API

Hydrocortisone (0.25% w/w) + Zinc Oxide (5% w/w) + Lidocaine (3% w/w) + Allantoin (0.5% w/w)

Drug classification

Topical antihemorrhoidal; corticosteroid, local anesthetic, skin protectant, and soothing agent combination.

Dosage form

Rectal suppository.

API strength per dosage

Dose

Pileum Suppository is typically used rectally in adults, usually one suppository inserted 1–2 times daily after defecation. Safety and dosing in children, or in patients with renal or hepatic impairment, are not established; use with caution. Prolonged use is not recommended. Always follow local prescribing information and consult a healthcare professional.

Mechanism of action

Hydrocortisone binds glucocorticoid receptors, reducing local inflammation. Zinc oxide acts as a protective barrier and has mild astringent properties. Lidocaine blocks voltage-gated sodium channels, inhibiting nerve impulse transmission and providing local anesthesia. Allantoin promotes tissue repair and soothes irritation, collectively relieving symptoms of hemorrhoids and anorectal discomfort.

Indications

Treatment of Anal fissure

Side effects

Application site reactions burning irritation itching and redness

Pregnancy category

Safety in pregnancy is not well established; use only if clearly needed and benefits outweigh potential risks. Consult a healthcare professional before use.

Precautions

Avoid prolonged use, monitor for local irritation or allergic reactions, do not apply to infected or broken skin, use with caution in rectal bleeding, avoid in known hypersensitivity to components, monitor for systemic corticosteroid effects with excessive use, not for ophthalmic use, keep out of reach of children.

Contraindications

Hypersensitivity to hydrocortisone, zinc oxide, lidocaine, allantoin, or excipients; systemic fungal, viral, or tuberculous infections; perianal or rectal infections; untreated bacterial infections; known hypersensitivity to local anesthetics of the amide type.