Forxiga

Forxiga

Manufacturer:

AstraZeneca

Distributor:

DKSH
Concise Prescribing Info
Contents
Dapagliflozin
Indications/Uses
Adults w/ type 2 DM as adjunct to diet & exercise given as monotherapy or in combination w/ medicinal products indicated for type 2 DM; as prevention of new or worsening heart failure, CV death or nephropathy.
Dosage/Direction for Use
10 mg once daily as monotherapy or in add-on combination therapy. Initial combination therapy w/ metformin 10 mg + 500 mg metformin once daily. Patients at risk for vol depletion Starting dose: 5 mg.
Administration
May be taken with or without food.
Contraindications
Special Precautions
Not recommended for the treatment of diabetes when eGFR <45 mL/min/1.73 m2; severe renal impairment (eGFR <30 mL/min/1.73 m2) or end-stage renal disease. Consider temporary interruption or discontinuation of treatment if signs & symptoms of ketoacidosis develops. Consider temporary interruption of treatment for patients who develop vol depletion; when treating pyelonephritis or urosepsis. Evaluate renal function prior to initiation of treatment & periodically thereafter. Patients w/ predisposing factors to ketoacidosis (eg, low β-cell function reserve from pancreatic disorders, insulin dose reduction, reduced caloric intake or increased insulin requirements due to infections, illness or surgery & alcohol abuse). Concomitant use w/ medications known to cause hypoglycemia eg, insulin & insulin secretagogues. Not recommended in monitoring glycemic control w/ 1,5-AG assay. Increased risk of UTI. Pregnancy (2nd & 3rd trimester) & lactation. Ped & adolescent.
Adverse Reactions
Genital infection, UTI; back pain; pollakiuria & polyuria.
Drug Interactions
Decreased systemic exposure w/ rifampin or increased systemic exposure w/ mefenamic acid w/ no clinical effect on urinary glucose excretion.
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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