Bactin - Ciprofloxacin 0.3% - Sterile Eye Drops & Ointment

Description:
Bactin® Eye Drops is 0.3% isotonic sterile aqueous ophthalmic solution of Ciprofloxacin. Bactin® Eye Ointment is 0.3% ophthalmic sterile ointment of Ciprofloxacin. Ciprofloxacin is a broad spectrum fluoroquinolone antibacterial, having bacteriocidal activity against a wide range of Gram positive and Gram negative pathogenic bacteria. Ciprofloxacin achieves therapeutic level in various ocular tissues and fluids, hence topical administration of this drug is useful in the treatment of various ocular infections.

Composition:
Bactin® Eye Drops : Each ml contains Ciprofloxacin USP 3 mg.
Bactin® Eye Ointment : Each gm contains Ciprofloxacin USP 3 mg.

Indication:
Bactin® Eye Drops or Ointment is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below:
Corneal Ulcer : Pseudomonas aeruginosa, Streptococcus viridans (Drops only), Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Serratia marcescens.
Cojunctivitis : Staphylococcus aureus, Staphylococcus epidermidis, Streptoccoccus pneumoniae. H. influenzae 
Also, Bactin Eye Drops is indicated for prevention of ocular infections after removal of corneal or conjunctival foreign body, after damage from chemical or physical agents, before and after surgery.

Dosage and Administration:
Corneal ulcer : Bactin® Eye Drops: 1st day : Two drops into the affected eye every 15 minutes for the first 6 hours and then 2 drops into the affected eye every 30 minutes for the remainder of the 1st day.
2nd day : Instill 2 drops in the affected eye hourly. 3rd day : On the 3rd through the 14th day, instill 2 drops in the affected eye every 4 hours. Treatment may be continued after 14 days if corneal re-epithelialization has not occurred.
Bacterial Conjunctivitis: Bactin® Eye Drops: 1 or 2 drops instilled into the conjunctival sac(s) every 2 hours while awake for 2 days and 1 or 2 drops every 4 hours while awake for the next 5 days.
Bactin® Eye Ointment: Apply a 1/2" ribbon into the conjunctival sac 3 times daily on the first two days, then apply a 1/2" ribbon two times a day for the next 5 days.

Precaution:
If irritation persists or increases, discontinue the use and consult with the physician. Don't touch the dropper tip to any surface since this may contaminate the solution. Use this solution within 1 month after opening the container. A white crystalline precipitate may be observed in the superficial portion of the corneal defect in patients of bacterial corneal ulcer. But the precipitate will not preclude continued use of Ciprofloxacin, nor will it adversely affect the clinical course of the ulcer or visual outcome.

Pregnancy and Nursing mother:
Safety in pregnancy & lactating mother have not been established. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when Bactin solution is administered to a nursing mother.

Paediatric Use:
Safety & effectiveness in children below the age of 1 year (drops) / 2 year (Ointment) have not been established.

Side effect:
The most frequently reported drug related adverse reaction was local burning or discomfort. Other reactions are lid margin crusting, crystals/ scales, foreign body sensation, itching, conjunctival hyperemia, corneal staining, keratopathy/keratitis, allergic reaction, lid edema, tearing, photophobia, nausea and decreased vision.

Contraindication:
Bactin Eye Drops/Ointment is contraindicated in patients with known hypersensitivity to any of its components.

How supplied:
Bactin® Eye Drops : Plastic dropper bottle contains 5ml or 10 ml drops.
Bactin® Eye ointment : Tube contains 3 gm ointment.

Manufacturer’s Source: IBN SINA