CARBIDOPA AND LEVODOPA tablet extended release

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

CARBIDOPA (UNII: MNX7R8C5VO) (CARBIDOPA - UNII:MNX7R8C5VO)

Dostopno od:

McKesson Contract Packaging

INN (mednarodno ime):

CARBIDOPA

Sestava:

CARBIDOPA 50 mg

Tip zastaranja:

PRESCRIPTION DRUG

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

CARBIDOPA AND LEVODOPA- CARBIDOPA AND LEVODOPA TABLET, EXTENDED
RELEASE
MCKESSON CONTRACT PACKAGING
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DESCRIPTION
Carbidopa and levodopa extended-release tablets are for the treatment
of Parkinson's disease and
syndrome.
Carbidopa, USP, an inhibitor of aromatic amino acid decarboxylation,
is a white, crystalline compound,
slightly soluble in water, with a molecular weight of 244.25. It is
designated chemically as(-)-L-alpha-
hydrazino-alpha-methyl-beta-(3,4-dihydroxybenzene) propanoic acid
monohydrate. 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 197.19. It is designated chemically as
(-)-L-alpha-amino- beta-(3,4-
dihydroxybenzene) propanoic acid. Its structural formula is:
Each extended-release tablet, for oral administration, contains either
25 mg of carbidopa and 100 mg of
levodopa or 50 mg of carbidopa and 200 mg of levodopa. In addition,
each tablet contains the following
inactive ingredients: FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40
Aluminum Lake,
hydroxypropyl cellulose, hypromellose, and magnesium stearate.
Carbidopa and levodopa extended-release tablets are designed in a drug
delivery system that controls
the release of carbidopa and levodopa as the tablets slowly erode. The
25 mg/100 mg carbidopa and
levodopa extended-release tablet is available to facilitate titration
and as an alternative to the half-tablet
of 50 mg/200 mg carbidopa and levodopa extended-release.
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. Symptomatic
treatments, such as levodopa
therapies, may permit the patient better mobility.
Current evidence indicates that