Anorel

• Anal Fissures and Hemorrhoids:
  Used for symptomatic relief of pain, itching, inflammation, and bacterial infection associated with hemorrhoids and anal fissures.
• Perianal and Perirectal Inflammatory Conditions:
  Treatment of inflamed and infected perianal skin and mucosa where bacterial infection coexists with inflammation.
• Postoperative Care:
  Management of pain, inflammation, and prevention of bacterial infections after anorectal surgery.
• Off-label/Clinically Accepted Uses:
• Minor infected perianal skin lesions with inflammation
• Adjunctive therapy in anorectal pruritus accompanied by infection

• Adults:
  Apply a thin layer of ointment or cream to the affected anal/perianal area 2–3 times daily, preferably after bowel movements and at bedtime.
  Duration is generally limited to up to 7 days unless otherwise directed by a healthcare provider.
• Pediatrics:
  Safety and efficacy not well established; use only under medical supervision.
• Elderly:
  Use standard adult dosing; monitor for corticosteroid-related adverse effects if prolonged use occurs.
• Administration Route:
  Topical application to the affected area after cleansing and drying. Wash hands before and after application.

This combination delivers multiple therapeutic effects:

• Cinchocaine acts as a local anesthetic by blocking voltage-gated sodium channels on neuronal membranes, inhibiting nerve impulse conduction and providing rapid analgesia and relief from pain and itching.
• Hydrocortisone is a low-potency corticosteroid that reduces inflammation by suppressing leukocyte migration, cytokine production, and inflammatory mediator release, thereby decreasing redness, swelling, and itching.
• Neomycin is an aminoglycoside antibiotic that binds irreversibly to bacterial 30S ribosomal subunits, inhibiting protein synthesis and leading to bactericidal activity against susceptible gram-negative and some gram-positive bacteria, preventing or treating secondary bacterial infections.
• Esculin, a natural plant-derived compound, exhibits anti-inflammatory and antioxidant properties, improves microcirculation, promotes vascular health, and supports tissue repair in the affected perianal region.

• Absorption: Minimal systemic absorption when applied topically on intact skin or mucous membranes; absorption may increase with damaged skin.
• Distribution: Effects are mainly localized; negligible systemic distribution expected.
• Metabolism: Hydrocortisone undergoes hepatic metabolism if systemically absorbed; neomycin and cinchocaine have minimal systemic metabolism due to low absorption; esculin metabolism occurs locally.
• Elimination: Hydrocortisone metabolites excreted renally; neomycin eliminated unchanged in urine if absorbed systemically; cinchocaine metabolized hepatically if systemically absorbed.
• Onset: Analgesic effect of cinchocaine within minutes; hydrocortisone and esculin act over hours to days; neomycin exerts antibacterial effects during treatment.

• Pregnancy:
• Hydrocortisone is generally classified as Category C; use topical corticosteroids cautiously only if benefits outweigh risks.
• Neomycin and cinchocaine lack sufficient data in pregnancy; use only if necessary.
• Lactation:
• Limited data on excretion into human milk; systemic absorption from topical use is minimal.
• Caution is advised during breastfeeding; use limited areas and shortest duration possible.

• Cinchocaine: Local anesthetic
• Hydrocortisone: Topical corticosteroid (anti-inflammatory)
• Neomycin: Aminoglycoside antibiotic
• Esculin: Anti-inflammatory and vascular protective agent (natural compound)

• Known hypersensitivity to cinchocaine, hydrocortisone, neomycin, esculin, or formulation excipients
• Viral, fungal, or tuberculous skin infections at the application site (due to corticosteroid use)
• Severe bacterial infections not sensitive to neomycin
• Open wounds or ulcers unsuitable for topical corticosteroid or aminoglycoside treatment without medical supervision
• Perianal abscess or fistula without surgical intervention

• Avoid prolonged corticosteroid use to prevent skin atrophy, striae, or systemic effects
• Monitor for allergic contact dermatitis, especially due to neomycin (known for sensitization risk)
• Use cautiously in patients with renal impairment, given potential neomycin nephrotoxicity if systemically absorbed
• Avoid contact with eyes and mucous membranes
• Discontinue use if condition worsens or no improvement within 7 days
• Use caution on broken or inflamed skin to limit systemic absorption

Common:

• Mild local burning or stinging sensation
• Skin dryness or irritation
• Transient redness at the application site

Less Common / Rare:

• Allergic contact dermatitis or sensitization, especially due to neomycin
• Skin thinning, striae, or telangiectasia with prolonged corticosteroid use
• Secondary fungal infections due to corticosteroid immunosuppression
• Rare systemic neomycin toxicity (nephrotoxicity, ototoxicity) if absorbed systemically (very rare with topical use)

• Minimal systemic interactions expected due to low absorption
• Avoid concomitant topical corticosteroids or aminoglycosides unless advised
• Caution when used with other nephrotoxic or ototoxic drugs due to neomycin component

• Continued recommendation for short-term use in symptomatic relief of infected and inflamed anorectal conditions
• Emphasis on limiting corticosteroid duration to minimize adverse effects
• Ongoing evaluation of esculin’s supportive role in microcirculation and tissue repair

• Store at 20°C to 25°C (68°F to 77°F)
• Protect from moisture, heat, and direct sunlight
• Keep container tightly closed
• Do not freeze
• Keep out of reach of children