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Adcirca Generic Name & Formulations
Legal Class
Rx
General Description
Tadalafil 20mg; tabs.
Pharmacological Class
Phosphodiesterase type 5 inhibitor (cGMP-specific).
How Supplied
Tabs—60
Manufacturer
Generic Availability
YES
Adcirca Indications
Indications
Pulmonary arterial hypertension (WHO Group I) to improve exercise ability.
Adcirca Dosage and Administration
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.
Adcirca Contraindications
Contraindications
Concomitant organic nitrates, guanylate cyclase stimulators (eg, riociguat).
Adcirca Boxed Warnings
Not Applicable
Adcirca Warnings/Precautions
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 Pharmacokinetics
See Literature
Adcirca Interactions
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).
Adcirca Adverse Reactions
Adverse Reactions
Headache, myalgia, nasopharyngitis, flushing, respiratory tract infection, pain, nausea, dyspepsia, sinus congestion; hypotension, sudden vision or hearing loss, priapism, prolonged erection, NAION.
Adcirca Clinical Trials
See Literature
Adcirca Note
Not Applicable
Adcirca Patient Counseling
See Literature
