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Indicaciones

Bromfenac Ophthalmic Solution 0.07% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. Bromfenac Ophthalmic Solution is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. ( 1 )

Advertencias y precauciones

Sulfite Allergic Reactions ( 5.1 ) Slow or Delayed Healing ( 5.2 ) Potential for Cross-Sensitivity ( 5.3 ) Increased Bleeding Time ( 5.4 ) Keratitis and Corneal Reactions ( 5.5 )

5.1Sulfite Allergic Reactions Bromfenac Ophthalmic

Solution contains sodium sulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.

5.2Slow or Delayed Healing

All topical nonsteroidal anti-inflammatory drugs (NSAIDs), including bromfenac, may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems.

5.3Potential for Cross-Sensitivity

There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs, including bromfenac. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.

Indicaciones

Advertencias y precauciones

Sulfite Allergic Reactions ( 5.1 ) Slow or Delayed Healing ( 5.2 ) Potential for Cross-Sensitivity ( 5.3 ) Increased Bleeding Time ( 5.4 ) Keratitis and Corneal Reactions ( 5.5 )

5.1Sulfite Allergic Reactions Bromfenac Ophthalmic

5.2Slow or Delayed Healing

5.3Potential for Cross-Sensitivity

Embarazo y lactancia

8.1Pregnancy Risk Summary

There are no available data on Bromfenac Ophthalmic Solution use in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. The systemic exposure to bromfenac following topical ocular administration is low [ see Clinical Pharmacology ( 12.3 )]. Consequently, the systemic exposure of a pregnant woman to bromfenac is expected to be minimal following topical ocular administration.

However, because of the known effects of prostaglandin biosynthesis-inhibiting drugs on the fetal cardiovascular system (closure of ductus arteriosus), the use of Bromfenac Ophthalmic Solution during late pregnancy should be avoided. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Premature closure of the ductus arteriosus in the fetus has occurred with third trimester use of oral and injectable NSAIDs. Measurable maternal and fetal plasma drug levels are available with oral and injectable routes of NSAID administration.

The maternal plasma level of Bromfenac Ophthalmic Solution following ocular administration is unknown [see Clinical Pharmacology ( 12.3 )] Data Animal Data Embryo-fetal lethality and maternal toxicity were produced in rats and rabbits treated with bromfenac during the period of organogenesis at oral doses up to 0.9 mg/kg/day and 7.5 mg/kg/day, respectively. These doses corresponded to a Cmax 90- and 150- times the predicted Cmax at the recommended human ophthalmic dose (RHOD), respectively.

In rats, bromfenac treatment caused delayed parturition at 0.3 mg/kg/day (30 times the predicted human Cmax at the RHOD), and caused dystocia, increased neonatal mortality, and reduced postnatal growth at 0.9 mg/kg/day (90 times the predicted human Cmax at the RHOD).

Prolensa

Indicaciones

Contraindicaciones

Advertencias y precauciones

5.1Sulfite Allergic Reactions Bromfenac Ophthalmic

5.2Slow or Delayed Healing

5.3Potential for Cross-Sensitivity

¿Dos medicamentos en una misma pregunta?

Prolensa

Indicaciones

Contraindicaciones

Advertencias y precauciones

5.1Sulfite Allergic Reactions Bromfenac Ophthalmic

5.2Slow or Delayed Healing

5.3Potential for Cross-Sensitivity

¿Dos medicamentos en una misma pregunta?

5.4Increased Bleeding Time

5.5Keratitis and Corneal Reactions Use

5.6Risk of Contamination Do

5.7Contact Lens Wear Bromfenac Ophthalmic

Embarazo y lactancia

8.1Pregnancy Risk Summary

Reacciones adversas

6.1Clinical Trials Experience

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