Compounded fissure cream: what it is, how to get one and why it doesn’t travel

What is a compounded fissure cream?

Most medicines you buy are made in a factory in large batches, approved by a regulator and sold in identical boxes. A compounded medicine is different: a pharmacist prepares it by hand, in a licensed pharmacy, for one named patient, following a doctor’s prescription. The name changes by country. In the US it is called compounding; in the UK an unlicensed medicine made to order is a "special"; in Australia, compounding pharmacies do the same work; in Spain, Mexico or Peru it is a "magistral formula".

For anal fissure, compounding is not a niche. It is often the main way patients get the creams that guidelines recommend. A chronic fissure stays open because the internal sphincter is in spasm and reduces blood flow to the tear. The ointments that relax it are nifedipine and diltiazem (calcium channel blockers) and nitroglycerin. Nitroglycerin exists as a licensed product in many countries (Rectiv in the US, Rectogesic in the UK, Australia and Europe). Topical nifedipine and diltiazem, in most countries, do not, so a pharmacist makes them.

A compounded fissure cream is not an experimental or "alternative" product. It contains the same active drugs used in clinical trials, at the same strengths, in a base chosen to suit the anal canal.

Why are diltiazem and nifedipine creams usually compounded?

Because the drugs are old and inexpensive, and few manufacturers have taken a topical anal version through the full licensing process in each country. The tablets exist everywhere for blood pressure and angina; the ointment is the part that is missing. The evidence for the ointment, though, is solid:

• The American (ASCRS 2023) and British (ACPGBI 2023) guidelines recommend topical calcium channel blockers or nitroglycerin as first-line treatment for a chronic fissure.
• A systematic review of seven randomized trials and 481 patients found diltiazem as effective as nitroglycerin, with fewer headaches (risk ratio 0.39) and fewer recurrences (Sajid, 2013).
• A randomized double-blind trial of nifedipine 0.3 % plus lidocaine 1.5 % reported healing in 94.5 % of chronic fissures at 6 weeks, against 16.4 % in the control group (Perrotti, 2002).

Typical compounded formulas are diltiazem 2 % or nifedipine 0.2 to 0.3 %, sometimes with lidocaine 1 to 2 % for pain, in an ointment, cream or gel base. They are applied 2 to 3 times a day for 6 to 8 weeks. In the UK, diltiazem 2 % is widely prescribed through the NHS, usually as a special. In the US, compounding pharmacies prepare both on prescription. Our guides to Diltiazem 2% cream for anal fissure: who it is for, how to use it and what to expect and Nifedipine cream for anal fissure: dose, application, side effects and the 8-week plan cover dosing and side effects.

How does a doctor prescribe a compounded fissure cream?

The prescription has to say exactly what the pharmacist must make. A complete one includes:

1. The active drug and strength: for example, diltiazem hydrochloride 2 %, or nifedipine 0.3 % with lidocaine 1.5 %.
2. The base: ointment (greasy, stays in place), cream or water-based gel. Our guide to Gel, cream, ointment or paste: which form is best for an anal fissure? explains the differences.
3. The quantity: enough for a defined period, often split into several smaller preparations because of the short shelf life.
4. Directions: how much, how often, where (just inside the anal opening) and for how long.

The pharmacy then prepares it, labels it with your name, the formula, the date of preparation and the beyond-use date, and explains storage. Expect to wait a day or more for the preparation. In some health systems the cost is partly covered; in others it is paid out of pocket, and prices vary widely between pharmacies. Our guide to All guides gives an overview by country.

How long does a compounded fissure cream last?

Much less than a factory-made tube. A licensed medicine goes through long stability studies to earn an expiry date of years. A compounded cream gets a beyond-use date set by the pharmacist from published stability data and the type of base, and it is usually counted in weeks, not years. Water-containing creams and gels, which can grow microbes, tend to have shorter dates than greasy ointments.

Nifedipine adds a practical twist: it is sensitive to light, which is why it is dispensed in opaque or amber containers. Some formulas need refrigeration; others must stay at room temperature. Follow the label, not the habit of keeping all creams in the bathroom cabinet.

• Do not use it after the beyond-use date, even if it looks fine.
• Change in color, smell, texture or separation means: ask the pharmacy before using it.
• Keep the lid closed, the container away from heat and light, and use a clean fingertip or the applicator provided.

Because a full course lasts 6 to 8 weeks, your doctor may prescribe it as several preparations, each made when you need it, rather than one large jar that would expire halfway through the treatment.

Why can’t a compounded cream be shipped to another country?

This is the question we hear most from patients who read about a specific formula abroad. There are four reasons, and each one alone is enough:

• It is prepared for one named patient under a local prescription. Compounding is legally a pharmacy service for a patient the pharmacy can identify and counsel, not a product made for distribution. A prescription issued in one country is generally not valid in another country’s pharmacy.
• It has no marketing authorization in the destination country. Importing an unlicensed medicine usually requires a specific permit. Parcels with prescription medicines can be held or destroyed at customs.
• Short shelf life and storage conditions. Days in transit, heat or cold, and customs delays eat into a beyond-use date measured in weeks, and nobody can check the conditions along the way.
• Follow-up. A fissure cream is part of a treatment plan: review at 4 and 8 weeks, management of side effects, decision about the next step. That follow-up belongs with a doctor who can see you.

The good news is that the formula travels even if the jar does not. Diltiazem 2 % and nifedipine 0.2 to 0.3 % are standard formulas that any compounding pharmacy can prepare. Take the exact composition to your own doctor or a colorectal surgeon, who can prescribe it locally. If you want to be seen remotely first, our guide to All guides explains what can and cannot be done at a distance.

How do you know a compounded cream is safe to use?

• Use a licensed pharmacy that asks for a prescription. Websites that sell "fissure cream" with nifedipine or diltiazem without a prescription are a red flag.
• Check the label: your name, the drug and strength, the base, the date of preparation, the beyond-use date and storage instructions.
• Expect counseling: how much to apply (usually a pea-sized amount), how often, and what side effects to watch for, such as local burning, headache or lightheadedness.
• Tell the pharmacist and doctor about your other medicines, especially blood pressure tablets, and about pregnancy or breastfeeding.

Most side effects of topical calcium channel blockers are mild and local; we cover them in Side effects of anal fissure creams and how to manage them. If the fissure is still open after 6 to 8 weeks of correct use, the next steps are botulinum toxin or a lateral internal sphincterotomy, discussed with a colorectal surgeon.

Any of these signs needs a medical review without delay, whatever cream you are using.

Where does FISURIN fit?

FISURIN is exactly the kind of preparation this article describes: a magistral (compounded) formula of nifedipine with lidocaine in a water-based hydrogel, prescribed by our surgeons at Clínica Proctológica de Lima with a written 6-week protocol and prepared by an authorized pharmacy in Peru. For the reasons explained above, it is dispensed only in Peru and is not shipped abroad. It does not replace soft stools and cannot promise closure in every case. For other countries, FISURIN Hydrogel (medical device) and FISURIN Relief are in preparation, with a waiting list by country. See what is inside FISURIN or how to get it where you live, and compare it with a pharmacy nifedipine ointment in FISURIN or a pharmacy nifedipine ointment: what really changes?.