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Tadalafil

    DEA Class; Rx

    Common Brand Names; Adcirca, Cialis, Alyq

    • PAH, PDE-5 Inhibitors; 
    • Phosphodiesterase-5 Enzyme Inhibitors

    Oral, selective phosphodiesterase type 5 (PDE5) inhibitor with longer duration of action
    Used for pulmonary arterial hypertension (PAH), erectile dysfunction (ED), benign prostatic hyperplasia (BPH), or a combination of ED and BPH
    As with other PDE5 inhibitors, contraindicated for use with nitrates because the combination can cause a sudden drop in blood pressure

    Indicated for the treatment of erectile dysfunction (ED).

    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

    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%)

    Hypersensitivity, including Stevens-Johnson syndrome and exfoliative dermatitis

    Soluble guanylate cyclase (sGC) stimulators (eg, riociguat); concomitant use can cause hypotension

    • 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%)
    • Nasal congestion (≤9%)
    • Gastroesophageal reflux disease (1-3%)
    • Hypertension (1-3%)
    • Bronchitis (≤2%)
    • Genitourinary tract infection (≤2%)

    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

    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

    There are no data on presence of drug and/or its metabolites in human milk, effects on breastfed child, or on milk production

    Adults

    40 mg/day PO for pulmonary hypertension; 5 mg/day PO for erectile dysfunction for once daily use; 20 mg/dose PO for erectile dysfunction for as needed use, not to exceed 1 dose/24 hours in most patients; 5 mg/day PO for benign prostatic hyperplasia (BPH) or combined treatment of erectile dysfunction/BPH for once daily use.

    Geriatric

    40 mg/day PO for pulmonary hypertension; 5 mg/day PO for erectile dysfunction for once daily use; 20 mg/dose PO for erectile dysfunction for as needed use, not to exceed 1 dose/24 hours in most patients; 5 mg/day PO for benign prostatic hyperplasia (BPH) or combined treatment of erectile dysfunction/BPH for once daily use.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    Tadalafil 

    tablet (Adcirca, Alyq, generic)

    • 20mg

    tablet (Cialis, generic)

    • 2.5mg
    • 5mg
    • 10mg
    • 20mg