Indication

Erectile Dysfunction

Administration

May take with or without food

Adult Dose

Erectile Dysfunction\r\n100 mg PO initially as early as 15 min before sexual activity; not to exceed 1 dose/day\r\n\r\nBased on individual efficacy and tolerability, the dose may be increased to 200 mg taken as early as ~15 minutes before sexual activity, or decreased to 50 mg taken ~30 minutes before sexual activity\r\n\r\nUse lowest effective dose\r\n\r\nHepatic impairment\r\nMild to moderate impairment: Dose adjustment not necessary\r\nSevere impairment: Safety and efficacy not established; do not use

Renal Dose

Renal Impairment\r\nMild-to-moderate (CrCl ?30 mL/min): Dose adjustment not necessary\r\nSevere impairment (CrCl 15-29 mL/min): Safety and efficacy not established; do not use

Contraindication

Hypersensitivity\r\nSoluble guanylate cyclase (sGC) stimulators (eg, riociguat); concomitant use can cause hypotension

Mode of Action

Sexual stimulation causes nitric oxide to be released in the corpus cavernosum; nitric oxide activates the enzyme guanylate cyclase, which in turn increases cGMP levels; increase in cGMP levels causes smooth muscle relaxation.\r\nPhosphodiesterase type 5 inhibitors enhance the effects of nitric oxide in smooth muscle relaxation of the corpus cavernosum by inhibiting the degradation of cGMP.

Precaution

$4c

Side Effect

>2%\r\nHeadache (5.6%)\r\nFlushing (3.5%)\r\nNasal congestion (2.1%)\r\nNasopharyngitis (3.4%)\r\nBack pain (2.5%)\r\nUpper respiratory infection (<2%)\r\nBronchitis (<2%)\r\nInfluenza (<2%)\r\nSinusitis (<2%)\r\nSinus congestion (<2%)\r\nHypertension (<2%)\r\nDyspepsia (<2%)\r\nNausea (<2%)\r\nConstipation (<2%)\r\nRash (<2%)\r\n\r\n<1%\r\nPeripheral edema\r\nFatigue\r\nAngina\r\nDeep vein thrombosis\r\nPalpitations\r\nGastritis\r\nGastroesophageal reflux disease\r\nHypoglycemia\r\nHyperglycemia\r\nOropharyngeal pain\r\nStomach discomfort\r\nVomiting\r\nDepression\r\nInsomnia\r\nCough\r\nDyspnea exertional\r\nEpistaxis\r\nWheezing\r\nPruritus\r\nUrinary tract infection\r\nPollakiuria\r\nNephrolithiasis\r\nHematuria\r\nIncreased erection\r\nBalanitis

Pregnancy Category Note

Pregnancy Category: C\r\n\r\nLactation: Safety and efficacy not established