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JANUMET (METFORMIN, SITAGLIPTIN): PATIENT INFORMATION

See FDA-Approved Patient Labeling (Medication Guide).

Instructions

Patients should be informed of the potential risks and benefits of Janumet and of alternative modes of therapy. They should also be informed about the importance of adherence to dietary instructions, regular physical activity, periodic blood glucose monitoring and A1C testing, recognition and management of hypoglycemia and hyperglycemia, and assessment for diabetes complications. During periods of stress such as fever, trauma, infection, or surgery, medication requirements may change and patients should be advised to seek medical advice promptly.

The risks of lactic acidosis due to the metformin component, its symptoms, and conditions that predispose to its development, should be explained to patients. Patients should be advised to discontinue Janumet (Sitagliptin, Metformin) immediately and to promptly notify their health practitioner if unexplained hyperventilation, myalgia, malaise, unusual somnolence, dizziness, slow or irregular heart beat, sensation of feeling cold (especially in the extremities) or other nonspecific symptoms occur. Gastrointestinal symptoms are common during initiation of metformin treatment and may occur during initiation of Sitagliptin with Metformin (Janumet) therapy; however, patients should consult their physician if they develop unexplained symptoms. Although gastrointestinal symptoms that occur after stabilization are unlikely to be drug related, such an occurrence of symptoms should be evaluated to determine if it may be due to lactic acidosis or other serious disease.

Patients should be counseled against excessive alcohol intake, either acute or chronic, while receiving Sitagliptin Phosphate with Metformin HCl (Janumet).

Patients should be informed about the importance of regular testing of renal function and hematological parameters when receiving treatment with Janumet.

Patients should be informed that acute pancreatitis has been reported during postmarketing use of Janumet (Sitagliptin Phosphate, Metformin Hydrochloride). Patients should be informed that persistent severe abdominal pain, sometimes radiating to the back, which may or may not be accompanied by vomiting, is the hallmark symptom of acute pancreatitis.

Patients should be instructed to promptly discontinue Janumet (Sitagliptin Phosphate, Metformin HCl) and contact their physician if persistent severe abdominal pain occurs.

Patients should be informed that the incidence of hypoglycemia is increased when Janumet (Sitagliptin, Metformin) is added to an insulin secretagogue (e.g., sulfonylurea) or insulin therapy and that a lower dose of the insulin secretagogue or insulin may be required to reduce the risk of hypoglycemia.

Patients should be informed that allergic reactions have been reported during postmarketing use of sitagliptin, one of the components of Sitagliptin with Metformin (Janumet). If symptoms of allergic reactions (including rash, hives, and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing) occur, patients must stop taking Janumet and seek medical advice promptly.

Inform patients that severe and disabling joint pain may occur with this class of drugs. The time to onset of symptoms can range from one day to years. Instruct patients to seek medical advice if severe joint pain occurs.

Patients should be informed that the tablets must never be split or divided before swallowing.

Physicians should instruct their patients to read the Medication Guide before starting Sitagliptin Phosphate with Metformin HCl (Janumet) therapy and to reread each time the prescription is renewed. Patients should be instructed to inform their doctor if they develop any bothersome or unusual symptom, or if any symptom persists or worsens.

Laboratory Tests

Response to all diabetic therapies should be monitored by periodic measurements of blood glucose and A1C levels, with a goal of decreasing these levels towards the normal range. A1C is especially useful for evaluating long-term glycemic control.

Initial and periodic monitoring of hematologic parameters (e.g., hemoglobin / hematocrit and red blood cell indices) and renal function (serum creatinine) should be performed, at least on an annual basis. While megaloblastic anemia has rarely been seen with metformin therapy, if this is suspected, Vitamin B12 deficiency should be excluded.

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