Diclofenac Sodium Enteric-Coated Tablets

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. Diclofenac sodium is one of the strongest non-steroidal anti-inflammatory drugs. Its inhibitory effect on prostaglandin synthesis is stronger than that of aspirin and indomethacin. Non-clinical toxicology study: Oral administration of diclofenac sodium to rats at 2 mg/kg per day, long-term observation, no increase in tumor incidence was found. In a two-year study on mice, 2 mg/kg was used daily, and no tumor-prone tendency was found. Various mutation studies did not find that diclofenac sodium induced gene mutations. Rats were given 4 mg/kg per day, and no infertility occurred in both males and females. Acute toxicity test results: oral LD50 for rats is 150 mg/kg; oral LD50 for mice is 390 mg/kg.

The main ingredient of this product is diclofenac sodium

This product is an enteric-coated tablet, which appears white or off-white after removing the coating.

Used for: ① Relieve joint swelling and pain symptoms of various arthritis such as rheumatoid arthritis, osteoarthritis, spondyloarthropathies, gouty arthritis, rheumatic arthritis, etc.; ② Treat various non-articular soft tissue rheumatic pains, such as shoulder pain, tenosynovitis, bursitis, myalgia and pain after sports injuries, etc.; ③ Acute mild and moderate pain such as: post-surgery, post-traumatic, post-strain, dysmenorrhea, toothache, headache, etc.; ④ It has an antipyretic effect on fever in adults and children.

1. As a regular dose, the initial daily dose is 100mg~150mg (4-6 tablets). For mild patients or patients who need long-term treatment, the daily dose is 75~100mg (3-4 tablets). The daily dose is usually taken in 2-3 times. 2. For primary dysmenorrhea, the daily dose is usually 50~150mg (2-6 tablets), taken in divided doses. The initial dose should be 50~150mg (2-6 tablets). If necessary, the dose can be increased to a maximum dose of 200mg (8 tablets)/day within several menstrual cycles. Once symptoms appear, treatment should be started immediately and continued for several days. The treatment plan depends on the symptoms. 3. Common dosage for children: 0.5~2.0mg/kg per day, the maximum daily dose is 3.0mg/kg, taken in 3 times.

1. Gastrointestinal reaction: the most common adverse reaction, which occurs in about 10% of patients. It mainly includes stomach discomfort, burning sensation, acid reflux, poor appetite, nausea, etc., which can disappear after stopping the drug or symptomatic treatment. A few of them may have ulcers, bleeding, and perforation; 2. Nervous system manifestations include headache, dizziness, drowsiness, excitement, etc.; 3. It causes edema, oliguria, electrolyte imbalance and other adverse reactions, which can disappear after stopping the drug and corresponding treatment; 4. Other rare reactions include transient increase of serum transaminase, and very rare cases of jaundice, rash, arrhythmia, granulocytopenia, thrombocytopenia, etc., which can all be recovered after stopping the drug.

This product is contraindicated for patients who are allergic to it. It is contraindicated for patients who have asthma, urticaria or other allergic reactions caused by aspirin or other non-steroidal anti-inflammatory drugs.

Precautions for children: Not suitable for children under 16 years old. Precautions for pregnancy and lactation: This product can cross the placenta. Animal experiments showed toxicity to fetal mice, but it was not teratogenic. Pregnant and lactating women should not take it. Precautions for the elderly: This product may induce or aggravate gastrointestinal bleeding, ulcers and perforations in the elderly. Use with caution in elderly patients taking diuretics or with extracellular fluid loss.

1. When used with alcohol or other non-steroidal anti-inflammatory drugs, gastrointestinal adverse reactions increase and there is a risk of ulcers. Long-term use with acetaminophen may increase the toxic side effects on the kidneys. 2. When used with aspirin or other salicylic acid drugs, the efficacy is not enhanced, but the incidence of gastrointestinal adverse reactions and bleeding tendency increases. 3. When used with anticoagulants such as heparin and dicoumarol and platelet aggregation inhibitors, there is an increased risk of bleeding. 4. When used with furosemide, the latter's sodium excretion and antihypertensive effects are weakened. 5. When used with verapamil and nifedipine, the blood concentration of this product increases. 6. This product can increase the blood concentration of digoxin, and the dose of digoxin should be adjusted when used together. 7. This product can enhance the effect of antidiabetic drugs (including oral hypoglycemic drugs). 8. When used with antihypertensive drugs, this product may affect the latter's antihypertensive effect. 9. Probenecid can reduce the excretion of this product, increase its blood concentration, and thus increase its toxicity. Therefore, it is advisable to reduce the dosage of this product when used together. 10. This product can reduce the excretion of methotrexate, increase its blood concentration, and even reach toxic levels. Therefore, this product should not be used with medium or large doses of methotrexate. 11. This product can reduce the effects of insulin and other hypoglycemic drugs, causing blood sugar to rise. 12. It can cause hyperkalemia when used together with potassium-sparing diuretics. 13. Aspirin can reduce the bioavailability of this product.

Keep away from light and store in sealed container.

25mg

24 months.

CSPC OUYI Pharmaceutical Co., Ltd.

• Founded in:

  2001-03-29

• Address:

  No. 88, Yangzi Road, Shijiazhuang Economic and Technological Development Zone

• Tax NO.:

  91130100601289268L

• Registered Funds:

  298 million yuan

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