Ciprofloxacin + Dexamethasone

Ciprofloxacin + Dexamethasone is a sterile eye and ear drop combination. Dexamethasone is a glucocorticoid with anti-inflammatory and anti-allergic action. It reduces prostaglandin synthesis by inhibiting phospholipase A2 and inhibits chemotactic infiltration of neutrophils. 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.

• Steroid-responsive inflammatory ocular conditions with bacterial infection or risk of infection
• Post-operative ocular inflammation
• Otitis externa
• Acute and chronic otitis media
• Post-operative ear infections

Dexamethasone is a glucocorticoid with anti-inflammatory and anti-allergic action. It is used topically in the treatment of inflammatory conditions of the anterior segment of the eye. It reduces prostaglandin synthesis by inhibiting phospholipase A2 and inhibits chemotactic infiltration of neutrophils. Ciprofloxacin has in vitro activity against a wide range of gram-negative and gram-positive organisms. The bactericidal action of Ciprofloxacin results from interference with the enzyme DNA gyrase which is needed for the synthesis of bacterial DNA.

Dexamethasone reduces inflammation and allergy; Ciprofloxacin inhibits bacterial DNA gyrase, preventing DNA synthesis and causing bacterial death.

For Eye: 1 drop into conjunctival sac(s) every four to six hours. During the initial 24 to 48 hours, may increase to 1 drop every two hours.

For Ear (Acute otitis media & otitis externa): 4 drops into the affected ear 2 times daily for 7 days.

Shake well before use. For eye: tilt head back, pull lower eyelid and instill 1 drop into conjunctival sac. For ear: tilt head to one side, instill 4 drops into affected ear and remain in position for a few minutes.

If you miss a dose, apply it as soon as possible. However, if it is almost time for your next application, skip the missed dose.

Eye Side Effects:

• Transient ocular burning or discomfort
• Stinging, redness, itching
• Conjunctivitis/keratitis
• Periocular/facial edema
• Foreign body sensation
• Photophobia, blurred vision
• Tearing, dryness, eye pain
• Elevation of intraocular pressure (glaucoma)
• Optic nerve damage
• Posterior subcapsular cataract
• Delayed wound healing

Ear Side Effects:

• Discomfort and ear pain
• Irritability, dizziness, erythema

• The possibility of fungal infections of the cornea should be considered after long-term steroid dosing.
• Prolonged use of antibiotic may result in overgrowth of non-susceptible organisms.
• Prolonged use of topical ophthalmic steroids may result in glaucoma, optic nerve damage, and cataract formation.
• Intraocular pressure should be routinely monitored.

• Hypersensitivity to any ingredient
• Herpes simplex and other viral conditions
• Mycosis
• Glaucoma
• Newborn babies
• Fungal diseases of ocular or auricular structures

Specific drug interaction studies have not been conducted with ophthalmic Ciprofloxacin and Dexamethasone. However, systemic quinolones may elevate theophylline levels, interfere with caffeine metabolism, enhance warfarin effects, and cause transient serum creatinine elevations with cyclosporin.

Can be used with or without food. No specific food interactions have been identified.

There are no adequate and well-controlled studies in pregnant women. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

It is not known whether this drug is excreted in human milk. Caution should be exercised when using this product in nursing mothers.

Safety and effectiveness in pediatric patients below 1 year have not been established.

No specific dosage adjustment is necessary for elderly patients.

No special precautions are necessary for patients with kidney or liver problems.

No adequate information on overdose is available. Excessive application may cause local irritation or systemic side effects.

Store in a cool and dry place, away from light. Keep out of reach of children. Shake well before each use. Use within 30 days after first opening. Close bottle tightly after use.

Ciprofloxacin + Dexamethasone