Negara: Indonesia
Bahasa: Bahasa Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
PFIZER INDONESIA - Indonesia -
140.450 Mg
TABLET SALUT SELAPUT
SILDENAFIL CITRATE
DUS, 1 BLISTER @ 4 TABLET SALUT SELAPUT
Obat
FAREVA AMBOISE - France
Berlakus/d 24-03-2028
2023-03-24
Generic Name: Sildenafil citrate Trade Name: VIAGRA® CDS Effective Date: August 31, 2015 Supersedes: October 24, 2013 Approved by BPOM: 2015-0011721; 2014-0007023; 2015-0011234; 2016-0015877; 2016-0022174 Page 1 of 23 PT. PFIZER INDONESIA LOCAL PRODUCT DOCUMENT Generic Name: Sildenafil citrate Trade Name: VIAGRA ® CDS Effective Date: August 31, 2015 Supersedes: October 24, 2013 CIMETIDINE (800 MG), A NONSPECIFIC CYP INHIBITOR, CAUSED A 56% INCREASE IN PLASMA SILDENAFIL CONCENTRATIONS WHEN CO-ADMINISTERED WITH VIAGRA (50 MG) TO HEALTHY VOLUNTEERS. WHEN A SINGLE 100 MG DOSE OF VIAGRA WAS ADMINISTERED WITH ERYTHROMYCIN, A MODERATE CYP3A4 INHIBITOR, AT STEADY STATE (500 MG BID FOR 5 DAYS), THERE WAS A 182% INCREASE IN SILDENAFIL SYSTEMIC EXPOSURE (AUC). IN ADDITION, IN A STUDY PERFORMED IN HEALTHY MALE VOLUNTEERS, CO-ADMINISTRATION OF THE HIV PROTEASE INHIBITOR SAQUINAVIR, ALSO A CYP3A4 INHIBITOR, AT STEADY STATE (1200 MG TID) WITH VIAGRA (100 MG SINGLE DOSE) RESULTED IN A 140% INCREASE IN SILDENAFIL C MAX AND A 210% INCREASE IN SILDENAFIL AUC. VIAGRA HAD NO EFFECT ON SAQUINAVIR PHARMACOKINETICS. STRONGER CYP3A4 INHIBITORS SUCH AS KETOCONAZOLE OR ITRACONAZOLE WOULD BE EXPECTED TO HAVE STILL GREATER EFFECTS, AND POPULATION DATA FROM PATIENTS IN CLINICAL TRIALS DID INDICATE A REDUCTION IN SILDENAFIL CLEARANCE WHEN IT WAS CO-ADMINISTERED WITH CYP3A4 INHIBITORS (SUCH AS KETOCONAZOLE, ERYTHROMYCIN, OR CIMETIDINE) (SEE DOSAGE AND ADMINISTRATION). IN ANOTHER STUDY IN HEALTHY MALE VOLUNTEERS, CO-ADMINISTRATION WITH THE HIV PROTEASE INHIBITOR RITONAVIR, WHICH IS A HIGHLY POTENT P450 INHIBITOR, AT STEADY STATE (500 MG BID) WITH VIAGRA (100 MG SINGLE DOSE) RESULTED IN A 300% (4-FOLD) INCREASE IN SILDENAFIL C MAX AND A 1000% (11-FOLD) INCREASE IN SILDENAFIL PLASMA AUC. AT 24 HOURS THE PLASMA LEVELS OF SILDENAFIL WERE STILL APPROXIMATELY 200 NG/ML, COMPARED TO APPROXIMATELY 5 NG/ML WHEN SILDENAFIL WAS DOSED ALONE. THIS IS CONSISTENT WITH RITONAVIR’S MARKED EFFECTS ON A BROAD RANGE OF P450 SUBSTRATES. VIAGRA HAD NO EFFECT ON R Baca dokumen lengkapnya