Country: United States
Language: English
Source: NLM (National Library of Medicine)
CARBIDOPA (UNII: MNX7R8C5VO) (CARBIDOPA ANHYDROUS - UNII:KR87B45RGH), LEVODOPA (UNII: 46627O600J) (LEVODOPA - UNII:46627O600J)
Preferred Pharmaceuticals, Inc.
CARBIDOPA
CARBIDOPA ANHYDROUS 25 mg
ORAL
PRESCRIPTION DRUG
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 tablets. These inhibitors must be discontinued at least two weeks prior to initiating therapy with carbidopa and levodopa tablets. Carbidopa and levodo
Carbidopa and levodopa tablets, USP 10 mg/100 mg are mottled blue to light blue colored oval shaped, biconvex, uncoated tablets debossed with "517" on one side and plain on the other side. They are supplied as follows: Bottle of 30 - 68788-9684-3 Bottle of 60 - 68788-9684-6 Bottle of 90 - 68788-9684-9 Bottle of 100 - 68788-9684-1 Storage 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.
Abbreviated New Drug Application
CARBIDOPA AND LEVODOPA- CARBIDOPA AND LEVODOPA TABLET PREFERRED PHARMACEUTICALS, INC. ---------- CARBIDOPA AND LEVODOPA TABLETS, USP DESCRIPTION Carbidopa and levodopa tablet, USP is 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, crystalline compound, slightly soluble in water, with a molecular weight of 244.24. 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 197.2. 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 is supplied as tablets in three strengths: Carbidopa and levodopa tablets, USP, 25 mg/100 mg, containing 25 mg of carbidopa and 100 mg of levodopa. Carbidopa and levodopa tablets, USP, 10 mg/100 mg, containing 10 mg of carbidopa and 100 mg of levodopa. Carbidopa and levodopa tablets, USP, 25 mg/250 mg, containing 25 mg of carbidopa and 250 mg of levodopa. Inactive ingredients are microcrystalline cellulose, corn starch, pregelatinized maize starch, sodium starch glycolate, magnesium stearate. 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 also contain D&C Yellow 10 and FD&C Yellow 6. CLINICAL PHARMACOLOGY 10 14 2 4 2 9 11 4 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 resting tremor, rigidity, and bradykinetic movements. Sympt Read the complete document