Tadalafil is a selective, reversible inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). When sexual stimulation causes the local release of nitric oxide; inhibition of PDE5 by Tadalafil produces increased levels of cGMP in the corpus cavernosum. This results in smooth muscle relaxation and inflow of blood into the penile tissues, thereby producing an erection. Tadalafil has no effect in the absence of sexual stimulation.
Treatment of erectile dysfunction, benign prostatic hyperplasia and erectile dysfunction with benign prostatic hyperplasia.
Dosage & Administration:
Erectile dysfunction: For oral use. In order for Tadalafil to be effective, sexual stimulation is required.
Use in adult men: The recommended dose is 10 mg taken prior to anticipated sexual activity and without regard to food. In those patients in whom Tadalafil 10 mg does not produce an adequate effect, 20 mg might be tried. It can be taken from 30 minutes to 12 hours prior to sexual activity. Efficacy of Tadalafil may persist up to 24 hours post-dose. The maximum recommended dosing frequency is once per day.
Benign prostatic hyperplasia: 5 mg, taken at approximately the same time every day.
Erectile dysfunction with benign prostatic hyperplasia: 5 mg, taken at approximately the same time every day.
Use in elderly men: Dosage adjustments are not required in elderly patients.
Use in men with impaired renal function: There are no available data about the administration of doses higher than 10 mg of Tadalafil to patients with renal impairment.
Use in men with impaired hepatic function: There are no available data about the administration of doses higher than 10 mg of Tadalafil to patients with hepatic impairment.
Use in men with diabetes: Dosage adjustments are not required in diabetic patients.
Use in children: Tadalafil should not be used in individuals below 18 years of age.
The most commonly reported adverse reactions are headache, dizziness, flushing and dyspepsia, nasal congestion, back pain, myalgia, swelling of eyelids is uncommon adverse reactions. The adverse events reported with Tadalafil were transient, and generally mild or moderate.
Tadalafil should not be used in patients with hypersensitivity to Tadalafil or to any of the excipients. In clinical studies, Tadalafil was shown to augment the hypotensive effects of nitrates. This is thought to result from the combined effects of nitrates and Tadalafil on the nitric oxide/cGMP pathway. Therefore, administration of Tadalafil to patients who are using any form of organic nitrate is contra-indicated. Agents for the treatment of erectile dysfunction, including Tadalafil, should not be used in men with cardiac disease for whom sexual activity is inadvisable. Physicians should consider the potential cardiac risk of sexual activity in patients with pre-existing cardiovascular disease.
The following groups of patients with cardiovascular disease were not included in clinical trials and the use of Tadalafil is therefore contra-indicated:
• Patients with myocardial infarction within the last 90 days.
• Patients with unstable angina or angina occurring during sexual intercourse.
• Patients with uncontrolled arrhythmias, hypotension (<90/50 mmHg) or uncontrolled hypertension.
• Patients with a stroke within the last 6 months.