Composition (per 100 g):

• Phenazone 5 g – a non-opioid analgesic with anti-inflammatory action, used to relieve pain.

• Chlorobutanol 1 g – an antiseptic and local anesthetic with mild sedative and preservative properties, helping prevent or reduce ear infections.

Dosage Form: Ear drops, 10 mL bottle.

Therapeutic Class: Analgesic and antiseptic otic preparation.

Indications:

• Relief of ear pain (otalgia) associated with otitis externa, otitis media, or after ear procedures.

• Provides local antiseptic action to reduce risk of secondary bacterial contamination in the external auditory canal.

Mechanism of Action:

• Phenazone reduces pain and inflammation in the ear by inhibiting prostaglandin synthesis.

• Chlorobutanol acts as a mild antiseptic and local anesthetic, enhancing pain relief and reducing microbial growth.

Administration & Dosage (general):

• Instill the prescribed number of drops into the affected ear canal, usually 3–4 drops, 2–3 times daily, or as directed by a physician.

Contraindications:

• Perforated tympanic membrane (unless specifically prescribed by a physician).

• Hypersensitivity to phenazone, chlorobutanol, or formulation components.

Precautions:

• For otic use only (not for ophthalmic use or ingestion).

• Avoid use in case of known tympanic membrane perforation, unless approved by a doctor.

• If symptoms persist or worsen, medical reassessment is needed.

Side Effects (rare):

• Local irritation, redness, or itching of the ear canal.

• Hypersensitivity reactions in sensitive patients.