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Sildenafil citrateProduct ingredient for Sildenafil

Sildenafil > sildenafil citrate drug


Based on experience in adults, the dose may be titrated as needed to a maximum of 40 mg PO 3 times daily based on symptoms and tolerability. Avoid higher dosing due to a greater risk of mortality in pediatric patients (age 1 to 17 years) treated with high dose sildenafil monotherapy. 0.5 to 1 mg/kg/dose PO every 8 hours. Prior to the release of pediatric pulmonary hypertension guidelines, the generally accepted dose of sildenafil was 0.5 to 2 mg/kg/dose every 6 to 8 hours, with some regimens, particularly those described in earlier reports, administering doses every 4 hours; however, guidelines recommend more conservative dosing based on a greater risk of mortality in pediatric patients (age 1 to 17 years) treated with high dose sildenafil monotherapy, as seen in the STARTS-2 trial. Relevance of this data to the infant population is unclear. 0.22 to 0.5 mg/kg/dose PO as a single dose 1 hour prior to discontinuing iNO or 4 times daily. None of the 15 patients receiving a single sildenafil dose of 0.3 to 0.5 mg/kg/dose PO 1 hour prior to discontinuation of iNO experienced rebound pulmonary hypertension compared to 10 of 14 patients receiving placebo. In 7 patients receiving sildenafil 0.22 to 0.47 mg/kg/dose PO 4 times daily, mean iNO dose was significantly reduced compared to baseline within 24 hours of sildenafil initiation (12.2 vs.

Further information

The duration sildenafil citrate tablets 50mg of treatment ranged from 6 to 51 days, and respiratory support was able to be decreased over time in all patents. Hepatic dosing adjustments for adults with erectile dysfunction:Consider a starting dose of 25 mg in adults with any degree of hepatic impairment.Hepatic dosing adjustments for patients with pulmonary hypertension:No adjustment needed for adults with mild to moderate hepatic impairment (Child Pugh class A or B). The effect of severe hepatic impairment (Child Pugh class C) has not been studied. Specific guidelines for pediatric patients are not available. Renal dosing adjustments for adults with erectile dysfunction:CrCl 30 mL/minute or greater: No dosage adjustment is needed.CrCl less than 30 mL/minute: Reducing starting dose to 25 mg PO.Renal dosing adjustments for patients with pulmonary hypertension:No adjustment needed for adults with renal impairment, including adults with severe renal impairment (CrCl less than 30 mL/minute).

How sildenafil is used

Specific guidelines for pediatric patients are not available.Intermittent hemodialysisFollow recommendations for patients with CrCl less than 30 mL/minute. A decreased pressor effect of phenylephrine might occur. Monitor for proper blood pressure when these drugs are used together. Acetaminophen; Dextromethorphan; Guaifenesin; Phenylephrine: (Minor) The therapeutic effect of phenylephrine injection may be decreased in patients receiving phosphodiesterase inhibitors. Acetaminophen; Dextromethorphan; Phenylephrine: (Minor) The therapeutic effect of phenylephrine injection may be decreased in patients receiving phosphodiesterase inhibitors. 29.8 ppm, p = 0.024). Guidelines recommend sildenafil use to prevent rebound pulmonary hypertension and facilitate iNO weaning in patients with evidence of increased pulmonary artery pressure upon iNO withdrawal; however, they do not provide specific dosing. Recommended maintenance dosing for pulmonary hypertension is 0.5 to 1 mg/kg/dose PO 3 times daily in persons younger than 1 year, 10 mg PO 3 times daily in persons weighing 20 kg or less, and 20 mg PO 3 times daily in persons weighing more than 20 kg. A double-blind, placebo-controlled, crossover study evaluated sildenafil for symptomatic secondary Raynaud's phenomenon resistant to vasodilatory therapy. Patients (n = 18, 15 were female) were randomly assigned to receive placebo or sildenafil 50 mg PO twice daily for 4 weeks; a washout period of 1 week was used before crossover. The results showed that sildenafil significantly improved microcirculation and symptoms associated with Raynaud's. In patients with chronic digital ulcerations, sildenafil treatment resulted in healing of trophic lesions which reappeared or progressed when sildenafil was stopped. Ulcerations did not heal while receiving placebo. Sildenafil therapy may be an alternative therapy in patients with Raynaud's resistant to vasodilatory therapy.

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50 mg PO every 8 hours starting the day before ascent and continuing for 5 days after reaching the target altitude or until descent is initiated as an alternative to nifedipine.

Prophylactic medications should only be considered for individuals with a prior history of high altitude pulmonary edema. Delay use in extremely premature infants until retinal vascularization is established.

Other uses for this medicine

Predictions based on a pharmacokinetic model suggest that drug-drug interactions with CYP3A4 inhibitors will be less for sildenafil injection than those observed after oral sildenafil administration. Amlodipine: (Moderate) Monitor for additive hypotension if amlodipine is administered concurrently with sildenafil, as both agents act independently to reduce blood pressure. When sildenafil 100 mg was co-administered with amlodipine (5 mg or 10 mg) to hypertensive patients, the mean additional reduction on supine blood pressure (SBP) was 8 mmHg systolic and 7 mmHg diastolic.

Other Interactions

The pharmacokinetics of sildenafil are highly variable pfizer sildenafil 100 in neonates; careful dose titration and monitoring is recommended.

Storage Condition Details Temperature Range Light Exposure Humidity
Preferred Storage Cool, dry place 15-30°C Keep in original container Avoid humidity
Keep away from light Protect from direct sunlight N/A Yes N/A
Out of reach of children Safety precaution N/A N/A N/A

Prior to the release of pediatric pulmonary hypertension guidelines, the generally accepted dose of sildenafil was 0.5 to 2 mg/kg/dose every 6 to 8 hours, with doses ranging up to 3 mg/kg/dose every 6 hours ; however, guidelines recommend more conservative dosing based on a greater risk of mortality in pediatric patients (age 1 to 17 years) treated with high dose sildenafil monotherapy, as seen in the STARTS-2 trial. Relevance of this data to the neonatal population is unclear. 0.4 mg/kg IV loading dose over 3 hours followed by a continuous infusion of 0.067 mg/kg/hour (1.6 mg/kg/day); this dose has been proposed based on the results of an open-label, dose-escalation study in 36 term neonates. Very limited data are available; intermittent IV infusions have been used when oral intake was not possible in 3 neonates. An initial dosage of 0.4 to 0.5 mg/kg/dose IV every 6 hours (infused over 3 hours) was given to 2 term neonates with pulmonary hypertension secondary to congenital diaphragmatic hernia. The dose was gradually titrated up to 2 mg/kg/dose IV based on clinical response. For doses less than 1.5 mg/kg/dose IV, the infusion time was gradually decreased to over 1 hour (weaned by 1 hour every 36 to 48 hours). The third neonate (gestational age 25 weeks, postnatal age 18.6 weeks) was receiving oral sildenafil 1.67 mg/kg/dose PO every 6 hours and was converted to sildenafil 1.25 mg/kg/dose IV every 6 hours when she became "nothing-by-mouth" (NPO) status. All 3 neonates were also receiving inhaled nitric oxide at the time of sildenafil initiation. The duration sildenafil citrate tablets 50mg of treatment ranged from 6 to 51 days, and respiratory support was able to be decreased over time in all patents. Hepatic dosing adjustments for adults with erectile dysfunction:Consider a starting dose of 25 mg in adults with any degree of hepatic impairment.Hepatic dosing adjustments for patients with pulmonary hypertension:No adjustment needed for adults with mild to moderate hepatic impairment (Child Pugh class A or B). The effect of severe hepatic impairment (Child Pugh class C) has not been studied. Specific guidelines for pediatric patients are not available. Renal dosing adjustments for adults with erectile dysfunction:CrCl 30 mL/minute or greater: No dosage adjustment is needed.CrCl less than 30 mL/minute: Reducing starting dose to 25 mg PO.Renal dosing adjustments for patients with pulmonary hypertension:No adjustment needed for adults with renal impairment, including adults with severe renal impairment (CrCl less than 30 mL/minute). Specific guidelines for pediatric patients are not available.Intermittent hemodialysisFollow recommendations for patients with CrCl less than 30 mL/minute. A decreased pressor effect of phenylephrine might occur. Monitor for proper blood pressure when these drugs are used together. Acetaminophen; Dextromethorphan; Guaifenesin; Phenylephrine: (Minor) The therapeutic effect of phenylephrine injection may be decreased in patients receiving phosphodiesterase inhibitors. Acetaminophen; Dextromethorphan; Phenylephrine: (Minor) The therapeutic effect of phenylephrine injection may be decreased in patients receiving phosphodiesterase inhibitors. Acetaminophen; Guaifenesin; Phenylephrine: (Minor) The therapeutic effect of phenylephrine injection may be decreased in patients receiving phosphodiesterase inhibitors. Acetaminophen; Phenylephrine: (Minor) The therapeutic effect of phenylephrine injection may be decreased in patients receiving phosphodiesterase inhibitors. Adagrasib: (Major) Coadministration with adagrasib is not recommended in patients receiving sildenafil for pulmonary arterial hypertension (PAH).

When sildenafil is used for erectile dysfunction, consider a starting dose of 25 mg for patients receiving adagrasib. Concurrent use may increase sildenafil plasma concentrations resulting in increased associated adverse events including hypotension, syncope, visual changes, and prolonged erection.

Coadministration of other strong CYP3A inhibitors increased the sildenafil AUC between 3- and 11-fold. Alfuzosin: (Moderate) Due to the potential for symptomatic hypotension, patients should be stable on alfuzosin therapy before initiating therapy with the lowest dose of sildenafil.

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The pharmacokinetics of sildenafil are highly variable pfizer sildenafil 100 in neonates; careful dose titration and monitoring is recommended. Prior to the release of pediatric pulmonary hypertension guidelines, the generally accepted dose of sildenafil was 0.5 to 2 mg/kg/dose every 6 to 8 hours, with doses ranging up to 3 mg/kg/dose every 6 hours ; however, guidelines recommend more conservative dosing based on a greater risk of mortality in pediatric patients (age 1 to 17 years) treated with high dose sildenafil monotherapy, as seen in the STARTS-2 trial. Relevance of this data to the neonatal population is unclear. 0.4 mg/kg IV loading dose over 3 hours followed by a continuous infusion of 0.067 mg/kg/hour (1.6 mg/kg/day); this dose has been proposed based on the results of an open-label, dose-escalation study in 36 term neonates. Very limited data are available; intermittent IV infusions have been used when oral intake was not possible in 3 neonates.

What’s the difference between sildenafil and Viagra?

An initial dosage of 0.4 to 0.5 mg/kg/dose IV every 6 hours (infused over 3 hours) was given to 2 term neonates with pulmonary hypertension secondary to congenital diaphragmatic hernia. The dose was gradually titrated up to 2 mg/kg/dose IV based on clinical response. For doses less than 1.5 mg/kg/dose IV, the infusion time was gradually decreased to over 1 hour (weaned by 1 hour every 36 to 48 hours). The third neonate (gestational age 25 weeks, postnatal age 18.6 weeks) was receiving oral sildenafil 1.67 mg/kg/dose PO every 6 hours and was converted to sildenafil 1.25 mg/kg/dose IV every 6 hours when she became "nothing-by-mouth" (NPO) status. All 3 neonates were also receiving inhaled nitric oxide at the time of sildenafil initiation. Conversely, patients already receiving an optimized dose of sildenafil should be started on the lowest dose of alfuzosin; increases in the alpha-blocker dose should be done in a stepwise fashion.

Before taking this medicine

Based on experience in adults, the dose may be titrated as needed to a maximum of 40 mg PO 3 times daily based on symptoms and tolerability. Avoid higher dosing due to a greater risk of mortality in pediatric patients (age 1 to 17 years) treated with high dose sildenafil monotherapy. 0.5 to 1 mg/kg/dose PO every 8 hours. Prior to the release of pediatric pulmonary hypertension guidelines, the generally accepted dose of sildenafil was 0.5 to 2 mg/kg/dose every 6 to 8 hours, with some regimens, particularly those described in earlier reports, administering doses every 4 hours; however, guidelines recommend more conservative dosing based on a greater risk of mortality in pediatric patients (age 1 to 17 years) treated with high dose sildenafil monotherapy, as seen in the STARTS-2 trial. Relevance of this data to the infant population is unclear.

Off-Label Use and Dosage (Adult)

0.22 to 0.5 mg/kg/dose PO as a single dose 1 hour prior to discontinuing iNO or 4 times daily. None of the 15 patients receiving a single sildenafil dose of 0.3 to 0.5 mg/kg/dose PO 1 hour prior to discontinuation of iNO experienced rebound pulmonary hypertension compared to 10 of 14 patients receiving placebo. In 7 patients receiving sildenafil 0.22 to 0.47 mg/kg/dose PO 4 times daily, mean iNO dose was significantly reduced compared to baseline within 24 hours of sildenafil initiation (12.2 vs. 29.8 ppm, p = 0.024). Guidelines recommend sildenafil use to prevent rebound pulmonary hypertension and facilitate iNO weaning in patients with evidence of increased pulmonary artery pressure upon iNO withdrawal; however, they do not provide specific dosing. Other variables, such as intravascular volume depletion, concurrent antihypertensive therapy, or evidence of hemodynamic instability with alpha-blocker monotherapy, may affect the safety of concomitant use of sildenafil and alfuzosin.

What is sildenafil?

Acetaminophen; Guaifenesin; Phenylephrine: (Minor) The therapeutic effect of phenylephrine injection may be decreased in patients receiving phosphodiesterase inhibitors. Acetaminophen; Phenylephrine: (Minor) The therapeutic effect of phenylephrine injection may be decreased in patients receiving phosphodiesterase inhibitors. Adagrasib: (Major) Coadministration with adagrasib is not recommended in patients receiving sildenafil for pulmonary arterial hypertension (PAH). When sildenafil is used for erectile dysfunction, consider a starting dose of 25 mg for patients receiving adagrasib. Concurrent use may increase sildenafil plasma concentrations resulting in increased associated adverse events including hypotension, syncope, visual changes, and prolonged erection.

Raynaud's phenomenon

Coadministration of other strong CYP3A inhibitors increased the sildenafil AUC between 3- and 11-fold. Alfuzosin: (Moderate) Due to the potential for symptomatic hypotension, patients should be stable on alfuzosin therapy before initiating therapy with the lowest dose of sildenafil. Conversely, patients already receiving an optimized dose of sildenafil should be started on the lowest dose of alfuzosin; increases in the alpha-blocker dose should be done in a stepwise fashion. Other variables, such as intravascular volume depletion, concurrent antihypertensive therapy, or evidence of hemodynamic instability with alpha-blocker monotherapy, may affect the safety of concomitant use of sildenafil and alfuzosin. Aliskiren: sildenafil pfizer 100g (Moderate) Aliskiren can enhance the effects of sildenafil on blood pressure if given concomitantly. Aliskiren: sildenafil pfizer 100g (Moderate) Aliskiren can enhance the effects of sildenafil on blood pressure if given concomitantly.

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This additive effect may be desirable, but dosages must be adjusted accordingly. Blood pressure and electrolytes should be routinely monitored in patients receiving aliskiren. Aliskiren; Hydrochlorothiazide, HCTZ: (Moderate) Aliskiren can enhance the effects of sildenafil on blood pressure if given concomitantly.

At a glance

Recommended maintenance dosing for pulmonary hypertension is 0.5 to 1 mg/kg/dose PO 3 times daily in persons younger than 1 year, 10 mg PO 3 times daily in persons weighing 20 kg or less, and 20 mg PO 3 times daily in persons weighing more than 20 kg. A double-blind, placebo-controlled, crossover study evaluated sildenafil for symptomatic secondary Raynaud's phenomenon resistant to vasodilatory therapy. Patients (n = 18, 15 were female) were randomly assigned to receive placebo or sildenafil 50 mg PO twice daily for 4 weeks; a washout period of 1 week was used before crossover. The results showed that sildenafil significantly improved microcirculation and symptoms associated with Raynaud's. In patients with chronic digital ulcerations, sildenafil treatment resulted in healing of trophic lesions which reappeared or progressed when sildenafil was stopped.

Nonclinical Toxicology

Ulcerations did not heal while receiving placebo. Sildenafil therapy may be an alternative therapy in patients with Raynaud's resistant to vasodilatory therapy. 50 mg PO every 8 hours starting the day before ascent and continuing for 5 days after reaching the target altitude or until descent is initiated as an alternative to nifedipine. Prophylactic medications should only be considered for individuals with a prior history of high altitude pulmonary edema. Delay use in extremely premature infants until retinal vascularization is established. Alpha-blockers: (Moderate) Due to the potential for symptomatic hypotension, patients should be stable on alpha-blocker therapy before initiating therapy with the lowest dose of sildenafil. Conversely, patients already receiving an optimized dose of sildenafil should be started on the lowest dose of the alpha-blocker; increases in the alpha-blocker dose should be done in a stepwise fashion. Other variables, such as intravascular volume depletion, concurrent antihypertensive therapy, or evidence of hemodynamic instability with alpha-blocker monotherapy, may affect the safety of concomitant use of sildenafil and an alpha-blocker. Ambrisentan: (Moderate) Although no specific interactions have been documented, ambrisentan has vasodilatory effects and may contribute additive hypotensive effects when given with other antihypertensive agents. Patients receiving ambrisentan in combination with other antihypertensive agents should be monitored for decreases in blood pressure. Amiodarone: (Moderate) Monitor for an increase in sildenafil-related adverse reactions if coadministration with amiodarone is necessary; consider a starting dose of 25 mg of sildenafil when prescribed for erectile dysfunction. In a drug interaction study, coadministration with a moderate CYP3A4 inhibitor increased the Cmax and AUC of sildenafil by 160% and 182%, respectively. Predictions based on a pharmacokinetic model suggest that drug-drug interactions with CYP3A4 inhibitors will be less for sildenafil injection than those observed after oral sildenafil administration. Amlodipine: (Moderate) Monitor for additive hypotension if amlodipine is administered concurrently with sildenafil, as both agents act independently to reduce blood pressure.

What other information should I know?

This additive effect may be desirable, but dosages must be adjusted accordingly. Blood pressure and electrolytes should be routinely monitored in patients receiving aliskiren. Aliskiren; Hydrochlorothiazide, HCTZ: (Moderate) Aliskiren can enhance the effects of sildenafil on blood pressure if given concomitantly. Alpha-blockers: (Moderate) Due to the potential for symptomatic hypotension, patients should be stable on alpha-blocker therapy before initiating therapy with the lowest dose of sildenafil. Conversely, patients already receiving an optimized dose of sildenafil should be started on the lowest dose of the alpha-blocker; increases in the alpha-blocker dose should be done in a stepwise fashion.

Incidence not known

Other variables, such as intravascular volume depletion, concurrent antihypertensive therapy, or evidence of hemodynamic instability with alpha-blocker monotherapy, may affect the safety of concomitant use of sildenafil and an alpha-blocker. Ambrisentan: (Moderate) Although no specific interactions have been documented, ambrisentan has vasodilatory effects and may contribute additive hypotensive effects when given with other antihypertensive agents. Patients receiving ambrisentan in combination with other antihypertensive agents should be monitored for decreases in blood pressure. Amiodarone: (Moderate) Monitor for an increase in sildenafil-related adverse reactions if coadministration with amiodarone is necessary; consider a starting dose of 25 mg of sildenafil when prescribed for erectile dysfunction. In a drug interaction study, coadministration with a moderate CYP3A4 inhibitor increased the Cmax and AUC of sildenafil by 160% and 182%, respectively. When sildenafil 100 mg was co-administered with amlodipine (5 mg or 10 mg) to hypertensive patients, the mean additional reduction on supine blood pressure (SBP) was 8 mmHg systolic and 7 mmHg diastolic.

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