16 HOW SUPPLIED/STORAGE AND HANDLING

rufinamide will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. sacubitril/valsartantadalafil increases effects of sacubitril/valsartan by pharmacodynamic synergism. tadalafil increases effects of sacubitril/valsartan by pharmacodynamic synergism.

1.3 Erectile Dysfunction and Benign Prostatic Hyperplasia

zafirlukast will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. acetazolamideacetazolamide will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. acetazolamide will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. anastrozoleanastrozole will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. anastrozole will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism.

3. Lifestyle factors

cyclophosphamidecyclophosphamide will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. cyclophosphamide will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. danazoldanazol will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. danazol will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. drospirenonedrospirenone will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism.

6. Dosage

drospirenone will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. larotrectiniblarotrectinib will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. larotrectinib will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. ranolazineranolazine will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Ranolazine may theoretically increase plasma concentrations of CYP3A4 substrates, such as tadalafil. Possible additive vasorelaxation, leading to low blood pressure. Coadministration of sepiapterin with drugs affecting nitric oxide-mediated relaxation may cause additive vasodilation and further reduce blood pressure. silodosintadalafil increases effects of silodosin by pharmacodynamic synergism. tadalafil increases effects of silodosin by pharmacodynamic synergism. sotaloltadalafil increases effects of sotalol by pharmacodynamic synergism. tadalafil increases effects of sotalol by pharmacodynamic synergism.

• Available as round, yellow, film-coated tablets imprinted with "10".
• Manufactured by various companies (e.g., Ajanta, Aurobindo, Teva).
• Generic tadalafil is bioequivalent to the brand-name drug.
• Check pill identification resources if unsure of medication.
• Report any suspected adverse reactions to the FDA or equivalent.
• Keep out of reach of children and pets.

spironolactonetadalafil increases effects of spironolactone by pharmacodynamic synergism. tadalafil increases effects of spironolactone by pharmacodynamic synergism. St John's WortSt John's Wort will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism.

• Tadalafil 10 mg is sometimes used for benign prostatic hyperplasia.
• It is available by prescription only in many countries.
• Tadalafil dosage can be adjusted based on efficacy and tolerability.
• The medication is generally well-tolerated when used properly.
• Avoid alcohol while taking tadalafil to reduce side effects.
• Tadalafil can interact with blood pressure medications.
• Overdose symptoms include persistent erections and dizziness.
• Tadalafil is not a hormone or a steroid.
• Pregnant or breastfeeding women should avoid it unless prescribed.
• The medication may cause vision changes in rare cases.

St John's Wort will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism.

Monitor CYP3A4 substrates coadministered with stiripentol for increased or decreased effects.

Pregnancy & Lactation

ranolazine will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Visual field defect, retinal vein occlusion, retinal artery occlusion, and non–arteritic anterior ischemic optic neuropathy (NAION) Hypersensitivity, including Stevens-Johnson syndrome and exfoliative dermatitis Guanylate cyclase (sGC) stimulators (eg, riociguat); concomitant use can cause hypotension Coadministration with nitrates (either regularly and/or intermittently) and nitric oxide donors Do not use nitrates within 48 hr of the last dose of macitentan/tadalafil This potentiation is thought to result from the combined effects of nitrates and tadalafil on the nitric oxide/cGMP pathway The potentiation is consistent with the effects of PDE5 inhibition on the nitric oxide/cyclic guanosine monophosphate (cGMP) pathway 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 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 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 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 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 milk Controlled studies in pregnant women show no evidence of fetal risk. tecovirimattecovirimat will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Monitor sensitive CYP3A4 substrates for effectiveness if coadministered.

8.2 Lactation

tecovirimat will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. telmisartantadalafil increases effects of telmisartan by pharmacodynamic synergism. tadalafil increases effects of telmisartan by pharmacodynamic synergism. terazosintadalafil increases effects of terazosin by pharmacodynamic synergism. tadalafil increases effects of terazosin by pharmacodynamic synergism. tetracyclinetetracycline will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism.

tetracycline will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. timololtadalafil increases effects of timolol by pharmacodynamic synergism. tadalafil increases effects of timolol by pharmacodynamic synergism. tipranavirtipranavir will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. tipranavir will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. tobramycin inhaledtobramycin inhaled and tadalafil both increase nephrotoxicity and/or ototoxicity. Avoid concurrent or sequential use to decrease risk for ototoxicity tobramycin inhaled and tadalafil both increase nephrotoxicity and/or ototoxicity. Avoid concurrent or sequential use to decrease risk for ototoxicity topiramatetopiramate will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism.

What is tadalafil?

topiramate will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. torsemidetadalafil increases effects of torsemide by pharmacodynamic synergism. tadalafil increases effects of torsemide by pharmacodynamic synergism. trandolapriltadalafil increases effects of trandolapril by pharmacodynamic synergism. tadalafil increases effects of trandolapril by pharmacodynamic synergism.

Side effects

triamterenetadalafil increases effects of triamterene by pharmacodynamic synergism. tadalafil tadacip 20 mg tadalafil increases effects of triamterene by pharmacodynamic synergism. valsartantadalafil increases effects of valsartan by pharmacodynamic synergism. tadalafil increases effects of valsartan by pharmacodynamic synergism. Comment: Avoid combination; duplicate therapy is not recommended.

Tadalafil 5 mg: How long does it last?

verapamilverapamil will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. verapamil will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. voriconazolevoriconazole will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. voriconazole will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. zafirlukastzafirlukast will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. topiramate will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. torsemidetadalafil increases effects of torsemide by pharmacodynamic synergism. tadalafil increases effects of torsemide by pharmacodynamic synergism.

Common side effects, affecting up to 1 in 10 people, include …

rufinamide will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. sacubitril/valsartantadalafil increases effects of sacubitril/valsartan by pharmacodynamic synergism. tadalafil increases effects of sacubitril/valsartan by pharmacodynamic synergism. Possible additive vasorelaxation, leading to low blood pressure. Coadministration of sepiapterin with drugs affecting nitric oxide-mediated relaxation may cause additive vasodilation and further reduce blood pressure.

Diagnostic evaluation of the erectile function domain of the International Index of Erectile Function

silodosintadalafil increases effects of silodosin by pharmacodynamic synergism. tadalafil increases effects of silodosin by pharmacodynamic synergism. sotaloltadalafil increases effects of sotalol by pharmacodynamic synergism. tadalafil increases effects of sotalol by pharmacodynamic synergism. spironolactonetadalafil increases effects of spironolactone by pharmacodynamic synergism.

Muscular Dystrophy (Orphan)

tadalafil increases effects of spironolactone by pharmacodynamic synergism. St John's WortSt John's Wort will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. St John's Wort will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Monitor CYP3A4 substrates coadministered with stiripentol for increased or decreased effects. tecovirimattecovirimat will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. trandolapriltadalafil increases effects of trandolapril by pharmacodynamic synergism.

tadalafil increases effects of trandolapril by pharmacodynamic synergism. triamterenetadalafil increases effects of triamterene by pharmacodynamic synergism. tadalafil tadacip 20 mg tadalafil increases effects of triamterene by pharmacodynamic synergism. valsartantadalafil increases effects of valsartan by pharmacodynamic synergism. tadalafil increases effects of valsartan by pharmacodynamic synergism.

• Tadalafil 10 mg is useful for sporadic or daily erectile issues.
• Keep a medication diary to track effectiveness and side effects.
• The pill should be stored away from moisture and heat.
• Discuss with your doctor any other health conditions before use.
• Tadalafil may cause back pain in some users.
• Do not use if you are allergic to tadalafil or its ingredients.
• The drug is approved by regulatory authorities in many countries.
• An erection should only occur with sexual arousal.
• Discuss potential interactions with your healthcare provider.
• Discontinue use and seek medical attention if adverse effects occur.

Comment: Avoid combination; duplicate therapy is not recommended.

What special dietary instructions should I follow?

Monitor sensitive CYP3A4 substrates for effectiveness if coadministered. tecovirimat will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. telmisartantadalafil increases effects of telmisartan by pharmacodynamic synergism. tadalafil increases effects of telmisartan by pharmacodynamic synergism. terazosintadalafil increases effects of terazosin by pharmacodynamic synergism.

Priapism and Your Cialis Dose

tadalafil increases effects of terazosin by pharmacodynamic synergism. tetracyclinetetracycline will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. tetracycline will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. timololtadalafil increases effects of timolol by pharmacodynamic synergism. tadalafil increases effects of timolol by pharmacodynamic synergism.

Tadalafil in the treatment of erectile dysfunction following bilateral nerve sparing radical retropubic prostatectomy: A randomized, double-blind, placebo controlled trial

tipranavirtipranavir will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. tipranavir will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. tobramycin inhaledtobramycin inhaled and tadalafil both increase nephrotoxicity and/or ototoxicity. Avoid concurrent or sequential use to decrease risk for ototoxicity tobramycin inhaled and tadalafil both increase nephrotoxicity and/or ototoxicity. Avoid concurrent or sequential use to decrease risk for ototoxicity topiramatetopiramate will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. verapamilverapamil will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. verapamil will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. voriconazolevoriconazole will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. voriconazole will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. zafirlukastzafirlukast will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. zafirlukast will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. acetazolamideacetazolamide will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. acetazolamide will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. anastrozoleanastrozole will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism.

14.3 Tadalafil Tablets 5 mg for Once Daily Use for Benign Prostatic Hyperplasia (BPH)

anastrozole will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. cyclophosphamidecyclophosphamide will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. cyclophosphamide will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. danazoldanazol will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. danazol will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. drospirenonedrospirenone will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism.

• Tadalafil 10 mg treats erectile dysfunction effectively.
• The recommended dose is one tablet daily or as prescribed.
• Tadalafil works by increasing blood flow to the penis.
• Onset of action is usually within 30-60 minutes.
• The effects of 10 mg may last up to 36 hours.
• Consult a doctor before starting tadalafil 10 mg.
• Avoid high-fat meals close to the dose for faster absorption.
• Common side effects include headache and flushing.
• Do not take tadalafil with nitrates or certain medications.
• Store tablets in a cool, dry place away from children.

drospirenone will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. larotrectiniblarotrectinib will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. larotrectinib will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. ranolazineranolazine will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Ranolazine may theoretically increase plasma concentrations of CYP3A4 substrates, such as tadalafil. ranolazine will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Visual field defect, retinal vein occlusion, retinal artery occlusion, and non–arteritic anterior ischemic optic neuropathy (NAION) Hypersensitivity, including Stevens-Johnson syndrome and exfoliative dermatitis Guanylate cyclase (sGC) stimulators (eg, riociguat); concomitant use can cause hypotension Coadministration with nitrates (either regularly and/or intermittently) and nitric oxide donors Do not use nitrates within 48 hr of the last dose of macitentan/tadalafil This potentiation is thought to result from the combined effects of nitrates and tadalafil on the nitric oxide/cGMP pathway The potentiation is consistent with the effects of PDE5 inhibition on the nitric oxide/cyclic guanosine monophosphate (cGMP) pathway 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 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 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 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 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 milk Controlled studies in pregnant women show no evidence of fetal risk.