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Ciprofloxacin and Fluocinolone

Medically reviewed by Drugs.com. Last updated on Jun 6, 2020.

Pronunciation

(sip roe FLOKS a sin & floo oh SIN oh lone)

Index Terms

  • Ciprofloxacin and Fluocinolone Acetonide
  • Fluocinolone and Ciprofloxacin

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Otic [preservative free]:

Otovel: Ciprofloxacin 0.3 % and fluocinolone acetonide 0.025 % (14 ea) [contains polysorbate 80]

Generic: Ciprofloxacin 0.3 % and fluocinolone acetonide 0.025 % (14 ea)

Brand Names: U.S.

  • Otovel

Pharmacologic Category

  • Antibiotic, Fluoroquinolone
  • Antibiotic, Otic
  • Antibiotic/Corticosteroid, Otic
  • Corticosteroid, Otic

Pharmacology

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

Fluocinolone: Topical corticosteroids have anti-inflammatory, antipruritic, and vasoconstrictive properties. May depress the formation, release, and activity of endogenous chemical mediators of inflammation (kinins, histamine, liposomal enzymes, prostaglandins) through the induction of phospholipase A2 inhibitory proteins (lipocortins) and sequential inhibition of the release of arachidonic acid.

Use: Labeled Indications

Acute otitis media: Treatment of acute otitis media with tympanostomy tubes (AOMT) due to susceptible isolates of Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenza, Moraxella catarrhalis, and Pseudomonas aeruginosa in pediatric patients 6 months and older.

Contraindications

Hypersensitivity to ciprofloxacin, other fluoroquinolones, fluocinolone, other corticosteroids, or any component of the formulation; viral infection of the external ear canal, including varicella and herpes simplex infections; fungal otic infections

Dosing: Adult

Acute otitis media in patients with tympanostomy tubes: Not indicated for use in adult patients; however, no major differences in safety/efficacy were observed between adult and pediatric patients.

Dosing: Pediatric

Acute otitis media in patients with tympanostomy tubes: Infants ≥6 months, Children, and Adolescents: Ciprofloxacin 0.3% fluocinolone 0.025% solution: Otic: Instill 0.25 mL (ciprofloxacin 0.75 mg/fluocinolone 0.0625 mg) into affected ear canal twice daily for 7 days

Administration

Otic: For otic use only; not for injection or ophthalmic use. Prior to use, warm solution by holding container in hands for 1 to 2 minutes. Patient should lie down with affected ear upward. Administer into ear canal. Gently pump tragus 4 times to facilitate penetration into the middle ear. Patients should remain on side for at least 1 minute to allow penetration of solution.

Storage

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light; store unused vials in pouch and discard 7 days after opening the pouch. Do not open until ready to use. Discard vial after use.

Drug Interactions

There are no known significant interactions.

Adverse Reactions

1% to 10%:

Dermatologic: Connective tissue disorder (excessive granulation tissue; 1%)

Local: Application site discharge (otorrhea: 5%)

Frequency not defined: Infection: Bacterial superinfection

<1%, postmarketing, and/or case reports: Auricular edema, candidiasis, dizziness, dysgeusia, equilibrium disturbance, eustachian tube congestion, exfoliation of skin, flushing, headache, hypersensitivity reaction, hypoacusis, otalgia, otic infection, paresthesia, pruritus of ear, tinnitus, tympanic membrane disease, tympanostomy tube blockage (device occlusion)

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity reactions: Severe hypersensitivity reactions have occurred with systemic 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 fluoroquinolones. 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: For otic use only; not for injection or ophthalmic use. Prior to instillation, suspension should be warmed in hands to prevent dizziness, which may occur following use of a cold solution.

Monitoring Parameters

Resolution of infection; if infection persists after one week of treatment, obtain cultures to guide further treatment. If otorrhea persists after a full course of therapy, or if ≥2 episodes occur within 6 months, evaluate to exclude an underlying condition (eg, cholesteatoma, foreign body, tumor).

Pregnancy Considerations

Due to limited systemic absorption, exposure of ciprofloxacin or fluocinolone to the fetus is not expected following maternal otic administration.

Patient Education

What is this drug used for?

• It is used to treat ear infections.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Ear drainage

• Fluid draining from the ear

• Ear irritation

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Dizziness

• Passing out

• Fast heartbeat

• Abnormal heartbeat

• Change in balance

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.