Indomethacin sustained-release tablets

This product has anti-inflammatory, antipyretic and analgesic effects. Its mechanism of action is to reduce the synthesis of prostaglandins by inhibiting cyclooxygenase. It stops the formation of pain nerve impulses in inflammatory tissues and inhibits inflammatory reactions, including inhibiting the chemotaxis of leukocytes and the release of lysosomal enzymes. As for the antipyretic effect, it acts on the hypothalamic temperature regulation center, causing peripheral vasodilation and sweating, which increases heat dissipation. This central antipyretic effect may also be related to the inhibition of prostaglandin synthesis in the hypothalamus.

The main ingredient of this product is indomethacin. Its chemical name is 2-methyl-1-(4-chlorobenzoyl)-5-methoxy-1H-indole-3-acetic acid. [Molecular formula] C19H16ClNO4 [Molecular weight] 357.79

This product is a green shaped film-coated tablet.

Used for rheumatoid arthritis, rheumatic arthritis, ankylosing spondylitis, osteoarthritis and acute gout attacks, etc.

Oral. 75 mg once a day; or 75 mg twice a day; or follow the doctor's advice. Rheumatoid patients take 50-75 mg once a day at the beginning, and gradually increase to 25-50 mg after one week to achieve satisfactory results. The maximum daily dose should not exceed 200 mg. For acute conditions, such as gouty arthritis, take 100 mg once a day at the beginning, and then 75 mg twice a day to control pain, then quickly reduce the dose and stop taking the medicine. [Overdose] Excessive dosage (especially more than 150 mg per day) is likely to cause toxic reactions, and the therapeutic effect does not increase accordingly.

This product has many adverse reactions. ① Gastrointestinal tract: 12.5% to 14% of patients experience indigestion, diarrhea, stomach pain, burning sensation in the stomach, nausea and acid reflux. Ulcers, gastric bleeding and gastric perforation occur in 2% to 5%; ② Nervous system: headache, dizziness, vertigo, anxiety and insomnia occur in about 10% to 25%, and severe cases may have mental and behavioral disorders or convulsions; ③ Kidney: hematuria, edema, and renal insufficiency occur, which are more common in the elderly; ④ Various types of rashes, the most serious of which is bullous erythema multiforme (Stevens-Johnson syndrome); ⑤ The hematopoietic system is suppressed, resulting in aplastic anemia, leukopenia or thrombocytopenia, etc.; ⑥ Allergic reactions, asthma, angioedema and shock, etc.

1. Use with caution in patients with renal insufficiency, pregnant women, breastfeeding women, children under 14 years old, those with active gastrointestinal lesions, hemophilia and other bleeding diseases, or those who are allergic to nonsteroidal anti-inflammatory drugs. 2. Use with caution in the elderly, epilepsy, Parkinson's disease, or emotional or mental disorders. [Pregnant and breastfeeding women] Pregnant and breastfeeding women are prohibited. [Children's medicine] Children under 14 years old are prohibited. [Elderly medicine] Elderly people should use with caution. [Overdose] Excessive dosage (especially when more than 150 mg per day) is likely to cause toxic reactions, and the therapeutic effect does not increase accordingly.

Precautions for children: Not for use in children under 14 years old. Precautions for pregnancy and lactation: Not for use in pregnant and lactating women. Precautions for the elderly: Use with caution in elderly patients.

1. Long-term use with acetaminophen can increase kidney toxicity and side effects, and the incidence of gastrointestinal ulcers increases when used with other non-steroidal anti-inflammatory drugs. 2. When used with aspirin or other salicylates, the efficacy cannot be enhanced, but the gastrointestinal side effects increase significantly. Due to the enhanced inhibition of platelet aggregation, the bleeding tendency can be increased: 3. Drinking alcohol or using it with corticosteroids and adrenocorticotropic hormone can increase the risk of gastrointestinal ulcers or bleeding. 4. When used with digitalis drugs, this product can increase the blood concentration of digitalis (due to inhibition of clearance from the kidneys) and increase toxicity, so the dose of digitalis needs to be adjusted. 5. When used with heparin, oral anticoagulants and thrombolytics, this product competes with them to bind to proteins, so the anticoagulant effect is enhanced. At the same time, this product has the effect of inhibiting platelet aggregation, so there is a potential risk of increasing bleeding. 6. When used with insulin or oral hypoglycemic drugs, this product can enhance the hypoglycemic effect, and the dose of hypoglycemic drugs needs to be adjusted. 7. When used with furosemide, it can weaken the latter's sodium excretion and antihypertensive effects. The reason may be due to the inhibition of the synthesis of prostaglandins in the kidney. This product also prevents furosemide, bumetanide and indapamide from enhancing plasma renin activity (PRA). This point should be noted when evaluating the significance of PRA in hypertensive patients. 8. When used in combination with triamterene, it can cause renal dysfunction (decreased creatinine clearance, azotemia). 9. When used in combination with nifedipine or verapamil, this product can increase the blood concentration of the latter two, thereby increasing toxicity. 10. Probenecid can reduce the clearance of this product from the kidney and bile. Increase the blood concentration and increase the toxicity. When used in combination, the dosage must be reduced. 11. When used in combination with colchicine and sulfinpyrazone, it can increase the risk of gastrointestinal ulcers and bleeding. 12. When used in combination with lithium salts, it can reduce the excretion of lithium from urine, increase the blood concentration and increase the toxicity. 13. This product can increase the blood concentration of methotrexate and prolong the high blood concentration time. If patients who are taking this product need to take medium or large doses of methotrexate, they should stop taking this product 24 to 48 hours in advance to avoid increasing its toxicity. 14. When used together with the antiviral drug zidovudine, the latter's clearance rate can be reduced and its toxicity increased. At the same time, the toxicity of this product is also increased, so it should be avoided in combination.

Keep in a light-proof and airtight container.

25 mg

36 months

Mundipharma Company

• Founded in:

  1993-09-10

• Address:

  Building 20, No. 13, Jingsheng South Fourth Street, Jinqiao Science and Technology Industrial Base, Tongzhou Park, Zhongguancun Science and Technology Park, Tongzhou District, Beijing

• Tax NO.:

  91110000600024559C

• Registered Funds:

  837.7 million yuan

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