Prednisolone + Neomycin Sulphate + Polymixin B Sulphate

Indications

This is indicated for the treatment of eye disorders requiring anti-inflammatory therapy and where complications by infection caused by bacteria sensitive to neomycin and/or polymyxin are present or a potential hazard, such as: nonpurulent conjunctivitis and blepharitis, scleritis, nonherpetic keratitis, dacryocystitis, and for prophylactic therapy following eye surgery, foreign body removal, chemical or thermal burns, abrasions, lacerations or other ocular trauma.

Composition

Each ml contains:
  • Prednisolone acetate 5 mg
  • Neomycin sulfate (equivalent to 3.5 mg neomycin base) 5 mg
  • Polymyxin B sulfate 10000 units

Dosage & Administration

To treat the eye: 1 drop every 3 to 4 hours, or more frequently as required.

To treat the lids: instill 1 drop in the eye every 3 to 4 hours, close the eye and rub the excess on the lids and lid margins.

To treat the surrounding skin areas: where the eye or lid inflammation co-exists with surrounding skin involvement, drops may be spread liberally on the area and allowed to dry.

Pediatric Use: Safety and effectiveness in children have not been evaluated.

Interaction

Synergistic effects with penicillins. Additive toxicity with neurotoxic, ototoxic or nephrotoxic drugs. May decrease absorption of digoxin and methotrexate. May increase effects of oral anticoagulants.

Contraindications

Acute herpes simplex (dendritic keratitis), vaccinia, varicella and most other viral diseases of the cornea and conjunctiva, ocular tuberculosis, fungal diseases of the eye, and in those individuals who have shown hypersensitivity to any of the drug’s ingredients.

Side Effects

Elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsular cataract formation and delayed wound healing.

Fungal and viral infections of the cornea are particularly may develop coincidentally with long-term applications of steroid

Pregnancy & Lactation

The safety of the use of topical steroids during pregnancy has not been established.

Precautions & Warnings

In diseases due to microorganisms, infection may be masked, enhanced or activated by the steroid. Extended use of topical steroid therapy may result in increased intraocular pressure resulting in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. It is advisable that intraocular pressure be checked frequently. Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning. Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation. Prolonged use may result in overgrowth of non-susceptible organisms. If superinfection occurs, discontinue use of this drug and institute appropriate therapy. When signs of chronic ocular inflammation persist following prolonged corticosteroid dosing, the possibility of fungal infections of the cornea should be considered. Wound healing may be delayed by the use of topical corticosteroids. Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. In acute purulent conditions of the eye, corticosteroids may mask infection or enhance existing infection. There exists a potential for neomycin sulfate to cause cutaneous sensitization. The exact incidence of this reaction is unknown.

Therapeutic Class

Ophthalmic steroid - antibiotic combined preparations

Storage Conditions

Store between 15°-25°C; protect from freezing. Store upright. On prescription only. Keep out of the reach of children. shake well before use.