Tadalafil(tah dal’ ah fill)
Adcirca, Cialis
PREGNANCY CATEGORY B
Drug Classes
Impotence drug
Phosphodiesterase-5 inhibitor
Therapeutic Actions
Selectively inhibits cyclic guanosine monophosphate (cGMP) specific phosphodiesterase type 5. The mechanism of penile erection involves the release of nitric oxide into the corpus cavernosum of the penis during sexual stimulation. Nitrous oxide activates cGMP, which causes smooth muscle relaxation allowing the flow of blood into the corpus cavernosum. Tadalafil prevents the breakdown of cGMP by phosphodiesterase, leading to increased cGMP levels and prolonged smooth muscle relaxation, thus promoting the flow of blood into the corpus cavernosum, relaxation of pulmonary muscle cells, and vasodilation of the pulmonary vascular bed.
Indications
Treatment of erectile dysfunction (ED) in the presence of sexual stimulation (Cialis)
Once daily for treatment of ED in men who anticipate having sex more than twice weekly (Cialis)
Treatment of pulmonary arterial hypertension, to improve exercise tolerance (Adcirca)
Treatment of symptoms of BPH; combination therapy for men with both ED and BPH (Cialis)
Unlabeled use: Raynaud phenomenon
Contraindications and Cautions
Contraindicated with allergy to any component of the tablet, concurrent use of nitrates.
Use cautiously with hepatic or renal impairment; with anatomical deformation of the penis, with known cardiac disease (effects of sexual activity need to be evaluated), congenital prolonged QT interval, unstable angina; hypotension (systolic pressure less than 90 mm Hg); uncontrolled hypertension (BP higher than 170/110 mm Hg); concurrent use of alpha blockers; hereditary degenerative retinal disorders; MI in past 3 months; angina during intercourse; stroke in last 6 mo; NYNA class II or greater HF.
Available Forms
Tablets—2.5, 5, 10, 20 mg (Cialis); 20 mg (Adcirca)
Dosages
Adults
ED: 10 mg PO taken before anticipated sexual activity; range 5–20 mg PO. Limit use to once per day. For once-daily use: 2.5 mg/day PO without regard to timing of sexual activity; may be increased to 5 mg/day PO based on patient response.
BPH: 5 mg/day PO.
Pulmonary arterial hypertension: 40 mg/day PO without regard to food, given as a once-daily dose. Do not divide.
Pediatric patients
Not intended for use in children.
Patients receiving itraconazole, ketoconazole, ritonavir other potent CYP3AY inhibitors being treated for ED
Do not exceed one 10-mg dose in 72-hr period.
Patients with renal impairment being treated for ED
For CrCl 31–50 mL/min, initial dose not to exceed 5 mg PO daily or 10 mg PO every 48 hr.; no further adjustment needed for once-daily use. For CrCl less than 30 mL/min, 5 mg PO every 72 hr; once-daily use not recommended (Cialis).
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