Properties
What is it?
Composition: Each mL contains: Prednisolone Acetate USP 10 mg Benzalkonium Chloride Solution BP 0.0001 mL (as preservative) Sterile fluid buffered medium q.s. Chemical Name: [2-[8S,9S,10R,11S,13S,14S,17R)-11,17-dihydroxy-10,13-dimethyl-3-oxo-7,8,9,11,12,14,15,16-octahydro-6H-cyclopenta[a]phenanthren-17-yl]-2-oxoethyl] acetate. Dosage Form: Ophthalmic Suspension. Category: Corticosteroids. Pharmacology: Pharmacodynamic Properties: Prednisolone acetate is a synthetic adrenocorticoid with the general properties of prednisolone. Adrenocorticoids diffuse across the cell membrane, bind to cytoplasmic receptors, and subsequently stimulate enzyme synthesis with an anti-inflammatory effect. Glucocorticoids inhibit edema, fibrin deposition, capillary dilation, and phagocytic migration of the acute inflammatory response, as well as capillary proliferation, collagen deposition, and scar formation. Prednisolone acetate is three to five times more potent than hydrocortisone on a weight basis. Pharmacokinetics: Prednisolone acetate rapidly penetrates the cornea following topical instillation of a suspension preparation. Tmax in aqueous humor is observed within 30-45 minutes after instillation. The half-life of prednisolone acetate in human aqueous humor is approximately 30 minutes. Indications: Steroid-responsive inflammatory conditions of the eyelid and bulbar conjunctiva, cornea, and anterior segment of the eye, such as: allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster, keratitis, iritis, cyclitis, certain infectious conjunctivitis when the accompanying hazards of steroid use are justifiable to reduce edema and inflammation; corneal injury due to chemical radiation, thermal burns, or foreign bodies. Dosage and Administration: Shake well before use. Two drops in the eye(s) four times daily. In cases of bacterial infections, concomitant use of the preparation and other anti-infective agents is mandatory. Treatment should not be discontinued prematurely. If symptoms and signs of disease do not improve after two days, the patient should be re-examined. The dosage of Prednisolone Acetate Ophthalmic Suspension USP, 1% may be reduced, but it is essential that treatment is not discontinued prematurely. In chronic conditions, withdrawal of treatment should be gradual by gradually decreasing the frequency of use. Contraindications: Prednisolone Acetate Ophthalmic Suspension USP, 1% is contraindicated in viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, as well as in mycobacterial infection of the eye and fungal diseases of the eye structures. Prednisolone Acetate Ophthalmic Suspension USP, 1% is also contraindicated in individuals who are hypersensitive to any component of this preparation or to other corticosteroids. Precautions and Warnings: Warnings: For topical ophthalmic use only. Prolonged use of corticosteroids may produce glaucoma with damage to the optic nerve, defects in visual acuity and visual field, and posterior subcapsular cataract formation. Prolonged use may also suppress the immune system and thus increase the hazard of secondary ocular infections. It is known that various diseases of the eye and long-term use of topical corticosteroids may cause thinning of the cornea and sclera. With the presence of thin corneal or scleral tissue, use of topical corticosteroids may lead to perforation. Acute purulent infections of the eye may be masked or aggravated by the use of corticosteroid preparation. If this product is used for 10 days or longer, regular monitoring of intraocular pressure is necessary, which can be quite difficult in children and uncooperative patients. Steroids should be used with caution in the presence of glaucoma. Intraocular pressure should be checked frequently. Ophthalmic steroids may prolong and exacerbate viral infections of the eye (including herpes simplex). Caution is necessary when using corticosteroids in the treatment of patients with a history of herpes simplex; frequent biomicroscopic examinations are recommended. Corticosteroids are not effective in keratitis and Sjögren's keratoconjunctivitis. Precautions: General: The initial and repeated administration of the preparation should be done by a physician after examination of the patient, such as biomicroscopy with a slit lamp and, if necessary, staining with fluorescein. If signs and symptoms do not improve after two days, patients must be re-examined. Since fungal infections of the cornea may develop with prolonged local use of corticosteroids, if a corneal ulcer is present, the possibility of fungal invasion should be considered after or during corticosteroid treatment. If necessary, fungal cultures should be taken. If the product is used for 10 days or longer, intraocular pressure monitoring is necessary. Information for Patients: If inflammation or pain persists for more than 48 hours or increases, the patient should be advised to discontinue use of the preparation and consult a physician. The packaged product is sterile. To prevent contamination, care should be taken in the use of the preparation so that the tip of the bottle does not touch the eyelids or any other surface. Use of this bottle by more than one person may spread infection. The bottle should be kept tightly closed. Keep out of reach of children. Pregnancy and Lactation: Teratogenic Effects Pregnancy Category C. Prednisolone has been found to be teratogenic when used in mice at doses exceeding 1-10 times the dose used in humans. Dexamethasone, hydrocortisone, and prednisolone were used in pregnant mice, in both eyes, five times daily, on days 10-13 of gestation. A significantly increased incidence of cleft palate was observed in the fetuses of such mice. There are no adequate and well-controlled studies in pregnant women. Prednisolone Acetate Ophthalmic Suspension USP, 1% may be used during pregnancy if the potential benefit justifies the potential risk to the fetus. Nursing Mothers: It is not known whether topical administration of corticosteroids results in sufficient systemic absorption to produce detectable amounts in breast milk. Systemically administered corticosteroids are excreted in breast milk and may cause growth inhibition, suppress endogenous corticosteroid production, or cause other adverse effects. Because of the potential for serious adverse reactions in nursing infants from prednisolone acetate, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Adverse Reactions: Adverse reactions, in order of decreasing frequency, are: increased intraocular pressure with possible development of glaucoma and infrequent optic nerve damage, formation of posterior subcapsular cataract, and delayed wound healing. Although systemic side effects are very rare, systemic hypercorticism has been reported rarely following local steroid use. Development of secondary ocular infection (bacterial, fungal, and viral) has been reported. Fungal and viral infections of the cornea are especially common with prolonged use of steroids. The possibility of fungal invasion should be considered in the presence of a corneal ulcer. Overdosage: Overdosage does not cause acute problems. In case of accidental ingestion, drink fluids. Storage Conditions: Store below 25°C. Do not freeze. Shake well before use. Shelf Life: 24 months. Packaging: Presented in a plastic bottle. Dispensing Rule: Pharmaceutical Product Group III, available without prescription.
