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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—if sensitivity or other untoward reactions occur, discontinue medication.
- Should be used with caution in the presence of narrow angle glaucoma.
- Reports in the literature indicate that posterior subcapsular lenticular opacities have been reported to occur after heavy or protracted use of topical ophthalmic corticosteroids.
- When signs of chronic ocular inflammation persist following prolonged corticosteroid dosing, the possibility of fungal infections of the cornea should be considered.
- Prolonged use may suppress the host immune response in ocular tissues and thus increase the possibility of secondary ocular infections.
- Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution.

DOSAGE AND ADMINISTRATION

Ophthalmic Suspension: 1 drop into the conjunctival sac(s) 2 to 4 times daily, depending upon the severity of the condition. In general, during early or acute stages of blepharitis, Predmide-P produces results most rapidly and most efficiently, with instillation directly into the eye, with the excess spread on the lid (Method I). When the condition is confined to the lid, however, Predmide-P may be applied directly to the site of the lesions (Method II).

METHOD I: In the Eye and on the Lid

Wash hands carefully. Tilt head back and drop 1 drop into the eye. Close the eye and spread the excess medication present after closing the eye over the full length of the upper and lower lids. Do not wipe any of the medication off the lids. It will dry completely in 4 or 5 minutes to a clear film that remains on the lids for several hours—it can not be seen by others, nor will it interfere with vision. The medication should be washed off the lids once or twice a day. However, it should be reapplied after each washing.

METHOD II: On the Lid

Wash hands carefully. With head tilted back and eye closed, drop 1 drop onto the lid, preferably at the corner of the eye close to the nose. Spread the medication over the full length of the upper and lower lids. Do not wipe away any medication—it will dry in 4 to 5 minutes to a clear, invisible film which will remain on the lids for several hours. The medication should be washed off the lids once or twice a day. However, it should be reapplied after each washing.
Predmide Eye Ointment: Apply a small amount (app. 1/2 inch ribbon) into the conjunctival sac(s) 3 to 4 times daily or as directed by the ophthalmologist.

HOW SUPPLIED

Predmide-P Ophthalmic Suspension is available as a sterile suspension in 5 ml pilfer proof plastic dropper bottles (Gamma Irradiated). Predmide Eye Ointment is available as a sterile ointment in 3.5 gm ophthalmic tube (Gamma Irradiated).

STORAGE

Protect from sunlight. Keep away from children’s reach. Do not freeze. Store between 15°C to 25°C.
After opening the bottle, use within 4 weeks