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JANUMET (METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE) TABLETS: WARNINGS

Pancreatitis

There have been postmarketing reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, in patients taking Janumet (Sitagliptin, Metformin). After initiation of Janumet, patients should be observed carefully for signs and symptoms of pancreatitis. If pancreatitis is suspected, Sitagliptin with Metformin (Janumet) should promptly be discontinued and appropriate management should be initiated. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using this drug.

Impaired Hepatic Function

Since impaired hepatic function has been associated with some cases of lactic acidosis, Sitagliptin Phosphate with Metformin HCl (Janumet) should generally be avoided in patients with clinical or laboratory evidence of hepatic disease.

Assessment of Renal Function

Metformin and sitagliptin are known to be substantially excreted by the kidney. The risk of metformin accumulation and lactic acidosis increases with the degree of impairment of renal function. Thus, patients with serum creatinine levels above the upper limit of normal for their age should not receive Janumet. In the elderly, this medicine should be carefully titrated to establish the minimum dose for adequate glycemic effect, because aging can be associated with reduced renal function.

There have been postmarketing reports of worsening renal function, including acute renal failure, sometimes requiring dialysis. Before initiation of therapy with Janumet (Sitagliptin Phosphate, Metformin Hydrochloride) and at least annually thereafter, renal function should be assessed and verified as normal. In patients in whom development of renal dysfunction is anticipated, particularly in elderly patients, renal function should be assessed more frequently and Janumet discontinued if evidence of renal impairment is present.

Vitamin B12 Levels

In controlled clinical trials of metformin of 29 weeks duration, a decrease to subnormal levels of previously normal serum Vitamin B12 levels, without clinical manifestations, was observed in approximately 7% of patients. Such decrease, possibly due to interference with B12 absorption from the B12-intrinsic factor complex, is, however, very rarely associated with anemia and appears to be rapidly reversible with discontinuation of metformin or Vitamin B12 supplementation. Measurement of hematologic parameters on an annual basis is advised in patients on Janumet (Sitagliptin Phosphate, Metformin HCl) and any apparent abnormalities should be appropriately investigated and managed.

Certain individuals (those with inadequate Vitamin B12 or calcium intake or absorption) appear to be predisposed to developing subnormal Vitamin B12 levels. In these patients, routine serum Vitamin B12 measurements at two- to three-year intervals may be useful.

Alcohol Intake

Alcohol is known to potentiate the effect of metformin on lactate metabolism. Patients, therefore, should be warned against excessive alcohol intake, acute or chronic, while receiving Janumet (Sitagliptin, Metformin).

Surgical Procedures

Use of Sitagliptin with Metformin (Janumet) should be temporarily suspended for any surgical procedure (except minor procedures not associated with restricted intake of food and fluids) and should not be restarted until the patient's oral intake has resumed and renal function has been evaluated as normal.



Janumet (Metformin HCl, Sitagliptin Phosphate) related pharmaceutical drugs and medications

Trade name of the drug Pharmaceutical forms and doses Companies
Sitagliptin Ratiopharm
  • Tablets, Film-Coated; Oral; Sitagliptin Phosphate 25 mg
  • Tablets, Film-Coated; Oral; Sitagliptin Phosphate 50 mg
  • Tablets, Film-Coated; Oral; Sitagliptin Phosphate 100 mg
  • Ratiopharm


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