ciprofloxacin otic

Ciprofloxacin otic is an antibiotic used to treat external ear infection (otitis externa) in adults and children, and middle ear infection (otitis media) in children. Ciprofloxacin is a broad-spectrum, second-generation fluoroquinolone effective against Gram-negative and Gram-positive bacteria. Gram-negative bacteria have an additional cell membrane outside the cell wall that Gram-positive bacteria lack.

Similar to other quinolones, ciprofloxacin otic kills susceptible bacteria by preventing the synthesis and replication of bacterial DNA. Ciprofloxacin inhibits gyrase, an enzyme essential for bacterial DNA synthesis. Ciprofloxacin otic binds to the broken strands of bacterial DNA and prevents their recombination, resulting in bacterial cell death.

Bacteria may develop resistance to ciprofloxacin. Ciprofloxacin is active against organisms resistant to other antibiotic classes.

Ciprofloxacin otic is approved by the FDA to treat acute otitis externa in patients 6 months and older due to Pseudomonas aeruginosa and Staphylococcus aureus – both Cetraxal and Otiprio brands. It is also used in pediatric patients (age 6 months and older) with bilateral otitis media with effusion undergoing ear tube surgery (tympanostomy tube placement) – Otiprio only.

Organisms susceptible to ciprofloxacin include Haemophilus influenzae, Moraxella catarrhalis, and Pseudomonas aeruginosa.

Warnings

• Do not use ciprofloxacin otic in patients with a history of hypersensitivity to ciprofloxacin or any other quinolones. Discontinue ciprofloxacin otic at the first sign of skin rash or other signs of hypersensitivity.
• Use only Otiprio brand of ciprofloxacin otic for treatment of children with bilateral otitis media with effusion undergoing tympanostomy tube placement.
• Use of ciprofloxacin otic may result in overgrowth of susceptible organisms. Use alternate therapy if the patient develops such superinfections.
• If otitis externa is not resolved after a week of treatment with ciprofloxacin otic, culture tests may be required to determine further treatment.

Common Side Effects

Cetraxal treatment for otitis externa:

• Application site pain
• Ear itching (pruritus)
• Fungal ear superinfection
• Headache

Otiprio treatment for otitis externa:

• Ear discomfort
• Ear pruritus
• Headache
• Otitis media

Otiprio treatment for otitis media with effusion:

• Irritability
• Nose and throat inflammation (nasopharyngitis)
• Nasal discharge (rhinorrhea)

Call your doctor immediately if you experience any of the following symptoms or serious side effects while using this drug:

• Serious heart symptoms include fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness;
• Severe headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
• Severe nervous system reaction with very stiff muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, and feeling like you might pass out; or
• Serious eye symptoms include blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.

This is not a complete list of all side effects or adverse reactions. Call your doctor for medical advice about serious side effects. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.

QUESTION

Dosages of ciprofloxacin otic

Otic solution (Cetraxal)

• 0.5 mg/0.25 mL (0.2%)/dropper

Otic suspension (Otiprio)

• 60 mg/mL (6%)/vial

Adult:

Otitis Externa

• Infection caused by susceptible isolates of Pseudomonas aeruginosa or Staphylococcus aureus
• Instill a one-time, single dose of 0.2 mL (12 mg) into external ear canal of each affected ear
• Instill contents of 1 single-use container (delivers 0.25 mL) into affected ear twice daily for 7 days

Pediatric:

Otitis Externa

Infection caused by susceptible isolates of Pseudomonas aeruginosa or Staphylococcus aureus

• Children below 6 months: Safety and efficacy not established
• Children 6 months and above: Instill a one-time, single dose of 0.2 mL (12 mg) to the external ear canal of each affected ear
• Children below 1 year: Safety and efficacy not established
• Children 1 year and above: Instill contents of 1 single-use container (delivers 0.25 mL) into affected ear twice daily for 7 days

Tympanostomy Tube Placement

• Indicated for pediatric patients aged 6 months and above with bilateral otitis media with effusion undergoing tympanostomy tube placement
• Children below 6 months: Safety and efficacy not established
• Children 6 months and above: Administer as a single intratympanic administration of 0.1 mL (6 mg) into each affected ear, following suctioning of the middle ear effusion

Overdose

Appropriate use of ciprofloxacin otic is unlikely to result in overdose. Ciprofloxacin oral overdose may be treated with symptomatic and supportive care.

Drug Interactions

Inform your doctor of all medications you are currently taking. Never begin, discontinue, or change the dosage of any medication without your doctor’s recommendation.

• Ciprofloxacin otic has no listed interactions with other drugs.

The drug interactions listed above are not all of the possible interactions or adverse effects. For more information, visit the RxList Drug Interaction Checker.

Always tell your doctor, pharmacist, or health care provider of all medications you use, and keep a list of the information. Check with your doctor or health care provider if you have any questions about the medication.

Pregnancy and Breastfeeding

• No animal reproduction studies with ciprofloxacin otic, nor adequate and well-controlled studies on the use of ciprofloxacin otic in pregnant women. Appropriate use of ciprofloxacin otic is not expected to result in fetal toxicity if administered to a pregnant woman.
• Ciprofloxacin is excreted in breastmilk with systemic administration. Ciprofloxacin otic is not expected to be present in breastmilk because of negligible systemic absorption, and should not affect breastfed infants if administered to nursing mothers.

Additional Information

• Use ciprofloxacin otic exactly as directed. Do not use ciprofloxacin otic for eye or skin infections.
• Use ciprofloxacin otic for as long as prescribed, even if symptoms improve.
• Discontinue ciprofloxacin otic immediately if you develop skin rash or other signs of hypersensitivity reactions and report to your physician.
• If symptoms of external ear infection persist after a week of treatment, inform your physician.
• If ear drainage continues or if the child develops ear pain or fever after ear tube surgery, notify the physician.
• Store ciprofloxacin otic safely out of reach of children.
• In case of oral ingestion and overdose, seek medical care or contact Poison Control.

Summary

Ciprofloxacin otic is an antibiotic used to treat external ear infection (otitis externa) in adults and children, and middle ear infection (otitis media) in children. Ciprofloxacin otic is a solution instilled into the ear canal to treat otitis externa, or injected into the eardrum by a healthcare professional to treat otitis media. Side effects of ciprofloxacin otic vary depending on the type of treatment.