Pulmonary hypertension:

Indications for: ADCIRCA

Pulmonary arterial hypertension (WHO Group I) to improve exercise ability.

Adult Dosage:

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.

Children Dosage:

Not established.

ADCIRCA Contraindications:

Concomitant organic nitrates, guanylate cyclase stimulators (eg, riociguat).

ADCIRCA Warnings/Precautions:

Underlying cardiovascular disease. Preexisting hypotension, autonomic dysfunction, left ventricular outflow obstruction. 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. Nursing mothers.

ADCIRCA Classification:

Phosphodiesterase type 5 inhibitor (cGMP-specific).

ADCIRCA Interactions:

See Contraindications. Hypotension with nitrates; do not use nitrates within 48hrs of the last tadalafil dose. 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 Adult dose).

Adverse Reactions:

Headache, myalgia, nasopharyngitis, flushing, respiratory tract infection, pain, nausea, dyspepsia, sinus congestion; hypotension, sudden vision or hearing loss, priapism, prolonged erection, NAION.

Generic Drug Availability:

YES

How Supplied:

Tabs—60