tadalafil: prescribing and clinical use
Focused clinical detail for use alongside current product information, local policy and patient-specific assessment.
tadalafil: clinical details
Prescribing considerations
- For erectile dysfunction, assess cardiovascular fitness for sexual activity and investigate potentially reversible underlying causes.
- Pulmonary arterial hypertension treatment should be initiated and monitored by a clinician experienced in the condition.
- Review renal and hepatic function because impairment can increase exposure and may make some product uses unsuitable.
- Reconcile nitrates, riociguat, alpha blockers, antihypertensives, CYP3A4 modifiers and other PDE5 inhibitors.
- Discuss urgent reporting of visual or hearing change and priapism.
Contraindications and cautions
- Hypersensitivity to tadalafil or product excipients.
- Any organic nitrate or riociguat use.
- Previous non-arteritic anterior ischaemic optic neuropathy with loss of vision in one eye.
- Myocardial infarction within the previous 90 days or severe hypotension.
- For the selected erectile-dysfunction product: cardiac disease where sexual activity is inadvisable, unstable angina, specified recent heart failure, uncontrolled arrhythmia or hypertension, or stroke within the previous six months.
Monitoring
- Blood pressure and symptoms of hypotension, particularly with antihypertensives or alpha blockers.
- Clinical response and tolerability for the licensed indication.
- Renal and hepatic status where clinically relevant.
- New visual, hearing, cardiovascular or prolonged-erection symptoms.
- Specialist assessment of pulmonary arterial hypertension and signs of clinical worsening or pulmonary oedema.
Clinical pharmacology
Tadalafil is a selective, reversible PDE5 inhibitor. It is absorbed orally, is predominantly metabolised by CYP3A4 and is eliminated mainly as inactive metabolites in faeces, with a smaller urinary contribution. Tablet absorption is not materially affected by food.
Formulation and product differences
- The selected products are film-coated oral tablets containing lactose, but they have different licensed indications and product-specific contraindications and precautions.
- For paediatric pulmonary arterial hypertension, an oral suspension may be used when tablets cannot be swallowed; unlike tablets, its administration is affected by food.
- Tablet appearance, excipients and pack presentation vary by manufacturer and product.
tadalafil preparations and strengths
Tablet
Route: Oral
Strengths: 2.5 mg, 5 mg, 10 mg, 20 mg
tadalafil interactions
Check all prescribed, pharmacy and recreational substances before tadalafil is supplied or prescribed.
Nitrates and nitrate-containing “poppers”
The combination is contraindicated because it can cause a dangerous fall in blood pressure.
Riociguat
Concurrent use is contraindicated because blood-pressure lowering can be excessive.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.