CARBIDOPA AND LEVODOPA tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aphena Pharma Solutions - Tennessee, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Carbidopa and levodopa extended-release tablets are indicated in the treatment of Parkinson’s disease, postencephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Nonselective monoamine oxidase (MAO) inhibitors are contraindicated for use with carbidopa and levodopa extended-release tablets. These inhibitors must be discontinued at least 2 weeks prior to initiating therapy with carbidopa and levodopa extended-release. Carbidopa and levodopa extended-release may be administered concomitantly with the manufacturer's recommended dose of an MAO inhibitor with selectivity for MAO type B (e.g., selegiline hydrochloride) (see PRECAUTIONS: Drug Interactions). Carbidopa and levodopa extended-release is contraindicated in patients with known hypersensitivity to any component of this drug and in patients with narrow-angle glaucoma.

Product summary:

Carbidopa and Levodopa Extended-release Tablets, USP are available containing 25 mg of carbidopa, USP and 100 mg of levodopa , USP or 50 mg of carbidopa, USP and 200 mg of levodopa, USP. The 25 mg/100 mg tablets are purple, oval, unscored tablets debossed with MYLAN on one side of the tablet and 88 on the other side of the tablet. They are available as follows: NDC 0378-0088-01 bottles of 100 tablets The 50 mg/200 mg tablets are purple, oval, scored tablets debossed with MYLAN on one side of the tablet and 9 to the left of the score and 4 to the right of the score on the other side of the tablet. They are available as follows: NDC 0378-0094-01 bottles of 100 tablets Dispense in a tight, light resistant container as defined in the USP using a child-resistant closure. Keep container tightly closed. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. REVISED SEPTEMBER 2014 CBLVER:R13

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CARBIDOPA AND LEVODOPA- CARBIDOPA AND LEVODOPA TABLET, EXTENDED
RELEASE
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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DESCRIPTION
Carbidopa and levodopa extended-release tablets, USP are an
extended-release 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, 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:
C H N O •H O
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:
C H NO
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.
_Meets USP Dissolution Test 3._
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
10
14
2
4
2
9
11
4
resting tremor, rigidity,