ciprofloxacin otic (Rx)

1-10%

Cetraxal

• Ear pruritus (2-3%)
• Fungal ear superinfection (2-3%)
• Application site pain (2-3%)
• Headache (2-3%)

Otiprio

• Otitis media with effusion

  • Nasopharyngitis (5%)
  • Irritability (5%)
  • Rhinorrhea (3%)

• Acute otitis externa

  • Ear pruritus (2%)
  • Headache (2%)
  • Otitis media (2%)
  • Ear discomfort (2%)

Contraindications

Hypersensitivity to ciprofloxacin, quinolones or any of the component of ciprofloxacin otic

Cautions

For otic use only; not for injection, inhalation or topical ophthalmic use

Discontinue at first appearance of skin rash or any other sign of hypersensitivity

May result in overgrowth of nonsusceptible organisms, including fungi

If infection not improved within 1 week consider culture to identify microorganism

Pregnancy

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

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Fluoroquinolone antibiotic; inhibits DNA gyrase; promotes breakage of double-stranded DNA; bactericidal

Otic Preparation

Otiprio

• 1 vial of Otiprio will supply 2 doses
• Other materials needed (for each ear treated): one 1-mL Luer lock syringe; one 18-21 gauge preparation needle; one 20-24 gauge blunt, flexible catheter or comparable administration needle; alcohol pads; optional ice pack and drape to keep vial cold
• Keep the product cold during preparation; if the suspension thickens during the preparation, place the vial back in the refrigerator
• Always hold the vial by the aluminum seal to prevent gelation
• To keep the vial cold during shaking, hold the vial by the aluminum seal to prevent gelation; shake the vial for 5-8 seconds to mix well until a visually homogenous suspension is obtained
• Using an 18-21 gauge needle, withdraw 0.3 mL of the suspension into the 1-mL syringe
• Replace the needle with a 20-24 gauge, 2-3 inch blunt, flexible needle to be used for administration
• Prime the needle leaving a dose of 0.1 mL (otitis media with effusion) or 0.2 mL (acute otitis externa)
• Repeat above steps with a new syringe for dose of second ear

Otic Administration

Otiprio

• For intratympanic or otic administration by a healthcare profession only
• Intended for single-patient use; each vial provides 2 doses
• Use within 3 hr of mixing; discard unsued portion

Cetraxal

• Warm solution by holding container in hands for at least 1 minute, to minimize dizziness caused by instillation of cold solution into ear canal
• Wash hand before use
• Patient should lie with affected ear upward and the solution instilled
• Maintain this position for at least 1 minute to facilitate penetration of drops into ear; repeat, if necessary, for opposite ear

Storage

Otiprio

• Unopened vial: Refrigerate at at 2-8ºC (36-46°F); protect from light; store in the original carton until dose preparation
• During preparation: Refrigerate at 2-8ºC (36-46°F) until prior to use to prevent thickening during preparation

• After preparation

  • Can be kept at room temperature or in the refrigerator prior to administration
  • Keep syringes on their side
  • Discard syringes if not administered in 3 hr

Cetraxal

• Store at controlled room temperature (15-25ºC [59-77ºF])
• Discard used containers
• Store unused containers in pouch to protect from light