Onglyza

Onglyza

Manufacturer:

AstraZeneca

Distributor:

AstraZeneca
Concise Prescribing Info
Contents
Saxagliptin
Indications/Uses
Adjunct to diet & exercise to improve glycemic control in patients w/ type 2 DM as monotherapy or in combination w/ metformin, thiazolidinedione, sulfonylurea, metformin w/ SGLT2 inhibitor, metformin w/ sulfonylurea, or insulin (w/ or w/o metformin). Initial combination therapy w/ metformin to improve glycemic control.
Dosage/Direction for Use
Monotherapy or as add-on combination 5 mg once daily, or in combination w/ metformin (w/ or w/o sulfonylurea), thiazolidinedione, sulfonylurea, metformin w/ SGLT2 inhibitor, or insulin (w/ or w/o metformin). Initial combination therapy 5 mg + metformin 500 mg once daily. Moderate (eGFR <45 mL/min/1.73 m2) or severe (eGFR <30 mL/min/1.73 m2) renal impairment or end-stage renal disease (ESRD) requiring hemodialysis 2.5 mg once daily.
Administration
May be taken with or without food: Do not split/cut.
Contraindications
History of serious hypersensitivity reaction eg, anaphylaxis or angioedema, to saxagliptin or any DPP4 inhibitor.
Special Precautions
Do not use in patients w/ type 1 DM for treatment of diabetic ketoacidosis. Discontinue if serious hypersensitivity reaction or pancreatitis is suspected. Known risk factors for hospitalization for heart failure eg, history of heart failure or moderate to severe renal impairment. Arthralgia. Concomitant use w/ sulfonylurea or insulin. Asses renal function prior to initiation & periodically thereafter. May impair ability to drive or operate machinery. Pregnancy & lactation. Adolescents & childn. Elderly.
Adverse Reactions
Upper resp tract infection, UTI, sinusitis, gastroenteritis; vomiting; headache.
Drug Interactions
Decreased Cmax w/ metformin. Increased Cmax w/ glybruide, simvastatin, famotidine. Increased plasma Cmax & AUC w/ diltiazem, ketoconazole. Decreased Cmax & AUC w/ rifampin, Al hydroxide + Mg hydroxide + simethicone. Increases Cmax of glyburide, pioglitazone, diltiazem. Decreases Cmax & AUC of ketoconazole. Increases AUC & Cmax of OCs.
MIMS Class
ATC Classification
A10BH03 - saxagliptin ; Belongs to the class of dipeptidyl peptidase 4 (DPP-4) inhibitors. Used in the treatment of diabetes.
Presentation/Packing
Form
Onglyza tab 2.5 mg
Packing/Price
28's
Form
Onglyza tab 5 mg
Packing/Price
28's
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