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BLEPHAMIDE
Overview
What is BLEPHAMIDE?
BLEPHAMIDE
Chemical Names:
N
Contains: Actives:
Preservative:
Inactives:
What does BLEPHAMIDE look like?
What are the available doses of BLEPHAMIDE?
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What should I talk to my health care provider before I take BLEPHAMIDE?
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How should I use BLEPHAMIDE?
BLEPHAMIDE
Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroid use in certain infective conjunctivitides is accepted to obtain diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns or penetration of foreign bodies.
The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.
The particular antibacterial drug in this product is active against the following common bacterial eye pathogens: group), species, and species.
The product does not provide adequate coverage against: species, species, and .
A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.
A small amount, approximately 1/2 inch ribbon of ointment, should be applied in the conjunctival sac three or four times daily and once or twice at night.
Not more than 8 g should be prescribed initially.
The dosing of
ophthalmic ointment 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 application.
If signs and symptoms fail to improve after two days, the patient should be re-evaluated (see ).
What interacts with BLEPHAMIDE?
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What are the warnings of BLEPHAMIDE?
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What are the precautions of BLEPHAMIDE?
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What are the side effects of BLEPHAMIDE?
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What should I look out for while using BLEPHAMIDE?
BLEPHAMIDE
This product is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation, to other sulfonamides and to other corticosteroids (see ). (Hypersensitivity to the antimicrobial component occurs at a higher rate than for other components.)
NOT FOR INJECTION INTO THE EYE.
Prolonged use of corticosteroids may result in ocular hypertension/glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation.
Acute anterior uveitis may occur in susceptible individuals, primarily Blacks.
Prolonged use of
ophthalmic ointment may suppress the host response and thus increase the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforation has been known to occur with the use of topical corticosteroids. In acute purulent conditions of the eye, corticosteroids may mask infection or enhance existing infection.
If the 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. Corticosteroids should be used with caution in the presence of glaucoma. Intraocular pressure should be checked frequently.
A significant percentage of staphylococcal isolates are completely resistant to sulfonamides.
The use of steroids after cataract surgery may delay healing and increase the incidence of filtering blebs.
The use of ocular corticosteroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of corticosteroid medication in the treatment of herpes simplex requires great caution.
Topical steroids are not effective in mustard gas keratitis and Sjögren's keratoconjunctivitis.
Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia and other blood dyscrasias. Sensitization may recur when a sulfonamide is readministered, irrespective of the route of administration.
If signs of hypersensitivity or other serious reaction occur, discontinue use of this preparation. Cross-sensitivity among corticosteroids has been demonstrated (see ).
What might happen if I take too much BLEPHAMIDE?
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How should I store and handle BLEPHAMIDE?
BLEPHAMIDE3.5 g - NDC 0023-0313-04 BLEPHAMIDE3.5 g - NDC 0023-0313-04
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Corticosteriods suppress the inflammatory response to a variety of agents and they probably delay or slow healing. Since corticosteroids may inhibit the body's defense mechanism against infection, a concomitant antibacterial drug may be used when this inhibition is considered to be clinically significant in a particular case.
When a decision to administer both a corticosteroid and an antibacterial is made, the administration of such drugs in combination has the advantage of greater patient compliance and convenience, with the added assurance that the appropriate dosage of both drugs is administered, plus assured compatibility of ingredients when both types of drugs are in the same formulation and, particularly, that the correct volume of drug is delivered and retained.
The relative potency of corticosteroids depends on the molecular structure, concentration and release from the vehicle.
Non-Clinical Toxicology
BLEPHAMIDEThis product is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation, to other sulfonamides and to other corticosteroids (see ). (Hypersensitivity to the antimicrobial component occurs at a higher rate than for other components.)
NOT FOR INJECTION INTO THE EYE.
Prolonged use of corticosteroids may result in ocular hypertension/glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation.
Acute anterior uveitis may occur in susceptible individuals, primarily Blacks.
Prolonged use of ophthalmic ointment may suppress the host response and thus increase the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforation has been known to occur with the use of topical corticosteroids. In acute purulent conditions of the eye, corticosteroids may mask infection or enhance existing infection.
If the 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. Corticosteroids should be used with caution in the presence of glaucoma. Intraocular pressure should be checked frequently.
A significant percentage of staphylococcal isolates are completely resistant to sulfonamides.
The use of steroids after cataract surgery may delay healing and increase the incidence of filtering blebs.
The use of ocular corticosteroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of corticosteroid medication in the treatment of herpes simplex requires great caution.
Topical steroids are not effective in mustard gas keratitis and Sjögren's keratoconjunctivitis.
Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia and other blood dyscrasias. Sensitization may recur when a sulfonamide is readministered, irrespective of the route of administration.
If signs of hypersensitivity or other serious reaction occur, discontinue use of this preparation. Cross-sensitivity among corticosteroids has been demonstrated (see ).
BLEPHAMIDE
The initial prescription and renewal of the medication order beyond 8 g of ointment 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.
The possibility of fungal infections of the cornea should be considered after prolonged corticosteroid dosing. Use with caution in patients with severe dry eye. Fungal cultures should be taken when appropriate.
The p-aminobenzoic acid present in purulent exudates competes with sulfonamides and can reduce their effectiveness.
Ophthalmic ointments may retard corneal healing.
Adverse reactions have occurred with corticosteroid/antibacterial combination drugs which can be attributed to the corticosteroid component, the antibacterial component, or the combination. Exact incidence figures are not available since no denominator of treated patients is available.
Reactions occurring most often from the presence of the antibacterial ingredient are allergic sensitizations. Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias (see ).
Sulfacetamide sodium may cause local irritation.
The reactions due to the corticosteroid component in decreasing order of frequency are: 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 corticosteroids.
Corticosteroid-containing preparations can also cause acute anterior uveitis or perforation of the globe. Mydriaisis, loss of accommodation and ptosis have occasionally been reported following local use of corticosteroids.
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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Interactions
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