Description
Ivinac-Solopharm Pharmacodynamics
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 ciliary body of the rabbit. 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).
In an experimental model of uveitis in rabbits, bromfenac at concentrations of 0.02 %, 0.05 %, 0.1 % and 0.2 % inhibited almost all symptoms of ocular inflammation.
Indications
Treatment of non-infectious inflammatory diseases of the anterior segment of the eye and post-operative inflammation (after cataract extraction, etc.).
Contraindications
The drug is contraindicated in patients with a history of hypersensitivity to any drug component.
The drug is contraindicated in patients with attacks of bronchial asthma, urticaria and symptoms of acute rhinitis aggravated by taking acetylsalicylic acid and other NSAIDs.
Age under 18 years (safety and efficacy of the drug in children have not been studied).
Administration during pregnancy and breast-feeding
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 following treatment with the drug in nonpregnant women are negligible, the risk during pregnancy can be considered low.
However, because of the known effects of drugs that inhibit prostaglandin biosynthesis on the fetal cardiovascular system (ductal closure), use of this drug in the third trimester of pregnancy should be avoided. In general, it is not recommended to use this drug during pregnancy, except in cases when the benefit exceeds the potential risk.
Dosage and administration
- Instillation into the conjunctival sac.
1-2 drops of the drug in the conjunctival sac twice a day for not more than
15 days. - If a dose of the drug is missed, it should be used as soon as possible in the dosage indicated in the instructions for use. If the missed dose of the drug is about 24 hours, the drug should be used at the next scheduled time without doubling the dose to compensate for the missed dose.
- Treatment of postoperative inflammation: one drop once a day. Treatment starts 1 day before surgery and continues during the first 14 days of the postoperative period (including the day of surgery).
- Treatment of non-infectious inflammatory diseases of the anterior segment of the eye: one drop twice a day. The course of treatment is determined by the doctor depending on the severity of the condition.
- Procedure for the vial (without stopper):
1. Rotating movements counter-clockwise to open the bottle and remove the cap. 2.
2 Carefully, without touching the tip of the vial with your fingers, turn the vial upside down, fix it between the thumb and forefinger of one hand.
3. Tilt your head back, place the tip of the vial over your eye and with the index finger of your other hand pull down the lower eyelid. Lightly press the bottle and inject the desired amount into the conjunctival sac of the eye.
Avoid contact of the tip of the open vial with the surface of the eye and hands.
4. After use put the cap on the bottle and close by rotating clockwise.
Procedure for use of the bottle with the stopper:
1. Take out the stopper and the vial from the package.
2. Turn the bottle counter-clockwise to open the bottle with the stopper and remove the cap. 3.
Carefully, not touching the tip of the vial, fix the stop on the neck of the vial. 4.
4. Tilt your head back, place the stopper on the eyelid so that the tip of the bottle is in front of the eyeball, gently press the bottle and drop the desired amount of the drug.
5. Remove the stopper from the neck of the bottle, put the cap on the bottle and close by rotating clockwise. - After opening the bottle the drug can be used for 1 month. At the end of this period the drug should be thrown away.
- Do not use the drug if the vial is visibly damaged.
- Administration in patients with hepatic and renal insufficiency
The effects of the drug in patients with hepatic and renal insufficiency have not been studied.
