CARBIDOPA tablet

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

CARBIDOPA (UNII: MNX7R8C5VO) (CARBIDOPA ANHYDROUS - UNII:KR87B45RGH)

Disponible des:

Zydus Pharmaceuticals USA Inc.

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Carbidopa is 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 is 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 is for use with levodopa in the occasional patient whose dosage requirement of carbidopa and levodopa necessitates separate titration of each medication. Carbidopa is 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 been shown to benefit from the addition of carbidopa.

Resumen del producto:

Carbidopa Tablets 25 mg, are mottled orange round uncoated tablet debossed "1221" on flat side and scored on convex side and are supplied as: NDC 70710-1221-1 in bottle of 100 tablets Store at 25°C (77°F), excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature] Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Please address medical inquiries to, ([e-mail]) Tel.: [phone].

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

CARBIDOPA- CARBIDOPA TABLET
ZYDUS PHARMACEUTICALS USA INC.
----------
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, USP is an inhibitor of aromatic amino acid decarboxylation.
It is white to
creamy white powder, freely soluble in 3N hydrochloric acid, slightly
soluble in water and
methanol, practically insoluble in alcohol, in acetone, in chloroform
and in ether, 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 molecular
formula is
C
H
N O •H O and its structural formula is:
Carbidopa tablets contain 25 mg of carbidopa, USP. Inactive
ingredients are
crospovidone type B, ferric oxide red, ferric oxide yellow,
hydroxypropyl cellulose,
magnesium stearate, mannitol and microcrystalline cellulose.
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.