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OMNIPRED
Overview
What is OMNIPRED?
OMNIPRED (prednisolone acetate ophthalmic suspension) is an adrenocortical steroid product prepared as sterile ophthalmic suspension. The active ingredient is represented by the chemical structure:
Established name: Prednisolone Acetate
Chemical name: Pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-11,17-dihydroxy-,(11β)-.
Each mL contains: Active:
Preservative:
Vehicle:
Inactives:
What does OMNIPRED look like?
What are the available doses of OMNIPRED?
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What should I talk to my health care provider before I take OMNIPRED?
Sorry No records found
How should I use OMNIPRED?
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 conjunctivitides, 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.
SHAKE WELL BEFORE USING.
The dosing of OMNIPRED suspension may be reduced, but care should be taken not to discontinue therapy prematurely.
In chronic conditions, withdrawal of treatment should be carried out by gradually decreasing the frequency of applications.
What interacts with OMNIPRED?
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What are the warnings of OMNIPRED?
Sorry No Records found
What are the precautions of OMNIPRED?
Sorry No Records found
What are the side effects of OMNIPRED?
Sorry No records found
What should I look out for while using OMNIPRED?
OMNIPRED (prednisolone acetate ophthalmic suspension) is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. OMNIPRED (prednisolone acetate ophthalmic suspension) is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.
FOR TOPICAL OPHTHALMIC USE ONLY. 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. 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 and scleral thinning. Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation. Acute purulent infections of the eye may be masked or activity enhanced by the presence of corticosteroid medication. If this product is used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients. Steroids should be used with caution in the presence of glaucoma.
Intraocular pressure should be checked frequently.
The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.
Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution; frequent slit lamp microscopy is recommended.
Corticosteroids are not effective in mustard gas keratitis and Sjogren's keratoconjunctivitis.
What might happen if I take too much OMNIPRED?
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How should I store and handle OMNIPRED?
OMNIPRED (prednisolone acetate ophthalmic suspension) is supplied in a white, round low density polyethylene DROP-TAINER dispenser with a natural low density polyethylene dispensing plug and pink polypropylene cap. Tamper evidence is provided with a shrink band around the closure and neck area of the package.OMNIPRED suspension:5 mL NDC 0065-0638-2710 mL NDC 0065-0638-25STORAGE: Rx OnlyOMNIPRED (prednisolone acetate ophthalmic suspension) is supplied in a white, round low density polyethylene DROP-TAINER dispenser with a natural low density polyethylene dispensing plug and pink polypropylene cap. Tamper evidence is provided with a shrink band around the closure and neck area of the package.OMNIPRED suspension:5 mL NDC 0065-0638-2710 mL NDC 0065-0638-25STORAGE: Rx OnlyOMNIPRED (prednisolone acetate ophthalmic suspension) is supplied in a white, round low density polyethylene DROP-TAINER dispenser with a natural low density polyethylene dispensing plug and pink polypropylene cap. Tamper evidence is provided with a shrink band around the closure and neck area of the package.OMNIPRED suspension:5 mL NDC 0065-0638-2710 mL NDC 0065-0638-25STORAGE: Rx OnlyOMNIPRED (prednisolone acetate ophthalmic suspension) is supplied in a white, round low density polyethylene DROP-TAINER dispenser with a natural low density polyethylene dispensing plug and pink polypropylene cap. Tamper evidence is provided with a shrink band around the closure and neck area of the package.OMNIPRED suspension:5 mL NDC 0065-0638-2710 mL NDC 0065-0638-25STORAGE: Rx OnlyOMNIPRED (prednisolone acetate ophthalmic suspension) is supplied in a white, round low density polyethylene DROP-TAINER dispenser with a natural low density polyethylene dispensing plug and pink polypropylene cap. Tamper evidence is provided with a shrink band around the closure and neck area of the package.OMNIPRED suspension:5 mL NDC 0065-0638-2710 mL NDC 0065-0638-25STORAGE: Rx OnlyOMNIPRED (prednisolone acetate ophthalmic suspension) is supplied in a white, round low density polyethylene DROP-TAINER dispenser with a natural low density polyethylene dispensing plug and pink polypropylene cap. Tamper evidence is provided with a shrink band around the closure and neck area of the package.OMNIPRED suspension:5 mL NDC 0065-0638-2710 mL NDC 0065-0638-25STORAGE: Rx Only
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing. They inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation. There is no generally accepted explanation for the mechanism of action of ocular corticosteroids. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A.
Corticosteroids are capable of producing a rise in intraocular pressure.
Non-Clinical Toxicology
OMNIPRED (prednisolone acetate ophthalmic suspension) is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. OMNIPRED (prednisolone acetate ophthalmic suspension) is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.FOR TOPICAL OPHTHALMIC USE ONLY. 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. 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 and scleral thinning. Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation. Acute purulent infections of the eye may be masked or activity enhanced by the presence of corticosteroid medication. If this product is used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients. Steroids should be used with caution in the presence of glaucoma.
Intraocular pressure should be checked frequently.
The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.
Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution; frequent slit lamp microscopy is recommended.
Corticosteroids are not effective in mustard gas keratitis and Sjogren's keratoconjunctivitis.
Elderly patients, compared to younger patients, are at greater risk for NSAID-associated serious cardiovascular, gastrointestinal, and/or renal adverse reactions. If the anticipated benefit for the elderly patient outweighs these potential risks, start dosing at the low end of the dosing range, and monitor patients for adverse effects (see , , , , ).
Diclofenac is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function (see , ).
The initial prescription and renewal of the medication order should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. If signs and symptoms fail to improve after two days, the patient should be re-evaluated.
As fungal infections of the cornea are particularly prone to develop coincidentally with long-term local corticosteroid applications, fungal invasion should be suspected in any persistent corneal ulceration where a corticosteroid has been used or is in use. Fungal cultures should be taken when appropriate.
If this product is used for 10 days or longer, intraocular pressure should be monitored (SEE ).
Adverse reactions include, in decreasing order of frequency, elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsular cataract formation, and delayed wound healing.
Although systemic effects are extremely uncommon, there have been rare occurrences of systemic hypercorticoidism after use of topical steroids.
Corticosteroid-containing preparations have also been reported to cause acute anterior uveitis and perforation of the globe.
Keratitis, conjunctivitis, corneal ulcers, mydriasis, conjunctival hyperemia, loss of accommodation and ptosis have occasionally been reported following local use of corticosteroids.
The development of secondary ocular infection (bacterial, fungal and viral) has occurred. Fungal and viral infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroid. The possibility of fungal invasion should be considered in any persistent corneal ulceration where steroid treatment has been used (SEE ).
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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