Civodex™ is a sterile solution containing a synthetic broad-spectrum antibacterial agent, Ciprofloxacin Hydrochloride, combined with an anti-inflammatory corticosteroid, Dexamethasone, in a sterile, preserved solution for ophthalmic & otic use.

 

Composition

Each ml of Civodex™ Eye/Ear Drops contains:

Active Substances: Ciprofloxacin Hydrochloride BP equivalent to Ciprofloxacin 3 mg and Dexamethasone BP 1 mg

 

Preservative: Benzalkonium Chloride 0.1 mg

Clinical Pharmacology

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).

 

Ciprofloxacin has in vitro activity against a wide range of gram-positive and gram-negative bacteria. The bactericidal action of Ciprofloxacin results from interference with the enzyme, DNA gyrase, which is needed for the synthesis of bacterial DNA

 

Indications and Usages

Civodex™ ophthalmic & otic solution is indicated for the, treatment of infections-(l8used by susceptible microorganisms in the specific conditions listed below:

 

Acute and chronic keratitis and conjunctivitis of an infectious, allergic but non-viral nature.

It is also Indicated in chronic anterior uveitis, scleritis, episcleritis, myositis and corneal Injury from chemical radiation or thermal bums, Of penetration of foreign bodies.

 

Post-operative management of cataract, glaucoma, and strabismus.

The use or combination with an anti-infective component is indicated where the risk of superficial ocular infection is high.

Acute Otitis Media in pediatric patients (age 6 months and older) with tympanostomy tubes due to Staphylococcus aureus, Streptococcus pne1JJI1oniae, Hemophilus influenzae,

Moraxella catarrhris, and Pseudomonas aeruginosa.

Acute Otitis Externa in pediatric {age 6 months and older), adult and elderly patients due to Staphylococcus aureus and Pseudomonas aeruginosa.

 

Dosage and Administration

Eye Drops:

1 drop into conjunctival sac(s) every four to six hours. During the initial 24 to 48 hours, the dosage may be increased to 1 drop every two hours.

 

Ear Drops:

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:

4 drops instilled into the affected ear twice daily for seven days.

 

The solution 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 solution. 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. Discard unused portion after therapy is completed.

Acute Otitis Externa: The recommended dosage regimen for the treatment of acute otitis externa in patients (age 6 months and older) is:

 

4 drops instilled into the affected ear twice daily for seven days. The solution 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 solution. 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. Discard unused portion after therapy is completed.

 

Contraindications

Known hypersensitivity to any ingredient of the product. This product is also contraindicated in viral infections of the external canal including herpes simplex infections, mycosis,

glaucoma, newborn babies, fungal diseases of ocular or auricular structures.

Precautions

Prolonged use of this product may result in overgrowth of nonsusceptible organisms, including yeast and fungi.

Patients wearing contact lenses must not use the drops during the time the lenses are worn.

 

Over dosage
Not known and not likely.
Pharmaceutical Precautions
Store at room temperature, protect from light. It is desirable that the contents should not be used more than 4 weeks after first opening of the bottle.

 

Commercial Pack
Dropper bottle of 5 ml.