Dapa-Z

Dapa-Z

Manufacturer:

Lloyd

Distributor:

InnoGen Pharmaceuticals
Concise Prescribing Info
Contents
Dapagliflozin
Indications/Uses
Insufficiently controlled type 2 DM as adjunct to diet & exercise as monotherapy when metformin is considered inappropriate due to intolerance or in addition to other medicinal products for type 2 diabetes in adults. Symptomatic chronic heart failure w/ reduced ejection fraction in adults. CKD in adults.
Dosage/Direction for Use
Type 2 DM 10 mg once daily in combination w/ insulin or sulphonylurea. Heart failure 10 mg once daily in conjunction w/ other heart failure therapies. CKD 10 mg once daily in conjunction w/ other CKD related therapies. Severe hepatic impairment Initially 5 mg. May be increased to 10 mg if well tolerated.
Administration
May be taken with or without food: Take at any time of day. Swallow whole.
Contraindications
Special Precautions
Not recommended to initiate treatment in patients w/ eGFR <15 mL/min/1.3 m2; patients w/ severe hepatic impairment. Assess patients for ketoacidosis immediately if nonspecific symptoms eg, nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue or sleepiness occur, regardless of blood glucose level. Stop treatment immediately if diabetic ketoacidosis is suspected or diagnosed. Patients at higher risk of diabetic ketoacidosis include patients w/ low β cell function reserve (eg, type 2 diabetes patients w/ low C peptide or latent autoimmune diabetes in adults or patients w/ history of pancreatitis), conditions that lead to restricted food intake or severe dehydration, for whom insulin doses are reduced & w/ increased insulin requirements due to acute medical illness, surgery or alcohol abuse. Not to be used for patients w/ type 1 diabetes. Evaluate patients w/ pain, tenderness, erythema, or swelling in genital or perineal area, w/ fever or malaise for necrotising fasciitis. Discontinue & institute prompt treatment if Fournier's gangrene is suspected. Consider temporary interruption of treatment when treating pyelonephritis or urosepsis. Cardiac failure, NYHA class IV. CKD in patients w/o diabetes who do not have albuminuria; w/ polycystic kidney disease, glomerulonephritis w/ flares, ongoing or recent requirements of cytotoxic, immunosuppressive or other immunomodulating renal therapy, or who received organ transplant. Lower limb amputations. +ve glucose in urine. Contains lactose; not to be taken by patients w/ galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Not recommended during 2nd or 3rd trimester of pregnancy. Not to be used while breast-feeding. Childn <18 yr. Elderly ≥65 yr.
Adverse Reactions
Hypoglycaemia (when used w/ sulphonylureas or insulin). Vulvovaginitis, balanitis & related genital infections, UTI; dizziness; rash; back pain; dysuria, polyuria; increased haematocrit, decreased renal CrCl during initial treatment, dyslipidaemia.
Drug Interactions
May add to diuretic effect of thiazide & loop diuretics & may increase risk of dehydration & hypotension. Increased risk of hypoglycaemia w/ insulin & insulin secretagogues eg, sulphonylureas. Decreased systemic exposure w/ rifampicin. Increased systemic exposure w/ mefenamic acid. 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
Dapa-Z FC tab 10 mg
Packing/Price
30's
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