国家: 澳大利亚
语言: 英文
来源: Department of Health (Therapeutic Goods Administration)
sildenafil citrate, Quantity: 70.24 mg (Equivalent: sildenafil, Qty 50 mg)
iX Biopharma Pty Ltd
Capsule
Excipient Ingredients: croscarmellose sodium; magnesium stearate; lactose monohydrate; titanium dioxide; tartrazine; sunset yellow FCF; Gelatin; silicon dioxide; sodium lauryl sulfate
Oral
8, 4, 12
(S4) Prescription Only Medicine
Sildenafil is indicated for the treatment of erectile dysfunction in adult males. ,Sildenafil is not indicated for use by women.
Visual Identification: SILDENAFIL-ISPL 50 mg capsules are yellow opaque/yellow opaque size 2 hard gelatin capsules with no markings.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2018-07-31
_Sildenafil (as citrate) 25 mg and 50 mg capsules _ _Product Information _ _iX Biopharma Pty Ltd _ Sildenafil capsule PI v2.0 260221 Page 1 of 15 AUSTRALIAN PRODUCT INFORMATION SILDENAFIL-ISPL (SILDENAFIL) CAPSULES 1 NAME OF THE MEDICINE Sildenafil (as citrate) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Excipients with known effect: lactose monohydrate. For the full list of excipients, see Section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM Sildenafil-ISPL 25 mg capsules are clear/clear size 2 hard gelatin capsules with no markings. Sildenafil-ISPL 50 mg capsules are yellow opaque/yellow opaque size 2 hard gelatin capsules with no markings. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Sildenafil is indicated for the treatment of erectile dysfunction in adult males. Sildenafil is not indicated for use by women. 4.2 D OSE AND METHOD OF ADMINISTRATION Sildenafil capsules are for oral administration. USE IN ADULTS The recommended dose is 50 mg taken as needed approximately one hour before sexual activity. Based on the efficacy and toleration, the dose may be increased to 100 mg or decreased to 25 mg. The maximum recommended dose is 100 mg. The maximum recommended dosing frequency is once per day. USE IN CHILDREN Sildenafil is not indicated for use in children. DOSAGE ADJUSTMENT IN RENAL IMPAIRMENT The dosing recommendations for USE IN ADULTS should be followed for patients with mild to moderate renal impairment (Cl cr = 30-80 mL/min). Since sildenafil clearance is reduced in patients with severe renal impairment (Cl cr <30 mL/min) a 25 mg starting dose should be considered. Based on efficacy and toleration, the dose may be increased to 50 mg and 100 mg. DOSAGE ADJUSTMENT IN HEPATIC IMPAIRMENT Since sildenafil clearance is reduced in patients with hepatic impairment (e.g., cirrhosis) a 25 mg starting dose should be considered. Based on efficacy and toleration, the dose may be increased to 50 mg and 100 mg. _Sildenafil (as citrate) 25 mg and 50 mg capsules _ _Product Information _ _iX Biopharma Pty Ltd _ Silde 阅读完整的文件