parcopa- Carbidopa and Levodopa tablet, orally disintegrating

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

Carbidopa (UNII: MNX7R8C5VO) (Carbidopa - UNII:MNX7R8C5VO), Levodopa (UNII: 46627O600J) (Levodopa - UNII:46627O600J)

Saadav alates:

Schwarz Pharma

INN (Rahvusvaheline Nimetus):

Carbidopa and Levodopa

Ravimvorm:

TABLET, ORALLY DISINTEGRATING

Koostis:

25 mg

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

PARCOPA®   is indicated 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. PARCOPA®   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-levodopa than with levodopa. However, patients with markedly irregular (“on-off”) responses to levodopa have not been shown to benefit from carbidopa-levodopa therapy. 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 other than in reducing naus

Toote kokkuvõte:

PARCOPA®   (carbidopa-levodopa orally disintegrating tablets) 25/100 are yellow, round, flat-faced, mint-flavored, scored and engraved “25/100” on the unscored side and “SP” above and “342” below the score on the other side. They are supplied as follows: Bottles of 100NDC 0091-3342-01 PARCOPA®   (carbidopa-levodopa orally disintegrating tablets) 10/100 are blue, round, flat-faced, mint-flavored, scored and engraved “10/100” on the unscored side and “SP” above and “341” below the score on the other side. They are supplied as follows: Bottles of 100NDC 0091-3341-01 PARCOPA®   (carbidopa-levodopa orally disintegrating tablets) 25/250 are blue, round, flat-faced, mint-flavored, scored, and engraved “25/250” on the unscored side and “SP” above and “343” below the score on the other side. They are supplied as follows: Bottles of 100NDC 0091-3343-01 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from moisture and light. Dispense in a tight, light-resistant container as defined in the USP/NF. By: CIMA LABS INC.® Eden Prairie, MN 55344, USA

Toote omadused

PARCOPA- CARBIDOPA AND LEVODOPA TABLET, ORALLY DISINTEGRATING
SCHWARZ PHARMA
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PARCOPA
(CARBIDOPA-LEVODOPA ORALLY DISINTEGRATING TABLETS)
RX ONLY
DES CRIPTION
PARCOPA (carbidopa-levodopa orally disintegrating tablets) is a
combination of carbidopa and
levodopa for the treatment of Parkinson’s disease and syndrome.
PARCOPA is an orally administered
formulation of carbidopa-levodopa which rapidly disintegrates on the
tongue and does not require
water to aid dissolution or swallowing.
Carbidopa, 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-ß-(3,4-dihydroxybenzene) propanoic acid
monohydrate. Its empirical 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 197.2. It is designated chemically as
(–)-L-α-amino-ß-(3,4-dihydroxybenzene)
propanoic acid. Its empirical formula is C H NO and its structural
formula is:
PARCOPA is supplied as tablets in three strengths:
PARCOPA 25/100, containing 25 mg of carbidopa and 100 mg of levodopa.
PARCOPA 10/100, containing 10 mg of carbidopa and 100 mg of levodopa.
PARCOPA 25/250, containing 25 mg of carbidopa and 250 mg of levodopa.
Inactive ingredients are aspartame, citric acid, crospovidone,
magnesium stearate, mannitol,
microcrystalline cellulose, natural and artificial mint flavor and
sodium bicarbonate. PARCOPA
10/100 and 25/250 also contain FD&C blue #2 HT aluminum lake. PARCOPA
25/100 also contains
yellow 10 iron oxide.
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
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