HIGHLIGHT
Forxiga

Forxiga

Manufacturer:

AstraZeneca

Distributor:

Zuellig
Concise Prescribing Info
Contents
Dapagliflozin propanediol monohydrate
Indications/Uses
Monotherapy or in combination w/ other medicinal products for the treatment of type 2 DM. Prevention of new or worsening heart failure or CV death; nephropathy. Heart failure w/ reduced ejection fracture in adults. CKD in adults.
Dosage/Direction for Use
10 mg once daily. Type 2 DM 10 mg once daily as monotherapy or add-on combination therapy. Initial combination therapy: 10 mg dapagliflozin + 500 mg metformin once daily.
Administration
May be taken with or without food.
Contraindications
Special Precautions
Not for the treatment of diabetes when eGFR is persistently <45 mL/min/1.73 m2; type 1 DM; diabetic ketoacidosis. Predisposing factors to ketoacidosis including 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 or surgery, & alcohol abuse. Discontinue or consider temporary interruption if ketoacidosis is suspected. Discontinue & prompt treatment should be instituted if necrotizing fasciitis of the perineum (Fournier's gangrene) is suspected. Concomitant use w/ medications known to cause hypoglycemia eg, insulin & insulin secretagogues (eg, sulfonylureas). Evaluate renal function prior to initiation of therapy & periodically thereafter. Severe renal impairment (eGFR <30 mL/min/1.73 m2) or ESRD. Avoid during pregnancy (2nd & 3rd trimester). Lactation. Childn & adolescents.
Adverse Reactions
Genital infections, UTI; back pain; pollakiuria, polyuria.
Drug Interactions
Decreased systemic exposure w/ rifampicin. Increased systemic exposure w/ mefenamic acid. May lead to reduction in serum lithium conc due to possible increased urinary clearance of lithium. Interference w/ 1,5-anhydroglucitol assay.
MIMS Class
Antidiabetic Agents / Other Cardiovascular Drugs
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
Form
Forxiga FC tab 5 mg
Packing/Price
28's
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