CARBIDOPA AND LEVODOPA tablet

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Avera McKennan Hospital

INN (Nama Internasional):

CARBIDOPA

Komposisi:

CARBIDOPA ANHYDROUS 10 mg

Jenis Resep:

PRESCRIPTION DRUG

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

CARBIDOPA AND LEVODOPA- CARBIDOPA AND LEVODOPA TABLET
AVERA MCKENNAN HOSPITAL
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CARBIDOPA AND LEVODOPA TABLETS, USP
40-9182
Revised — February 2016
RX ONLY
DESCRIPTION
Carbidopa and levodopa is a combination product 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-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, 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-α-amino-β-(3,4-dihydroxybenzene)
propanoic acid. Its molecular formula is C H NO , and its structural
formula is:
Carbidopa and levodopa tablets, USP 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 (maize).
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 (maize).
25 mg/250 mg — Corn starch, FD&C blue #2 aluminum lake, magnesium
stearate, microcrystalline
10
14
2
4
2
9
11
4
cellulose, and pregelatinized starch (maize).
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION: Parkinson's disease is a progressive,
neurodegenerative disorder of the
extrapyramidal nervous system affecting the mobility