Negara: Indonesia
Bahasa: Bahasa Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
PIROXICAM
PFIZER INDONESIA - Indonesia
PIROXICAM
0,5 %
GEL
DUS, TUBE @ 25 GRAM
PFIZER INDONESIA - Indonesia
2017-12-29
Generic Name: Piroxicam Trade Name: Feldene CDS Effective Date: September 02, 2021 Supersedes: November 01, 2019 Approved by BPOM: 2021-0069708 Page 1 of 6 PT PFIZER INDONESIA LOCAL PRODUCT DOCUMENT Generic Name: Piroxicam Trade Name: Feldene CDS Effective Date: September 02, 2021 Supersedes: November 01, 2019 TRADE NAME FELDENE QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient: anhydrous piroxicam PHARMACEUTICAL FORM Gel: 0.5% (5 mg per gram of gel) by weight anhydrous piroxicam PHARMACOLOGICAL PROPERTIES PHARMACODYNAMIC PROPERTIES Piroxicam is a non-steroid anti-inflammatory agent useful in the treatment of inflammatory conditions. Although the mode of action for this agent is not precisely understood, piroxicam inhibits prostaglandin synthesis and release through a reversible inhibition of the cyclo- oxygenase enzyme. PHARMACOKINETIC PROPERTIES On the basis of various pharmacokinetic and tissue distribution studies in rats and dogs, piroxicam 0.5% gel is continuously and gradually released from the skin to the underlying muscle or synovial fluid. In addition, equilibrium between the skin and muscle or synovial fluid appears to be reached rapidly, within a few hours after application. A multiple dose study of twice daily application of piroxicam 0.5% gel (total daily dose equivalent to 20 mg per day, piroxicam) for 14 days found that plasma levels rose slowly over the course of the treatment period and reached a value of over 200 ng/ml on the fourth day. On an average, steady state plasma levels were between 300 ng/ml and 400 ng/ml and mean values remained below 400 ng/ml even on the fourteenth day of treatment. These piroxicam levels observed at equilibrium were approximately 5% of those observed in subjects receiving similar oral dosing (20 mg daily). Elimination half-life in this study was DISETUJUI OLEH BPOM : 08/11/2021 EREG100241VR12100520 - 21 Generic Name: Piroxicam Trade Name: Feldene CDS Effective Date: September 02, 2021 Supersedes: November 01, 2019 Approved by BPOM: 2021-0069708 Page 2 of Baca dokumen lengkapnya