Individual generic drug information

tadalafil

Reference monograph

Part of registered formulation

TADALAFIL

Reference record: Tadalafil
Source: BNF 80 (2020–2021)
Printed source pages: 882, 883
Age groups indexed: 1

Individual active ingredientSource records are displayed separately

Some source sections could not be separated reliably in the extraction. Review the printed source pages when a field is missing or incomplete.

Overview

Extracted information for Tadalafil only.

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

Source page 882

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

Source page 882

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.

Source pages 882, 883

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.

Source page 883

Safety

Extracted information for Tadalafil only.

Interactions

→Appendix 1: phosphodiesterase type-5 inhibitors

Source page 883

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

Source page 883

Pregnancy

Manufacturer advises avoid.

Source page 883

Breast Feeding

Manufacturer advises avoid—present in milk in animal studies.

Source page 883

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).

Source page 883

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.

Source page 883

Dose and formulations

Extracted information for Tadalafil only.

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)

Source page 883

Dose text by age group

Filter the extracted dose blocks for this individual drug.

Adults

First line only; read the complete Indications and dose section above.

40 mg once daily

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 882

Adults

First line only; read the complete Indications and dose section above.

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

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 882

Adults

First line only; read the complete Indications and dose section above.

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

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 882

Adults

First line only; read the complete Indications and dose section above.

5 mg once daily

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 882

Age labels are extracted from the printed dose headings and require clinical review. Confirm current local guidance, dose, route, formulation, contraindications and interactions before prescribing.

Individual generic drug information

tadalafil

Reference monograph

Part of registered formulation

TADALAFIL

Reference record: Tadalafil
Source: BNF 80 (2020–2021)
Printed source pages: 882, 883
Age groups indexed: 1

Individual active ingredientSource records are displayed separately

Some source sections could not be separated reliably in the extraction. Review the printed source pages when a field is missing or incomplete.

Overview

Extracted information for Tadalafil only.

Indications And Dose

Source page 882

Contra Indications

Source page 882

Cautions

Source pages 882, 883

National Funding Access Decisions

Source page 883

Safety

Extracted information for Tadalafil only.

Interactions

→Appendix 1: phosphodiesterase type-5 inhibitors

Source page 883

Side Effects

Source page 883

Pregnancy

Manufacturer advises avoid.

Source page 883

Breast Feeding

Manufacturer advises avoid—present in milk in animal studies.

Source page 883

Hepatic Impairment

Source page 883

Renal Impairment

Source page 883

Dose and formulations

Extracted information for Tadalafil only.

Medicinal Forms

Source page 883

Dose text by age group

Filter the extracted dose blocks for this individual drug.

Adults

First line only; read the complete Indications and dose section above.

40 mg once daily

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 882

Adults

First line only; read the complete Indications and dose section above.

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

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 882

Adults

First line only; read the complete Indications and dose section above.

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

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 882

Adults

First line only; read the complete Indications and dose section above.

5 mg once daily

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 882

Age labels are extracted from the printed dose headings and require clinical review. Confirm current local guidance, dose, route, formulation, contraindications and interactions before prescribing.