Invokamet(canagliflozin/metformin HCl tablets)-新类别第一个用于2型糖尿病 
Generic Name and Formulations:
Canagliflozin, metformin HCl; 50mg/500mg, 50mg/1000mg, 150mg/500mg, 150mg/1000mg; tabs.

Company:
Janssen Pharmaceuticals, Inc.
Indications for INVOKAMET:
Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are not adequately controlled on a regimen containing metformin or canagliflozin or who are already being treated with both canagliflozin and metformin. Limitations of use: not for treating type 1 diabetes or diabetic ketoacidosis.

Adult:
See full labeling. Individualize. Take twice daily with meals; increase dose gradually. Max daily dose: 300mg/2000mg. Moderate renal impairment (eGFR 45–<60mL/min/1.73m2): max canagliflozin 50mg twice daily. Concomitant UGT inducers in patients with eGFR ≥60mL/min/1.73m2: consider increase to canagliflozin 150mg twice daily; if eGFR 45–<60mL/min/1.73m2: consider other antihyperglycemics.

Children:
<18yrs: not established.

Pharmacological Class:
Sodium-glucose co-transporter 2 inhibitor + biguanide.

Contraindications:
Renal impairment (SCr ≥1.5mg/dL [men], ≥1.4mg/dL [women], or eGFR <45mL/min/1.73m2), ESRD, or on dialysis. Metabolic acidosis, diabetic ketoacidosis.

Warnings/Precautions:
Confirm normal renal function before starting and monitor thereafter (esp. in elderly). Discontinue if lactic acidosis, renal impairment, shock, acute MI or CHF, dehydration, sepsis, hypoxemia, pancreatitis, or hypersensitivity reactions occur. Avoid in hepatic disease. Discontinue prior to any intravascular radiocontrast study or surgery; withhold for 48hrs after procedure. Correct volume depletion before initiating. Monitor for symptomatic hypotension after starting therapy (esp. elderly, renal impairment, low systolic BP, on diuretics or drugs that interfere with the RAAS system [eg, ACEIs, ARBs]). Monitor serum K+ levels in patients predisposed to hyperkalemia. Elderly, debilitated, uncompensated strenuous exercise, malnourished or deficient caloric intake, adrenal or pituitary insufficiency, or alcohol intoxication: increased risk of hypoglycemia. Monitor for genital mycotic infections, hematology (esp. serum Vit. B12), increases in LDL-C; treat if occur. Pregnancy (Cat.C). Nursing mothers.

Interactions:
Cationic drugs eliminated by renal tubular secretion (eg, amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, vancomycin); may increase metformin levels; monitor. Increased risk of lactic acidosis with topiramate, other carbonic anhydrase inhibitors (eg, zonisamide, acetazolamide, dichlorphenamide). Diuretics, steroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, sympathomimetics, nicotinic acid, CCBs, and isoniazid may cause hyperglycemia. Avoid excessive alcohol. Concomitant drugs that may affect renal function or metformin disposition; monitor and adjust dose. Antagonized by UGT inducers (eg, rifampin, phenytoin, phenobarbital, ritonavir): see Adults. Concomitant digoxin: monitor. Concomitant insulin or insulin secretagogue: consider a lower dose of insulin/insulin secretagogue to reduce risk of hypoglycemia. May cause false (+) urine glucose tests or unreliable measurements of 1, 5-AG assay; use alternative methods to monitor glycemic control.

Adverse Reactions:
Female genital mycotic infections, UTI, increased urination, GI upset, flatulence, asthenia, indigestion, abdominal discomfort, headache.

How Supplied:
Tabs—60