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Edistride

Edistride

Manufacturer:

AstraZeneca

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Dapagliflozin
Indications/Uses
Adjunct to diet & exercise in adults w/ type 2 DM as monotherapy or in combination w/ other medicinal products. Reduce risk of new or worsening heart failure or CV death & nephropathy in adults w/ type 2 DM. Symptomatic treatment of chronic heart failure in adults. CKD in adults.
Dosage/Direction for Use
Heart failure & CKD 10 mg once daily at any time of the day. Type 2 DM Monotherapy & add-on combination therapy: 10 mg once daily as monotherapy or add-on to metformin (w/ or w/o sulfonylurea), thiazolidinedione, sulfonylurea, DPP4-inhibitor (w/ or w/o metformin), or insulin (w/ or w/o oral antidiabetic therapy, either metformin plus insulin dual therapy or metformin plus sulfonylurea plus insulin triple therapy). Initial combination therapy: Dapagliflozin 10 mg + metformin 500 mg once daily.
Administration
May be taken with or without food.
Contraindications
History of serious hypersensitivity reaction.
Special Precautions
Not to be used for type 1 diabetes; diabetic ketoacidosis (DKA). Not recommended for use in the treatment of diabetes to improve glycemic control when eGFR is persistently <45 mL/min/1.73 m2. Interrupt treatment temporarily in patients who develop vol depletion until depletion is corrected. Consider discontinuation or temporary interruption of treatment if ketoacidosis is suspected. Decreased BP. Patients on anti-hypertensive therapy w/ history of hypotension. Patients w/ 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. Assess patients who present w/ signs & symptoms consistent w/ ketoacidosis including nausea, vomiting, abdominal pain, malaise, shortness of breath. Evaluate renal function prior to treatment initiation & periodically thereafter. Monitor vol status (eg, physical exam, BP measurements, lab tests including haematocrit & electrolytes) in case of intercurrent conditions that may lead to vol depletion eg, GI illness. DKA in patients concurrently taking SGLT2 inhibitors. Hypoglycemia when used w/ insulin or insulin secretagogue. Severe renal impairment (eGFR <25 mL/min/1.73 m2) or ESRD. Discontinue treatment when pregnancy is detected. Not to be used during 2nd & 3rd trimesters of pregnancy; lactation. Ped & adolescent patients. Elderly.
Adverse Reactions
Genital infection, UTI; back pain; pollakiuria & polyuria.
Drug Interactions
Decreased systemic exposure w/ rifampicin. Increased systemic exposure w/ mefenamic acid. Reduced serum lithium conc. Interference w/ 1,5-anhydroglucitol (1,5-AG) 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
Edistride FC tab 10 mg
Packing/Price
3 × 10's
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