ﺑﺎﺯﮔﺸﺖ ﺑﻪ ﺻﻔﺤﻪ ﻗﺒﻠﯽ
خرید پکیج
تعداد آیتم قابل مشاهده باقیمانده : 3 مورد
نسخه الکترونیک
medimedia.ir

Ciprofloxacin (otic): Drug information

Ciprofloxacin (otic): Drug information
(For additional information see "Ciprofloxacin (otic): Patient drug information" and see "Ciprofloxacin (otic): Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Cetraxal;
  • Otiprio [DSC]
Pharmacologic Category
  • Antibiotic, Fluoroquinolone;
  • Antibiotic, Otic
Dosing: Adult
Otitis externa, acute

Otitis externa, acute:

Solution 0.2%: Otic: Instill 0.25 mL (0.5 mg) solution (contents of 1 single-dose container) into affected ear twice daily for 7 days (Ref); may extend an additional 7 days if symptoms are improving but not yet resolved (Ref).

Suspension 6%: Otic: Instill 0.2 mL (12 mg) suspension into affected ear as a single dose.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Ciprofloxacin (otic): Pediatric drug information")

Otitis externa, acute

Otitis externa, acute:

Otic solution 0.2% (Cetraxal): Children and Adolescents: Otic: Instill 0.25 mL (0.5 mg, contents of 1 single-dose container) into affected ear(s) twice daily (approximately 12 hours apart) for 7 days

Otic suspension 6% (Otiprio): Infants ≥6 months, Children, and Adolescents: Otic: Instill 0.2 mL (12 mg) suspension into each affected ear as a single dose. Note: Intended for administration by health care professional.

Otitis media with effusion, bilateral

Otitis media with effusion, bilateral: Infants ≥6 months and Children undergoing tympanostomy tube placement: Otic suspension 6% (Otiprio): Intratympanic: Instill 0.1 mL (6 mg) into each affected ear following suctioning of middle ear effusion

Dosing: Kidney Impairment: Pediatric

There are no dosing adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely due to low systemic absorption.

Dosing: Hepatic Impairment: Pediatric

There are no dosing adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely due to low systemic absorption.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

1% to 10%:

Central nervous system: Irritability (infants and children: 5%), headache (2% to 3%)

Dermatologic: Pruritus of ear (2% to 3%)

Infection: Fungal superinfection (otic: 2% to 3%)

Local: Application site pain (2% to 3%)

Otic: Otitis media (2%)

Respiratory: Nasopharyngitis (infants and children: 5%), rhinorrhea (infants and children: 3%)

Contraindications

Hypersensitivity to ciprofloxacin, other quinolones, or any component of the formulation.

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity reactions: Severe hypersensitivity reactions have occurred with quinolone therapy. Prompt discontinuation of drug should occur if skin rash or other symptoms of hypersensitivity arise.

• Superinfection: Prolonged use may result in fungal or bacterial superinfection. If superinfection occurs, discontinue use and institute appropriate alternative therapy.

• Tendon inflammation/rupture: There have been reports of tendon inflammation and/or rupture with systemic quinolone antibiotics. Exposure following otic administration is substantially lower than with systemic therapy. Discontinue at first sign of tendon inflammation or pain.

Other warnings/precautions:

• Appropriate use: Solution: For otic use only; not for injection, inhalation, or topical ophthalmic use. If infection is not improved after 1 week, consider culture to identify organism.

• Appropriate use: Suspension: For intratympanic (otitis media) and otic (otitis externa) administration.

Warnings: Additional Pediatric Considerations

In pediatric patients, use of quinolone ear drops after tympanostomy tube placement may increase the risk of tympanic rupture. A retrospective cohort study of over 96,000 patients (<18 years of age) compared patients who received a quinolone-containing ear drop (n=78,275) to those who received a neomycin plus hydrocortisone ear drop (n=18,320). Patients who received quinolone ear drops after tympanostomy tube placement had an increased incidence of tympanic perforation requiring tympanoplasty with an adjusted hazard ratio of 1.61 (95% confidence interval [CI]: 1.15 to 2.26); combination products containing corticosteroids may amplify adverse effect risk; monitor and counsel patients accordingly (Alrwisan 2017)

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Otic, as hydrochloride [strength expressed as base, preservative free]:

Cetraxal: 0.2% (1 ea)

Generic: 0.2% (1 ea)

Suspension, Intratympanic [preservative free]:

Otiprio: 6% (1 mL [DSC])

Generic Equivalent Available: US

May be product dependent

Pricing: US

Solution (Cetraxal Otic)

0.2% (per each): $52.68

Solution (Ciprofloxacin HCl Otic)

0.2% (per each): $9.30

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

Otic solution: For otic use only; not for injection, inhalation, or topical ophthalmic use. Wash hands prior to use. Administer approximately every 12 hours. Prior to use, warm solution by holding container in hands for at least 1 minute. Patient should lie down with affected ear upward and medication instilled. Patients should remain in the position for at least 1 minute to allow penetration of solution.

Otic suspension: Refer to manufacturer's product labeling for administration instructions; separate syringes should be used for each ear. Vials are for single-patient use; discard unused portion.

Administration: Pediatric

Otic:

Otitis externa, acute:

Otic solution (Cetraxal): For otic use only. Prior to use, warm solution by holding container in hands for at least 1 minute. Patient should lie down with affected ear upward. Patients should remain in the position for at least 1 minute to allow penetration of solution.

Otic suspension (Otiprio): For otic use; should only be administered by health care professional. Hold vial by aluminum seal to prevent gelation and shake the vial for 5 to 8 seconds until suspension is visually homogenous. Using an 18- to 21-gauge needle, withdraw 0.3 mL from vial into a 1 mL syringe. Prepare second dose for bilateral otitis externa (use separate syringe for each ear), using same vial; vials are single-patient use, discard unused portion. Replace preparation needle with a 20- to 24-gauge, 1.5-inch blunt, flexible catheter (or comparable administration needle/device); a separate administration catheter/needle should be used for each ear. After administration needle/catheter attached to the syringe, prime needle leaving the desired 0.2 mL dose. If gelation occurs during preparation, place vial back in refrigeration.

Otitis media with effusion, bilateral: Intratympanic: Otic suspension (Otiprio): For intratympanic use only during tympanostomy placement. Hold vial by aluminum seal to prevent gelation and shake vial for 5 to 8 seconds until suspension is visually homogenous. Using an 18- to 21-gauge needle, withdraw 0.3 mL from vial into a 1 mL syringe. Remove needle and attach a 20- to 24-gauge, 2- to 3-inch blunt, flexible catheter/needle to be used for administration. After administration needle/catheter attached, prime needle leaving the desired 0.1 mL dose. Prepare second dose for bilateral otitis media (use separate syringe for each ear and administration catheter/needle), using same vial; vials are single-patient use, discard unused portion. Replace preparation needles with administration needles (separate needles for each ear). If gelation occurs during preparation, place vial back in refrigeration.

Use: Labeled Indications

Otitis externa, acute (0.2% solution; 6% suspension): Treatment of acute otitis externa caused by susceptible isolates of Pseudomonas aeruginosa or Staphylococcus aureus

Otitis media (6% suspension): Treatment of bilateral otitis media in pediatric patients ≥6 months of age with effusion undergoing tympanostomy tube placement

Medication Safety Issues
Sound-alike/look-alike issues:

Cetraxal may be confused with cefTRIAXone

Ciprofloxacin may be confused with cephalexin

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

Animal reproduction studies have not been conducted with ciprofloxacin otic solution. When administered orally or IV, ciprofloxacin crosses the placenta (Giamarellou 1989; Ludlam 1997). The amount of ciprofloxacin available systemically following topical application of the otic drops is expected to be significantly less in comparison to oral or IV doses. Minimal risk to the fetus and mother is expected following maternal administration.

Breastfeeding Considerations

When administered systemically, ciprofloxacin enters breast milk. The amount of ciprofloxacin available systemically following topical application of the otic drops is expected to be significantly less in comparison to oral or IV doses. Due to the potential for serious adverse reactions in the nursing infant, the manufacturer recommends a decision be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of treatment to the mother. Negligible exposure to the nursing infant is expected following maternal administration.

Mechanism of Action

Inhibits DNA-gyrase in susceptible organisms; inhibits relaxation of supercoiled DNA and promotes breakage of double-stranded DNA

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (BD) Bangladesh: Neofloxin | Raciprox;
  • (BE) Belgium: Ciproxine;
  • (CO) Colombia: Oxtin | Procif;
  • (DE) Germany: Infectocipro;
  • (DO) Dominican Republic: Ciprenit;
  • (ES) Spain: Baycip otico | Cetraflux | Cetraxal | Ciprenit | Ciprofloxacino qualigen | Otociprin | Septocipro otico | Velmonit | Velmonit otico;
  • (FI) Finland: Cetraxal;
  • (GB) United Kingdom: Cetraxal | Ciproxin;
  • (GR) Greece: Cetraxal | Cipratic;
  • (ID) Indonesia: Cylowam | Ulcori;
  • (IN) India: Ceflox | Ciprocil | Ciprolar | Cipromac | Ciprox | Swiflox;
  • (IT) Italy: Cetraflux | Ciproxin;
  • (LB) Lebanon: Septocipro otico;
  • (MX) Mexico: Ciproxina;
  • (MY) Malaysia: Cetraxal;
  • (NO) Norway: Cetraxal;
  • (PK) Pakistan: Cipromen | Dv cipro | Hemel | Megacip | Nexcip | Paraflox | Synocip;
  • (PR) Puerto Rico: Ciprofloxacin | Otiprio;
  • (PT) Portugal: Cetraflux | Ciprofloxacina;
  • (SE) Sweden: Cetraxal;
  • (SG) Singapore: Cetraxal;
  • (UY) Uruguay: Neoxetic;
  • (VE) Venezuela, Bolivarian Republic of: Ciproxina | Oxtin;
  • (ZW) Zimbabwe: Ciprobay
  1. Alrwisan A, Antonelli PJ, Winterstein AG. Quinolone ear drops after tympanostomy tubes and the risk of eardrum perforation: a retrospective cohort study. Clin Infect Dis. 2017;64(8):1052-1058. [PubMed 28329128]
  2. Cetrexal (ciprofloxacin) [prescribing information]. Ridgeland, MS: WraSer Pharmaceuticals; December 2017.
  3. Giamarellou H, Kolokythas E, Petrikkos G, et al. "Pharmacokinetics of Three Newer Quinolones in Pregnant and Lactating Women," Ciprofloxacin: major advances in intravenous and oral quinolone therapy. Proceedings of a symposium. April 28 to 29, 1989, Naples, Florida. Am J Med. 1989; 87(5A):49S-51S. [PubMed 2589353]
  4. Ludlam H, Wreghitt TG, Thornton S, et al. Q fever in pregnancy. J Infect. 1997;34(1):75-78. [PubMed 9120330]
  5. Otiprio (ciprofloxacin) [prescribing information]. Port Washington, NY: ALK-Abello Inc; June 2021.
  6. Refer to manufacturer’s labeling.
  7. Rosenfeld RM, Schwartz SR, Cannon CR, et al. Clinical practice guideline: acute otitis externa. Otolaryngol Head Neck Surg. 2014;150(1 suppl):S1-S24. doi:10.1177/0194599813517083 [PubMed 24491310]
Topic 9050 Version 152.0

آیا می خواهید مدیلیب را به صفحه اصلی خود اضافه کنید؟