Glipten Special Precautions



Ajanta Pharma Phil


Ajanta Pharma Phil
Full Prescribing Info
Special Precautions
Patients with severe hepatic impairment (Safety has not been investigated/established).
Patients with heart failure NYHA classification III-IV (Safety has not been investigated/established).
Patients with pituitary or adrenal insufficiency, poor nutritional state, starvation, irregular food intake, or debilitating condition, intensive exercise or excessive alcohol intake (may enhance blood glucose lowering effect).
Patients taking medication that may enhance the blood glucose lowering effect of Teneligliptin (β-blockers, MAO Inhibitors, etc.) or attenuate the blood glucose lowering effect of Teneligliptin (steroids, thyroid hormones, etc.).
History of bowel obstruction or a history of abdominal surgery. (Rare cases of intestinal obstruction have been reported with the use of DPP-4 Inhibitors, including Teneligliptin).
Patients taking sulfonylureas or insulin (The risk of hypoglycemia is increased). Reduce dose of sulfonylurea or insulin.
In a randomized, double-blind, placebo and moxifloxacin-controlled thorough QT/QTc comparative study (n=240), supratherapeutic doses of Teneligliptin 160 mg once daily (8 times the usual dose and 4 times the maximum recommended daily dose) momentarily prolonged QTc interval by 9.3 msec at around the time of Tmax. No clinically significant change in QTc interval was observed with the maximum recommended dose of Teneligliptin 40 mg once daily (3.9 msec). In clinical trials involving up to 904 subjects with Type 2 diabetes, no adverse events related to QTc prolongation were detected with Teneligliptin when used up to its maximum daily dose of 40 mg/day. Nevertheless, Teneligliptin should be used with caution in subjects who are prone to QT prolongation; patients with or with a medical history of arrhythmia, bradycardia, heart failure, low serum potassium, Torsades de pointes, or patients using antiarrhythmic drugs (Class IA and III antiarrhythmics).
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