Xilodex Ear Suspension

Adult use

Acute otitis media: Instill 4 drops of this medication into the infected ear, twice a day for 7 days. Acute external otitis: Instill 4 drops of this medication into the infected ear, twice a day for 7 days. Shake well before use. Instilling a cold solution into the ear may cause dizziness; therefore, warm the container in your hand for 1-2 minutes before administration. The patient should lie with the infected ear facing upwards.

Child use

Children aged 2 to under 12 years: Instill 3 drops of this medication into the infected ear, twice a day for 7 days.

This medication should be discontinued immediately if skin rashes or other allergic symptoms occur. Caution is necessary, especially in patients who have received systemic administration of medications in the same class, as serious and sometimes life-threatening allergic reactions may occur. It is important to seek medical attention immediately if an allergic reaction is suspected. This medication should not be used in patients who have experienced allergic reactions to this drug or similar medications, or in patients with viral or fungal ear infections. While using this medication, symptoms such as ear pain, ear discharge, and ear itching may commonly occur, and rare neurological side effects such as headache or dizziness have also been reported. Even if symptoms improve during treatment, do not stop the medication until directed by a physician, and if skin rashes or allergy symptoms appear, discontinue use immediately and consult a doctor. This medication is to be used only in the ear, and should not be used in the eyes or as an injection. Prior to use, warm the solution by holding the container in your hand and shake well; care must be taken to prevent contamination of the medication. Pregnant women and nursing mothers should exercise special caution when using this medication, and in the case of breastfeeding, the decision to use it should be made considering the necessity and risks of the medication. The safety and efficacy of this medication in children, especially infants under 2 years old or patients under 6 months, has not been established, and should be used cautiously. This medication can cause serious side effects in case of overdose; therefore, prescribed dosages and durations must be adhered to, and immediate medical attention is required if an overdose is suspected. Moreover, this medication contains ingredients that may cause skin irritation, so individuals with sensitive skin should be cautious. The effects on driving or operating machinery are not known; however, caution is advised if dizziness or other symptoms occur. Finally, this medication should be stored away from direct sunlight and should not be frozen; it is safest to discard any remaining medication after use.

Serious side effects

Angioedema (including swelling of the larynx, pharynx, or face), airway obstruction, respiratory distress, hives, cardiovascular collapse, loss of consciousness, allergic reactions (anaphylaxis).

Mild side effects

• Paresthesia (tingling in the eyes)
• crying
• dizziness
• headache
• ear pain
• ear discharge
• ear fullness
• ear discomfort
• ear itching
• fungal ear infection

This medication should be stored in a container that protects it from light and air, preferably at room temperature, not exceeding 25 degrees Celsius. By storing it this way, the effectiveness and safety of the medication can be maintained.

Appearance

A homogeneous suspension that is white to pale yellow in a clear plastic container.

Package unit

7.5mL/bottle