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Forxiga

Forxiga

Manufacturer:

AstraZeneca

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Dapagliflozin propanediol
Indications/Uses
Adults w/ type 2 DM to improve glycemic control as an adjunct to diet & exercise as monotherapy or in combination therapy. Adults w/ heart failure (NYHA class II-IV) to reduce risk of CV death & hospitalization. Adjunct to standard therapy to reduce risk of sustained eGFR decline, ESRD & CV death in adults w/ CKD at risk of progression.
Dosage/Direction for Use
Recommended dose: 10 mg once daily at any time of the day.
Administration
May be taken with or without food.
Contraindications
Special Precautions
Not indicated for patients w/ type 1 diabetes. Not to be used for diabetic ketoacidosis. Patients for whom a dapagliflozin-induced BP drop (eg, those w/ known CV disease, on antihypertensive therapy w/ history of hypotension or elderly) pose a risk. Carefully monitor vol status & electrolytes; consider temporary interruption for patients who develop vol depletion. Patients w/ predisposing factors to ketoacidosis [eg, low β-cell function reserve resulting from pancreatic disorders (eg, type 1 diabetes, history of pancreatitis or pancreatic surgery), insulin dose reduction, reduced caloric intake or increased insulin requirements due to infections, illness, surgery & alcohol abuse]. Assess for signs & symptoms consistent w/ ketoacidosis including nausea, vomiting, abdominal pain, malaise & shortness of breath even if blood glucose levels are <14 mmol/L. Consider discontinuation or temporary interruption if ketoacidosis is suspected & promptly evaluate patient. Interrupt treatment in patients who are hospitalized for major surgical procedures or acute serious medical illnesses. Discontinue use if Fournier's gangrene is suspected & institute prompt treatment. Hypoglycemia w/ insulin & insulin secretagogues (eg, sulfonylureas). Not recommended to initiate in patients w/ GFR <25 mL/min; may continue 10 mg once daily to reduce risk of eGFR decline, ESRD & CV death. Reduced glucose-lowering efficacy in patients w/ eGFR <45 mL/min/1.73 m2. Not to be used in patients w/ severe hepatic impairment. Not to be used in 2nd & 3rd trimester of pregnancy; discontinue use if pregnancy is detected. Not to be used by a nursing woman. Childn & adolescent. Elderly.
Adverse Reactions
Genital infection, UTI; back pain; pollakiuria & polyuria.
Drug Interactions
May reduce serum lithium conc. May increase diuretic effects of thiazide & loop diuretics. May interfere w/ 1,5-anhydroglucitol assay.
MIMS Class
Antidiabetic Agents / Other Cardiovascular Drugs / Other Therapeutic Products
ATC Classification
A10BK01 - dapagliflozin ; Belongs to the class of sodium-glucose co-transporter 2 (SGLT2) inhibitors. Used in the treatment of diabetes.
Presentation/Packing
Form
Forxiga FC tab 10 mg
Packing/Price
28's;7's
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