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Common extrinsic factors appear to exert no influence on the pharmacokinetics
of tadalafil. For example, in a clinical pharmacology study
conducted in 18 healthy subjects, on the effect of food on tadalafil absorption,
the mean plasma tadalafil concentration was similar among subjects
who received a single 20-mg dose of tadalafil after eating a high-fat
meal and among subjects who fasted, indicating that tadalafil may be
taken with or without food. This study also demonstrated that the presence
of high-fat food affects neither the rate nor the extent of tadalafil
absorption.
Other drug interactions do exert influence on the pharmacokinetics of
tadalafil. For example, since tadalafil is metabolized predominantly by
CYP3A4 in the liver, the dosage should be limited to 10 mg not more than
once every 72 h in patients taking potent inhibitors of CYP3A4, such as
ritonavir and ketoconazole. In addition, drugs that induce CYP3A4, such
as rifampin (600 mg daily), reduce tadalafil exposure. Although specific
interactions have not been studied, other CYP3A4 inducers, such as carbamazepine,
phenytoin, and phenobarbital, would likely decrease tadalafil
exposure. No dose adjustment is warranted, however.
In addition, tadalafil did not potentiate the increase in bleeding time
caused by aspirin. Simultaneous administration of an antacid (magnesium hydroxide/aluminum hydroxide) and tadalafil reduced the apparent rate of
absorption of tadalafil without altering exposure AUC to tadalafil, and no
dose adjustment is warranted.

Studies conducted in 421 men, either healthy or with mild ED, have
found no evidence that tadalafil has adverse effects on spermatogenesis.
Tadalafil had no clinically relevant effect on sperm concentration, sperm
count per ejaculate, sperm motility, or sperm morphology. Similarly,
tadalafil has no effect on serum levels of testosterone, luteinizing hormone,
or follicle-stimulating hormone.

Studies conducted in 421 men, either healthy or with mild ED, have
found no evidence that tadalafil has adverse effects on spermatogenesis.
Tadalafil had no clinically relevant effect on sperm concentration, sperm
count per ejaculate, sperm motility, or sperm morphology. Similarly,
tadalafil has no effect on serum levels of testosterone, luteinizing hormone,
or follicle-stimulating hormone.