Active ingredient: Prednisolone sodium phosphate 10 mg/ml.
Excipients/Inactive Ingredients: Sodium phosphate monobasic monohydrate, Sodium phosphate dibasic dihydrate, Sodium chloride, Edetate disodium, Benzalkonium chloride, Water for injection.
For the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe, such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitis when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation, corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies.
Depending on the severity of inflammation, instill one or two drops of solution into the conjunctival sac up to every hour during the day and every two hours during the night as necessary as initial therapy.
When a favorable response is observed, reduce dosage to one drop every four hours.
Later, further reduction in dosage to one drop three to four times daily may suffice to control symptoms.
The duration of treatment will vary with the type of lesion and may extend from a few days to several weeks, according to therapeutic response. Relapses, more common in chronic active lesions than in self-limited conditions, usually respond to retreatment.
The use of this preparation is contraindicated in the presence of: Acute superficial herpes simplex keratitis; Fungal diseases of ocular structures; Acute infectious stages of vaccinia, varicella and most other viral diseases of the cornea and conjunctiva; Tuberculosis of the eye; Hypersensitivity to a component of this medication.
The use of this preparation is always contraindicated after uncomplicated removal of a superficial corneal foreign body.
General: As fungal infections of the cornea are particularly prone to develop coincidentally with long-term steroid applications, fungus invasion must be suspected in any persistent corneal ulceration where a steroid has been used or is in use.
Intraocular pressure should be checked frequently.
Information for Patients: Do not touch dropper tip to any surface as this may contaminate the solution.
Use in Pregnancy: See Usage in Pregnancy under Use in Pregnancy & Lactation.
Use in Lactation: See Nursing Mothers under Use in Pregnancy & Lactation.
Use in Children: Safety and effectiveness in pediatric patients have not been established.
Usage in Pregnancy: Pregnancy Category C: Animal reproductive studies have not been conducted with prednisolone sodium phosphate. It is also not known whether prednisolone sodium phosphate can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Prednisolone sodium phosphate should be given to a pregnant woman only if clearly needed.
The effect of prednisolone sodium phosphate on the later growth, development and functional maturation of the child is unknown.
Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when prednisolone sodium phosphate is administered to a nursing woman.
Glaucoma with optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, secondary ocular infections from pathogens including herpes simplex and fungi, and perforation of the globe.
Rarely, filtering blebs have been reported when topical steroids have been used following cataract surgery.
Rarely, stinging or burning may occur.
Very rare (<1/10000): Very rare cases of coronary catheterisation have been reported in patients with significantly damaged corneas in combination with the use of phosphate-containing ophthalmic drops.
Not Known (frequency cannot be estimated from available data): Immune system disorders: Hypersensitivity, usually of a delayed type, which can lead to irritation, burning, tingling and itching.
Nervous system disorders: Headache.
Skin and subcutaneous tissue disorders: Dermatitis, itching, rash.
Eye disorders: Topical administration of corticosteroids may result in elevated intraocular pressure which can lead to optic nerve damage, reduced visual acuity and visual field defects. Other side effects are chorioretinopathy, mydriasis, ptosis, epithelial punctate keratitis and possible softening of the cornea or sclera. Within a few days after discontinuation of topical ophthalmic corticosteroids and occasionally during treatment, acute anterior uveitis without pre-existing ocular inflammation or infection has occurred in patients (mostly Black patients).
Intensive or prolonged use of topical corticosteroids may lead to formation of posterior subcapsular cataracts.
In those diseases causing thinning of the cornea or sclera, corticosteroid therapy may result in thinning of the globe leading to perforation.
Vision blurred.
Foreign body sensation.
Gastrointestinal disorders: Dysgeusia.
Adelon will increase the effect of: Barbiturates, sedative hypnotics, tricyclic antidepressants.
Adelon will decrease the effect of: Anticholinesterases, antiviral eye preparations and salicylates.
Store at 25°C or below.
Shelf life before opening: 3 years.
S01BA04 - prednisolone ; Belongs to the class of corticosteroids. Used in the treatment of inflammation of the eye.
Adelon eye drops soln 1% w/v
5 mL x 1's
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