Diclofenac Sodium Eye Drops for Uveitis, Keratitis, Scleritis

• Application: Ophthalmology
• Usage Mode: For external use
• Suitable for: Elderly, Children, Adult
• State: Liquid
• Shape: Liquid
• Type: Western Finished Medicine
• Pharmaceutical Technology: Chemical Synthesis
• Drug Reg./Approval No.: H20093603
• Transport Package: Carton
• Specification: 5ML, 8ML
• Trademark: NO
• Origin: China
• HS Code: 3003909090
• Production Capacity: 100000 Boxes/Week

Product Description

Diclofenac Sodium Eye Drops

ingredients
The main ingredient of this product is diclofenac sodium.

traits
This product is a colorless or slightly yellow clear solution.

Indications:
It is used to treat uveitis, keratitis, scleritis, inhibit the formation of corneal neovascularization, treat the inflammatory reaction after intraocular surgery, after laser keratoplasty or various eye injuries, and inhibit the miotic reaction in cataract surgery; It is used for pain relief and anti-inflammatory after excimer laser keratectomy; allergic eye diseases such as vernal conjunctivitis and seasonal allergic conjunctivitis, prevention and treatment of cataract and intraocular lens postoperative inflammation and cystoid macular edema, and promotion of postoperative glaucoma filtration Filter bubble formation, etc.

Specification
5ml:5mg.

Dosage
4~6 times a day, 1 drop at a time; Ophthalmic surgery medication: 1 drop at a time 3, 2, 1 and 0.5 hours before surgery. The drug was started 24 hours after cataract surgery, 4 times a day, and continued for two weeks; the drug could be used 15 minutes after corneal refractive surgery, 4 times a day, and continued for three days.

Adverse reactions
Ophthalmic adverse reactions: a large number of clinical reports, 15% of patients have transient tingling and burning sensations when applying diclofenac sodium eye drops, in clinical trials of cataracts, patients receiving diclofenac sodium eye drops were approximately Keratitis occurred in 28%, and the vast majority of cases occurred before drug therapy, and 15% caused increased intraocular pressure, most of which occurred after surgery and before drug therapy. It can also cause other eye diseases, such as ocular chamber reactions and eye allergies.

Systemic adverse reactions: Nausea and vomiting occurred in 1% of patients receiving diclofenac sodium eye drops and 0.5% of patients receiving placebo. Viral infection rates in both the control and placebo groups were ≤1%.

taboo
1. Patients who are known to be allergic to this product.

2. Derivatives of acetylsalicylic acid, phenethyl esters and other non-steroidal anti-inflammatory drugs have potential cross-allergies, so those with a history of allergies to such drugs should pay attention to this product. NSAIDs can interfere with platelet aggregation and have a tendency to increase intraoperative or postoperative bleeding in eye tissue.

3. Patients who have induced asthma, urticaria or allergic reactions after taking aspirin or other non-steroidal anti-inflammatory drugs.

4. It is contraindicated in the treatment of perioperative pain during coronary artery bypass graft surgery (CABG).

5. Patients with a history of gastrointestinal bleeding or perforation after the application of non-steroidal anti-inflammatory drugs.

6. Patients with active peptic ulcer/bleeding, or previous recurrence of ulcer/bleeding.

7. Patients with severe heart failure.

Precautions
1. This product is only for eye drops.

2. This product can hinder platelet aggregation and has a tendency to increase intraoperative or postoperative bleeding in eye tissue. It is recommended that the following groups of people should pay attention to the application of diclofenac sodium eye drops. One is for surgical patients with bleeding phenomenon, and the other is for Patients who are taking other drugs that may prolong bleeding time.

3. Diclofenac sodium is contraindicated for those who are allergic to contact lenses or this product. Those who wear hydrophilic soft lenses may cause redness and stinging of the eyes.

4. Avoid concomitant medication with other non-steroidal anti-inflammatory drugs, including selective COX-2 inhibitors.

5. According to the needs of symptom control, the use of the lowest effective dose within the shortest treatment time can minimize adverse reactions.

6. Adverse effects of gastrointestinal bleeding, ulceration, and perforation may occur at any time during treatment with all NSAIDs, and the risk may be fatal. These adverse reactions may or may not be accompanied by warning symptoms, regardless of whether the patient has a history of gastrointestinal adverse reactions or a history of serious gastrointestinal events. Patients with a previous history of gastrointestinal disease (ulcerative colitis, Crohn's disease) should use NSAIDs with caution to avoid worsening the condition. The drug should be discontinued when patients develop gastrointestinal bleeding or ulcers while taking this drug. Elderly patients experience increased frequency of adverse effects with NSAID use, especially gastrointestinal bleeding and perforation, with potentially fatal risks.

7. Clinical trials for a variety of COX-2 selective or non-selective NSAIDs for up to 3 years have shown that this product may cause an increased risk of serious cardiovascular thrombotic adverse events, myocardial infarction and stroke. The risk may be fatal. All NSAIDs, including COX-2 selective or non-selective drugs, may have similar risks. Patients with cardiovascular disease or risk factors for cardiovascular disease are at greater risk. Physicians and patients should be vigilant about the occurrence of such events even in the absence of previous cardiovascular symptoms. Patients should be informed of symptoms and/or signs of serious cardiovascular safety and steps to take if they occur.

Patients should be alert for signs and symptoms such as chest pain, shortness of breath, weakness, and slurred speech, and should seek medical help immediately if any of these symptoms or signs occur.

8. Like all non-steroidal anti-inflammatory drugs (NSAIDs), this product can cause new-onset hypertension or exacerbate existing hypertension symptoms, any of which can lead to an increased incidence of cardiovascular events. Non-steroidal anti-inflammatory drugs (NSAIDs) in patients taking thiazides or loop diuretics may interfere with the efficacy of these drugs. Non-steroidal anti-inflammatory drugs (NSAIDs), including this product, should be used with caution in hypertensive patients. Blood pressure should be closely monitored during initiation of therapy with this product and throughout treatment.

9. It should be used with caution in patients with a history of hypertension and/or heart failure (such as fluid retention and edema).

10. NSAIDs, including this product, may cause fatal and serious skin adverse reactions, such as exfoliative dermatitis, Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). These serious events can occur without warning. Patients should be informed of the signs and symptoms of severe skin reactions, and the product should be discontinued at the first appearance of a skin rash or other signs of an allergic reaction.

women's medication
In animal teratogenicity studies, no teratogenicity was found in mice and 2500 times (10mg/kg/day) of the local dose in mice and 2500 times (10mg/kg/day) in rats and rabbits. effects, although these amounts have reached the level of toxicity to the mother and fetus. Maternal toxicity of diclofenac sodium in rats is manifested as dystocia, prolonged pregnancy, and decreased fetal weight, growth and survival. Diclofenac sodium has been shown to penetrate the placental barrier in rats and mice. However, there is no research report in humans, so pregnant women should use it with caution.

Because this product has the inhibitory effect of prostaglandins, it can affect the cardiovascular system of the fetus, so pregnant women should avoid it.

Medication for children
This trial has not been performed and there are no reliable references.

geriatric medication
This trial has not been performed and there are no reliable references.

medicine interactions
This trial has not been performed and there are no reliable references.

overdose
Excessive use generally does not cause emergencies. If it is accidentally taken orally, it can be diluted with water.

pharmacology and toxicology
Pharmacological effects:

Diclofenac sodium is a non-steroidal anti-inflammatory analgesic derived from phenylacetic acids. 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 triglyceride, 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 that cause intraocular inflammation, which can lead to the breakdown of the blood-aqueous barrier, vasodilation, increased vascular permeability, leukocyte chemotaxis, and noncholinergic miosis. Diclofenac sodium is one of the most powerful non-steroidal anti-inflammatory drugs, and 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 breakdown of the blood-aqueous barrier caused by mechanical, chemical, biological and other stimuli. Clinical studies have shown that 0.1% diclofenac sodium in the treatment of postoperative inflammation after cataract can reduce the flare and cell count of the anterior chamber; it can relieve postoperative pain and photophobia in patients undergoing corneal radial incision or laser refractive keratectomy , better than placebo.

Non-clinical toxicology study: Oral administration of diclofenac sodium up to 2 mg/kg per day to rats, long-term observation, no increase in tumor incidence was found. In a two-year study in rats, 2 mg/kg daily did not show any tendency to develop tumors. Various mutation studies have not found diclofenac sodium-induced gene mutation. The rats were given 4 mg/kg daily, and neither male nor female was sterile.

Pharmacokinetics
After 0.1% diclofenac sodium eye instillation, the drug can be detected in the aqueous humor within 10 minutes, reaching a peak value of 82ng/ml in 2.4 hours; the concentration remains above 20ng/ml for more than 4 hours, while maintaining at The 3~16ng/ml level can exceed 24 hours; the average drug retention time at the atrial level is 7.4 hours. If there are multiple drops in one eye, the drug level in the aqueous humor will increase, and the peak time can be advanced to about 1 hour.

After two drops of 0.1% diclofenac sodium were instilled in both eyes, no drug was detected in the plasma within 4 hours (the lowest detection limit was 10 ng/ml), indicating that the systemic absorption of the drug after eye instillation was very limited.

storage
Shade from light, sealed and stored in a cool and dark place (not more than 20ºC).

Package
1. Packed in low density polyethylene medicinal eye drops bottle, 5ml each.

2. Packed in low density polyethylene medicinal eye drops bottle, each 6ml.

3. Packed in low density polyethylene medicinal eye drops bottle, 8ml each.

4. Packed in low density polyethylene medicinal eye drops bottle, 10ml each.

Validity period
24 months.