CARBIDOPA AND LEVODOPA tablet

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

CARBIDOPA (UNII: MNX7R8C5VO) (CARBIDOPA ANHYDROUS - UNII:KR87B45RGH), LEVODOPA (UNII: 46627O600J) (LEVODOPA - UNII:46627O600J)

Boleh didapati daripada:

Mylan Pharmaceuticals Inc.

INN (Nama Antarabangsa):

CARBIDOPA

Komposisi:

CARBIDOPA ANHYDROUS 10 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Carbidopa and levodopa tablets are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Carbidopa allows patients treated for Parkinson's disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on carbidopa and levodopa tablets. This is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa. Carbidopa may also reduce nausea and vomiting and permit more rapid titration of levodopa. Nonselective monoamine oxidase (MAO) inhibitors are contraindicated for use with carbidopa and levodopa tablets. These inhibitors must be discontinued at least two weeks prior to initiating therapy with carbidopa and levodopa tablets. Carbidopa and levodopa tablets

Ringkasan produk:

Carbidopa and Levodopa Tablets, USP are available containing 10 mg or 25 mg of carbidopa, USP and 100 mg or 250 mg of levodopa, USP. The 10 mg/100 mg tablets are blue, round, scored tablets debossed with M above the score and CL1 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0078-01 bottles of 100 tablets The 25 mg/100 mg tablets are yellow, round, scored tablets debossed with M above the score and CL2 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0085-01 bottles of 100 tablets The 25 mg/250 mg tablets are blue, round, scored tablets debossed with M above the score and CL3 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-1133-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: ALPHAPHARM PTY LTD 15 Garnet Street Carole Park QLD 4300 Australia Revised: 10/2022 ALP:CDLDT:R2 3478/1

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

CARBIDOPA AND LEVODOPA- CARBIDOPA AND LEVODOPA TABLET
MYLAN PHARMACEUTICALS INC.
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DESCRIPTION
Carbidopa and Levodopa Tablets, USP are a combination of carbidopa and
levodopa for
the treatment of Parkinson's disease and syndrome.
Carbidopa USP, an inhibitor of aromatic amino acid decarboxylation, is
a white to creamy
white powder, slightly soluble in water, with a molecular weight of
244.2. It is designated
chemically as (-)-L-α-Hydrazino-3,4-dihydroxy-α-methylhydrocinnamic
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 226.2.
Levodopa USP, an aromatic amino acid, is a white to off-white
crystalline powder, slightly
soluble in water, with a molecular weight of 197.2. It is designated
chemically as (-)-3-
(3,4-Dihydroxyphenyl)-L-alanine. Its molecular formula is C H
NO and its structural
formula is:
Carbidopa and Levodopa Tablets, USP are supplied as tablets in three
strengths:
Carbidopa and Levodopa Tablets USP, 10 mg/100 mg contains 10 mg of
carbidopa and
100 mg of levodopa.
Carbidopa and Levodopa Tablets USP, 25 mg/100 mg contains 25 mg of
carbidopa and
100 mg of levodopa.
Carbidopa and Levodopa Tablets USP, 25 mg/250 mg contains 25 mg of
carbidopa and
10
14
2
4
2
9
11
4
250 mg of levodopa.
Inactive ingredients are crospovidone, hydroxypropyl cellulose,
magnesium stearate,
microcrystalline cellulose and pregelatinized starch (corn). In
addition, the 10 mg/100 mg
and 25 mg/250 mg tablets contain FD&C Blue No. 2 Aluminum Lake and the
25 mg/100
mg tablets contain D&C Yellow No. 10 Aluminum Lake.
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