CARBIDOPA tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Ingenus Pharmaceuticals NJ, LLC

INN (International Name):

CARBIDOPA

Composition:

CARBIDOPA ANHYDROUS 25 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CARBIDOPA- CARBIDOPA TABLET
INGENUS PHARMACEUTICALS NJ, LLC
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CARBIDOPA TABLETS
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 molecular formula is
C
H N O •H O and its structural formula is:
Carbidopa tablets contain 25 mg of carbidopa. Inactive ingredients are
colloidal silicon dioxide, FD&C
Red 40, microcrystalline cellulose, magnesium stearate and
pregelatinized starch.
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 where