- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Oral formulations of avanafil.
Treatment of erectile dysfunction
100mg taken as needed approximately 15 to 30 minutes before sexual activity.
Based on efficacy and tolerability, the dose may be increased to 200mg or decreased to 50mg.
The maximum recommended dosing frequency is once daily.
Additional Dosage Information
In order for avanafil to be effective, sexual stimulation is required.
If avanafil is taken with food, the onset of activity may be delayed compared to the fasted state.
In patients who are stable on alpha-blocker therapy, avanafil should be initiated at the lowest dose of 50mg.
In those patients already taking an optimised dose of avanafil, alpha-blocker therapy should be initiated at the lowest dose. Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure when taking avanafil.
The safety of combined use of avanafil and alpha-blockers may be affected by other variables, including intravascular volume depletion and other anti-hypertensive medicinal products.
Children under 18 years
Systolic blood pressure < 90mmHg
Systolic blood pressure above 170mm Hg
Angina during sexual intercourse
Hereditary degenerative retinal disorder
History of non-arteritic anterior ischaemic optic neuropathy (NAION)
New York Heart Association class II failure
Renal impairment - creatinine clearance below or equal to 30ml/minute
Serious cardiac arrhythmias
Severe hepatic impairment
Within 6 month of cerebrovascular accident
Within 6 months of a myocardial infarction
Precautions and Warnings
Predisposition to priapism
Risk factors for cardiovascular disorder
Anatomical deformation of penis
Hypertrophic obstructive cardiomyopathy
Left ventricular outflow obstruction
Renal impairment - creatinine clearance 30-80ml/minute
Sickle cell disease
Advise ability to drive/operate machinery may be affected by side effects
Concurrent alpha blockers: only initiate therapy when blood pressure stable
Pre-treatment medical history and exam. to diagnose erectile dysfunction
Assess baseline cardiac function prior to treatment
Advise patient to report hearing loss or tinnitus
Cardiovascular events may occur during or shortly after sexual intercourse
Seek medical advice if priapism does not resolve within 4 hours
Advise patient not to take St John's wort concurrently
Advise patients not to take nitrates or amyl nitrite concurrently
Hypotensive effects may be potentiated by alcohol
Advise patient grapefruit products may increase plasma level
Advise patients to discontinue if any kind of visual disturbances occur
Advise patients to discontinue if hearing disturbances occur
Pregnancy and Lactation
Not indicated for use in women.
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 for use in women.
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
Increase in prostate specific antigen (PSA)
Increased blood pressure
Increased heart rate
Increases in hepatic enzymes
Lower abdominal pain
Occult blood in urine
Rise in body temperature
Serum bilirubin increased
Serum creatinine increased
Shortness of breath on exertion
Spontaneous penile erection
Upper respiratory tract congestion
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: July 2018
Summary of Product Characteristics: Spedra 50mg, 100mg & 200mg tables. A.Menarini pharmaceuticals UK Ltd. Revised April 2018.
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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.