Broxinac, eye drops 0.09% 2.5ml

Bromfenac, a nonsteroidal anti-inflammatory drug (NSAID) with anti-inflammatory and analgesic effects, blocks the synthesis of prostaglandins from arachidonic acid, by inhibiting cyclooxygenase 1 and 2, resulting in reduced inflammation and pain response.

In vivo studies have shown that prostaglandins mediate some types of ocular inflammation. In animal studies, prostaglandins contributed to disruption of the blood-ophthalmic barrier, increased vascular permeability, caused vasodilation, leukocytosis, and increased intraocular pressure.

Pharmacokinetics

The drug concentration in plasma is well below the limit of measurement and has no clinical significance.

Bromfenac effectively penetrates into the cornea: with single instillation, the concentration in the aqueous humor of the eye is 79±68 ng/ml after 150-180 minutes after administration of the drug. This concentration persists for 12 hours in the aqueous humor of the eye with retention of therapeutically significant concentration in the tissues of the eye, including the retina, for up to 24 hours.

The half-life from the aqueous humor of the eye is about 1.4 hours.

Indications

• treatment of postoperative inflammation and pain reduction in patients after cataract extraction.

Active ingredient

Bromfenac

Composition

1 ml contains:

Active ingredients:

bromfenac sodium sesquihydrate – 0.9 mg, which corresponds to the content of bromfenac 1.035 mg.

Excipients: benzalkonium chloride – 0.

Excipients: benzalkonium chloride – 0.05 mg, boric acid – 11 mg, disodium edetate dihydrate – 0.2 mg, polysorbate 80 – 1.5 mg, povidone K-30 – 20 mg, sodium borate decahydrate – 11 mg, anhydrous sodium sulfite – 2 mg, sodium hydroxide – to pH 8.3, water d/I – to 1 ml.

How to take, the dosage

Installation into the conjunctival sac

One drop once a day. Treatment begins 1 day before surgery and continues for the first 14 days of the postoperative period (including the day of surgery).

Instructions if one or more doses of the medication are missed

If the medication is missed, the medication should be used as soon as possible in the dosage prescribed. If the missed dose approaches 24 hours, the medication should be used at the next scheduled time, without doubling the dose to compensate for the missed dose.

The use in patients over 65 years of age

The mode of administration of the drug is not different from that in younger patients.

Interaction

The drug may be used simultaneously with other ophthalmic drugs: α-adrenomimetics, β-adrenoblockers, carboenhydrase inhibitors, mydriatics. At the same time, the drugs should be applied with a break of at least five minutes.

Special Instructions

The use of topical NSAIDs 24 hours before eye surgery and for 14 days after ophthalmic surgery may increase the risk and severity of adverse corneal reactions.

The use of topical NSAIDs may lead to the development of keratitis. In some susceptible patients, prolonged use of topical NSAIDs may cause epithelial tearing, corneal thinning, corneal erosion, corneal ulceration, or corneal perforation. These side effects may pose a risk of vision loss. Patients with signs of corneal epithelium rupture should immediately discontinue use of the drug and be under medical supervision until corneal condition normalizes.

The use of NSAIDs may slow the healing process, especially when combined with topical corticosteroids. Patients should be advised that healing may be delayed while using NSAIDs.

Patients should not use contact lenses when using Broxinac.

Patients should be warned not to touch the tip of the dropper or any surface with it as this may cause contamination of the contents of the vial.

Impact on driving and operating machinery

The drug slightly affects the ability to drive and operate machinery. There may be short-term blurred vision after drug administration, therefore it is recommended to wait until full recovery of vision before starting to drive vehicles and operate machinery.

Contraindications

• high sensitivity to the components of the drug, as well as to other non-steroidal anti-inflammatory drugs;
• Aged below 18 years (the safety and effectiveness of the drug in children has not been studied).

With caution: Sodium sulfite in the drug may cause an allergic reaction, including anaphylactic shock, asthma attacks in susceptible persons. Sensitivity to sulfites is increased in people with a history of bronchial asthma and allergic reactions.

When using the drug Broxinac there is a possibility of cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives and other NSAIDs. Caution should be exercised when treating persons with previous sensitivity to these drugs.

NSAIDs may increase bleeding time due to impaired platelet aggregation. Use of topical NSAIDs in conjunction with ophthalmic surgery may increase bleeding of ocular tissues (including in the anterior chamber of the eye). Broxinac should be used with caution in patients with a history of bleeding tendency, or if patients receive other drugs that may increase blood clotting time.

. Experience with topical NSAIDs shows that patients with complications from ophthalmic surgery, corneal denervation, corneal epithelial defects, diabetes mellitus, superficial eye conditions (such as dry eye syndrome), rheumatoid arthritis, or repeated surgery performed within a short period of time may have an increased risk for corneal adverse reactions.

Side effects

WHO side effect frequency classification: very common (>1/10); common (>1/100 to <1/10); sometimes (>1/1000 to <1/100); rare (>1/10 000 to <1/1000); very rare (<1/10 000, including individual reports).

An adverse reaction has been observed with a single use of the drug:

Visual disturbances:

Often (observed in 2-7% of patients): feeling of discomfort and unusual sensations in the eyes, eye irritation, pain, itching and burning in the eyes, eye redness, conjunctival hyperemia, iris inflammation.

Very rare: there have been single post-marketing reports of corneal erosion, corneal perforation, corneal thinning, and epithelial destruction.

Nervous system disorders: headache.

When using 0.09% bromfenac solution twice, reactions have also been observed:

Visual disorders:

Sometimes: decreased visual acuity, retinal hemorrhage, corneal edema, photophobia, bleeding from eyelid vessels, exudates on the fundus.

Rarely: corneal ulcer,

Respiratory, thoracic and mediastinal disorders: nasal bleeding, cough, nasal discharge, asthma.

General disorders and disorders at the injection site: facial edema.

Overdose

If you accidentally take the drug orally, you should immediately drink plenty of fluids to reduce the concentration of the drug in the stomach.