Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
CARBIDOPA (UNII: MNX7R8C5VO) (CARBIDOPA ANHYDROUS - UNII:KR87B45RGH), LEVODOPA (UNII: 46627O600J) (LEVODOPA - UNII:46627O600J)
McKesson Corporation dba SKY Packaging
CARBIDOPA
CARBIDOPA ANHYDROUS 10 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. These inhibitors must be discontinued at least two weeks prior to initiating therapy with carbidopa and levodopa. Carbidopa and levodopa may be administe
Product: 63739-046 NDC: 63739-046-10 10 TABLET in a BLISTER PACK / 10 in a BOX, UNIT-DOSE Product: 63739-047 NDC: 63739-047-10 10 TABLET in a BLISTER PACK / 10 in a BOX, UNIT-DOSE Product: 63739-048 NDC: 63739-048-10 10 TABLET in a BLISTER PACK / 10 in a BOX, UNIT-DOSE
Abbreviated New Drug Application
CARBIDOPA AND LEVODOPA- CARBIDOPA AND LEVODOPA TABLET MCKESSON CORPORATION DBA SKY PACKAGING ---------- CARBIDOPA AND LEVODOPA TABLETS USP 0292 0293 0294 RX ONLY 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 in three strengths: Carbidopa and levodopa tablets USP, 25 mg/100 mg, containing 25 mg of carbidopa, USP and 100 mg of levodopa, USP. Carbidopa and levodopa tablets USP, 10 mg/100 mg, containing 10 mg of carbidopa, USP and 100 mg of levodopa, USP. Carbidopa and levodopa tablets USP, 25 mg/250 mg, containing 25 mg of carbidopa, USP and 250 mg of 10 14 2 4 2 9 11 4 Carbidopa and levodopa tablets USP, 25 mg/250 mg, containing 25 mg of carbidopa, USP and 250 mg of levodopa, USP. Inactive ingredients are magnesium stearate, microcrystalline cellulose, pregelatinized starch, and corn starch. 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 contain D&C Yellow #10 and FD&C Yellow #6. 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 Läs hela dokumentet