VIASTAR BLUE 100

Land: Indonesien

Språk: indonesiska

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

Aktiva substanser:

SILDENAFIL CITRATE

Tillgänglig från:

SOHO INDUSTRI PHARMASI - Indonesia

INN (International namn):

SILDENAFIL CITRATE

Dos:

140.45 MG

Läkemedelsform:

ORAL DISSOLVING FILM

Enheter i paketet:

DUS, 4 POUCH @ 1 ODF

Tillverkad av:

SEOUL PHARMA CO.,LTD - Republic Of Korea

Tillstånd datum:

2019-08-21

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
VIASTAR BLUE 50 mg Oral Dissolving Film
VIASTAR BLUE 100 mg Oral Dissolving Film
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
VIASTAR BLUE 50 mg Oral Dissolving Film
Each film contains sildenafil citrate 70.23 mg equivalent to 50 mg of
sildenafil.
VIASTAR BLUE 100 mg Oral Dissolving Film
Each film contains sildenafil citrate 140.45 mg equivalent to 100 mg
of sildenafil.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
VIASTAR BLUE 50 mg Oral Dissolving Film
Pale blue, rectangular oral dissolving film.
Dimension of film is 7.04 cm
2
(3.2cm x 2.2 cm x 110µm)
VIASTAR BLUE 100 mg Oral Dissolving Film
Pale pink, rectangular oral dissolving film.
Dimension of film is 8.64 cm
2
(3.2cm x 2.7 cm x 110µm)
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Treatment of erectile dysfunction.
4.2
Posology and method of administration
Posology
For most patients, the recommended dose is 50 mg taken, as needed,
approximately 1 hour before sexual activity.
However, SILDENAFIL may be taken anywhere from 4 hours to 0.5 hour
before sexual activity. Based on
effectiveness and toleration, the dose may be increased to a maximum
recommended dose of 100 mg or
decreased to 25 mg. The maximum recommended dosing frequency is once
per day.
THE
FOLLOWING
FACTORS
ARE
ASSOCIATED
WITH
INCREASED
PLASMA
LEVELS
OF
SILDENAFIL:
AGE >65 (40% INCREASE IN AUC), HEPATIC IMPAIRMENT (E.G. CIRRHOSIS,
80%) SEVERE
RENAL IMPAIRMENT (CREATININE CLEARANCE <30 ML/MIN, 100%) AND
CONCOMITANT
USE OF POTENT CYTOCHROME P450 3A4 INHIBITORS [KETOCONAZOLE,
ITRACONAZOLE,
ERYTHROMYCIN
(182%),
SAQUINAVIR
(210%)].
SINCE
HIGHER
PLASMA
LEVELS
MAY
INCREASE BOTH THE EFFICACY AND INCIDENCE OF ADVERSE EVENTS, A STARTING
DOSE
OF 25 MG SHOULD BE CONSIDERED IN THESE PATIENTS.
RITONAVIR GREATLY INCREASED THE SYSTEMIC LEVEL OF SILDENAFIL IN A
STUDY OF
HEALTHY,
NON-HIV
INFECTED
VOLUNTEERS
(11-FOLD
INCREASE
IN
AUC,
SEE
DRUG
INTERACTIONS). BASED ON THESE PHARMACOKINETIC DATA, IT IS RECOMMENDED
NO