Indications:

Treatment of pulmonary arterial hypertension (WHO group I) (Adcirca); treatment of erectile dysfunction (Cialis) Unlabeled Uses Raynaud phenomenon

Contraindications:

Administration with nitrates; hypersensitivity to any component.

Adverse reactions:

Cardiovascular Flushing (13%); hypertension (3%); angina pectoris, chest pain, hypotension, MI, palpitations, postural hypotension, syncope, tachycardia (less than 2%); stroke, sudden cardiac death. CNS Headache (42%); asthenia, dizziness, fatigue, hypesthesia, insomnia, paresthesia, somnolence, vertigo (less than 2%); migraine, seizure and seizure recurrence, transient global amnesia. Dermatologic Pruritus, rash, sweating (less than 2%); exfoliative dermatitis, Stevens-Johnson syndrome, urticaria. EENT Nasopharyngitis (13%); nasal congestion (9%); blurred vision, changes in color vision, conjunctivitis including conjunctival hyperemia, epistaxis, eye pain, increased lacrimation, pharyngitis, sudden decrease or loss of hearing, swelling of eyelids, tinnitus (less than 2%); nonarteritic anterior ischemic optic neuropathy, retinal artery occlusion, retinal vein occlusion, visual field defect. GI Dyspepsia (13%); nausea (11%); viral gastroenteritis (5%); gastroesophageal reflux (3%); abdominal pain, diarrhea (2%); dry mouth, dysphagia, esophagitis, gastritis, increased gamma-glutamyl transpeptidase, loose stools, upper abdominal pain, vomiting (less than 2%). Genitourinary UTI (2%); increased erection, spontaneous penile erection (less than 2%); priapism. Hepatic Abnormal LFTs (less than 2%). Musculoskeletal Myalgia (14%); back pain (12%); pain in extremities (11%); limb pain (3%); arthralgia, neck pain (less than 2%). Respiratory Upper and lower respiratory tract infection (13%); cough (4%); bronchitis (2%); dyspnea (less than 2%). Miscellaneous Influenza (5%); face edema, pain (less than 2%).

Interactions:

Alcohol Decreased BP may occur. Risk of orthostatic signs and symptoms, including increased heart rate, decreased standing BP, dizziness, and headache, may be increased. Alpha blockers (eg, doxazosin, tamsulosin) Anticipate additive effects on BP. Use with caution. Antihypertensive agents (eg, amlodipine, angiotensin II receptor blockers [eg, candesartan], enalapril, metoprolol) Decreased BP may occur. CYP3A4 inducers (eg, bosentan, carbamazepine, phenobarbital, phenytoin, rifampin) Plasma levels may be decreased, reducing Tadalafil exposure; however, no dosage adjustment is warranted. Avoid use of Tadalafil with potent CYP3A4 inducers. CYP3A4 inhibitors (eg, itraconazole, ketoconazole, ritonavir, serotonin reuptake inhibitors [eg, fluoxetine, fluvoxamine]) Tadalafil plasma concentrations may be elevated, increasing the risk of adverse reactions. The Cialis dosage should not exceed 10 mg once every 72 h for as-needed use or 2.5 mg daily for once-daily use. Avoid use of Adcirca during the initiation of ritonavir and for at least 1 wk. Restart Tadalafil at 20 mg once daily. Avoid use of Tadalafil with other potent CYP3A4 inhibitors. Nitrates Coadministration is contraindicated withTadalafil . In life-threatening situations where nitrate administration is deemed medically necessary, allow at least 48 h to elapse after the last dose of Adcirca before nitrate administration is considered.

Warnings:

Pregnancy Category B . Lactation Undetermined. Children Safety and efficacy not established. Elderly No dosage adjustments are needed based on age alone; a greater sensitivity to medications in some older individuals should be considered. Renal Function Start Adcirca at 20 mg in patients with mild to moderate renal impairment; not recommended in those with severe renal impairment. Dosage adjustment may be needed in patients with severe renal impairment who are taking Cialis on an as-needed basis. Once-daily use is not recommended. Hepatic Function Start Adcirca at 20 mg in patients with mild to moderate hepatic impairment; not recommended in those with severe hepatic impairment. Dosage adjustment may be needed in patients with hepatic impairment who are taking Cialis on an as-needed basis. Caution is advised for once-daily use. Use is not recommended in patients with severe hepatic impairment. Special Risk Patients Because there are no clinical data on safety and efficacy, use is not recommended in patients with unstable angina or angina occurring during sexual intercourse, MI within last 90 days, New York Heart Association class II or higher heart failure in last 6 mo, uncontrolled arrhythmias, hypotension, uncontrolled hypertension, stroke within last 6 mo, clinically significant aortic or mitral valve disease, pericardial constriction, restrictive or congestive cardiomyopathy, significant left ventricular dysfunction, symptomatic coronary artery disease, pulmonary veno-occlusive disease, or hereditary degenerative retinal disorder (eg, retinitis pigmentosa). Bleeding disorders/active peptic ulceration Safety of tadalafil is unknown in patients with bleeding disorders or active peptic ulceration. CV risk Evaluate CV status and left ventricular outflow obstruction (eg, aortic stenosis) before treatment. Hearing loss Sudden decrease or loss of hearing, which may be accompanied by tinnitus and dizziness, has been reported. Other erectile dysfunction therapy Combined use with tadalafil is not recommended. Priapism Prolonged erections, exceeding 4 h, may occur and require immediate medical attention. Use with caution in patients with conditions that may predispose them to priapism (eg, sickle cell anemia, multiple myeloma, leukemia), or in patients with anatomical deformation of the penis (eg, angulation, cavernosal fibrosis, Peyronie disease). Vision Sudden decrease in or loss of vision in 1 or both eyes has been reported in postmarketing experience. Visual loss may be permanent.

Form:

COATED TABLET