Cipro-D Eye/Ear Drop

Cipro-D

Description

Cipro-D is a combination of Ciprofloxacin, a synthetic fluoroquinolone antimicrobial and Dexamethasone, a potent corticosteroid. The combination effectively resolves inflammation and infection in severe eye or ear conditions.

Composition

Each ml contains Ciprofloxacin Hydrochloride USP equivalent to Ciprofloxacin 3 mg and Dexamethasone BP 1 mg.

Indications

Eye: Cipro-D is indicated for the treatment of steroid responsive inflammatory ocular conditions where bacterial infections or risk of bacterial infections co-exist. The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The combination can also be used for post-operative inflammation and any other ocular inflammation associated with infection.

Ear: Cipro-D is also indicated in the treatment of ear infections accompanied by inflammation such as otitis externa, acute and chronic otitis media etc. The combination may also be used post-operatively in the ear.

Dosage and Administration

Eye: One or two drops to be instilled into conjunctival sac(s) every four to six hours. During the initial 24 to 48 hours, the dosage may be increased to one to two drops every two hours.

Frequency should be decreased gradually or warranted in clinical signs. Care should be taken not to discontinue therapy prematurely.

Ear: 2-4 drops to be installed into ear 3-4 times daily.

OR AS DIRECTED BY THE PHYSICIAN.

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.

Side effects

Eye : The most frequently reported drug-related adverse reactions seen with Ciprofloxacin are transient ocular burning or discomfort. Other reported reactions include stinging, redness, itching, conjunctivitis/keratitis, periocular/facial edema, foreign body sensation, photophobia, blurred vision, tearing, dryness, and eye pain. Rare reports of dizziness have been received. The reactions due to the steroid component are elevation of intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve damage, posterior sub capsular cataract formation, and delayed wound healing.

Ear: The most common adverse effects are discomfort and ear pain. Other reported reaction are irritability, dizziness, erythema etc. Precautions and warning

 Prolonged use may result in overgrowth of nonsusceptible organisms including fungi; in ocular hypertension and/or glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision and posterior sub capsular cataract formation.

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

 If the sign of hypersensitivity occur the otic combination should be discontinued.

Use in Pregnancy & Lactation

Pregnancy : Cipro-D 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. It is also not known whether Ciprofloxacin is excreted in human milk following topical ophthalmic administration. Because many drugs are excreted in human milk, caution should be exercised when the combination is administered to a nursing woman.

For Children

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

Ear : The safety and efficacy of Cipro-D ear drops have been established in paediatric patients 6 month and older in adequate and well controlled clinical trials. Although data are available on patients less than age 6 months, there are no safety concern or differences in this process in this population that would preclude use of this product.

Supply

Each pack contains 5 ml sterile eye/ear drops in plastic dropper bottle