Forxiga

Forxiga

Manufacturer:

AstraZeneca

Distributor:

DKSH
Concise Prescribing Info
Contents
Dapagliflozin
Indications/Uses
Adults w/ type 2 DM as adjunct to diet & exercise as monotherapy or in combination w/ other medicinal products indicated for type 2 DM; for prevention of new or worsening heart failure, CV death or nephropathy. Reduces risk of CV death & hospitalization in adults w/ heart failure (NYHA class II-IV) w/ reduced ejection fraction. CKD in adults.
Dosage/Direction for Use
Type 2 DM Monotherapy & add-on combination therapy: 10 mg once daily. Initial combination therapy: Dapagliflozin 10 mg + metformin 500 mg once daily. Heart failure, CKD 10 mg once daily.
Administration
May be taken with or without food.
Contraindications
Special Precautions
Discontinue or interrupt treatment temporarily if ketoacidosis is suspected. Interrupt treatment temporarily in patients who develop vol depletion. Not for type 1 diabetes; diabetic ketoacidosis. Not recommended in diabetic patients w/ persistent eGFR <45 mL/min/1.73 m2. Decreased BP; ketoacidosis, including diabetic ketoacidosis in patients w/ type 2 DM. Patients w/ very high blood glucose conc; on anti-hypertensive therapy w/ history of hypotension; w/ predisposing factors to ketoacidosis including 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 or surgery & alcohol abuse. Evaluate renal function prior to initiation of treatment & periodically thereafter. Monitor vol status eg, physical exam, BP measurements, lab tests including haematocrit & electrolytes in case of vol-depleting conditions eg, GI illness. Risk of hypoglycemia in combination w/ insulin & insulin secretagogues eg, sulfonylureas. Severe renal impairment (eGFR <25 mL/min/1.73 m2) or ESRD. Not to be used during pregnancy (2nd or 3rd trimester) & lactation. Ped & adolescents. Elderly.
Adverse Reactions
Genital infection, UTI; back pain; pollakiuria, polyuria. Diabetic ketoacidosis.
Drug Interactions
Decreased exposure w/ rifampicin. Increased exposure w/ mefenamic acid. Reduced serum lithium conc.
MIMS Class
Antidiabetic Agents
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
3 × 10's
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