САЩ - английски - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - sildenafil citrate (unii: bw9b0ze037) (sildenafil - unii:3m7ob98y7h) - sildenafil 25 mg - sildenafil tablets are indicated for the treatment of erectile dysfunction. consistent with its known effects on the nitric oxide/cgmp pathway [see clinical pharmacology (12.1, 12.2) ], sildenafil tablets were shown to potentiate the hypotensive effects of nitrates, and their administration to patients who are using nitric oxide donors such as organic nitrates or organic nitrites in any form either regularly and/or intermittently is therefore contraindicated. after patients have taken sildenafil tablets, it is unknown when nitrates, if necessary, can be safely administered. although plasma levels of sildenafil at 24 hours post dose are much lower than at peak concentration, it is unknown whether nitrates can be safely coadministered at this time point [see dosage and administration (2.3), drug interactions (7.1), and clinical pharmacology (12.2) ]. sildenafil tablets are contraindicated in patients with a known hypersensitivity to sildenafil, as contained in sildenafil tablets and revatio® , or any component of the tablet. hypersensitivity reactions have been reported, including rash and urticaria [see adverse reactions (6.1) ]. do not use sildenafil tablets in patients who are using a gc stimulator, such as riociguat. pde5 inhibitors, including sildenafil tablets, may potentiate the hypotensive effects of gc stimulators. risk summary sildenafil is not indicated for use in females. there are no data with the use of sildenafil in pregnant women to inform any drug-associated risks for adverse developmental outcomes. animal reproduction studies conducted with sildenafil did not show adverse developmental outcomes when administered during organogenesis in rats and rabbits at oral doses up to 16 and 32 times, respectively, the maximum recommended human dose (mrhd) of 100 mg/day on a mg/m2 basis (see data ). data animal data no evidence of teratogenicity, embryotoxicity or fetotoxicity was observed in rats and rabbits which received oral doses up to 200 mg/kg/day during organogenesis. these doses represent, respectively, about 16 and 32 times the mrhd on a mg/m2 basis in a 50 kg subject. in the rat pre- and postnatal development study, the no observed adverse effect dose was 30 mg/kg/day given for 36 days, about 2 times the mrhd on a mg/m2 basis in a 50 kg subject. risk summary sildenafil is not indicated for use in females. limited data indicate that sildenafil and its active metabolite are present in human milk. there is no information on the effects on the breastfed child, or the effects on milk production. sildenafil is not indicated for use in pediatric patients. safety and effectiveness have not been established in pediatric patients. healthy elderly volunteers (65 years or over) had a reduced clearance of sildenafil resulting in approximately 84% and 107% higher plasma auc values of sildenafil and its active n-desmethyl metabolite, respectively, compared to those seen in healthy young volunteers (18 to 45 years) [see clinical pharmacology (12.3) ]. due to age-differences in plasma protein binding, the corresponding increase in the auc of free (unbound) sildenafil and its active n-desmethyl metabolite were 45% and 57%, respectively [see clinical pharmacology (12.3) ]. of the total number of subjects in clinical studies of sildenafil, 18% were 65 years and older, while 2% were 75 years and older. no overall differences in safety or efficacy were observed between older (≥ 65 years of age) and younger (< 65 years of age) subjects. however, since higher plasma levels may increase the incidence of adverse reactions, a starting dose of 25 mg should be considered in older subjects due to the higher systemic exposure [see dosage and administration (2.5) ]. no dose adjustment is required for mild (clcr = 50 to 80 ml/min) and moderate (clcr = 30 to 49 ml/min) renal impairment. in volunteers with severe renal impairment (clcr < 30 ml/min), sildenafil clearance was reduced, resulting in higher plasma exposure of sildenafil (~2 fold), approximately doubling of cmax and auc. a starting dose of 25 mg should be considered in patients with severe renal impairment [see dosage and administration (2.5) and clinical pharmacology (12.3) ]. in volunteers with hepatic impairment (child-pugh class a and b), sildenafil clearance was reduced, resulting in higher plasma exposure of sildenafil (47% for cmax and 85% for auc). the pharmacokinetics of sildenafil in patients with severely impaired hepatic function (child-pugh class c) have not been studied. a starting dose of 25 mg should be considered in patients with any degree of hepatic impairment [see dosage and administration (2.5) and clinical pharmacology (12.3) ].

САЩ - английски - NLM (National Library of Medicine)

major pharmaceuticals - sildenafil citrate (unii: bw9b0ze037) (sildenafil - unii:3m7ob98y7h) - sildenafil 20 mg - sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (who group i) in adults to improve exercise ability and delay clinical worsening. the delay in clinical worsening was demonstrated when sildenafil tablets were added to background epoprostenol therapy [see clinical studies (14)] . studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with new york heart association (nyha) functional class ii-iii symptoms and idiopathic etiology (71%) or associated with connective tissue disease (ctd) (25%). limitation of use : adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity [ see clinical studies (14) ]. sildenafil citrate is contraindicated in patients with: risk summary limited published data from randomized controlled trials, case-controlled trials, and case series do not report a clear associati

Малта - английски - Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - sildenafil citrate - film-coated tablet - sildenafil citrate 50 mg - urologicals

Малта - английски - Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - sildenafil citrate - film-coated tablet - sildenafil citrate 100 mg - urologicals

Малта - английски - Medicines Authority

pfizer hellas s.a. - sildenafil - film-coated tablet - sildenafil 25 milligram(s) - urologicals

Малта - английски - Medicines Authority

pfizer hellas s.a. - sildenafil - film-coated tablet - sildenafil 50 milligram(s) - urologicals

Малта - английски - Medicines Authority

pfizer hellas s.a. - sildenafil - film-coated tablet - sildenafil 100 milligram(s) - urologicals

Малта - английски - Medicines Authority

aurobindo pharma (malta) limited vault 14, level 2, valletta waterfront, floriana frn 1913, malta - sildenafil - film-coated tablet - sildenafil 50 mg - urologicals

Малта - английски - Medicines Authority

aurobindo pharma (malta) limited vault 14, level 2, valletta waterfront, floriana frn 1913, malta - sildenafil - film-coated tablet - sildenafil 100 mg - urologicals

Великобритания - английски - myHealthbox

milpharm limited - sildenafil - film-coated tablets - 50mg - urologicals; drugs used in erectile dysfunction - treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. in order for sildenafil to be effective, sexual stimulation is required.