Aceclofenac Enteric-coated Tablets

1. Pharmacological action Aceclofenac 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. 2. Toxicological studies (1) Repeated dose toxicity: Wistar rats were given oral administration for one month at doses of 15.50 and 100 mg/kg/day. As a result, only the 100 mg/kg/day group had animal deaths, accompanied by fecal occult blood. 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. However, the results of toxicological tests at the maximum tolerated dose in rats (which can metabolize aceclofenac to diclofenac) and monkeys (some of which are unmetabolized prototype drugs) showed that aceclofenac did not have other toxic effects other than the common toxicity of non-steroidal anti-inflammatory drugs. (2) Genetic toxicity: The results of the genetic toxicity test of aceclofenac were negative. (3) 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 closure 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. (4) Carcinogenicity: No carcinogenic effect of aceclofenac was found in carcinogenicity studies conducted in mice and rats.

The main ingredient of this product is aceclofenac, its chemical name is: 2-[(2,6-dichlorophenyl)amino]phenylacetic acid carboxymethyl ester, its chemical structure is: Molecular formula: C16H13Cl2NO4 Molecular weight: 354.19

This product is an enteric-coated tablet, which appears off-white after removing the enteric coating.

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 (0.1g) twice a day or as directed by a doctor. Patients with hepatic insufficiency: Patients with mild to moderate hepatic insufficiency should reduce the dosage of aceclofenac, the recommended initial dose is 1 tablet (0.1g) per day. Patients with renal insufficiency: Patients with mild to moderate renal insufficiency do not need to adjust the dosage, but should use with caution.

According to foreign research data: The main adverse reactions are gastrointestinal (dyspepsia, abdominal pain, nausea and diarrhea). The most common are dyspepsia (7.5%) and abdominal pain (6.2%). 1. Common (>1%) (1) Gastrointestinal system dysfunction: dyspepsia, abdominal pain, nausea and diarrhea. (2) Liver and gallbladder: elevated liver enzymes. 2. Occasionally (1/100-1/1000) (1) General: dizziness (2) Gastrointestinal system: abdominal distension, gastritis, constipation, vomiting, ulcerative oral mucositis. (3) Skin: eczema, rash and dermatitis. (4) Metabolism and nutrition: elevated urea nitrogen and creatinine. 3. Rare: (<1/1000) (1) General: headache, fatigue, facial edema, allergic reaction, weight gain. (2) Blood: anemia, granulocytopenia, thrombocytopenia, neutropenia. (3) Cardiovascular: edema, palpitations. (4) Central and peripheral nervous systems: paresthesia, epilepsy. (5) Gastrointestinal system disorders: gastrointestinal bleeding and ulcers, bloody diarrhea, hepatitis or pancreatitis, tarry stools, oral mucosal inflammation. (6) Urinary system disorders: interstitial nephritis. (7) Skin: eczema. (8) Metabolism and nutrition: elevated alkaline phosphatase, hyperkalemia. (9) Psychiatry: depression, dreaminess, drowsiness, insomnia. (10) Eyes: visual abnormalities (11) Others: taste perversion, vasculitis, gastrocnemius spasm, flushing, purpura. Like other NSAIDs, severe allergic reactions of the skin and mucous membranes may occur.

1. Patients with known allergies to this product. 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, so 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 using 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, lithium salts should be avoided in combination. 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 combined medications require dose adjustment or attention: When using low-dose methotrexate, attention should also be paid to the possibility of drug interactions between NSAIDs and methotrexate, especially in patients with renal insufficiency. If NSAIDs and methotrexate are used simultaneously within 24 hours, caution should be exercised because the blood concentration of methotrexate may increase, leading to increased toxicity. When NSAIDs are used together with cyclosporine or taclidinium, the risk of renal toxicity increases due to reduced renal prostaglandin synthesis, so renal function should be closely monitored during combined treatment. Taking aspirin and other non-steroidal anti-inflammatory drugs at the same time will increase the incidence of adverse reactions. Be vigilant. Non-steroidal anti-inflammatory drugs can weaken the diuretic effect of furosemide (diuretic) and bufenoxic acid (budatanide, diuretic). The possible mechanism of action is to inhibit prostaglandin synthesis. They also reduce the antihypertensive effect of thiazide drugs (diuretics). Concomitant use with potassium-sparing diuretics will increase potassium levels, so blood potassium should be monitored. The simultaneous use of nonsteroidal anti-inflammatory drugs and ACE (angiotensin converting enzyme) inhibitors will increase the risk of acute renal failure in patients with dehydration. Although interactions with other antihypertensive drugs such as beta-receptor antagonists cannot be ruled out, the combined use of aceclofenac and bendroflumethiazide (diuretic antihypertensive drug) has not been found to affect its control of blood pressure. 3. Other possible interactions. There are reports on hypoglycemic and hyperglycemic effects, respectively. Aceclofenac may cause hypoglycemia, and the dose adjustment of hypoglycemic drugs should be considered when using it. No clinically significant differences in pharmacokinetics were observed after a single dose in patients with mild and moderate renal insufficiency. 4. Aceclofenac is mainly metabolized by cytochrome P4502G9, so there may be a risk of drug interactions with phenytoin sodium, digoxin, cimetidine, tolbutamide, phenylbutazone, amiodarone, imidazole and sulfaphenazole. 5. Like other NSAIDs, there is a risk of drug interaction with drugs that are eliminated through renal excretion, such as methotrexate and lithium salts. Aceclofenac is actually completely bound to plasma proteins, and will subsequently undergo a displacement effect with other highly protein-bound drugs, so attention must be paid.

Keep sealed.

0.1g

Tentative 24 months

Weiao Pharmaceutical (Sichuan) Co., Ltd.

• Founded in:

  1998-01-08

• Address:

  No. 652, Tianfu East Road, Pengzhou City, Chengdu City, Sichuan Province

• Tax NO.:

  91510000620854656K

• Registered Funds:

  26 million yuan

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