CARBIDOPA AND LEVODOPA tablet, extended release

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

BluePoint Laboratories

INN (International namn):

CARBIDOPA

Sammansättning:

CARBIDOPA ANHYDROUS 50 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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.

Produktsammanfattning:

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 68001-172-00 bottles of 100 with child-resistant closure. 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 68001-171-00 bottles of 100 with child-resistant closure. 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.

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

CARBIDOPA AND LEVODOPA- CARBIDOPA AND LEVODOPA TABLET, EXTENDED
RELEASE
BLUEPOINT LABORATORIES
----------
CARBIDOPA AND LEVODOPA EXTENDED-RELEASE TABLETS 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, hydroxypropyl methyl
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 controls the release of carbidopa and
levodopa as it slowly erodes. The 25
mg/100 mg carbidopa and levodopa extended-release tablets USP is
available to facilitate titration and
as an alternative to the half-tablet of 50 mg/200 mg carbidopa and
levodopa extended-release tablets
USP.
Carbidopa and levodopa extended-rel