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:

Golden State Medical Supply, Inc.

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. 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 this combination product. Carbidopa and levodopa may be administered co

Product summary:

Carbidopa and Levodopa Tablets, USP are supplied as follows: 10 mg/100 mg — Each dark blue, mottled, round tablet imprinted with   on one side and 538 and bisect on the other contains 10 mg of Carbidopa and 100 mg of Levodopa and is supplied in bottles of 100 ( NDC 60429-152-01 ). 25 mg/100 mg — Each yellow, mottled, round tablet imprinted with  on one side and 539 and bisect on the other contains 25 mg of Carbidopa and 100 mg of Levodopa and is supplied in bottles of 100 (NDC  60429-153-01 ) and 1000 ( NDC 60429-153-10 ). 25 mg/250 mg — Each light blue, mottled, round tablet imprinted with   on one side and 540 and bisect on the other contains 25 mg of Carbidopa and 250 mg of Levodopa and is supplied in bottles of 100 ( NDC 60429-154-01 ) and 500 ( NDC 60429-154-05 ). Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [See USP Controlled Room Temperature]. Protect from light. Dispense in a well-closed, light-resistant container as defined in the USP. Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Marketed/ Packaged by: GSMS, Inc. Camarillo, CA 93012 USA 40-9182 Revised — February 2016

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CARBIDOPA AND LEVODOPA- CARBIDOPA AND LEVODOPA TABLET
GOLDEN STATE MEDICAL SUPPLY, INC.
----------
CARBIDOPA AND LEVODOPA
CARBIDOPA AND LEVODOPA TABLETS, USP
40-9182
Revised — February 2016
RX ONLY
DESCRIPTION
Carbidopa and levodopa is a combination product 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 244.25. 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 197.19. 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 tablets, USP for oral administration, are
supplied in three strengths:
10 mg/100 mg, containing 10 mg of carbidopa and 100 mg of levodopa.
25 mg/100 mg, containing 25 mg of carbidopa and 100 mg of levodopa.
25 mg/250 mg, containing 25 mg of carbidopa and 250 mg of levodopa.
In addition, each tablet contains the following inactive ingredients:
10 mg/100 mg — Corn starch, FD&C blue #2 aluminum lake, magnesium
stearate, microcrystalline
cellulose, and pregelatinized starch (maize).
25 mg/100 mg — Corn starch, D&C yellow #10 aluminum lake, FD&C
yellow #6 aluminum lake (sunset
yellow lake), magnesium stearate, microcrystalline cellulose, and
pregelatinized starch (maize).
10
14
2
4
2
9
11
4
25 mg/250 mg — Corn starch, FD&C blue #2 aluminum lake, magnesium
stearate, microcrystalline
cellulose, and pregelatinized starch (maize).
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION: Parkinson's disease is a progressive,
neurodegenerative disorder of the
extrapyramidal nerv