Instructions for use Broxinac eye drops 0.9 mg/ml bottle 1.7 ml
Composition
active ingredient: bromfenac;
1 ml of eye drops solution contains 1.035 mg of bromfenac sodium sesquihydrate, which is equivalent to 0.9 mg of bromfenac free acid;
Excipients: benzalkonium chloride, boric acid, disodium edetate, polysorbate 80, povidone K-30, sodium borate, anhydrous sodium sulfate (E 221), sodium hydroxide, water for injections.
Dosage form
Eye drops.
Main physicochemical properties: transparent solution of greenish-yellow color.
Pharmacotherapeutic group
Nonsteroidal anti-inflammatory drugs.
ATX code S01B C11.
Pharmacological properties
Pharmacodynamics.
Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID) that has anti-inflammatory and analgesic effects. It 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 ocular inflammation. In animal studies, prostaglandins have been shown to disrupt the blood-ophthalmic barrier, increase vascular permeability, cause vasodilation, leukocytosis, and increase intraocular pressure.
Pharmacokinetics.
Absorption.
Bromfenac effectively penetrates the cornea: after a single instillation, the concentration in the aqueous humor of the eye is 79 ± 68 ng/ml 150-180 minutes after application of the drug.
Distribution.
The concentration of the drug in blood plasma is well below the limit of measurement and has no clinical significance.
The above concentration is maintained for 12 hours in the aqueous humor of the eye, with therapeutically significant concentrations maintained in the tissues of the eye, including the retina, for up to 24 hours.
Metabolism and excretion.
The half-life from the aqueous humor of the eye is about 1.4 hours.
Indication
Treatment of postoperative inflammation and pain reduction in patients after cataract extraction.
Contraindication
Hypersensitivity to any of the components of the drug, as well as to other non-steroidal anti-inflammatory drugs.
The drug is contraindicated in patients who experience exacerbation of bronchial asthma attacks, urticaria, and symptoms of acute rhinitis when taking acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs.
Use in patients under 18 years of age is contraindicated (safety and efficacy of the drug in children have not been studied).
Interaction with other medicinal products and other types of interactions
The drug can be used simultaneously with other ophthalmic drugs:
α-adrenergic agonists, β-adrenergic blockers, carbonic anhydrase inhibitors, mydriatics.
In this case, the drugs should be used with an interval of at least five minutes.
Application features
The use of topical NSAIDs within 24 hours before and within 14 days after ophthalmic surgery increases the risk and severity of corneal adverse reactions.
Topical NSAIDs may cause keratitis. In some susceptible patients, prolonged use of topical NSAIDs may cause epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration, or corneal perforation. These adverse events carry a risk of vision loss. Patients with signs of corneal epithelial breakdown should discontinue the drug and remain under medical supervision until the cornea has normalized.
The use of NSAIDs may delay healing, especially when used concomitantly with topical corticosteroids. Patients should be advised that NSAIDs may delay healing. Patients should not wear contact lenses while using Broxinac. Patients should be advised not to touch the dropper tip or any surface as this may contaminate the contents of the vial.
Sodium sulfite contained in the preparation may cause allergic reactions, including anaphylactic shock, asthma attacks, in susceptible individuals. Sensitivity to sulfites is increased in individuals with bronchial asthma and a history of allergic reactions.
When using the drug BROXINAC, there is a possibility of developing cross-sensitivity to acetylsalicylic acid, phenylacetyl acid derivatives, as well as to other nonsteroidal anti-inflammatory drugs. Caution should be exercised when treating individuals who have previously shown sensitivity to drugs.
Experience with topical NSAIDs suggests that patients with complications following ophthalmic surgery, corneal denervation, corneal epithelial defects, diabetes mellitus, superficial ocular diseases (e.g. dry eye syndrome), rheumatoid arthritis, and patients who have been repeatedly treated with NSAIDs over a period of time are at increased risk of developing corneal adverse reactions.
Use during pregnancy or breastfeeding
Pregnancy.
The safety of bromfenac 0.09% eye drops during pregnancy has not been studied. The drug may be used if the expected benefit to the mother outweighs the potential risk to the fetus.
The drug should be avoided in the third trimester of pregnancy.
Breast-feeding.
Caution should be exercised when used in women.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug has a minor effect on the ability to drive or use machines. Short-term blurred vision is possible after administration of the drug, so it is recommended to wait until vision is fully restored before driving or using machines.
Method of administration and doses
Adults (including elderly patients)
It is recommended to instill 1 drop into the conjunctival sac once a day. Treatment is started 1 day before surgery and continued for the first 14 days of the postoperative period (including the day of surgery). Contact lenses should be removed before instilling eye drops. They can be reinserted 15 minutes after instillation.
When using multiple topical ophthalmic medications, the interval between their administration should be at least 5 minutes.
If you miss a dose, take the medicine as soon as possible at the recommended dose. If it is more than 24 hours since you missed a dose, take the medicine at the next scheduled time without doubling the dose to make up for the missed dose.
For elderly patients, the drug regimen does not differ from that for younger patients.
Children.
Age up to 18 years (the safety and efficacy of the drug in children have not been studied).
Overdose
In case of overdose, eye irritation and conjunctival hyperemia are possible.
If the drug is accidentally taken orally, you should immediately drink plenty of fluids to reduce the concentration of the drug in the stomach and consult a doctor.
Adverse reactions
On the part of the organs of vision: feeling of 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 iris of the eyes.
There have been isolated post-marketing reports of corneal erosion, corneal perforation, corneal thinning, and corneal epithelial destruction.
From the nervous system: headache.
From the respiratory system: nosebleeds, cough, nasal discharge, bronchial asthma.
General disorders: facial swelling.
Expiration date
2 years.
The shelf life after opening the bottle is 16 days.
Do not use after the expiry date stated on the packaging.
Storage conditions
Store at a temperature not exceeding 25 °C in the original packaging.
Keep out of reach of children.
Packaging
1.7 ml of eye drops in a bottle with a dropper in a cardboard box.
Vacation category
According to the recipe.
Producer
Sentiss Pharma Pvt. Ltd., India/Sentiss Pharma Pvt. Ltd., India.
Location of the manufacturer and address of its place of business.
Village Khera Nihla, Tehsil Nalagarh, Distt. Solan, Himachal Pradesh, 174 101, India/Village Khera Nihla, Tehsil Nalagarh, Distt. Solan, Himachal Pradesh, 174 101, India.
Applicant.
Sentiss Pharma Pvt. Ltd., India/Sentiss Pharma Pvt. Ltd., India.
Location.
212/D-1, Ashirwad Commercial Complex, Green Park, New Delhi, 110016, India/212/D-1, Ashirwad Commercial Complex, Green Park, New Delhi, 110016, India.
