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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 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 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 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 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 May increase risk of sudden vision loss attributed to nonarteritic ischemic optic neuropathy; 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 Not indicated for use in females; there are no data in pregnant women to inform any drug-associated risks for adverse developmental outcomes; in animal reproduction studies, no adverse developmental effects observed with oral administration of tadalafil to pregnant rats or mice during organogenesis at exposures up to 11 times the maximum recommended human dose (MRHD) of 20 mg/day Not indicated for use in females; there is no information on presence of tadalafil and/or 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-fold greater than found in plasma Erectile dysfunction: Inhibits PDE-5, increasing cyclic guanosine monophosphate (c GMP) to allow smooth-muscle relaxation and inflow of blood into corpus cavernosum Pulmonary arterial hypertension (PAH): Inhibits PDE-5, increasing c GMP to allow relaxation of pulmonary vascular smooth-muscle cells and vasodilation of pulmonary vasculature The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

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