Otocort Drops

Otocort Drops

Description:

Otocort Ear Drops 10 ml is a prescription otic medication used to treat inflammatory and infectious conditions of the external ear. It combines an anti-infective agent (clioquinol / iodochlorhydroxyquin) with a potent topical corticosteroid (flumethasone) to relieve pain, redness, swelling, and itching associated with ear infections and eczema of the ear canal. Otocort is intended for local use in the ear only and should be used under medical supervision, especially in adults and children with ear inflammation or suspected bacterial or fungal infection.

Indications:

• Treatment of inflammatory conditions of the external ear canal (otitis externa) that are responsive to corticosteroids and where a bacterial or fungal infection is suspected or present.
• Relief of symptoms such as ear pain, itching, redness, swelling, and irritation of the external auditory canal.
• Management of eczematous or allergic dermatitis affecting the outer ear and ear canal when infection risk is present.
• Adjunctive therapy in mixed inflammatory and infectious ear conditions, as directed by a physician.

Active Ingredients / Key Components:

• Clioquinol (Iodochlorhydroxyquin) – concentration in mg/ml is not specified in the available information (For full ingredient information, please check the product leaflet or the manufacturer’s official website.).
• Flumethasone – concentration in mg/ml is not specified in the available information (For full ingredient information, please check the product leaflet or the manufacturer’s official website.).
• Other excipients: Full list of inactive ingredients is not available in the provided data. Please refer to the product leaflet for complete composition.

Dosage & Administration / How to Use:

• Otocort Ear Drops are for otic (ear) use only. Do not swallow or use in the eyes or on the skin away from the ear unless specifically instructed by your doctor.
• Typical adult dosing: The exact recommended dose and frequency are not specified in the available information (For full ingredient information, please check the product leaflet or the manufacturer’s official website.). Common clinical practice for similar ear drops is several drops into the affected ear 2–3 times daily, but you must follow your doctor’s specific instructions and the product leaflet.
• Children: Use only under medical supervision. The doctor will determine the appropriate dose and duration based on age and condition.
• Administration steps:
  • Wash and dry your hands thoroughly before use.
  • Warm the bottle in your hand for a few minutes to reduce dizziness that may occur from cold drops.
  • Shake gently if recommended by the leaflet (check instructions).
  • Tilt the head to one side so the affected ear faces upward.
  • Instill the prescribed number of drops into the ear canal without touching the ear with the dropper tip.
  • Keep the head tilted for several minutes to allow the drops to penetrate the ear canal.
  • If both ears are affected, repeat in the other ear as directed.
• Duration of treatment: Use for the full duration prescribed by your doctor. Do not use longer than recommended, as prolonged use of topical corticosteroids in the ear may increase the risk of side effects.
• If a dose is missed: Apply it as soon as you remember. If it is almost time for the next dose, skip the missed dose and continue with your regular schedule. Do not double the dose.

Clinical Benefits:

• Provides targeted anti-inflammatory action in the ear canal, reducing swelling, redness, and discomfort.
• Helps control itching and irritation associated with otitis externa and eczematous ear conditions.
• Offers broad-spectrum anti-infective activity through clioquinol, which is active against certain bacteria and fungi commonly implicated in external ear infections.
• Supports faster symptom relief and recovery when used as part of a physician-directed treatment plan for ear inflammation and infection.

Warnings & Contraindications:

• Do not use Otocort Ear Drops if you are allergic (hypersensitive) to clioquinol (iodochlorhydroxyquin), flumethasone, other quinoline derivatives, corticosteroids, or any of the excipients in the formulation.
• Contraindicated in patients with known or suspected perforation of the tympanic membrane (eardrum) unless specifically prescribed and monitored by an ear specialist.
• Do not use in viral infections of the ear (such as herpes simplex or varicella) or in untreated tuberculosis or syphilitic infections of the ear.
• Prolonged or repeated use of topical corticosteroids in the ear may increase the risk of local side effects (thinning of skin, delayed healing) and, rarely, systemic absorption, especially in children.
• Avoid contact with eyes, mouth, or broken skin. If accidental contact occurs, rinse thoroughly with water.
• Consult your doctor before use if pregnant or breastfeeding. The safety of prolonged otic use of corticosteroids during pregnancy and lactation should be carefully evaluated by a healthcare professional.
• Inform your doctor if you have chronic ear disease, previous ear surgery, persistent ear discharge, or hearing problems before starting treatment.
• If symptoms worsen, hearing changes, severe pain, or persistent discharge occur, stop use and seek medical attention promptly.
• Not intended to diagnose, treat, cure, or prevent any disease without appropriate medical evaluation and prescription.
• Keep out of reach of children.

Side Effects:

• Common local side effects may include mild burning, stinging, or irritation in the ear canal after instillation.
• Less common side effects can include dryness, itching, or rash around the ear, or allergic reactions such as redness, swelling, or worsening irritation.
• Prolonged use may rarely lead to thinning of the skin in the ear canal or overgrowth of non-susceptible organisms (secondary infection).
• Serious side effects are rare but may include severe allergic reaction (swelling of face, lips, tongue, or throat; difficulty breathing), marked hearing changes, or severe ear pain. Stop use and seek immediate medical attention if these occur.
• If you notice any unexpected or persistent side effects, inform your doctor or pharmacist.

Storage Instructions:

Store in a cool, dry place away from direct sunlight. Keep container tightly closed. Do not freeze. Keep out of reach of children. Do not use after the expiry date printed on the packaging. Discard the bottle a certain period after first opening as indicated in the leaflet (information not specified here; please check the pack).

Specifications:

• Product type: Prescription otic medicine (ear drops).
• Form: Sterile solution for ear instillation (drops).
• Volume: 10 ml bottle.
• Intended users: Adults and children as directed by a physician.
• Route of administration: Otic (into the ear canal) only.

Disclaimer:
All pharmacy products are intended for general use only and do not replace professional medical advice, diagnosis, or treatment. Always consult a healthcare provider before use. Results may vary, and no specific outcomes are guaranteed. Products are not intended to diagnose, treat, cure, or prevent any disease unless stated. Follow label instructions carefully, as misuse may cause adverse effects. Compliance with local laws is the customer’s responsibility.