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, LLC

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. 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 2 weeks prior to initiating therapy with carbidopa and levodopa tablets. Carbidopa and levodopa tabl

Product summary:

Carbidopa and Levodopa Tablets, USP are available containing 10 mg or 25 mg of carbidopa, USP and 100 mg or 250 mg of levodopa, USP. The 10 mg/100 mg tablets are blue, round, scored and debossed with M above the score and CL1 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 60429-650-01 bottles of 100 tablets NDC 60429-650-05 bottles of 500 tablets The 25 mg/100 mg tablets are yellow, round, scored and debossed with M above the score and CL2 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 60429-651-01 bottles of 100 tablets NDC 60429-651-05 bottles of 500 tablets The 25 mg/250 mg tablets are blue, round, scored and debossed with M above the score and CL3 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 60429-652-01 bottles of 100 tablets NDC 60429-652-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Marketed/ Packaged by: GSMS, Inc. Camarillo, CA 93012 USA REVISED OCTOBER 2014 CDLDT:R3

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CARBIDOPA AND LEVODOPA- CARBIDOPA AND LEVODOPA TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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CARBIDOPA AND LEVODOPA TABLETS, USP
DESCRIPTION
Carbidopa and Levodopa Tablets, USP are 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 to creamy white
powder. It is slightly soluble in water; freely soluble in 3 N
hydrochloric acid; slightly soluble in
methanol; practically insoluble in acetone, chloroform, ether and
methylene chloride, with a molecular
weight of 244.2. It is designated chemically as
(-)-L-α-Hydrazino-3,4-dihydroxy-α-
methylhydrocinnamic 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 226.2.
Levodopa USP, an aromatic amino acid, is a white to off-white
crystalline powder. It is slightly soluble
in water; freely soluble in 3 N hydrochloric acid; readily soluble in
formic acid; practically insoluble in
ethanol, benzene, chloroform and ethyl acetate; insoluble in acetone,
acetic acid and methanol; with a
molecular weight of 197.2. It is designated chemically as
(-)-3-(3,4-Dihydroxyphenyl)-L-alanine. Its
molecular formula is C H NO and its structural formula is:
Carbidopa and Levodopa Tablets, USP are supplied as tablets in three
strengths:
Carbidopa and Levodopa Tablets USP, 10 mg/100 mg contains 10 mg of
carbidopa and 100 mg of
levodopa.
Carbidopa and Levodopa Tablets USP, 25 mg/100 mg contains 25 mg of
carbidopa and 100 mg of
levodopa.
Carbidopa and Levodopa Tablets USP, 25 mg/250 mg contains 25 mg of
carbidopa and 250 mg of
levodopa.
Inactive ingredients are crospovidone, hydroxypropyl cellulose,
magnesium stearate, microcrystalline
cellulose and pregelatinized starch (corn). In addition, the 10 mg/100
mg and 25 mg/250 mg tablets
10
14
2
4
2
9
11
4
contain FD&C Blue No. 2 Aluminum Lake and the 25 mg/100 mg tablets
contain D&C Yellow No