Risedronate Sodium Tablets

Pharmacological action: Risedronate sodium can bind to hydroxyapatite in bones and has the effect of inhibiting 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. Histomorphometric measurements of rats, dogs, and piglets revealed that this product can reduce bone turnover (activation frequency, that is, the rate at which bone tissue remodeling sites are activated) and resorption at bone remodeling sites. Animal experiments suggest that this product can inhibit osteoclasts and bone resorption in osteoporosis model rats and miniature pigs. Rats and piglets were orally administered this product (the doses were 4 and 25 times the human dose of 5 mg/m2, respectively, calculated by body surface area, and the calculation method is the same below). Bone mass and bone biomechanical strength increased in a dose-dependent manner, and the increase in bone density was

Risedronate

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

This product is used to treat and prevent 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. The 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. Other symptoms such as flu-like syndrome, headache, dizziness, rash, joint pain, etc.

The following patients are contraindicated: 1. Those who are known to be allergic to this product; 2. Patients with hypocalcemia; 3. Those 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 higher in the this product group (24.5%).

Keep sealed. The validity period is tentatively 24 months.

5mg (calculated as C7H10NO7P2Na)

24 months

Changzhou Watson Pharmaceuticals Co., Ltd.

• Founded in:

  1996-03-25

• Address:

  No. 98, Hehai Road, Xinbei District, Changzhou

• Tax NO.:

  91320411608126453T

• Registered Funds:

  $18 million

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