Dapagliflozin Tablets

Dapagliflozin.

This product is a yellow, biconvex, diamond-shaped film-coated tablet engraved with "10" on one side and "1428" on the other side.

(1) The recommended starting dose is 5 mg once daily, taken in the morning, without restriction of food. (2) The dose can be increased to 10 mg once daily in patients who tolerate FARXIGA and require additional glycemic control. (3) Assess renal function before starting FARXIGA. Do not start FARXIGA if eGFR is less than 60 mL/min/1.73 m2. (4) Discontinue FARXIGA if eGFR continues to decrease below 60 mL/min/1.73 m2.

The most common adverse reactions associated with FARXIGA (5% or greater incidence) are female genital mycotic infections, nasopharyngitis, and urinary tract infections. To report suspected adverse reactions, contact Bristol-Myers Squibb at 1-800-721-5072 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

(1) History of severe hypersensitivity reaction to FARXIGA; (2) Severe renal impairment, end-stage renal disease, or dialysis.

Precautions for children: Not yet clear. Precautions for pregnancy and lactation: There are no appropriate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit outweighs the potential risk to the fetus. Precautions for the elderly: The incidence of adverse reactions related to reduced intravascular volume is high.

This product is mainly metabolized by UGT1A9 in the liver and is a substrate of P-glycoprotein. Studies have confirmed that the pharmacokinetic characteristics of dapagliflozin are not changed by metformin, pioglitazone, sitagliptin, glimepiride, voglibose, simvastatin, valsartan, warfarin, digoxin, etc., and dapagliflozin has no clinically significant effect on the blood concentrations of the above drugs. Rifampicin can reduce the in vivo exposure of dapagliflozin by 22%, and mefenamic acid can increase the in vivo exposure by 51%, but it has no clinically significant effect on 24h urinary sugar excretion.

Sealed, stored below 30℃

10mg*30s

24 months