Etodolac Tablets

This product is a non-steroidal anti-inflammatory drug. It has anti-inflammatory, antipyretic and analgesic effects. Its mechanism of action may be to inhibit the synthesis of prostaglandins (PG) by blocking the activity of cyclooxygenase.

The main ingredient of this product is etodolac, whose chemical name is (plusmn;) 1,8-diethyl-1,3,4,9-tetrahydropyrano[3,4-b]indole-1-acetic acid.

This product is an orange oval film-coated tablet, which appears white or off-white after removing the coating.

(1) Osteoarthritis (degenerative joint disease). (2) Rheumatoid arthritis. (3) Pain symptoms This product can be used to treat acute attacks of the above diseases, and can also be used for long-term treatment of the above diseases.

According to the doctor's advice, the dosage of etodolac should be individualized to ensure the best efficacy and tolerance. 1. Analgesia: The recommended dose for acute pain is 200-400 mg, once every 8 hours, and the maximum daily dose should not exceed 1.2 g. For patients weighing less than 60 kg, the maximum daily dose should not exceed 20 mg/kg body weight. Clinical observations have found that etodolac still has analgesic effects in some patients when administered once every 12 hours. 2. Chronic diseases: The recommended dose of etodolac for the treatment of chronic diseases (such as osteoarthritis and rheumatoid arthritis) is 0.4-1.2 g per day, taken orally in divided doses, each The maximum daily dose should not exceed 1.2g. For patients weighing less than 60kg, the maximum daily dose should not exceed 20mg/kg body weight. The daily dose of etodolac is less than 0.4g, taken orally in divided doses, or a single dose of 0.4g or 0.6g is given every night. It has a certain therapeutic effect in some patients. 3. For the elderly: The pharmacokinetics of etodolac in the elderly are not significantly different from those in the general population. Therefore, there is no need to adjust the dose when using it in the elderly, but caution should be exercised. In addition, the elderly are more sensitive to the effects of prostaglandin antibodies than young people. Therefore, more caution should be exercised when increasing the dose of drug treatment for a particular individual.

According to foreign data reports, the results of 4 to 320 weeks of observation of 2,629 arthritis patients in open, double-blind clinical validation and the monitoring results of approximately 60,000 patients worldwide after the launch of etodolac, and spontaneous reports after the launch are also included. Clinical studies have shown that etodolac has good overall tolerance, and most adverse reactions are mild and short-lived. The incidence of the following is 1%, which may be related to the drug. Incidence 1%: Systemic symptoms: abdominal pain, fatigue, discomfort, chills, fever. Digestive system: constipation, diarrhea, indigestion, abdominal distension, gastritis, black stools, nausea, vomiting. Nervous system: anxiety, depression, dizziness Skin and appendages: itching, rash. Special senses: blurred vision, tinnitus. Urogenital system: difficulty in excretion, frequent urination. Incidence 1% Systemic symptoms: allergic reaction, allergic-like reaction, chest pain, chest tightness. Cardiovascular system: congestive heart failure, facial flushing, hypertension, palpitations, syncope, vasculitis (including necrotizing and allergic). Digestive system: anorexia, dry mouth, duodenitis, elevated liver enzymes, colitis, belching, liver failure, hepatitis (including cholestatic hepatitis), intestinal ulcer, jaundice (including cholestasis), pancreatitis, peptic ulcer with or without bleeding and perforation, stomatitis (including ulcerative stomatitis), thirst. Blood and lymphatic system: agranulocytosis, anemia, prolonged bleeding time, ecchymoses, hemolytic anemia, neutropenia, pancytopenia, thrombocytopenia. Metabolism and nutrition: edema, increased urea nitrogen, increased blood sugar and increased blood creatinine in patients with previously well-controlled diabetes. Nervous system: insomnia, lethargy. Respiratory system: asthma. Skin and appendages: angioedema, purpura caused by cutaneous vasculitis, erythema multiforme, Steven-Johnson syndrome, hyperhidrosis, urticaria, vesicular rash. Special senses: photophobia, transient visual impairment. Urogenital system: glomerulonephritis, pyelonephritis, renal failure, renal papillary necrosis. The following symptoms are reported to occur simultaneously with the use of etodolac, with an incidence rate of less than 1%, but it is unclear whether there is an inevitable connection between the two. They are only used to remind doctors to pay attention. These include those with unclear causal relationship between the two and those determined to be unrelated to etodolac after causal analysis, but due to the seriousness of the situation and a higher incidence rate than that of accidental events. Systemic manifestations: infection, involuntary muscle movement, muscle spasm, muscle weakness, muscle pain, rectal-pubic pain, subcutaneous nodules, tenderness of the first metacarpophalangeal joint. Cardiovascular system: arrhythmia (including tachycardia), cardiovascular accident, myocardial infarction. Digestive system: changes in appetite, colitis (including ischemic colitis), esophagitis with or without cardia spasm or stenosis, hematemesis, and blood in the stool. Blood and lymphatic system: atypical lymphocytes, decreased hematocrit, decreased hemoglobin, eosinophilia, leukopenia. Metabolism and nutrition: weight changes. Nervous system: confusion, hand tremors, headaches, inability to concentrate, frequent dreams, paresthesia, irritability. Respiratory system: bronchitis, bronchospasm, shortness of breath, hyperventilation, pharyngitis, rhinitis, sinusitis, sneezing. Skin and appendages: hair loss, brittle nails, increased capillary fragility, maculopapular rash, allergies, skin desquamation. Special senses: burning sensation in the eyes/nose, conjunctivitis, deafness, earache, epistaxis, pica, stinging pain behind the eyes. Urogenital system: breast tenderness, cystitis, impotence, hematuria, interstitial nephritis, increased leucorrhea, frequent urination at night, kidney stones, irregular uterine bleeding, vaginal bleeding.

1. Active peptic ulcer or history of gastrointestinal ulcer or bleeding related to the use of another NSAIDs; 2. There may be cross-reactions between different NSAIDs, so asthma, rhinitis, urticaria or other allergic reactions may occur during treatment with aspirin or other NSAIDs; 3. People who are allergic to this product.

Precautions for children: The safety and effectiveness of etodolac for children have not been confirmed, so it is not recommended. Precautions for pregnancy and lactation: Pregnant women: Due to the lack of an appropriate control group, there is no definite conclusion about the effect of etodolac on pregnant women, but it should be used with caution, and the benefits of the drug to the patient and the potential risks to the fetus must be weighed. NSAIDs have effects on human delivery, ductus arteriosus closure and other cardiovascular systems, so they should be avoided in late pregnancy. Precautions for the elderly: The elderly generally do not need to adjust the dose, but the elderly should be careful when taking etodolac. When the dose is individualized and increased, the patient should receive special care because the elderly seem to have worse tolerance for non-steroidal anti-inflammatory drugs than young people.

Antacids: Taking antacids at the same time has no significant effect on the absorption of etodolac. However, antacids can reduce the peak concentration of etodolac by 15-20%, but it does not affect the time to peak. Aspirin: When etodolac is used together with aspirin, although the clearance of free etodolac does not change, its protein binding rate decreases. The clinical significance of this drug interaction is still unclear. However, due to the increased potential adverse reactions when the two are used together, this usage is not recommended clinically. Warfarin: The simultaneous use of etodolac and warfarin can reduce the protein binding rate of warfarin, but it does not affect the clearance of free warfarin and prothrombin. time, so the combination of the two drugs does not require adjustment of the dose of either drug. However, some post-marketing reports show that the combination of the two drugs prolongs the prothrombin time, so they should be used with caution. Phenytoin sodium: There is no obvious pharmacokinetic interaction between etodolac and phenytoin sodium. Glyburide: When etodolac is used in combination with glyburide, there is no significant change in pharmacokinetics and pharmacodynamics. Diuretics: In healthy volunteers, there is no obvious pharmacokinetic interaction between etodolac and furosemide or hydrochlorothiazide, and etodolac will not weaken the diuretic effect of diuretics. However, in patients who have taken diuretics or suffer from heart, kidney, or liver failure, the two Be careful when using these drugs together. Methotrexate: There is no obvious pharmacokinetic interaction between etodolac and methotrexate. Cyclosporine, digoxin and lithium: Etodolac inhibits the synthesis of prostaglandins, which changes the kidney's clearance of these drugs, increases drug concentrations and increases toxicity. Cyclosporine-related renal toxicity will also increase. Therefore, patients who have taken these drugs should be closely monitored for possible drug toxicity when receiving etodolac or other NSAIDs, especially those with impaired renal function. Protein binding: In vitro research data show that ibuprofen, acetaminophen, phenytoin, probenecid, indomethacin, chlorosulfuron Propionamide, glyburide, naproxen, glipizide, and piroxicam have no significant effect on the proportion of free etodolac. On the contrary, phenylbutazone increases the free concentration (about 80%). Although in vivo tests have not confirmed whether phenylbutazone changes the clearance of etodolac, its co-administration is not recommended clinically. Laboratory test interactions: Phenolic metabolites of etodolac will appear in the urine of patients taking etodolac, so false positive reactions may occur in the determination of urine bilirubin. Rapid diagnostic methods have found false positive reactions in urine ketone bodies in some patients taking etodolac. This phenomenon is not related to other clinical conditions and is unrelated to the dosage.

Keep away from light and keep in airtight container.

0.4g

24 months

Zhejiang Yatai Pharmaceutical Co., Ltd.

• Founded in:

  2001-12-31

• Address:

  Room 1501, No. 2003, Qunxian Road, Keqiao District, Shaoxing City, Zhejiang Province

• Tax NO.:

  91330000146008822C

• Registered Funds:

  609.17106 million yuan

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