CARBIDOPA AND LEVODOPA tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

McKesson Contract Packaging

INN (International Name):

CARBIDOPA

Sammensetning:

CARBIDOPA 25 mg

Resept typen:

PRESCRIPTION DRUG

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

CARBIDOPA AND LEVODOPA- CARBIDOPA AND LEVODOPA TABLET
MCKESSON CONTRACT PACKAGING
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CARBIDOPA AND LEVODOPA TABLETS, USP
RX ONLY
DESCRIPTION
Carbidopa and levodopa is a combination product 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, with a molecular weight of 244.25. 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:
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, with a
molecular weight of 197.19. It is designated chemically as
(-)-L-α-amino-β-(3,4-dihydroxybenzene)
propanoic acid. Its molecular formula is C H NO , and its structural
formula is:
Carbidopa and levodopa tablets, for oral administration, are supplied
in three strengths:
10 mg/100 mg, containing 10 mg of carbidopa and 100 mg of levodopa.
25 mg/100 mg, containing 25 mg of carbidopa and 100 mg of levodopa.
25 mg/250 mg, containing 25 mg of carbidopa and 250 mg of levodopa.
In addition, each tablet contains the following inactive ingredients:
10 mg/100 mg — Corn starch, FD&C blue #2 aluminum lake, magnesium
stearate, microcrystalline
cellulose, and pregelatinized starch.
25 mg/100 mg — Corn starch, D&C yellow #10 aluminum lake, FD&C
yellow #6 aluminum lake (sunset
yellow lake), magnesium stearate, microcrystalline cellulose, and
pregelatinized starch.
25 mg/250 mg — Corn starch, FD&C blue #2 aluminum lake, magnesium
stearate,
microcrystalline cellulose, and pregelatinized starch.
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,