Classes
DEA Class; Rx
Common Brand Names; Adcirca, Cialis, Alyq
- PAH, PDE-5 Inhibitors;
- Phosphodiesterase-5 Enzyme Inhibitors
Description
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
Indications
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%)
Contraindications
Hypersensitivity, including Stevens-Johnson syndrome and exfoliative dermatitis
Soluble guanylate cyclase (sGC) stimulators (eg, riociguat); concomitant use can cause hypotension
Adverse Effects
- 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%)
Warnings
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
Pregnancy and Lactation
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
Maximum Dosage
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.
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.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Tadalafil
tablet (Adcirca, Alyq, generic)
- 20mg
tablet (Cialis, generic)
- 2.5mg
- 5mg
- 10mg
- 20mg