Diclofenac sodium sustained-release tablets (Ⅳ)

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 a stronger non-steroidal anti-inflammatory drug. 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. Its chemical name is [o-(2,6-dichloroaniline)] phenylacetate sodium.

This product is a double-layer tablet in white and pink.

1. Acute and chronic rheumatoid arthritis, acute and chronic arthritis, acute and chronic ankylosing spondylitis, osteoarthritis. 2. Periarthritis of shoulder, bursitis, tendinitis and tenosynovitis. 3. Low back pain, sprains, strains and other soft tissue injuries. 4. Acute gout. 5. Dysmenorrhea or adnexitis, toothache and postoperative pain. 6. Pain and inflammation after trauma, such as sprains, muscle strains, etc. 7. Severe infectious pain and inflammation of the ear, nose and throat (such as tonsillitis, otitis, sinusitis, etc.), should be treated with anti-infective drugs at the same time.

Oral: 1 tablet (100 mg) once a day, or 1 to 2 tablets (75 mg) 1 to 2 times a day, or as directed by a doctor. Take with warm water after dinner. Swallow the tablet whole without crushing or chewing.

1. May cause gastrointestinal reactions such as headache and abdominal pain, constipation, diarrhea, stomach burning sensation, nausea, indigestion, etc.; 2. Occasionally, headache, dizziness, and vertigo. Serum glutamate oxaloacetate aminotransferase (GOT) and serum glutamate pyruvate aminotransferase (SGPT) are elevated; 3. Rarely, renal function decline may lead to water and sodium retention, manifested by low urine volume, facial edema, sudden weight gain, etc. Rarely, it may cause arrhythmia, tinnitus, etc.; 4. Rare: rash, gastrointestinal bleeding, peptic ulcer, hematemesis, melena, gastrointestinal ulcer, perforation, bloody diarrhea, drowsiness, allergic reactions such as asthma, hepatitis, edema; 5. May cause bone marrow suppression or aggravate it.

1. It is contraindicated for patients with allergic reactions to this product, aspirin or other non-steroidal anti-inflammatory drugs, asthma, urticaria or other allergic reactions; 2. It is contraindicated for patients with gastrointestinal ulcers.

Precautions for children: Children under 16 years of age should not take this medicine. Precautions for pregnancy and lactation: The use of diclofenac in pregnant women has not been studied. Therefore, unless the potential benefit to the mother outweighs the risk to the fetus, this product is contraindicated for women in the first two months of pregnancy. Like other nonsteroidal anti-inflammatory drugs, it may cause uterine atony and premature closure of the ductus arteriosus in the last three months of pregnancy, so it is contraindicated. For lactating women, as with other nonsteroidal anti-inflammatory drugs, diclofenac will also enter breast milk in small amounts, so this product should be avoided during lactation to avoid adverse effects on the baby. Fertility is the same as other nonsteroidal anti-inflammatory drugs. The use of diclofenac sodium may impair female fertility, so this product is not recommended for women who are preparing to become pregnant. Women who have difficulty conceiving and are undergoing infertility tests should also consider stopping this product. Precautions for the elderly: When using medication for the elderly, attention should be paid to the basic medical principles. In particular, the minimum effective dose should be given to patients who are physically weak and underweight. As with all NSAIDs, close medical monitoring is required when used in patients with gastrointestinal disease or a history of gastrointestinal ulcers, bleeding, or perforation. The risk of gastrointestinal bleeding increases significantly with increasing doses in patients with a history of ulcer disease, especially in patients with bleeding or perforation and in the elderly. Patients with a history of gastrointestinal toxicity, especially the elderly, must record any abnormal abdominal symptoms (especially gastrointestinal bleeding). In patients with a history of ulcer disease, especially those with bleeding or perforation and in the elderly, both the initial dose and the maintenance dose should be kept at the lowest effective dose level to reduce gastrointestinal toxicity. Because fluid retention and edema have been reported to be associated with NSAID therapy, patients with impaired cardiac or renal function, patients with a history of hypertension, elderly patients, patients taking diuretics or drugs that can significantly affect renal function, and patients with any cause of extracellular fluid loss (such as patients before and after major surgery) should be treated with caution. Monitoring of renal function is recommended as a precautionary measure when such patients take this drug. If adverse renal reactions occur, patients will usually recover to their pre-treatment condition after discontinuation of this drug.

Diclofenac can increase the plasma concentrations of digoxin and lithium-containing preparations and reduce 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.

75mg

60 months

Sandoz (China) Pharmaceutical Co.