Finished product reference

Lidocaine / Hydrocortisone Acetate

Ointment · Rectal · 5 %/0.5 % · 15 g

List code
762
Pharmacologic class
Corticosteroid and local anaesthetic combination (rectal)

What it is and how it works

Hydrocortisone acetate is a mild corticosteroid that reduces local inflammation, oedema and itching. Lidocaine is an amide local anaesthetic that blocks sodium channels in sensory nerve membranes, relieving pain and discomfort.

Indications

Short-term symptomatic relief of pain, irritation, itching and inflammation associated with haemorrhoids, anal fissure and pruritus ani.

Dosage and administration (summary)

Apply a small amount to the anal area and/or insert into the rectum with the applicator, usually 2–3 times daily and after each bowel movement; use for no longer than about 7 days.

Contraindications

Hypersensitivity to the components or to amide local anaesthetics; untreated local bacterial, viral (e.g. herpes), fungal or tuberculous infection.

Warnings and precautions

Prolonged use should be avoided because of local corticosteroid effects (skin atrophy) and possible systemic absorption. Persistent rectal bleeding or symptoms require investigation to exclude serious disease. Sensitisation to lidocaine may occur.

Pregnancy

Use only short term when clearly needed.

Storage and supply

Store below 25 °C; do not freeze.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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