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Hydrocortisone 1% | Lidocaine 2% | Nifedipine 0.2%

Hydrocortisone 1% | Lidocaine 2% | Nifedipine 0.2% is a gastrointestinal or oral/rectal preparation selected when the prescriber needs a customized route, strength, texture, flavor, or combination for a patient-specific need.

OintmentRectalRx Only503A Compounded

Hydrocortisone 1% | Lidocaine 2% | Nifedipine 0.2% is a compounded topical anorectal ointment or cream combining a low-potency corticosteroid, a local anesthetic, and a calcium channel blocker. This three-component formulation is designed prescriber-directed for management of conditions such as anal fissures, hemorrhoidal pain, and anorectal inflammation. Genesis Compounding prepares this as a prescription-only, patient-specific, 503A compounded preparation not FDA-approved as a compounded product.

Active IngredientPharmacologic Role
Hydrocortisone 1%Low-potency corticosteroid that reduces anorectal inflammation, pruritus, and mucosal edema by suppressing prostaglandin and cytokine-mediated inflammatory pathways.
Lidocaine 2%Amide-class local anesthetic that reversibly blocks voltage-gated sodium channels in sensory nerve endings, providing rapid topical pain relief and analgesia during defecation.
Nifedipine 0.2%Dihydropyridine calcium channel blocker that relaxes internal anal sphincter smooth muscle by reducing calcium-mediated contraction, lowering resting anal pressure and improving blood flow to facilitate fissure healing.

Route: Topical anorectal. Apply a small amount (approximately 1 cm strip or as prescribed) to the anal area and, if instructed, gently insert into the anal canal using a rectal applicator tip. Apply every 12 hours (twice daily) or as directed by the prescriber — typically for 4–6 weeks. Wash hands before and after application. Avoid prolonged use of the hydrocortisone component (>2 weeks) to prevent anodermal atrophy.

Dosing is prescriber-determined:

  • Typical regimen: apply twice daily (every 12 hours) for 4–6 weeks for anal fissure management.
  • Some prescribers direct pre-defecation application for pain management during bowel movements.
  • The hydrocortisone component should be limited in duration — prescriber monitors for steroid-induced anodermal thinning.
  • All timing, quantity, and duration are determined by the prescribing clinician.
  • Hydrocortisone 1%: Binds intracellular glucocorticoid receptors, forming a complex that translocates to the nucleus and suppresses transcription of pro-inflammatory cytokines (IL-1, TNF-α), reduces prostaglandin synthesis via phospholipase A2 inhibition, and attenuates anorectal edema and pruritus.
  • Lidocaine 2%: Reversibly binds and blocks voltage-gated Na⁺ channels in sensory nerve membranes, preventing depolarization and action potential propagation, resulting in local analgesia and reduced pain with defecation.
  • Nifedipine 0.2%: Blocks L-type voltage-dependent calcium channels in smooth muscle cells of the internal anal sphincter, reducing intracellular Ca²⁺ and causing sphincter relaxation. This decreases resting anal pressure, relieves ischemia-associated fissure pain, and improves anoderm blood flow to promote healing.

This triple-combination topical is used prescriber-directed for chronic or acute anal fissure, hemorrhoidal pain and inflammation, and other anorectal conditions requiring concurrent pain relief, anti-inflammatory action, and sphincter relaxation. Nifedipine-lidocaine combinations have demonstrated fissure healing rates up to 94.5% in randomized controlled trials (Perrotti et al.), representing a well-evidenced therapeutic strategy. The addition of hydrocortisone addresses the inflammatory and pruritic component.

Monitoring: Healing assessment at 4–6 weeks; limit corticosteroid application duration to minimize anodermal atrophy; blood pressure awareness with nifedipine in patients on antihypertensives (systemic absorption is negligible at 0.2%, but possible).

Contraindications:

  • Known hypersensitivity to lidocaine (amide anesthetics), nifedipine (dihydropyridines), hydrocortisone, or formulation components.
  • Active untreated perianal infection (abscess, fistula) — treat infection first.

Warnings & Precautions:

  • Prolonged corticosteroid use: limit hydrocortisone duration to 2 weeks to avoid anodermal atrophy, telangiectasia, and risk of secondary infection.
  • Nifedipine 0.2%: systemic absorption from anorectal mucosa is low; no postural hypotension was observed in clinical trials at this concentration.
  • Lidocaine: systemic toxicity risk is negligible at topical anorectal doses; avoid large-area application with compromised mucosa.

Drug Interactions:

  • Concomitant antihypertensive medications: theoretical additive hypotensive effect from nifedipine topical (clinically minimal at 0.2%).
  • Class I antiarrhythmics: additive sodium channel blockade with lidocaine (negligible risk at topical doses).

Common Side Effects: Local hyperemia, mild burning or stinging at application site. Rare: allergic contact dermatitis to any component.

Store at room temperature (15°C–25°C). Keep tightly closed. Protect from excessive heat and light. Do not freeze. Use within the beyond-use date assigned by Genesis Compounding. Nifedipine is photosensitive — store in an opaque container or away from light.

What conditions is this cream used for?

This triple-combination ointment is prescriber-directed for anal fissures, hemorrhoidal pain and inflammation, and other anorectal conditions requiring concurrent analgesia, anti-inflammatory action, and internal sphincter relaxation to promote healing.

How does nifedipine help with anal fissures?

Nifedipine relaxes the internal anal sphincter by blocking calcium channels in smooth muscle, lowering resting anal pressure. Elevated sphincter tone is a key factor in fissure pain and impaired healing; reducing this pressure improves blood flow to the anoderm and allows the fissure to heal.

How long should I use this medication?

Typically 4–6 weeks, as directed by your prescriber. The hydrocortisone component should not be used for more than 2 weeks without prescriber reassessment, due to risk of skin thinning.

Is this FDA-approved?

No. This is a patient-specific, prescriber-directed 503A compounded preparation from Genesis Compounding, not FDA-approved as a compounded drug.

Will nifedipine lower my blood pressure?

At the 0.2% concentration applied topically to the anorectal area, systemic absorption is very low and significant blood pressure changes are not expected. Clinical trials found no systemic hypotensive effects. Inform your prescriber of all antihypertensive medications you are taking.

Clinical References

Authoritative sources reviewed in preparing this clinical summary. Provided for prescriber reference; not a substitute for the prescriber’s clinical judgment.

Topical nifedipine with lidocaine ointment vs. active control for treatment of chronic anal fissure
PubMed / Perrotti et al., Diseases of the Colon & Rectum, 2002
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DailyMed: Hydrocortisone Rectal Cream label
NIH DailyMed
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DailyMed: Lidocaine Topical label
NIH DailyMed
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Nifedipine — NCBI StatPearls
StatPearls Publishing / NCBI
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