CARBIDOPA tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

ANI Pharmaceuticals, Inc.

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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 been shown to ben

leaflet_short:

Carbidopa Tablets are provided as peach orange, round tablets, flat side scored and debossed with "A" above the score and "25" below the score, with convex side blank and are supplied as: Bottles of 100    (NDC 43975-220-10) Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN . Mfd. by: Suzhou Amerigen Pharmaceutical Co. Ltd. Jiangsu, China 215006 Dist. By: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 USA 1-877-220-3784 OS1005/01                                    Rev. 02/2014

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

CARBIDOPA- CARBIDOPA TABLET
ANI PHARMACEUTICALS, INC.
----------
CARBIDOPA TABLETS, 25 MG
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, crystalline
compound, slightly soluble in water, 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 empirical formula is C10H14N2O4•H2O, and its
structural formula is:
Carbidopa tablets contain 25 mg of carbidopa. Inactive ingredients are
FD&C Yellow 6,
magnesium stearate, microcrystalline cellulose, pregelatinized starch
and silicon dioxide.
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.
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 presumably is converted to dopamine in the
brain. This is
thought to be the mechanism whereby le