Sildenafil oral 25mg, 50mg, 100mg
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of sildenafil for treatment of erectile dysfunction.
Drugs List
Therapeutic Indications
Uses
Treatment of erectile dysfunction
Unlicensed Uses
Digital ulcers in systemic sclerosis
Dosage
Adults
50mg to be taken approximately one hour before sexual activity.
The dose may be increased to 100mg or decreased to 25mg based on efficacy and tolerance. The maximum recommended dose is 100mg. The maximum recommended dosing frequency is once per day.
Digital ulcers associated with systemic sclerosis (unlicensed)
25mg three times a day, increasing to 50mg three times a day.
Patients with Renal Impairment
Creatinine clearance below 30 ml/minute Initially 25mg, increasing stepwise to 50mg up to 100mg depending on efficacy and tolerance.
Patients with Hepatic Impairment
Initially 25mg, increasing stepwise to 50mg up to 100mg depending on efficacy and tolerance.
Additional Dosage Information
In order for sildenafil to be effective, sexual stimulation is required.
If sildenafil is taken with food, the onset of activity may be delayed compared to a fasted state.
Patients receiving alpha-blocker therapy should be stable before sildenafil is administered to reduce the risk of postural hypotension. A starting dose of 25mg should be considered in these patients.
Contraindications
Children under 18 years
Females
Patients in whom sexual activity is inadvisable
Systolic blood pressure < 90mmHg
Hereditary degenerative retinal disorder
History of non-arteritic anterior ischaemic optic neuropathy (NAION)
Recent cerebrovascular accident
Recent myocardial infarction
Severe cardiac failure
Severe cardiovascular disorder
Severe hepatic impairment
Unstable angina
Precautions and Warnings
Multiple system atrophy
Predisposition to priapism
Risk factors for cardiovascular disorder
Visual field defects
Anatomical deformation of penis
Aortic stenosis
Cardiovascular disorder
Cavernosal fibrosis
Coagulopathy
Galactosaemia
Glucose-galactose malabsorption syndrome
Hepatic impairment
Hypertrophic obstructive cardiomyopathy
Lactose intolerance
Left ventricular outflow obstruction
Leukaemia
Multiple myeloma
Peptic ulcer
Peyronie's disease
Renal impairment - creatinine clearance below 30 ml/minute
Sickle cell disease
Reduce dose in patients with creatinine clearance below 30ml/min
Reduce dose in patients with hepatic impairment
Advise ability to drive/operate machinery may be affected by side effects
Concurrent alpha blockers: only initiate therapy when blood pressure stable
Some formulations contain lactose
Pre-treatment medical history and exam. to diagnose erectile dysfunction
Assess baseline cardiac function prior to treatment
Cardiovascular events may occur during or shortly after sexual intercourse
Seek medical advice if priapism does not resolve within 4 hours
Discontinue if any kind of visual disturbance occurs
Advise patient not to take St John's wort concurrently
Advise patients not to take nitrates or amyl nitrite concurrently
Advise patient grapefruit products may increase plasma level
Before initiating treatment for erectile dysfunction, patients cardiovascular status should be considered due to the cardiac risk associated with sexual activity. Sildenafil has vasodilator properties resulting in mild and transient decreases in blood pressure. Patients with increased susceptibility to vasodilators include those with left ventricular outflow obstruction (e.g. aortic stenosis, hypertrophic obstructive cardiomyopathy) or those with the rare syndrome of multiple system atrophy manifesting as severely impaired autonomic control of blood pressure.
Pregnancy and Lactation
Pregnancy
Not indicated for use in women.
Lactation
Not indicated for use in women.
Side Effects
Alopecia
Angina pectoris
Anxiety
Arteriosclerotic retinopathy
Asthenopia
Atrial fibrillation
Blurred vision
Cerebrovascular accident
Chest pain
Chromatopsia
Colour vision deficiencies
Conjunctival hyperaemia
Conjunctivitis
Cyanopsia
Diplopia
Dizziness
Dry mouth
Dyspepsia
Epistaxis
Eye disorder
Eye irritation
Eye swelling
Eyelid oedema
Fatigue
Flushing
Gastroesophageal reflux
Glaucoma
Haematospermia
Haematuria
Headache
Hypersensitivity reactions
Hypertension
Hypoaesthesia
Hypotension
Increased heart rate
Insomnia
Iris disorder
Irritability
Lacrimation disorder
Myalgia
Mydriasis
Myocardial infarction
Myopia
Nasal congestion
Nasal dryness
Nasal oedema
Nausea
Non-arteritic anterior ischaemic optic neuropathy (NAION)
Ocular oedema
Painful extremities
Palpitations
Penile haemorrhage
Photophobia
Photopsia
Priapism
Prolonged erection
Rash
Reduced visual acuity
Retinal haemorrhage
Retinal vein occlusion
Rhinitis
Scleral discolouration
Seizures
Somnolence
Stevens-Johnson syndrome
Sudden cardiac death
Sudden deafness
Syncope
Tachycardia
Throat tightness
Tinnitus
Toxic epidermal necrolysis
Transient ischaemic attack
Upper abdominal pain
Ventricular arrhythmias
Vertigo
Visual disturbances
Visual field defects
Visual haloes
Vitreous floaters
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: June 2019
Reference Sources
Summary of Product Characteristics: Aronix 50mg film coated tablets. Dr Reddys. Revised September 2019.
Summary of Product Characteristics: Liberize (sildenafil) 50mg film-coated tablets. Teva UK limited. Revised February 2021.
Summary of Product Characteristics: Sildenafil 25mg film coated tablets. Dr Reddys. Revised December 2016.
Summary of Product Characteristics: Sildenafil 50mg film coated tablets. Dr Reddys. Revised December 2016.
Summary of Product Characteristics: Sildenafil 100mg film coated tablets. Dr Reddys. Revised December 2016.
Summary of Product Characteristics: Viagra 25mg, 50mg, 100mg. Pfizer Ltd. Revised May 2019.
Summary of Product Characteristics: Viagra Connect 50mg. Pfizer Ltd. Revised November 2017.
Summary of Product Characteristics: Vizarsin 25mg tablets. Consilient health Ltd. Revised March 2013.
Summary of Product Characteristics: Vizarsin 50mg tablets. Consilient health Ltd. Revised March 2013.
Summary of Product Characteristics: Vizarsin 100mg tablets. Consilient health Ltd. Revised March 2013.
Summary of Product Characteristics: Zamantos 50mg film-coated tablets. Crescent Pharma Ltd. Revised October 2019.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 08 November 2022
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.