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Co-Zincretin 50/500/Co-Zincretin 50/1000/Co-Zincretin XR 100/1000

Co-Zincretin 50/500/Co-Zincretin 50/1000/Co-Zincretin XR 100/1000

metformin + sitagliptin

Manufacturer:

Zydus Healthcare

Distributor:

Zydus Healthcare
Concise Prescribing Info
Contents
Per Co-Zincretin 50/500 FC tab Sitagliptin phosphate monohydrate 50 mg, metformin HCl 500 mg. Per Co-Zincretin 50/1000 FC tab Sitagliptin phosphate monohydrate 50 mg, metformin HCl 1 g. Per Co-Zincretin XR 100/1000 XR-FC tab Sitagliptin phosphate monohydrate 100 mg, metformin HCl 1 g
Indications/Uses
Adjunct to diet & exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated w/ combination of sitagliptin & metformin. Co-Zincretin 50/1000 Type 2 DM in adults. In combination w/ sulphonylurea (ie, triple combination therapy) as an adjunct to diet & exercise in patients inadequately controlled on their maximal tolerated dose of metformin & sulphonylurea. Triple combination therapy w/ peroxisome proliferator-activated receptor γ (PPARγ) agonist (i.e. thiazolidinedione) as an adjunct to diet & exercise in patients inadequately controlled on their maximal tolerated dose of metformin & PPARγ agonist. Add-on to insulin (i.e. triple combination therapy) as an adjunct to diet & exercise to improve glycaemic control in patients when stable dose of insulin & metformin alone does not provide adequate glycaemic control.
Dosage/Direction for Use
Individualized dosing while not exceeding the max recommended daily dose of 100 mg sitagliptin. Co-Zincretin 50/1000 Adult w/ normal renal function (GFR ≥90 mL/min): Patient not adequately controlled on metformin alone Usual starting dose: Sitagliptin 50 mg bid (100 mg total daily dose) + dose of metformin already being taken. Patient switching from co-administration of sitagliptin & metformin Initiate at the dose of sitagliptin & metformin already being taken. Patient inadequately controlled on dual combination therapy w/ maximal tolerated dose of metformin & sulphonylurea Sitagliptin 50 mg bid (100 mg total daily dose) + metformin similar to the dose already being taken. Patient inadequately controlled on dual combination therapy w/ maximal tolerated dose of metformin & PPARγ agonist Sitagliptin 50 mg bid (100 mg total daily dose) + metformin similar to the dose already being taken. Patient inadequately controlled on dual combination therapy w/ insulin & the maximal tolerated dose of metformin Sitagliptin 50 mg bid (100 mg total daily dose) + metformin similar to the dose already being taken.
Administration
Should be taken with food.
Contraindications
Hypersensitivity. Severe renal impairment (eGFR <30 mL/min/1.73 m2). Acute or chronic metabolic acidosis, including diabetic ketoacidosis, w/ or w/o coma. Sitagliptin phosphate + Metformin HCl should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials. Co-Zincretin 50/1000 Diabetic ketoacidosis, diabetic pre-coma. Moderate & severe renal impairment (CrCl <6 mL/min). Acute conditions w/ potential to alter renal function eg, dehydration, severe infection, shock. Acute or chronic disease which may cause tissue hypoxia eg, cardiac or resp failure, recent MI, hepatic impairment, acute alcohol intoxication, alcoholism. Lactation.
Special Precautions
Hypersensitivity reactions. Not to be used in patients w/ type 1 diabetes or for the treatment of diabetic ketoacidosis. Discontinue use if pancreatitis; hypersensitivity reaction; bullous pemphigoid; hypoxic states is suspected; evidence of renal impairment is present. Monitor renal function. Risk of hypoglycemia w/ sulfonylurea or insulin. Elderly, debilitated, or malnourished patients, & those w/ adrenal or pituitary insufficiency or alcohol intoxication are susceptible to hypoglycemic effects. Lactic acidosis. Caution w/ concomitant medication(s) that may affect renal function eg, cationic drugs. Intravascular studies w/ iodinated materials can lead to acute alteration of renal function & associated w/ lactic acidosis. Temporarily discontinue treatment at the time of or prior to the procedure, & w/hold for 48 hr subsequent to the procedure & reinstitute only after renal function has been re-evaluated & found to be acceptable. Temporarily suspend for any surgical procedure (except minor procedures not associated w/ restricted intake of food & fluids). Temporary loss of glycemic control may occur if exposed to stress. Avoid in patients w/ hepatic disease. Pregnancy & lactation. Childn <18 yr. Elderly. Metformin: Caution against excessive alcohol intake, either acute or chronic. Temporarily discontinue prior to any intravascular radiocontrast study & for any surgical procedure. Routine serum vit B12 measurements at 2-3 yr interval.
Adverse Reactions
Diarrhea, nausea, dyspepsia, flatulence, vomiting, headache, hypoglycemia.
Drug Interactions
Metformin: Enhanced absorption w/ nifedipine. Increased systemic exposure to metformin w/ concomitant use of drugs that interfere w/ common renal tubular transport systems involved in the renal elimination of metformin (eg, organic cationic transporter-2 [OCT2]/multidrug & toxin extrusion [MATE] inhibitors eg, ranolazine, vandetanib, dolutegravir, & cimetidine). May produce hyperglycemia & lead to loss of glucose control w/ thiazides, other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, OCs, phenytoin, nicotinic acid, sympathomimetics, Ca channel blocking drugs, & INH. Co-Zincretin 50/1000 Concomitant use w/ alcohol or iodinated contrast agents is not recommended. Caution in medicinal products that can adversely affect renal function eg, NSAIDs, including selective (COX) II inhibitors, ACE inhibitors (may decrease blood glucose levels), AIIAs & diuretics, especially loop diuretics; glucocorticoids (given by systemic & local routes) β2-agonists, & diuretics have intrinsic hyperglycaemic activity.
MIMS Class
Antidiabetic Agents
ATC Classification
A10BD07 - metformin and sitagliptin ; Belongs to the class of combinations of oral blood glucose lowering drugs. Used in the treatment of diabetes.
Presentation/Packing
Form
Co-Zincretin 50/1000 FC tab
Packing/Price
30's
Form
Co-Zincretin 50/500 FC tab
Packing/Price
30's
Form
Co-Zincretin XR 100/1000 XR-FC tab
Packing/Price
30's
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