Blephamide

Blephamide is a prescription medication used to treat inflammatory conditions of the eye and bacterial infections of the eye caused by susceptible bacteria.

Blephamide is not effective in treating bacterial eye infections caused by Neisseria species, Pseudomonas species, and Serratia marcescens.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Blephamide including the following:

• Bacterial and fungal corneal ulcers. Consult your physician right away and stop taking Blephamide if you experience severe eye pain and/or pus or blood discharge from the eye.
• Non-specific conjunctivitis, conjunctival hyperemia, and secondary infections. Consult your physician right away and stop taking Blephamide if you experience eye hypersensitivity, eye aggravation, eye swelling, or severe eye pain.
• Stevens-Johnson syndrome and toxic epidermal necrolysis. Consult your physician right away and stop taking Blephamide if you experience skin rashes or other serious reactions after taking Blephamide.
• High blood pressure of the eye and/or glaucoma. If Blephamide is used for 10 days or longer, eye blood pressure should be routinely monitored.
• Defects in visual acuity and fields of vision. Consult your physician right away and stop taking Blephamide if you experience impaired vision.
• Posterior subcapsular cataract formation. Consult your physician right away and stop taking Blephamide if you experience grey spots in your field of vision.
• Acute anterior uveitis. Consult your physician right away and stop taking Blephamide if you experience abnormal eye pain.

Do not take Blephamide if:

• you are allergic to Blephamide or any of its ingredients
• you have a viral or fungal eye infection

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.

Serious side effects are not expected with this medication.

Some burning, stinging, irritation, itching, redness, blurred vision, eyelid itching, eyelid swelling, or sensitivity to light may occur.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Use care when driving or doing other tasks that call for clear eyesight.
• Do not use Blephamide for longer than you were told by your doctor.
• Long-term use may raise the chance of cataracts or glaucoma. Talk with the doctor.
• Have your eye pressure checked if you are on this medicine for a long time. Talk with your doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Blephamide while you are pregnant.

• Store at room temperature.
• Keep lid tightly closed.
• Store upright with the cap on.
• Protect from heat.
• Protect from light.
• Do not freeze.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

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-Trihydroxypregna-1,4-diene-3,20-dione 21-acetate.

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

Blephamide® (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2% is supplied sterile in ointment tubes of the following size:

3.5 g - NDC 0023-0313-04

Storage: Store at 15°-25°C (59°-77°F).

Revised: 03/2014

© 2014 Allergan, Inc.
Irvine, CA 92612, U.S.A.
® marks owned by Allergan, Inc.
Made in the U.S.A.

71412US12

ALLERGAN

NDC 0023-0313-04

3.5 g

Blephamide ®

(sulfacetamide
sodium and
prednisolone
acetate
ophthalmic
ointment, USP)

10 % / 0.2 %

sterile

Rx only

Applies to prednisolone / sulfacetamide sodium ophthalmic: ophthalmic ointment, ophthalmic solution, ophthalmic suspension

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Change in eyesight, eye pain, or very bad eye irritation.
• Eye is bothered by bright light.
• Very bad and rarely deadly effects have happened with sulfa (sulfonamide) drugs like this one. These effects have included liver problems, blood problems, and very bad skin reactions (Stevens-Johnson syndrome/toxic epidermal necrolysis). Call your doctor right away if you have a rash; red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, or eyes; fever, chills, or sore throat; cough that is new or worse; feeling very tired or weak; any bruising or bleeding; or signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.

There are no data on the excretion of prednisolone-sodium sulfacetamide ophthalmic into human milk. Topically applied steroids have been reported to be absorbed systemically. Sulfonamides are excreted into human milk. However, adverse effects in the nursing infant are unlikely from maternal use of sodium sulfacetamide ophthalmic. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue the drug or to discontinue nursing, taking into account the importance of the drug to the mother.