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:

Aphena Pharma Solutions - Tennessee, Inc.

INN (International Name):

CARBIDOPA

Composition:

CARBIDOPA 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Carbidopa and levodopa tablets are indicated in the treatment of the symptoms of idiopathic Parkinson's disease (paralysis agitans), post-encephalitic parkinsonism, and symptomatic parkinsonism which may follow injury to the nervous system by carbon monoxide intoxication and/or manganese intoxication. This product is indicated in these conditions to permit the administration of lower doses of levodopa with reduced nausea and vomiting, with more rapid dosage titration, with a somewhat smoother response, and with supplemental pyridoxine (vitamin B6 ). In some patients a somewhat smoother antiparkinsonian effect results from therapy with carbidopa and levodopa than with levodopa. However, patients with markedly irregular ("on-off") responses to levodopa have not been shown to benefit from carbidopa and levodopa. Although the administration of carbidopa permits control of parkinsonism and Parkinson's disease with much lower doses of levodopa, there is no conclusive evidence at present that this is beneficial othe

Product summary:

Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. 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 0228-2538-10) and 500 (NDC 0228-2538-50). 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 0228-2539-10), 500 (NDC 0228-2539-50) and 1000 (NDC 0228-2539-96). 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 0228-2540-10), 500 (NDC 0228-2540-50) and 1000 (NDC 0228-2540-96). Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [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 200 Elmora Avenue Elizabeth, NJ 07207 USA 40-8774 Revised — January 2010

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CARBIDOPA AND LEVODOPA - CARBIDOPA AND LEVODOPA TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, INC.
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CARBIDOPA AND LEVODOPA TABLETS, USP
40-8774
Revised — January 2010
RX ONLY
DESCRIPTION
Carbidopa and levodopa is a combination product for the treatment of
Parkinson's disease and syndrome.
Carbidopa, 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, 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, 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.
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.
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.
CLINICAL PHARMACOLOGY
Parkinson's disease is a progressive, neurodegenerative disorder of
the extrapyramidal nervous system
affecting the mobility and control of the skeletal muscular sy