Indomethacin Enteric-coated 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. Acute toxicity test results: The oral LD50 for rats is 12mg/kg; the oral LD50 for mice is 50mg/kg.

Indomethacin.

Used for: 1. Arthritis, to relieve pain and swelling; 2. Soft tissue injury and inflammation; 3. Antipyretic; 4. Others: used to treat migraine, dysmenorrhea, postoperative pain, post-traumatic pain, etc.

Oral. 1. Common dosage for adults: ① Anti-rheumatic, initial dose 25-50 mg once, 2-3 times a day, maximum daily dose should not exceed 150 mg. ② Analgesia, first dose 25-50 mg once, followed by 25 mg 3 times a day, until pain is relieved, then the drug can be discontinued; ③ Antipyretic, 6.25-12.5 mg once, no more than 3 times a day. 2. Common dosage for children: 1.5-2.5 mg/kg per day, divided into 3-4 times according to body weight.

This product has many adverse reactions. 1. Gastrointestinal tract: symptoms such as indigestion, stomach pain, burning sensation in the stomach, nausea and acid reflux, ulcers, gastric bleeding and gastric perforation. 2. Nervous system: headache, dizziness, anxiety and insomnia, etc., severe cases may have mental and behavioral disorders or convulsions. 3. Kidney: hematuria, edema, renal insufficiency, 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. 6. Allergic reactions, asthma, angioedema and shock, etc.

It is contraindicated for patients with active ulcer disease, ulcerative colitis or a history of the disease, epilepsy, Parkinson's disease and mental illness, liver and kidney dysfunction, allergic to this product or to aspirin or other non-steroidal anti-inflammatory drugs, angioedema or bronchial asthma.

Precautions for children: Children under 14 years old are generally not suitable for this drug. If it must be used, they should be closely observed to prevent the occurrence of serious adverse reactions. Precautions for pregnancy and lactation: 1. This product can cause fetal ductus arteriosus occlusion and persistent pulmonary hypertension when used in the last 3 months of pregnancy. It is contraindicated for pregnant women. 2. This product can be excreted from breast milk and can cause toxic and side effects to infants. It is contraindicated for lactating women. Precautions for the elderly: Elderly patients are prone to renal toxicity and should be used with caution.

1. Long-term use with acetaminophen can increase renal toxicity, 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 gastrointestinal adverse reactions 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 in combination 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. This point should be noted when evaluating the significance of plasma renin activity 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 blood concentration, and increase 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 blood concentration, and increase 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.

Store in a dark place and keep sealed.

25 mg

24 months.

Anhui Aike'er Pharmaceutical Co., Ltd.

• Founded in:

  2014-06-20

• Address:

  No. 290, Guandian Economic Development Zone, Mingguang City, Anhui Province

• Tax NO.:

  913411823976695617

• Registered Funds:

  10 million yuan

• Email:

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