Econopred

Name: Econopred

Econopred Drug Class

Econopred is part of the drug classes:

  • Corticosteroids acting locally

  • Antiinflammatory Corticosteroids

  • Corticosteroids, weak group I

  • Corticosteroids, weak, other combinations

  • Corticosteroids/antiinfectives/mydriatics in combination

  • Glucocorticoids

Description

Econopred® and Econopred® Plus (Prednisolone Acetate) are adrenocortical steroid products prepared as sterile ophthalmic suspensions. The active ingredient is represented by the chemical structure:

Each mL contains: Active: Prednisolone Acetate 1.0% or 0.125%. Preservative: Benzalkonium Chloride 0.01%. Vehicle: Hydroxypropyl Methylcellulose. Inactive: Dibasic Sodium Phosphate, Polysorbate 80, Edetate Disodium, Glycerin, Citric Acid and/or Sodium Hydroxide (to adjust pH), Purified Water. DM-02, DM-03

Clinical 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 A2.

Corticosteroids are capable of producing a rise in intraocular pressure.

Contraindications

Econopred and Econopred Plus are 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. Econopred and Econopred Plus are also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

Adverse reactions

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 WARNINGS).

Dosage and administration

SHAKE WELL BEFORE USING. Two drops topically in the eye(s) four times daily. In cases of bacterial infections, concomitant use of anti-infective agents is mandatory. Care should be taken not to discontinue therapy prematurely.

If signs and symptoms fail to improve after two days, the patient should be re-evaluated (SEE PRECAUTIONS).

The dosing of Econopred and Econopred Plus 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.

For the Consumer

Applies to prednisolone ophthalmic: ophthalmic ointment, ophthalmic solution, ophthalmic suspension

Side effects include:

Elevated IOP, transient stinging or burning, blurred vision, ocular irritation, foreign body sensation.

For Healthcare Professionals

Applies to prednisolone ophthalmic: ophthalmic solution, ophthalmic suspension

General

While the exact frequency of the reported side effects is unknown, the manufacturer reports the following in decreasing order of frequency: elevation of intraocular pressure with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsular cataract formation, and delayed wound healing.[Ref]

Ocular

Rare (less than 0.1%): Filtering bleb
Frequency not reported: Intraocular pressure increased, glaucoma, optic nerve damage, posterior subcapsular cataract formation, acute anterior uveitis, perforation of globe, keratitis, conjunctivitis, corneal ulcer, mydriasis, conjunctival hyperemia, ptosis, loss of accommodation, secondary ocular infection developed, visual acuity defect, field defect, transient ocular discomfort, ocular hypertension, scleral/corneal perforation, foreign body sensation, burning, stinging, irritation, vision blurred/impaired, corneal calcification[Ref]

Dermatologic

Frequency not reported: Urticaria, pruritus, rash[Ref]

Immunologic

Frequency not reported: Allergic reaction, anaphylaxis[Ref]

Other

Frequency not reported: Wound healing delayed[Ref]

Nervous system

Frequency not reported: Headache[Ref]

Endocrine

Frequency not reported: Systemic hypercorticoidism[Ref]

Gastrointestinal

Frequency not reported: Dysgeusia[Ref]

Some side effects of Econopred may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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