All the Active Ingredient Drugs
SGLT2 Inhibitor. Dapagliflozin (propanediol monohydrate) 5 mg, 10 mg. F.C. TAB.: 7, 14, 28, 30, 90, 98.
Monother., add-on comb. ther.: 10
mg×1/d for monother., add-on comb.
ther. with other glucose-low. med. prod.
include. insulin. Pts. with severe hep.
imair. init. recom. dose is 5 mg. If well
tolerated, the dose may be incr. to 10
mg.
Indic. In adults aged 18 yrs., older with
type 2 diabetes mell. to improve
glycaemic control as: Monother.: when
diet and exercise alone do not provide
adequate glycaemic control in pts. for
whom use of metformin is considered
inappropriate due to intolerance. Add-on
comb. ther.: In comb. with other glucoselow.
med. products includ. insulin, when these,
together with diet and exercise, do not
provide adequate glycaemic control.
C/I: Hypersens.
Biguanide, SGLT2 Inhibitor. Dapagliflozin 5 mg, 10 mg, Metformin Hydrochloride 500 mg, 1000 mg. E.R. TABS.: 56× 5/1000mg, 28×10/1000mg. Dosing may be adjust. based on effective. and tolerab. while not exceed. the max. recomm. dly. dose of 10 mg dapagliflozin and 2000 mg metformin HCl. Pts. taking an eve. dose of metformin XR should skip their last dose before the init. of the therap.
The drug should be taken once dly. in the morn. with food with gradual dose escalat. to reduce the GI side effects due to metformin.
Tabs. must be swallow. whole and never crushed, cut, or chewed.
In pts. with volume depletion, correct. this condit. prior to initiat. of this drug.
Indicated as an adjunct to diet and exercise to improve glycem. control in adults with type 2 diabetes mell. when tmt. with both dapagliflozin and metformin is appropriate.
C/I: Moder.-sev. renal impair. (e.g., serum creatinine levels ≥1.5 mg/dL for men, ≥1.4 mg/dL for women, or eGFR<60 mL/min/1.73m² or CrCl<60 mL/min), which may also result from conditions such as cardiovasc. collapse (shock), acute MI, and septicemia.
History of a serious hypersens. reaction to dapagliflozin or hypersens. to metformin HCl.
Acute/chron. metabolic acidosis, include. diabetic ketoacidosis, with/without coma. Diabetic ketoacidosis should be treated with insulin.
