Drug reference

Vardenafil

BNF 80 (2020–2021)

Source: BNF 80 (2020–2021)
PDF pages: 883, 884

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

Overview

Indications And Dose

Erectile dysfunction ▶BY MOUTH USING TABLETS ▶Adult: Initially 10 mg (max. per dose 20 mg), to be taken approximately 25–60 minutes before sexual activity, subsequent doses adjusted according to response, onset of effect may be delayed if taken with high-fat meal; maximum 1 dose per day ▶BY MOUTH USING ORODISPERSIBLE TABLET ▶Adult: 10 mg, to be taken approximately 25–60 minutes before sexual activity; maximum 10 mg per day Erectile dysfunction (patients on alpha-blocker therapy) ▶BY MOUTH USING TABLETS ▶Adult: Initially 5 mg (max. per dose 20 mg), to be taken approximately 25–60 minutes before sexual activity, subsequent doses adjusted according to response, onset of effect may be delayed if taken with high-fat meal; maximum 1 dose per day DOSE EQUIVALENCE AND CONVERSION ▶Levitra ® 10 mg orodispersible tablets and Levitra ® 10 mg ﬁlm coated tablets are not bioequivalent.

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Contra Indications

Avoid if systolic blood pressure below 90 mmHg. hereditary degenerative retinal disorders . myocardial infarction. patients in whom vasodilation or sexual activity are inadvisable. previous history of non- arteritic anterior ischaemic optic neuropathy. recent stroke. unstable angina

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Cautions

Active peptic ulceration. anatomical deformation of the penis (e.g. angulation, cavernosal ﬁbrosis, Peyronie’s disease). bleeding disorders. cardiovascular disease. elderly. left ventricular outﬂow obstruction. predisposition to priapism (e.g. in sickle-cell disease, multiple myeloma, or leukaemia). susceptibility to prolongation of QT interval 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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Prescribing And Dispensing Information

Orodispersible tablets not suitable for initiation of therapy in patients taking alpha-blockers.

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National Funding Access Decisions

Scottish Medicines Consortium (SMC) decisions The Scottish Medicines Consortium has advised (October 2011) that vardenaﬁl orodispersible tablets (Levitra ®) are accepted for restricted use within NHS Scotland for treatment of erectile dysfunction in men for whom an orodispersible tablet is an appropriate formulation. NHS restrictions Levitra ® 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 Genito-urinary system

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Side Effects

▶Common or very common Dizziness. ﬂushing. gastrointestinal discomfort. headache. nasal congestion ▶Uncommon Allergic oedema. angioedema. arrhythmias. back pain. diarrhoea. drowsiness. dry mouth. dyspnoea. eye discomfort. eye disorders. gastrointestinal disorders. malaise. muscle complaints. muscle tone increased. nausea. palpitations. sensation abnormal. sinus congestion. skin reactions. sleep disorder. tinnitus. vertigo. vision disorders. vomiting ▶Rare or very rare Angina pectoris. anxiety. chest pain. conjunctivitis. haemorrhage. hypertension. hypotension. memory loss. myocardial infarction. photosensitivity reaction. priapism. seizure. syncope ▶Frequency not known Haematospermia. optic neuropathy (discontinue if sudden visual impairment occurs). QT interval prolongation. sudden hearing loss

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Hepatic Impairment

For ﬁlm-coated tablets, manufacturer advises caution in mild to moderate impairment; avoid in severe impairment. For orodispersible tablets, manufacturer advises caution in mild impairment; avoid in moderate to severe impairment. Dose adjustments For ﬁlm-coated tablets, manufacturer advises initial dose reduction to 5 mg in mild to moderate impairment, increase according to response; max. 10 mg in moderate impairment. For orodispersible tablets, manufacturer advises initial dose reduction to 5 mg using ﬁlm-coated tablets in mild impairment, increase according to response.

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Renal Impairment

Orodispersible tablets not suitable if eGFR less than 30 mL/minute/1.73 m2. Dose adjustments Initial dose 5 mg if eGFR less than 30 mL/minute/1.73 m2.

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Dose and formulations

Medicinal Forms

There can be variation in the licensing of different medicines containing the same drug. Orodispersible tablet EXCIPIENTS: May contain Aspartame ▶Levitra (Bayer Plc) Vardenafil (as Vardenafil hydrochloride trihydrate) 10 mg Levitra 10mg orodispersible tablets sugar-free | 4 tablet P £19.67 DT = £19.67 Tablet ▶Vardenafil (Non-proprietary) Vardenafil (as Vardenafil hydrochloride trihydrate) 5 mg Vardenafil 5mg tablets | 4 tablet P £11.35 DT = £11.35 | 8 tablet P £12.70–£22.69 Vardenafil (as Vardenafil hydrochloride trihydrate) 10 mg Vardenafil 10mg tablets | 4 tablet P £20.03 DT = £20.02 | 8 tablet P £26.61–£40.03 Vardenafil (as Vardenafil hydrochloride trihydrate) 20 mg Vardenafil 20mg tablets | 4 tablet P £35.20 DT = £13.47 | 8 tablet P £42.52–£70.40 ▶Levitra (Bayer Plc) Vardenafil (as Vardenafil hydrochloride trihydrate) 5 mg Levitra 5mg tablets | 4 tablet P £8.32 DT = £11.35 Vardenafil (as Vardenafil hydrochloride trihydrate) 10 mg Levitra 10mg tablets | 4 tablet P £14.78 DT = £20.02 | 8 tablet P £29.57 Vardenafil (as Vardenafil hydrochloride trihydrate) 20 mg Levitra 20mg tablets | 4 tablet P £24.30 DT = £13.47 | 8 tablet P £48.60 PROSTAGLANDINS AND ANALOGUES

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Dose text by age group

Adult

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

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

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Adult

10 mg, to be taken approximately

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

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Adult

Initially 5 mg (max. per dose 20 mg), to be taken

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

PDF page 883

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

Drug reference

Vardenafil

BNF 80 (2020–2021)

Source: BNF 80 (2020–2021)
PDF pages: 883, 884

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

Overview

Indications And Dose

PDF page 883

Contra Indications

PDF page 883

Cautions

PDF pages 883, 884

Prescribing And Dispensing Information

Orodispersible tablets not suitable for initiation of therapy in patients taking alpha-blockers.

PDF page 884

National Funding Access Decisions

PDF page 884

Safety

Interactions

→Appendix 1: phosphodiesterase type-5 inhibitors Genito-urinary system

PDF page 884

Side Effects

PDF page 884

Hepatic Impairment

PDF page 884

Renal Impairment

Orodispersible tablets not suitable if eGFR less than 30 mL/minute/1.73 m2. Dose adjustments Initial dose 5 mg if eGFR less than 30 mL/minute/1.73 m2.

PDF page 884

Dose and formulations

Medicinal Forms

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Dose text by age group

Adult

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

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

PDF page 883

Adult

10 mg, to be taken approximately

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

PDF page 883

Adult

Initially 5 mg (max. per dose 20 mg), to be taken

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

PDF page 883

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