देश: इंडोनेशिया
भाषा: इंडोनेशियाई
स्रोत: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
SOHO INDUSTRI PHARMASI - Indonesia -
200 MG /200 MG /54 MG
TABLET SALUT SELAPUT
LEVODOPA, ENTACAPONE, CARBIDOPA MONOHYDRATE
DUS, 3 BLISTER @ 10 TABLET SALUT SELAPUT
Obat
MACLEODS PHARMACEUTICALS LIMITED - India
Berlakus/d 20-07-2028
2023-07-20
CARLEPONE CARBIDOPA/LEVODOPA/ENTACAPONE FILM COATED TABLETS 18.75/75/200MG. 25/100/200MG, 31.25/125/200MG DAN 50/200/200MG SUMMARY OF PRODUCTS CHARACTERISTIC 1. NAME OF THE MEDICINAL PRODUCT CARLEPONE 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablets contains: • Carbidopa + Levodopa + Entacapone tablet 18.75/75/200mg • Carbidopa + Levodopa + Entacapone tablet 25/100/200mg • Carbidopa + Levodopa + Entacapone tablet 31.25/125/200mg • Carbidopa + Levodopa + Entacapone tablet 50/200/200mg FOR EXCIPIENTS SEE POINT 6.1 3. PHARMACEUTICAL FORM Film coated tablets 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Carbidopa + Levodopa + Entacapone tablet is indicated for the treatment of adult patients with Parkinson's disease and end-of-dose motor fluctuations not stabilised on levodopa/dopa decarboxylase (DDC) inhibitor treatment. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The optimum daily dosage must be determined by careful titration of levodopa in each patient. The daily dose should preferably be optimised using one of the four available tablet strengths (18.75/75/200mg, 25/100/200mg, 31.25/125/200mg or 50/200/200mg carbidopa/ levodopa/entacapone). Patients should be instructed to take only one Carbidopa + Levodopa + Entacapone tablet per dose administration. Patients receiving less than 70- 100 mg carbidopa a day are more likely to experience nausea and vomiting. While the experience with total daily dosage greater than 200 mg carbidopa is limited, the maximum recommended daily dose of entacapone is 2000 mg and therefore the maximum Carbidopa + Levodopa + Entacapone dose, for the Carbidopa + Levodopa + Entacapone strengths of 18.75/75/200mg, 25/100/200mg, 31.25/125/200mg is 10 tablets per day. Ten (10) tablets of Carbidopa + Levodopa + Entacapone tablet 150/37.5/200 mg equal 375 mg of carbidopa a day. Therefore, using maximum recommended daily dose of 375 mg of carbidopa, the maximum daily dose of Carbidopa + Levodopa + Entacapone tablet 50/200/200 mg is 7 tablets per day. The maximum tot पूरा दस्तावेज़ पढ़ें