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Avanafil oral

Updated 2 Feb 2023 | Erectile dysfunction

Presentation

Oral formulations of avanafil.

Drugs List

  • avanafil 100mg tablets
  • avanafil 200mg tablets
  • avanafil 50mg tablets
  • SPEDRA 100mg tablets
  • SPEDRA 200mg tablets
  • SPEDRA 50mg tablets
  • Therapeutic Indications

    Uses

    Treatment of erectile dysfunction

    Dosage

    Adults

    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.

    Contraindications

    Children under 18 years
    Females
    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
    Unstable angina
    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
    Aortic stenosis
    Cardiovascular disorder
    Cavernosal fibrosis
    Coagulopathy
    Hepatic impairment
    Hypertrophic obstructive cardiomyopathy
    Left ventricular outflow obstruction
    Leukaemia
    Multiple myeloma
    Peptic ulcer
    Peyronie's disease
    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

    Pregnancy

    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 ).

    Lactation

    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

    Side Effects

    Angina pectoris
    Asthenia
    Back pain
    Blurred vision
    Chest pain
    Diarrhoea
    Dizziness
    Dry mouth
    Dyspepsia
    ECG changes
    Ejaculation disorders
    Epistaxis
    Fatigue
    Flank pain
    Flushing
    Gastritis
    Genital pruritus
    Gout
    Headache
    Heart murmur
    Hot flushes
    Hypertension
    Increase in prostate specific antigen (PSA)
    Increased blood pressure
    Increased heart rate
    Increases in hepatic enzymes
    Influenza
    Influenza-like symptoms
    Insomnia
    Lower abdominal pain
    Muscle spasm
    Muscle tension
    Myalgia
    Nasal congestion
    Naso-sinus congestion
    Nasopharyngitis
    Nausea
    Occult blood in urine
    Palpitations
    Peripheral oedema
    Pollakiuria
    Priapism
    Psychomotor hyperactivity
    Rash
    Rhinorrhoea
    Rise in body temperature
    Seasonal allergy
    Serum bilirubin increased
    Serum creatinine increased
    Shortness of breath on exertion
    Sinus headache
    Somnolence
    Spontaneous penile erection
    Stomach discomfort
    Tachycardia
    Upper respiratory tract congestion
    Vomiting
    Weight gain

    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: July 2018

    Reference Sources

    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

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