Individual generic drug information

sildenafil

Reference monograph

Part of registered formulation

SILDENAFIL

Reference record: Sildenafil
Source: BNF 80 (2020–2021)
Printed source pages: 881, 882
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 Sildenafil only.

Indications And Dose

Pulmonary arterial hypertension (initiated under specialist supervision) ▶BY MOUTH ▶Adult: 20 mg 3 times a day ▶BY INTRAVENOUS INJECTION ▶Adult: 10 mg 3 times a day, use intravenous route when the oral route is not appropriate Erectile dysfunction ▶BY MOUTH ▶Adult: Initially 50 mg, to be taken approximately 1 hour before sexual activity, adjusted according to response to 25–100 mg (max. per dose 100 mg) as required, to be taken as a single dose; maximum 1 dose per day Digital ulcers [associated with systemic sclerosis] ▶BY MOUTH ▶Adult: 25 mg 3 times a day, increased to 50 mg 3 times a day

Source page 881

Dose Adjustments

DUE TO INTERACTIONS ▶When used for Erectile dysfunction Manufacturer advises a starting dose of 25 mg with concurrent use of moderate and potent inhibitors of CYP3A4. Manufacturer advises if concurrent use of ritonavir is unavoidable, the max. dose should not exceed 25 mg within 48 hours. ▶With oral use for Pulmonary arterial hypertension Manufacturer advises reduce dose to 20 mg twice daily with concurrent use of moderate inhibitors of CYP3A4. Manufacturer advises reduce dose to 20 mg once daily with concurrent use of some potent inhibitors of CYP3A4 (avoid with ketoconazole, itraconazole and ritonavir). ▶With intravenous use for Pulmonary arterial hypertension Manufacturer advises reduce dose to 10 mg twice daily with concurrent use of moderate inhibitors of CYP3A4. Manufacturer advises reduce dose to 10 mg once daily with concurrent use of some potent inhibitors of CYP3A4 (avoid with ketoconazole, itraconazole and ritonavir). l UNLICENSED USE g Sildenaﬁl is used for the treatment of digital ulcer, l but is not licensed for this indication. Genito-urinary system

Source page 881

Contra Indications

GENERAL CONTRA-INDICATIONS Hereditary degenerative retinal disorders. history of non- arteritic anterior ischaemic optic neuropathy. recent history of myocardial infarction. recent history of stroke SPECIFIC CONTRA-INDICATIONS ▶When used for erectile dysfunction Avoid if systolic blood pressure below 90 mmHg (no information available). patients in whom vasodilation or sexual activity are inadvisable. recent unstable angina ▶When used for pulmonary arterial hypertension Sickle-cell anaemia

Source page 881

Cautions

GENERAL CAUTIONS Active peptic ulceration. anatomical deformation of the penis (e.g. angulation, cavernosal ﬁbrosis, Peyronie’s disease). autonomic dysfunction. bleeding disorders. cardiovascular disease. left ventricular outﬂow obstruction. predisposition to priapism (e.g. in sickle-cell disease, multiple myeloma, or leukaemia) SPECIFIC CAUTIONS ▶When used for pulmonary arterial hypertension Hypotension (avoid if systolic blood pressure below 90 mmHg). intravascular volume depletion. pulmonary veno- occlusive disease 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 page 881

National Funding Access Decisions

Scottish Medicines Consortium (SMC) decisions The Scottish Medicines Consortium has advised (February 2010) that sildenaﬁl tablets (Revatio ®) is accepted for restricted use within NHS Scotland and should be initiated for patients with pulmonary arterial hypertension only by specialists in the Scottish Pulmonary Vascular Unit or other similar specialists. The Scottish Medicines Consortium has advised (March 2011) that sildenaﬁl injection (Revatio ®) is accepted for restricted use within NHS Scotland for patients with pulmonary arterial hypertension who are currently prescribed oral sildenaﬁl and are temporarily unable to take oral medicine, and should be prescribed only on the advice of specialists in the Scottish Pulmonary Vascular Unit or the Scottish Adult Congenital Cardiac Service. Viagra ® is not prescribable in NHS NHS restrictions primary care for 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 882

Safety

Extracted information for Sildenafil only.

Interactions

→Appendix 1: phosphodiesterase type-5 inhibitors

Source page 881

Side Effects

▶Common or very common Alopecia. anaemia. anxiety. cough. diarrhoea. dizziness. ﬂuid retention. gastrointestinal discomfort. gastrointestinal disorders. headaches. increased risk of infection. insomnia. nasal complaints. nausea. night sweats. pain. skin reactions. tremor. vasodilation. vision disorders ▶Uncommon Arrhythmias. chest pain. drowsiness. dry eye. dry mouth. eye discomfort. eye disorders. eye inﬂammation. fatigue. feeling hot. gynaecomastia. haemorrhage. hypertension. hypotension. myalgia. numbness. palpitations. sinus congestion. tinnitus. vertigo. vomiting ▶Rare or very rare Acute coronary syndrome. arteriosclerotic retinopathy. cerebrovascular insufﬁciency . glaucoma. haematospermia. hearing impairment. irritability. optic neuropathy (discontinue if sudden visual impairment occurs). oral hypoaesthesia. priapism. retinal occlusion. scleral discolouration. seizure. severe cutaneous adverse reactions (SCARs). sudden cardiac death. syncope. throat tightness

Source page 881

Pregnancy

Use only if potential beneﬁt outweighs risk— no evidence of harm in animal studies.

Source page 881

Breast Feeding

Manufacturer advises avoid—no information available.

Source page 881

Hepatic Impairment

Manufacturer advises caution in mild to moderate impairment; avoid in severe impairment (no information available). Dose adjustments ▶With intravenous use for Pulmonary arterial hypertension Manufacturer advises if usual dose not tolerated, consider dose reduction to 10 mg twice daily in mild to moderate impairment. ▶With oral use for Pulmonary arterial hypertension Manufacturer advises if usual dose not tolerated, consider dose reduction to 20 mg twice daily in mild to moderate Genito-urinary system impairment. ▶When used for Erectile dysfunction Manufacturer advises consider initial dose reduction to 25 mg in mild to moderate impairment; adjust according to response.

Source page 882

Renal Impairment

Dose adjustments Use initial dose of 25 mg in erectile dysfunction if eGFR less than 30 mL/minute/1.73 m2. In pulmonary hypertension, if usual dose not tolerated, reduce oral dose to 20 mg twice daily and intravenous dose to 10 mg twice daily.

Source page 882

Dose and formulations

Extracted information for Sildenafil only.

Medicinal Forms

There can be variation in the licensing of different medicines containing the same drug. Forms available from special-order manufacturers include: oral suspension, oral solution, pessary Tablet ▶Sildenafil (Non-proprietary) Sildenafil (as Sildenafil citrate) 20 mg Sildenafil 20mg tablets | 90 tablet P £424.01–£446.33 DT = £446.33 Sildenafil (as Sildenafil citrate) 25 mg Sildenafil 25mg tablets | 4 tablet P £16.59 DT = £0.90 | 8 tablet P £1.73–£33.19 Sildenafil (as Sildenafil citrate) 50 mg Sildenafil 50mg tablets | 4 tablet P £21.27 DT = £1.02 | 8 tablet P £1.26–£42.54 Sildenafil (as Sildenafil citrate) 100 mg Sildenafil 100mg tablets | 4 tablet P £23.50 DT = £1.09 | 8 tablet P £1.44–£46.99 ▶Granpidam (Accord Healthcare Ltd) Sildenafil (as Sildenafil citrate) 20 mg Granpidam 20mg tablets | 90 tablet P £424.01 DT = £446.33 ▶Mysildecard (Mylan) Sildenafil (as Sildenafil citrate) 20 mg Mysildecard 20mg tablets | 90 tablet P £379.38 DT = £446.33 ▶Revatio (Upjohn UK Ltd) Sildenafil (as Sildenafil citrate) 20 mg Revatio 20mg tablets | 90 tablet P £446.33 DT = £446.33 ▶Viagra (Upjohn UK Ltd, Pfizer Consumer Healthcare Ltd) Sildenafil (as Sildenafil citrate) 25 mg Viagra 25mg tablets | 4 tablet P £16.59 DT = £0.90 | 8 tablet P £33.19 Sildenafil (as Sildenafil citrate) 50 mg Viagra 50mg tablets | 4 tablet P £21.27 DT = £1.02 | 8 tablet P £42.54 Sildenafil (as Sildenafil citrate) 100 mg Viagra 100mg tablets | 4 tablet P £23.50 DT = £1.09 | 8 tablet P £46.99 ▶Vizarsin (Consilient Health Ltd) Sildenafil (as Sildenafil citrate) 25 mg Vizarsin 25mg tablets | 4 tablet P £14.10 DT = £0.90 Sildenafil (as Sildenafil citrate) 50 mg Vizarsin 50mg tablets | 4 tablet P £18.07 DT = £1.02 Sildenafil (as Sildenafil citrate) 100 mg Vizarsin 100mg tablets | 4 tablet P £19.97 DT = £1.09 Solution for injection ▶Revatio (Upjohn UK Ltd) Sildenafil (as Sildenafil citrate).8 mg per 1 ml Revatio 10mg/12.5ml solution for injection vials | 1 vial P £45.28 (Hospital only) Oral suspension ▶Revatio (Upjohn UK Ltd) Sildenafil (as Sildenafil citrate) 10 mg per 1 ml Revatio 10mg/ml oral suspension sugar-free | 112 ml P £186.75 DT = £186.75

Source page 882

Clinical care

Extracted information for Sildenafil only.

Treatment Cessation

▶When used for Pulmonary arterial hypertension Consider gradual withdrawal.

Source page 882

Patient And Carer Advice

▶When used for Erectile dysfunction Onset of effect may be delayed if taken with food.

Source page 882

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.

20 mg 3 times a day

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

Candidate age grouping · source page 881

Adults

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

10 mg 3 times a day, use intravenous route when

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

Candidate age grouping · source page 881

Adults

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

Initially 50 mg, to be taken approximately 1 hour

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

Candidate age grouping · source page 881

Adults

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

25 mg 3 times a day, increased to 50 mg 3 times

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

Candidate age grouping · source page 881

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

sildenafil

Reference monograph

Part of registered formulation

SILDENAFIL

Reference record: Sildenafil
Source: BNF 80 (2020–2021)
Printed source pages: 881, 882
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 Sildenafil only.

Indications And Dose

Source page 881

Dose Adjustments

Source page 881

Contra Indications

Source page 881

Cautions

Source page 881

National Funding Access Decisions

Source page 882

Safety

Extracted information for Sildenafil only.

Interactions

→Appendix 1: phosphodiesterase type-5 inhibitors

Source page 881

Side Effects

Source page 881

Pregnancy

Use only if potential beneﬁt outweighs risk— no evidence of harm in animal studies.

Source page 881

Breast Feeding

Manufacturer advises avoid—no information available.

Source page 881

Hepatic Impairment

Source page 882

Renal Impairment

Source page 882

Dose and formulations

Extracted information for Sildenafil only.

Medicinal Forms

Source page 882

Clinical care

Extracted information for Sildenafil only.

Treatment Cessation

▶When used for Pulmonary arterial hypertension Consider gradual withdrawal.

Source page 882

Patient And Carer Advice

▶When used for Erectile dysfunction Onset of effect may be delayed if taken with food.

Source page 882

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.

20 mg 3 times a day

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

Candidate age grouping · source page 881

Adults

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

10 mg 3 times a day, use intravenous route when

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

Candidate age grouping · source page 881

Adults

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

Initially 50 mg, to be taken approximately 1 hour

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

Candidate age grouping · source page 881

Adults

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

25 mg 3 times a day, increased to 50 mg 3 times

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

Candidate age grouping · source page 881

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.