Aceclofenac Tablets

This product is a newly synthesized, orally effective, non-steroidal, phenylacetic acid anti-inflammatory, antipyretic and analgesic drug. Structurally, it is related to diclofenac, alclofenac and fenclofenac. In clinical practice, the pharmacological effects of this product are characterized by a significant and extensive anti-inflammatory effect, strong analgesic and antipyretic effect, and gastrotoxic effect in acute and chronic inflammation experimental models compared with other non-steroidal drugs (NSAIDs). 1. Anti-inflammatory effect This product shows a highly effective inhibitory effect on the development of edema and abscesses caused by injection of caraway gum in rats. It also reduces the increase in vascular permeability caused by intraperitoneal injection of acetic acid in mice and the edema and inflammatory response of cellular components of pleurisy caused by caraway gum in rats. The intensity of the anti-inflammatory effect of this product on acute inflammation is similar to that of the highly effective NSAIDs indolemethazine and diclofenac. It is stronger than naproxen and phenylbutazone. Oral prevention and treatment of this product also improves the pathological gait caused by intra-articular injection of sodium urate in dogs in a dose-dependent manner. The anti-inflammatory effect of this product has also been confirmed in the cotton ball granuloma experiment. In this experiment, it was found that steroids are more effective than NSAIDs. For chronic adjuvant arthritis in mice, this product has a significant anti-arthritis effect similar to that of indole methylsuccinate and diclofenac. Its effectiveness in chronic arthritis has been clinically confirmed. 2. Analgesic effect For many animal pain models caused by chemical, mechanical or arthritic stimulation, the efficacy of this product is similar to diclofenac or indole methylsuccinate, but stronger than naproxen and phenylbutazone. In particular, this product shows a strong anti-nociceptive effect on mouse paw arthritis caused by injection of silver nitrate and periostitis pain caused by injection of sodium urate into dog joints. In clinical practice, the analgesic effect of this product has been confirmed by patients with pain of different causes. This product has a prominent peripheral analgesic mechanism like other NSAIDs. It may be due to the inhibition of the formation of endogenous pain mediators. 3. Antipyretic effect This product can significantly reduce the increase in body temperature caused by injection of Brewer's yeast in rats. Even if the lowest oral dose is 0.25 mg/kg, its antipyretic effect is 8 times greater than its anti-inflammatory effect. The high antipyretic effect of this product suggests that in addition to inhibiting the synthesis or release of prostaglandins in the body, it may also be due to the inhibition of the hypothalamus.

The main ingredient of this product is aceclofenac.

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

It is used to treat the symptoms of pain and inflammation caused by osteoarthritis, rheumatoid arthritis and ankylosing spondylitis, and can promote the regeneration and repair of joint cartilage. It can also be used to treat chronic polyarthritis, postoperative pain, post-traumatic pain, neck and shoulder pain, waist and leg pain, headache, migraine, sprain, strain, muscle pain, toothache, dysmenorrhea, etc.

Aceclofenac tablets are taken orally with at least half a cup of water and can be taken with food. 1. Adults: The maximum recommended daily dose is 2 tablets, taken twice a day, 1 tablet each time, once in the morning and once in the evening. 2. Elderly: Generally, there is no need to reduce the dose, but it must be used with caution and close observation of possible adverse reactions. 3. Children's medication: The safety and effectiveness of children's medication have not been confirmed. 4. Patients with hepatic insufficiency: Patients with mild to moderate hepatic insufficiency should reduce the dose of aceclofenac. The recommended initial dose is 1 tablet per day. 5. 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: Gastrointestinal adverse reactions (dyspepsia, abdominal pain, nausea and diarrhea) are the main ones. 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: elevated 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: elevated urea nitrogen and creatinine. 3. Rare (1/1000) General: headache, fatigue, facial edema, allergic reactions, weight gain. Blood: anemia, granulocytopenia, thrombocytopenia, neutropenia. Cardiovascular: edema, palpitations, gastrocnemius spasm, flushing, purpura. Central and peripheral nervous system: sensory disturbances, tremors. Gastrointestinal disorders: gastrointestinal bleeding and ulcers, bloody diarrhea, hepatitis or pancreatitis, tarry stools, oral mucosal inflammation. Urinary system disorders: interstitial nephritis. Skin: eczema. Metabolism and nutrition: increased alkaline phosphatase, hyperkalemia. Psychiatric: depression, dreaminess, drowsiness, insomnia. Eyes: abnormal vision. Other: taste perversion, vasculitis. As with other NSAIDs, severe hypersensitivity reactions of the skin and mucous membranes may occur.

1. Patients with known allergies to this product. 2. Patients who have experienced 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: Not recommended for children. Precautions for pregnancy and lactation: Pregnant women are prohibited from using this product during the last three months of pregnancy. Precautions for the elderly: Generally, the elderly do not need to reduce the dosage, but should use it with caution.

1. Avoid co-administration with the following drugs: (1) 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 (2) 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 combined medications require dose adjustment or precautions: (1) 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 (2) 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 tacrolimus, the risk of renal toxicity increases due to reduced renal prostaglandin synthesis, so renal function should be closely monitored during combined treatment. (3) Concomitant use of aspirin and other nonsteroidal anti-inflammatory drugs will increase the incidence of side effects, so caution should be exercised. (4) Nonsteroidal anti-inflammatory drugs can weaken the diuretic effect of furosemide (diuretic) and bumetanide (diuretic), possibly through the inhibition of prostaglandin synthesis. They can also reduce the antihypertensive effect of thiazides (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 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. 3. 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. Like other NSAID drugs, 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 high-protein-bound drugs, which must be noted. 4. Other possible interactions: There are reports on hypoglycemic and hyperglycemic effects, respectively. Aceclofenac may cause hypoglycemia, and the dose of hypoglycemic drugs should be adjusted when used. No clinically significant differences in pharmacokinetics were observed in patients with mild and moderate renal insufficiency after a single dose.

Keep tightly closed in a cool place.

0.1 g

24 months.