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Sidapvia

Sidapvia

Manufacturer:

AstraZeneca

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Per 10 mg/100 mg FC tab Dapagliflozin propanediol monohydrate 10 mg, sitagliptin phosphate monohydrate 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 day.
Administration
May be taken with or without food: Swallow whole.
Contraindications
Special Precautions
Discontinue use if hypersensitivity reaction, ketoacidosis, necrotising perineum fasciitis/Fournier's gangrene, pancreatitis & bullous pemphigoid are suspected; prior to major surgery. Not to be used in patients w/ type 1 diabetes or diabetic ketoacidosis. Risk of vol depletion &/or hypotension; insulin deficiency/dose reduction, reduced caloric intake, increased insulin requirements due to infections, low carbohydrate diet, acute illness, surgery, previous ketoacidosis & alcohol abuse; urosepsis & pyelonephritis, recurrent UTI; cardiac failure (NYHA class IV); arthralgia, exacerbation of joint symptoms; patients w/ known CV disease. Monitor vol status eg, physical exam, BP & electrolytes in intercurrent conditions leading to vol depletion eg, GI illness, heat stress, severe infections; haematocrit, Hb. Evaluate renal function prior to initiation & periodically thereafter. Counsel diabetic patients on routine preventative footcare. Hypoglycaemia w/ insulin & insulin secretagogues. Concomitant use w/ diuretics, antihypertensives. May affect ability to drive & use machines. Not to be used in patients w/ eGFR <45 mL/min/1.73 m2 & severe hepatic impairment. Not to be used during pregnancy & lactation. Not to be used in childn & adolescents 10-17 yr. Elderly.
Adverse Reactions
Genital infection, UTI; back pain; polyuria. Sitagliptin: URTI, nasopharyngitis; hypoglycaemia; headache.
Drug Interactions
Interference w/ 1,5-anhydroglucitol assay. Dapagliflozin: Reduced serum lithium conc. Sitagliptin: Concomitant use w/ GLP-1 or α-glucosidase inhibitors.
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;7's
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