Meloxicam dispersible tablets
Function and Efficacy
Pharmacological action: This product is a non-steroidal anti-inflammatory drug. It has analgesic, 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) by oral administration 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) by oral administration for 99 weeks. No carcinogenic effect was observed in this product. 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 adult dose 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 the use of this product should be avoided in the 6th to 9th month of pregnancy. When the oral dose of this product is ≥1mg/kg/day (equivalent to 0.5 times the clinically recommended dose for adults based on body surface area), the stillbirth rate increases, delivery is delayed, and the delivery time is prolonged; when the oral dose of 4mg/kg/day (equivalent to 2.1 times the clinically recommended dose for adults based on body surface area) is administered to rats during the organogenesis period, and when the oral dose is ≥0.125mg/kg/day (as mentioned above) during the late pregnancy and lactation period, the survival rate of the offspring is reduced. 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 lactation or medication.
Ingredients
Ciprofloxacin lactate
| Name | Description | Content | CAS NO. | Manufacturer |
|---|---|---|---|---|
| Ciprofloxacin lactateIngredients |
This product is a non-steroidal anti-inflammatory drug. It has analgesic, anti-inflammatory and antipyretic effects in animal models, and its mechanism may be related to the inhibition of prostaglandin synthesis. More |
97867-33-9 | 13 |
Appearance
This product is light yellow tablet.
Indication
Suitable for: rheumatoid arthritis, painful osteoarthritis, rheumatic arthritis, headache, migraine, shoulder and neck pain, back and leg pain, muscle pain, sprain, strain, dysmenorrhea, toothache, and ENT pain.
Usage and Dosage
Vaginal administration, once a day, after cleaning the vulva before going to bed every night, put 0.1g (1 tablet) of this product into the posterior fornix of the vagina, use for 7 consecutive days or as directed by the doctor.
Adverse Reactions
According to foreign research data: The following adverse reactions occur after the administration of meloxicam dispersible tablets, but their frequency is based on the results of clinical trial records, regardless of whether there is a causal relationship with the use of meloxicam dispersible 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 or capsules orally every day. (The average duration of treatment is 127 days) Gastrointestinal: Frequency exceeds 1%: indigestion, 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, gastric and duodenal ulcers, latent or visible gastrointestinal bleeding.
Precautions
It is contraindicated for patients who are allergic to this product or other NSAIDs, have active peptic ulcers, severe liver dysfunction, severe renal dysfunction without dialysis, hemorrhagic diseases, those under 15 years old, pregnant or lactating women, and those with proctitis.
Special Population Medication
Precautions for children: The dosage for children has not been determined. Children and adolescents under 15 years of age are prohibited from using this drug. Precautions for pregnancy and lactation: Although no teratogenic effects were found in preclinical trials, meloxicam dispersible tablets should not be used in pregnant women and breastfeeding women. Precautions for the elderly: Use with caution in elderly patients who may have liver, kidney, and heart dysfunction.
Drug Interactions
This product should not be used in combination with the following drugs: anticoagulants, lithium, methotrexate, diuretics, cyclosporine, thrombolytic drugs and other NAIDs.
Storage
Keep in a dark and airtight container, out of the reach of children.
Packaging Specification
7.5mg
Validity Period
24 months
Manufacturer
Hainan Quanxing Pharmaceutical Co., Ltd.
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Founded in:
2001-10-29 -
Address:
A06-2, Bonded Area, Haikou City, Hainan Province -
Tax NO.:
91460000730066028H -
Registered Funds:
54.29 million yuan -
Website:
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Email: