A A A

Predmide-P & Predmide (Ophthalmic Suspension & Ointment)

COMPOSITION

Eye drops
Each ml contains:
Sulphacetamide sodium U.S.P. ………………. 100 mg.
Prednisolone acetate U.S.P. …………………….. 2 mg.
Phenylephrine HCl U.S.P ……………………….. 1.2 mg.
with: Phenylmercuric nitrate 0.004%, antipyrine, polysorbate 80, edetate disodium, sodium phosphate (dibasic), sodium phosphate (monobasic), sodium thiosulphate, polyvinyl alcohol 14mg and purified water.
Eye Ointment: Each ml contains:
Sulphacetamide sodium U.S.P. ………………. 100 mg.
Prednisolone acetate U.S.P. …………………… 2.5 mg.
with: Mineral oil, white petrolatum & lanolin alcohol. (Preservative Free)

CLINICAL PHARMACOLOGY

Sulphacetamide sodium exerts a bacteriostatic effect against a wide range of gram-positive and gram-negative microorganisms by restricting through competition with p-aminobenzoic acid, the synthesis of folic acid which bacteria require for growth.
Prednisolone acetate is a glucocorticoid. It effectively counters the allergic and inflammatory manifestations of blepharitis.
Phenylephrine HCl is an alpha sympathetic receptor agonist producting rasoconstriction. It rapidly whitens the engorged vessels in the eye and lid.

INDICATIONS

Predmide-P/Predmide is indicated for the treatment of nonpurulent blepharitis and blepharoconjunctivitis (seborrheal, staphylococcal, allergic); nonpurulent conjunctivitis (allergic and bacterial).

CONTRAINDICATIONS

Acute herpes simplex (dendritic keratitis), purulent untreated infections, vaccinia, varicella and most other viral diseases of the cornea and conjunctiva, ocular tuberculosis and fungal diseases of the eye. Hypersensitivity to any component of the medication.

ADVERSE REACTIONS AND PRECAUTIONS

In diseases due to microorganisms, infection may be masked, enhanced or activated by the steroid.
- Extended use may cause increased intraocular pressure in susceptible individuals. It is advisable that the 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.
- Use with caution in patients with known or suspected sensitivity to sulfonamides