MEMANTINE AND DONEPEZIL HYDROCHLORIDES EXTENDED-RELEASE- memantine and donepezil capsule, extended release

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

MEMANTINE HYDROCHLORIDE (UNII: JY0WD0UA60) (MEMANTINE - UNII:W8O17SJF3T), DONEPEZIL HYDROCHLORIDE (UNII: 3O2T2PJ89D) (DONEPEZIL - UNII:8SSC91326P)

Verfügbar ab:

Amneal Pharmaceuticals NY LLC

INN (Internationale Bezeichnung):

MEMANTINE HYDROCHLORIDE

Zusammensetzung:

MEMANTINE HYDROCHLORIDE 14 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Memantine and donepezil hydrochlorides extended-release capsules are 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. Memantine and donepezil hydrochlorides extended-release capsules are 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 memantine and donepezil hydrochlorides extended-release capsules 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 re

Produktbesonderheiten:

Memantine and donepezil hydrochlorides extended-release capsules, 14 mg/10 mg , are supplied as two-piece hard gelatin capsules with green opaque cap and green opaque body filled with white to off-white pellets. Imprinted in white ink AN on the cap and imprinted in white ink 1248 on the body. They are available as follows: Bottle of 30:    NDC 69238-1248-3 Bottle of 90:    NDC 69238-1248-9 Memantine and donepezil hydrochlorides extended-release capsules, 28 mg/10 mg , are supplied as two-piece hard gelatin capsules with yellow opaque cap and yellow opaque body filled with white to off-white pellets. Imprinted in black ink AN on the cap and imprinted in black ink 1247 on the body. They are available as follows: Bottle of 30:    NDC 69238-1247-3 Bottle of 90:    NDC 69238-1247-9 Store at 20º to 25°C (68º to 77°F); excursions permitted between 15° to 30ºC (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container, as defined in the USP.

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

MEMANTINE AND DONEPEZIL HYDROCHLORIDES EXTENDED-RELEASE- MEMANTINE
AND DONEPEZIL CAPSULE, EXTENDED RELEASE
AMNEAL PHARMACEUTICALS NY LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MEMANTINE AND DONEPEZIL
HYDROCHLORIDES EXTENDED-RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION
FOR MEMANTINE AND DONEPEZIL HYDROCHLORIDES EXTENDED-RELEASE CAPSULES.
MEMANTINE AND DONEPEZIL HYDROCHLORIDES EXTENDED-RELEASE CAPSULES, FOR
ORAL USE
INITIAL U.S. APPROVAL: 2014
RECENT MAJOR CHANGES
Indications and Usage (1) 07/2016
Dosage and Administration (2.1, 2.3) 07/2016
INDICATIONS AND USAGE
Memantine and donepezil hydrochlorides extended-release capsules are 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 memantine and donepezil
hydrochlorides extended-release capsules 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 memantine and
donepezil hydrochlorides extended-release
capsules 28 mg/10 mg, taken once daily in the evening. (2.1)
Memantine and donepezil hydrochlorides extended-release capsules 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
memantine and donepezil hydrochlorides
extended-release capsules is 14 mg/10 mg once daily in the evening