10ML

Predira

Prednisolone Acetate Ophthalmic Suspension USP

Prednisolone Acetate Ophthalmic Suspension USP is indicated for the treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe.

Composition:

Prednisolone Acetate IP 1.0 % w/v
Benzalkonium Chloride Solution IP 0.01 % v/v (As Preservative)
Sterile Aqueous Base q.s.

Drug Substance:

Prednisolone Acetate

Actions & Clinical Pharmacology:

Prednisolone acetate is a glucocorticoid that, on the basis of weight, has 3 to 5 times the anti-inflammatory potency of hydrocortisone. Glucocorticoids inhibit the edema, fibrin deposition, capillary dilation, and phagocytic migration of the acute inflammatory response, as well as capillary proliferation, deposition of collagen, and scar formation.

Indications:

Prednisolone Acetate Ophthalmic Suspension USP is indicated for the treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe.

Pharmacokinetics:

Prednisolone acetate has been shown to penetrate rapidly the cornea after topical application of a suspension preparation. Aqueous humor Tmax occurs between 30 and 45 minutes after installation. The half-life of prednisolone acetate in human aqueous humor is approximately 30 minutes.

Contraindications:

Acute untreated purulent ocular infections. Acute superficial herpes simplex (dendritic keratitis); vaccinia, varicella and most other viral diseases of the cornea and conjunctiva. Fungal diseases of the eye. Mycobacterial infection such as tuberculosis of the eye. Hypersensitivity to the active substance or to any of the excipients used in the formulation.

Dosage and Administration:

Adults:

One to two drops instilled into the conjunctival sac two to four times daily. During the initial 24 to 48 hours the dosing frequency may be safely increased to 2 drops every hour. Care should be taken not to discontinue therapy prematurely. No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Method of administration:

Route of administration is by ocular instillation. To reduce possible systemic absorption, it may be recommended that the lacrimal sac be compressed at the medial canthus (punctal occlusion) for 1 minute. This should be performed immediately following the instillation of each drop. Shake well before use.

Special Instructions:

Shake well before use. Patients should be advised to avoid contamination of the dispensing tip.

Storage:

Store below 30°C. Protect from light & moisture. Do not freeze.

Presentation:

Predira Eye Drops is available in 5ml sterile plastic bottles.

Prolonged use may also suppress the host immune response and thus increase the hazard of secondary ocular infections. Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal or scleral thinning. Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation.

Eye drops containing corticosteroids should not be used for more than 10 days except under strict ophthalmic supervision with regular checks for intraocular pressure.

The preservative in Prednisolone Acetate Ophthalmic Suspension USP, benzalkonium chloride, may be absorbed by and cause discoloration of soft contact lenses. Patients wearing soft contact lenses should be instructed to remove contact lenses prior to administration of the solution and wait at least 15 minutes after instilling Prednisolone Acetate Ophthalmic Suspension USP before reinserting soft contact lenses.

To prevent eye injury or contamination, care should be taken to avoid touching the bottle tip to the eye or to any other surface.

Pregnancy:

Pregnancy Category C: There is inadequate evidence of safety in human pregnancy. Administration of corticosteroids to pregnant animals can cause abnormalities of fetal development including cleft palate and intra-uterine growth retardation. There may therefore be a very small risk of such defects in the human fetus. Therefore, this product should be used with caution during pregnancy only if the potential benefit outweighs the potential risk to the fetus.

Nursing Mothers:

It is not known whether topical administration of Prednisolone Acetate Ophthalmic Suspension USP could result in sufficient systemic absorption to produce detectable quantities in breast milk. Therefore, use is not recommended in women breast-feeding infants.

Paediatric Use:

Safety and effectiveness in pediatric patients below the age of 2 years have not been established.

Geriatric Use:

No overall differences in safety and effectiveness have been observed between elderly and younger patients.

Symptoms and Treatment of Overdosage:

Overdosage will not ordinarily cause acute problems. If accidentally ingested, drink fluids to dilute.