ciprofloxacin otic (Rx)

Brand and Other Names:Cetraxal, Otiprio
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Dosing & Uses

AdultPediatric

Dosing Strength

otic solution

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

Otitis Externa

Indicated for the treatment of acute otitis externa due to susceptible isolates of Pseudomonas aeruginosa or Staphylococcus aureus

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

Dosing Strength

otic solution

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

otic suspension

  • 60mg/mL (6%) per single-use vial (Otiprio)

Otitis Externa

Indicated for the treatment of acute otitis externa due to susceptible isolates of Pseudomonas aeruginosa or Staphylococcus aureus

<1 year: Safety and efficacy not established

≥1 year (Cetraxal): 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 with bilateral otitis media with effusion undergoing tympanostomy tube placement

Otiprio: 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

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

Contraindications

Hypersensitivity

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 Category: C

Lactation: Excretion in milk unknown/not recommended

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

  • Materials needed: Two 1-mL luer lock syringes; two 18-21 gauge preparation needles; two 20-24 gauge, 2-3 inch blunt, flexible administration needles; 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
  • Repeat above steps with a new syringe for dose of second ear

Otic Administration

Otiprio

  • For intratympanic administration only
  • Intended for single-patient use with two 0.1 mL doses available in each vial

Storage

Otiprio

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

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

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
  • Manage and view all your plans together – even plans in different states.
  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

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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