Data from FDA - Curated by EPG Health - Last updated 05 July 2018

Indication(s)

INDICATIONS AND USAGE BLEPHAMIDE ® ophthalmic ointment is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. 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: Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species. The product does not provide adequate coverage against: Neisseria species, Pseudomonas species, and Serratia marcescens. A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.

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Advisory information

contraindications
CONTRAINDICATIONS BLEPHAMIDE ® ophthalmic ointment 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. BLEPHAMIDE ® ophthalmic ointment 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 WARNINGS). (Hypersensitivity to the antimicrobial component occurs at a higher rate than for other components.)
Special warnings and precautions
PRECAUTIONS General 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. Fungal cultures should be taken when appropriate. Use with caution in patients with severe dry eye. The p-aminobenzoic acid present in purulent exudates competes with sulfonamides and can reduce their effectiveness. Ophthalmic ointments may retard corneal healing. Information for Patients If inflammation or pain persists longer than 48 hours or becomes aggravated, the patient should be advised to discontinue use of the medication and consult a physician (see WARNINGS). This product is sterile when packaged. To prevent contamination, care should be taken to avoid touching the tube tip to eyelids or to any other surface. The use of this tube by more than one person may spread infection. Keep tube tightly closed when not in use. Keep out of the reach of children. Laboratory Tests Eyelid cultures and tests to determine the susceptibility of organisms to sulfacetamide may be indicated if signs and symptoms persist or recur in spite of the recommended course of treatment with BLEPHAMIDE ® ophthalmic ointment. Drug Interactions BLEPHAMIDE ® ophthalmic ointment is incompatible with silver preparations. Local anesthetics related to p-aminobenzoic acid may antagonize the action of the sulfonamides. Carcinogenesis, Mutagenesis, Impairment of Fertility Prednisolone has been reported to be noncarcinogenic. Long-term animal studies for carcinogenic potential have not been performed with sulfacetamide. One author detected chromosomal nondisjunction in the yeast Saccharomyces cerevisiae following application of sulfacetamide sodium. The significance of this finding to topical ophthalmic use of sulfacetamide sodium in the human is unknown. Mutagenic studies with prednisolone have been negative. Studies on reproduction and fertility have not been performed with sulfacetamide. A long-term chronic toxicity study in dogs showed that high oral doses of prednisolone prevented estrus. A decrease in fertility was seen in male and female rats that were mated following oral dosing with another glucocorticosteroid. Pregnancy Teratogeni c Effects Animal reproduction studies have not been conducted with sulfacetamide sodium. Prednisolone has been shown to be teratogenic in rabbits, hamsters, and mice. In mice, prednisolone has been shown to be teratogenic when given in doses 1 to 10 times the human ocular dose. Dexamethasone, hydrocortisone and prednisolone were ocularly applied to both eyes of pregnant mice five times per day on days 10 through 13 of gestation. A significant increase in the incidence of cleft palate was observed in the fetuses of the treated mice. There are no adequate well-controlled studies in pregnant women dosed with corticosteroids. Kernicterus may be precipitated in infants by sulfonamides being given systemically during the third trimester of pregnancy. It is not known whether sulfacetamide sodium can cause fetal harm when administered to a pregnant woman or whether it can affect reproductive capacity. BLEPHAMIDE ® ophthalmic ointment should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Systemically administrated sulfonamides are capable of producing kernicterus in infants of lactating women. Because of the potential for serious adverse reactions in nursing infants from sulfacetamide sodium and prednisolone acetate ophthalmic ointments, a decision should be made whether to discontinue nursing or to discontinue the medication. Pediatric Use Safety and effectiveness in children below the age of 6 years have not been established.
Adverse reactions
ADVERSE REACTIONS The following adverse reactions have been identified during use of BLEPHAMIDE ® ophthalmic ointment. Because reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Adverse reactions have occurred with corticosteroid/antibacterial combination drugs which can be attributed to the corticosteroid component, the antibacterial component, or the combination. Reactions occurring with BLEPHAMIDE® ophthalmic ointment include: cataract, dizziness, eye discharge, eyelid edema, eyelid erythema, eye irritation, eye pain, eye pruritus, and hypersensitivity including rash, skin pruritus, urticaria, ocular hyperemia, and visual disturbance (blurry vision). 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 WARNINGS). The reactions due to the corticosteroid component in decreasing order of frequency are: delayed wound healing, elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, and posterior subcapsular cataract formation. 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. Mydriasis, loss of accommodation and ptosis have occasionally been reported following local use of corticosteroids. Secondary Infection The development of secondary infection has occurred after use of combinations containing corticosteroids and antibacterials. Fungal and viral infections of the cornea are particularly prone to develop coincidentally with long-term applications of corticosteroid. The possibility of fungal invasion must be considered in any persistent corneal ulceration where corticosteroid treatment has been used. Secondary bacterial ocular infection following suppression of host responses also occurs.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION 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 BLEPHAMIDE ® 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 PRECAUTIONS).
Pregnancy and lactation
Nursing Mothers It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Systemically administrated sulfonamides are capable of producing kernicterus in infants of lactating women. Because of the potential for serious adverse reactions in nursing infants from sulfacetamide sodium and prednisolone acetate ophthalmic ointments, a decision should be made whether to discontinue nursing or to discontinue the medication.

Interactions

Drug Interactions BLEPHAMIDE ® ophthalmic ointment is incompatible with silver preparations. Local anesthetics related to p-aminobenzoic acid may antagonize the action of the sulfonamides.

More information

Category Value
Authorisation number ANDA087748
Agency product number 8B2807733D
Orphan designation No
Product NDC 0023-0313
Date Last Revised 29-06-2018
Type HUMAN PRESCRIPTION DRUG
Storage and handling Storage : Store at 15°-25°C (59°-77°F). Revised: 0 6 /2018 Distributed by: Allergan USA, Inc. Madison, NJ 07940 © 2018 Allergan. All rights reserved. All trademarks are the property of their respective owners.
Marketing authorisation holder Allergan, Inc.