CARBIDOPA AND LEVODOPA tablet, extended release

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Accord Healthcare, Inc.

INN（国際名）:

CARBIDOPA

構図:

CARBIDOPA ANHYDROUS 50 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

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. These inhibitors must be discontinued at least two weeks prior to initiating therapy with carbidopa and levodopa extended-release. Carbidopa and levodopa extended-release 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 is contraindicated in patients with known hypersensitivity to any component of this drug, and in patients with narrow-angle glaucoma.

製品概要:

Carbidopa and Levodopa Extended-release Tablets USP 50 mg/200 mg containing 50 mg of carbidopa and 200 mg of levodopa, are peach to light peach coloured with mosaic appearance, oval shaped biconvex, tablets, debossed with 'L200' on one side and breakline on other. They are supplied as follows: NDC 16729-079-10 bottles of 30. NDC 16729-079-01 bottles of 100. NDC 16729-079-16 bottles of 500. NDC 16729-079-17 bottles of 1000. Carbidopa and Levodopa Extended-release Tablets USP 25/100 containing 25 mg of carbidopa and 100 mg of levodopa, are peach to light peach coloured with mosaic appearance, oval shaped, biconvex tablets debossed with 'L100' on one side and plain on other. They are supplied as follows: NDC 16729-078-10 bottles of 30. NDC 16729-078-01 bottles of 100. NDC 16729-078-16 bottles of 500. NDC 16729-078-17 bottles of 1000. 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. Dispense in a tightly closed, light-resistant container. For more information, go to www.accordhealthcare.us or call Accord Healthcare Inc. at 1-866-941-7875.

認証ステータス:

Abbreviated New Drug Application

製品の特徴

CARBIDOPA AND LEVODOPA- CARBIDOPA AND LEVODOPA TABLET, EXTENDED
RELEASE
ACCORD HEALTHCARE, INC.
----------
CARBIDOPA AND LEVODOPA EXTENDED-RELEASE TABLETS USP
RX ONLY
DESCRIPTION
Carbidopa and levodopa extended-release tablets USP are 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 empirical 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 empirical formula is C
H
NO
and its
structural formula is:
Each extended-release tablet, for oral administration, contains 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, lactose
monohydrate,
hydroxypropylmethyl cellulose, hypromellose, colloidal anhydrous
silica, magnesium
stearate, ferric oxide red and ferric oxide yellow.
The 50 mg/200 mg tablet is supplied as an oval, scored, biconvex,
compressed tablet
that is peach to light peach colored. The 25 mg/100 mg tablet is
supplied as an oval,
biconvex, compressed tablet that is peach to light peach colored.
Carbidopa and
levodopa extended-release tablets USP are designed in a drug delivery
system that
10
14
2
4
2
9
11
4
controls the release of carbidopa and levodopa as it slowly erodes.
The 25 mg/100 mg
carbidopa and levodopa extended-release tablet USP is available to
facilitate titration and
as an alternative to the half-tablet of 50 mg/200 mg carbidopa and
levodopa extended-
release tablet USP.
Carbidopa and