Saxagliptin Metformin Sustained-Release Tablets (III)
Function and Efficacy
See the instruction manual for details
Ingredients
This product is a compound preparation, its components are saxagliptin and metformin hydrochloride.
| Name | Description | Content | CAS NO. | Manufacturer |
|---|---|---|---|---|
| SaxagliptinIngredients |
See the instruction manual for details More |
361442-04-8 | 17 | |
| 1,1-DIMETHYLBIGUANIDE HYDROCHLORIDEIngredients |
See the instruction manual for details More |
15537-72-1 | 55 |
Appearance
This product is a slightly yellow to light yellow film-coated tablet, which appears white or off-white after removing the coating.
Indication
This product is suitable for adults with type 2 diabetes treated with saxagliptin and metformin to improve glycemic control in these patients, in combination with diet and exercise (see Clinical Trials). Limitations of Use This product is not for use in patients with type 1 diabetes or diabetic ketoacidosis. This product has not been studied in patients with a history of pancreatitis. It has not been determined whether patients with a history of pancreatitis are at increased risk of pancreatitis when using this product (see Precautions, Pancreatitis).
Usage and Dosage
Follow doctor's advice
Adverse Reactions
Since the conditions of various clinical trials vary greatly, the incidence of adverse reactions in a drug's clinical trial cannot be directly compared with the incidence of adverse reactions in another drug's clinical trial, and the incidence cannot reflect the incidence of adverse reactions in actual use of the drug. (See the instructions for details)
Precautions
Renal insufficiency (such as serum creatinine level ≥1.5mg/dL (male), ≥1.4mg/dL (female); or abnormal creatinine clearance), may also be caused by cardiovascular failure (shock), acute myocardial infarction, and sepsis. Hypersensitivity to metformin hydrochloride. (See instructions for details)
Special Population Medication
Precautions for children: The safety and efficacy of this product have not been studied in pediatric patients (0-18 years old). Precautions for pregnancy and lactation: There are no adequate controlled studies on the use of this product or its ingredients in pregnant women. Precautions for the elderly: Elderly patients are more susceptible to renal impairment. Because metformin is contraindicated in patients with renal impairment, the renal function of the elderly should be closely monitored, and this product should be used with caution as age increases (see Precautions, Lactic Acidosis, Renal Function Assessment and Pharmacokinetics).
Drug Interactions
Ketoconazole significantly increases the exposure of saxagliptin. The use of other strong CYP3A4/5 inhibitors (such as atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir and telithromycin) also increases the plasma concentration of saxagliptin as expected. (See instructions for details)
Storage
normal temperature
Packaging Specification
2.5mg/1000mg*14 tablets/box