Ciprofloxacin and Dexamethasone

Ciprofloxacin and Dexamethasone
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Deepika Beereddy, MBBS [2]

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Overview

Ciprofloxacin and Dexamethasone is an anti-infective/anti inflammatory that is FDA approved for the treatment of acute otitis externa, acute otitis media associated with typanostomy tube. Common adverse reactions include discomfort of ear, otalgia, pruritus of skin and ear.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Acute Otitis Externa

• CIPRODEX® Otic is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in acute otitis externa in pediatric, adult and elderly patients due to Staphylococcus aureus and Pseudomonas aeruginosa.

• Dosing information:

• Otitis externa, acute: 4 drops into the affected ear twice a day for 7 days.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Ciprofloxacin and Dexamethasone in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Ciprofloxacin and Dexamethasone in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

• CIPRODEX® Otic is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below:

• Acute Otitis Media in pediatric patients (age 6 months and older) with tympanostomy tubes due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Pseudomonas aeruginosa.
  • Acute Otitis Externa in pediatric (age 6 months and older) patients due to Staphylococcus aureus and Pseudomonas aeruginosa.

Acute Otitis Media with typanostomy tube

• Dosing information:

• Acute Otitis Media in pediatric patients with tympanostomy tubes: The recommended dosage regimen for the treatment of acute otitis media in pediatric patients (age 6 months and older) through tympanostomy tubes is: Four drops (0.14 mL, 0.42 mg ciprofloxacin, 0.14 mg dexamethasone) instilled into the affected ear twice daily for seven days.

Acute Otitis Externa

• Dosing information:

• The recommended dosage regimen for the treatment of acute otitis externa is: For patients (age 6 months and older): Four drops (0.14 mL, 0.42 mg ciprofloxacin, 0.14 mg dexamethasone) instilled into the affected ear twice daily for seven days.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Ciprofloxacin and Dexamethasone in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Ciprofloxacin and Dexamethasone in pediatric patients.

Contraindications

CIPRODEX® Otic is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, to other quinolones, or to any of the components in this medication. Use of this product is contraindicated in viral infections of the external canal including herpes simplex infections.

Warnings

FOR OTIC USE ONLY

(This product is not approved for ophthalmic use.)

NOT FOR INJECTION

• CIPRODEX® Otic should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolones. Serious acute hypersensitivity reactions may require immediate emergency treatment.

PRECAUTIONS

General:

• As with other antibacterial preparations, use of this product may result in overgrowth of nonsusceptible organisms, including yeast and fungi. If the infection is not improved after one week of treatment, cultures should be obtained to guide further treatment. If otorrhea persists after a full course of therapy, or if two or more episodes of otorrhea occur within six months, further evaluation is recommended to exclude an underlying condition such as cholesteatoma, foreign body, or a tumor.

• The systemic administration of quinolones, including ciprofloxacin at doses much higher than given or absorbed by the otic route, has led to lesions or erosions of the cartilage in weight-bearing joints and other signs of arthropathy in immature animals of various species.

• Guinea pigs dosed in the middle ear with CIPRODEX® Otic for one month exhibited no drug-related structural or functional changes of the cochlear hair cells and no lesions in the ossicles. CIPRODEX® Otic was also shown to lack dermal sensitizing potential in the guinea pig when tested according to the method of Buehler.

• No signs of local irritation were found when CIPRODEX® Otic was applied topically in the rabbit eye.

Adverse Reactions

Clinical Trials Experience

• In Phases II and III clinical trials, a total of 937 patients were treated with CIPRODEX® Otic. This included 400 patients with acute otitis media with tympanostomy tubes and 537 patients with acute otitis externa. The reported treatment-related adverse events are listed below:

Acute Otitis Media in pediatric patients with tympanostomy tubes

• The following treatment-related adverse events occurred in 0.5% or more of the patients with non-intact tympanic membranes.

• The following treatment-related adverse events were each reported in a single patient: tympanostomy tube blockage; ear pruritus; tinnitus; oral moniliasis; crying; dizziness; and erythema.

Acute Otitis Externa

• The following treatment-related adverse events occurred in 0.4% or more of the patients with intact tympanic membranes.

• The following treatment-related adverse events were each reported in a single patient: ear discomfort; decreased hearing; and ear disorder (tingling).

Postmarketing Experience

There is limited information regarding Ciprofloxacin and Dexamethasone Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Ciprofloxacin and Dexamethasone Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Ciprofloxacin and Dexamethasone in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Ciprofloxacin and Dexamethasone in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Ciprofloxacin and Dexamethasone during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Ciprofloxacin and Dexamethasone in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Ciprofloxacin and Dexamethasone in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Ciprofloxacin and Dexamethasone in geriatric settings.

Gender

There is no FDA guidance on the use of Ciprofloxacin and Dexamethasone with respect to specific gender populations.

Race

There is no FDA guidance on the use of Ciprofloxacin and Dexamethasone with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Ciprofloxacin and Dexamethasone in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Ciprofloxacin and Dexamethasone in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Ciprofloxacin and Dexamethasone in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Ciprofloxacin and Dexamethasone in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Ciprofloxacin and Dexamethasone Administration in the drug label.

Monitoring

There is limited information regarding Ciprofloxacin and Dexamethasone Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Ciprofloxacin and Dexamethasone and IV administrations.

Overdosage

There is limited information regarding Ciprofloxacin and Dexamethasone overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Ciprofloxacin and Dexamethasone Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Ciprofloxacin and Dexamethasone Mechanism of Action in the drug label.

Structure

• CIPRODEX® (ciprofloxacin 0.3% and dexamethasone 0.1%) Sterile Otic Suspension contains the synthetic broad-spectrum antibacterial agent, ciprofloxacin hydrochloride, combined with the anti-inflammatory corticosteroid, dexamethasone, in a sterile, preserved suspension for otic use. Each mL of CIPRODEX® Otic contains ciprofloxacin hydrochloride (equivalent to 3 mg ciprofloxacin base), 1 mg dexamethasone, and 0.1 mg benzalkonium chloride as a preservative. The inactive ingredients are boric acid, sodium chloride, hydroxyethyl cellulose, tyloxapol, acetic acid, sodium acetate, edetate disodium, and purified water. Sodium hydroxide or hydrochloric acid may be added for adjustment of pH.

• Ciprofloxacin, a fluoroquinolone is available as the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-qui nolinecarboxylic acid. The empirical formula is C17H18FN3O3·HCl·H2O and the structural formula is:

• Dexamethasone,9-fluoro-11(beta),17,21-trihydroxy-16(alpha)-methylpregna-1,4-di ene-3,20-dione, is an anti-inflammatory corticosteroid. The empirical formula is C22H29FO5 and the structural formula is:

Pharmacodynamics

There is limited information regarding Ciprofloxacin and Dexamethasone Pharmacodynamics in the drug label.

Pharmacokinetics

• Pharmacokinetics: Following a single bilateral 4-drop (total dose = 0.28 mL, 0.84 mg ciprofloxacin, 0.28 mg dexamethasone) topical otic dose of CIPRODEX® Otic to pediatric patients after tympanostomy tube insertion, measurable plasma concentrations of ciprofloxacin and dexamethasone were observed at 6 hours following administration in 2 of 9 patients and 5 of 9 patients, respectively.

• Mean ± SD peak plasma concentrations of ciprofloxacin were 1.39 ± 0.880 ng/mL (n=9). Peak plasma concentrations ranged from 0.543 ng/mL to 3.45 ng/mL and were on average approximately 0.1% of peak plasma concentrations achieved with an oral dose of 250-mg [1]. Peak plasma concentrations of ciprofloxacin were observed within 15 minutes to 2 hours post dose application.

• Mean ± SD peak plasma concentrations of dexamethasone were 1.14 ± 1.54 ng/mL (n=9). Peak plasma concentrations ranged from 0.135 ng/mL to 5.10 ng/mL and were on average approximately 14% of peak concentrations reported in the literature following an oral 0.5-mg tablet dose[2]. Peak plasma concentrations of dexamethasone were observed within 15 minutes to 2 hours post dose application.

• Dexamethasone has been added to aid in the resolution of the inflammatory response accompanying bacterial infection (such as otorrhea in pediatric patients with AOM with tympanostomy tubes).

• Microbiology:' Ciprofloxacin has in vitro activity against a wide range of gram-positive and gram-negative microorganisms. The bactericidal action of ciprofloxacin results from interference with the enzyme, DNA gyrase, which is needed for the synthesis of bacterial DNA. Cross-resistance has been observed between ciprofloxacin and other fluoroquinolones. There is generally no cross-resistance between ciprofloxacin and other classes of antibacterial agents such as beta-lactams or aminoglycosides.

• Ciprofloxacin has been shown to be active against most isolates of the following microorganisms, both in vitro and clinically in otic infections as described in the INDICATIONS AND USAGE section.

Aerobic and facultative gram-positive microorganisms

• Staphylococcus aureus

• Streptococcus pneumoniae

Aerobic and facultative gram-negative microorganisms

• Haemophilus influenzae

• Moraxella catarrhalis

• Pseudomonas aeruginosa

Nonclinical Toxicology

There is limited information regarding Ciprofloxacin and Dexamethasone Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Ciprofloxacin and Dexamethasone Clinical Studies in the drug label.

How Supplied

• CIPRODEX® (ciprofloxacin 0.3% and dexamethasone 0.1%) Sterile Otic Suspension is supplied as follows: 7.5 mL fill in a DROP-TAINER® system. The DROP-TAINER® system consists

• Of a natural polyethylene bottle and natural plug, with a white polypropylene closure. Tamper evidence is provided with a shrink band around the closure and neck area of the package.

• NDC 0065-8533-02, 7.5 mL fill

Storage

• Store at controlled room temperature, 15°C to 30°C (59°F to 86°F). Avoid freezing. Protect from light.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

Information for Patients

• For otic use only. (This product is not approved for use in the eye.) Warm the bottle in your hand for one to two minutes prior to use and shake well immediately before using.

• Avoid contaminating the tip with material from the ear, fingers, or other sources.

• Protect from light.

• If rash or allergic reaction occurs, discontinue use immediately and contact your physician.

• It is very important to use the ear drops for as long as the doctor has instructed, even if the symptoms improve.

• Discard unused portion after therapy is completed.

Acute Otitis Media in pediatric patients with tympanostomy tubes

• Prior to administration of CIPRODEX® Otic in patients (6 months and older) with acute otitis media through tympanostomy tubes, the suspension should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness which may result from the instillation of a cold suspension. The patient should lie with the affected ear upward, and then the drops should be instilled. The tragus should then be pumped 5 times by pushing inward to facilitate penetration of the drops into the middle ear. This position should be maintained for 60 seconds. Repeat, if necessary, for the opposite ear.

Acute Otitis Externa

• Prior to administration of CIPRODEX® Otic in patients with acute otitis externa, the suspension should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness which may result from the instillation of a cold suspension. The patient should lie with the affected ear upward, and then the drops should be instilled. This position should be maintained for 60 seconds to facilitate penetration of the drops into the ear canal. Repeat, if necessary, for the opposite ear.

Precautions with Alcohol

Alcohol-Ciprofloxacin and Dexamethasone interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Ciprofloxacin and Dexamethasone Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Ciprofloxacin and Dexamethasone Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.