Naquan, eye drops 0.09% 5 ml
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Bromfenac is a non-steroidal anti-inflammatory drug (NSAID) whose anti-inflammatory effect is realized by blocking prostaglandin synthesis by inhibiting cyclooxygenase 1 and 2.
In in vitro studies, bromfenac inhibited prostaglandin synthesis in the ciliary body of rabbits. 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).
Inflammatory diseases of the eyeTreatment of non-infectious inflammatory diseases of the anterior segment of the eye and postoperative inflammation.
How to take, the dosage
1 to 2 drops of the drug in the conjunctival sac twice a day for no more than 15 days.
If a dose of the drug is missed, the drug should be used as soon as possible in the dosage indicated in the instructions for use. If the missed dose of the medication is about 24 hours, the medication should be used at the next scheduled time, without doubling the dose to compensate for the missed dose.
Studies of interaction with other drugs have not been conducted.
This drug should be used for symptomatic treatment and not for etiotropic therapy.
This drug is contraindicated in patients with a history of hypersensitivity to any component of the drug.
This drug is contraindicated in patients with attacks of bronchial asthma, urticaria and symptoms of acute rhinitis when taking acetylsalicylic acid and other NSAIDs.
The age under 18 years (the safety and effectiveness in children has not been studied).
Unwanted reactions to the drug were reported in 72 of 3,843 patients (1.87%) reported in clinical studies or post-registration use. Serious adverse reactions included corneal erosion in 16 cases (0.42%), conjunctivitis (including conjunctival injection and conjunctival follicles) in 11 cases (0.29%), blepharitis in 9 cases (0.23%) irritation in 8 cases (0.21%), ocular pain [transient] in 8 cases (0.21%), superficial pitting keratitis in 6 cases (0.16%), itching in 6 cases (0.16%), corneal epithelial detachment in 1 case (0.03%) and burning sensation [eyelids] in 1 case (0.03%).
The adverse reactions were classified according to the following frequency of occurrence gradation:
Very common >1/10
Frequent from ≥1/100 to <1/10
p> Rarely from ≥1/10000 to <1/100
Very rarely <1/10000
Within each group, adverse events are classified according to decreasing severity and grouped according to frequency of occurrence and system-organ class.
The table below describes the adverse reactions.
Frequency of occurrence
Corneal erosion (*), conjunctivitis (*), blepharitis (*), irritation (*), ocular pain [transient](*), superficial pitting keratitis (*), itching (*)
Corneal epithelial detachment (*), burning sensation [eyelids](*)
Corneal ulcer (**)(***), corneal perforation (**)(***)
Contact dermatitis (*)
(*)If adverse reactions occur, discontinue treatment with the drug.
(**)If there are clinically significant adverse reactions, such as corneal epithelial disease, etc., treatment with this drug must be discontinued and appropriate action taken.
(***) Serious adverse reactions, isolated reports from post-registration experience.
There is currently no information on overdose with topical use in humans.
According to foreign reports, patients who have taken bromfenac sodium orally at a total dose greater than 1500 mg for a prolonged period longer than 1 month have experienced serious liver dysfunction (including deaths). Therefore, if abnormalities that are suspected to be associated with early symptoms of liver failure are detected, treatment with this drug should be discontinued and appropriate measures taken.
Sufficient data on the use of bromfenac in pregnant women are not available. Animal studies have demonstrated reproductive toxicity. The potential risk to humans is unknown. Because systemic effects after treatment with the drug in nonpregnant women are negligible, the risk during pregnancy can be considered low.
2 years. Do not use after the expiration date stated on the package. After the first opening of the bottle, store for no more than 30 days.
|Conditions of storage|
Store at the temperature not more than 25 °С. Keep out of reach of children.
Senju Pharmaceutical, Japan
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