Diclofenac sodium eye drops

Pharmacological action: Diclofenac sodium is a non-steroidal anti-inflammatory analgesic derived from phenylacetic acid. Its mechanism of action is to inhibit the activity of cyclooxygenase, thereby blocking the conversion of arachidonic acid to prostaglandins. At the same time, it can also promote the combination of arachidonic acid and triglycerides, reduce the concentration of free arachidonic acid in cells, and indirectly inhibit the synthesis of leukotrienes. Animal experiments have confirmed that prostaglandins are one of the mediators of intraocular inflammation, which can lead to the collapse of the blood-aqueous barrier, vasodilation, increased vascular permeability, leukocyte chemotaxis, non-cholinergic mechanism pupil constriction, etc. Diclofenac sodium is a stronger non-steroidal anti-inflammatory drug. Its inhibitory effect on prostaglandin synthesis is stronger than that of aspirin and indomethacin. Diclofenac sodium eye drops have a strong inhibitory effect on the collapse of the blood-aqueous barrier caused by mechanical, chemical, biological and other stimuli. Clinical studies have shown that 0.1% diclofenac sodium can reduce the flare and cell count in the anterior chamber in the treatment of postoperative inflammation of cataract surgery; it can relieve postoperative pain and photophobia in patients undergoing radial corneal incision or laser refractive keratectomy, which is better than placebo. Non-clinical toxicology studies: Rats were given oral diclofenac sodium at 2 mg/kg per day, and no increase in tumor incidence was found in long-term observation. In a two-year study on rats, 2 mg/kg was used daily, and no tumor-prone tendency was found. Various mutation studies have not found that diclofenac sodium induces gene mutations. Rats were given 4 mg/kg per day, and no infertility occurred in both males and females.

The main ingredient is diclofenac sodium, whose chemical name is 2-[(2,6-dichlorophenyl)amino]phenylacetate sodium.

This product is a colorless or slightly yellow clear solution.

It is used to treat uveitis, keratitis, scleritis, inhibit the formation of corneal neovascularization, treat inflammatory reactions after intraocular surgery, laser keratoconjunctivitis or various eye injuries, and inhibit the pupillary constriction reaction during cataract surgery; it is used to relieve pain and inflammation after excimer laser keratectomy; it is used for allergic eye diseases such as spring conjunctivitis and seasonal allergic conjunctivitis, prevent and treat inflammation and macular cystoid edema after cataract and intraocular lens surgery, and promote the formation of filtration blebs after glaucoma filtration surgery.

4 to 6 times a day, 1 drop each time; for ophthalmic surgery: 1 drop each time, 3, 2, 1, and 0.5 hours before surgery. Start taking the medication 24 hours after cataract surgery, 4 times a day, and continue for two weeks; start taking the medication 15 minutes after corneal refractive surgery, 4 times a day, and continue for three days.

Local adverse reactions of the eye: According to a large number of clinical reports, 15% of patients experienced a short-term stinging and burning sensation when using diclofenac sodium eye drops. In clinical trials of cataracts, approximately 28% of patients treated with diclofenac sodium eye drops developed keratitis, and most cases occurred in the early stages of drug treatment. 15% of patients experienced increased intraocular pressure, and most cases occurred after surgery and in the early stages of drug treatment. Other eye diseases may also occur, such as atrial reactions and eye allergies. Systemic adverse reactions: 1% of patients experienced nausea and vomiting when using diclofenac sodium eye drops and 0.5% of patients experienced nausea and vomiting when using placebo. The viral infection rates in the control group and the placebo group were both ≤1%.

It is contraindicated for those who are allergic to this product.

Precautions for children: The safety and effects of this product in children have not been investigated. Precautions for pregnancy and lactation: In animal teratogenicity studies, mice were given doses of 5000 times the human topical dose (20 mg/kg/day) and rats and rabbits were given doses of 2500 times (10 mg/kg/day), and no teratogenic effects were found, although these doses have reached toxicity to the mother and fetus. The toxicity of diclofenac sodium to rat mothers is manifested as dystocia, prolonged pregnancy, and decreased fetal weight, growth and survival rate. It has been shown that diclofenac sodium can pass through the placental barrier of rats and mice. However, there are currently no studies in humans, so pregnant women should use it with caution. Because this product has an inhibitory effect on prostaglandins and can affect the cardiovascular system of the fetus, pregnant women should avoid using it. Precautions for the elderly: This product may induce or aggravate gastrointestinal bleeding, ulcers and perforations in the elderly. It should be used with caution in elderly patients taking diuretics or with extracellular fluid loss.

Not yet clear.

Keep sealed.

0.4ml:0.4mg(0.1%)

24 months

Shenyang XINGQI Pharmaceutical Co., Ltd.

• Founded in:

  1977-03-24

• Address:

  No. 25, Xinyunhe Road, Shenyang Area, China (Liaoning) Pilot Free Trade Zone

• Tax NO.:

  912101001179988209

• Registered Funds:

  124.589194 yuan

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