מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
CARBIDOPA (UNII: MNX7R8C5VO) (CARBIDOPA ANHYDROUS - UNII:KR87B45RGH)
Aurobindo Pharma Limited
ORAL
PRESCRIPTION DRUG
Carbidopa tablets are indicated for use with carbidopa-levodopa or with levodopa in the treatment of the symptoms of idiopathic Parkinson’s disease (paralysis agitans), postencephalitic parkinsonism, and symptomatic parkinsonism, which may follow injury to the nervous system by carbon monoxide intoxication and/or manganese intoxication. Carbidopa tablets are for use with carbidopa-levodopa in patients for whom the dosage of carbidopa-levodopa provides less than adequate daily dosage (usually 70 mg daily) of carbidopa. Carbidopa tablets are for use with levodopa in the occasional patient whose dosage requirement of carbidopa and levodopa necessitates separate titration of each medication. Carbidopa tablets are used with carbidopa-levodopa or with levodopa to permit the administration of lower doses of levodopa with reduced nausea and vomiting, more rapid dosage titration, and with a somewhat smoother response. However, patients with markedly irregular (“on-off”) responses to levodopa have not be
Carbidopa Tablets, 25 mg: White to off-white, round shaped, uncoated scored tablets debossed with “R” above the score line and “1” below the score line on one side and plain on other side. They are supplied as follows: Bottles of 100’s NDC 59651-146-01 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 038, India Issued: June 2018
Abbreviated New Drug Application
CARBIDOPA - CARBIDOPA TABLET AUROBINDO PHARMA LIMITED ---------- CARBIDOPA TABLETS RX ONLY WHEN CARBIDOPA IS TO BE GIVEN TO CARBIDOPA-NAIVE PATIENTS WHO ARE BEING TREATED WITH LEVODOPA, THE TWO DRUGS SHOULD BE GIVEN AT THE SAME TIME, STARTING WITH NO MORE THAN 20 TO 25% OF THE PREVIOUS DAILY DOSAGE OF LEVODOPA WHEN GIVEN WITHOUT CARBIDOPA. AT LEAST TWELVE HOURS SHOULD ELAPSE BETWEEN THE LAST DOSE OF LEVODOPA AND INITIATION OF THERAPY WITH CARBIDOPA AND LEVODOPA. SEE THE WARNINGS AND DOSAGE AND ADMINISTRATION SECTIONS BEFORE INITIATING THERAPY. DESCRIPTION Carbidopa, an inhibitor of aromatic amino acid decarboxylation, is a white to yellowish white powder, slightly soluble in water, very slightly soluble in ethanol (96%), practically insoluble in methylene chloride, with a molecular weight of 244.3. 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: Each tablet contains 25 mg of carbidopa USP (anhydrous equivalent). Inactive ingredients are magnesium stearate, microcrystalline cellulose and pregelatinized starch (maize). Tablet content is expressed in terms of anhydrous carbidopa which has a molecular weight of 226.3. CLINICAL PHARMACOLOGY 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. 10 14 2 4 2 Symptomatic treatments, such as levodopa therapies, may permit the patient better mobility. MECHANISM OF ACTION 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 קרא את המסמך השלם