CARBIDOPA AND LEVODOPA tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Physicians Total Care, Inc.

INN (Algemene Internationale Benaming):

CARBIDOPA

Samenstelling:

CARBIDOPA 10 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Carbidopa and levodopa tablets are indicated in the treatment of the symptoms of idiopathic Parkinson's disease (paralysis agitans), post-encephalitic parkinsonism, and symptomatic parkinsonism which may follow injury to the nervous system by carbon monoxide intoxication and/or manganese intoxication. This product 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 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, there is no conclusive evidence at present that this is benefic

Product samenvatting:

Carbidopa and levodopa tablets USP, 10 mg/100 mg are available in the following form: Mottled-blue, round, scored tablets, debossed "93"-"292" on the scored side and plain on the other side, packaged in Carbidopa and levodopa tablets USP, 25 mg/100 mg are available in the following form: Mottled-yellow, round, scored tablets, debossed "93"-"293" on the scored side and debossed "TEVA" on the other side, packaged in Carbidopa and levodopa tablets USP, 25 mg/250 mg are available in the following form: Mottled-blue, round, scored tablets, debossed "93"-"294" on the scored side and plain on the other side, packaged in Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. PROTECT FROM LIGHT. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 91010, Israel Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. Q 2/2011 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, Oklahoma       74146

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

CARBIDOPA AND LEVODOPA - CARBIDOPA AND LEVODOPA TABLET
PHYSICIANS TOTAL CARE, INC.
----------
CARBIDOPA AND LEVODOPA TABLETS USP
0292
0293
0294
RX ONLY
DESCRIPTION
Carbidopa and levodopa tablets USP are a combination of carbidopa and
levodopa for the treatment of
Parkinson’s disease and syndrome.
Carbidopa, 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, 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 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
10
14
2
4
2
9
11
4
Carbidopa and levodopa tablets USP, 25 mg/250 mg, containing 25 mg of
carbidopa and 250 mg of
levodopa.
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 include
resting tremor, rigidity, and bradykinetic movements. Sym