JANUMET 50MG/500MG 56 TABLETS

JANUMET 50MG/500MG 56 TABLETS
Product Description
Janumet 50 mg/500 mg Tablet is a combination of two medicines that control high blood sugar levels in people with type 2 diabetes mellitus. This helps prevent serious complications of diabetes such as kidney damage and blindness and may reduce your chances of having a heart attack or stroke
JANUMET ® 50 / 500 mg ( sitagliptin + metformin hydrochloride ) 56 film-coated tablets
JANUMET ® 50 / 500 mg ( sitagliptin + metformin hydrochloride ) 56 film-coated tabletsHIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to useJANUMET safely and effectively. See full prescribing informationfor JANUMET.JANUMET®(sitagliptin and metformin hydrochloride) tablets, fororal useInitial U.S. Approval: 2007WARNING: LACTIC ACIDOSISSee full prescribing information for complete boxed warning. Postmarketing cases of metformin-associated lactic acidosishave resulted in death, hypothermia, hypotension, andresistant bradyarrhythmias. Symptoms included malaise,myalgias, respiratory distress, somnolence, and abdominalpain. Laboratory abnormalities included elevated blood lactatelevels, anion gap acidosis, increased lactate/pyruvate ratio,and metformin plasma levels generally >5 mcg/mL. (5.1) Risk factors include renal impairment, concomitant use ofcertain drugs, age ≥65 years old, radiological studies withcontrast, surgery and other procedures, hypoxic states,excessive alcohol intake, and hepatic impairment. Steps toreduce the risk of and manage metformin-associated lacticacidosis in these high risk groups are provided in the FullPrescribing Information. (5.1) If lactic acidosis is suspected, discontinue JANUMET andinstitute general supportive measures in a -INDICATIONS AND USAGE----------------------------JANUMET is a combination of sitagliptin, a dipeptidyl peptidase-4(DPP-4) inhibitor, and metformin hydrochloride (HCl), a biguanide,indicated as an adjunct to diet and exercise to improve glycemiccontrol in adults with type 2 diabetes mellitus. (1)Limitations of Use: JANUMET should not be used in patients with type 1 diabetes or forthe treatment of diabetic ketoacidosis. (1) JANUMET has not been studied in patients with a history ofpancreatitis. (1, 5.2)----------------------- DOSAGE AND ADMINISTRATION------------------------ Individualize the starting dose of JANUMET based on the patient’scurrent regimen. (2.1) Adjust the dosing based on effectiveness and tolerability while notexceeding the maximum recommended daily dose of 100 mgsitagliptin and 2000 mg metformin. (2.1) Give twice daily with meals, with gradual dose escalation, to reducethe gastrointestinal effects due to metformin. (2.1) Prior to initiation, assess renal function with estimated glomerularfiltration rate (eGFR) (2.2)o Do not use in patients with eGFR below 30 mL/min/1.73 m2.o JANUMET is not recommended in patients with eGFR between30 and less than 45 mL/min/1.73 m2. JANUMET may need to be discontinued at time of, or prior to,iodinated contrast imaging procedures. (2.3)--------------------- DOSAGE FORMS AND STRENGTHS ---------------------Tablets: 50 mg sitagliptin/500 mg metformin HCl and 50 mgsitagliptin/1000 mg metformin HCl (3)-------------------------------CONTRAINDICATIONS------------------------------- Severe renal impairment: (eGFR below 30 mL/min/1.73 m2) (4) Metabolic acidosis, including diabetic ketoacidosis. (4) History of a serious hypersensitivity reaction to JANUMET,sitagliptin, or metformin, such as anaphylaxis or angioedema. (5.9,6.2)----------------------- WARNINGS AND PRECAUTIONS------------------------ Lactic acidosis: See boxed warning. (5.1) There have been postmarketing reports of acute pancreatitis,including fatal and non-fatal hemorrhagic or necrotizing pancreatitis.If pancreatitis is suspected, promptly discontinue JANUMET. (5.2) Heart failure has been observed with two other members of theDPP-4 inhibitor class. Consider risks and benefits of JANUMET in patients who have known risk factors for heart failure. Monitorpatients for signs and symptoms. (5.3) There have been postmarketing reports of acute renal failure,sometimes requiring dialysis. Before initiating JANUMET and atleast annually thereafter, assess renal function. (5.4) Vitamin B12 deficiency: Metformin may lower vitamin B12 levels.Measure hematologic parameters annually. (5.5) When used with an insulin secretagogue (e.g., sulfonylurea) or withinsulin, a lower dose of the insulin secretagogue or insulin may berequired to reduce the risk of hypoglycemia. (5.7) There have been postmarketing reports of serious allergic andhypersensitivity reactions in patients treated with sitagliptin (one ofthe components of JANUMET), such as anaphylaxis, angioedema,and exfoliative skin conditions including Stevens-Johnsonsyndrome. In such cases, promptly stop JANUMET, assess forother potential causes, institute appropriate monitoring andtreatment, and initiate alternative treatment for diabetes. (5.9) Severe and disabling arthralgia has been reported in patients takingDPP-4 inhibitors. Consider as a possible cause for severe joint painand discontinue drug if appropriate. (5.10) There have been postmarketing reports of bullous pemphigoidrequiring hospitalization in patients taking DPP-4 inhibitors. Tellpatients to report development of blisters or erosions. If bullouspemphigoid is suspected, discontinue JANUMET. (5.11) There have been no clinical studies establishing conclusiveevidence of macrovascular risk reduction with JANUMET. (5.12)------------------------------ A most common adverse reactions reported in ≥5% of patientssimultaneously started on sitagliptin and metformin and morecommonly than in patients treated with placebo were diarrhea,upper respiratory tract infection, and headache. (6.1) Adverse reactions reported in ≥5% of patients treated withsitagliptin in combination with sulfonylurea and metformin and morecommonly than in patients treated with placebo in combination withsulfonylurea and metformin were hypoglycemia and headache. (6.1) Hypoglycemia was the only adverse reaction reported in ≥5% ofpatients treated with sitagliptin in combination with insulin andmetformin and more commonly than in patients treated withplacebo in combination with insulin and metformin. (6.1)To report SUSPECTED ADVERSE REACTIONS, contact MerckSharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.-------------------------------DRUG INTERACTIONS------------------------------- Carbonic anhydrase inhibitors may increase risk of lactic acidosis.Consider more frequent monitoring. (7.1) Drugs that reduce metformin clearance (such as ranolazine,vandetanib, dolutegravir, and cimetidine) may increase theaccumulation of metformin. Consider the benefits and risks ofconcomitant use. (7.2) Alcohol can potentiate the effect of metformin on lactatemetabolism. Warn patients against excessive alcohol intake. (7.3)----------------------- USE IN SPECIFIC POPULATIONS ----------------------- There are no adequate and well-controlled studies in pregnantwomen. To report drug exposure during pregnancy call 1-800-986-8999. (8.1) Geriatric Use: Assess renal function more frequently. (8.5) Hepatic Impairment: Avoid use in patients with hepatic impairment.(8.7)See 17 for PATIENT COUNSELING INFORMATION and MedicationGuide.
JANUMET 50MG/500MG