Jardiance

Jardiance

empagliflozin

Manufacturer:

Boehringer Ingelheim

Distributor:

DKSH
Concise Prescribing Info
Contents
Empagliflozin
Indications/Uses
Monotherapy or in combination w/ other glucose-lowering medicinal products including insulin for type 2 DM to improve glycaemic control in adults when diet & exercise alone do not provide adequate glycaemic control. Adult patients w/ heart failure (NYHA class II-IV) w/ or w/o type 2 DM to reduce risk of CV death & hospitalisation. Adjunct to diet, exercise & standard care therapy to reduce incidence of CV death in patients w/ type 2 DM & established CV disease who have inadequate glycemic control. Reduce risk of sustained decline in eGFR, end-stage kidney disease, CV death & hospitalisation in adults w/ CKD at risk of progression.
Dosage/Direction for Use
Adult Type 2 DM Recommended starting dose: 10 mg once daily for monotherapy & add-on combination therapy w/ other medicinal products including insulin. Patient tolerating empagliflozin 10 mg once daily & need tighter glycaemic control May increase to 25 mg once daily. Max daily dose: 25 mg. When used in combination w/ sulphonylurea or insulin, consider lower dose for sulphonylurea or insulin to reduce risk of hypoglycaemia. Heart failure & CKD 10 mg once daily. Renal impairment (eGFR <45 mL/min/1.73 m2) Recommended dose: 10 mg & consider additional glucose lowering treatment if needed.
Administration
May be taken with or without food: Swallow whole w/ water.
Contraindications
Special Precautions
Not to be used in patients w/ type 1 diabetes. Discontinue use if ketoacidosis; necrotizing fasciitis of the perineum (Fournier's gangrene) are suspected. Patients on a very low carbohydrate diet; w/ acute illness; pancreatic disorders suggesting insulin deficiency (eg, type 1 diabetes, history of pancreatitis or pancreatic surgery); insulin dose reduction; alcohol abuse; severe dehydration; history of ketoacidosis. Consider monitoring of ketones even if treatment has been interrupted in clinical situations known to predispose to ketoacidosis (eg, prolonged fasting due to acute illness or surgery). May lead to modest BP decrease; carefully monitor vol status (eg, physical exam, BP measurements, lab tests including haematocrit) & electrolytes. Consider temporary treatment interruption until fluid loss is corrected; patients w/ complicated UTI including pyelonephritis & urosepsis. May cause +ve result for glucose in urine lab assessment. Contain lactose; not to be taken by patients w/ rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Not recommended to initiate treatment in patients w/ eGFR <20 mL/min/1.73 m2. Assess renal function prior to initiation & periodically during treatment; prior to initiation of any concomitant medicinal product that may have -ve impact on renal function. Not recommended in patients w/ severe hepatic impairment. Possible hepatic injury. Minor influence on the ability to drive & use machines. Avoid use during early pregnancy; not recommended during 2nd & 3rd trimester of pregnancy. Not to be used during breast-feeding. Childn & adolescents. Increased risk of vol depletion in elderly ≥75 yr.
Adverse Reactions
Hypoglycaemia (when used w/ sulphonylurea or insulin). Vag moniliasis, vulvovaginitis, balanitis & other genital infection, UTI (including pyelonephritis & urosepsis); constipation; generalised pruritus, rash; increased serum lipids. Type 2 DM: Thirst; increased urination. Heart failure: Vol depletion.
Drug Interactions
May increase risk of dehydration & hypotension w/ thiazide & loop diuretics. May increase risk of hypoglycaemia w/ insulin & insulin secretagogues (eg, sulphonylureas). Not recommended to monitor glycemic control w/ 1,5-anhydroglucitol assay. May decrease blood lithium levels. Potential risk of decreased efficacy w/ UGT enzyme inducers.
MIMS Class
Antidiabetic Agents / Other Cardiovascular Drugs
ATC Classification
A10BK03 - empagliflozin ; Belongs to the class of sodium-glucose co-transporter 2 (SGLT2) inhibitors. Used in the treatment of diabetes.
Presentation/Packing
Form
Jardiance FC tab 10 mg
Packing/Price
30's
Form
Jardiance FC tab 25 mg
Packing/Price
30's
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