Tadalafil oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of tadalafil.
Drugs List
Therapeutic Indications
Uses
Benign prostatic hyperplasia
Pulmonary arterial hypertension: functional grades II and III
Treatment of erectile dysfunction
Dosage
Not all brands or strengths are licensed for all indications.
In order for tadalafil to be effective in the treatment of erectile dysfunction, sexual stimulation is required.
Adults
Treatment of erectile dysfunction
10mg to be taken at least 30 minutes prior to sexual activity. If 10mg does not produce an adequate effect, a 20mg dose may be appropriate.
The effect of intermittent dosing may persist for longer than 24 hours.
The maximum recommended dosing frequency for tadalafil 10mg and 20mg is one dose per 24 hours.
Tadalafil 10mg and 20mg is intended for use before anticipated sexual activity and is not recommended for continuous daily use.
Once daily dosing
Tadalafil 2.5mg or 5mg once a day, may be used in patients who anticipate a frequent use of tadalafil (i.e. at least twice weekly).
Recommended dose is 5mg once a day at approximately the same time of day. The dose may be decreased to 2.5mg once a day depending on individual tolerability.
Physicians should monitor and re-assess the use of the daily regimen periodically.
Treatment of benign prostatic hyperplasia (BPH)
5mg taken once daily (at approximately the same time each day).
Treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III
40mg taken once daily.
Patients with Renal Impairment
Treatment of erectile dysfunction or BPH
Severe renal impairment: Maximum dose 10mg for intermittent use.
Once daily dosing:
Severe renal impairment: Not recommended.
Treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III
Mild to moderate renal impairment: Starting dose of 20mg once a day increasing to 40mg once a day based on efficacy and tolerance.
Severe renal impairment: Not recommended.
Patients with Hepatic Impairment
Once daily dosing in the treatment of erectile dysfunction or BPH has not been evaluated in patients with hepatic impairment.
Treatment of erectile dysfunction
10mg to be taken at least 30 minutes prior to sexual activity.
There is limited clinical data on the safety of tadalafil in patients with severe hepatic impairment (Child-Pugh Class C). Potential risks and benefits should be evaluated before tadalafil is prescribed to these patients.
Treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III
Child Pugh Class A and B: 10mg starting dose and 20mg once a day.
Child-Pugh Class C: Not recommended by the manufacturer.
Contraindications
Children under 18 years
Systolic blood pressure < 90mmHg
Angina during sexual intercourse
Breastfeeding
Cardiac arrhythmias
Galactosaemia
Hereditary degenerative retinal disorder
History of non-arteritic anterior ischaemic optic neuropathy (NAION)
Patients in whom sexual activity is inadvisable - if treating BPH or ED
Pregnancy
Retinitis pigmentosa
Severe hepatic impairment - if treating pulmonary arterial hypertension
Uncontrolled hypertension
Unstable angina
Within 3 months of a myocardial infarction
Within 6 months of a cerebrovascular accident - if treating BPH or ED
Within 6 months of NYHA class II failure - if treating BPH or ED
Precautions and Warnings
Predisposition to priapism
Anatomical deformation of penis
Cardiomyopathy - if treating pulmonary arterial hypertension
Cardiovascular disorder
Constrictive pericarditis - if treating pulmonary arterial hypertension
Glucose-galactose malabsorption syndrome
Hepatic impairment
Lactose intolerance
Left ventricular dysfunction
Leukaemia
Multiple myeloma
Renal impairment
Sickle cell disease
Valvular heart disease
Advise ability to drive/operate machinery may be affected by side effects
Benign prostatic hyperplasia: Exclude prostate carcinoma before treatment
BPH or ED: Pre-treatment medical history and examination required
Concurrent alpha blockers: only initiate therapy when blood pressure stable
Not all available brands are licensed for all indications
Not all available strengths are licensed for all indications
Pulmonary hypertension: Treatment to be initiated by a specialist
Contains lactose
Assess baseline cardiac function prior to treatment
Monitor patients for signs of adverse cardiovascular effects
Advise patient to report any erection lasting more than 4 hours
Advise patient to report hearing loss or tinnitus
Advise patient to report new visual problems and symptoms
BPH or ED: Discontinue and see doctor if sudden visual defect
Consider veno-occlusive disease if pulmonary oedema occurs
PAH:Advise patient to seek immediate medical advice if sudden visual defect
Concurrent anti-hypertensive medication may require adjustment
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
Advise patients to discontinue if any kind of visual disturbances occur
Tadalafil has systemic vasodilatory properties which may result in decreases in blood pressure. Patients with severe left ventricular outflow obstruction, fluid depletion, autonomic hypotension or resting hypotension could be adversely affected.
Pulmonary vasodilators may worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD) and use in such patients is not recommended. If signs of pulmonary oedema occur, consider the possibility of PVOD.
Pregnancy and Lactation
Pregnancy
Tadalafil is contraindicated in pregnancy.
Not all brands are indicated for use in women. There is limited data on the use of tadalafil in pregnant women.
Animal studies have not shown any teratogenicity, embryotoxicity or foetotoxicity.
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
Tadalafil is contraindicated in breastfeeding.
Animal data shows excretion in milk and as a risk to a breastfeeding infant cannot be excluded, tadalafil should not be used 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
Amnesia (transient)
Angina pectoris
Angioedema
Back pain
Blurred vision
Cardiovascular effects
Chest pain
Conjunctival hyperaemia
Dizziness
Dyspepsia
Epistaxis
Exfoliative dermatitis
Eye pain
Eyelid swelling
Facial oedema
Flushing
Gastroesophageal reflux
Haematospermia
Haematuria
Headache
Hearing disturbances
Hyperhidrosis
Hypersensitivity reactions
Hypertension
Hypotension
Irregular uterine bleeding
Migraine
Myalgia
Myocardial infarction
Nasal congestion
Nasopharyngitis
Nausea
Non-arteritic anterior ischaemic optic neuropathy (NAION)
Painful extremities
Palpitations
Penile haemorrhage
Priapism
Prolonged erection
Rash
Retinal vein occlusion
Seizures
Sinus bradycardia
Stevens-Johnson syndrome
Stroke
Sudden cardiac death
Sudden deafness
Syncope
Tachycardia
Tinnitus
Transient ischaemic attack
Urticaria
Ventricular arrhythmias
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: October 2014
Reference Sources
Summary of Product Characteristics: Adcirca 20 mg film-coated tablets. Eli Lilly and Company Ltd. Revised February 2017.
Summary of Product Characteristics: Cialis 2.5 mg, 5 mg, 10 mg and 20 mg film-coated tablets. Eli Lilly and Company Ltd. Revised March 2017.
Summary of Product Characteristics: Talmanco 20 mg film-coated tablets. Mylan S.A.S. Revised January 2017.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 16 July 2018
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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