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Vardenafil tablets

Updated 2 Feb 2023 | Erectile dysfunction

Presentation

Tablets of vardenafil.

Drugs List

  • LEVITRA 10mg film coated tablets
  • LEVITRA 20mg film coated tablets
  • vardenafil 10mg tablets
  • vardenafil 20mg tablets
  • vardenafil 5mg tablets
  • Therapeutic Indications

    Uses

    Treatment of erectile dysfunction

    Dosage

    In order for vardenafil to be effective, sexual stimulation is required.

    Adults

    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).

    Contraindications

    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)
    Hypotension
    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
    Unstable angina

    Precautions and Warnings

    Family history of long QT syndrome
    Predisposition to priapism
    Risk factors for cardiovascular disorder
    Anatomical deformation of penis
    Aortic stenosis
    Cardiovascular disorder
    Cavernosal fibrosis
    Coagulopathy
    Electrolyte imbalance
    History of torsade de pointes
    Idiopathic hypertrophic subaortic stenosis
    Left ventricular outflow obstruction
    Leukaemia
    Mild hepatic impairment
    Multiple myeloma
    Peptic ulcer
    Peyronie's disease
    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

    Pregnancy

    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).

    Lactation

    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

    Counselling

    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.

    Side Effects

    Amnesia (transient)
    Angina pectoris
    Anxiety
    Back pain
    Blurred vision
    Cardiac arrhythmias
    Cerebral haemorrhage
    Cerebrovascular disorders
    Chromatopsia
    Conjunctivitis
    Creatine phosphokinase increased
    Dizziness
    Dyspepsia
    Dyspnoea
    Epistaxis
    Erectile disturbance
    Eye pain
    Facial oedema
    Flushing
    Gamma glutamyl transferase (GGT) increased
    Haematospermia
    Haematuria
    Headache
    Hypersensitivity reactions
    Hypertension
    Hypertonia
    Hypotension
    Increase of liver transaminases
    Increased intra-ocular pressure
    Increased lacrimation
    Laryngeal oedema
    Muscle rigidity
    Myalgia
    Myocardial infarction
    Myocardial ischaemia
    Nasal congestion
    Nausea
    Non-arteritic anterior ischaemic optic neuropathy (NAION)
    Palpitations
    Penile haemorrhage
    Photosensitivity
    Priapism
    Rash
    Reddening of eyes
    Retinal vein occlusion
    Seizures
    Sleep disorders
    Somnolence
    Sudden deafness
    Sudden death reported
    Syncope
    Tachycardia
    Tinnitus
    Transient ischaemic attack
    Vertigo
    Visual disturbances
    Visual field defects
    Vomiting

    Overdosage

    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 ).

    Further Information

    Last Full Review Date: December 2017.

    Reference Sources

    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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