Sildenafil oral 20mg, 10mg/ml
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of sildenafil for treatment of pulmonary arterial hypertension.
Drugs List
Therapeutic Indications
Uses
Pulmonary arterial hypertension: functional grades II and III
To improve exercise capacity in adult patients with pulmonary arterial hypertension (WHO functional class II and III). Efficacy has been shown in patients with primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease.
To increase exercise capacity in paediatric patients aged 1 year to 17 years with pulmonary arterial hypertension. Efficacy has been shown in patients with primary pulmonary hypertension and pulmonary hypertension associated with congenital heart disease.
Dosage
Adults
20mg three times a day.
Children
Children aged 1 year to 18 years
Patients more than 20kg: 20mg three times a day.
Patients less than or equal to 20kg: 10mg three times a day.
Children aged 1 month to 1 year (unlicensed)
Initial dose: 250micrograms/kg to 500micrograms/kg every 4 to 8 hours. Start with a lower dose and frequency (especially if used with other vasodilators)
Maximum dose: 30mg daily.
Neonates
Pulmonary arterial hypertension (unlicensed; manufacturer advises avoid use in neonates as the risks outweight the benefits)
Initial dose: 250micrograms/kg to 500micrograms/kg every 4 to 8 hours. Start with a lower dose and frequency (especially if used with other vasodilators).
Maximum dose: 30mg daily.
Patients with Renal Impairment
No initial dosage adjustments are required. Reduce dose to 20mg twice daily if treatment is not tolerated.
Patients with Hepatic Impairment
Mild to moderate hepatic impairment (Child-Pugh class A and B)
No initial dosage adjustments are required. Reduce dose to 20mg twice daily if treatment is not tolerated.
Additional Dosage Information
Missed dose
Patients who forget to take sildenafil should take a dose as soon as possible and then continue with the normal dosing schedule. Patients should not to take a double dose to compensate for the missed dose.
Contraindications
Blood pressure <90/50mmHg at initiation
Breastfeeding
Hereditary degenerative retinal disorder
History of non-arteritic anterior ischaemic optic neuropathy (NAION)
Recent cerebrovascular accident
Recent myocardial infarction
Severe hepatic impairment
Sickle cell disease
Precautions and Warnings
Children under 1 year
Predisposition to priapism
Acute peptic ulcer
Anatomical deformation of penis
Autonomic dysfunction
Cardiovascular disorder
Coagulopathy
Dehydration
Galactosaemia
Glucose-galactose malabsorption syndrome
Hepatic impairment
Hereditary fructose intolerance
Hypotension
Lactose intolerance
Left ventricular outflow obstruction
Leukaemia
Multiple myeloma
Pregnancy
Pulmonary hypertension secondary to venous occlusive disorder
Renal impairment
Advise ability to drive/operate machinery may be affected by side effects
Concurrent alpha blockers: only initiate therapy when blood pressure stable
Treatment to be initiated and supervised by a specialist
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Some formulations contain lactose
Advise patient that postural hypotension may occur
Advise patient to report any erection lasting more than 4 hours
Cardiovascular events may occur during or shortly after sexual intercourse
Consider veno-occlusive disease if pulmonary oedema occurs
To discontinue, reduce dose gradually
Discontinue if any kind of visual disturbance occurs
Not licensed for all indications in all age groups
Advise patient not to take St John's wort concurrently
Advise patients not to take nitrates or amyl nitrite concurrently
Advise patient to avoid grapefruit products
Female: Ensure adequate contraception during treatment
The use of sildenafil in forms other than pulmonary arterial hypertension relating to primary, connective tissue disease or congenital heart disease are not recommended.
Patients using vitamin K antagonists may be at an increased risk of bleeding.
Pregnancy and Lactation
Pregnancy
Use sildenafil with caution during pregnancy.
The manufacturer does not recommend using sildenafil during pregnancy unless strictly necessary. At the time of writing there is limited data regarding the use of sildenafil during pregnancy. Animal studies do not indicate direct or indirect harmful effects on pregnancy or embryonal development, but have shown toxicity with respect to postnatal development. Increased risk of persistent pulmonary hypertension in neonates and increased mortality have been reported when sildenafil was used off license for early-onset intrauterine growth restriction.
Lactation
Sildenafil is contraindicated during breastfeeding.
The manufacturer does not recommend the use of sildenafil during breastfeeding. Whilst available data indicates that low levels of sildenafil and its metabolites are present in human breast milk, some manufacturers state that this amount is unlikely to cause adverse effects in the breastfed infant. The overall effects on exposed infants are unknown.
Side Effects
Abdominal distension
Alopecia
Anaemia
Angina pectoris
Anxiety
Arrhythmias
Back pain
Blurred vision
Bronchitis
Burning sensation
Cardiovascular accident
Cellulitis
Cerebrovascular haemorrhage
Chromatopsia
Cough
Cyanopsia
Diarrhoea
Diplopia
Dizziness
Dry mouth
Dyspepsia
Enterocolitis
Epistaxis
Erythema
Eye disorder
Eye irritation
Fluid retention
Flushing
Gastritis
Gastro-enteritis
Gastroesophageal reflux disease
Gynaecomastia
Haematospermia
Haematuria
Haemorrhoids
Headache
Hypersensitivity reactions
Hypertension
Hypoaesthesia
Hypotension
Hypoxia
Influenza
Insomnia
Limb pain
Migraine
Myalgia
Myocardial infarction
Nasal congestion
Night sweats
Non-arteritic anterior ischaemic optic neuropathy (NAION)
Ocular hyperaemia
Oedema
Painful extremities
Palpitations
Paraesthesia
Penile haemorrhage
Photophobia
Priapism
Prolonged erection
Pyrexia
Rash
Reddening of eyes
Reduced visual acuity
Retinal haemorrhage
Retinal vein occlusion
Rhinitis
Seizures
Sinusitis
Stevens-Johnson syndrome
Stridor
Sudden cardiac death
Sudden deafness
Syncope
Tachycardia
Transient ischaemic attack
Tremor
Upper respiratory tract infection
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: April 2019
Reference Sources
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.
Summary of Product Characteristics: Granpidam 20mg film-coated tablets. Accord Healthcare Ltd. Revised March 2019.
Summary of Product Characteristics: Sildenafil Teva 20mg film-coated tablets. Teva UK Ltd. Revised October 2016.
Summary of Product Characteristics: Mysildecard 20mg film-coated tablets. Mylan Ltd. Revised September 2016.
Summary of Product Characteristics: Revatio 20mg film-coated tablets. Pfizer Ltd. Revised June 2020.
Summary of Product Characteristics: Revatio 10mg/ml powder for oral suspension. Pfizer Ltd. Revised June 2020.
MHRA Drug Safety Update November 2018
Available at: https://www.mhra.gov.uk
Last accessed: 16 April 2019
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 22 June 2020
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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