What Is Diltiazem Topical Cream?
It is a compounded topical preparation of diltiazem — a calcium channel blocker — applied to the perianal area, most often prescribed for chronic anal fissure. It is prepared by prescription for an individual patient.
How Does It Work?
Chronic anal fissures are associated with hypertonia of the internal anal sphincter and reduced blood flow to the ischemic anoderm, so treatment aims to lower internal sphincter resting pressure and improve local circulation. Internal sphincter tone is calcium-dependent, and calcium channel blockers relax this smooth muscle. Diltiazem blocks L-type calcium channels, helping the sphincter relax, reducing resting anal pressure, and improving mucosal blood flow to promote healing without damaging the sphincter.
What Does the Evidence Show?
- In its 2023 guideline, the American Society of Colon and Rectal Surgeons states that calcium channel blockers are comparably effective to nitrates for chronic anal fissures, have a better side-effect profile, and can be used as first-line treatment.
- A double-blind randomized trial also compared topical diltiazem with botulinum toxin for chronic anal fissure. PubMed Central
These findings come from the cited studies and are not a promise of any individual outcome.
Why Is It Compounded?
There is no commercially licensed topical diltiazem product for anal fissure; oral diltiazem is approved for angina and blood pressure, not for this indication. When a prescriber wants topical diltiazem, a compounding pharmacy prepares it to the specified strength (commonly 2%).
How Is It Typically Used?
In published protocols, 2% diltiazem is applied to the perianal area about twice daily for roughly six weeks, alongside conservative measures such as a high-fiber diet, fluids, and sitz baths. Dosing and duration are the prescriber's clinical decision.
Safety Information
Topical diltiazem is generally well tolerated, with mostly minor local effects such as perianal dermatitis, and fewer systemic effects than the headaches commonly seen with topical nitrates. As a calcium channel blocker, prescribers consider cardiovascular history and interacting medications. Patient selection, dosing, and monitoring are the prescriber's responsibility.
Quality and Compliance
Mixwell Compounding Pharmacy prepares this cream in our purpose-built lab to the prescriber's exact strength, dispensed only with a valid prescription. Mixwell follows USP <795> standards for non-sterile compounding, and our facility also meets USP <800> standards for hazardous-drug compounding. Mixwell is a non-sterile pharmacy and does not prepare sterile products or injectables. Compounded medications are not reviewed or approved by the FDA. Nothing here promises a specific result, and compounded preparations are not presented as superior to commercially available products.
References
- The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Management of Anal Fissures. Dis Colon Rectum. 2023.
- Nelson RL, Thomas K, Morgan J, Jones A. Non-surgical therapy for anal fissure. Cochrane Database Syst Rev. 2012;(2):CD003431.
- Jonas M, Neal KR, Abercrombie JF, Scholefield JH. A randomized trial of oral vs. topical diltiazem for chronic anal fissures. Dis Colon Rectum. 2001;44(8):1074–1078.
- Samim M, Twigt B, Stoker L, Pronk A. Topical diltiazem cream versus botulinum toxin A for the treatment of chronic anal fissure: a double-blind randomized clinical trial. Ann Surg. 2012;255(1):18–22.