Broxinac eye drops 0.09%, 1.7 ml (Bromofenac)

Latin name

BROXINAC

Release form

Eye drops transparent, greenish yellow.

Packaging

1.7 ml - bottles (1) - packs of cardboard.

Pharmacological action

Bromfenac is a non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory and analgesic effects, blocks the synthesis of prostaglandins from arachidonic acid by inhibiting cyclooxygenase 1 and 2, which reduces inflammation and pain.

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

Indications

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

Contraindications

hypersensitivity to the drug’s components, as well as to other non-steroidal anti-inflammatory drugs

, the use of the drug is contraindicated in patients with bronchial asthma, urticaria and symptoms of acute rhinitis, aggravated by taking acetylsalicylic acid of 18 years old and safety and efficacy of the drug in children have not been investigated).

Caution: sodium sulfite contained in the preparation can cause an allergic reaction, including anaphylactic shock, asthma attacks in susceptible people. Sensitivity to sulfites is increased in individuals with a history of bronchial asthma and allergic reactions.

When using Broxinac, there is the possibility of developing cross-sensitivity to acetylsalicylic acid, a phenylacetyl acid derivative, as well as other NSAIDs. Caution must be exercised in the treatment of individuals who have previously identified sensitivity to these drugs.

NSAIDs may increase bleeding time as a result of impaired platelet aggregation. The use of local NSAIDs in combination with ophthalmic surgery can increase bleeding of the eye tissue (including in the anterior chamber of the eye). Broxinac should be used with caution in patients in the history of which a tendency to bleeding is recorded, or if patients receive other medications that can increase the coagulation time.

Experience with local NSAIDs shows that patients with complications after surgical ophthalmic interventions, corneal denervation, corneal epithelial defects, diabetes mellitus, superficial eye diseases (for example, dry eye syndrome), rheumatoid arthritis, or repeated surgical interventions during a short period of time, may have an increased risk of adverse reactions from the cornea.

Use in children

Contraindicated in children under 18 years of age.

Use in elderly patients

The regimen of administration of the drug does not differ from that in younger patients.

Pregnancy and lactation

Pregnancy

The safety of using 0.09% ophthalmic bromfenac drops during pregnancy has not been studied. However, data from some animal embryotoxicity studies indicate a potential reduction in embryo viability. The use of the drug is possible if the expected effect for the mother outweighs the potential risk to the fetus. Prescription of the drug in late pregnancy should be avoided.

Breastfeeding period

Caution should be exercised when used in women during breastfeeding.

Composition

The substance contains one active component of sodium brombenac sesquihydrate at a concentration of 0.9 mg in 1 ml of solution.

Among the auxiliary components in the solution are: benzalkonium chloride (0.05 mg), polysorbate 80 (1.5 mg), edetate disodium dihydrate (0.2 mg), povidone K-30 (20 mg), anhydrous sodium sulfite (2 mg), sodium borate decahydrate (11 mg), sodium hydroxide to create the optimal pH of 8.3, water for injection.

Dosage and administration

Installation in 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).

Directions for skipping one or more doses of the drug

If you skip taking the drug, you should use the medicine as soon as possible in the dosage prescribed by the instructions. If the pass in the use of the drug approaches 24 hours, the drug should be used at the next appointed time, without doubling the dose to compensate for the missed.

Side effects

Visual disturbances:

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

Very rare: there are few post-marketing messages about corneal erosion, corneal perforation, thinning of the cornea, and destruction of the epithelium.

Disorders of the nervous system: headache.

When twice applied with a 0.09% solution of bromfenac, reactions were also observed:

Visual disturbances:

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

Rarely: corneal ulcer,

Disorders of the respiratory system, chest and mediastinal organs: nosebleeds, cough, nasal discharge, asthma.

General disorders and disorders at the injection site: swelling of the face.

Drug Interaction

The drug can be used at the same time as other ophthalmic drugs: -adrenomimetics, -adrenergic blockers, carbonic anhydrase inhibitors, mydriatics. In this case, the drugs should be applied with a break of at least five minutes.

Overdose

If you accidentally use the medicine inside, you should immediately drink plenty of fluid to reduce the concentration of the drug in your stomach.

Storage conditions

Store at 15-25 ° C. Keep out of the reach of children.

Expiration

2 years.

Active ingredient

Bromfenac

Dosage form

Dosage form

eye drops



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