Sildenafil Citrate 2.5 mg/mL Oral Liquid

Partner's questionnaire: Generally increasing partner satisfaction was seen with increasing sildenafil dose (10-100mg). Quality of life: Statistically significant but small quality of life treatment effects were seen in 4 RCTs. Adverse effects: Adverse events reported in >2% (range 2% - 10%) of patient treated (2RCTs) include headache, flushing, dyspepsia, nasal congestion, urinary tract infection, abnormal vision, diarrhoea, dizziness, rash, respiratory tract infection. No cases of priapism were reported in any of the sildenafil studies. Cardiovascular: 18 RCTs give an overall incidence of cardiovascular events (other than flushing) of 3.0% with sildenafil and 3.5% with placebo.

Dosing & Uses

nitroglycerin rectalsildenafil increases effects of nitroglycerin rectal by additive vasodilation. Use of nitroglycerin within a few days of PDE5 inhibitors is contraindicated. PDE5 inhibitors have been shown to potentiate the hypotensive effects of organic nitrates. A comparable incidence rate was seen with sildenafil and placebo for serious cardiovascular events. No clinically significant changes in blood pressure, heart rate or ECG were seen with sildenafil treatment. Sildenafil had no direct effect on platelet aggregation. Death: 8/4500 patients treated with sildenafil in clinical trial died whilst taking the study drug or within 30 days of treatment. Six deaths were related to cardiovascular causes; in all cases it was plausible that the event was not related to the study drug. Diabetics: In general, smaller improvements were seen in diabetics than in those without diabetes.

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Spinal cord injury: sildenafil appears to show comparable efficacy in patients with erectile dysfunction solely attributable to spinal cord injury (but with intact spinal cord-mediated reflexes) to patients with erectile dysfunction of broad-spectrum aetiology.

• Sildenafil is not a cure for erectile dysfunction but helps improve function.
• Use sildenafil only as prescribed to ensure safety and efficacy.
• It is not intended for recreational use and can be harmful.

Radical prostatectomy: 4% of participants had erectile dysfunction as a result of radical prostatectomy. A subgroup analysis of the patients appeared ot show lower efficacy with sildenafil, with 40-50% achieving improved erections.

Where to buy Sildenafil Citrate

Age: Age did not affect response to sildenafil. A cost-utility analysis concluded that there is a great deal of uncertainty surrounding the assumptions used to calculate the cost/QALY of treating erectile dysfunction with sildenafil. The best estimate was approximately £7,000/QALY. Sensitivity analysis around the assumptions produced a range of cost/QALYs within the £3,000-£20,000/QALY "strongly supported" decision band used by the Development and Evaluation Committee.

This formulation may be used in cases where the risk-benefit profile for a specific pediatric patient is acceptable.

Partner's questionnaire: Generally increasing partner satisfaction was seen with increasing sildenafil dose (10-100mg). Quality of life: Statistically significant but small quality of life treatment effects were seen in 4 RCTs. Adverse effects: Adverse events reported in >2% (range 2% - 10%) of patient treated (2RCTs) include headache, flushing, dyspepsia, nasal congestion, urinary tract infection, abnormal vision, diarrhoea, dizziness, rash, respiratory tract infection. No cases of priapism were reported in any of the sildenafil studies. Cardiovascular: 18 RCTs give an overall incidence of cardiovascular events (other than flushing) of 3.0% with sildenafil and 3.5% with placebo.

Postmarketing Reports

A comparable incidence rate was seen with sildenafil and placebo for serious cardiovascular events. No clinically significant changes in blood pressure, heart rate or ECG were seen with sildenafil treatment. Sildenafil had no direct effect on platelet aggregation. Death: 8/4500 patients treated with sildenafil in clinical trial died whilst taking the study drug or within 30 days of treatment. Six deaths were related to cardiovascular causes; in all cases it was plausible that the event was not related to the study drug.

Product Overview

Diabetics: In general, smaller improvements were seen in diabetics than in those without diabetes. Spinal cord injury: sildenafil appears to show comparable efficacy in patients with erectile dysfunction solely attributable to spinal cord injury (but with intact spinal cord-mediated reflexes) to patients with erectile dysfunction of broad-spectrum aetiology. Radical prostatectomy: 4% of participants had erectile dysfunction as a result of radical prostatectomy. A subgroup analysis of the patients appeared ot show lower efficacy with sildenafil, with 40-50% achieving improved erections. Age: Age did not affect response to sildenafil. All trials showed a statistically significant improvement in erectile function in patients using sildenafil compared to placebo. About 75-80% of men show a clinically significant improvement in erectile or sexual function on sildenafil compared to around 25% on placebo. The number needed to treat sildenafil softgel capsule (NNT) was about 2. Many of the patients in the studies had some baseline erectile function and it is probable that in clinical practice, where the erectile function tends to be more impaired, the NNT may be higher. The drug has a relatively safe side-effect profile. The major contraindication is concurrent use of nitrates. The research question and inclusion criteria for the review were clear, however inclusion criteria for the primary studies were quite restrictive and possibly resulted in the population studied having more baseline erectile function than would be seen in clinical practice, which would limit the generalisability of the review findings.

• Common side effects include headache, flushing, and nasal congestion.
• Serious side effects are rare but can include vision changes and priapism.
• Report any severe reactions to your doctor immediately.

The authors state that validity assessment was undertaken but few details of this are presented in the report.The literature search was comprehensive and it is unlikely that any studies were missed. Some details of the review process are given but it is not stated how many reviewers screened studies for relevance.

Side Effect	Incidence (%)	Severity	Recommendations
Headache	16-30	Mild to moderate	Usually resolves spontaneously
Flushing	10-15	Mild	Can be reduced with lower doses
Dyspepsia	10-20	Mild	Take with food to reduce symptoms
Nasal Congestion	10-20	Mild	Usually transient
Visual Disturbances	2-4	Mild to moderate	Rare, discontinue if persistent

As all included phase III trials used the same outcome measures data could have been pooled using standard methods for meta-analysis and presented as forest plot and as relative risks and weighted mean differences with 95%CIs: this was not done and there is no description in the methods section of how the review authors synthesised data. The authors' conclusions do seem to follow from the results.

Parameter	Description	Typical Value	Notes
Absorption Rate	How quickly sildenafil enters bloodstream	Rapid	Peaks in 30-120 minutes
Bioavailability	Percentage of dose reaching systemic circulation	~40%	Affected by food intake
Half-life	Time for plasma concentration to reduce by half	3-5 hours	Determines dosing frequency
Peak Plasma Concentration	Maximum concentration after dose	1 hour	Influenced by gastric emptying and food intake

The authors state that if sildenafil were available for prescription in primary care the drug costs to an average health authority with a total population of 500,000 are estimated to be between 750,000 and 1,250,000 per annum, depending on the percentage of men who present for treatment. Burls A, Clark W, Gold L, Simpson S. Sildenafil: an oral drug for the treatment of male erectile dysfunction. Birmingham: University of Birmingham, Department of Public Health and Epidemiology. West Midlands Development and Evaluation Committee Report; 12.

Condition	Caution / Notes	Risk Factors
Cardiovascular disease	Use with caution	Heart failure, recent MI
Concomitant nitrate use	Absolute contraindication	Risk of severe hypotension
Severe hepatic impairment	May require dose adjustment	Reduced clearance
Retinitis Pigmentosa	Cautious use	Potential for vision disturbances

This is a critical abstract of a systematic review that meets the criteria for inclusion on DARE. Each critical abstract contains a brief summary of the review methods, results and conclusions followed by a detailed critical assessment on the reliability of the review and the conclusions drawn. Implications of the review for practice and research Sildenafil: an oral drug for the treatment of male erectile dysfunction - Databa...Sildenafil: an oral drug for the treatment of male erectile dysfunction - Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews 50 mg PO ~1 hr before sexual activity; however, may be taken anywhere from 30 min to 4 hr before sexual activity Maximum dosing frequency is once per day Based on effectiveness and toleration, may increase dose to maximum of 100 mg or decrease to 25 mg Indicated for treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) to improve exercise ability and delay clinical worsening Revatio (PO), Liqrev: 20 mg PO TID; may titrate up to 80 mg TID, if required, based on symptoms and tolerability Revatio (IV): 10 mg IV bolus TID 10-mg IV predicted to provide pharmacologic effect equivalent to 10-mg oral dose Do not exceed recommended PO/IV dose Viagra, VibriqueSevere (eg, cirrhosis): Consider initial dose of 25 mg Severe (eg, cirrhosis): Consider initial dose of 25 mg RevatioMild or moderate (Child-Pugh A or B): No dose adjustment requiredSevere (Child-Pugh C): Not studied Mild or moderate (Child-Pugh A or B): No dose adjustment required Viagra, VibriqueMild or moderate (CrCl 30-80 mL/min): No dose adjustment requiredSevere (CrCl <30 mL/min): Consider initial dose of 25 mg Mild or moderate (CrCl 30-80 mL/min): No dose adjustment required Severe (CrCl <30 mL/min): Consider initial dose of 25 mg RevatioAny severity, including severe (CrCl <30 mL/min): No dose adjustment required Any severity, including severe (CrCl <30 mL/min): No dose adjustment required Indicated in children aged 1-17 years for treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise ability and, in pediatric patients too young to perform standard exercise testing, pulmonary hemodynamics thought to underly improvements in exercise 20-45 kg: 20 mg PO TID Maximum dose in pediatric patients not identified Based on experience in adults, dose may be titrated up to 40 mg TID, if required, based on symptoms and tolerability Mild or moderate (Child-Pugh A or B): No dose adjustment required Any severity, including severe (CrCl <30 mL/min): No dose adjustment required ≥65 years: 25 mg PO initially ~1 hr before sexual activity; however, may be taken anywhere from 30 min to 4 hr before sexual activity Maximum dosing frequency is once per day Based on effectiveness and toleration, may increase dose to maximum of 100 mg or decrease to 25 mg Indicated for treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) to improve exercise ability and delay clinical worsening PO: 20 mg PO TID; may titrate up to 80 mg TID, if required , based on symptoms and tolerability 10-mg IV predicted to provide pharmacologic effect equivalent to 10-mg oral dose Recommended PO/IV dose not to be exceeded Adding Revatio to bosentan does not have any beneficial effect on exercise capacity Clinical trials found no significant difference in response between elderly patients and younger adults; however, cautious dose selection should be considered in elderly because of greater frequency of decreased hepatic, renal, and cardiac function, as well as comorbid conditions and concomitant pharmacotherapy Compared with healthy younger volunteers, healthy elderly volunteers (≥65 years) had reduced clearance of sildenafil, resulting in approximately 84% and 107% higher plasma concentrations of sildenafil and its active N-desmethyl metabolite, respectively atazanaviratazanavir will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Never use combination with chronic sildenafil for PAH cobicistatcobicistat will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism.

What side effects can this medication cause?

A cost-utility analysis concluded that there is a great deal of uncertainty surrounding the assumptions used to calculate the cost/QALY of treating erectile dysfunction with sildenafil. The best estimate was approximately £7,000/QALY. Sensitivity analysis around the assumptions produced a range of cost/QALYs within the £3,000-£20,000/QALY "strongly supported" decision band used by the Development and Evaluation Committee. All trials showed a statistically significant improvement in erectile function in patients using sildenafil compared to placebo. About 75-80% of men show a clinically significant improvement in erectile or sexual function on sildenafil compared to around 25% on placebo.

Storage and Handling

The number needed to treat sildenafil softgel capsule (NNT) was about 2. Many of the patients in the studies had some baseline erectile function and it is probable that in clinical practice, where the erectile function tends to be more impaired, the NNT may be higher. The drug has a relatively safe side-effect profile. The major contraindication is concurrent use of nitrates. The research question and inclusion criteria for the review were clear, however inclusion criteria for the primary studies were quite restrictive and possibly resulted in the population studied having more baseline erectile function than would be seen in clinical practice, which would limit the generalisability of the review findings.

Clinical Uses

The authors state that validity assessment was undertaken but few details of this are presented in the report.The literature search was comprehensive and it is unlikely that any studies were missed. Some details of the review process are given but it is not stated how many reviewers screened studies for relevance. As all included phase III trials used the same outcome measures data could have been pooled using standard methods for meta-analysis and presented as forest plot and as relative risks and weighted mean differences with 95%CIs: this was not done and there is no description in the methods section of how the review authors synthesised data. The authors' conclusions do seem to follow from the results. The authors state that if sildenafil were available for prescription in primary care the drug costs to an average health authority with a total population of 500,000 are estimated to be between 750,000 and 1,250,000 per annum, depending on the percentage of men who present for treatment. When used chronically for PAH, sildenafil is contraindicated for use with cobicistat; if used for erectile dysfunction, do not exceed sildenafil 25 mg q48hr cobicistat will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Cobicistat is a CYP3A4 inhibitor; contraindicated with CYP3A4 substrates for which elevated plasma concentrations are associated with serious and/or life-threatening events; contraindication applies to chronic administration of sildenafil for PAH; for ED, not to exceed 25 mg in 48 hr.

• Sildenafil can improve exercise capacity in pulmonary hypertension patients.
• Regular monitoring may be required for long-term use.
• Be aware of potential side effects related to blood pressure changes.

nelfinavirnelfinavir will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism.

• Always consult a healthcare provider before starting sildenafil.
• Do not exceed the prescribed dose to avoid side effects.
• Sildenafil can interact with nitrates, causing dangerous blood pressure drops.

nelfinavir will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Coadministration contraindicated if sildenafil used for pulmonary arterical hypertension. Reduce sildenafil dose if used for erectile dysfunction. nirmatrelvir/ritonavir will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism.

Society and culture

Burls A, Clark W, Gold L, Simpson S. Sildenafil: an oral drug for the treatment of male erectile dysfunction. Birmingham: University of Birmingham, Department of Public Health and Epidemiology. West Midlands Development and Evaluation Committee Report; 12. This is a critical abstract of a systematic review that meets the criteria for inclusion on DARE.

Impotence in diabetic men

Each critical abstract contains a brief summary of the review methods, results and conclusions followed by a detailed critical assessment on the reliability of the review and the conclusions drawn. Implications of the review for practice and research Sildenafil: an oral drug for the treatment of male erectile dysfunction - Databa...Sildenafil: an oral drug for the treatment of male erectile dysfunction - Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews 50 mg PO ~1 hr before sexual activity; however, may be taken anywhere from 30 min to 4 hr before sexual activity Maximum dosing frequency is once per day Based on effectiveness and toleration, may increase dose to maximum of 100 mg or decrease to 25 mg Indicated for treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) to improve exercise ability and delay clinical worsening Revatio (PO), Liqrev: 20 mg PO TID; may titrate up to 80 mg TID, if required, based on symptoms and tolerability Revatio (IV): 10 mg IV bolus TID 10-mg IV predicted to provide pharmacologic effect equivalent to 10-mg oral dose Do not exceed recommended PO/IV dose Viagra, VibriqueSevere (eg, cirrhosis): Consider initial dose of 25 mg Severe (eg, cirrhosis): Consider initial dose of 25 mg RevatioMild or moderate (Child-Pugh A or B): No dose adjustment requiredSevere (Child-Pugh C): Not studied Mild or moderate (Child-Pugh A or B): No dose adjustment required Viagra, VibriqueMild or moderate (CrCl 30-80 mL/min): No dose adjustment requiredSevere (CrCl <30 mL/min): Consider initial dose of 25 mg Mild or moderate (CrCl 30-80 mL/min): No dose adjustment required Severe (CrCl <30 mL/min): Consider initial dose of 25 mg RevatioAny severity, including severe (CrCl <30 mL/min): No dose adjustment required Any severity, including severe (CrCl <30 mL/min): No dose adjustment required Indicated in children aged 1-17 years for treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise ability and, in pediatric patients too young to perform standard exercise testing, pulmonary hemodynamics thought to underly improvements in exercise 20-45 kg: 20 mg PO TID Maximum dose in pediatric patients not identified Based on experience in adults, dose may be titrated up to 40 mg TID, if required, based on symptoms and tolerability Mild or moderate (Child-Pugh A or B): No dose adjustment required Any severity, including severe (CrCl <30 mL/min): No dose adjustment required ≥65 years: 25 mg PO initially ~1 hr before sexual activity; however, may be taken anywhere from 30 min to 4 hr before sexual activity Maximum dosing frequency is once per day Based on effectiveness and toleration, may increase dose to maximum of 100 mg or decrease to 25 mg Indicated for treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) to improve exercise ability and delay clinical worsening PO: 20 mg PO TID; may titrate up to 80 mg TID, if required , based on symptoms and tolerability 10-mg IV predicted to provide pharmacologic effect equivalent to 10-mg oral dose Recommended PO/IV dose not to be exceeded Adding Revatio to bosentan does not have any beneficial effect on exercise capacity Clinical trials found no significant difference in response between elderly patients and younger adults; however, cautious dose selection should be considered in elderly because of greater frequency of decreased hepatic, renal, and cardiac function, as well as comorbid conditions and concomitant pharmacotherapy Compared with healthy younger volunteers, healthy elderly volunteers (≥65 years) had reduced clearance of sildenafil, resulting in approximately 84% and 107% higher plasma concentrations of sildenafil and its active N-desmethyl metabolite, respectively atazanaviratazanavir will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Never use combination with chronic sildenafil for PAH cobicistatcobicistat will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. When used chronically for PAH, sildenafil is contraindicated for use with cobicistat; if used for erectile dysfunction, do not exceed sildenafil 25 mg q48hr cobicistat will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Cobicistat is a CYP3A4 inhibitor; contraindicated with CYP3A4 substrates for which elevated plasma concentrations are associated with serious and/or life-threatening events; contraindication applies to chronic administration of sildenafil for PAH; for ED, not to exceed 25 mg in 48 hr.

Cite this article

nelfinavirnelfinavir will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. nelfinavir will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Coadministration contraindicated if sildenafil used for pulmonary arterical hypertension. Reduce sildenafil dose if used for erectile dysfunction. nirmatrelvir/ritonavir will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. nitroglycerin rectalsildenafil increases effects of nitroglycerin rectal by additive vasodilation. Use of nitroglycerin within a few days of PDE5 inhibitors is contraindicated. PDE5 inhibitors have been shown to potentiate the hypotensive effects of organic nitrates.