Ciprofloxacin with Dexamethasone (Otic)
Brand Name: CiproDex
Common Dosage Forms:
Otic Suspension: Each mL of suspension contains 3 mg (0.3%) ciprofloxacin (as ciprofloxacin hydrochloride) and 1 mg dexamethasone (0.1%). Also contains benzalkonium chloride as a preservative.
FDA Indications/Dosages:
For the treatment of acute otitis media in pediatric patients with tympanostomy tubes due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Pseudomonas aeruginosa: Four drops instilled into the affected ear twice a day for 7 days. The suspension should be shaken well and warmed in the hands prior to use. After installation, the tragus (small flap of cartilage slightly covering the ear opening) should be pumped 5 times to force the drops to pass into the middle ear.
For the treatment of acute otitis externa in pediatric, adult, and elderly patients due to S. aureus and P. aeruginosa: Four drops instilled into the affected ear twice a day for 7 days. The suspension should be shaken well and warmed in the hands prior to use.
Pharmacology/Pharmacokinetics: Ciprofloxacin is a fluoroquinolone antibiotic which prevents the synthesis of bacterial DNA by interfering with the enzyme DNA gyrase. Ciprofloxacin has a wide range of activity against Gram-positive and Gram-negative bacteria. Dexamethasone binds to certain receptor proteins found in the cytoplasm of sensitive cells to form a steroid-receptor complex. This steroid-receptor complex enters the nucleus of the cell where it reacts with chromatin, or DNA. The steroid (or possibly the receptor) then uses stored information to stimulate, or in some cases inhibit, the transcription of mRNA. The stimulation of mRNA results in the synthesis of specific enzyme that carry out its anti-allergy and anti-inflammatory actions.
Drug Interactions: No known clinically significant drug interactions exist.
Contraindications/Precautions: Contraindicated in patients with known hypersensitivity to quinolones and in patients with viral infections of the external canal including herpes simplex infections. FLUOROQUINOLONES MAY CAUSE SERIOUS ADVERSE REACTIONS INCLUDING TENDONITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS, AND EXACERBATION OF MYASTHENIA GRAVIS. As with other antibiotic medications, use of this product may result in the overgrowth of nonsusceptible organisms. If the infection is not improved after 7 days, cultures should be obtained to guide further treatment. Pregnancy Category C.
Adverse Effects: Adverse effects are generally mild and transient. Adverse effects occurring more than 1% of patients include ear discomfort (3%), ear pain (2%), and ear pruritus (1.5%).
Patient Consultation:
Complete full course of therapy unless otherwise directed.
To instill drops: Rub the bottle between the hands for 1-2 minutes to warm the suspension. Shake gently. Have the patient lie down on their side with the affected ear facing upwards. Instill the prescribed amount into the ear canal. In patients without an intact tympanic membrane, gently pump the tragus 5 times to force the suspension into the middle ear. In patients with an intact tympanic membrane, pull the tragus up and out a few times to allow the drops to flow down into the ear canal.
Do not use in the eyes.
Store in a cool, dry place away from sunlight and children.
If a dose is missed instill it as soon as possible. If it is almost time for the next dose, skip the missed dose and return to the normal dosing schedule.
Contact a physician if the above side effects are severe or persistent.
