Review of diltiazem cream in treatment of anal fissures.

Diltiazem cream: use side effects & availability

Diltiazem cream (diltiazem hydrochloride cream) is a medicine prescribed in the UK to manage chronic anal fissures. Diltiazem cream is classified as a ‘special medication’, which means it is not readily available in pharmacies. Today I will answer the most common questions surrounding the use, availability and treatment with diltiazem cream.

What is diltiazem cream used for?

Diltiazem hydrochloride 2% cream is used in the treatment of anal fissures.

An anal fissure is a common condition characterised by a tear (a cut) or an ulcer present at the edge of the anal margin. Two main symptoms of an anal fissure are anal pain during bowel movement with or without the presence of bright blood) and anal spasm.

How does diltiazem help with anal fissures?

Diltiazem hydrochloride cream promotes healing and controls pain associated with anal fissures by relaxing the muscles and improving blood flow to the site of injury. Diltiazem is classified as a calcium channel blocker. Calcium channel blockers are a group of medicines used mainly in the management of high blood pressure and angina. For example, amlodipine is the most common prescription high-blood pressure medication.

Classification of anal fissures

Anal fissures are classified according to the duration of symptoms present and underlying cause if known (NICE, 2017):

  • Acute: symptoms present for less than six weeks
  • Chronic: symptoms present for longer than six weeks
  • Primary: with uncertain cause for the fissure
  • Secondary: the cause of anal fissure is known, for example, underlying conditions like inflammatory bowel disease (IBD), colorectal cancer or sexually transmitted infection (HIV and AIDS).

Diltiazem cream may be offered for the management of anal fissures together with other recommendations, for example, the use of simple analgesics like paracetamol or ibuprofen. Codeine-containing products, such as co-codamol, may not be the best choice since codeine can cause constipation, possibly aggravating the condition. Constipation can be managed with over the counter laxatives.

Diltiazem cream: legal classification

Diltiazem 2% cream is a prescription-only medicine (POM), which means a doctor needs to issue a prescription for the supply to happen.

Diltiazem 2% cream is not a first-line treatment choice for the management of anal fissures due to the fact that it is an unlicensed medication.  

GTN ointment (available as Rectogesic 4 mg/g Rectal Ointment) is usually recommended in the first instance for the management of anal fissures. Even though diltiazem cream is an unlicensed medication, a doctor can prescribe it, for example, if a patient found GTN ointment not acceptable. GTN ointment can commonly cause severe headaches, which may cause some patients to stop the treatment.

Diltiazem cream alternative Rectogesic ointment

One of the implications of unlicensed medicines is their immediate availability. Almost with certainty, pharmacies would not keep diltiazem cream as a part of the regular dispensing stock. Very often, unlicensed medicines are ordered from suppliers, which make and redistribute unlicensed products.

Diltiazem cream used to be manufactured as a special preparation for each order, which means it would take a few days before the cream would reach the pharmacy and patient.

Recently, diltiazem became available as ready-made cream called Anoheal 2% cream. Anoheal 2% diltiazem cream comes in a pack size of 30g. The availability of Anoheal 2% speeded up the supply process. It still has to be ordered from ‘specials’; however, it is usually delivered to the pharmacy the next day (depending on the timing of the order).

Can you buy diltiazem hydrochloride 2% cream?

Diltiazem cream is a prescription-only medication, which means it cannot be bought without a prescription. Some online clinics and pharmacies may offer a private service to supply the cream. This usually means a private online consultation with a doctor who then issues the medication. Alternatively, patients may be asked to complete a questionnaire (about their health and symptoms), which then is reviewed by a doctor. Patients are usually charged for the consultation and cream supplied (it may come as one fee).

How often to apply diltiazem cream?

When used to treat a chronic anal fissure, diltiazem cream is applied twice a day until the pain stops. The maximum recommended duration of the treatment is eight weeks (BNF, 2021). Please follow the prescriber’s directions on how often and for how long to use the cream.

Diltiazem hydrochloride 2% cream: common side effects

Common side effects may be experienced by 1 in 10 patients. The most common side effects which may be experienced when using diltiazem cream are:

  • Headaches
  • Dizziness or light-headedness
  • Local irritation at the site of application, for example, burning or itching.

Diltiazem cream alternative options

GTN ointment (Rectogesic Ointment)

The use of GTN ointment (Rectogesic 4 mg/g Rectal Ointment)) as a first-line option in treating anal fissures was already discussed. GTN ointment is the preferred alternative to diltiazem cream. 

Oral diltiazem

Diltiazem can also be prescribed in the form of oral tablets for the treatment of anal fissures, taken twice a day (60mg) with a maximum duration of 8 weeks use.

Lidocaine cream / ointment

Lidocaine is a local anaesthetic that is commonly used to help manage pain associated with anal fissures. Anal fissures are small tears in the lining of the anus, which can cause significant discomfort and pain during bowel movements. Lidocaine provides temporary pain relief by numbing the area where it is applied. Lidocaine can be purchased from pharmacies, for example, Vagsil cream, which can be used to help with the discomfort of minor itching and irritation of the skin around the anus.

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Lidocaine cream and ointment are also available as generic product (pharmacy-only medicines), which is usually kept away in the dispensary. Patients can request to buy lidocaine cream or ointment.

A combination of steroid (hydrocortisone) and lidocaine (local anaesthetic) may provide relief from the pain and itchiness. Prescription-only Xyloproct ointment (5% of lidocaine and 0.275% of hydrocortisone) is licensed in the management of pain associated with haemorrhoids and anal fissures.

Surgery

Surgery is a final option for patients who do not respond to drug treatment.  

References:

BNF (2021). Diltiazem hydrochloride. Available at: https://bnf.nice.org.uk/drug/diltiazem-hydrochloride.html Accessed on 19/07/2023

NICE (2017). Anal fissure. Available at: https://cks.nice.org.uk/topics/anal-fissure/ Accessed on 19/07/2023

 

I am a qualified pharmacist working in an independent pharmacy in the UK.
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