Country: Ինդոնեզիա
language: ինդոնեզերեն
source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
SILDENAFIL CITRATE
SOHO INDUSTRI PHARMASI - Indonesia
SILDENAFIL CITRATE
140.45 MG
ORAL DISSOLVING FILM
DUS, 4 POUCH @ 1 ODF
SEOUL PHARMA CO.,LTD - Republic Of Korea
2019-08-21
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 read_full_document