What are the prescription topical treatments for anal fissures?

Prescription Topical Treatments for Anal Fissures

The prescription topical treatments for anal fissures are compounded nifedipine 0.3% (often combined with lidocaine 1.5%) and diltiazem 2%, both calcium channel blockers that require compounding by a pharmacy, as well as glyceryl trinitrate (GTN) ointment. 1, 2

Primary Prescription Options

Topical Nifedipine (First-Line Prescription Choice)

• The recommended formulation is 0.3% nifedipine compounded with 1.5% lidocaine, applied three times daily for at least 6 weeks, achieving a 95% healing rate. 2
• Nifedipine demonstrates superior efficacy compared to diltiazem (77.4% vs 54% remission rate) and provides earlier pain relief. 3
• This agent has significantly fewer side effects (5%) compared to GTN (40%), particularly avoiding the common headache and flushing associated with nitrates. 4
• The mechanism involves blocking L-type calcium channels in vascular smooth muscle, reducing internal anal sphincter tone and increasing local blood flow to the ischemic ulcer. 2

Topical Diltiazem (Alternative Prescription Option)

• Diltiazem 2% ointment is applied in the same manner as nifedipine (three times daily for 6-8 weeks) with healing rates of 65-95%. 1, 5
• While effective, it shows lower remission rates than nifedipine in head-to-head trials (54% vs 77.4%). 3
• It shares the same mechanism of action as nifedipine but appears less potent clinically. 2

Glyceryl Trinitrate (GTN) Ointment (Less Preferred Prescription)

• GTN demonstrates healing rates of only 25-50%, significantly lower than calcium channel blockers. 1, 5
• Headaches occur in 40% of patients, often limiting compliance and effectiveness. 5, 4
• GTN is marginally better than placebo (48.9% vs 35.5%) but inferior to both nifedipine and diltiazem. 6

Treatment Algorithm

Initial Approach (All Patients)

• Start with conservative management including increased fiber intake, adequate fluid consumption, stool softeners, warm sitz baths, and topical lidocaine for pain control. 1, 2, 5
• Approximately 50% of acute anal fissures heal within 10-14 days with conservative measures alone. 1, 5

When to Prescribe Topical Medications

• If the fissure persists beyond 2 weeks despite conservative management, prescribe compounded nifedipine 0.3% with lidocaine 1.5% applied three times daily. 1, 5
• Continue treatment for a minimum of 6-8 weeks, with pain relief typically occurring after 14 days. 2, 5
• If symptoms persist after 8 weeks of topical treatment, the condition is classified as chronic and surgical options should be considered. 2

Important Clinical Considerations

Compounding Requirements

• Both nifedipine and diltiazem require compounding by a pharmacy as they are not available as FDA-approved commercial preparations for anal fissures. 2
• The combination with lidocaine provides immediate pain relief while the calcium channel blocker promotes healing. 2

Cost-Effectiveness

• Calcium channel blockers demonstrate remarkable cost-effectiveness compared to other non-operative treatments and surgical interventions. 2
• The high healing rates make topical nifedipine an excellent first-line pharmacologic option before considering more invasive procedures. 2

Critical Pitfalls to Avoid

• Never perform manual dilatation as it is strongly contraindicated due to high risk of incontinence. 2, 5
• Surgical interventions should be avoided in acute fissures and reserved only for chronic fissures non-responsive after 8 weeks of conservative management. 5

Recurrence Rates

• Late recurrence is common with all medical therapies, occurring in 31-42% of patients after initial healing. 4
• Recurrence rates are similar between nifedipine (42%) and GTN (31%), though nifedipine achieves higher initial healing. 4
• No medical therapy approaches the efficacy of surgical sphincterotomy, though medical options avoid the risk of incontinence. 6

Special Populations

• In children, the same prescription topicals may be considered if conservative management fails after 2 weeks, though most pediatric fissures heal with conservative care alone. 5
• Atypical fissures (not in the midline) require evaluation for underlying conditions such as Crohn's disease before initiating topical therapy. 1, 5