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:

Mayne Pharma Inc

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:

Carbidopa and levodopa tablets USP, 10 mg/100 mg are available in the following form: Mottled-blue, round, scored tablets, debossed "93"-"292" on the scored side and plain on the other side, packaged in bottles of 100 (NDC 51862-077-01) and 500 (NDC 51862-077-05). 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
MAYNE PHARMA INC
----------
CARBIDOPA AND LEVODOPA TABLETS USP
RX ONLY
REV. V 6/2016
322K019800716
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:
Carbidopa and levodopa tablets USP, 10 mg/100 mg, containing 10 mg of
carbidopa, USP and 100 mg
of levodopa, USP.
Inactive ingredients are FD&C Blue #2, magnesium stearate,
microcrystalline cellulose, pregelatinized
starch, and corn starch.
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 include
10
14
2
4
2
9
11
4
resting tremor, rigidity, and bradykinetic movements. Symptomatic
treatments, such as levodopa
therapies, may permit the patient better mobility.
Current evidence indicates that symptoms of Parkinson's disease are
related to depletion of dopamine in
the corpus striatum. Administration of dopamine is ineffective in the
treatment of Parkinson's disease
apparently because it does not cross the blood-brain barrier. However,
levodopa, the metabolic
precursor of dopamine, does cross the blood-brain barrier, and
presumably