CreamTopicalNon sterile Rx only

Diltiazem Topical Cream (VersaBase®)

Topical Cream Base

A compounded diltiazem cream, commonly 2%, prepared in Chino, CA to a prescriber's order for perianal application in chronic anal fissure.

Reviewed by Linda Pungpravat, Compounding Pharmacist, RPh Mixwell Compounding Pharmacy, Chino, CA

USP <795> compliant
USP <800> hazardous drug lab
PCCA member

At a Glance

Preparation details for Diltiazem Topical Cream (VersaBase®)
Dosage form	Cream
Route	Topical
Active ingredients	Diltiazem hydrochloride
Technology	Topical Cream Base
Strengths in literature	Diltiazem 2% applied to the perianal area two to three times daily for 8 weeks to 3 months in published trials
Commercial product	No U.S. commercial product
Strength and directions	Per prescriber
Dispensing	Valid prescription

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Phone (909) 378-7301. Fax (909) 378-7071

Clinical Advantages

Custom strength available
Dye free option
Non sterile preparation
Applied topically

How It Works

What is Diltiazem Topical Cream?

Diltiazem Topical Cream is a compounded cream of diltiazem, a calcium channel blocker, in VersaBase cream. It is applied to the perianal area, most often for chronic anal fissure, and is prepared by prescription for one patient, commonly at 2%.

How it works

Chronic anal fissures are linked to a tight internal anal sphincter and reduced blood flow to the fissure [1].
The internal sphincter relies on calcium to contract. Diltiazem blocks L type calcium channels, which relaxes the muscle and lowers resting pressure in the anal canal, and is thought to improve blood flow to the fissure [1].
This is sometimes called a chemical sphincterotomy, a medical alternative to surgery or injection [1].

When prescribers choose it

Colorectal surgeons and gastroenterologists treating chronic anal fissure
Primary care practices starting medical therapy before referral
Prescribers whose patients had headaches with topical nitrates
Patients who want to try medical treatment before an injection or surgery

Clinical Details

What does the evidence show?

The 2023 guideline of the American Society of Colon and Rectal Surgeons states that topical calcium channel blockers can be used as first line medical therapy for chronic anal fissure, with effectiveness comparable to nitrates and a better side effect profile [1].
A UK evidence summary of a Cochrane review and additional randomized trials found that 2% topical diltiazem was not significantly different from topical glyceryl trinitrate in adults, with limited evidence of fewer headaches. In one small trial that included a no treatment group, healing was 80% with diltiazem and 33% without treatment [3].
Samim and colleagues (2012, Annals of Surgery) randomized 134 adults with anal fissure to 2% diltiazem cream twice daily for 3 months or botulinum toxin injection. Healing was 43% in both groups, and recurrence over a median of 39 months was 17.6% with diltiazem and 11.7% with botulinum toxin [3][4].
Results vary widely between trials: healing with 2% diltiazem ranged from 43% to 92.9% and recurrence from 10.4% to 65%. Two trials suggested diltiazem was less effective than surgical sphincterotomy, for example healing of 80% versus 95% at 8 weeks, though this was not tested statistically [3].

Findings come from the cited studies and do not promise any individual outcome.

Why is it compounded, and how is it typically used?

Why it is compounded

There is no commercially licensed topical diltiazem product for anal fissure. Oral diltiazem is approved for angina and high blood pressure, not for this use. When a prescriber wants topical diltiazem, a compounding pharmacy prepares it at the strength ordered, commonly 2%.

Dosage forms and strengths

Strength set by the prescriber, commonly 2%, applied to the perianal area two to three times daily for 8 weeks to 3 months in published trials [3]
VersaBase cream base
Dye free and preservative conscious versions on request
Quantities matched to the prescribed course

Dosing, duration, and any conservative measures such as fiber, fluids, and sitz baths are the prescriber's decision.

How Mixwell prepares it

Mixwell compounds this cream in Chino, California under USP 795 standards for non sterile preparations [6]. Our pharmacist confirms the strength and application directions with the prescriber before compounding. Batch records document every preparation, and finished creams ship across California.

Safety information

Topical diltiazem is generally well tolerated, with mostly minor local effects such as perianal skin irritation, and limited evidence suggests fewer headaches than with topical nitrates [3]. Because diltiazem is a calcium channel blocker, prescribers consider cardiovascular history and interacting medications, as they would for oral diltiazem. Patient selection, dosing, and monitoring are the prescriber's responsibility.

References

Davids JS, Hawkins AT, Bhama AR, et al. The American Society of Colon and Rectal Surgeons clinical practice guidelines for the management of anal fissures. Dis Colon Rectum. 2023;66(2):190 to 199. doi:10.1097/DCR.0000000000002664
Nelson RL, Thomas K, Morgan J, Jones A. Non surgical therapy for anal fissure. Cochrane Database Syst Rev. 2012;(2):CD003431. doi:10.1002/14651858.CD003431.pub3
National Institute for Health and Care Excellence. Chronic anal fissure: 2% topical diltiazem hydrochloride. Evidence summary ESUOM3. NICE
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 to 22.
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 to 1078.
United States Pharmacopeia. General Chapter 795, Pharmaceutical Compounding: Nonsterile Preparations. USP NF. Official November 1, 2023.

What to include on the prescription

APIs and strengths
Base or vehicle
Quantity
Directions for use
Refills
Allergies or dye free needs

Call (909) 378-7301 Fax (909) 378-7071

Compounded in Chino, CA. Delivered across California.

Chino
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Ontario
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Mixwell Compounding Pharmacy 13788 Roswell Ave, Ste 158, Chino, CA 91710
(909) 378-7301

Compounded medications are not reviewed or approved by the FDA. Dispensed only with a valid prescription. Mixwell is a non sterile pharmacy and does not prepare sterile products or injectables. Compounded preparations are not presented as superior to commercially available products, and nothing here promises a specific result. Mixwell does not accept insurance. Call for pricing.

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