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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
Mechanism of Action
Tadalafil inhibits phosphodiesterase type 5 (PDE5), the enzyme responsible for the degradation of cyclic guanosine monophosphate (cGMP). Pulmonary arterial hypertension is associated with impaired release of nitric oxide by the vascular endothelium and consequent reduction of cGMP concentrations in the pulmonary vascular smooth muscle. PDE5 is the predominant phosphodiesterase in the pulmonary vasculature. Inhibition of PDE5 by tadalafil increases the concentrations of cGMP resulting in relaxation of pulmonary vascular smooth muscle cells and vasodilation of the pulmonary vascular bed.
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) or 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
