PREDNISOLONE ACETATE

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Overview

What is PREDNISOLONE ACETATE?

Prednisolone acetate ophthalmic suspension, USP 1% is a topical anti-inflammatory agent for ophthalmic use.

What does PREDNISOLONE ACETATE look like?

What are the available doses of PREDNISOLONE ACETATE?

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What should I talk to my health care provider before I take PREDNISOLONE ACETATE?

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How should I use PREDNISOLONE ACETATE?

Prednisolone acetate ophthalmic suspension 1% is indicated for the treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe.

Shake well before using.

If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated (see ).

What interacts with PREDNISOLONE ACETATE?

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What are the warnings of PREDNISOLONE ACETATE?

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What are the precautions of PREDNISOLONE ACETATE?

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What are the side effects of PREDNISOLONE ACETATE?

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What should I look out for while using PREDNISOLONE ACETATE?

Prednisolone acetate ophthalmic suspension 1% 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. Prednisolone acetate ophthalmic suspension 1% is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

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 Sjögren's keratoconjunctivitis.

Contains sodium bisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

What might happen if I take too much PREDNISOLONE ACETATE?

Overdosage will not ordinarily cause acute problems. If accidentally ingested, drink fluids to dilute.

How should I store and handle PREDNISOLONE ACETATE?

Storage and HandlingStore XELJANZ/XELJANZ XR at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature].Storage and HandlingStore XELJANZ/XELJANZ XR at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature].Prednisolone acetate ophthalmic suspension, USP 1% is supplied sterile in opaque white LDPE plastic bottles with droppers with white high impact polystyrene (HIPS) caps as follows: 5 mL in 10 mL bottle - NDC 60758-119-0510 mL in 15 mL bottle - NDC 60758-119-1015 mL in 15 mL bottle - NDC 60758-119-15 Storage:Revised: 03/2014© 2014 Allergan, Inc.Irvine, CA 92612, U.S.A.® marks owned by Allergan, Inc.Made in the U.S.A. 71592PY11 Prednisolone acetate ophthalmic suspension, USP 1% is supplied sterile in opaque white LDPE plastic bottles with droppers with white high impact polystyrene (HIPS) caps as follows: 5 mL in 10 mL bottle - NDC 60758-119-0510 mL in 15 mL bottle - NDC 60758-119-1015 mL in 15 mL bottle - NDC 60758-119-15 Storage:Revised: 03/2014© 2014 Allergan, Inc.Irvine, CA 92612, U.S.A.® marks owned by Allergan, Inc.Made in the U.S.A. 71592PY11 Prednisolone acetate ophthalmic suspension, USP 1% is supplied sterile in opaque white LDPE plastic bottles with droppers with white high impact polystyrene (HIPS) caps as follows: 5 mL in 10 mL bottle - NDC 60758-119-0510 mL in 15 mL bottle - NDC 60758-119-1015 mL in 15 mL bottle - NDC 60758-119-15 Storage:Revised: 03/2014© 2014 Allergan, Inc.Irvine, CA 92612, U.S.A.® marks owned by Allergan, Inc.Made in the U.S.A. 71592PY11 Prednisolone acetate ophthalmic suspension, USP 1% is supplied sterile in opaque white LDPE plastic bottles with droppers with white high impact polystyrene (HIPS) caps as follows: 5 mL in 10 mL bottle - NDC 60758-119-0510 mL in 15 mL bottle - NDC 60758-119-1015 mL in 15 mL bottle - NDC 60758-119-15 Storage:Revised: 03/2014© 2014 Allergan, Inc.Irvine, CA 92612, U.S.A.® marks owned by Allergan, Inc.Made in the U.S.A. 71592PY11 Prednisolone acetate ophthalmic suspension, USP 1% is supplied sterile in opaque white LDPE plastic bottles with droppers with white high impact polystyrene (HIPS) caps as follows: 5 mL in 10 mL bottle - NDC 60758-119-0510 mL in 15 mL bottle - NDC 60758-119-1015 mL in 15 mL bottle - NDC 60758-119-15 Storage:Revised: 03/2014© 2014 Allergan, Inc.Irvine, CA 92612, U.S.A.® marks owned by Allergan, Inc.Made in the U.S.A. 71592PY11 Prednisolone acetate ophthalmic suspension, USP 1% is supplied sterile in opaque white LDPE plastic bottles with droppers with white high impact polystyrene (HIPS) caps as follows: 5 mL in 10 mL bottle - NDC 60758-119-0510 mL in 15 mL bottle - NDC 60758-119-1015 mL in 15 mL bottle - NDC 60758-119-15 Storage:Revised: 03/2014© 2014 Allergan, Inc.Irvine, CA 92612, U.S.A.® marks owned by Allergan, Inc.Made in the U.S.A. 71592PY11

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Prednisolone acetate is a glucocorticoid that, on the basis of weight, has 3 to 5 times the anti-inflammatory potency of hydrocortisone. Glucocorticoids inhibit the edema, fibrin deposition, capillary dilation, and phagocytic migration of the acute inflammatory response, as well as capillary proliferation, deposition of collagen, and scar formation.

Non-Clinical Toxicology

Prednisolone acetate ophthalmic suspension 1% 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. Prednisolone acetate ophthalmic suspension 1% is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

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 Sjögren's keratoconjunctivitis.

Contains sodium bisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

Tropicamide may interfere with the antihypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.

General

The initial prescription and renewal of the medication order beyond 20 milliliters of prednisolone acetate ophthalmic suspension 1% 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 2 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) have occurred. Fungal and viral infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroids. The possibility of fungal invasion should be considered in any persistent corneal ulceration where steroid treatment has been used (see ).

Transient burning and stinging upon instillation and other minor symptoms of ocular irritation have been reported with the use of prednisolone acetate ophthalmic suspension 1%. Other adverse events reported with the use of prednisolone acetate ophthalmic suspension 1% include: visual disturbance (blurry vision); foreign body sensation; and allergic reactions.

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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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Review

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

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