Aceclofenac Capsules

This product is a non-steroidal anti-inflammatory drug with anti-inflammatory and analgesic effects. Its mechanism of action is mainly to reduce the synthesis of prostaglandins by highly selectively inhibiting the activity of cyclooxygenase (mainly COX-2). Unlike other NSAs, aceclofenac can stimulate the synthesis of matrix in chondrocytes during the in vitro culture of cartilage tissue of patients with rheumatoid arthritis (RA) and osteoarthritis (OA). It has a positive effect on the repair of joint function damage in patients with rheumatoid arthritis and osteoarthritis. The toxic and side effects of aceclofenac are equivalent to 1/2 and 1/4 of diclofenac and indomethacin, respectively. The irritation to the intestine after oral administration is only 1/4 of naproxen and phenylbutazone, and the median lethal dose is about 2 times that of naproxen and phenylbutazone. Aceclofenac has a lower gastric ulcerogenic effect. Its ulcerogenic effect is 4 or 7 times weaker than that of indomethacin and diclofenac. The acute toxicity is about 2 and 6 times lower than that of diclofenac and indomethacin, respectively.

Ingredients: Aceclofenac. Chemical name: 2-(2,6-dichlorophenyl)-aminophenylacetoxyacetic acid.

This product is a capsule, and the contents are white or off-white granular powder.

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

Adults take 1 tablet (100 mg) twice a day or as directed by a doctor. The maximum recommended daily dose is 4 tablets; patients with mild to moderate liver dysfunction should reduce the dosage, and the recommended initial dose is 1 tablet (100 mg) per day. Patients with mild to moderate renal impairment do not need to adjust the dosage but should use with caution.

The main adverse reactions were gastrointestinal (dyspepsia, abdominal pain, nausea and diarrhea, with dyspepsia and abdominal pain being the most common.

Patients with known allergies to aceclofenac and other nonsteroidal drugs are contraindicated. Patients taking drugs with similar mechanisms of action (such as aspirin or other nonsteroidal anti-inflammatory drugs) that cause asthma, bronchospasm, acute rhinitis or urticaria or known allergies to anti-inflammatory drugs are contraindicated. Patients with severe heart failure, liver and kidney dysfunction are contraindicated. Patients with or suspected of having gastric or duodenal ulcers or a history of recurrent gastric or duodenal ulcers, gastrointestinal bleeding or other bleeding or coagulation disorders are contraindicated. Pregnant women during the last three months of pregnancy are contraindicated.

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 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 occur. Elderly patients are more likely to suffer from renal, cardiovascular and liver damage.

1. Avoid co-administration with the following drugs: NSAIDS inhibits 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. Some NSAIDS can inhibit the elimination of lithium salts in the kidneys, resulting in increased serum lithium concentrations. Unless serum potassium levels can be measured frequently, co-administration with potassium 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 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 prostate 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 side effects. 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, and 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. Concomitant use of nonsteroidal anti-inflammatory drugs 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 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. 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 used. No clinically significant differences in pharmacokinetics were observed in patients with mild and moderate renal insufficiency after a single dose; 3 Aceclofenac is mainly metabolized by cytochrome P4502G9, so there may be a risk of drug interactions with phenytoin, digoxin, cimetidine, tolbutamide, phenylbutazone, amiodarone, imidazole and sulfaphenazole. Like other NSAIDs, there is a risk of drug interactions with drugs eliminated by renal excretion, such as methotrexate and lithium salts, but aceclofenac is actually completely bound to plasma proteins, and subsequent displacement with other highly protein-bound drugs must be noted.

Keep away from light and store in a sealed container.

0.1g

Tentative 24 months