CARBIDOPA AND LEVODOPA tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Sun Pharmaceutical Industries, Inc.

INN (Mezinárodní Name):

CARBIDOPA

Složení:

CARBIDOPA ANHYDROUS 10 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Carbidopa and levodopa tablets, USP are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Carbidopa allows patients treated for Parkinson's disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on carbidopa and levodopa tablets, USP. This is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa. Carbidopa may also reduce nausea and vomiting and permit more rapid titration of levodopa. Nonselective monoamine oxidase (MAO) inhibitors are contraindicated for use with carbidopa and levodopa tablets. These inhibitors must be discontinued at least two weeks prior to initiating therapy with carbidopa and levodopa tablets. Carbidopa and levodo

Přehled produktů:

Carbidopa and levodopa tablets, USP 25 mg/100 mg are mottled (orange colored speckles) yellow to light yellow colored oval shaped, biconvex, uncoated tablets debossed with "518" on one side and plain on the other side. They are supplied as follows: Bottle of 30 with child-resistant closure,        NDC 62756-518-83 Bottle of 100 with child-resistant closure,      NDC 62756-518-88 Bottle of 100, NDC 62756-518-08 Bottle of 500, NDC 62756-518-13 Bottle of 1000, NDC 62756-518-18 Carbidopa and levodopa tablets, USP 10 mg/100 mg are mottled blue to light blue colored oval shaped, biconvex, uncoated tablets debossed with "517" on one side and plain on the other side. They are supplied as follows: Bottle of 30 with child-resistant closure, NDC 62756-517-83 Bottle of 100 with child-resistant closure, NDC 62756-517-88 Bottle of 100, NDC 62756-517-08 Bottle of 500, NDC 62756-517-13 Bottle of 1000, NDC 62756-517-18 Carbidopa and levodopa tablets, USP 25 mg/250 mg are mottled blue to light blue colored oval shaped, biconvex, uncoated tablets debossed with "519" on one side and plain on the other side. They are supplied as follows: Bottle of 30 with child-resistant closure, NDC 62756-519-83 Bottle of 100 with child-resistant closure, NDC 62756-519-88 Bottle of 100, NDC 62756-519-08 Bottle of 500, NDC 62756-519-13 Bottle of 1000, NDC 62756-519-18 Carbidopa and levodopa tablets, USP 25 mg/250 mg are mottled blue to light blue colored round shaped, biconvex, uncoated tablets debossed with "519" on one side and plain on the other side. They are supplied as follows: Bottle of 100 with child-resistant closure, NDC 62756-985-01 Bottle of 500, NDC 62756-985-02 Storage Store at 20° to 25°C (68° to 77°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.

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

CARBIDOPA AND LEVODOPA - CARBIDOPA AND LEVODOPA TABLET
SUN PHARMACEUTICAL INDUSTRIES, INC.
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CARBIDOPA AND LEVODOPA TABLETS, USP
DESCRIPTION
Carbidopa and levodopa tablet, USP is a combination of carbidopa and
levodopa for the
treatment of Parkinson’s disease and syndrome.
Carbidopa USP, an inhibitor of aromatic amino acid decarboxylation, is
a white,
crystalline compound, slightly soluble in water, with a molecular
weight of 244.24. 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 226.23.
Levodopa USP, 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 is supplied as tablets in three strengths:
Carbidopa and levodopa tablets, USP, 25 mg/100 mg, containing 25 mg of
carbidopa
10
14
2
4
2
9
11
4
and 100 mg of levodopa.
Carbidopa and levodopa tablets, USP, 10 mg/100 mg, containing 10 mg of
carbidopa
and 100 mg of levodopa.
Carbidopa and levodopa tablets, USP, 25 mg/250 mg, containing 25 mg of
carbidopa
and 250 mg of levodopa.
Inactive ingredients are microcrystalline cellulose, corn starch,
pregelatinized
maize starch, sodium starch glycolate, magnesium stearate. Carbidopa
and levodopa
tablets, USP 10 mg/100 mg and 25 mg/250 mg also contain FD&C Blue 2.
Carbidopa and
levodopa tablets, USP 25 mg/100 mg also contain D&C Yellow 10 and FD&C
Yellow 6.
FDA approved dissolution method differs from that of the USP.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Parkinson's disease is a progressive, neurodegenerative disorder of
the extrapyramidal
nervous system affecting the mobility and control of the skeletal
muscular system. Its
characteristic features