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These medications, known as phosphodiesterase-5 inhibitors, are prescribed for the treatment of erectile dysfinction or pulmonary hypertension and include the medications sildenafil, vardenafil, and tadalafil. Although specific interactions have not been studied, other HIV protease inhibitors would likely increase tadalafil exposure [see Dosage and Administration (2. Ritonavir (200?mg twice daily), increased tadalafil 20-mg single-dose exposure (AUC) by 124% with no change in Cmax, relative to the values for tadalafil 20?mg alone. Ketoconazole (200?mg daily) increased tadalafil 10-mg single-dose exposure (AUC) by 107% and Cmax by 15%, relative to the values for tadalafil 10?mg alone [see Dosage and Administration (2. Studies have shown that drugs that inhibit CYP3A4 can increase tadalafil exposure. Tadalafil did not affect alcohol plasma concentrations and alcohol did not affect tadalafil plasma concentrations. Clinical pharmacology studies have been conducted with coadministration of tadalafil with doxazosin or tamsulosin [see Warnings and Precautions (5. , Rifampin) — Rifampin (600?mg daily), a CYP3A4 inducer, reduced tadalafil 10-mg single-dose exposure (AUC) by 88% and Cmax by 46%, relative to the values for tadalafil 10?mg alone. When administered in combination with aspirin, tadalafil 20?mg did not prolong bleeding time, relative to aspirin alone. Warfarin) — Tadalafil had no significant effect on exposure (AUC) to S-warfarin or R-warfarin, nor did tadalafil affect changes in prothrombin time induced by warfarin. In tadalafil clinical pharmacology trials, back pain or myalgia generally occurred 12 to 24 hours after dosing and typically resolved within 48 hours. In one of two perinatal/postnatal developmental studies in rats, postnatal pup survival decreased following maternal exposure to tadalafil doses greater than 10 times the MRHD based on AUC. The back pain/myalgia associated with tadalafil treatment was characterized by diffuse bilateral lower lumbar, gluteal, thigh, or thoracolumbar muscular discomfort and was exacerbated by recumbancy. Clinical pharmacology studies were conducted to assess the effect of tadalafil on the potentiation of the blood-pressure-lowering effects of selected antihypertensive medications (amlodipine, angiotensin II receptor blockers, bendrofluazide, enalapril, and metoprolol). Small reductions in blood pressure occurred following coadministration of tadalafil with these agents compared with placebo. There are no available data for doses higher than 10?mg of tadalafil in patients with hepatic impairment. The reduced exposure of tadalafil with the coadministration of rifampin or other CYP3A4 inducers can be anticipated to decrease the efficacy of Cialis for once daily use; the magnitude of decreased efficacy is unknown. Theophylline) — Tadalafil had no significant effect on the pharmacokinetics of theophylline. , Ketoconazole) — Ketoconazole (400 mg daily), a selective and potent inhibitor of CYP3A4, increased tadalafil 20?mg single-dose exposure (AUC) by 312% and Cmax by 22%, relative to the values for tadalafil 20?mg alone. Tadalafil is a member of the following drug classes: agents for pulmonary hypertension, impotence agents. Digoxin) — Coadministration of tadalafil (40 mg once per day) for 10 days did not have a significant effect on the steady-state pharmacokinetics of digoxin (0. Although specific interactions have not been studied, other CYP3A4 inducers, such as carbamazepine, phenytoin, and phenobarbital, would likely decrease tadalafil exposure. When tadalafil was administered to subjects taking theophylline, a small augmentation (3 beats per minute) of the increase in heart rate associated with theophylline was observed. Midazolam or Lovastatin) — Tadalafil had no significant effect on exposure (AUC) to midazolam or lovastatin. In a clinical pharmacology study, tadalafil 20?mg resulted in a mean maximal decrease in supine blood pressure, relative to placebo, of 1. Tadalafil is used to treat the following conditions: Erectile Dysfunction, Pulmonary Arterial Hypertension.


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