civodex

Civodex

Description

Civodex┬« is a sterile ophthalmic solution containing Dexamethasone – a corticosteroid and Ciprofloxacin – a quinolone derivative for topical administration to the eyes.

 

Composition
Each ml Civodex® eye drops contains:
Active Substances: Dexamethasone Sodium Phosphate BP 1 mg and Ciprofloxacin Hydrochloride BP equivalent to Ciprofloxacin 3 mg
Preservative: Benzalkonium Chloride 0.1 mg

 

Clinical Pharmacology
Dexamethasone reduces prostaglandin synthesis by inhibiting the enzyme phospholipase A2. Also, Dexamethasone inhibits the chemotactic infiltration of neutrophils into the site of inflammation.

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

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

It is also indicated in chronic anterior uveities, scleritis, episcleritis, myositis and corneal injury from chemical radiation or thermal burns, or penetration of foreign bodies.
Post-operative management of cataract, glaucoma, and strabismus.
The use of combination with an anti-infective component is indicated where the risk of superficial ocular infection is high.

 

Dosage and Administration
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.

 

Contraindications
Known hypersensitivity to any ingredient of the product. Herpes simplex and other viral conditions, mycosis, glaucoma, newborn babies, fungal diseases of ocular or auricular structures.

 

Precautions
Prolonged use may result in overgrowth of non-susceptible organisms including fungi; in ocular hypertension, damage to the optic nerve, defects in visual acuity and posterior sub capsular cataract formation may occur. Patients wearing contact lenses must not use the drops during the time the lenses are worn.

 

Pediatric:
Safety & effectiveness for the use of this eye drops in children below the age of one year have not been established.

 

Side Effects
Frequently reported adverse reactions are transient ocular burning or discomfort. Other reported reactions include stinging, redness, itching, photophobia, conjunctivitis/keratitis, Periocular/facial edema, foreign body sensation, blurred vision, tearing, dryness, and eye pain. Elevation of IOP with development of glaucoma, and delayed wound healing may rarely occur.

 

Use in Pregnancy & Lactation
Pregnancy:
It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

 

Nursing Mother:
It is not known whether topical administration of corticosteroids would result in sufficient systemic absorption to produce detectable quantities in human milk. So caution should be exercised when the combination is administered to a nursing woman.

 

Drug Interactions
Specific drug interaction studies have not been conducted with ophthalmic Ciprofloxacin and Dexamethasone. However, the systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine, enhance the effects of the oral anticoagulant warfarin and its derivatives and have been associated with transient elevations in serum creatinine in patients receiving cyclosporin concomitantly.

 

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.

Product Description

CIPROFLOXACIN (0,3%), + DEXAMETHASONE (0.1) EYE/EAR DROPS