Sulfacetamide and Prednisolone

Sulfacetamide Sodium and Prednisolone Sodium Phosphate Ophthalmic Solution is a sterile topical ophthalmic solution combining an anti-infective and an adrenocortical steroid.

Each mL contains: ACTIVES: Sulfacetamide Sodium 100 mg, Prednisolone Sodium Phosphate 2.5 mg (equivalent to Prednisolone Phosphate 2.3 mg); INACTIVES: Poloxamer 407, Boric Acid, Edetate Disodium, Purified Water. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH (6.5-7.5). PRESERVATIVE ADDED: Thimerosal 0.01%.

The chemical name for sulfacetamide sodium is N-sulfanilylacetamide monosodium salt monohydrate.

The chemical name for prednisolone sodium phosphate is 11β, 17, 21-trihydroxypregna-1, 4-diene-3,20-dione, 21-(disodium phosphate).

They have the following structural formulas:

Sulfacetamide Sodium

C8H9N2NaO3S•H2O                Mol. Wt. 254.24

Prednisolone Sodium Phosphate

C21H27Na2O8P              Mol. Wt. 484.39

Instill two drops of Sulfacetamide Sodium and Prednisolone Sodium Phosphate Ophthalmic Solution topically in the eye(s) every four hours. Not more than 20 mL should be prescribed initially. If signs and symptoms fail to improve after two days, patients should be re-evaluated (see PRECAUTIONS).

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.

FOR OPHTHALMIC USE ONLY

Inflammatory ocular conditions: Treatment of steroid-responsive inflammatory ocular conditions (where either a superficial bacterial ocular infection or the risk of bacterial ocular infection exists) of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe; chronic anterior uveitis; corneal injury from chemical, radiation, or thermal burns; penetration of foreign bodies

Inflammatory ocular conditions: Ophthalmic:

Ointment: Apply ~1/2 inch ribbon to lower conjunctival sac 3 to 4 times daily and 1 to 2 times at night

Solution: Instill 2 drops every 4 hours

Suspension: Instill 2 drops every 4 hours during the day and at bedtime

Refer to adult dosing.

There are no dosage adjustments provided in the manufacturer's labeling.

Animal reproduction studies have not been conducted with this combination. Use of systemic sulfonamides during pregnancy may cause kernicterus in the newborn. See individual agents.

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Have patient report immediately to prescriber signs of a severe sulfonamide reaction (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; loss of strength and energy; 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), vision changes, eye pain, or severe eye irritation (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Eye irritation.
• Dizziness.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.