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Sidapvia

Sidapvia

Manufacturer:

SK Chemicals

Distributor:

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
Adult 1 tab once daily taken at any time of the day.
Administration
May be taken with or without food.
Contraindications
Special Precautions
Discontinue or temporarily interrupt treatment if ketoacidosis is suspected. Discontinue treatment if hypersensitivity reactions, pancreatitis, or bullous pemphigoid is suspected. Not indicated for treatment of patients w/ type 1 DM. Use of dipeptidyl peptidase 4 (DPP4) inhibitors has been associated w/ risk of developing acute pancreatitis; caution in patients w/ history of pancreatitis. Evaluate renal function prior to initiation of treatment & periodically thereafter. Risk of hypoglycemia in combination w/ insulin or an insulin secretagogue eg, sulfonylurea. Post-marketing reports of joint pain for DPP4 inhibitors. Continuation of therapy should be individually assessed if patient presents w/ severe joint pain. Take into account reports of dizziness w/ sitagliptin & risk of hypoglycemia in combination w/ insulin or insulin secretagogue when driving or operating machines. Not to be used in patients w/ estimated GFR <45 mL/min/1.73 m2. Caution in patients w/ severe hepatic impairment. Discontinue treatment if pregnancy is detected. Not to be used in nursing woman. Not indicated for use in ped & adolescent patients.
Adverse Reactions
Dapagliflozin: Genital infection, UTI; back pain; pollakiuria, polyuria. Sitagliptin: URTI, nasopharyngitis; hypoglycaemia; headache.
Drug Interactions
Interference w/ 1,5-anhydroglucitol assay. Dapagliflozin: May lead to 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. Monitor patients at risk for digoxin toxicity when administered concomitantly w/ digoxin. May be a mild inhibitor of P-gp in vivo.
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
28's