Beuflox D Eye Drop Suspension 0.3%+0.1%/5ml

PRESENTATION

Beuflox-D Sterile Ophthalmic/Otic Suspension: Each ml contains Ciprofloxacin Hydrochloride BP equivalent to Ciprofloxacin 3 mg &

Dexamethasone BP 1 mg.

DESCRIPTION

Beuflox-D is a combination preparation of Ciprofloxacin and Dexamethasone. Ciprofloxacin is fluoroquinolone antimicrobial and

Dexamethasone is a potent corticosteroid. The combination effectively resolves inflammation and infection in severe eye or ear

conditions.

INDICATIONS

Eye

It is indicated for the treatment of steroid-responsive inflammatory ocular conditions where bacterial infections or a risk of

bacterial ocular infections 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 eyes. The

combination can also be used for post-operative inflammation and any other ocular inflammation associated with infection.

Ear

It is indicated for the treatment of ear infections accompanied by inflammation such as otitis externa, otitis media and Chronic

suppurative otitis media etc. The combination can also be used for post-operative inflammation of ear.

DOSAGE & ADMINISTRATION

Eye:

Corneal Ulcers: The recommended dosage regimen for the treatment of corneal ulcer is two drops into the affected eye every 15

minutes for the first six hours and then two drops into the affected eye every 30 minutes for the remainder of the first day. On

the second day, instill two drops in the affected eye hourly. On the third through the fourteenth day, place two drops in the

affected eye every four hours. Treatment may be continued after 14 days if corneal re-epithelialization has not occurred.

Bacterial Conjunctivitis:

The recommended dosage regimen for the treatment of bacterial conjunctivitis is one or two drops instilled into the conjunctival

sac(s) every two hours while awake for two days and one or two drops every four hours while awake for the next five days.

Ear:

Four drops instilled into the affected ear twice daily for seven days. The suspension 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 suspension. The patient

should lie with the affected ear upward, and then the suspension should be instilled. This position should be maintained for 60

seconds. Repeat, if necessary, for the opposite ear.

Paediatric Use:

Ear: Safety and effectiveness of this suspension in pediatric (6 months of age and older) patients for ear application have been

established.

Eye:

Safety and effectiveness of this suspension in pediatric patients for eye application have not been established.

SIDE EFFECTS

Side Effects

The most frequently reported drug-related adverse reactions seen with Ciprofloxacin are transient ocular burning or discomfort.

Other reported reactions include stinging, redness, itching, 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.

PRECAUTIONS

Shake the bottle well before use. Prolonged use of Ciprofloxacin may result in overgrowth of nonsusceptible organisms, including

fungi. Prolonged use of steroids may result in glaucoma.The possibility of fungal infections of the cornea should be considered

after long-term steroid dosing. Patients-wearing contact lenses must not use the drops during time the lenses are worn.

USE IN PREGNANCY & LACTATION

Pregnancy

Beuflox-D should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation

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.

OVER DOSE

A topical overdose may be flushed from the eye(s) with warm water.

STORAGE

Store in a cool, dry place and protect from light.

Keep out of the reach of children.

Protect from freezing.

Shake well before using.

COMMERCIAL PACK

Beuflox-D Sterile Ophthalmic/Otic Suspension: Plastic dropper bottle containing 5 ml sterile Ophthalmic/Otic Suspension.