国家: 澳大利亚
语言: 英文
来源: Department of Health (Therapeutic Goods Administration)
sildenafil citrate, Quantity: 28.1 mg (Equivalent: sildenafil, Qty 20 mg)
Arrotex Pharmaceuticals Pty Ltd
Sildenafil citrate
Tablet, film coated
Excipient Ingredients: macrogol 8000; microcrystalline cellulose; magnesium stearate; colloidal anhydrous silica; croscarmellose sodium; hypromellose; titanium dioxide; hyprolose
Oral
90
(S4) Prescription Only Medicine
Sildenafil is used to treat patients with pulmonary arterial hypertension classified as WHO functional classes II and III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease. The efficacy of sildenafil has not been evaluated in patients currently on bosentan therapy.
Visual Identification: White to off white, round biconvex, film coated tablets, engraved "APO" on one side and "SIL" over "20" on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2011-01-12
1 AUSTRALIAN PRODUCT INFORMATION APO-SILDENAFIL PHT (SILDENAFIL CITRATE) FILM COATED TABLETS 1 NAME OF THE MEDICINE Sildenafil citrate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg sildenafil as the active ingredient. For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM APO-Sildenafil PHT 20 mg tablets are white to off-white round, biconvex, film coated tablets, engraved “APO” on one side and “SIL” over “20” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sildenafil is indicated for the treatment of patients with pulmonary arterial hypertension classified as WHO functional classes II and III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease. The efficacy of sildenafil has not been established in patients currently on bosentan therapy (see section 4.4 SPECIAL PRECAUTIONS AND WARNINGS FOR USE). 4.2 DOSE AND METHOD OF ADMINISTRATION APO-Sildenafil PHT tablets are intended for oral administration. DOSAGE Treatment should only be initiated and monitored by a health care professional experienced in the treatment of pulmonary arterial hypertension. In case of clinical deterioration in spite of sildenafil treatment, alternative therapies should be considered. USE IN ADULTS (≥ 18 YEARS) The recommended dose for sildenafil is 20 mg three times a day (TID). Sildenafil tablets should be taken approximately 6-8 hours apart, with or without food. No greater efficacy was achieved with doses higher than 20 mg TID, therefore, treatment with doses higher than 20 mg TID is not recommended (see section 5.1 PHARMACODYNAMIC PROPERTIES - CLINICAL TRIALS). Dosages lower than 20 mg TID have not been examined and the efficacy of these doses is not known. USE IN CHILDREN (< 18 YEARS) Sildenafil is not indicated for use in children < 18 years of age. 2 DISCONTINUATION OF TREATMENT Limited data suggests that the abrupt discontinuation of s 阅读完整的文件