CARBIDOPA AND LEVODOPA tablet, orally disintegrating

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Mylan Pharmaceuticals Inc.

INN (Tarptautinis Pavadinimas):

CARBIDOPA

Sudėtis:

CARBIDOPA ANHYDROUS 10 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Carbidopa and levodopa orally disintegrating tablets are indicated in the treatment of the symptoms of idiopathic Parkinson's disease (paralysis agitans), postencephalitic parkinsonism, and symptomatic parkinsonism which may follow injury to the nervous system by carbon monoxide intoxication and/or manganese intoxication. Carbidopa and levodopa orally disintegrating tablets are indicated in these conditions to permit the administration of lower doses of levodopa with reduced nausea and vomiting, with more rapid dosage titration, with a somewhat smoother response, and with supplemental pyridoxine (vitamin B6 ). In some patients, a somewhat smoother antiparkinsonian effect results from therapy with carbidopa and levodopa than with levodopa. However, patients with markedly irregular ("on-off") responses to levodopa have not been shown to benefit from carbidopa and levodopa therapy. Although the administration of carbidopa permits control of parkinsonism and Parkinson's disease with much lower doses of levodopa,

Produkto santrauka:

Carbidopa and Levodopa Orally Disintegrating Tablets, USP are available containing 10 mg or 25 mg of carbidopa, USP, with 100 mg or 250 mg of levodopa, USP providing the following available combinations: 10 mg/100 mg, 25 mg/100 mg or 25 mg/250 mg. The 10 mg/100 mg orally disintegrating tablets are green, round, scored and debossed with M above the score and C51 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-5051-01 bottles of 100 tablets The 25 mg/100 mg orally disintegrating tablets are blue, round, scored and debossed with M above the score and C52 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-5052-01 bottles of 100 tablets The 25 mg/250 mg orally disintegrating tablets are green, round, scored and debossed with M above the score and C53 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-5053-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture and light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 Revised: 9/2016 CLODT:R3

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

CARBIDOPA AND LEVODOPA- CARBIDOPA AND LEVODOPA TABLET, ORALLY
DISINTEGRATING
MYLAN PHARMACEUTICALS INC.
----------
DESCRIPTION
Carbidopa and levodopa orally disintegrating tablets, USP are a
combination of carbidopa and levodopa
for the treatment of Parkinson's disease and syndrome. Carbidopa and
levodopa orally disintegrating
tablets are an orally administered formulation of carbidopa and
levodopa which rapidly disintegrates on
the tongue and does not require water to aid dissolution or
swallowing.
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 orally disintegrating tablets, USP are supplied
as tablets in three strengths:
Carbidopa and Levodopa Orally Disintegrating Tablets 10 mg /100 mg,
containing 10 mg of carbidopa
and 100 mg of levodopa.
Carbidopa and Levodopa Orally Disintegrating Tablets 25 mg/100 mg,
containing 25 mg of carbidopa
and 100 mg of levodopa.
10
14
2
4
2
9
11
4
Carbidopa and Levodopa Orally Disintegrating Tablets 25 mg/250 mg,
containing 25 mg of carbidopa
and 250 mg of levodopa.
Inactive ingredients are aspartame, crospovidone, mannitol,
microcrystalline cellulose, peppermint
flavor, silica, sodium stearyl fumarate and sorbitol. In addition, the
25 mg/100 mg tablets contain FD&C
Blue No. 1 Aluminum Lake and the 10 mg/100 mg and 25 mg/250 mg tablets
contain D&C Yellow No.
10 Aluminum Lake and FD&C Blue No. 1 A