CARBIDOPA AND LEVODOPA tablet, orally disintegrating

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

CARBIDOPA (UNII: MNX7R8C5VO) (CARBIDOPA ANHYDROUS - UNII:KR87B45RGH), LEVODOPA (UNII: 46627O600J) (LEVODOPA - UNII:46627O600J)

Saadav alates:

Sun Pharmaceutical Industries, Inc.

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Carbidopa and levodopa orally disintegrating tablets are 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. Carbidopa and levodopa orally disintegrating tablets are 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 and levodopa than with levodopa. However, patients with markedly irregular (“on-off”) responses to levodopa have not been shown to benefit from carbidopa and levodopa therapy. Although the administration of carbidopa permits control of parkinsonism and Parkinson’s disease with much lower doses of levodopa,

Toote kokkuvõte:

Carbidopa and levodopa orally disintegrating tablets 10 mg/100 mg are light blue colored, circular, biconvex, uncoated tablets debossed with “186” on one side and scored on the other side. They are supplied as follows: Bottles of 30’s with Child Resistant Cap…...NDC 47335-186-83 Bottles of 100’s with Child Resistant Cap…...NDC 47335-186-88 Bottles of 100’s with Non Child Resistant Cap…...NDC 47335-186-08 Bottles of 1000’s with Non Child Resistant Cap…...NDC 47335-186-18 Carbidopa and levodopa orally disintegrating tablets 25 mg/100 mg are light yellow colored, circular, biconvex, uncoated tablets debossed with “187” on one side and scored on the other side. They are supplied as follows: Bottles of 30’s with Child Resistant Cap…...NDC 47335-187-83 Bottles of 100’s with Child Resistant Cap…...NDC 47335-187-88 Bottles of 100’s with Non Child Resistant Cap…...NDC 47335-187-08 Bottles of 1000’s with Non Child Resistant Cap…...NDC 47335-187-18 Carbidopa and levodopa orally disintegrating tablets 25 mg/250 mg are light blue colored, circular, biconvex, uncoated tablets debossed with “188” on one side and scored on the other side. They are supplied as follows: Bottles of 30’s with Child Resistant Cap…...NDC 47335-188-83 Bottles of 100’s with Child Resistant Cap…...NDC 47335-188-88 Bottles of 100’s with Non Child Resistant Cap…...NDC 47335-188-08 Bottles of 1000’s with Non Child Resistant Cap…...NDC 47335-188-18 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 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. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 PJPI0511 ISS. 11/2014

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

CARBIDOPA AND LEVODOPA - CARBIDOPA AND LEVODOPA TABLET, ORALLY
DISINTEGRATING
SUN PHARMACEUTICAL INDUSTRIES, INC.
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CARBIDOPA AND LEVODOPA ORALLY DISINTEGRATING TABLETS
DESCRIPTION
Carbidopa and levodopa orally disintegrating tablet is a combination
of carbidopa and levodopa for the
treatment of Parkinson’s disease and syndrome. Carbidopa and
levodopa orally disintegrating tablet is an
orally administered formulation of carbidopa and levodopa which
rapidly disintegrates on the tongue
and does not require water to aid dissolution or swallowing.
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 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 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 empirical formula is C H NO , and its structural
formula is:
Carbidopa and levodopa orally disintegrating tablets are supplied as
tablets in three strengths:
Carbidopa and levodopa orally disintegrating tablets 25 mg/100 mg,
containing 25 mg of carbidopa and
100 mg of levodopa.
Carbidopa and levodopa orally disintegrating tablets 10 mg/100 mg,
containing 10 mg of carbidopa and
100 mg of levodopa.
Carbidopa and levodopa orally disintegrating tablets 25 mg/250 mg,
containing 25 mg of carbidopa and
250 mg of levodopa.
Inactive ingredients are povidone, mannitol, calcium silicate,
crospovidone, talc, magnesium stearate,
aspartame, tutti-frutti flavor, colloidal silicon dioxide,
microcrystalline cellulose. Carbidopa and
levodopa orally disintegrating tablets 10 mg/100 mg and 25 mg/250 mg
also contain FD&C