AdultPediatricGeriatricDosage Forms & Strengths tablet (Adcirca, Alyq, generic) 20mg tablet (Cialis, generic) 2.5mg 5mg 10mg 20mg oral suspension (Tadliq) 20mg5/mL Erectile Dysfunction Indicated for treatment of erectile dysfunction (ED) Cialis or generic equivalent only PRN use: 10 mg PO initially before sexual activity, with or without food; may be increased to 20 mg or reduced to 5 mg on basis of efficacy and tolerability; in most patients, maximum dosing frequency is once daily Once-daily use: 2.5 mg/day PO in single daily dose, without regard to timing of sexual activity, with or without food; may be increased to 5 mg/day on basis of efficacy and tolerability Dosing considerations PRN use: Decrease dose with concomitant use of potent CYP3A4 inhibitor (eg, ritonavir, ketoconazole, itraconazole); not to exceed 10 mg/72 hr Once-daily use: Decrease dose with concomitant use of potent CYP3A4 inhibitor (eg, ritonavir, ketoconazole, itraconazole); not to exceed 2.5 mg/day Benign Prostatic Hyperplasia Indicated for treatment of signs and symptoms of benign prostatic hyperplasia (BPH); daily use also indicated for treatment of patients with both BPH and erectile dysfunction Cialis or generic equivalent only BPH: 5 mg PO once daily BPH with ED: 5 mg PO once daily, taken at approximately same time each day without regard to timing of sexual activity Coadministration with finasteride for BPH: Tadalafil 5 mg plus finasteride 5 mg PO once daily for ≤26 weeks; incremental benefit of tadalafil decreases from 4 weeks until 26 weeks, and the benefit beyond 26 weeks is unknown Pulmonary Arterial Hypertension Indicated for pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability; studies establishing effectiveness included predominately patients with NYHA Functional Class II – III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%) Adcirca, Alyq, Tadliq, or generic equivalent only 40 mg PO once daily; dividing dose for more frequent dosing is not recommended Patients also taking ritonavir: 20 mg PO once daily initially for ≥1 week; may be increased to 40 mg/day on basis of tolerability Dosing considerations If possible, avoid coadministration with CYP3A4 inhibitors; if coadministration is essential, long-term therapy is indicated, or strong CYP3A4 inhibitors are required, modify or hold dose Patients already taking strong CYP3A4 inhibitor who require tadalafil: 20 mg PO once daily; may be increased to 40 mg/day on basis of tolerability Patients already taking tadalafil who require strong CYP3A4 inhibitor: Avoid using tadalafil while starting strong CYP3A4 inhibitor; stop tadalafil ≥24 hours before starting strong CYP3A4 inhibitor; after 1 week, resume tadalafil at 20 mg PO once daily; may be increased to 40 mg/day on basis of tolerability Dosing Modifications Renal impairment (ED) Cialis (PRN use) Mild (CrCl ≥51 mL/min): No dosage adjustment needed Moderate (CrCl 30-50 mL/min): Not to exceed 5 mg PO once daily initially; maximum dosage, 10 mg PO q48hr Severe (CrCl <30 mL/min and on hemodialysis): Not to exceed 5 mg PO q72hr Cialis (once daily use) ED (CrCl ≥30 mL/min): No dosage adjustment needed BPH or BPH/ED (CrCl 30-50 mL/min): 2.5 mg/day starting dose recommended; may increase to 5 mg according to individual response ED or BPH (CrCl <30 mL/min:) Not recommended Renal impairment (PAH) Adcirca or Alyq Mild-to-moderate (CrCl 31-80 mL/min): 20 mg PO once daily initially; may be increased to 40 mg once daily on basis of tolerability Severe (CrCl <30 mL/min and on hemodialysis): Avoid use Hepatic impairment (ED) Cialis (PRN use) Mild-to-moderate (Child-Pugh class A or B): Not to exceed 10 mg PO once daily Severe (Child-Pugh class C): Not recommended Cialis (once daily use) Mild-to-moderate (Child-Pugh class A or B): Data limited; caution advised Severe (Child-Pugh class C): Not recommended Hepatic impairment (PAH) Adcirca or Alyq Mild-to-moderate (Child-Pugh class A or B): Consider starting dosage of 20 mg PO once daily Severe (Child-Pugh class C): Avoid use Muscular Dystrophy (Orphan) Orphan designation for Duchenne muscular dystrophy (DMD) Sponsor Eli Lilly and Company; Lilly Corporate Center; Indianapolis, IN 46285 Pulmonary Arterial Hypertension (Orphan) Orphan designation of a fixed dose combination of macitentan and tadalafil for treatment of pulmonary arterial hypertension Sponsor Actelion Clinical Research, Inc; 1820 Chapel Avenue West, Suite 300; Cherry Hill, New Jersey 08002 Safety and efficacy not establishedErectile Dysfunction Indicated for treatment of erectile dysfunction (ED) Cialis or generic equivalent only: No dosage adjustment is warranted solely on basis of age; however, greater sensitivity to medications in some older individuals should be considered Pulmonary Arterial Hypertension Indicated for pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability; studies establishing effectiveness included predominately patients with NYHA Functional Class II – III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%) Adcirca, Alyq, or generic equivalent only: Lower dose or reduced dosing frequency may be required in elderly because of decreased renal or hepatic clearanceInteraction CheckerEnter a drug name and tadalafilNo Results No Interactions Found Interactions FoundContraindicatedSerious - Use AlternativeSignificant - Monitor CloselyMinorAll Interactions Sort By: SeverityName Contraindicated (11)isosorbide dinitrateisosorbide dinitrate, tadalafil. Mechanism: additive vasodilation. Contraindicated. Contraindicated. Potentially fatal hypotension. Allow 48h after last tadalafil dose before nitrate administration.isosorbide mononitrateisosorbide mononitrate, tadalafil. Mechanism: additive vasodilation. Contraindicated. Contraindicated. Potentially fatal hypotension. Allow 48h after last tadalafil dose before nitrate administration.nitroglycerin IVnitroglycerin IV, tadalafil. Mechanism: additive vasodilation. Contraindicated. Potentially fatal hypotension.nitroglycerin POnitroglycerin PO, tadalafil. Mechanism: additive vasodilation. Contraindicated. Potentially fatal hypotension.nitroglycerin rectaltadalafil increases effects of nitroglycerin rectal by additive vasodilation. Contraindicated. 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.nitroglycerin sublingualnitroglycerin sublingual, tadalafil. Mechanism: additive vasodilation. Contraindicated. Potentially fatal hypotension.nitroglycerin topicalnitroglycerin topical, tadalafil. Mechanism: additive vasodilation. Contraindicated. Potentially fatal hypotension.nitroglycerin transdermalnitroglycerin transdermal, tadalafil. Mechanism: additive vasodilation. Contraindicated. Potentially fatal hypotension.nitroglycerin translingualnitroglycerin translingual, tadalafil. Mechanism: additive vasodilation. Contraindicated. Potentially fatal hypotension.riociguattadalafil, riociguat. Either increases effects of the other by additive vasodilation. Contraindicated. 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 24 hr before or within 48hr of each other.vericiguattadalafil, vericiguat. Either increases effects of the other by pharmacodynamic synergism. Contraindicated. Coadministration of vericiguat with PDE-5 inhibitors may result in additive hypotensive effects.Serious - Use Alternative (29)abametapirabametapir will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. For 2 weeks after abametapir application, avoid taking drugs that are CYP3A4 substrates. If not feasible, avoid use of abametapir.amyl nitriteamyl nitrite, tadalafil. Mechanism: additive vasodilation. Avoid or Use Alternate Drug. Contraindicated. Potentially fatal hypotension. Allow 48h after last tadalafil dose before nitrate administration.apalutamideapalutamide will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. 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.atazanaviratazanavir will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Stop tadalafil >24 hours prior to protease inhibitor (PI) initiation, restart 7 days after PI initiation at 20 mg once daily, and increase to 40 mg once daily based on tolerability.ceritinibceritinib will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.clarithromycinclarithromycin will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. For ED limit tadalafil to max of 2.5 mg/day (for daily use) or 10 mg dose every 72 hr (for use as needed). Avoid concurrent use of tadalafil for pulmonary HTN in patients taking strong CYP3A4 inhibitors.cobicistatcobicistat will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Adjust tadalafil dose for PAH; if on cobicistat, start tadalafil 20 mg/day and may increase up to 40 mg/day; avoid tadalafil when starting cobicistat; for ED, may take a single dose of tadalafil not exceeding 10 mg in 72 hr.darunavirdarunavir will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Adjust tadalafil dose for PAH; if on cobicistat, start tadalafil 20 mg/day and may increase up to 40 mg/day; avoid tadalafil when starting cobicistat; for ED, may take a single dose of tadalafil not exceeding 10 mg in 72 hr.enzalutamideenzalutamide will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.erythromycin baseerythromycin base will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. For ED limit tadalafil to max of 2.5 mg/day (for daily use) or 10 mg dose every 72 hr (for use as needed). Avoid concurrent use of tadalafil for pulmonary HTN in patients taking strong CYP3A4 inhibitors.erythromycin ethylsuccinateerythromycin ethylsuccinate will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. For ED limit tadalafil to max of 2.5 mg/day (for daily use) or 10 mg dose every 72 hr (for use as needed). Avoid concurrent use of tadalafil for pulmonary HTN in patients taking strong CYP3A4 inhibitors.erythromycin lactobionateerythromycin lactobionate will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. For ED limit tadalafil to max of 2.5 mg/day (for daily use) or 10 mg dose every 72 hr (for use as needed). Avoid concurrent use of tadalafil for pulmonary HTN in patients taking strong CYP3A4 inhibitors.erythromycin stearateerythromycin stearate will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. For ED limit tadalafil to max of 2.5 mg/day (for daily use) or 10 mg dose every 72 hr (for use as needed). Avoid concurrent use of tadalafil for pulmonary HTN in patients taking strong CYP3A4 inhibitors.fexinidazolefexinidazole will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Fexinidazole inhibits CYP3A4. Coadministration may increase risk for adverse effects of CYP3A4 substrates.fosamprenavirfosamprenavir will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Stop tadalafil >24 hours prior to protease inhibitor (PI) initiation, restart 7 days after PI initiation at 20 mg once daily, and increase to 40 mg once daily based on tolerability.idelalisibidelalisib will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Idelalisib is a strong CYP3A inhibitor; avoid coadministration with sensitive CYP3A substratesindinavirindinavir will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Stop tadalafil >24 hours prior to protease inhibitor (PI) initiation, restart 7 days after PI initiation at 20 mg once daily, and increase to 40 mg once daily based on tolerability.itraconazoleitraconazole will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. For ED limit tadalafil to max of 2.5 mg/day (for daily use) or 10 mg dose every 72 hr (for use as needed). Avoid concurrent use of tadalafil for pulmonary HTN in patients taking strong CYP3A4 inhibitors.ketoconazoleketoconazole will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. CYP3A4 inhibitors may reduce tadalafil clearance increasing systemic exposure to tadalafil; significantly increased levels may result in significant adverse events including severe hypotension, syncope, visual changes, and priapism. lenacapavirlenacapavir will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Refer to the prescribing information of PDE5 inhibitors for dose recommendations. levoketoconazolelevoketoconazole will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. CYP3A4 inhibitors may reduce tadalafil clearance increasing systemic exposure to tadalafil; significantly increased levels may result in significant adverse events including severe hypotension, syncope, visual changes, and priapism. lonafarniblonafarnib will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration with sensitive CYP3A substrates. If coadministration unavoidable, monitor for adverse reactions and reduce CYP3A substrate dose in accordance with product labeling.lopinavirlopinavir