Rectogesic

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Rectogesic on Prescriptsy

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Rectogesic is a rectal ointment containing glyceryl trinitrate (GTN) 0.4% w/w. It is the only licensed topical medical treatment for chronic anal fissure in the United Kingdom.

A chronic anal fissure is a painful tear in the lining of the anal canal that has failed to heal after at least 6 to 8 weeks.

The condition is common, affecting people of all ages, and causes sharp pain during and after bowel movements, often accompanied by bright red rectal bleeding.

Rectogesic works by releasing nitric oxide locally, which relaxes the internal anal sphincter and restores blood flow to the fissure, creating the conditions necessary for healing.

It is a prescription-only medicine (POM) manufactured by Kyowa Kirin.

Anal fissures are one of the most frequently encountered conditions in primary care and colorectal surgery.

They typically occur in the posterior midline of the anal canal and are often triggered by the passage of a hard or large stool, straining during defecation, or prolonged diarrhoea.

Childbirth is another common precipitant.

Once established, a vicious cycle develops: spasm of the internal anal sphincter reduces blood supply to the area, pain causes further spasm, and the reduced perfusion prevents healing.

Breaking this cycle is the key to treatment.

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

Important safety information about Rectogesic

Before reading further, please note these essential safety points.

• Rectogesic must not be used with phosphodiesterase type 5 (PDE5) inhibitors such as sildenafil (Viagra), tadalafil (Cialis), vardenafil (Levitra), or avanafil (Spedra) due to the risk of severe hypotension.
• Headache is the most common side effect, affecting up to half of users, but usually improves within 1 to 2 weeks.
• If your fissure has not healed after 8 weeks of treatment, consult your prescriber for further assessment.
• Do not use Rectogesic if you have very low blood pressure, recent heart attack, or severe anaemia.
• Persistent rectal bleeding or a change in bowel habit should always be investigated regardless of whether you have a known fissure.

Understanding chronic anal fissure

An anal fissure is a linear tear or ulcer in the squamous epithelium of the anal canal, typically extending from the dentate line to the anal margin.

Acute fissures are superficial tears that usually heal within 4 to 6 weeks with conservative measures such as increased dietary fibre, adequate fluid intake, and simple analgesia.

Chronic fissures, by contrast, are deeper and develop features of chronicity including a sentinel skin tag at the external margin, hypertrophied anal papilla at the internal margin, and visible transverse fibres of the internal anal sphincter at the base of the fissure.

These features indicate that the fissure is unlikely to heal without specific intervention to reduce sphincter tone.

The internal anal sphincter (IAS) is a ring of smooth muscle that maintains the resting tone of the anal canal.

In patients with chronic anal fissure, the IAS is in a state of sustained hypertonia.

Manometric studies have consistently shown elevated resting anal pressures in these patients compared with healthy controls.

This hypertonia compresses the branches of the inferior rectal artery that supply the posterior midline of the anal canal, creating a relative area of ischaemia that prevents healing.

The posterior midline is the most vulnerable zone because it has the poorest blood supply, which is why approximately 90% of anal fissures occur at this location.

How Rectogesic works

Glyceryl trinitrate is an organic nitrate that acts as a nitric oxide (NO) donor.

When applied to the perianal skin and anal canal, GTN is absorbed through the mucosal and skin surfaces.

In the smooth muscle cells of the IAS, nitric oxide activates the enzyme soluble guanylate cyclase, which converts guanosine triphosphate (GTP) to cyclic guanosine monophosphate (cGMP).

Elevated cGMP levels trigger smooth muscle relaxation by reducing intracellular calcium concentrations.

This relaxation of the IAS reduces resting anal pressure by approximately 20% to 30%, which restores blood flow through the compressed anodermal vessels and breaks the cycle of ischaemia, pain, and spasm.

In addition to reducing sphincter tone, nitric oxide has direct effects on local blood flow.

It is a potent vasodilator that increases perfusion of the anodermal tissue, further supporting the healing process.

Laser Doppler flowmetry studies have demonstrated significant increases in anodermal blood flow following topical GTN application.

Clinical evidence for Rectogesic

The use of topical GTN for chronic anal fissure has been studied in numerous randomised controlled trials.

A Cochrane systematic review of medical management of chronic anal fissure concluded that topical GTN is superior to placebo, with healing rates of approximately 49% compared with 36% for placebo over 6 to 8 weeks.

While these healing rates are lower than those achieved by surgical sphincterotomy (approximately 95%), topical GTN is non-invasive, reversible, and avoids the risk of permanent incontinence associated with surgery.

NICE Clinical Knowledge Summaries (CKS) on anal fissure recommend a stepwise approach to management.

Initial treatment should include dietary advice (high-fibre diet, adequate fluid intake), bulk-forming laxatives, and topical analgesia.

If the fissure has not healed after 6 to 8 weeks of conservative management, topical GTN 0.4% (Rectogesic) should be considered as first-line pharmacological treatment.

If GTN fails or is not tolerated (usually due to headache), topical diltiazem cream (unlicensed, prepared by specials manufacturers) is an alternative.

Botulinum toxin injection and lateral internal sphincterotomy are reserved for fissures that do not respond to topical treatment.

Rectogesic compared with other treatments

Topical diltiazem (2% cream) is the main alternative to Rectogesic for medical management of chronic anal fissure.

Diltiazem is a calcium channel blocker that also relaxes the IAS but through a different mechanism (blocking voltage-gated calcium channels).

It causes headache less frequently than GTN, which makes it preferable for patients who cannot tolerate GTN-related headaches.

However, diltiazem cream is not licensed for this indication in the UK and must be prepared as a special by a compounding pharmacy.

Rectogesic remains the only licensed topical treatment for chronic anal fissure in the UK.

Botulinum toxin (Botox) injection into the IAS is used in secondary care for fissures that fail to respond to topical treatments.

It causes temporary chemical denervation of the sphincter, reducing tone for approximately 3 months. Healing rates are comparable to topical GTN in some studies.

The injection carries a small risk of temporary faecal incontinence.

Lateral internal sphincterotomy is the gold-standard surgical treatment, with healing rates exceeding 95%.

However, it carries a risk of permanent impairment of fine continence control (flatus incontinence in approximately 5% to 10% of patients), which is why medical treatments are preferred as initial management.

Dosage and administration

Apply Rectogesic twice daily, approximately every 12 hours.

Each application should use the dosing line on the carton lid to measure approximately 375 mg of ointment (equivalent to 1.5 mg GTN).

Cover your fingertip with a finger cover or cling film, pick up the measured ointment, and gently insert it approximately 1 cm into the anal canal.

Wash your hands thoroughly before and after application to avoid transferring GTN to other parts of the body, which can cause headache.

Continue treatment for up to 8 weeks. If you forget a dose, apply it as soon as you remember unless the next dose is due shortly.

Do not apply a double dose. If the fissure has not healed after 8 weeks, consult your prescriber for further assessment and possible referral.

During treatment, maintain a high-fibre diet (aim for 25 to 30 grams of fibre daily), drink plenty of water, and avoid straining during bowel movements.

A bulk-forming laxative such as ispaghula husk (Fybogel) may help soften stools and reduce pain on defecation.

Side effects of Rectogesic

Headache

Headache is by far the most commonly reported side effect, occurring in approximately 25% to 60% of users across clinical trials.

The headache results from GTN-induced vasodilation of cerebral blood vessels. It typically starts within 30 to 60 minutes of application and may last 1 to 2 hours.

Taking paracetamol 30 minutes before applying Rectogesic can reduce the severity. Most patients develop tolerance to the headache within 1 to 2 weeks of regular use.

If headache is severe and persistent, discuss alternative treatments with your prescriber.

Cardiovascular effects

Dizziness, lightheadedness, and postural hypotension may occur due to the vasodilatory effect of GTN. Stand up slowly after applying the ointment.

Rarely, significant hypotension or fainting (syncope) can occur, particularly in patients who are dehydrated, elderly, or taking other blood pressure-lowering medicines. Tachycardia and palpitations are uncommon.

Local effects

Perianal burning, itching, or irritation at the application site has been reported. These effects are usually mild and transient. If local irritation is severe, stop using the ointment and consult your prescriber.

When to seek medical advice

Seek urgent medical attention if you experience severe dizziness, fainting, chest pain, or a rapid or irregular heartbeat. Call 999 in an emergency.

Contact your GP or call NHS 111 if you notice worsening rectal bleeding, increased pain despite treatment, or signs of perianal infection (swelling, redness, fever).

Report suspected adverse reactions to the MHRA at yellowcard.mhra.gov.uk .

Warnings and precautions

Contraindications

Rectogesic must not be used with PDE5 inhibitors (sildenafil, tadalafil, vardenafil, avanafil) due to the risk of severe, potentially life-threatening hypotension.

It is also contraindicated in patients with severe hypotension (systolic blood pressure below 90 mmHg), recent myocardial infarction, acute heart failure, severe anaemia, marked hypovolaemia, conditions associated with raised intracranial pressure, or known hypersensitivity to GTN or other organic nitrates.

Drug interactions

Medicines that lower blood pressure may have additive hypotensive effects when used alongside Rectogesic. These include antihypertensives, diuretics, calcium channel blockers, beta-blockers, alpha-blockers, tricyclic antidepressants, and alcohol.

Other nitrate preparations (isosorbide mononitrate, isosorbide dinitrate, GTN patches or sprays) should not be used concurrently.

Riociguat, a guanylate cyclase stimulator used for pulmonary hypertension, is contraindicated with organic nitrates.

Special populations

Pregnancy and breastfeeding: data on the use of topical GTN during pregnancy are limited. Use Rectogesic only if the expected benefit outweighs the potential risk.

It is not known whether GTN is excreted in breast milk. Discuss alternatives with your prescriber.

Children: Rectogesic is not recommended for children as safety and efficacy have not been established in this age group.

When to seek further help

If your symptoms do not improve after 8 weeks of treatment, your GP should reassess and may refer you to a colorectal surgeon.

Persistent rectal bleeding, a change in bowel habit lasting more than 3 weeks, unexplained weight loss, or a lump near the anus should always be investigated promptly, regardless of any known fissure, to exclude other conditions including inflammatory bowel disease, perianal abscess, and colorectal cancer.

NICE guideline NG12 (suspected cancer: recognition and referral) recommends urgent 2-week-wait referral for anyone aged 40 or over with unexplained rectal bleeding combined with a change in bowel habit.

How to get Rectogesic in the UK

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

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

Prepayment certificates are available for those who need multiple prescription items. Rectogesic may also be prescribed privately.

Sources

• Rectogesic, Summary of Product Characteristics (EMC)
• Glyceryl trinitrate, British National Formulary (BNF)
• Anal fissure, NICE CKS
• Anal fissure, NHS
• MHRA Yellow Card Scheme