VIAGRA

国家: 印度尼西亚

语言: 印度尼西亚文

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

可用日期:

PFIZER INDONESIA - Indonesia -

剂量:

70.225 Mg

药物剂型:

TABLET SALUT SELAPUT

组成:

SILDENAFIL CITRATE

每包单位数:

DUS, 1 BLISTER @ 4 TABLET SALUT SELAPUT

类:

Obat

厂商:

FAREVA AMBOISE - France

授权状态:

Berlakus/d 24-03-2028

授权日期:

2023-03-24

产品特点

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