Formulary
Vardenafil: Indications, Dosing, Side Effects and Interactions
Vardenafil clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 4 min read
Vardenafil: Indications, Dosing, Side Effects and Interactions
Vardenafil clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Erectile dysfunction**
- **Adult** (By Mouth Using Tablets): 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.
- **Adult** (By Mouth Using Orodispersible Tablet): 10 mg, to be taken approximately 25-60 minutes before sexual activity; maximum 10 mg per day.
**Erectile dysfunction (patients on alpha-blocker therapy)**
- **Adult** (By Mouth Using Tablets): 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.
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, Screening Tool of Older Persons' potentially inappropriate Prescriptions (STOPP) criteria to aid medication reviews (see Prescribing in the elderly for information): potentially inappropriate 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).
Contraindications
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
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
Interactions
**Severe interactions:**
- Ritonavir significantly prolonged the half-life of vardenafil to 25.7 hours (see section 4.3).
- Due to the nitrate component it has the potential to have serious interaction with vardenafil.
- In two interaction studies with healthy normotensive volunteers after forced titration of the alpha-blockers tamsulosin or terazosin to high doses, hypotension (in some cases symptomatic) was...
- No significant interactions were shown when warfarin (25 mg), which is metabolised by CYP2C9, or digoxin (0.375 mg) was co-administered with vardenafil (20 mg tablets).
**Other interactions (34):**
- Effects of other medicinal products on vardenafil In vitro studies Vardenafil is metabolised predominantly by hepatic enzymes via cytochrome P450 (CYP) isoform 3A4, with some contribution from...
- Therefore, inhibitors of these isoenzymes may reduce vardenafil clearance.
- In vivo studies Co-administration of the HIV protease inhibitor indinavir (800 mg three times a day), a potent CYP3A4 inhibitor, with vardenafil (10 mg tablet) resulted in a 16-fold increase in...
- At 24 hours, the plasma levels of vardenafil had fallen to approximately 4% of the maximum vardenafil plasma level (Cmax).
- Co-administration of vardenafil with ritonavir (600 mg twice daily) resulted in a 13-fold increase in vardenafil Cmax and a 49-fold increase in vardenafil AUC0-24 when co-administered with...
- The interaction is a consequence of blocking hepatic metabolism of vardenafil by ritonavir, a highly potent CYP3A4 inhibitor, which also inhibits CYP2C9.
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.
Renal impairment
Dose adjustments Consider initial dose of 5 mg if creatinine clearance less than 30 mL/minute; orodispersible tablets not suitable for initial doses. M See Prescribing in renal impairment .
Medicinal forms
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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