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JANUVIA (SITAGLIPTIN): WARNINGS AND PRECAUTIONS

Pancreatitis

There have been postmarketing reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, in patients taking Januvia (Sitagliptin Phosphate). After initiation of Sitagliptin Phosphate (Januvia), patients should be observed carefully for signs and symptoms of pancreatitis. If pancreatitis is suspected, Sitagliptin (Januvia) 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.

Renal Impairment

Assessment of renal function is recommended prior to initiating Januvia (Sitagliptin Phosphate) and periodically thereafter. A dosage adjustment is recommended in patients with moderate or severe renal insufficiency and in patients with ESRD requiring hemodialysis or peritoneal dialysis. Caution should be used to ensure that the correct dose of Januvia is prescribed for patients with moderate (creatinine clearance >= 30 to < 50 ml / min) or severe (creatinine clearance < 30 ml / min) renal impairment.

There have been postmarketing reports of worsening renal function, including acute renal failure, sometimes requiring dialysis. A subset of these reports involved patients with renal insufficiency, some of whom were prescribed inappropriate doses of sitagliptin. A return to baseline levels of renal insufficiency has been observed with supportive treatment and discontinuation of potentially causative agents. Consideration can be given to cautiously reinitiating Januvia (Sitagliptin) if another etiology is deemed likely to have precipitated the acute worsening of renal function.

Sitagliptin (Januvia) has not been found to be nephrotoxic in preclinical studies at clinically relevant doses, or in clinical trials.

Use with Medications Known to Cause Hypoglycemia

When Sitagliptin Phosphate (Januvia) was used in combination with a sulfonylurea or with insulin, medications known to cause hypoglycemia, the incidence of hypoglycemia was increased over that of placebo used in combination with a sulfonylurea or with insulin. Therefore, a lower dose of sulfonylurea or insulin may be required to reduce the risk of hypoglycemia.

Hypersensitivity Reactions

There have been postmarketing reports of serious hypersensitivity reactions in patients treated with Januvia. These reactions include anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Onset of these reactions occurred within the first 3 months after initiation of treatment with Januvia (Sitagliptin Phosphate), with some reports occurring after the first dose. If a hypersensitivity reaction is suspected, discontinue this medicine, assess for other potential causes for the event, and institute alternative treatment for diabetes.

Macrovascular Outcomes

There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Januvia (Sitagliptin) or any other anti-diabetic drug.

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