- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Tablets of vardenafil.
Treatment of erectile dysfunction
In order for vardenafil to be effective, sexual stimulation is required.
10mg taken as needed approximately 25 to 60 minutes prior to sexual activity. The dose may be increased to 20mg or decreased to 5mg based on efficacy and tolerability.
The maximum recommended dose is 20mg and the maximum recommended dosing frequency is once per day.
Patients with Renal Impairment
Creatinine clearance rate less than 30ml/minute
A starting dose of 5mg tablets should be considered. Based on tolerability and efficacy the dose may then be increased.
Patients with Hepatic Impairment
Mild to moderate hepatic impairment (Child-Pugh A to B)
A starting dose of 5mg should be considered in these patients. Based on tolerability and efficacy the subsequent dose may then be increased.
A maximum dose of 10mg is recommended in patients with moderate hepatic impairment (Child-Pugh B).
Children under 18 years
Patients in whom sexual activity is inadvisable
End stage renal disease
Hereditary degenerative retinal disorder
History of non-arteritic anterior ischaemic optic neuropathy (NAION)
Long QT syndrome
New York Heart Association class III failure
New York Heart Association class IV failure
Recent cerebrovascular accident
Recent myocardial infarction
Severe cardiac failure
Severe cardiovascular disorder
Severe hepatic impairment
Torsade de pointes
Precautions and Warnings
Family history of long QT syndrome
Predisposition to priapism
Risk factors for cardiovascular disorder
Anatomical deformation of penis
History of torsade de pointes
Idiopathic hypertrophic subaortic stenosis
Left ventricular outflow obstruction
Mild hepatic impairment
Renal impairment - creatinine clearance below 30 ml/minute
Sickle cell disease
Correct electrolyte disorders before treatment
Advise patient dizziness may affect ability to drive or operate machinery
Advise visual disturbances may affect ability to drive or operate machinery
Concurrent alpha blockers: only initiate therapy when blood pressure stable
Evaluate patients for cardiovascular disease prior to treatment
Advise patient to avoid alpha blockers within 6 hours of dose
Pre-treatment medical history and exam. to diagnose erectile dysfunction
Assess baseline cardiac function prior to treatment
Consider monitoring ECG in patients at risk of QT prolongation
Monitor ECG in patients at risk of QT prolongation
Monitor serum electrolytes
Monitor the elderly for optimum dosing
Advise patient to report any blurred vision or any other eye symptoms
Advise patient to report hearing loss or tinnitus
Discontinue if any kind of visual disturbance occurs
Discontinue if first occurrence or worsening of hearing disturbances
Advise patients not to take nitrates or amyl nitrite concurrently
Advise patient grapefruit products may increase plasma level
Before initiating treatment, physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Vardenafil has vasodilator properties, resulting in mild and transient decreases in blood pressure. Patients with left ventricular outflow obstruction can be sensitive to the action of vasodilators including type 5 phosphodiesterase inhibitors.
Tolerability of the maximum dose of 20mg may be lower in patients over 65 years old. In this patient group a higher frequency of headaches and dizziness was observed than younger patients.
Pregnancy and Lactation
Not indicated in females. At the time of writing there is limited published information regarding the use of vardenafil during pregnancy.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet (www.toxbase.org) or if this is unavailable at the backup site (www.toxbasebackup.org).
Not indicated in females. At the time of writing there is limited published information regarding the use of vardenafil during breastfeeding.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Advise patient that the effect of vardenafil may be delayed if taken with a high fat meal.
Advise patient that consuming grapefruit products will increase plasma concentration of vardenafil.
Advise patients not to take nitrates or amyl nitrite concurrently.
Advise patient to report side effects such as dizziness, visual disturbances and hearing loss.
Advise patient that their ability to drive or operate machinery may be affected.
Creatine phosphokinase increased
Gamma glutamyl transferase (GGT) increased
Increase of liver transaminases
Increased intra-ocular pressure
Non-arteritic anterior ischaemic optic neuropathy (NAION)
Reddening of eyes
Retinal vein occlusion
Sudden death reported
Transient ischaemic attack
Visual field defects
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: December 2017.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 17 January 2020.
The Renal Drug Handbook. Fourth Edition (2014) ed. Ashley, C and Dunleavy, A, Radcliffe Publishing Ltd, London.
Martindale: The Complete Drug Reference. 39th Edition. London: Brayfield A (ed). Pharmaceutical Press; 2017.
Summary of Product Characteristics: Levitra 5mg, 10mg and 20mg film-coated tablets, Bayer PLC. Revised October 2019.
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.