Each ml contains:
- Prednisolone Acetate USP 10 mg
- Benzalkonium chloride solution BP 0.0001 ml (as a preservative)
- Sterile liquid buffer q.s.
Prednisolone acetate is a synthetic adrenocorticoid with the general properties of prednisolone. Adrenocorticoids diffuse into the cell membrane, bind to cytoplasmic receptors and further stimulate the synthesis of enzymes with an anti-inflammatory effect. Glucocorticoids inhibit edema, fibrin deposition, capillary dilatation, 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.
Inflammatory conditions of the eyelid and bulbar conjunctiva, cornea and anterior segment responsive to steroids, such as: allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster, keratitis, iritis, cyclitis, certain infectious conjunctivitis, when the risks associated with steroid use are acceptable to reduce swelling and inflammation; Damage to the cornea caused by chemical radiation, thermal burns or foreign bodies.
Dosage and method of administration:
Shake well before use. Two drops in the eye(s), four times a day. In case of bacterial infections, it is mandatory to use the drug together with other anti-infective agents. Treatment should not be stopped prematurely. If the symptoms and signs of the 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 treatment should not be discontinued prematurely. In chronic conditions, withdrawal of treatment should be done gradually, gradually reducing the frequency of use.
Shake well before use. Two drops in the eye(s), four times a day. In case of bacterial infections, it is mandatory to use the drug together with other anti-infective agents. Treatment should not be stopped prematurely. If the symptoms and signs of the 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 treatment should not be discontinued prematurely. In chronic conditions, withdrawal of treatment should be done gradually, gradually reducing the frequency of use.
Overdose:
An overdose does not cause acute problems. In case of accidental ingestion, take fluids.
Prednisolone Acetate Ophthalmic Suspension USP, 1% is contraindicated in viral diseases of the cornea and conjunctiva, including epithelial herpes complex, keratitis (dendritic keratitis), vaccinia, and varicella, as well as in mycobacterial eye infections and fungal diseases of ocular structures. Prednisolone Acetate Ophthalmic Suspension USP, 1% is also contraindicated in individuals with known or suspected hypersensitivity to this drug and other corticosteroids.
Adverse reactions in order of decreasing frequency are: increased intraocular pressure with possible development of glaucoma and rarely optic nerve damage, posterior subcapsular cataract formation and delayed wound healing.
Although systemic side effects are very uncommon, systemic hypercorticoidism has been reported rarely after topical steroid use.
The development of secondary eye infection (bacterial, fungal and viral) was noted. Fungal and viral infections of the cornea especially develop during long-term use of steroids. The possibility of fungal infection should be considered in case of presence of corneal ulcer treated with steroids
Warnings:
Long-term use of corticosteroids can cause glaucoma with optic nerve damage, visual acuity and visual field defects, and posterior subcapsular cataract formation. Long-term use may also suppress immunity and thus increase the risk of secondary eye infections. It is known that various eye diseases and long-term use of topical corticosteroids can cause thinning of the cornea and sclera. In the presence of thin corneal or scleral tissues, the use of topical corticosteroids may cause perforation. Acute purulent eye infections may be masked or aggravated by the use of corticosteroids. If this product is used for 10 days or more, regular monitoring of intraocular pressure is necessary, which may be difficult in children and non-contact patients. Steroids are used with caution in the presence of glaucoma. Intraocular pressure should be checked frequently.
Ophthalmic steroids can prolong and worsen viral eye infections (including herpes simplex). Caution should be exercised when using corticosteroids in the treatment of patients with a history of herpes simplex; Frequent biomicroscopy is recommended. Corticosteroids are not effective in keratitis and Sjogren’s keratoconjunctivitis.
Storage conditions:
Store up to 250C. It cannot be frozen.
Shake well before use.
Shelf life:
24 months.
Packaging:
Presented in a plastic bottle.
Issuance method:
Pharmaceutical product group III, issued without a prescription.
Manufacturer: SWISS PARENTERALS LTD.
809, Kerala G.I.D.C., no. Bavla
District: Ahmedabad-382 220, Gujarat, India
