A homogenous opaque white sterile ophthalmic suspension.
Each mL sterile suspension contains: Prednisolone Acetate USP 10 mg.
Anti-Inflammatory Agent and Anti-Infective.
Pharmacology: Pharmacodynamics: Prednisolone acetate is a synthetic adrenocorticoid with the general properties of prednisolone. Adrenocorticoids diffuse across cell membranes to complex with cytoplasmic receptors and subsequently stimulate the synthesis of enzymes with anti-inflammatory effects. Glucocorticoids inhibit the oedema, fibrin deposition, capillary dilation, and phagocytic migration of the acute inflammatory response, as well as capillary proliferation, deposition of collagen, and scar formation. Prednisolone acetate has, on a weight-to-weight basis, a potency three to five times that of hydrocortisone.
Pharmacokinetics: Prednisolone acetate has been shown to penetrate rapidly into the cornea after topical application of a suspension preparation. Aqueous humour Tmax occurs between 30 and 45 minutes after installation. The half-life of prednisolone acetate in human aqueous humour is approximately 30 minutes.
For short-term treatment of steroid-responsive inflammatory conditions of the eye, after excluding the presence of viral, fungal and bacterial pathogens in adults.
Instill 1-2 drops in the infected eye(s) 2-4 times daily. In cases of bacterial infections, concomitant use of an antibacterial agent is mandatory.
Method of administration: Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the dropper tip down. Look up and away from the dropper as you squeeze out a drop and then close your eye. Gently press your finger to the inside corner of the eye (near your nose) for about 1 minute to keep the liquid from draining into your tear duct. If you use more than one drop in the same eye, wait about 5 minutes before putting in the next drop.
Discard instruction: Do not use for more than 28 days after first opening.
There is no clinical experience of overdose. Acute overdosage is unlikely to occur via the ophthalmic route.
Prednisolone Acetate eye suspension is contraindicated in most viral diseases of the cornea and conjunctiva, and also in mycobacterial infection of the eye.
If this medication is used for 10 days or longer, intraocular pressure should be monitored. Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation.
Use in Children: Safety and effectiveness in pediatric patients have not been established.
Use in the Elderly: No overall differences in safety and effectiveness have been observed between elderly and younger patients.
Pregnancy category C. Prednisolone has been shown to be teratogenic in mice when given in doses 1-10 times the human dose. There are no adequate, well-controlled studies in pregnant women. Prednisolone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. As systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects, 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.
Elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, and posterior subcapsular cataract formation.
None known.
Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.
Special Precautions for Handling and Disposal: Any unused medicine should be disposed of properly. Consult a pharmacist or local waste management center for more details about how to safely discard expired or unused medicines.
Store at temperatures not exceeding 30°C. Protect from light.
S01BA04 - prednisolone ; Belongs to the class of corticosteroids. Used in the treatment of inflammation of the eye.
Italmisone ophth susp 10 mg/mL (1% w/v)
5 mL x 1's
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