Etoricoxib Tablets

Pharmacological action Etoricoxib is a nonsteroidal anti-inflammatory drug that has anti-inflammatory, analgesic and antipyretic effects in animal models. Within or above the clinical dose range, Ankangxin is an orally active, selective cyclooxygenase-2 inhibitor. Two isoforms of cyclooxygenase have been discovered: cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2). COX-1 is involved in normal physiological functions mediated by prostaglandins, such as gastric mucosal cell protection and platelet aggregation. Non-selective nonsteroidal anti-inflammatory drugs inhibit the production of COX-1, thereby causing gastric mucosal damage and weakened platelet aggregation. COX-2 is mainly involved in the production of inflammatory prostaglandins, causing pain, inflammation and fever. Etoricoxib is a selective inhibitor of cyclooxygenase-2, which can alleviate these symptoms and signs, reduce gastrointestinal side effects and do not affect platelet function. According to clinical pharmacology studies, Ankangxin's inhibitory effect on COX-2 is dose-dependent within a daily dose of 150 mg, but it has no inhibitory effect on COX-1. In clinical trials, subjects were given 120 mg of Ankangxin (once a day), 500 mg of naproxen (twice a day) or placebo, and the level of prostaglandin synthesis in gastric mucosal biopsy specimens was monitored. Compared with placebo, Ankangxin did not inhibit the synthesis of prostaglandins in the gastric mucosa, while naproxen inhibited the synthesis of prostaglandins in the gastric mucosa by about 80%. These studies further support that Ankangxin is a selective inhibitor of COX-2. In a multiple-dose study, subjects took 150 mg of Ankangxin daily (for 9 days in total), and bleeding time was not affected compared with placebo. Single doses of 250 mg or 500 mg also had no effect on bleeding time. In vivo studies showed that at a dose of 150 mg, when the blood concentration reached steady state, in vitro arachidonic acid or collagen-mediated platelet aggregation was not inhibited. These results are consistent with the COX-2 selectivity of Ankangxin. Toxicology studies Heritage toxicity: Etoricoxib has no genotoxic and mutagenic effects. Reproductive toxicity: Studies in rats have shown that no developmental abnormalities were found when the dose was 15 mg/kg/day (exposure is about 1.5 times the exposure in humans when taking 90 mg). In rabbit studies, when the drug exposure was about twice the exposure in humans when taking 90 mg, low incidences of cardiovascular malformations and increased post-implantation loss were found. No developmental abnormalities were found when the drug exposure was equivalent to or lower than the exposure in humans when taking 90 mg. Etoricoxib can be secreted in the milk of lactating rats. Carcinogenicity: Mouse studies have not found that etoricoxib has a carcinogenic effect. Rats were given the drug continuously for about 2 years, and the daily drug exposure was more than 6 times the human clinical dose (90 mg), and hepatocellular and thyroid follicular cell adenomas may occur. (See the inner package insert for details).

The main ingredient is etoricoxib. Chemical name: 5-fluoro-6'-methyl-3-[4-(methylsulfonyl)phenyl]-2,3'-bipyridine Molecular formula: Molecular weight: C18H15ClN2O2S

The product is a light green, apple-shaped, biconvex film-coated tablet engraved with ARCOXIA 120 on one side and 204 on the other side.

This product is suitable for 1. Treating the symptoms and signs of acute and chronic osteoarthritis. 2. Treating acute gouty arthritis.

This product is for oral administration and can be taken with or without food. Acute gouty arthritis--The recommended dose is 120 mg, once a day. 120 mg of this product is only suitable for acute attacks of symptoms and can be used for up to 8 days. When the dose is higher than the recommended dose, it has not been proven to have better efficacy or has not been studied yet. Therefore, the above dose is the maximum recommended dose. Because the cardiovascular risk of selective cyclooxygenase-2 inhibitors increases with higher doses and longer medication duration, the duration of medication should be shortened as much as possible and the lowest effective daily dose should be used. The patient's symptom relief and the patient's response to treatment should be evaluated regularly. (See Precautions) Elderly, gender, race--No dose adjustment is required for the elderly, people of different genders and races. Hepatic insufficiency--Mild liver dysfunction

According to foreign literature reports, in clinical trials, safety evaluations were conducted on approximately 4,800 individuals, including approximately 3,400 patients with osteoarthritis, rheumatoid arthritis, or chronic low back pain (approximately 600 patients with osteoarthritis or rheumatoid arthritis were treated for 1 year or longer). The following drug-related adverse events were reported in several clinical studies of up to 12 weeks in patients with osteoarthritis, rheumatoid arthritis, or chronic low back pain. The incidence in patients treated with Ankangxin was ≥1% and was higher than that in the placebo group: weakness/fatigue, dizziness, lower limb edema, hypertension, indigestion, heartburn, nausea, headache, increased alanine aminotransferase (ALT) and increased aspartate aminotransferase (AST). The incidence of adverse events in patients with osteoarthritis or rheumatoid arthritis treated with Ankangxin for 1 year or longer was similar. In another clinical study of 7111 patients with osteoarthritis, the gastrointestinal tolerability of etoricoxib 90 mg (equivalent to 1.5 times the dose for treating osteoarthritis) once daily and diclofenac sodium 50 mg three times daily for 9 months were compared. The adverse events of Ankangxin were generally similar to those reported in Phase IIb or Phase III placebo-controlled clinical studies; however, the incidence of hypertension adverse events in the Ankangxin group was higher than that in the diclofenac group. In a clinical study of ankylosing spondylitis, patients received Ankangxin 90 mg once daily for up to 1 year (126 patients were enrolled). The adverse events in this study were similar to the results of long-term studies of osteoarthritis, rheumatoid arthritis, and chronic low back pain. In a clinical study of acute gouty arthritis, patients received Ankangxin 120 mg once daily for 8 days, and the adverse events in this study were similar to those reported in studies of osteoarthritis, rheumatoid arthritis, and chronic low back pain. In the acute analgesic clinical study, patients received Ankangxin 120 mg once daily for 1 to 7 days. The adverse events in these studies were generally similar to the comprehensive reports of osteoarthritis, rheumatoid arthritis and chronic low back pain studies. Post-marketing experience: The following adverse reactions have been reported after Ankangxin was marketed: Immune system abnormalities: allergic reactions, including allergic or allergic-like reactions; Psychiatric abnormalities: anxiety, insomnia; Nervous system abnormalities: taste disorders, drowsiness; Cardiac abnormalities: congestive heart failure; Vascular abnormalities: hypertensive crisis; Respiratory, chest and mediastinal abnormalities: bronchospasm; Gastrointestinal abnormalities: abdominal pain, oral ulcers, peptic ulcers including perforation and bleeding (mainly in elderly patients), vomiting, diarrhea. Hepatobiliary abnormalities: hepatitis. Skin and subcutaneous tissue abnormalities: angioedema, itching, rash, Stevens-Johnson syndrome, urticaria. Kidney and urinary system abnormalities: renal insufficiency, including renal failure, generally recovers after discontinuation of medication (see precautions). (See the inner package insert for details).

The following patients are contraindicated to use this product: 1. Allergic to any of its ingredients. 2. Patients with active peptic ulcer/bleeding, or patients with recurrent ulcer/bleeding in the past. 3. Patients who have asthma, urticaria or allergic reactions after taking aspirin or other nonsteroidal anti-inflammatory drugs. 4. Congestive heart failure (New York Heart Association [NYHA] heart function class II-IV). 5. Confirmed ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease (including patients who have recently undergone coronary artery bypass grafting or angioplasty).

Precautions for children: Ankangxin has not established its safety and efficacy in pediatric patients. Precautions for pregnancy and lactation: Ankangxin, like other drugs known to inhibit prostaglandin synthesis, can cause premature closure of the ductus arteriosus. Ankangxin should be avoided in late pregnancy. Reproduction studies in rats have shown that no developmental abnormalities were found when Ankangxin was used at doses up to 15 mg/kg/day [equivalent to 1.5 times the human dose (90 mg)]. In experimental studies of rabbits treated with etoricoxib, a very low incidence of cardiovascular malformations and an increase in the incidence of post-implantation failure were found at doses approximately equivalent to 2 times the human dose (90 mg), while no developmental abnormalities were found at doses approximately equivalent to or lower than the daily human dose (90 mg). However, animal reproduction studies do not always predict human responses. Appropriate, strictly controlled studies have not yet been conducted on pregnant women. Therefore, in the first 6 months of pregnancy, the pharmacokinetic properties of the elderly (65 years and older) are similar to those of young people. Clinical studies have also confirmed that the safety and efficacy of Ankangxin in elderly patients are no different from those in young patients.

drugInteractions

Store tightly closed at 30°C.

120mg*5s

36 months