Risedronate Sodium Tablets

Risedronate sodium can bind to hydroxyapatite in bone and inhibit bone resorption. At the cellular level, this product inhibits osteoclasts. Osteoclasts are usually present on the surface of bones, but do not have obvious resorption activity. Tissue morphology of rats, dogs, and piglets was determined to reduce bone turnover (activation frequency, that is, the rate at which bone tissue remodeling sites are activated) and the resorption of bone remodeling sites. 1. Genotoxicity: This product did not show genotoxicity in the in vitro reverse mutation test (Ames test) of Salmonella typhi and Escherichia coli, the gene mutation test of mammalian cells (CHO/HPRT), the unscheduled DNA synthesis test of rat liver cells, and the micronucleus test of rat bone marrow cells. In the CHO cell chromosome fission test, positive results appeared when the concentration reached the cytotoxic level (1675mcg/ml, survival rate 6%~7%), but no chromosome damage was found at the dose level with a cell survival rate of 29%. 2. Reproductive toxicity: Female rats were orally administered 16 mg/kg/day (equivalent to 5.2 times the human dose of 30 mg/day, calculated by body surface area, the same below), and ovulation was inhibited; at a dose of 7 mg/kg/day (equivalent to 2.3 times the human dose), implantation was reduced; male rats were orally administered 40 mg/kg/day, and testicular and epididymal shrinkage and inflammatory cell infiltration were observed; rats were orally administered 16 mg/kg/day for 13 consecutive weeks, and testicular shrinkage was also observed; dogs were orally administered 8 mg/kg/day for 13 consecutive weeks (equivalent to 8 times the human dose), and moderate to severe spermatogenesis disorders were observed. These changes become more serious with the increase of the dosage and the extension of the administration time. When the drug was orally administered to pregnant rats at a dose of ≥16 mg/kg/day (equivalent to 5.2 times the human dose), the survival rate of the fetuses decreased; at a dose of 80 mg/kg/day, the weight of the fetuses decreased; at a dose of 7.1 mg/kg/day, the number of sternal or skull ossifications increased significantly; at a dose of ≥16 mg/kg/day, the number of sternal unossified or incomplete ossifications increased significantly; at a dose of ≥3.2 mg/kg/day, the incidence of embryonic cleft palate decreased, but the clinical relevance of this finding is unclear. When the drug was orally administered to pregnant rabbits at a dose of 10 mg/kg/day (equivalent to 6.7 times the human dose), no effect on embryonic ossification was found, but one of the 14 litters had a miscarriage and another one had premature delivery. Similar to other bisphosphonates, when administered to rats during mating and pregnancy, doses as low as 3.2 mg/kg/day (equivalent to 1 times the human dose) can cause hypocalcemia and death during delivery in parent animals. In addition, this product can be secreted in rat milk. 3. Carcinogenicity: In a 104-week carcinogenicity study, rats were orally administered this product up to 24 mg/kg/day, and no obvious drug-induced tumors were found. In the experiment, the high-dose group of male rats (24 mg/kg/day) was stopped at the 93rd week due to a large toxic reaction. In an 80-week carcinogenicity study in rats, no obvious drug-induced tumors were found when this product was administered at a dose of 32 mg/kg/day.

The main ingredient of this product is risedronate sodium. Molecular weight: C7H10NO7P2Na2.5H2O

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

For the treatment and prevention of osteoporosis in postmenopausal women.

For oral administration, it should be taken in an upright position at least 30 minutes before meals, with a glass (about 200ml) of water. It is not advisable to stay in bed within 30 minutes after taking the medicine. The dosage is once a day, 5mg (one tablet) each time.

1. Digestive system can cause upper gastrointestinal disorders, manifested as dysphagia, esophagitis, esophageal or gastric ulcers, and can also cause diarrhea, abdominal pain, nausea, constipation, etc. 2. Others such as flu-like syndrome, headache, dizziness, rash, joint pain, etc.

1. People who are known to be allergic to this product. 2. People with hypocalcemia. 3. People who have difficulty standing or sitting for 30 minutes.

Precautions for children: The safety and effectiveness of the drug for children has not been established. Precautions for pregnancy and lactation: The safety and effectiveness of the drug for pregnant women has not been established. This product should be used during pregnancy only when the disease itself is more harmful to the mother and child and there is no other safer drug alternative. This product has serious adverse reactions to breastfeeding infants. Lactating women should stop taking the drug or stop breastfeeding. Precautions for the elderly: Clinical trial data show that there is no difference in safety and effectiveness between the elderly and young people when taking this product, but it does not rule out that the elderly are highly sensitive to this product.

There are no reports of specific drug interactions for this product. This product is not metabolized, nor does it induce or inhibit hepatic cytochrome P450. Calcium/Antacids Taking this product with calcium, antacids, and oral preparations containing divalent cations will affect the absorption of this product. If hormone replacement therapy is used properly, this product can be used in combination with hormones. Aspirin/non-steroidal anti-inflammatory drugs In the Phase III clinical trial of this product involving 5,700 patients, 31% of the patients took aspirin, of which 24% took it regularly, and 48% of the patients took non-steroidal anti-inflammatory drugs, of which 21% took it regularly. The results showed that the incidence of upper gastrointestinal adverse reactions in patients taking aspirin/non-steroidal anti-inflammatory drugs was similar in the this product group (24.5%) and the placebo group (24.8%). H2

Seal tightly and store in a cool, dry place.

35mg

36 months

Kunming Jida Pharmaceutical Co., Ltd.

• Founded in:

  1993-08-14

• Address:

  No. 389, Kexin Road, High-tech Development Zone, Kunming, Yunnan Province

• Tax NO.:

  91530000622600182R

• Registered Funds:

  370 million yuan

• Website:

  Log in to view

• Email:

  Log in to view