Blephamide

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Side Effects & Adverse Reactions

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 BLEPHAMIDE® 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 asulfonamide 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 ADVERSE REACTIONS).

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

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Uses

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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History

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Other Information

BLEPHAMIDE® (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) is a sterile topical ophthalmic ointment combining an antibacterial and a corticosteroid which have the following chemical structures:

Chemical Names:

Sulfacetamide sodium: N-sulfanilylacetamide monosodium salt monohydrate. Prednisolone acetate: 11β, 17, 21-trihydroxpregna-1, 4-diene-3, 20-dione, 21-acetate.

Contains: Actives: sulfacetamide sodium 10%, prednisolone acetate 0.2%; Preservative: phenylmercuric acetate 0.0008%; Inactives: mineral oil, petrolatum (and) lanolin alcohol, and white petrolatum.

Sources

Blephamide Manufacturers

Physicians Total Care, Inc.

Blephamide | Physicians Total Care, Inc.

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).

No Recall
A-s Medication Solutions Llc

Blephamide | A-s Medication Solutions Llc

SHAKE WELL BEFORE USING. Two drops should be instilled into the conjunctival sac every four hours during the day and at bedtime.

Not more than 20 milliliters should be prescribed initially, and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.

BLEPHAMIDE® dosage 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).

No Recall
A-s Medication Solutions Llc

Blephamide | A-s Medication Solutions Llc

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).

No Recall
Physicians Total Care, Inc.

Blephamide | Physicians Total Care, Inc.

SHAKE WELL BEFORE USING. Two drops should be instilled into the conjunctival sac every four hours during the day and at bedtime.

Not more than 20 milliliters should be prescribed initially, and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.

BLEPHAMIDE® dosage 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).

No Recall
Allergan, Inc.

Blephamide |

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).

No Recall
Allergan, Inc.

Blephamide | Allergan, Inc.

SHAKE WELL BEFORE USING. Two drops should be instilled into the conjunctival sac every four hours during the day and at bedtime.

Not more than 20 milliliters should be prescribed initially, and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.

BLEPHAMIDE® dosage 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).

No Recall