GLAZITA-M
SITAGLIPTIN AND METFORMIN · by ASIANCONTINENTAL
Composition
Tab 50 mg/500 mg: Sitagliptin (as phosphate monohydrate) 50 mg, metformin hydrochloride 500 mg. Tab 50 mg/850 mg: Sitagliptin (as phosphate monohydrate) 50 mg, metformin hydrochloride 850 mg.
Indications & Dosage
Type 2 diabetes mellitus not controlled by metformin alone or in combination with either a sulfonylurea or pioglitazone or insulin: Adult: Initially 1 tablet50mg/500 mg or 50 mg/1000 mg twice daily. Doses of sulfonylurea or insulin may need to be reduced. Max daily dose of sitagliptin 100 mg. Children: Not recommended.
Contraindications
Renal or hepatic impairment, diabetic ketoacidosis or pre-coma, cardiac or respiratory failure, recent MI, acute alcohol intoxication, alcoholism.
Precautions
Assess risk factors for lactic acidosis. Monitor renal function at least annually. Discontinue for 48 hours before and after surgery and measure renal function before resuming therapy, Elderly.
Interactions
Alcohol, cimetidine, iodinated contrast agents, glucocorticoids, ACE inhibitors, potent CYP3A4 inhibitors, digoxin, insulin, sulfonylureas, diuretics, beta2-agonists.
Pregnancy
Contraindicated in pregnancy.
Lactation
Not recommended.
Side Effects
Serious hyper sensitivity reactions including anaphylaxis and Stevens-Johnson syndrome (discontinue),nausea, lactic acidosis (discontinue), hypoglycaemia, constipation, headache, diarrhoea, vomiting.