Iklan
Iklan
Forxiga

Forxiga

Manufacturer:

AstraZeneca
Concise Prescribing Info
Contents
Dapagliflozin
Indications/Uses
Type 2 DM to improve glycemic control in combination w/ metformin, pioglitazone, sitagliptin (w/ or w/o metformin), gliclazide, glimepiride or glyburide (w/ or w/o metformin) or insulin (alone or w/ up to 2 antidiabetic medication) when the existing therapy, along w/ diet & exercise does not provide adequate glycemic control. Symptomatic treatment of chronic heart failure in adults. CKD (eGFR 30-75 mL/min/1.73 m2) in reducing composite risk of ≥50% sustained eGFR decline, ESRD & renal or CV death.
Dosage/Direction for Use
Type 2 DM add-on combination therapy 10 mg once daily. Combination w/ insulin secretagogue Lower dose of insulin secretagogue may be considered. Heart failure & CKD Recommended dose: 10 mg once daily. Severe hepatic impairment Initially 5 mg, may be increased to 10 mg if well tolerated.
Administration
May be taken with or without food: Swallow whole.
Contraindications
Special Precautions
Discontinue or temporarily interrupt use if ketoacidosis is suspected. Not to be used in type 1 DM or for diabetic ketoacidosis. Not to be initiated in patients w/ GFR <60 mL/min & discontinued at GFR persistently <45 mL/min. Not recommended for heart failure in patients w/ type 1 DM. CKD in patients w/o diabetes & albuminuria; UTI, pyelonephritis or urosepsis. Heart failure in patients w/ severe renal impairment (GFR <30 mL/min). Patients w/ predisposing factors to ketoacidosis, insulin dose reduction, reduced caloric intake or increased insulin requirements due to infections, illness or surgery & alcohol abuse. Intercurrent conditions leading to vol depletion eg, GI illness; patients on anti-hypertensive therapy w/ history of hypotension; NYHA class IV; elevated haematocrit; +ve glucose test in urine. Risk of hypoglycaemia in combination w/ sulphonylurea. Combination w/ glucagon-like peptide 1 (GLP-1) analogues. Galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Monitor renal function prior to initiation of therapy & at least yrly thereafter; prior to initiation of concomitant medicinal products reducing renal function & periodically thereafter; w/ GFR <60 mL/min for at least 2-4 times yrly. Monitor vol status eg, physical exam, BP, lab tests & electrolytes. Severe renal impairment (GFR <30 mL/min) or ESRD; hepatic impairment. Not recommended during the 2nd & 3rd trimester of pregnancy; discontinue use if pregnancy is detected. Not to be used during pregnancy & breastfeeding. Childn <18 yr. Elderly.
Adverse Reactions
Hypoglycaemia (w/ sulphonylurea or insulin). Vulvovaginitis, balanitis & related genital infections, UTI; dizziness; rash; back pain; dysuria, polyuria; increased haematocrit, decreased renal CrCl, dyslipidaemia.
Drug Interactions
Increased risk of dehydration & hypotension w/ thiazide & loop diuretics. Risk of hypoglycaemia w/ insulin secretagogues eg, sulphonylureas. Decreased blood lithium levels. Interference w/ 1,5-anhydroglucitol assay.
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
2 × 14's (Rp777,101/boks);3 × 10's (Rp832,608/boks)
Form
Forxiga FC tab 5 mg
Packing/Price
2 × 14's (Rp777,101/boks);3 × 10's (Rp832,608/boks)
Iklan
Iklan
Iklan
Iklan
Iklan
Iklan
Iklan