Prolensa

• Bausch & Lomb Incorporated

If you take too much Prolensa, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• It is used to treat swelling and pain after cataract surgery.

• If you have an allergy to bromfenac or any other part of Prolensa (bromfenac).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you are more than 24 weeks pregnant.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

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.
• Bleeding in the eye.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

None

Prolensa (bromfenac ophthalmic solution) 0.07% is a sterile, topical, nonsteroidal anti-inflammatory drug (NSAID) for ophthalmic use. Each mL of Prolensa contains 0.805 mg bromfenac sodium sesquihydrate (equivalent to 0.7 mg bromfenac free acid). The USAN name for bromfenac sodium sesquihydrate is bromfenac sodium. Bromfenac sodium is designated chemically as sodium [2-amino-3-(4-bromobenzoyl) phenyl] acetate sesquihydrate, with an empirical formula of C15H11BrNNaO3• 1½H2O. The chemical structure for bromfenac sodium sesquihydrate is:

Bromfenac sodium is a yellow to orange crystalline powder. The molecular weight of bromfenac sodium is 383.17.

Prolensa ophthalmic solution is supplied as a sterile aqueous 0.07% solution, with a pH of 7.8. The osmolality of Prolensa ophthalmic solution is approximately 300 mOsmol/kg.

Each mL of Prolensa ophthalmic solution contains:

Active: Each mL contains bromfenac sodium sesquihydrate 0.0805%, which is equivalent to bromfenac free acid 0.07%.

Preservative: benzalkonium chloride 0.005%

Inactives: boric acid, edetate disodium, povidone, sodium borate, sodium sulfite, tyloxapol, sodium hydroxide to adjust pH, and water for injection, USP.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term carcinogenicity studies in rats and mice given oral doses of bromfenac up to 0.6 mg/kg/day (systemic exposure 30 times the systemic exposure predicted from the recommended human ophthalmic dose [RHOD] assuming the human systemic concentration is at the limit of quantification) and 5 mg/kg/day (340 times the predicted human systemic exposure), respectively, revealed no significant increases in tumor incidence.

Bromfenac did not show mutagenic potential in various mutagenicity studies, including the reverse mutation, chromosomal aberration, and micronucleus tests.

Bromfenac did not impair fertility when administered orally to male and female rats at doses up to 0.9 mg/kg/day and 0.3 mg/kg/day, respectively (systemic exposure 90 and 30 times the predicted human exposure, respectively).

Prolensa (bromfenac ophthalmic solution) 0.07% is supplied in a white LDPE plastic squeeze bottle with a 15 mm LDPE white dropper tip and 15 mm polypropylene gray cap as follows:

• 1.6 mL in a 7.5 mL container (NDC 24208-602-01)

• 3 mL in a 7.5 mL container (NDC 24208-602-03)

Storage: Store at 15º-25ºC (59º-77ºF).