Dosing and uses of Cetraxal, Otiprio (ciprofloxacin otic)
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
Pediatric dosage forms and strengths
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
Cetraxal, Otiprio (ciprofloxacin otic) adverse (side) 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%)
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
Pregnancy and 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.
Pharmacology of Cetraxal, Otiprio (ciprofloxacin otic)
Mechanism of action
Fluoroquinolone antibiotic; inhibits DNA gyrase; promotes breakage of double-stranded DNA; bactericidaL
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
