Meloxicam Tablets

Pharmacodynamic properties Meloxicam is a non-steroidal anti-inflammatory drug in the oxicams family, with anti-inflammatory, analgesic and antipyretic properties. Meloxicam has anti-inflammatory activity in all standard inflammatory models. Like other non-steroidal anti-inflammatory drugs, its exact mechanism of action is still unclear. However, all non-steroidal anti-inflammatory drugs have at least one common mechanism of action (including meloxicam): inhibition of the biosynthesis of known inflammatory mediators prostaglandins. Preclinical safety (toxicology) data Preclinical studies have shown that the toxicological properties of meloxicam are the same as those of other non-steroidal anti-inflammatory drugs: gastrointestinal ulcers and erosions, and renal papillary necrosis in two animal species at high doses in long-term toxicity studies. The dose with adverse effects appears when the dose is 5 to 10 times higher than the clinical dose (7.5-15 mg) when administered in mg/kg (human body weight 75 kg). It has been reported that, like all prostaglandin synthesis inhibitors, embryotoxicity occurs in the third trimester of pregnancy. Neither in vivo nor in vitro tests showed any mutagenicity. No carcinogenicity was found in rats and mice at doses higher than clinical doses.

The main ingredient of this product is meloxicam.

This product is light yellow tablet.

1. Short-term symptomatic treatment of osteoarthritis symptoms. 2. Long-term symptomatic treatment of rheumatoid arthritis and ankylosing spondylitis.

Oral. When osteoarthritis symptoms worsen: 1 tablet once a day. If symptoms do not improve, the dose can be increased to 2 tablets once a day if necessary; each tablet is 7.5 mg. Rheumatoid arthritis, ankylosing spondylitis: 2 tablets once a day. Depending on the response after treatment, the dose can be reduced to 1 tablet once a day; each tablet is 7.5 mg (see "Special Populations"). The daily dose should not exceed 15 mg/day. The total daily dose should be taken at one time, with water or other fluids and food. Special Populations 1. Elderly patients and patients with increased risk of adverse reactions: For elderly patients, the recommended dose for long-term treatment of rheumatoid arthritis and ankylosing spondylitis is 7.5 mg/day. The starting dose for patients with increased risk of adverse reactions is 7.5 mg/day. 2. Patients with renal insufficiency: Patients with severe renal failure requiring dialysis - the dose should not exceed 7.5 mg/day. Patients with mild and moderate renal insufficiency do not need to adjust the dose (such as patients with creatinine clearance greater than 25 ml/minute). For patients with severe renal failure who do not require dialysis, see [Contraindications]. 3. Patients with impaired liver function: No dosage adjustment is required for patients with mild and moderate impaired liver function. For patients with severe impaired liver function, see [Contraindications]. 4. Children: This product should not be used in children under 15 years of age. Meloxicam is available in other dosage forms and may be applicable.

a) General Some of the adverse reactions reported below may be associated with the use of meloxicam. The frequencies listed below are obtained in clinical trials and no causal relationship has been investigated. This information is based on clinical trials conducted over 18 months on 3750 patients who took 7.5 or 15 mg of meloxicam tablets or capsules orally daily (the average duration of treatment was 127 days). Included are reports of adverse reactions that may be related to the use of meloxicam received after the product was marketed. The following convention is used to express the probability of adverse reactions: very common (1/10); common (1/100, 1/10); uncommon (1/1000, 1/100); rare (1/10000, 1/100); very rare (

This product is contraindicated in the following cases: pregnant or lactating women (see [Pregnant and lactating women use]); patients with known allergies to the active ingredient meloxicam or its excipients or allergies to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs. This product should not be used in patients who have symptoms such as asthma, nasal polyps, angioedema or urticaria after using acetylsalicylic acid or other non-steroidal anti-inflammatory drugs; patients with active peptic ulcer or patients with a history of recurrent peptic ulcer; patients with severe liver dysfunction; patients with non-dialysis severe renal insufficiency; patients with gastrointestinal bleeding, cerebral hemorrhage or other bleeding disorders; patients with severe uncontrolled heart failure.

Precautions for children: This product should not be used in children under 15 years old. Meloxicam has other dosage forms that may be suitable. Precautions for pregnancy and lactation: Pregnant women - The lethal dose for the embryo in animal experiments is higher than the clinical dose; - It is recommended not to take meloxicam in the first six months of pregnancy; - In the last three months of pregnancy, all prostaglandin synthesis inhibitors will cause cardiopulmonary (pulmonary hypertension with premature closure of the ductus arteriosus) and renal toxicity to the fetus or inhibit uterine contraction. This effect on the uterus is associated with an increased chance of dystocia and delayed delivery in animals. Therefore, nonsteroidal anti-inflammatory drugs are absolutely prohibited in the last three months of pregnancy. Nonsteroidal anti-inflammatory drugs enter the mother's milk during lactation. Therefore, lactating women should avoid using nonsteroidal anti-inflammatory drugs. Precautions for the elderly: Compared with young people, the average plasma clearance rate in the steady state of the elderly is slightly reduced. For elderly patients, the recommended dose for long-term treatment of rheumatoid arthritis and ankylosing spondylitis is 7.5 mg/day. Elderly patients are usually less tolerant to side effects and should be carefully monitored.

Pharmacodynamic interactions: Other nonsteroidal anti-inflammatory drugs including salicylates (acetylsalicylic acid ge; 3g/day): The simultaneous use of several nonsteroidal anti-inflammatory drugs may increase the possibility of gastrointestinal ulcers and bleeding through synergistic effects. The combination of meloxicam and other nonsteroidal anti-inflammatory drugs is not recommended. Diuretics: Treatment with nonsteroidal anti-inflammatory drugs has the potential to cause acute renal failure in dehydrated patients. Patients using this product and diuretics should be supplemented with adequate water, and renal function should be monitored before starting treatment. Oral anticoagulants: Because of the inhibition of platelet function and damage to the gastroduodenal mucosa, the risk of bleeding is increased. The combination of nonsteroidal anti-inflammatory drugs and oral anticoagulants is not recommended. If combined use cannot be avoided, the INR should be carefully monitored. Thrombolytics and antiplatelet drugs: Because of the inhibition of platelet function and damage to the gastroduodenal mucosa, the risk of bleeding is increased. ACE inhibitors and angiotensin II receptor antagonists: NSAIDs and angiotensin II receptor antagonists have a synergistic inhibitory effect on glomerular filtration, and symptoms may be aggravated when renal function is affected. In elderly patients and/or dehydrated patients, the combination of the two may cause acute renal failure due to direct effects on glomerular filtration. Renal function should be monitored at the beginning of treatment and patients should be rehydrated regularly. In addition, co-administration may reduce the antihypertensive effect of ACE inhibitors and angiotensin II receptor antagonists, resulting in partial loss of efficacy (due to inhibition of the vasodilatory effect of prostaglandins). Other antihypertensive drugs (such as beta-blockers); beta-blockers may have a reduced antihypertensive effect (due to inhibition of the vasodilatory effect of prostaglandins). Cyclosporine: NSAIDs may increase the nephrotoxicity of cyclosporine through their effects mediated by renal prostaglandins. Renal function should be measured during co-administration. Careful monitoring of renal function is particularly necessary in elderly patients. Intrauterine contraceptive devices: NSAIDs have been reported to reduce the efficacy of intrauterine contraceptive devices. There has been one case report of NSAIDs reducing the efficacy of intrauterine contraceptive devices, but further confirmation is needed. Pharmacokinetic interactions (effects of meloxicam on the pharmacokinetics of other drugs) Lithium: NSAIDs have been reported to increase plasma concentrations of lithium (by inhibiting renal excretion of lithium), potentially to toxic concentrations. Therefore, it is recommended that NSAIDs not be used with lithium. If coadministration is necessary, it is recommended that plasma lithium levels be monitored during initiation, adjustment, and discontinuation of meloxicam. Methotrexate: NSAIDs decrease renal tubular secretion of methotrexate and thus increase plasma concentrations of methotrexate. Therefore, it is recommended that patients receiving higher doses of methotrexate (greater than 15 mg/week) not use NSAIDs together. The potential for interaction between NSAIDs and methotrexate should also be considered in patients receiving lower doses of methotrexate, especially in patients with renal impairment. If coadministration is necessary, blood cell counts and renal function should be monitored. Special attention should be paid to the co-administration of NSAIDs and methotrexate within 3 days, as plasma methotrexate concentrations may increase and cause increased toxicity. Although the pharmacokinetics of methotrexate (15 mg/week) are not proportionally affected by the co-administration of meloxicam, it should be considered that the hematotoxicity of methotrexate may be amplified by the co-administration of NSAIDs (see above). Pharmacokinetic interactions (effects of other drugs on the pharmacokinetics of meloxicam) Cholestyramine: By affecting the enterohepatic circulation, cholestyramine accelerates the elimination of meloxicam, accelerating the clearance of meloxicam by 50% and reducing the half-life to 13 plus min; 3 hours. This interaction is clinically significant. No clinically relevant pharmacokinetic drug interactions have been observed with the concomitant use of antacids, cimetidine and digoxin.

Keep in a dark place and sealed in an environment below 30℃! Please keep out of reach of children!

7.5 mg

60 months.