Carbidopa Levodopa and Entacapone CARBIDOPA ANHYDROUS 50 mg LEVODOPA 200 mg ENTACAPONE 200 mg
1 INDICATIONS AND USAGE 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, 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 )
Mylan Pharmaceuticals Inc.
OVAL BROWN Sto 200
Sto 200 OVAL BROWN
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16 HOW SUPPLIED/STORAGE AND HANDLING 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).
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