Janumet XR康諾胰 XR

Janumet XR

metformin + sitagliptin

Manufacturer:

MSD

Distributor:

Zuellig
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Per 50/500 mg FC tab Sitagliptin 50 mg, metformin HCl ER 500 mg. Per 50/1,000 mg FC tab Sitagliptin 50 mg, metformin HCl ER 1,000 mg. Per 100/1,000 mg FC tab Sitagliptin 100 mg, metformin HCl ER 1,000 mg
Indications/Uses
Adjunct to diet & exercise to improve glycemic control in adults w/ type 2 DM when treatment w/ both sitagliptin & metformin ER is appropriate.
Dosage/Direction for Use
Individualize dosage not exceeding max recommended daily dose of 100 mg sitagliptin & 2,000 mg metformin HCl ER. Patient not currently treated w/ metformin Starting dose: 100 mg sitagliptin/1,000 mg metformin HCl ER daily, may be titrated to reduce GI side effects. Patient already treated w/ metformin Starting dose: 100 mg sitagliptin daily w/ previously prescribed metformin dose. Patient taking metformin IR 850 mg bd or 1,000 mg bd Starting dose: 2 tab of 50 mg sitagliptin/1,000 mg metformin HCl ER taken together once daily.
Administration
Should be taken with food: Swallow whole, do not split/crush/chew tab.
Contraindications
History of serious hypersensitivity (eg, anaphylaxis or angioedema). Acute or chronic metabolic acidosis, including diabetic ketoacidosis. Severe renal impairment (eGFR <30 mL/min/1.73 m2).
Special Precautions
Not for patients w/ type 1 DM or for treatment of diabetic ketoacidosis. Reports of acute pancreatitis; hypoglycemia. Monitor renal function prior to treatment initiation & at least annually thereafter. Pregnancy & lactation. Elderly. Childn <18 yr. Sitagliptin phosphate: Hypersensitivity reactions. Bullous pemphigoid. Metformin HCl: Risk of lactic acidosis. Radiologic studies w/ intravascular iodinated contrast materials. Hypoxic states. Temporarily suspend therapy in case of any surgical procedures. Excessive alcohol intake. Subnormal vit B12 levels. Changes in clinical status of patients w/ previously controlled type 2 DM. Temporary loss of glycemic control in case of stress exposure (eg, fever, trauma, infection, or surgery). Hepatic impairment.
Adverse Reactions
Diarrhea, upper resp tract infection, headache; nausea, vomiting, abdominal pain.
Drug Interactions
Frequent serum bicarbonate reduction & induction of non-ionic gap, hyperchloremic metabolic acidosis w/ topiramate or other carbonic anhydrase inhibitors (eg, zonisamide, acetazolamide or dichlorphenamide). Potential competition for common renal tubular transport systems w/ cationic drugs eliminated by renal tubular secretion (eg, amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, or vancomycin). Loss of glycemic control w/ thiazides & other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, OCs, phenytoin, nicotinic acid, sympathomimetics, Ca channel blocking drugs, & INH.
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
Janumet XR 100/1000 mg FC tab
Packing/Price
28's
Form
Janumet XR 50/1000 mg FC tab
Packing/Price
56's
Form
Janumet XR 50/500 mg FC tab
Packing/Price
56's
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