NAMENDA- memantine hydrochloride tablet

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)

Sẵn có từ:

Rebel Distributors Corp

INN (Tên quốc tế):

MEMANTINE HYDROCHLORIDE

Thành phần:

MEMANTINE HYDROCHLORIDE 5 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Namenda (memantine hydrochloride) is indicated for the treatment of moderate to severe dementia of the Alzheimer's type. Namenda (memantine hydrochloride) is contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation. Controlled Substance Class: Memantine HCl is not a controlled substance. Physical and Psychological Dependence: Memantine HCl is a low to moderate affinity uncompetitive NMDA antagonist that did not produce any evidence of drug-seeking behavior or withdrawal symptoms upon discontinuation in 2,504 patients who participated in clinical trials at therapeutic doses. Post marketing data, outside the U.S., retrospectively collected, has provided no evidence of drug abuse or dependence.

Tóm tắt sản phẩm:

5 mg Tablet: The capsule-shaped, film-coated tablets are tan, with the strength (5) debossed on one side and FL on the other. 10 mg Tablet: The capsule-shaped, film-coated tablets are gray, with the strength (10) debossed on one side and FL on the other. Repackaged by Rebel Distributors Corp Thousand Oaks, CA 91320

Tình trạng ủy quyền:

New Drug Application

Đặc tính sản phẩm

NAMENDA- MEMANTINE HYDROCHLORIDE TABLET
REBEL DISTRIBUTORS CORP
----------
NAMENDA
RX ONLY
DESCRIPTION
Namenda® (memantine hydrochloride) is an orally active NMDA receptor
antagonist. The chemical
name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane
hydrochloride with the
following structural formula:
The molecular formula is C
H N•HCl and the molecular weight is 215.76.
Memantine HCl occurs as a fine white to off-white powder and is
soluble in water. Namenda is
available as tablets or as an oral solution. Namenda is available for
oral administration as capsule-
shaped, film-coated tablets containing 5 mg and 10 mg of memantine
hydrochloride. The tablets also
contain the following inactive ingredients: microcrystalline
cellulose/colloidal silicon dioxide, talc,
croscarmellose sodium, and magnesium stearate. In addition the
following inactive ingredients are also
present as components of the film coat: hypromellose, titanium
dioxide, polyethylene glycol 400,
FD&C yellow #6 and FD&C blue #2 (5 mg tablets), and hypromellose,
titanium dioxide,
macrogol/polyethylene glycol 400 and iron oxide black (10 mg tablets).
Namenda oral solution contains
memantine hydrochloride in a strength equivalent to 2 mg of memantine
hydrochloride in each mL. The
oral solution also contains the following inactive ingredients:
sorbitol solution (70%), methyl paraben,
propylparaben, propylene glycol, glycerin, natural peppermint flavor
#104, citric acid, sodium citrate,
and purified water.
CLINICAL PHARMACOLOGY
Mechanism of Action and Pharmacodynamics
Persistent activation of central nervous system N-methyl-D-aspartate
(NMDA) receptors by the
excitatory amino acid glutamate has been hypothesized to contribute to
the symptomatology of
Alzheimer's disease. Memantine is postulated to exert its therapeutic
effect through its action as a low
to moderate affinity uncompetitive (open-channel) NMDA receptor
antagonist which binds
preferentially to the NMDA receptor-operated cation channels. There is
no evidence that memantine
preve