Tadalafil

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Tadalafil on Prescriptsy

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Tadalafil is a phosphodiesterase type 5 (PDE5) inhibitor used to treat erectile dysfunction (ED) and the signs and symptoms of benign prostatic hyperplasia (BPH), including lower urinary tract symptoms (LUTS).

It is the generic form of Cialis, one of the most widely prescribed ED treatments worldwide.

Tadalafil is distinguished from other PDE5 inhibitors by its long duration of action, with effects lasting up to 36 hours after a single dose, earning it the informal name "the weekend pill." It is also the only PDE5 inhibitor licensed for daily use in the treatment of BPH-LUTS.

Tadalafil is a prescription-only medicine (POM) in the United Kingdom.

Erectile dysfunction affects an estimated 4.3 million men in the UK and becomes more prevalent with age, affecting approximately 40% of men aged 40 and over 70% of men aged 70.

It is often an early marker of underlying cardiovascular disease, as the penile arteries are among the smallest in the body and may develop atherosclerosis before larger vessels.

BPH affects approximately 50% of men aged 50 and 80% of men aged 80, causing bothersome urinary symptoms including urinary frequency, urgency, nocturia, weak stream, hesitancy, and incomplete emptying.

This page provides a comprehensive clinical guide to tadalafil, covering how it works, dosage instructions, side effects, safety warnings, and how to obtain a prescription in the United Kingdom.

Important safety information about tadalafil

Before reading further, please note these essential safety points.

• Never take tadalafil with nitrate medicines (GTN spray, isosorbide mononitrate, amyl nitrite) as the combination can cause a severe, potentially fatal drop in blood pressure.
• If you experience chest pain during sexual activity after taking tadalafil, call 999 and tell the paramedics you have taken a PDE5 inhibitor. Do not use GTN spray.
• Seek emergency treatment if you experience an erection lasting more than 4 hours (priapism).
• Seek urgent medical attention if you experience sudden loss of vision or sudden hearing loss.
• Discuss cardiovascular fitness for sexual activity with your prescriber before starting tadalafil.

Understanding erectile dysfunction

Erectile dysfunction is defined as the persistent inability to achieve or maintain an erection sufficient for satisfactory sexual performance. The physiology of erection involves a coordinated neurovascular event.

Sexual stimulation causes parasympathetic nerve fibres to release nitric oxide (NO) at the nerve terminals and from the endothelium of the penile arteries and sinusoidal spaces of the corpora cavernosa.

Nitric oxide activates soluble guanylate cyclase, which converts guanosine triphosphate (GTP) to cyclic guanosine monophosphate (cGMP).

Elevated cGMP causes relaxation of the smooth muscle in the walls of the penile arteries and the trabeculae of the corpora cavernosa, allowing increased blood flow into the erectile tissue.

The expanding corpora cavernosa compress the subtunical venules against the tunica albuginea, reducing venous outflow and trapping blood within the penis to produce and maintain rigidity.

Erection is terminated when PDE5 hydrolyses cGMP back to inactive GMP, allowing smooth muscle contraction, reduced arterial inflow, and restored venous drainage. In ED, this process is impaired.

Common causes include vascular disease (atherosclerosis, diabetes, hypertension, hyperlipidaemia), neurological conditions (multiple sclerosis, spinal cord injury, radical prostatectomy), hormonal abnormalities (hypogonadism, hyperprolactinaemia), psychological factors (performance anxiety, depression, relationship difficulties), and medications (antihypertensives, antidepressants, antiandrogens).

Often, ED has multiple contributing factors.

Understanding benign prostatic hyperplasia

Benign prostatic hyperplasia is a non-cancerous enlargement of the prostate gland caused by proliferation of both stromal and epithelial cells in the transitional zone of the prostate.

As the prostate enlarges, it compresses the prostatic urethra, increasing resistance to urinary outflow.

This produces lower urinary tract symptoms (LUTS), which are divided into storage symptoms (frequency, urgency, nocturia, urge incontinence) and voiding symptoms (hesitancy, poor stream, intermittency, straining, terminal dribble, incomplete emptying).

BPH-LUTS significantly affects quality of life, sleep quality, and daily functioning.

The pharmacological management of BPH-LUTS includes alpha-1 adrenergic blockers (tamsulosin, alfuzosin, doxazosin), which relax smooth muscle in the prostate and bladder neck; 5-alpha reductase inhibitors (finasteride, dutasteride), which reduce prostate volume by blocking the conversion of testosterone to dihydrotestosterone; and PDE5 inhibitors (tadalafil 5 mg daily), which relax smooth muscle in the prostate, bladder, and urethra through the cGMP pathway.

NICE guideline CG97 (lower urinary tract symptoms in men) recommends alpha-blockers as first-line pharmacological treatment, with 5-alpha reductase inhibitors for men with prostates estimated to be larger than 30 grams.

Tadalafil 5 mg daily is an option for men who have both ED and BPH-LUTS.

How tadalafil works

Tadalafil is a potent, selective, reversible inhibitor of PDE5.

By blocking the breakdown of cGMP, tadalafil amplifies the natural physiological mechanism of erection that is initiated by sexual stimulation and nitric oxide release.

Without sexual stimulation, there is no significant increase in cGMP and tadalafil does not produce an erection.

This distinguishes PDE5 inhibitors from older treatments such as intracavernosal alprostadil, which can produce erection regardless of stimulation.

The selectivity of tadalafil for PDE5 over other phosphodiesterase isoenzymes explains its side effect profile.

Tadalafil has greater than 10,000-fold selectivity for PDE5 over PDE1, PDE2, PDE3, PDE4, and PDE7.

It has approximately 700-fold selectivity over PDE6 (found in the retina), which is why visual disturbances are less commonly reported with tadalafil compared with sildenafil (which has lower PDE6 selectivity).

Tadalafil also inhibits PDE11A, which is found in skeletal muscle, the prostate, and the testes.

Inhibition of PDE11A is thought to contribute to back pain and myalgia, which are more commonly reported with tadalafil than with sildenafil or vardenafil.

In BPH-LUTS, tadalafil relaxes smooth muscle in the prostate, bladder neck, urethra, and detrusor muscle through the cGMP pathway.

Additional proposed mechanisms include improved blood flow to the lower urinary tract, reduction of afferent nerve activity, and anti-inflammatory effects mediated by the nitric oxide/cGMP pathway.

Tadalafil compared with other PDE5 inhibitors

Four PDE5 inhibitors are currently available in the UK: sildenafil (Viagra), tadalafil (Cialis), vardenafil (Levitra), and avanafil (Spedra).

All work by the same mechanism but differ in pharmacokinetic profile, selectivity, and side effects.

Sildenafil has an onset of 30 to 60 minutes and duration of 4 to 6 hours. It should be taken on an empty stomach for optimal absorption.

Vardenafil has similar onset and duration to sildenafil. Avanafil has the fastest onset (15 to 30 minutes) and duration of approximately 6 hours.

Tadalafil has an onset of 30 minutes and the longest duration of up to 36 hours. It can be taken with food without affecting absorption.

Tadalafil is also the only PDE5 inhibitor available in a daily dosing formulation (2.5 mg and 5 mg).

The choice between PDE5 inhibitors depends on patient preference, frequency of sexual activity, comorbidities, concomitant medications, and tolerability.

Tadalafil is often preferred by men who value spontaneity, as its long duration means they do not need to plan sexual activity around dosing.

The daily regimen is particularly suitable for men with both ED and BPH-LUTS, as it addresses both conditions with a single tablet.

Clinical evidence for tadalafil

The efficacy of tadalafil for ED was established in multiple large randomised controlled trials involving over 4,000 men.

In pivotal trials, tadalafil 20 mg on demand improved successful intercourse attempts from approximately 32% at baseline to 73%, compared with 34% for placebo.

The Integrated Analysis of clinical trials reported that tadalafil significantly improved IIEF (International Index of Erectile Function) scores across all severity categories of ED.

For BPH-LUTS, a pooled analysis of four 12-week randomised controlled trials demonstrated that tadalafil 5 mg daily produced a mean improvement of 4.5 to 5.6 points on the IPSS (International Prostate Symptom Score) compared with 2.3 to 3.6 points for placebo.

Improvements were seen in both storage and voiding symptom domains. In men with coexisting ED and BPH-LUTS, tadalafil 5 mg daily improved both IPSS and IIEF scores simultaneously.

Dosage and administration

For on-demand ED treatment, the recommended starting dose is 10 mg, taken at least 30 minutes before sexual activity.

The dose may be adjusted to 20 mg or reduced to 5 mg based on efficacy and tolerability. Do not take more than one dose per day.

For daily ED treatment or combined ED and BPH-LUTS treatment, the recommended dose is 5 mg taken once daily at approximately the same time.

It may take 4 to 5 days of daily dosing to reach steady-state plasma concentrations. For BPH-LUTS without ED, the dose is 5 mg once daily.

Tadalafil can be taken with or without food. Swallow the tablet whole with water. Avoid grapefruit juice in large quantities, as it is a mild CYP3A4 inhibitor and may increase tadalafil levels.

Side effects of tadalafil

Common side effects

Headache is the most frequently reported side effect, occurring in 10% to 15% of users.

It results from PDE5-mediated vasodilation of cerebral blood vessels and usually resolves within a few hours.

Back pain and myalgia are more common with tadalafil than with other PDE5 inhibitors, reported in approximately 4% to 6% of users.

They typically begin 12 to 24 hours after dosing and resolve within 48 hours. These effects are thought to relate to PDE11A inhibition in skeletal muscle.

Nasal congestion, flushing, and dyspepsia are each reported in approximately 3% to 5% of users.

Serious side effects

Priapism (erection lasting more than 4 hours) is rare but constitutes a medical emergency. Seek immediate treatment by calling 999 or attending Accident and Emergency.

Delay in treatment can cause permanent ischaemic damage to the corpus cavernosum. Sudden loss of vision in one or both eyes (NAION) has been reported very rarely.

Risk factors include age over 50, diabetes, hypertension, hyperlipidaemia, smoking, and pre-existing optic disc crowding. Sudden hearing loss, sometimes with tinnitus, has also been reported very rarely.

Cardiovascular events including myocardial infarction and sudden cardiac death have been reported in temporal association with PDE5 inhibitor use, but these events are generally attributed to the cardiovascular risk factors and exertion associated with sexual activity rather than the medicine itself.

Report suspected adverse reactions to the MHRA via the Yellow Card scheme at yellowcard.mhra.gov.uk.

Warnings and precautions

Absolute contraindications

Concurrent use with organic nitrates in any form is absolutely contraindicated. This includes sublingual GTN spray, GTN patches, isosorbide mononitrate, isosorbide dinitrate, and recreational nitrites (poppers/amyl nitrite). Concurrent use with riociguat or other guanylate cyclase stimulators is also contraindicated.

Cardiovascular precautions

Sexual activity represents a moderate physical exertion (approximately 3 to 5 metabolic equivalents). Men with significant cardiovascular disease should be assessed for cardiovascular fitness before prescribing tadalafil.

Conditions that represent contraindications include recent myocardial infarction (within 90 days), unstable angina, uncontrolled heart failure (NYHA Class II or greater within 6 months), uncontrolled arrhythmias, severe valvular disease, uncontrolled hypertension (above 170/100 mmHg), hypotension (below 90/50 mmHg), and recent stroke (within 6 months).

Drug interactions

Alpha-blockers: use tadalafil with caution alongside alpha-blockers. Start with the lowest tadalafil dose and ensure the patient is stable on alpha-blocker therapy first.

CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir, clarithromycin) increase tadalafil exposure and may require dose adjustment. CYP3A4 inducers (rifampicin, phenytoin, carbamazepine) may reduce efficacy.

Antihypertensives may have additive blood pressure lowering effects.

How to get tadalafil in the UK

Tadalafil is available on NHS prescription from your GP or an authorised online prescriber registered with the General Pharmaceutical Council (GPhC).

Since April 2014, all PDE5 inhibitors have been available on the NHS for ED, following the removal of previous NHS prescribing restrictions.

The standard NHS prescription charge in England is 9.90 pounds per item; prescriptions are free in Scotland, Wales, and Northern Ireland.

Private prescriptions are also available from registered online prescribers.

Sources

• Tadalafil, Summary of Product Characteristics (EMC)
• Tadalafil, British National Formulary (BNF)
• Erectile dysfunction, NICE CKS
• LUTS in men, NICE CKS
• Erectile dysfunction, NHS
• MHRA Yellow Card Scheme