CARBIDOPA AND LEVODOPA tablet, extended release

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

CARBIDOPA (UNII: MNX7R8C5VO) (CARBIDOPA ANHYDROUS - UNII:KR87B45RGH), LEVODOPA (UNII: 46627O600J) (LEVODOPA - UNII:46627O600J)

Boleh didapati daripada:

American Health Packaging

INN (Nama Antarabangsa):

CARBIDOPA

Komposisi:

CARBIDOPA ANHYDROUS 25 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Carbidopa and levodopa extended-release tablets are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Nonselective monoamine oxidase (MAO) inhibitors are contraindicated for use with carbidopa and levodopa extended-release tablets. These inhibitors must be discontinued at least two weeks prior to initiating therapy with carbidopa and levodopa extended-release tablets. Carbidopa and levodopa extended-release tablets may be administered concomitantly with the manufacturer's recommended dose of an MAO inhibitor with selectivity for MAO type B (e.g., selegiline HCl) (See PRECAUTIONS, Drug Interactions). Carbidopa and levodopa extended-release tablets are contraindicated in patients with known hypersensitivity to any component of this drug, and in patients with narrow-angle glaucoma.

Ringkasan produk:

Carbidopa and levodopa extended-release tablets 50 mg/200 mg containing 50 mg of carbidopa and 200 mg of levodopa, are buff colored, oval, biconvex uncoated tablets debossed “457” on one side and scored on other side, with mottled appearance. They are supplied as follows: Unit dose packages of 100 (10 x 10) NDC 68084-282-01 Carbidopa and levodopa extended-release tablets 25 mg/100 mg containing 25 mg carbidopa and 100 mg of levodopa, are buff colored, oval, biconvex, uncoated tablets debossed “461” on one side and plain on other side, with mottled appearance. They are supplied as follows: Unit dose packages of 100 (10 x 10) NDC 68084-281-01 Storage Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]. Store in a tightly closed container. Protected from light and moisture. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

CARBIDOPA AND LEVODOPA- CARBIDOPA AND LEVODOPA TABLET, EXTENDED
RELEASE
AMERICAN HEALTH PACKAGING
----------
CARBIDOPA AND LEVODOPA EXTENDED-RELEASE TABLETS
8228101/0715
RX ONLY
DESCRIPTION
Carbidopa and levodopa extended-release tablets are extended-release
combination of
carbidopa and levodopa for the treatment of Parkinson's disease and
syndrome.
Carbidopa, an inhibitor of aromatic amino acid decarboxylation, is a
white, crystalline
compound, slightly soluble in water, with a molecular weight of 244.3.
It is designated
chemically as (-)-L-α-hydrazino-α-methyl-β-(3,4-dihydroxybenzene)
propanoic acid
monohydrate. Its molecular formula is C
H
N
O
·H
O and its structural formula is:
Tablet content is expressed in terms of anhydrous carbidopa, which has
a molecular
weight of 226.3.
Levodopa, an aromatic amino acid, is a white, crystalline compound,
slightly soluble in
water, with a molecular weight of 197.2. It is designated chemically
as (-)-L-α-amino-β-
(3,4-dihydroxybenzene) propanoic acid. Its molecular formula is C
H
NO
and its
structural formula is:
Carbidopa and levodopa extended-release tablets are supplied as
extended-release
tablets containing either 50 mg of carbidopa USP and 200 mg of
levodopa USP, or 25
mg of carbidopa USP and 100 mg of levodopa USP. Inactive ingredients:
microcrystalline
cellulose, colloidal silicon dioxide, hypromellose, hydroxypropyl
cellulose, magnesium
stearate, red ferric oxide and D&C Yellow 10 Aluminum lake.
The 50 mg/200 mg tablet is supplied as an oval, scored, biconvex,
compressed tablet
debossed “457” on one side and scored on other side that is buff
colored with mottled
appearance. The 25 mg/100 mg tablet is supplied as an oval, biconvex,
compressed
tablet debossed “461” on one side and plain on other side that is
buff colored with
mottled appearance. Carbidopa and levodopa extended-release tablet is
a polymeric-
based drug delivery system that controls the release of carbidopa and
levodopa as it
10
14
2
4
2
9
11
4
slowly erodes. Carbidopa and levodopa extend