Drugs List

Therapeutic Indications

Uses

Treatment of erectile dysfunction

Contraindications

Children under 18 years
Patients in whom sexual activity is inadvisable
End stage renal disease
Hereditary degenerative retinal disorder
Hereditary fructose intolerance
History of non-arteritic anterior ischaemic optic neuropathy (NAION)
Hypotension
Long QT syndrome
Moderate hepatic impairment
New York Heart Association class III failure
New York Heart Association class IV failure
Phenylketonuria
Recent cerebrovascular accident
Recent myocardial infarction
Severe cardiac failure
Severe cardiovascular disorder
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

Contains aspartame - caution in phenylketonuria
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
Presentations with sorbitol unsuitable in hereditary fructose intolerance
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
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.

Pregnancy and Lactation

Pregnancy

Not indicated in females. At the time of writing there is limited published information regarding the use of vardenafil during breastfeeding.

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

Side Effects

Abdominal pain
Allergic reaction
Amnesia (transient)
Angina pectoris
Angioedema
Anxiety
Back pain
Cerebral haemorrhage
Cerebrovascular disorders
Chest pain
Chromatopsia
Conjunctivitis
Creatine phosphokinase increased
Diarrhoea
Dizziness
Drowsiness
Dry mouth
Dysaesthesia
Dyspepsia
Dyspnoea
Epistaxis
Erectile disturbance
Erythema
Eye pain
Flushing
Gamma glutamyl transferase (GGT) increased
Gastritis
Gastro-intestinal pain
Gastroesophageal reflux disease
Haematospermia
Haematuria
Headache
Hypersensitivity reactions
Hypertension
Hypertonia
Hypotension
Increase of liver transaminases
Increased intra-ocular pressure
Increased lacrimation
Muscular cramps
Myalgia
Myocardial infarction
Myocardial ischaemia
Nasal congestion
Naso-sinus congestion
Nausea
Non-arteritic anterior ischaemic optic neuropathy (NAION)
Ocular hyperaemia
Palpitations
Paraesthesia
Penile haemorrhage
Photophobia
Photosensitivity
Priapism
Rash
Seizures
Sleep disturbances
Somnolence
Sudden deafness
Sudden death reported
Syncope
Tachycardia
Tinnitus
Transient ischaemic attack
Ventricular tachyarrhythmias
Vertigo
Visual disturbances
Visual field defects
Vomiting

Presentation

Orodispersible tablets of vardenafil.

Drugs List

Therapeutic Indications

Uses

Treatment of erectile dysfunction

Dosage

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

Vardenafil orodispersible tablets are not bioequivalent to vardenafil tablets.

Adults

Patients with Renal Impairment

Patients with Hepatic Impairment

Contraindications

Children under 18 years
Patients in whom sexual activity is inadvisable
End stage renal disease
Hereditary degenerative retinal disorder
Hereditary fructose intolerance
History of non-arteritic anterior ischaemic optic neuropathy (NAION)
Hypotension
Long QT syndrome
Moderate hepatic impairment
New York Heart Association class III failure
New York Heart Association class IV failure
Phenylketonuria
Recent cerebrovascular accident
Recent myocardial infarction
Severe cardiac failure
Severe cardiovascular disorder
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

Contains aspartame - caution in phenylketonuria
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
Presentations with sorbitol unsuitable in hereditary fructose intolerance
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
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.

Pregnancy and Lactation

Pregnancy

Not indicated in females. At the time of writing there is limited published information regarding the use of vardenafil during breastfeeding.

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.

Advise patients with phenylketonuria that this product contains aspartame.

Side Effects

Abdominal pain
Allergic reaction
Amnesia (transient)
Angina pectoris
Angioedema
Anxiety
Back pain
Cerebral haemorrhage
Cerebrovascular disorders
Chest pain
Chromatopsia
Conjunctivitis
Creatine phosphokinase increased
Diarrhoea
Dizziness
Drowsiness
Dry mouth
Dysaesthesia
Dyspepsia
Dyspnoea
Epistaxis
Erectile disturbance
Erythema
Eye pain
Flushing
Gamma glutamyl transferase (GGT) increased
Gastritis
Gastro-intestinal pain
Gastroesophageal reflux disease
Haematospermia
Haematuria
Headache
Hypersensitivity reactions
Hypertension
Hypertonia
Hypotension
Increase of liver transaminases
Increased intra-ocular pressure
Increased lacrimation
Muscular cramps
Myalgia
Myocardial infarction
Myocardial ischaemia
Nasal congestion
Naso-sinus congestion
Nausea
Non-arteritic anterior ischaemic optic neuropathy (NAION)
Ocular hyperaemia
Palpitations
Paraesthesia
Penile haemorrhage
Photophobia
Photosensitivity
Priapism
Rash
Seizures
Sleep disturbances
Somnolence
Sudden deafness
Sudden death reported
Syncope
Tachycardia
Tinnitus
Transient ischaemic attack
Ventricular tachyarrhythmias
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 10mg orodispersible tablets, Bayer PLC. Revised October 2019.