4 CONTRAINDICATIONS

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. 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. sildenafil increases effects of nitroglycerin rectal by additive vasodilation.

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

sildenafil increases effects of doxazosin sildenafil white by pharmacodynamic synergism. Potent CYP3A4 inducers are expected to cause substantial decreases in sildenafil plasma levels eslicarbazepine acetate will decrease the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Potent CYP3A4 inducers are expected to cause substantial decreases in sildenafil plasma levels fexinidazolefexinidazole will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Coadministration may increase risk for adverse effects of CYP3A4 substrates. fexinidazole will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism.

Erectile Dysfunction

ivosidenibivosidenib will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid coadministration of sensitive CYP3A4 substrates with ivosidenib or replace with alternative therapies. If coadministration is unavoidable, monitor patients for loss of therapeutic effect of these drugs. ivosidenib will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. ketoconazoleketoconazole will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism.

How does sildenafil work (mechanism of action)?

Either increases effects of the other by additive vasodilation.

Coadministration of PDE-5 inhibitors (eg, avanafil, sildenafil, tadalafil, vardenafil) and guanylate cyclase stimulators (eg, riociguat) is contraindicated due to risk of additive hypotension; do not administer within 24 hr of each other.

• Sildenafil citrate 50 mg is used to treat erectile dysfunction in men.
• The typical starting dose is 50 mg taken about one hour before activity.
• It should not be used more than once per 24 hours.

Either increases effects of the other by pharmacodynamic synergism. Coadministration of vericiguat with PDE-5 inhibitors may result in additive hypotensive effects. alfuzosinsildenafil increases effects of alfuzosin by pharmacodynamic synergism. sildenafil increases effects of alfuzosin by pharmacodynamic synergism. apalutamideapalutamide tablet sildenafil 50 mg will decrease the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Coadministration of apalutamide, a strong CYP3A4 inducer, with drugs that are CYP3A4 substrates can result in lower exposure to these medications. Avoid or substitute another drug for these medications when possible.

8.1 Pregnancy

chloramphenicol will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. clarithromycinclarithromycin will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Coadministration of these phosphodiesterase inhibitors with clarithromycin, a CYP3A4 inhibitor is not recommended. Increased systemic exposure of these drugs may occur with clarithromycin; consider reduction of dosage for phosphodiesterase inhibitors. clarithromycin will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism.

Revatio for Oral Suspension

conivaptanconivaptan will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Delay initiation of treatment with any CYP3A4 substrates for at least 7 days following discontinuation of conivaptan. conivaptan will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. crizotinibcrizotinib increases levels of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. If concomitant use of strong CYP3A inhibitors is unavoidable, reduce crizotnib to 250 mg PO qDay.

Oral Administration

After discontinuation of a strong CYP3A inhibitor, resume crizotinib dose used prior to initiating the strong CYP3A4 inhibitor. crizotinib increases levels of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. dabrafenibdabrafenib will decrease the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Potent CYP3A4 inducers are expected to cause substantial decreases in sildenafil plasma levels dabrafenib will decrease the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Potent CYP3A4 inducers are expected to cause substantial decreases in sildenafil plasma levels doxazosinsildenafil increases effects of doxazosin by pharmacodynamic synergism. Evaluate for loss of therapeutic effect if medication must be coadministered.

Adjust dose according to prescribing information if needed. apalutamide will decrease the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. asenapinesildenafil increases effects of asenapine by pharmacodynamic synergism. sildenafil increases effects of asenapine by pharmacodynamic synergism. ceritinibceritinib will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. ceritinib will increase sildenafil cenforce the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. chloramphenicolchloramphenicol will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. chloramphenicol will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. clarithromycinclarithromycin will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Coadministration of these phosphodiesterase inhibitors with clarithromycin, a CYP3A4 inhibitor is not recommended. Increased systemic exposure of these drugs may occur with clarithromycin; consider reduction of dosage for phosphodiesterase inhibitors. clarithromycin will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. conivaptanconivaptan will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Delay initiation of treatment with any CYP3A4 substrates for at least 7 days following discontinuation of conivaptan. conivaptan will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. crizotinibcrizotinib increases levels of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. If concomitant use of strong CYP3A inhibitors is unavoidable, reduce crizotnib to 250 mg PO qDay. After discontinuation of a strong CYP3A inhibitor, resume crizotinib dose used prior to initiating the strong CYP3A4 inhibitor.

5.5 Hearing Loss

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

Raynaud's phenomenon

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.

Low blood pressure

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. sildenafil increases effects of nitroglycerin rectal by additive vasodilation. Either increases effects of the other by additive vasodilation. Coadministration of PDE-5 inhibitors (eg, avanafil, sildenafil, tadalafil, vardenafil) and guanylate cyclase stimulators (eg, riociguat) is contraindicated due to risk of additive hypotension; do not administer within 24 hr of each other. crizotinib increases levels of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism.

Chemical synthesis

Either increases effects of the other by pharmacodynamic synergism. Coadministration of vericiguat with PDE-5 inhibitors may result in additive hypotensive effects. alfuzosinsildenafil increases effects of alfuzosin by pharmacodynamic synergism. sildenafil increases effects of alfuzosin by pharmacodynamic synergism. apalutamideapalutamide tablet sildenafil 50 mg will decrease the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism.

Can I drink alcohol while on Sildenafil Citrate?

Coadministration of apalutamide, a strong CYP3A4 inducer, with drugs that are CYP3A4 substrates can result in lower exposure to these medications. Avoid or substitute another drug for these medications when possible. Evaluate for loss of therapeutic effect if medication must be coadministered. Adjust dose according to prescribing information if needed. apalutamide will decrease the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism.

Sildenafil Oral Film for ED

asenapinesildenafil increases effects of asenapine by pharmacodynamic synergism. sildenafil increases effects of asenapine by pharmacodynamic synergism. ceritinibceritinib will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. ceritinib will increase sildenafil cenforce the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. chloramphenicolchloramphenicol will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. dabrafenibdabrafenib will decrease the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Potent CYP3A4 inducers are expected to cause substantial decreases in sildenafil plasma levels dabrafenib will decrease the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Potent CYP3A4 inducers are expected to cause substantial decreases in sildenafil plasma levels doxazosinsildenafil increases effects of doxazosin by pharmacodynamic synergism.

• Avoid grapefruit juice while taking sildenafil, as it may increase drug levels.
• Use caution if combining with other medications for managing blood pressure.
• Not suitable for women or children under 18 years old.

sildenafil increases effects of doxazosin sildenafil white by pharmacodynamic synergism. Potent CYP3A4 inducers are expected to cause substantial decreases in sildenafil plasma levels eslicarbazepine acetate will decrease the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Potent CYP3A4 inducers are expected to cause substantial decreases in sildenafil plasma levels fexinidazolefexinidazole will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Coadministration may increase risk for adverse effects of CYP3A4 substrates. fexinidazole will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. ivosidenibivosidenib will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid coadministration of sensitive CYP3A4 substrates with ivosidenib or replace with alternative therapies. If coadministration is unavoidable, monitor patients for loss of therapeutic effect of these drugs. ivosidenib will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. ketoconazoleketoconazole will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism.