Diclofenac Sodium Enteric-Coated Tablets

[Pharmacology and Toxicology] This product inhibits cyclooxygenase to reduce the synthesis of prostaglandins, and inhibits lipoxygenase to a certain extent to reduce the production of products such as leukotrienes and bradykinin, thereby exerting antipyretic, analgesic and anti-inflammatory effects. This product has been confirmed to have antipyretic effects in animal experiments and human clinical practice. Results of acute toxicity tests: oral LD50 for rats is 150 mg/kg; oral LD50 for mice is 390 mg/kg. [Pharmacokinetics] Oral absorption is fast and complete. Taking it with food reduces the absorption rate. The blood drug concentration reaches the peak value in an average of 1 to 2 hours after taking the drug on an empty stomach, and reaches the peak value in 6 hours when taken with food, and the plasma concentration decreases. The drug half-life is about 2 hours. The plasma protein binding rate is 99%. The drug concentration in milk is extremely low and negligible. In the synovial fluid, after taking the drug for 4 hours, its level is higher than the serum level at that time and can be maintained for 12 hours. About 50% is metabolized in the liver, 40% to 65% is excreted from the kidneys, and 35% is excreted from the bile and feces within 1.2 to 2 hours. There is no accumulation effect after long-term use.

The main ingredient of this product is diclofenac. Its chemical name is [o-(2,6-dichloroaniline)]phenylacetic acid.

This product is enteric-coated tablets, which appear white after removing the enteric 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.

Oral administration: once a day, or 1 to 2 times a day, or as directed by a doctor, after meals.

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 in mild cases; ④ Other rare reactions include transient increase in serum transaminase, and very rare cases of jaundice, rash, arrhythmia, granulocytopenia, thrombocytopenia, etc., which can all recover after stopping the drug.

1. Patients with allergic reactions, asthma, urticaria or other allergic reactions to this product, aspirin or other non-steroidal anti-inflammatory drugs. 2. Patients with peptic ulcers.

Precautions for children: Children under 16 years old should not take this medicine. Precautions for pregnancy and lactation: Pregnant and lactating women should not take this medicine. Precautions for the elderly: This product may induce or aggravate gastrointestinal bleeding, ulcers and perforations in the elderly. Use with caution in elderly patients who are taking diuretics or have extracellular fluid loss.

Diclofenac can increase the plasma concentration of digoxin and lithium-containing preparations and reduce the renal excretion of methotrexate. Therefore, special caution should be exercised when used in combination with these drugs.

Keep away from light, tightly closed and in a dry place.

25mg

24 months

Heilongjiang Yidahong Pharmaceutical Co., Ltd.

• Founded in:

  2021-01-12

• Address:

  No. 21-1, Gongye Street, Hulin City, Jixi City, Heilongjiang Province (declaration commitment)

• Tax NO.:

  91230781MA1CE97561

• Registered Funds:

  60 million yuan

• Email:

  Log in to view