Catania Plus/Catania Max

Supplement to diet & exercise to help adults & childn ≥10 yr w/ type 2 DM to achieve better glycemic control. Reduce chance of heart failure hospitalization in patients w/ type 2 DM who also have several CV risk factors or existing CV disease; risk for CV mortality & heart failure hospitalization in patients w/ heart failure (NYHA class II-IV) who have a lower ejection fraction; risk of end-stage kidney disease, CV death, hospitalization for heart failure & prolonged reduction in estimated GFR in patients w/ CKD at risk of progression.

Patient w/ heart failure & chronic renal disease 10 mg once daily. Max recommended daily dose: Dapagliflozin 10 mg & metformin 2,000 mg may be exceeded, however dosage may be changed based on effectiveness & tolerability. Patient ≥10 yr who is not currently taking dapagliflozin Initially 5 mg once daily.

Should be taken with food: Taken in the morning. Do not chew/cut/crush. Swallow whole.

Hypersensitivity & history of severe allergic reaction. Diabetic ketoacidosis & other forms of acute or chronic metabolic acidosis, w/ or w/o coma. ESRD, dialysis patients, or severe renal impairment (eGFR <30 mL/min/1.73 m²).

Not advised for patients w/ type 1 DM; polycystic kidney disease or those who need or have recently received immunosuppressive therapy for renal disease; eGFR <45 mL/min/1.73 m²; patients w/ liver impairment. Stop therapy for patients w/ history of liver disease, alcoholism, heart failure, as well as those who will receive intra-arterial iodinated contrast at the time of or before an iodinated contrast imaging procedure. Avoid for at least 3 days before undergoing major surgery or extended fasting procedures. Consider ketone monitoring in patients at risk for ketoacidosis; discontinue therapy if ketoacidosis is suspected. Assess & correct vol status in elderly, patients w/ renal impairment or low systolic BP & in patients on diuretics. Evaluate for signs & symptoms of UTI & treat promptly. Consider a lower dosage of insulin or insulin secretagogue when used concomitantly. Institute prompt treatment if necrotizing fasciitis of the perineum (Fournier's gangrene) is suspected. Monitor & treat genital mycotic infections. May lead to +ve urine glucose tests & interference w/ 1,5-anhydroglucitol (1,5-AG) assay. Childn <10 yr. Evaluate renal function for elderly. Not advised during 2nd & 3rd trimesters of pregnancy & during lactation. Possibility of unwanted pregnancy in premenopausal women. Metformin: Metformin-associated lactic acidosis in patients w/ hepatic impairment. May lower vit B₁₂ levels; measure hematological parameters annually.

Lactic acidosis, diabetic ketoacidosis in patients w/ type 1 DM & other ketoacidosis, vol depletion, urosepsis, pyelonephritis, hypoglycemia w/ concomitant use w/ insulin & insulin secretagogues, necrotizing fasciitis of the perineum (Fournier's gangrene), may lower vit B₁₂ conc, genital mycotic infections.

Increased risk for lactic acidosis w/ topiramate or other carbonic anhydrase inhibitors (eg, zonisamide, acetazolamide or dichlorphenamide). Increased risk of hypoglycemia w/ insulin or insulin secretagogues (eg, sulfonylurea). May tend to produce hyperglycemia & may lead to loss of glycemic control w/ certain drugs eg, thiazides, other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, OCs, phenytoin, nicotinic acid, sympathomimetics, Ca channel blocking drugs & INH. Decreased serum lithium conc. Metformin: May increase systemic exposure & risk for lactic acidosis in concomitant use w/ drugs that interfere w/ common renal tubular transport systems involved in the renal elimination of metformin (eg, organic cationic transporter-2 [OCT2]/multidrug & toxin extrusion [MATE] inhibitors eg, ranolazine, vandetanib, dolutegravir & cimetidine). Potentiated effect on lactate metabolism w/ alcohol.

Antidiabetic Agents

A10BD15 - metformin and dapagliflozin ; Belongs to the class of combinations of oral blood glucose lowering drugs. Used in the treatment of diabetes.

Rx