Naquan, eye drops 0.09% 5 ml

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).

Indications

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

Pharmacological effect

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 rabbit ciliary body. The half-maximal inhibition concentration (IC50) for bromfenac (1.1 µmol) was lower than for indomethacin (4.2 µmol) and pranoprofen (11.9 µmol).

Special instructions

This drug should be used as part of symptomatic treatment, and not for the purpose of etiotropic therapy.
This medication should only be used as eye drops.

Active ingredient

Bromfenac

Composition

1 ml of solution contains:

Pregnancy

There are no sufficient data on the use of bromfenac in pregnant women. Animal studies have demonstrated reproductive toxicity. The potential risk to humans is unknown. Since systemic exposure following drug treatment in non-pregnant women is negligible, the risk during pregnancy can be considered low.

However, due to the known effects of drugs that inhibit prostaglandin biosynthesis on the fetal cardiovascular system (ductal closure), use of this drug should be avoided during the third trimester of pregnancy. In general, the use of this drug during pregnancy is not recommended unless the benefits outweigh the potential risks.

Contraindications

This drug is contraindicated in patients with a history of hypersensitivity to any component of the drug.

This drug is contraindicated in patients whose attacks of bronchial asthma, urticaria and symptoms of acute rhinitis are aggravated by taking acetylsalicylic acid and other NSAIDs.

Age up to 18 years (the safety and effectiveness of the drug in children have not been studied).

Side Effects

Adverse reactions to the drug were observed in 72 of 3843 patients (1.87%), data on which were obtained as part of clinical trials or during 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 punctate keratitis in 6 cases (0.16%), itching in 6 cases (0.16%), corneal epithelial detachment in 1 case (0.03%) and burning sensation [of the eyelids] in 1 case (0.03%).

Adverse reactions are classified according to the following gradation of frequency of occurrence:

Very common >1/10

Often ≥1/100 to <1/10

Rarely from ≥1/10000 to <1/100

Very rare <1/10000

In each group, adverse events were classified according to decreasing severity and grouped according to frequency of occurrence and organ system class.

The table below describes adverse reactions.

Frequency of occurrence

Adverse reaction

Visual disorders

Uncommon

Corneal erosion (*), conjunctivitis (*), blepharitis (*), irritation (*), eye pain [transient](*), superficial punctate keratitis (*), itching (*)

Rarely

Detachment of the corneal epithelium (*), burning sensation [eyelids](*)

Unknown

Corneal ulcer (**)(***), corneal perforation (**)(***)

Hypersensitivity

Unknown

Contact dermatitis (*)

(*) If adverse reactions occur, you must stop treatment with the drug.

(**) If clinically significant adverse reactions occur, such as the development of diseases of the corneal epithelium, etc., it is necessary to stop treatment with this drug and take appropriate measures.

(***) Serious adverse reaction, isolated reports from experience with post-registration use of the drug.

Interaction

No interaction studies have been conducted with other drugs.

Overdose

At the moment, there is no information on overdose with topical use in humans.

According to foreign reports, patients who took oral bromfenac sodium at a total dose exceeding 1500 mg for an extended period of time greater than 1 month experienced serious liver dysfunction (including deaths). In this regard, if abnormalities are detected that are presumably associated with early symptoms of liver failure, it is necessary to stop treatment with this drug and take appropriate measures.

Storage conditions

Store at a temperature not exceeding 25 °C. Keep out of the reach of children.

Shelf life

2 years. Do not use after the expiration date stated on the package. After the first opening of the bottle, it should be stored for no more than 30 days.

Manufacturer

Senju Pharmaceutical, Japan