Aceclofenac Dispersible Tablets

1. 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. 2. Toxicological studies: 1) 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 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 this product. In addition, the difference in pharmacokinetics between animals and humans makes it difficult to judge its potential toxicity, but the results of toxicological tests at the maximum tolerated dose of rats (which can metabolize aceclofenac into diclofenac) and monkeys (some of which are unmetabolized prototype drugs) showed that this product 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 this product 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 arterial blood duct 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. However, there are literature reports that this product can also affect fetal development in the middle and early stages of pregnancy. It is not clear whether this product is excreted through human milk. Therefore, breastfeeding women should not use this product unless the doctor deems it necessary. 4) Carcinogenicity: No carcinogenic effect of this product was found in carcinogenicity studies conducted in mice and rats.

The chemical name of Aceclofenac: 2-[(2.6-dichlorophenyl)amino]phenylacetoxyacetic acid. Its structural formula is: Molecular formula: C16H13Cl2NO4 Molecular weight: 354.19

This product is white or off-white tablets.

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

Directly orally, with at least half a cup of water, or dispersed with warm water and taken orally, can be taken with food. 1. The maximum recommended daily dose for adults is 0.2g (2 tablets), taken twice a day, 0.1g (1 tablet) each time, once in the morning and once in the evening. 2. Elderly people generally do not need to reduce the dose, but should be used with caution and closely observe possible adverse reactions. 3. Patients with hepatic insufficiency Patients with mild to moderate hepatic insufficiency should reduce the dose of aceclofenac, and the recommended initial dose is 0.1g per day. 4. Patients with renal insufficiency Patients with mild to moderate renal insufficiency do not need to adjust the dose, but should be cautious.

According to foreign research data: The main adverse reactions are gastrointestinal tract (dyspepsia, abdominal pain, nausea and diarrhea). The most common are dyspepsia (7.5%) and abdominal pain (6.2%). 1. Common (>1/100) gastrointestinal system disorders: dyspepsia, abdominal pain, nausea and diarrhea. Liver and gallbladder: increased liver enzymes. 2. Occasionally (1/100-1/1000) General: dizziness. Gastrointestinal system: flatulence, gastritis, constipation, vomiting, ulcerative oral mucositis. Skin: itching, rash and dermatitis. Metabolism and nutrition: increased urea nitrogen and creatinine. 3. Rare (<1/1000) General: headache, fatigue, facial edema, allergic reactions, weight gain. Blood: anemia, granulocytopenia,

1. Patients who are known to be allergic 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 taking 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: 1. 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 contraction 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. Anti-inflammatory drugs are contraindicated in the last three months of pregnancy. 2. It is unclear whether aceclofenac can be secreted into human milk. Therefore, aceclofenac should not be used during lactation 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 side effects and should be used with caution. During treatment, many times patients have no prodromal symptoms or obvious medical history, resulting in severe gastrointestinal bleeding and/or perforation. Elderly patients are more likely to cause renal, cardiovascular and liver damage.

1. Avoid using the following drugs together: NSAIDs inhibit the secretion of methotrexate in the renal tubules and may have slight metabolic interactions, resulting in reduced methotrexate clearance. Therefore, NSAIDs should always be avoided during high-dose methotrexate treatment. Some NSAIDs can inhibit the elimination of lithium salts in the kidneys, resulting in increased serum lithium concentrations. Unless serum lithium levels can be measured frequently, 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 are used with methotrexate within 24 hours, caution should be exercised because methotrexate blood concentrations may increase, leading to increased toxicity. The use of NSAIDs with cyclosporine or tacrolimus increases the risk of nephrotoxicity due to decreased renal prostaglandin synthesis, so renal function should be closely monitored during combined therapy. Concomitant use of aspirin and other NSAIDs increases the incidence of side effects and should be used with caution. NSAIDs can reduce the diuretic effect of furosemide (diuretics) and bumetanide (diuretics), possibly by inhibiting prostaglandin synthesis. They can also reduce the antihypertensive effect of thiazides (diuretics). Concomitant use with potassium-sparing diuretics can increase potassium levels, so serum potassium should be monitored. Concomitant use of NSAIDs and ACE (angiotensin-converting enzyme) inhibitors increases the risk of acute renal failure in patients with dehydration. Although interactions with other antihypertensive drugs, such as β-receptor antagonists, cannot be ruled out, the combined use of aceclofenac and bendroflumethiazide (diuretic antihypertensive drug) has not been found to affect its blood pressure control effect. 3. Other possible interactions have been reported on hypoglycemic and hyperglycemic effects. Aceclofenac may cause hypoglycemia, and the dose of hypoglycemic drugs should be adjusted when used. 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 P4502C9, so there may be a risk of drug interactions with phenytoin, digoxin, cimetidine, tolbutamide, phenylbutazone, amiodarone, miconazole and sulfaphenazole. 5. Like other NSAIDs, there is also a risk of drug interactions with drugs eliminated by renal excretion, such as methotrexate and lithium salts. Aceclofenac is actually completely bound to plasma proteins, and will then undergo a displacement effect with other highly protein-bound drugs, so attention must be paid.

Keep away from light and store in a sealed container.

0.1g

24 months

Henan Nuomei Pharmaceutical Co., Ltd.

• Founded in:

  2000-06-16

• Address:

  North section of Bianque Road, Tangyin County Industrial Cluster Area

• Tax NO.:

  91410900721879369R

• Registered Funds:

  15 million yuan

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