Generic Name and Formulations:
Tadalafil 20mg; tabs.
Lilly, Eli and Company
Indications for ADCIRCA:
Pulmonary arterial hypertension (WHO Group I) to improve exercise ability.
40mg once daily. CrCl 31–80mL/min: initially 20mg once daily, increase to 40mg once daily if tolerated. CrCl <30mL/min: not recommended. Mild or moderate hepatic cirrhosis (Child Pugh Class A or B): initially 20mg once daily. Severe hepatic cirrhosis (Child Pugh Class C): not recommended. Use with ritonavir: patients receiving ritonavir (for at least 1 week): initiate tadalafil at 20mg once daily, may increase to 40mg once daily if tolerated; patients already on tadalafil: stop tadalafil at least 24hrs prior to initiating ritonavir; resume tadalafil at 20mg once daily after at least 1 week; may increase to 40mg once daily if tolerated.
Concomitant organic nitrates, guanylate cyclase stimulators (eg, riociguat).
Cardiovascular disease (eg, clinically significant aortic and mitral valve disease, pericardial constriction, restrictive or congestive cardiomyopathy, left ventricular dysfunction, life-threatening arrhythmias, symptomatic coronary artery disease, hypotension [<90/50mmHg], uncontrolled hypertension), impaired autonomic BP control. Pulmonary veno-occlusive disease, severe renal and hepatic impairment, hereditary degenerative retinal disorders including retinitis pigmentosa: not recommended. Monitor for pulmonary edema. Anatomical penile deformation. Predisposition to priapism. History of non-arteritic anterior ischemic optic neuropathy (NAION). "Crowded" optic disc. Bleeding disorders. Active peptic ulcer. Pregnancy (Cat.B). Nursing mothers.
See Contraindications. Hypotension with nitrates; allow at least 48hrs to elapse after last tadalafil dose before taking nitrates; administer nitrates under close supervision if taken within 48hrs of tadalafil for anginal chest pain. Avoid concomitant potent CYP3A inhibitors (eg, ketoconazole, itraconazole) and potent CYP3A inducers (eg, rifampin). Concomitant α-blockers (eg, doxazosin, alfuzosin, tamsulosin), alcohol may cause symptomatic hypotension. Concomitant other tadalafil products (eg, Cialis) or PDE5 inhibitors: not recommended. Caution with ritonavir (see Dose).
Phosphodiesterase type 5 inhibitor (cGMP-specific).
Headache, myalgia, nasopharyngitis, flushing, respiratory tract infection, pain, nausea, dyspepsia, sinus congestion; hypotension, sudden vision or hearing loss, priapism, prolonged erection, NAION.