Aceclofenac Enteric-coated Capsules

Pharmacological action: This product is a non-steroidal anti-inflammatory drug with anti-inflammatory and analgesic effects. Its mechanism of action may be mainly through inhibiting cyclooxygenase activity, thereby reducing prostaglandin synthesis. Toxicological study: Repeated administration toxicity: Wistar rats were orally administered for 1 month at doses of 15, 50 and 100 mg/kg/day. As a result, only the animals in the 100 mg/kg/day group died, accompanied by occult blood in the stool. Histopathological examination showed that the animals in this group had gastric or intestinal mucosal irritation reactions. Similar to other non-steroidal anti-inflammatory drugs, the test animals have poor tolerance to aceclofenac. In addition, the difference in pharmacokinetics between animals and humans makes it difficult to judge its potential toxicity, but the results of toxicological tests on rats (which can metabolize aceclofenac to diclofenac) and monkeys (some of which are unmetabolized prototype drugs) at the maximum tolerated dose showed that aceclofenac had no other toxic effects other than the common toxicity of non-steroidal anti-inflammatory drugs. Genetic toxicity: The results of the genetic toxicity test of aceclofenac were negative. Reproductive toxicity: It is reported that the inhibitory effect of anti-inflammatory drugs on prostaglandin synthesis may lead to severe embryotoxicity. It can inhibit uterine contractions, thereby delaying delivery; it can cause stenosis or atresia of the fetal ductus arteriosus in the uterus, leading to pulmonary hypertension and respiratory insufficiency in the newborn. Anti-inflammatory drugs can also inhibit fetal platelet function and affect its renal function, leading to oligohydramnios and neonatal anuria. Therefore, anti-inflammatory drugs are prohibited in the last 3 months of pregnancy. Carcinogenicity: No carcinogenic effect of aceclofenac was found in carcinogenicity studies conducted in mice and rats.

The main ingredient of this product is aceclofenac

This product is an enteric-coated capsule, the contents are off-white powder

Symptomatic treatment of pain and inflammation caused by osteoarthritis, rheumatoid arthritis and ankylosing spondylitis, etc.

Oral administration, with at least half a glass of water, can be taken with food. Adults take 1 tablet twice a day or as directed by a doctor. Patients with hepatic impairment: Patients with mild to moderate hepatic impairment should reduce the dose of aceclofenac. The recommended initial dose is 1 tablet per day. Patients with renal impairment: Patients with mild to moderate renal impairment do not need to adjust the dose, but should use with caution.

According to foreign research data: The main adverse reactions are gastrointestinal tract reactions and abdominal pain. 1. Dysfunction of the gastrointestinal system: indigestion, abdominal pain, nausea and diarrhea. Liver and gallbladder: elevated liver enzymes. 2. Occasional general: dizziness Gastrointestinal system: abdominal distension, gastritis, constipation, vomiting, ulcerative oral mucositis. Skin: eczema, rash and dermatitis. Metabolism and nutrition: elevated urea nitrogen and creatinine. Metabolism and nutrition: elevated urea nitrogen and creatinine. 3. Rare general: headache, fatigue, facial edema, allergic reactions, weight gain. Blood: anemia, granulocytopenia, thrombocytopenia, neutropenia. Cardiovascular: edema, palpitations Central and peripheral nervous systems: paresthesia, epilepsy. Gastrointestinal system disorders: gastrointestinal bleeding and ulcers, hemorrhagic diarrhea

1. Patients with known allergies to this product are contraindicated. 2. Patients who have asthma urticaria or allergic reactions after taking aspirin or other non-steroidal anti-inflammatory drugs. 3. Contraindicated for the treatment of perioperative pain during coronary artery bypass grafting (CABG). 4. Patients with a history of gastrointestinal bleeding or perforation after the use of non-steroidal anti-inflammatory drugs. 5. Patients with active peptic ulcers/bleeding, or patients with recurrent ulcers/bleeding in the past. 6. Patients with severe heart failure.

Precautions for children: The safety and effectiveness of the drug for children have not been determined, so it is not recommended for children. Precautions for pregnancy and lactation: There have been several reports of anti-inflammatory drugs affecting the fetus, which may be caused by inhibiting prostaglandin synthesis. Anti-inflammatory drugs can block uterine contractions and delay delivery. They can cause constriction and atresia of the intrauterine ductus arteriosus, leading to pulmonary hypertension and respiratory insufficiency in the newborn. Anti-inflammatory drugs can reduce fetal platelet function and inhibit fetal renal function, resulting in oligohydramnios and neonatal anuria. This product is contraindicated in the last three months of pregnancy. It is not clear whether aceclofenac can be secreted into human milk. Therefore, aceclofenac should not be used during breastfeeding unless the doctor deems it necessary. Precautions for the elderly: Generally, there is no need to reduce the dose, but the following situations should be noted: Elderly patients are generally more likely to have adverse reactions and should be used with caution. During treatment, many patients have no previous symptoms or obvious medical history, but severe gastrointestinal bleeding and/or perforation occurs. Elderly patients are more likely to suffer from renal, cardiovascular and liver damage.

1. Avoid co-administration with the following drugs: NSAIDs inhibit the secretion of methotrexate in the renal tubules and may have slight metabolic interactions, resulting in reduced clearance of methotrexate. Therefore, NSAIDs should always be avoided during high-dose methotrexate treatment. Certain NSAIDs can inhibit the elimination of lithium salts in the kidneys, resulting in increased serum lithium concentrations. Unless serum lithium levels can be measured regularly, co-administration with lithium salts should be avoided. NSAIDs inhibit platelet aggregation and damage the gastrointestinal mucosa, which can increase the activity of anticoagulants and increase the risk of gastrointestinal bleeding in patients using anticoagulants unless close monitoring can be performed. Aceclofenac should be avoided in combination with coumarin oral anticoagulants, ticlopidine, thrombolytic agents and heparin. 2. The following

Sealed storage

0.1g

30 months

Shaanxi Kaiyuan Pharmaceutical Co., Ltd.

• Founded in:

  1996-06-07

• Address:

  No. 68, West Avenue, High-tech Zone, Xi'an, Shaanxi Province

• Tax NO.:

  91610000623107963J

• Registered Funds:

  25 million yuan

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