ciprofloxacin otic (Rx)

Brand and Other Names:Cetraxal, Otiprio
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

otic solution

  • 0.5mg/0.25mL (0.2%) in single-use droppers (Cetraxal)

otic suspension

  • 60mg/mL (6%) per single-use vial (Otiprio); up to 2 doses available in each vial

Otitis Externa

Indicated for the treatment of acute otitis externa caused by susceptible isolates of Pseudomonas aeruginosa or Staphylococcus aureus

Otiprio

  • Instill a one-time, single dose of 0.2 mL (12 mg) to the external ear canal of each affected ear

Cetraxal

  • Instill contents of 1 single-use container (delivers 0.25 mL) into affected ear BID for 7 days

Dosage Forms & Strengths

otic solution

  • 0.5mg/0.25mL (0.2%) in single-use droppers (Cetraxal)

otic suspension

  • 60mg/mL (6%) per single-use vial (Otiprio); up to 2 doses available in each vial

Otitis Externa

Indicated for the treatment of acute otitis externa caused by susceptible isolates of Pseudomonas aeruginosa or Staphylococcus aureus

Otiprio

  • <6 months: Safety and efficacy not established
  • ≥ 6 months: Instill a one-time, single dose of 0.2 mL (12 mg) to the external ear canal of each affected ear

Cetraxal

  • <1 year: Safety and efficacy not established
  • ≥1 year: Instill contents of 1 single-use container (delivers 0.25 mL) into affected ear BID for 7 days

Tympanostomy Tube Placement

Indicated for pediatric patients aged ≥6 months with bilateral otitis media with effusion undergoing tympanostomy tube placement

<6 months: Safety and efficacy not established

Otiprio only

  • ≥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

Dosing Considerations

Antimicrobial activity

  • Ciprofloxacin has been shown to be active against most isolates of the following bacteria:
  • Gram-positive bacteria: Staphylococcus aureus, Streptococcus pneumoniae
  • Gram-negative bacteria: Haemophilus influenzae, Moraxella catarrhalis, Pseudomonas aeruginosa
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Adverse Effects

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%)
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Warnings

Contraindications

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

Cautions

Cetraxal: Warm solution with hands to prevent dizziness

May result in overgrowth of nonsusceptible organisms, including fungi

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

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Pregnancy & Lactation

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.

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Pharmacology

Mechanism of Action

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

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Administration

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

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
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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.