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ADCIRCA
Pulmonary hypertension
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Drug Name:

ADCIRCA Rx

Generic Name and Formulations:
Tadalafil 20mg; tabs.

Company:
Lilly, Eli and Company

Therapeutic Use:

Indications for ADCIRCA:

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

Adult:

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:

Not established.

Contraindications:

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

Warnings/Precautions:

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.

Interactions:

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).

Pharmacological Class:

Phosphodiesterase type 5 inhibitor (cGMP-specific).

Adverse Reactions:

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

How Supplied:

Tabs—60

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