Bromfenac (Okofenak) eye drops 0.09% – [5 ml vial]

Description

Ocophenac Pharmacodynamics
Bromfenac is a non-steroidal anti-inflammatory drug (NSAID), the anti-inflammatory effect of which is realized by blocking the synthesis of prostaglandins by inhibiting cyclooxygenase 1 and 2
In in vitro studies, bromfenac inhibited prostaglandin synthesis in the ciliary body of the rabbit. The concentration of half-maximal inhibition (IC50) for bromfenac (1.1 μmol) was lower than for indomethacin (4.2 μmol) and pranoprofen (11.9 μmol).
In an experimental model of uveitis in rabbits, bromfenac at concentrations of 0.02 %, 0.05 %, 0.1 % and 0.2 % inhibited almost all symptoms of ocular inflammation.

Indications
Treatment of non-infectious inflammatory diseases of the anterior segment of the eye and postoperative inflammation

Contraindications
Hypersensitivity to the active substance and any of the excipients of the drug, as well as to other non-steroidal anti-inflammatory drugs.
The drug is contraindicated in patients with bronchial asthma, urticaria and symptoms of acute rhinitis which are increased when taking acetylsalicylic acid and other NSAIDs
Age under 18 years (safety and effectiveness of the drug in children has not been studied).
Administration during pregnancy and breastfeeding
Pregnancy
Sufficient data on the use of bromfenac in pregnant women are not available. Animal studies have demonstrated reproductive toxicity. Because systemic effects following treatment with the drug in nonpregnant women are negligible, the risk during pregnancy can be considered low.
However, because of the known effects of drugs that inhibit prostaglandin biosynthesis on the fetal cardiovascular system (ductal closure), the use of this drug in the third trimester of pregnancy should be avoided. In general, the use of this drug during pregnancy is not recommended unless the benefit exceeds the potential risk.
Breast-feeding period
Caution should be exercised when using in women during breast-feeding period.

Directions for use and dosages

• Topically. Instillation into the conjunctival sac.
• Treatment of noninfectious inflammatory diseases of the anterior segment of the eye: in one drop twice a day for not more than 15 days.
• Treatment of postoperative inflammation: one drop once a day. The treatment starts 1 day before the surgery and continues during the first 14 days of the postoperative period (including the day of surgery)
• Directions in case of missing one or more doses of the drug
  If the drug is skipped it should be administered as soon as possible in the dose prescribed in the instruction. If the missed dose is closer to 24 hours, the drug should be used at the next prescribed time without doubling the dose to compensate for the missed dose.
• Patients with renal and hepatic impairment
  Effects of the drug in patients with renal and hepatic impairment have not been studied.
• Elderly persons.
  Regimen of drug administration in patients aged over 65 years old does not differ from the regimen of younger patients.