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Sidapvia

Sidapvia

Manufacturer:

AstraZeneca

Marketer:

AstraZeneca
Concise Prescribing Info
Contents
Per 10 mg/100 mg FC tab Dapagliflozin 10 mg, sitagliptin 100 mg
Indications/Uses
Adjunct to diet & exercise to improve glycaemic control in adults w/ type 2 DM.
Dosage/Direction for Use
1 tab once daily taken at any time of the day.
Administration
May be taken with or without food: Swallow whole.
Contraindications
Special Precautions
Serious hypersensitivity reactions including anaphylaxis, angioedema, & exfoliative skin conditions (eg, SJS); discontinue use if hypersensitivity reaction is suspected. Discontinue use if pancreatitis is suspected & do not restart if acute pancreatitis is confirmed; patient develops blisters or erosions during treatment & bullous pemphigoid is suspected & consider referral to a dermatologist. Not to be used in patients w/ type 1 DM or treatment of diabetic ketoacidosis. Consider temporary interruption of treatment when treating pyelonephritis or urosepsis; in patients who develop vol depletion until it is corrected. Carefully monitor vol status (eg, physical exam, BP measurements, lab tests including electrolytes) in intercurrent conditions leading to vol depletion (eg, GI illness). Caution in patients w/ predisposing factors to ketoacidosis; discontinue or consider temporary interruption if ketoacidosis is suspected. Risk of hypoglycaemia when used in combination w/ insulin & insulin secretagogues (eg, sulfonylureas); developing acute pancreatitis. Patients w/ history of pancreatitis. Arthralgia; individually assess drug therapy continuation if patient presents w/ severe joint pain. Take into account reports of dizziness w/ sitagliptin when driving or operating machines. Not to be used in patients w/ eGFR <45 mL/min/1.73 m2; evaluate renal function prior to treatment initiation & periodically thereafter. Severe hepatic impairment. Not to be used during pregnancy & lactation. Not indicated for use in ped & adolescent patients. Elderly.
Adverse Reactions
Genital infection, UTI, URTI, nasopharyngitis; hypoglycaemia; headache; back pain; pollakiuria & polyuria.
Drug Interactions
Not recommended to use 1,5-AG assay for monitoring glycaemic control. Dapagliflozin: Concomitant use w/ lithium may lead to a reduction in serum lithium conc. Sitagliptin: Potent CYP3A4 inhibitors (ie, ketoconazole, itraconazole, ritonavir, clarithromycin) could possibly alter the pharmacokinetics of sitagliptin in patients w/ severe renal impairment or ESRD. Slightly increased digoxin AUC & Cmax; monitor patients receiving digoxin appropriately.
MIMS Class
Antidiabetic Agents
ATC Classification
A10BD29 - sitagliptin and dapagliflozin ; Belongs to the class of combinations of oral blood glucose lowering drugs. Used in the treatment of diabetes.
Presentation/Packing
Form
Sidapvia 10 mg/100 mg FC tab
Packing/Price
2 × 14's
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