Usual Adult Dose for Acute Otitis Externa

Otic Solution: Instill the contents of 1 single-use container into the affected ear 2 times a day (about 12 hours apart) for 7 days.
Otic Suspension: Administer 12 mg as a single dose to the external ear canal of each affected ear.

Use: For the treatment of acute otitis externa due to susceptible isolates of Pseudomonas aeruginosa or Staphylococcus aureus

Usual Pediatric Dose for Acute Otitis Externa

Otic Solution:

• Aged 1 year or older: Instill the contents of 1 single-use container into the affected ear 2 times a day (about 12 hours apart) for 7 days.

• Aged 6 months or older: Administer 12 mg as a single dose to the external ear canal of each affected ear.

Usual Pediatric Dose for Otitis Media

Otic Suspension:

• Aged 6 months or older: After suctioning of middle ear effusion, administer 6 mg intratympanically as a single dose into each affected ear.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS:
Hypersensitivity to the active component, other quinolones, or any of the ingredients

Otic solution: Safety and efficacy have not been established in patients younger than 1 year.
Otic suspension: Safety and efficacy have not been established in patients younger than 6 months.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

OTIC SOLUTION:
Administration advice:

• For otic use only; do not use for injection, inhalation, or topical ophthalmic use.
• Wash hands before use; warm the solution by holding the container in the hands for at least 1 minute (to reduce the dizziness associated with instillation of a cold solution into the ear canal).
• While the patient lies with the affected ear upward, instill the solution; have the patient remain in this position for at least 1 minute (to help the drops penetrate into the ear); if necessary, repeat for the opposite ear.

• Store at 15C to 25C (59F to 77F).
• Store unused containers in pouch to protect from light.

• If infection is not improved after 1 week of therapy, cultures may help guide further treatment.
• The deliverable volume in 1 single-use container is 0.25 mL.

• For otic use only; not for ophthalmic use, inhalation, or injection.
• Avoid missing doses and complete the entire course of therapy.
• Follow these directions while using this drug:
• Wash hands before use; warm the container in the hands for at least 1 minute before use (to reduce dizziness from instillation of a cold solution into the ear canal); twist off and discard top of container.
• Lie with affected ear upward; instill the contents of 1 container into the ear; remain in this position for at least 1 minute (to help the drops penetrate into the ear); if necessary, repeat for the opposite ear.
• Stop this drug immediately if skin rash or any other sign of hypersensitivity develops.

• For intratympanic or otic administration by healthcare professional only
• For single-patient use; discard unused portion.
• Dosing directions differ for each indication; consult the manufacturer product information and follow the correct directions.
• Use a different syringe for each ear.

• Before preparation: Store at 2C to 8C (36F to 46F) until before use to prevent thickening during preparation; protect from light; store in original carton until dose is prepared.
• After preparation: May keep syringes at room temperature or in the refrigerator before use; keep syringes on their side; discard syringes if not used in 3 hours.

• The manufacturer product information should be consulted.

• There may be drainage from the ear the first few days after ear tube surgery; if ear becomes painful, continuous ear discharge is observed, or fever develops, consult physician.
• For acute otitis externa: If the ear remains painful, swollen, or itchy after a week, consult physician.