Studies in vitro have shown that sildenafil is selective for PDE-5.Single oral doses of sildenafil up to 100 mg in healthy volunteers produced no clinically relevant effects on ECG.
In a small, prematurely terminated study of patients with pulmonary hypertension (PH) secondary to sickle cell disease, vaso-occlusive crises requiring hospitalization were more commonly reported by patients who received sildenafil citrate than by those randomized to placebo.The safety and efficacy of combinations of sildenafil tablets, 20 mg with sildenafil citrate tablets, 25 mg, 50 mg and 100 mg or other PDE-5 inhibitors have not been studied.The following adverse reactions have been identified during post approval use of sildenafil (marketed for both PAH and erectile dysfunction).Sildenafil exposure at a dose of 80 mg three times a day without concomitant medication is shown to be 5-fold the exposure at a dose of 20 mg three times a day.Patients with severe hepatic impairment (Child-Pugh class C) have not been studied.The safety and efficacy of sildenafil citrate during labor and delivery have not been studied.Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening.
Visual disturbances were identified as mild and transient, and were predominately color-tinge to vision, but also increased sensitivity to light or blurred vision.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%).Most, but not all, of these patients had preexisting cardiovascular risk factors.There are no adequate and well-controlled studies of sildenafil in pregnant women.
Sildenafil is not expected to affect the pharmacokinetics of compounds which are substrates of these CYP enzymes at clinically relevant concentrations.After either oral or intravenous administration, sildenafil is excreted as metabolites predominantly in the feces (approximately 80% of the administered oral dose) and to a lesser extent in the urine (approximately 13% of the administered oral dose).There was a statistically significant greater increase from baseline in 6-minute walk distance at Week 16 (primary endpoint) for the sildenafil citrate group compared with the placebo group.There was also a doubling of C min levels compared to healthy volunteers.
But if Sildenafil Soft tablets are used for pulmonary arterial hypertension, then the missed dose should be taken as you remember it.Published Date Published Date - The date that a drug label is published on DailyMed for public view.
Hearing or visual impairment: Seek medical attention if sudden decrease or loss of vision or hearingoccurs. (5.5, 5.6).The maximum recommended dosing frequency is one tablet per day.Others were reported to have occurred hours to days after use concurrent with sexual activity.Sildenafil is also marketed as sildenafil citrate tablets, 25 mg, 50 mg and 100 mg for erectile dysfunction.Sildenafil tablets improve the ability to exercise and can slow down worsening changes in your physical condition.Many of these events were reported to occur during or shortly after sexual activity, and a few were reported to occur shortly after the use of sildenafil without sexual activity.Concomitant administration of potent CYP3A inducers is expected to cause substantial decreases in plasma levels of sildenafil.If it is close to your next dose, skip the missed dose, and take your next dose at the regular time.
Treatment with doses higher than 20 mg three times a day is not recommended.
Sildenafil citrate is a phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) in adults to improve exercise ability and delay clinical worsening.Sildenafil is an inhibitor of cGMP specific phosphodiesterase type-5 (PDE-5) in the smooth muscle of the pulmonary vasculature, where PDE-5 is responsible for degradation of cGMP.Nitroglycerin in any form including tablets, patches, sprays, and ointments.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.
This finding is consistent with the inhibition of PDE6, which is involved in phototransduction in the retina.Inform patients that sildenafil is also marketed as sildenafil citrate tablets, 25 mg, 50 mg and 100 mg for erectile dysfunction.Therefore, inhibitors of these isoenzymes may reduce sildenafil clearance and inducers of these isoenzymes may increase sildenafil clearance.During the study, there were 42 reported deaths, with 37 of these deaths reported prior to a decision to titrate subjects to a lower dosage because of a finding of increased mortality with increasing sildenafil citrate doses.Therefore, the slight decrease of sildenafil exposure in the presence of epoprostenol is not considered clinically relevant.Age, gender, race, and renal and hepatic function were included as factors assessed in the population pharmacokinetic model to evaluate sildenafil pharmacokinetics in patients with PAH.