FELDENE

국가: 인도네시아

언어: 인도네시아어

출처: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

유효 성분:

PIROXICAM

제공처:

PFIZER INDONESIA - Indonesia

INN (국제 이름):

PIROXICAM

복용량:

0,5 %

약제 형태:

GEL

패키지 단위:

DUS, TUBE @ 25 GRAM

Manufactured by:

PFIZER INDONESIA - Indonesia

승인 날짜:

2017-12-29

제품 특성 요약

Generic Name: Piroxicam
Trade Name: Feldene
CDS Effective Date: September 02, 2021
Supersedes: November 01, 2019
Approved by BPOM:
2021-0069708
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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