZARIC- MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE
ALLERGAN, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NAMZARIC CAPSULES SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR NAMZARIC CAPSULES.
NAMZARIC (MEMANTINE AND DONEPEZIL HYDROCHLORIDES) EXTENDED-RELEASE
CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2014
INDICATIONS AND USAGE
NAMZARIC is a combination of memantine hydrochloride, an NMDA receptor
antagonist, and donepezil hydrochloride, an
acetylcholinesterase inhibitor, indicated for the treatment of
moderate to severe dementia of the Alzheimer's type in
patients stabilized on 10 mg of donepezil hydrochloride once daily.
(1)
DOSAGE AND ADMINISTRATION
For patients on donepezil hydrochloride 10 mg only, the recommended
starting dose of NAMZARIC is 7 mg/10 mg,
taken once daily in the evening. The dose should be increased in 7 mg
increments to the recommended maintenance
dose of 28 mg/10 mg. The minimum recommended interval between dose
increases is one week. (2.1)
Patients on memantine hydrochloride (10 mg twice daily or 28 mg
extended-release once daily) and donepezil
hydrochloride 10 mg once daily can be switched to NAMZARIC 28 mg/10
mg, taken once daily in the evening. (2.1)
NAMZARIC can be taken with or without food, whole or sprinkled on
applesauce; do not divide, chew, or crush. (2.2)
Severe renal impairment: the recommended maintenance dose for NAMZARIC
is 14 mg/10 mg once daily in the
evening. (2.3)
DOSAGE FORMS AND STRENGTHS
-Extended-Release Capsules:
7 mg memantine hydrochloride and 10 mg donepezil hydrochloride (3)
14 mg memantine hydrochloride and 10 mg donepezil hydrochloride (3)
21 mg memantine hydrochloride and 10 mg donepezil hydrochloride (3)
28 mg memantine hydrochloride and 10 mg donepezil hydrochloride (3)
CONTRAINDICATIONS
NAMZARIC is contraindicated in patients with known hypersensitivity to
memantine hydrochloride, donepezi