CARBIDOPA, LEVODOPA AND ENTACAPONE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LEVODOPA (UNII: 46627O600J) (LEVODOPA - UNII:46627O600J), ENTACAPONE (UNII: 4975G9NM6T) (ENTACAPONE - UNII:4975G9NM6T), CARBIDOPA (UNII: MNX7R8C5VO) (CARBIDOPA ANHYDROUS - UNII:KR87B45RGH)

Available from:

Wockhardt USA LLC.

INN (International Name):

LEVODOPA

Composition:

LEVODOPA 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Carbidopa, levodopa and entacapone tablets, a combination drug consisting of levodopa, carbidopa (dopa decarboxylase inhibitor), and entacapone (catechol-O-methyltransferase-COMT inhibitor) is indicated for the treatment of Parkinson's disease. Carbidopa, levodopa and entacapone tablets can be used: - To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products. - To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose "wearing-off" and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias. Carbidopa, levodopa and entacapone tablets are contraindicated in patients: - Taking nonselective monoamine oxidase (MAO) inhibitors (e.g., phenelzine and tranylcypromine). These nonselective MAO inhibitors must be discontinued at least two weeks prior to in

Product summary:

Carbidopa, levodopa and entacapone tablets are supplied as film-coated tablets for oral administration in the following six strengths: Carbidopa, levodopa and entacapone tablets 12.5 mg/50 mg/200 mg film-coated tablets containing 12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone. The round, bi-convex shaped tablets are brownish- or greyish-red, unscored, and embossed "W782" on one side.            HDPE bottle of 100 tablets     NDC 64679-782-04 Carbidopa, levodopa and entacapone tablets 18.75 mg/75 mg/200 mg film-coated tablets containing 18.75 mg of carbidopa, 75 mg of levodopa and 200 mg of entacapone. The oval-shaped tablets are light brownish red, unscored and embossed with code "W783" on one side.            HDPE bottle of 100 tablets     NDC 64679-783-04 Carbidopa, levodopa and entacapone tablets 25 mg/100 mg/200 mg film-coated tablets containing 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone. The oval-shaped tablets are brownish- or greyish-red, unscored, and embossed "W784" on one side.            HDPE bottle of 100 tablets     NDC 64679-784-04 Carbidopa, levodopa and entacapone tablets 31.25 mg/125 mg/200 mg film-coated tablets containing 31.25 mg of carbidopa, 125 mg of levodopa and 200 mg of entacapone. The oval-shaped tablets are light brownish red, unscored and embossed with code "W785" on one side.            HDPE bottle of 100 tablets     NDC 64679-785-04 Carbidopa, levodopa and entacapone tablets 37.5 mg/150 mg/200 mg film-coated tablets containing 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone. The elongated-ellipse shaped tablets are brownish- or greyish-red, unscored, and embossed "W786" on one side.            HDPE bottle of 100 tablets     NDC 64679-786-04 Carbidopa, levodopa and entacapone tablets 50 mg/200 mg/200 mg film-coated tablets containing 50 mg of carbidopa, 200 mg of levodopa and 200 mg of entacapone. The oval shaped tablets are dark brownish red, unscored, and embossed "W787" on one side.            HDPE bottle of 100 tablets     NDC 64679-787-04 Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).  [See USP Controlled Room Temperature] Dispense in tight container (USP).

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

CARBIDOPA, LEVODOPA AND ENTACAPONE - CARBIDOPA, LEVODOPA AND
ENTACAPONE TABLET,
FILM COATED
WOCKHARDT USA LLC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CARBIDOPA, LEVODOPA AND ENTACAPONE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
CARBIDOPA, LEVODOPA AND ENTACAPONE TABLETS.
CARBIDOPA, LEVODOPA AND ENTACAPONE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL:2003
INDICATIONS AND USAGE
Carbidopa, levodopa and entacapone tablets, a combination drug
consisting of levodopa (aromatic amino acid), carbidopa
(aromatic amino acid decarboxylation inhibitor), and entacapone
(catechol-O-methyltransferase (COMT) inhibitor) is
indicated for the treatment of Parkinson's disease.
Carbidopa, levodopa and entacapone tablets are to be used:
To substitute (with equivalent strengths of each of the three
components) for carbidopa/levodopa and entacapone
previously administered as individual products (1)
To replace carbidopa/levodopa therapy (without entacapone) when
patients experience the signs and symptoms of
end-of-dose "wearing-off" and when they have been taking a total daily
dose of levodopa of 600 mg or less and have not
been experiencing dyskinesias (1)
DOSAGE AND ADMINISTRATION
The optimum daily dosage of carbidopa, levodopa and entacapone tablets
must be determined by careful titration in
each patient (2.1)
Individual tablets should not be split or fractionated. Administer
only one tablet at each dosing interval (2.6)
DOSAGE FORMS AND STRENGTHS
Each carbidopa, levodopa and entacapone tablet contains a 1:4 ratio of
carbidopa to levodopa and 200 mg of entacapone
(mg of carbidopa per mg of levodopa per mg of entacapone) (3)
CARBIDOPA, LEVODOPA AND ENTACAPONE TABLETS 12.5 mg per 50 mg per 200
mg
CARBIDOPA, LEVODOPA AND ENTACAPONE TABLETS 18.75 mg per 75 mg per 200
mg
CARBIDOPA, LEVODOPA AND ENTACAPONE TABLETS 25 mg per 100 mg per 200 mg
CARBIDOPA, LEVODOPA AND ENTACAPONE TABLETS 31.25 mg per 125 mg per 200
mg
CARBIDOPA, LEVODOPA AND ENTA