Drug reference

Tadalafil

BNF 80 (2020–2021)

Source: BNF 80 (2020–2021)
PDF pages: 882, 883

Review source pages for extracted sections and age labels. BNF dose snippets show only their first line.

Overview

Indications And Dose

Pulmonary arterial hypertension (initiated under specialist supervision) ▶BY MOUTH ▶Adult: 40 mg once daily Erectile dysfunction ▶BY MOUTH ▶Adult: Initially 10 mg (max. per dose 20 mg), to be taken at least 30 minutes before sexual activity, subsequent doses adjusted according to response, the effect of intermittent dosing may persist for longer than 24 hours, continuous daily use not recommended; maximum 1 dose per day Erectile dysfunction; for patients who anticipate sexual activity at least twice a week ▶BY MOUTH ▶Adult: 5 mg once daily, reduced to 2.5 mg once daily, adjusted according to response Benign prostatic hyperplasia ▶BY MOUTH ▶Adult: 5 mg once daily

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Contra Indications

GENERAL CONTRA-INDICATIONS Acute myocardial infarction in past 90 days. history of non-arteritic anterior ischaemic optic neuropathy. hypotension (avoid if systolic blood pressure below 90 mmHg) SPECIFIC CONTRA-INDICATIONS ▶When used for benign prostatic hyperplasia Mild to severe heart failure. patients in whom vasodilation or sexual activity are inadvisable. recent stroke. uncontrolled arrhythmias. uncontrolled hypertension. unstable angina ▶When used for erectile dysfunction Mild to severe heart failure . patients in whom vasodilation or sexual activity are inadvisable. recent stroke. uncontrolled arrhythmias. uncontrolled hypertension. unstable angina

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Cautions

▶When used for benign prostatic hyperplasia or erectile dysfunction Anatomical deformation of the penis (e.g. angulation, cavernosal ﬁbrosis, Peyronie’s disease). cardiovascular disease. left ventricular outﬂow obstruction. predisposition to priapism (e.g. in sickle-cell disease, multiple myeloma, or leukaemia) ▶When used for pulmonary arterial hypertension Anatomical deformation of the penis. aortic and mitral valve disease. congestive cardiomyopathy. coronary artery disease. hereditary degenerative retinal disorders. left ventricular dysfunction. life-threatening arrhythmias. pericardial constriction. predisposition to priapism. pulmonary veno- occlusive disease. uncontrolled hypertension CAUTIONS, FURTHER INFORMATION ▶Elderly For phosphodiesterase type-5 inhibitors, prescription potentially inappropriate (STOPP criteria) in severe heart failure characterised by hypotension i.e. systolic blood pressure less than 90 mmHg, or concurrent nitrate therapy for angina (risk of cardiovascular collapse). See also Prescribing in the elderly p. 33.

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National Funding Access Decisions

Scottish Medicines Consortium (SMC) decisions The Scottish Medicines Consortium has advised (July 2012) that tadalaﬁl (Adcirca ®) is accepted for restricted use within NHS Scotland for adults with pulmonary arterial hypertension and should be initiated only by specialists in the Scottish Pulmonary Vascular Unit or other similar specialists. This advice is contingent upon the continuing availability of the Patient Access Scheme in NHS Scotland. NHS restrictions Cialis ® is not prescribable in NHS primary care for the treatment of erectile dysfunction except in men who meet the criteria listed in part XVIIIB of the Drug Tariff (Part XIb of the Northern Ireland Drug Tariff, Part 12 of the Scottish Drug Tariff). The prescription must be endorsed ’SLS’. For more information see Prices in the BNF, under How to use the BNF.

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Safety

Interactions

→Appendix 1: phosphodiesterase type-5 inhibitors

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Side Effects

▶Common or very common Flushing. gastrointestinal discomfort. headaches. myalgia. nasal congestion. pain ▶Uncommon Arrhythmias. chest pain. dizziness. dyspnoea . eye pain. fatigue. gastrooesophageal reﬂux disease. haemorrhage. hypertension. hypotension. nausea. oedema. palpitations. skin reactions. tinnitus. vision disorders. vomiting ▶Rare or very rare Acute coronary syndrome. angioedema. cerebrovascular insufﬁciency. eye erythema. eye swelling . haematospermia. hyperhidrosis. memory loss. optic neuropathy (discontinue if sudden visual impairment occurs). priapism. retinal occlusion. seizure. Stevens- Johnson syndrome. sudden cardiac death. sudden hearing loss (discontinue drug and seek medical advice). syncope

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Pregnancy

Manufacturer advises avoid.

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Breast Feeding

Manufacturer advises avoid—present in milk in animal studies.

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Hepatic Impairment

▶When used for Pulmonary arterial hypertension Manufacturer advises caution in mild to moderate impairment (limited information available); avoid in severe impairment (no information available). ▶When used for Benign prostatic hyperplasia or Erectile dysfunction Manufacturer advises caution for regular once- daily dosing (no information available), and in severe impairment for intermittent use (limited information available). Dose adjustments ▶When used for Pulmonary arterial hypertension Manufacturer advises consider initial dose reduction to 20 mg once daily in mild to moderate impairment. ▶When used for Erectile dysfunction Manufacturer advises dose of 10 mg for intermittent use (no information available for higher doses).

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Renal Impairment

▶When used for Pulmonary arterial hypertension Manufacturer advises avoid in severe impairment. ▶When used for Erectile dysfunction or Benign prostatic hyperplasia Manufacturer advises avoid regular once-daily dosing in severe impairment. Dose adjustments ▶When used for Pulmonary arterial hypertension Manufacturer advises initial dose of 20 mg once daily in mild-to- moderate impairment; dose may be increased to 40 mg once daily if tolerated. ▶When used for Erectile dysfunction Manufacturer advises maximum dose of 10 mg for intermittent use in severe impairment.

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Dose and formulations

Medicinal Forms

There can be variation in the licensing of different medicines containing the same drug. Genito-urinary system Tablet ▶Tadalafil (Non-proprietary) Tadalafil 2.5 mg Tadalafil 2.5mg tablets | 28 tablet P £54.99 DT = £39.73 Tadalafil 5 mg Tadalafil 5mg tablets | 28 tablet P £54.99 DT = £6.14 Tadalafil 10 mg Tadalafil 10mg tablets | 4 tablet P £28.88 DT = £1.39 Tadalafil 20 mg Tadalafil 20mg tablets | 4 tablet P £54.99 DT = £2.05 | 8 tablet P £3.87–£109.98 | 56 tablet P £283.99– £466.66 ▶Adcirca (Eli Lilly and Company Ltd) Tadalafil 20 mg Adcirca 20mg tablets | 56 tablet P £491.22 ▶Cialis (Eli Lilly and Company Ltd) Tadalafil 2.5 mg Cialis 2.5mg tablets | 28 tablet P £54.99 DT = £39.73 Tadalafil 5 mg Cialis 5mg tablets | 28 tablet P £54.99 DT = £6.14 Tadalafil 10 mg Cialis 10mg tablets | 4 tablet P £28.88 DT = £1.39 Tadalafil 20 mg Cialis 20mg tablets | 4 tablet P £28.88 DT = £2.05 | 8 tablet P £57.76 ▶Talmanco (Mylan) Tadalafil 20 mg Talmanco 20mg tablets | 56 tablet P £417.54 (Hospital only)

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Dose text by age group

Adult

40 mg once daily

First-line fragment. Read the complete Indications and Dose section above.

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Adult

Initially 10 mg (max. per dose 20 mg), to be

First-line fragment. Read the complete Indications and Dose section above.

PDF page 882

Adult

5 mg once daily, reduced to 2.5 mg once daily,

First-line fragment. Read the complete Indications and Dose section above.

PDF page 882

Adult

5 mg once daily

First-line fragment. Read the complete Indications and Dose section above.

PDF page 882

Age labels are extracted for navigation. Check the complete source section and current local guidance before clinical use.

Drug reference

Tadalafil

BNF 80 (2020–2021)

Source: BNF 80 (2020–2021)
PDF pages: 882, 883

Review source pages for extracted sections and age labels. BNF dose snippets show only their first line.

Overview

Indications And Dose

PDF page 882

Contra Indications

PDF page 882

Cautions

PDF pages 882, 883

National Funding Access Decisions

PDF page 883

Safety

Interactions

→Appendix 1: phosphodiesterase type-5 inhibitors

PDF page 883

Side Effects

PDF page 883

Pregnancy

Manufacturer advises avoid.

PDF page 883

Breast Feeding

Manufacturer advises avoid—present in milk in animal studies.

PDF page 883

Hepatic Impairment

PDF page 883

Renal Impairment

PDF page 883

Dose and formulations

Medicinal Forms

PDF page 883

Dose text by age group

Adult

40 mg once daily

First-line fragment. Read the complete Indications and Dose section above.

PDF page 882

Adult

Initially 10 mg (max. per dose 20 mg), to be

First-line fragment. Read the complete Indications and Dose section above.

PDF page 882

Adult

5 mg once daily, reduced to 2.5 mg once daily,

First-line fragment. Read the complete Indications and Dose section above.

PDF page 882

Adult

5 mg once daily

First-line fragment. Read the complete Indications and Dose section above.

PDF page 882

Age labels are extracted for navigation. Check the complete source section and current local guidance before clinical use.