effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Possible additive vasorelaxation, leading to low blood pressure.saquinavirMonitor Closely (1)saquinavir increases levels of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Potential for increased toxicity. .secobarbitalMonitor Closely (1)secobarbital will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Avoid combination in pulmonary HTN patients. For patients with ED, monitor response to tadalafil carefully because of potential for decreased effectiveness.sertralineMonitor Closely (1)sertraline will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. CYP3A4 inhibitors may reduce tadalafil clearance increasing systemic exposure to tadalafil; increased levels may result in increased associated adverse events. silodosinMonitor Closely (1)tadalafil increases effects of silodosin by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.sotalolMonitor Closely (1)tadalafil increases effects of sotalol by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.spironolactoneMonitor Closely (1)tadalafil increases effects of spironolactone by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.St John's WortMonitor Closely (1)St John's Wort will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Avoid combination in pulmonary HTN patients. For patients with ED, monitor response to tadalafil carefully because of potential for decreased effectiveness.stiripentolMonitor Closely (1)stiripentol, tadalafil. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Stiripentol is a CYP3A4 inhibitor and inducer. Monitor CYP3A4 substrates coadministered with stiripentol for increased or decreased effects. CYP3A4 substrates may require dosage adjustment.tamsulosinMonitor Closely (1)tadalafil, tamsulosin. Either increases effects of the other by additive vasodilation. Use Caution/Monitor. Risk of hypotension.tazemetostatMonitor Closely (1)tazemetostat will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.tecovirimatMonitor Closely (1)tecovirimat will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Tecovirimat is a weak CYP3A4 inducer. Monitor sensitive CYP3A4 substrates for effectiveness if coadministered.telmisartanMonitor Closely (1)tadalafil increases effects of telmisartan by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.terazosinMonitor Closely (1)tadalafil increases effects of terazosin by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.tetracyclineMonitor Closely (1)tetracycline will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. CYP3A4 inhibitors may reduce tadalafil clearance increasing systemic exposure to tadalafil; increased levels may result in increased associated adverse events. timololMonitor Closely (1)tadalafil increases effects of timolol by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.tipranavirMonitor Closely (1)tipranavir will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. 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.tobramycin inhaledMonitor Closely (1)tobramycin inhaled and tadalafil both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicitytopiramateMonitor Closely (1)topiramate will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.torsemideMonitor Closely (1)tadalafil increases effects of torsemide by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.trandolaprilMonitor Closely (1)tadalafil increases effects of trandolapril by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.triamtereneMonitor Closely (1)tadalafil increases effects of triamterene by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.tucatinibSerious - Use Alternative (1)tucatinib will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid concomitant use of tucatinib with CYP3A substrates, where minimal concentration changes may lead to serious or life-threatening toxicities. If unavoidable, reduce CYP3A substrate dose according to product labeling.valsartanMonitor Closely (1)tadalafil increases effects of valsartan by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.vardenafilMonitor Closely (1)vardenafil, tadalafil. Other (see comment). Use Caution/Monitor. Comment: Avoid combination; duplicate therapy is not recommended.verapamilMonitor Closely (1)verapamil will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Risk of hypotension.vericiguatContraindicated (1)tadalafil, vericiguat. Either increases effects of the other by pharmacodynamic synergism. Contraindicated. Coadministration of vericiguat with PDE-5 inhibitors may result in additive hypotensive effects.voriconazoleMonitor Closely (1)voriconazole will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.voxelotorSerious - Use Alternative (1)voxelotor will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Voxelotor increases systemic exposure of sensitive CYP3A4 substrates. Avoid coadministration with sensitive CYP3A4 substrates with a narrow therapeutic index. Consider dose reduction of the sensitive CYP3A4 substrate(s) if unable to avoid.zafirlukastMonitor Closely (1)zafirlukast will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. >10% Headache (11-42%) Myalgia (1-14%) Respiratory tract infection (3-13%) Nasopharyngitis (2-13%) Dyspepsia (1-13%) Flushing (1-13%) Back pain (2-12%) Nausea (10-11%) 1-10% Nasal congestion (≤9%) Gastroesophageal reflux disease (1-3%) Hypertension (1-3%) Bronchitis (≤2%) Genitourinary tract infection (≤2%) <1% Amnesia Angina pectoris Arthralgia Change in color vision Conjunctival hyperemia Dyspnea Epistaxis Postmarketing reports Hypotension Visual field defect, retinal vein occlusion, retinal artery occlusion, and non–arteritic anterior ischemic optic neuropathy (NAION) Hearing loss Priapism Contraindications Hypersensitivity, including Stevens-Johnson syndrome and exfoliative dermatitis Soluble guanylate cyclase (sGC) stimulators (eg, riociguat); concomitant use can cause hypotension Coadministration with nitrates Coadministration with nitrates (either regularly and/or intermittently) and nitric oxide donors Consistent with the effects of PDE5 inhibition on the nitric oxide/cyclic guanosine monophosphate pathway, PDE5 inhibitors may potentiate the hypotensive effects of nitrates A suitable time interval following PDE5 dosing for the safe administration of nitrates or nitric oxide donors has not been determined Cautions Use caution in patients with anatomic deformation of penis, cardiovascular disease, left ventricular outflow obstruction, myocardial infarction in preceding 90 days, unstable angina, angina occurring during sexual intercourse, NYHA class 2 or greater heart failure in preceding 6 months, uncontrolled arrhythmias, hypotension, uncontrolled hypertension, cerebrovascular accident in preceding 6 months, bleeding disorders, active peptic ulcer disease, liver disease, renal impairment, conditions predisposing to priapism, concomitant use of CYP3A4 inhibitors May cause dose-related impairment of color discrimination; use caution in patients with retinitis pigmentosa Evaluate underlying causes of erectile dysfunction or BPH before initiating therapy Do not use nitrates within 48 hours of last dose of tadalafil Drug has vasodilatory properties that may result in transient decreases in blood pressure; prior to prescribing, carefully consider whether patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects; patients with preexisting hypotension, with autonomic dysfunction, with left ventricular outflow obstruction, may be particularly sensitive to actions of vasodilators When used to treat erectile dysfunction, non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, reported postmarketing; if vision problems arise, discontinue, and contact physician Risk of sudden hearing loss CYP3A4 inhibitors (eg, erythromycin, ketoconazole, itraconazole, indinavir, ritonavir) may significantly increase tadalafil serum levels CYP3A4 inducers (eg, rifampin, St John’s wort) may decrease tadalafil serum levels Potentiates hypotensive effect of nitrates (see Contraindications) Concomitant use with alpha blockers (other than tamsulosin 0.4 mg/day) should be stabilized before initiation of phosphodiesterase (PDE)-5 inhibitors; patients with instability on alpha-blocker therapy alone are at increased risk for symptomatic hypotension with concurrent PDE-5 inhibitor therapy Not to be taken with other PDE-5 inhibitors (eg, sildenafil, vardenafil) Not recommended in patients with pulmonary veno-occlusive disease Advise patients to seek emergency treatment if an erection lasts >4 hr Pregnancy Limited data from case series with use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes Pregnant women with untreated pulmonary arterial hypertension are at risk for heart failure, stroke, preterm delivery, and maternal and fetal death Animal data In animal reproduction studies, no adverse developmental effects were observed with oral administration to pregnant rats or mice during organogenesis at exposures 7 times the exposure at maximum recommended human dose (MRHD) of 40 mg/day based on AUC Lactation There are no data on presence of drug and/or its metabolites in human milk, effects on breastfed child, or on milk production; drug and/or its metabolites are present in milk of lactating rats at concentrations approximately 2.4-times that found in the plasma; when a drug is present in animal milk, it is likely that the drug will be present in human milkPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Erectile dysfunction: Inhibits PDE-5, increasing cyclic guanosine monophosphate (cGMP) to allow smooth-muscle relaxation and inflow of blood into corpus cavernosum Pulmonary arterial hypertension (PAH): Inhibits PDE-5, increasing cGMP to allow relaxation of pulmonary vascular smooth-muscle cells and vasodilation of pulmonary vasculature Absorption Duration: ≤36 hr Peak plasma time: Erectile dysfunction, 0.5-6 hr; PAH, 2-8 hr Distribution Protein bound: 94% Vd: Erectile dysfunction, 63 L; PAH, 77 L Metabolism Metabolized in liver by CYP3A4 Elimination Half-life: Erectile dysfunction, 15-17.5 hr; PAH (not on bosentan), 35 hr Total body clearance: Erectile dysfunction, 2.5 L/hr; PAH (not on bosentan), 1.6 L/hr Excretion: Feces (61%), urine (36%) Oral Administration May take with or without food Erectile dysfunction (PRN use): Take before anticipated sexual activity Erectile dysfunction (once-daily use): Take at approximately same time each day without regard to timing of sexual activity BRAND FORM. UNIT PRICE PILL IMAGE tadalafil oral- 5 mg tablettadalafil oral- 5 mg tablettadalafil oral- 5 mg tablettadalafil oral- 20 mg tablettadalafil oral- 10 mg tablettadalafil oral- 5 mg tablettadalafil oral- 2.5 mg tablettadalafil oral- 5 mg tablettadalafil oral- 20 mg tablettadalafil oral- 5 mg tablettadalafil oral- 10 mg tablettadalafil oral- 10 mg tablettadalafil oral- 20 mg tablettadalafil oral- 20 mg tablettadalafil oral- 20 mg tablettadalafil oral- 2.5 mg tablettadalafil oral- 5 mg tablettadalafil oral- 2.5 mg tablettadalafil oral- 5 mg tablettadalafil oral- 2.5 mg tablettadalafil oral- 10 mg tablettadalafil oral- 20 mg tablettadalafil oral- 5 mg tablettadalafil oral- 20 mg tablettadalafil oral- 10 mg tablettadalafil oral- 20 mg tablettadalafil oral- 10 mg tablettadalafil oral- 5 mg tablettadalafil oral- 5 mg tablettadalafil oral- 2.5 mg tablettadalafil oral- 2.5 mg tablettadalafil oral- 10 mg tablettadalafil oral- 5 mg tablettadalafil oral- 2.5 mg tablettadalafil oral- 2.5 mg tablettadalafil oral- 20 mg tablettadalafil oral- 5 mg tablettadalafil oral- 5 mg tablettadalafil oral- 20 mg tablettadalafil oral- 2.5 mg tablettadalafil oral- 10 mg tablettadalafil oral- 20 mg tablettadalafil oral- 10 mg tablettadalafil oral- 10 mg tablettadalafil oral- 2.5 mg tablettadalafil oral- 10 mg tablettadalafil oral- 20 mg tablettadalafil oral- 10 mg tablettadalafil oral- 2.5 mg tablettadalafil oral- 5 mg tablettadalafil oral- 20 mg tablettadalafil oral- 2.5 mg tablettadalafil oral- 5 mg tablettadalafil oral- 2.5 mg tablettadalafil oral- 20 mg tablettadalafil oral- 2.5 mg tablettadalafil oral- 2.5 mg tablettadalafil oral- 10 mg tablettadalafil oral- 20 mg tablettadalafil oral- 5 mg tablettadalafil oral- 10 mg tablettadalafil oral- 20 mg tablettadalafil oral- 10 mg tablettadalafil oral- 20 mg tablettadalafil oral- 10 mg tablettadalafil oral- 5 mg tablettadalafil oral- 2.5 mg tablettadalafil oral- 10 mg tablettadalafil oral- 2.5 mg tablettadalafil oral- 20 mg tabletCialis oral- 20 mg tabletCialis oral- 5 mg tabletCialis oral- 10 mg tabletCialis oral- 2.5 mg tabletCopyright © 2010 First DataBank, Inc.Print Patient Educationtadalafil oral TADALAFIL - ORAL (tah-DA-la-fil) COMMON BRAND NAME(S): Cialis USES: Tadalafil is used to treat male sexual function problems (impotence or erectile dysfunction-ED). In combination with sexual stimulation, tadalafil works by increasing blood flow to the penis to help a man get and keep an erection.Tadalafil is also used to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia-BPH). It helps to relieve symptoms of BPH such as difficulty in beginning the flow of urine, weak stream, and the need to urinate often or urgently (including during the middle of the night). Tadalafil is thought to work by relaxing the smooth muscle in the prostate and bladder.This drug does not protect against sexually transmitted diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Practice "safe sex" such as using latex condoms. Consult your doctor or pharmacist for more details. HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start taking tadalafil and each