Ciprofloxacin Otic

Ciprofloxacin Otic is a prescription medicine used for the treatment of ear infections caused due to pseudomonas aeruginosa and staphylococcus aureus.

• Ciprofloxacin Otic is available under the following different brand names: Cetraxal, Otiprio

Adult and pediatric dosage

Otic solution (Cetraxal)

• 0.5mg/0.25mL (0.2%)/dropper

Otic suspension (Otiprio)

• 60mg/mL (6%)/vial

Otitis Externa

Adult dosage

• Otiprio
  • Instill a one-time, single dose of 0.2 mL (12 mg) into the external ear canal of each affected ear
• Cetraxal
  • Instill contents of 1 single-use container (delivers 0.25 mL) into the affected ear twice daily for 7 days

Pediatric dosage

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

Tympanostomy Tube Placement

Pediatric dosage

• Children below 6 months: Safety and efficacy not established

Otiprio only

• Children above 6 months: Administer as a single intratympanic administration of 0.1 mL (6 mg) into each affected ear, following suctioning of the middle ear effusion

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of the Ciprofloxacin Otic include:

• itching or pain after using the ear drops,
• fussiness,
• irritability,
• headache,
• stuffy nose, and
• sore throat

Serious side effects of the Ciprofloxacin Otic include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• skin rash (no matter how mild), and
• new ear drainage with severe itching

Rare side effects of the Ciprofloxacin Otic include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Ciprofloxacin Otic has no noted severe interactions with any other drugs.
• Ciprofloxacin Otic has no noted serious interactions with any other drugs.
• Ciprofloxacin Otic has no noted moderate interactions with any other drugs.
• Ciprofloxacin Otic has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity to ciprofloxacin, quinolones, or any of the components of Ciprofloxacin Otic

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Ciprofloxacin Otic?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Ciprofloxacin Otic?”

Cautions

• For otic use only; not for injection, inhalation, or topical ophthalmic use
• Discontinue at the first appearance of skin rash or any other sign of hypersensitivity
• May result in overgrowth of nonsusceptible organisms, including fungi
• If infection not improve within 1 week consider culture to identify the microorganism

Pregnancy and Lactation

• Data are not available regarding use in pregnant women; owing to negligible systemic exposure associated with otic administration of ciprofloxacin, minimal risk is expected
• Lactation
  • Ciprofloxacin is excreted in human milk with systemic administration; however, owing to negligible systemic exposure after otic administration, breastfed infants should not be affected