ciprofloxacin/fluocinolone acetonide, otic

Action and Spectrum

Actions and Spectrum: 

Actions: 

ciprofloxacin is a fluoroquinolone antibiotic that works by inhibiting the activity of bacterial DNA gyrase and topoisomerase IV enzymes. These enzymes are essential for bacterial DNA replication, transcription, and repair. By interfering with these processes, ciprofloxacin disrupts bacterial cell growth and division, leading to the death of susceptible bacteria. 

fluocinolone acetonide is a corticosteroid with potent anti-inflammatory properties. It helps reduce inflammation, itching, redness, and swelling in the ear canal by suppressing the immune response and inhibiting the release of inflammatory mediators. 

Spectrum: 

ciprofloxacin/fluocinolone acetonide otic has a broad spectrum of activity against various bacteria commonly associated with ear infections. The ciprofloxacin component provides antibacterial coverage against pathogens such as Staphylococcus aureus (including methicillin-resistant strains), Pseudomonas aeruginosa, Proteus species, Escherichia coli, Haemophilus influenzae, and Streptococcus pneumoniae. 

The specific spectrum of activity may vary depending on the local resistance patterns of bacteria in different regions.

Drug Interaction

Adverse Reaction

Frequency defined 

1-10% 

Excessive granulation tissue (1.3%) 

Otorrhea (5.4%) 

<1% 

Ear infection (0.9%) 

Tympanic membrane disorder (0.9%) 

Ear pruritus (0.9%) 

Balance disorder (0.4%) 

Auricular swelling (0.4%) 

Black Box Warning

Black Box Warning: 

None 

Contraindication / Caution

Contraindication/Caution: 

Contraindications 

• Hypersensitivity 
• Viral/fungal infections 

Cautions 

• Perforated tympanic membrane 
• Systemic effects 
• Bacterial resistance 
• Pediatric use 

Pregnancy / Lactation

Pregnancy consideration:  

Safe during pregnancy. 

Breastfeeding warnings:  

The drug is not exposed to lactating infants through breastfeeding. 

Pregnancy category: 

Category A: well-controlled and satisfactory studies show no risk to the fetus in the first or later trimester. 

Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women. 

Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.    

Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.    

Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.    

Category N: No data is available for the drug under this category. 

Pharmacology

Pharmacology: 

Ciprofloxacin is a fluoroquinolone antibiotic that acts by inhibiting the activity of bacterial DNA gyrase and topoisomerase IV enzymes. These enzymes are essential for bacterial DNA replication, transcription, and repair. By interfering with these processes, ciprofloxacin disrupts bacterial cell growth and division, leading to the death of susceptible bacteria. 

fluocinolone acetonide is a synthetic corticosteroid with potent anti-inflammatory, anti-allergic, and immunosuppressive effects. It exerts its pharmacological actions by binding to glucocorticoid receptors, modulating gene expression, and suppressing the release of pro-inflammatory mediators. 

Pharmacodynamics: 

Ciprofloxacin exhibits bactericidal activity, meaning it kills susceptible bacteria rather than just inhibiting their growth. It achieves this by interfering with crucial bacterial DNA processes, resulting in the destruction of bacterial cells.  

fluocinolone acetonide also exhibits immunosuppressive effects by inhibiting immune cell activation and reducing the immune response. This helps to alleviate hypersensitivity reactions and immune-mediated inflammation in the ear.

Pharmacokinetics: 

ciprofloxacin/fluocinolone acetonide, otic is intended for topical use in the ear, and its systemic absorption is minimal. The medication is primarily concentrated at the application site, allowing for local antimicrobial effects while reducing systemic exposure. The low systemic absorption contributes to a reduced risk of systemic side effects. 

Adminstartion

Administration: 

Before administration, wash your hands thoroughly with soap and water to maintain proper hygiene. Position yourself or the person receiving the medication comfortably and stable.

Tilting the head sideways with the affected ear facing upward is often helpful. For children, gently holding the earlobe and pulling it backward and upward can help straighten the ear canal. 

Before administration, gently clean the outer ear with a clean cloth or tissue. Hold the container or bottle and warm it to body temperature by rolling it between your hands. Cold drops can cause discomfort. Carefully remove the cap from the bottle. 

Tilt the head slightly backward and gently pull the earlobe upward and backward to straighten the ear canal. With your other hand, hold the vial upside down over the ear canal and squeeze the droplets into the ear. Avoid touching the dropper tip to the ear or any other surface to prevent contamination. 

After administering the drops, keep the head tilted for a few minutes. This allows the medication to enter the ear canal fully. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: ciprofloxacin/fluocinolone acetonide, otic  

Pronounced: SIP-roe-FLOX-a-sin-and-FLOO-oh-SIN-oh-lone a-si-to-nide 

Why do we use ciprofloxacin/fluocinolone acetonide, otic? 

ciprofloxacin/fluocinolone acetonide otic is used for the treatment of ear infections, specifically otitis externa, also known as swimmer’s ear. It is a combination medication that contains two active ingredients: ciprofloxacin, an antibiotic, and fluocinolone acetonide, a corticosteroid. Here are the reasons why ciprofloxacin/fluocinolone acetonide otic is used.