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:

McKesson Corporation dba SKY Packaging

INN (International Name):

CARBIDOPA

Composition:

CARBIDOPA ANHYDROUS 10 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. These inhibitors must be discontinued at least two weeks prior to initiating therapy with carbidopa and levodopa. Carbidopa and levodopa may be administe

Product summary:

Product: 63739-046 NDC: 63739-046-10 10 TABLET in a BLISTER PACK / 10 in a BOX, UNIT-DOSE Product: 63739-047 NDC: 63739-047-10 10 TABLET in a BLISTER PACK / 10 in a BOX, UNIT-DOSE Product: 63739-048 NDC: 63739-048-10 10 TABLET in a BLISTER PACK / 10 in a BOX, UNIT-DOSE

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CARBIDOPA AND LEVODOPA- CARBIDOPA AND LEVODOPA TABLET
MCKESSON CORPORATION DBA SKY PACKAGING
----------
CARBIDOPA AND LEVODOPA TABLETS USP
0292
0293
0294
RX ONLY
DESCRIPTION
Carbidopa and levodopa tablets USP are a combination of carbidopa, USP
and levodopa, USP 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. It is designated chemically as
(-)-L-α-hydrazino-α-methyl-β-(3,4-
dihydroxybenzene) propanoic acid monohydrate, and has the following
structural formula:
C
H N O ·H O M.W. 244.24
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. It is
designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene)
propanoic acid, and has the
following structural formula:
C H NO M.W. 197.19
Carbidopa and levodopa is supplied as tablets in three strengths:
Carbidopa and levodopa tablets USP, 25 mg/100 mg, containing 25 mg of
carbidopa, USP and 100 mg of
levodopa, USP.
Carbidopa and levodopa tablets USP, 10 mg/100 mg, containing 10 mg of
carbidopa, USP and 100 mg
of levodopa, USP.
Carbidopa and levodopa tablets USP, 25 mg/250 mg, containing 25 mg of
carbidopa, USP and 250 mg of
10
14
2
4
2
9
11
4
Carbidopa and levodopa tablets USP, 25 mg/250 mg, containing 25 mg of
carbidopa, USP and 250 mg of
levodopa, USP.
Inactive ingredients are magnesium stearate, microcrystalline
cellulose, pregelatinized starch, and corn
starch. 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 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 system.
Its characteristic features