CARBIDOPA, LEVODOPA AND ENTACAPONE tablet, film coated

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), ENTACAPONE (UNII: 4975G9NM6T) (ENTACAPONE - UNII:4975G9NM6T)

Available from:

Mylan Pharmaceuticals Inc.

INN (International Name):

CARBIDOPA

Composition:

CARBIDOPA ANHYDROUS 12.5 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: Carbidopa, levodopa and entacapone tablets are contraindicated in patients: There are no adequate and well-controlled studies in pregnant women. It has been reported from individual cases that levodopa crosses the human placental barrier, enters the fetus, and is metabolized. In animals, administration of carbidopa-levodopa or entacapone during pregnancy was associated with developmental toxicity, including increased incidences of fetal malformations. Carbidopa, levodopa and entacapone tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In nonclinical studies in which carbidopa-levodopa was administered to pregnant animals, increased incidences of viscer

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 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 “STO” over “50” on one side of the tablet and plain on the other side. HDPE bottle of 100 tablets       NDC 0378-8300-01 Carbidopa, levodopa and entacapone 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 “STO” over “75” on one side of the tablet and plain on the other side. HDPE bottle of 100 tablets       NDC 0378-8301-01 Carbidopa, levodopa and entacapone 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 “STO” over “100” on one side of the tablet and plain on the other side. HDPE bottle of 100 tablets       NDC 0378‑8302‑01 Carbidopa, levodopa and entacapone 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 “STO” over “125” on one side of the tablet and plain on the other side. HDPE bottle of 100 tablets       NDC 0378-8303-01 Carbidopa, levodopa and entacapone 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 “STO” over “150” on one side of the tablet and plain on the other side. HDPE bottle of 100 tablets       NDC 0378‑8304‑01 Carbidopa, levodopa and entacapone 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 “STO” over “200” on one side of the tablet and plain on the other side. HDPE bottle of 100 tablets       NDC 0378-8305-01 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
MYLAN PHARMACEUTICALS INC.
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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:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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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)
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)
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)
12.5 mg per 50 mg per 200 mg
18.75 mg per 75 mg per 200 mg
25 mg per 100 mg per 200 mg
31.25 mg per 125 mg per 200 mg
37.5 mg per 150 mg per 200 mg
50 mg per 200 mg per 200 mg
Conco