CARBIDOPA AND LEVODOPA- carbidopa and levodopa tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NuCare Pharmaceuticals,Inc.

INN (International Name):

CARBIDOPA

Composition:

CARBIDOPA ANHYDROUS 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Carbidopa and levodopa tablets, USP 25 mg/100 mg are 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: NDC 68071-4067-1 Bottles of 100 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CARBIDOPA AND LEVODOPA- CARBIDOPA AND LEVODOPA TABLET
NUCARE PHARMACEUTICALS,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 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
10
14
2
4
2
9
11
4
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.
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 syste