Januet 50/1,000 mg

/ MSD

The dose should be individualized on the basis of the patient’s current regimen, effectiveness, and tolerability while not exceeding the maximum recommended daily dose of 100 mg sitagliptin and 2000 mg metformin. Initial combination therapy or maintenance of combination therapy should be individualized and left to the discretion of the health care provider. In patients not currently treated with metformin, the recommended total daily starting dose is 100 mg sitagliptin and 1000 mg metformin hydrochloride (HCl) extended-release. Patients with inadequate glycemic control on this dose of metformin can be titrated gradually, to reduce gastrointestinal side effects associated with metformin, up to the maximum recommended daily dose. In patients already treated with metformin, the recommended total daily starting dose is 100 mg sitagliptin and the previously prescribed dose of metformin.
For patients taking metformin immediate-release 850 mg twice daily or 1000 mg twice daily, the recommended starting dose is two 50 mg sitagliptin/1000 mg metformin hydrochloride extended-release tablets taken together once daily.
Maintain the same total daily dose of sitagliptin and metformin when changing between JANUET (sitagliptin and metformin HCl immediate-release) and JANUET XR. Patients with inadequate glycemic control on this dose of metformin can be titrated gradually, to reduce gastrointestinal side effects associated with metformin, up to the maximum recommended daily dose. This product should be administered with food to reduce the gastrointestinal side effects associated with the metformin component. It should be given once daily with a meal preferably in the evening. It should be swallowed whole. The tablets must not be split, crushed, or chewed before swallowing.
The 100 mg sitagliptin/1000 mg metformin hydrochloride extended-release tablet should be taken as a single tablet once daily. Patients using two XR tablets (such as two 50 mg sitagliptin/500 mg metformin hydrochloride extended-release tablets or two 50 mg sitagliptin/1000 mg metformin hydrochloride extended-release tablets) should take the two tablets together once daily.
Patients treated with an insulin secretagogue or insulin: Co-administration of this drug with an insulin secretagogue (e.g., sulfonylurea) or insulin may require lower doses of the insulin secretagogue or insulin to reduce the risk of hypoglycemia. No studies have been performed specifically examining the safety and efficacy in patients previously treated with other oral antihyperglycemic agents and switched to this product. Any change in therapy of type 2 diabetes should be undertaken with care and appropriate monitoring as changes in glycemic control can occur.
The dose should be individualized on the basis of the patient’s current regimen, effectiveness, and tolerability while not exceeding the maximum recommended daily dose of 100 mg sitagliptin and 2000 mg metformin.
It should be administered once daily with food to reduce GI side effects associated with the metformin component, preferably in the evening. The tablets should be swallowed whole, must not be split, crushed, or chewed before swallowing.
100 mg /1000 mg XR tablets should be taken as a single tablet once daily. Patients using two tablets (such as two 50 mg sitagliptin/500 mg metformin hydrochloride extended-release tablets or two 50 mg sitagliptin/1000 mg metformin hydrochloride extended-release tablets) should take the two tablets together once daily.
For full details see prescribing information.

As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin extended-release is appropriate.

Renal impairment, which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia. Hypersensitivity to metformin hydrochloride. Acute or chronic metabolic acidosis, including diabetic ketoacidosis. History of a serious hypersensitivity reaction to the drug or sitagliptin.

– Lactic acidosis- a rare, but serious complication that can occur due to metformin accumulation. Risk increases with conditions such as sepsis, dehydration, excess alcohol intake, hepatic/renal impairment, and acute congestive heart failure.
– Pancreatitis- There have been postmarketing reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, in patients taking sitagliptin with or without metformin.
– Impaired Hepatic Function.
– Assessment of Renal Function.
See prescribing information for full details.

Upper Respiratory Tract Infection, nasopharyngitis, Headache, Nausea, Vomiting, Abdominal Pain, Hypoglycemia most likely when co-administered with a sulfonylurea or with insulin.
See prescribing information for full details.

Pregnancy Category B: JANUET There are no adequate and well-controlled studies in pregnant women with JANUET or its individual components; therefore, the safety of JANUET in pregnant women is not known. JANUET should be used during pregnancy only if clearly needed. No animal studies have been conducted with the combined products in JANUET to evaluate effects on reproduction. The following data are based on findings in studies performed with sitagliptin or metformin individually.
Nursing Mothers: No studies in lactating animals have been conducted with the combined components of JANUET. In studies performed with the individual components, both sitagliptin and metformin are secreted in the milk of lactating rats. It is not known whether sitagliptin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when JANUET is administered to a nursing woman.
For full details see prescribing information.

Sitagliptin: During controlled clinical trials in healthy subjects, single doses of up to 800 mg sitagliptin were administered. Maximal mean increases in QTc of 8.0 msec were observed in one study at a dose of 800 mg sitagliptin, a mean effect that is not considered clinically important. There is no experience with doses above 800 mg in clinical studies. In Phase I multiple-dose studies, there were no dose-related clinical adverse reactions observed with sitagliptin with doses of up to 400 mg per day for periods of up to 28 days.
In the event of an overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring (including obtaining an electrocardiogram), and institute supportive therapy as indicated by the patient’s clinical status. Sitagliptin is modestly dialyzable. In clinical studies, approximately 13.5% of the dose was removed over a 3- to 4-hour hemodialysis session. Prolonged hemodialysis may be considered if clinically appropriate. It is not known if sitagliptin is dialyzable by peritoneal dialysis.
Metformin Hydrochloride: Overdose of metformin hydrochloride has occurred, including ingestion of amounts greater than 50 grams. Hypoglycemia was reported in approximately 10% of cases, but no causal association with metformin hydrochloride has been established. Lactic acidosis has been reported in approximately 32% of metformin overdose cases. Metformin is dialyzable with a clearance of up to 170 mL/min under good hemodynamic conditions. Therefore, hemodialysis may be useful for removal of accumulated drug from patients in whom metformin overdose is suspected.