Meloxicam Granules

Pharmacological action: This product is a non-steroidal anti-inflammatory drug. It has anti-disease, anti-inflammatory and antipyretic effects in animal models. Its mechanism may be related to the inhibition of prostaglandin synthesis. Toxicological studies: Carcinogenicity: Rats were given 0.8 mg/kg/day (equivalent to 0.4 times the clinically recommended dose for humans based on body surface area) orally for 104 weeks and mice were given 8 mg/kg/day (equivalent to 2.2 times the clinically recommended dose for humans based on body surface area) orally for 99 weeks. No carcinogenic effect was observed. Genetic toxicity: The results of the Ames test, human lymphocyte chromosome aberration test and mouse bone marrow micronucleus test were all negative. Reproductive toxicity: When the oral doses of this product in male and female rats reached 9 mg/kg/day and 5 mg/kg/day, respectively (equivalent to 4.9 times and 2.5 times the clinically recommended dose for adults based on body surface area), there was no significant effect on the fertility of female and male rats. However, the stillbirth rate increased when female rats were orally administered this product at a dose of ≥1 mg/kg/day (equivalent to 0.5 times the clinically recommended dose for adults based on body surface area) 2 weeks before mating and in the early stages of embryonic development. Oral administration of this product at 60 mg/kg/day (equivalent to 64.5 times the clinically recommended dose for humans based on body surface area) to rabbits throughout the period of organogenesis can lead to an increased incidence of cardiac septal defects (a rare phenomenon), and the stillbirth rate increased when the dose was ≥5 mg/kg/day (equivalent to 5.4 times the clinically recommended dose for humans based on body surface area). This product was not teratogenic when administered orally to rats at a dose of 4 mg/kg/day (equivalent to 2.2 times the clinically recommended dose for humans based on body surface area) during the period of organogenesis, but the stillbirth rate increased when the dose was ≥1 mg/kg/day. This product can cross the placental barrier. There are no adequate and strictly controlled clinical studies on pregnant patients to confirm the above reproductive toxicity, but from the results of animals, this product should not be taken during pregnancy unless its potential benefits outweigh the potential risks to the fetus. Oral administration of this product ≥ 0.125 mg/kg/day (equivalent to 0.07 times the clinically recommended dose for adults based on body surface area) to rats during late pregnancy and lactation can lead to a decrease in birth index, live birth rate and newborn survival rate. No clinical studies have been conducted to evaluate the effect of this product on arterial duct closure, and this product should be avoided in the 6th to 9th month of pregnancy. No studies have been conducted on the secretion of this product in human milk, but the concentration of this product in rat milk is higher than its plasma concentration. In view of the potential serious adverse reactions of this product to lactating infants, after considering the importance of this product to the mother, a decision should be made whether to stop breastfeeding or stop taking the drug.

The main ingredient of this product is meloxicam.

This product is light yellow granules.

Suitable for the symptomatic treatment of rheumatoid arthritis and symptomatic treatment of painful osteoarthritis (arthrosis, degenerative bone joint disease).

Oral administration, swallow with water or liquid. 1. Rheumatoid arthritis: 2 bags at a time, once a day, the dose can be reduced to 1 bag according to the response after treatment. 2. Osteoarthritis: 1 bag at a time, once a day, if necessary, the dose can be increased to 2 bags. 3. For patients with increased adverse reactions: the initial dose of treatment is 1 bag per day. 4. Patients with severe renal failure on dialysis: the dose should not exceed 1 bag per day. The maximum recommended daily dose of Meloxicam tablets is 2 bags.

According to foreign research data: The following adverse reactions occur after the administration of meloxicam tablets, however, their frequency is based on the results of clinical trial records, regardless of whether there is a causal relationship with the use of meloxicam tablets. This information is based on clinical trials conducted on 3,750 patients for more than 18 months. Patients took 7.5 or 15 mg of meloxicam tablets orally every day (the average duration of treatment was 127 days). Gastrointestinal: Frequency exceeds 1%: dyspepsia, nausea, vomiting, abdominal pain, constipation, flatulence, diarrhea. Frequency is between 0.1% and 1%: transient abnormal liver function indicators (such as elevated transaminases or bilirubin). Esophagitis, gastroduodenal ulcer, latent or visible gastrointestinal bleeding. Frequency is less than 0.1%: gastrointestinal perforation, colitis. Hematologic: Frequency greater than 1%: Anemia Between 0.1% and 1%: Blood cell count disturbances, including differential white blood cell count, leukopenia and thrombocytopenia, and concurrent use of potentially myelotoxic drugs, particularly methotrexate, is a contributing factor to the development of cytopenias. Dermatologic: Frequency greater than 1%: Itching, rash Between 0.1% and 1%: Stomatitis, urticaria Less than 0.1%: Photosensitivity Respiratory: Frequency less than 0.1%: Acute asthma has been reported in individuals following use of aspirin or other NSAIDs, including meloxicam tablets. Central nervous system: Frequency greater than 1%: Mild dizziness, headache Between 0.1% and 1%: Vertigo, tinnitus, lethargy Cardiovascular: Frequency greater than 1%: Edema Between 0.1% and 1%: Increased blood pressure, palpitations, flushing Urogenital: Between 0.1% and 1%: Abnormal indices of renal function (elevated serum creatinine and/or serum urea).

1. People who are known to be allergic to the active ingredient meloxicam or its excipients. 2. Patients who have experienced asthma, rhinitis, angioedema or urticaria after using acetylsalicylic acid or other NSAIDs (non-steroidal anti-inflammatory drugs) should not use meloxicam tablets. 3. Active peptic ulcer. 4. Severe liver dysfunction. 5. Severe renal dysfunction not on dialysis. 6. Children and adolescents under 15 years old. 7. Pregnant women or breastfeeding women.

Precautions for children: This product should not be used in children under 15 years old. Meloxicam is available in other dosage forms and may be suitable. Precautions for pregnancy and lactation: Although no teratogenic effects were found in preclinical trials, meloxicam tablets should not be used in pregnant women and breastfeeding women. Precautions for the elderly: It should be used with caution in elderly patients who may have liver, kidney and heart dysfunction.

The simultaneous use of more than one NSAID may increase the possibility of gastrointestinal ulcers and bleeding through synergistic effects. Oral anticoagulants, ampicillin, systemic heparin, thrombolytics, etc. may increase the possibility of bleeding. If the above-mentioned combined use is unavoidable, the effect of the anticoagulant must be closely monitored. It has been reported that NSAIDs can increase the plasma concentration of lithium, so it is recommended that plasma lithium levels should be monitored when starting, adjusting and stopping this drug. Similar to other NSAIDs, this drug can increase the blood toxicity of methotrexate. In this case, strict monitoring of blood cell counts is recommended. It has been reported that NSAIDs can reduce the effectiveness of intrauterine contraceptive devices. Treatment with NSAIDs has the potential to cause severe renal insufficiency in dehydrated patients. There have been reports of renal insufficiency during treatment with NSAIDs.

7.5mg

24 months

Hainan Selection Pharmaceutical Co., Ltd.

• Founded in:

  2001-03-12

• Address:

  No. 6 Shunda Road, Meilan District, Haikou City

• Tax NO.:

  91460000721284605J

• Registered Funds:

  30 million yuan

• Email:

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