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Safety is not established in severe hepatic impairment and NYHA (classification III ~ IV) heart failure patients. There is a risk of hypoglycemia if administered along with insulin formulations or sulfonylurea drugs.
There is a risk of hypoglycemia [state or patient listed as follows]: Adrenal insufficiency or pituitary gland dysfunction; Debilitating condition, malnourishment, starvation, irregular dietary intake, or lack of dietary intake; Intense muscular exercise; Excessive alcohol intake.
There is a risk of intestinal obstruction in patients with a history of bowel obstruction or a history of abdominal surgery.
There is a possibility that adverse reactions, such as QT prolongation, might occur. Caution in patients prone to QT prolongation (patients with heart disease such as congestive heart failure, patients having hypokalemia, patients with or with a history of arrhythmia such as severe bradycardia).
Acute pancreatitis: Use of DPP-4 inhibitors has been associated with a risk of developing acute pancreatitis. Patients should be informed of the characteristic symptom of acute pancreatitis (persistent, severe abdominal pain). Resolution of pancreatitis has been observed after discontinuation of DPP-4 inhibitors (with or without supportive treatment), but very rare cases of necrotizing or hemorrhagic pancreatitis and/or death have been reported. If pancreatitis is suspected, the Teneligliptin plus Pioglitazone tablet and other potentially suspect medicinal products should be discontinued. Caution should be exercised in patients with a history of pancreatitis.
Hypoglycemia: Patients receiving Teneligliptin plus Pioglitazone tablet in combination with a sulphonylurea or with insulin may be at risk for hypoglycemia. Therefore, a reduction in the dose of the sulphonylurea or insulin may be necessary.
Hypersensitivity reactions: Serious hypersensitivity reactions have been reported in patients treated with other DPP-4 inhibitors. These reactions include anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. If a hypersensitivity reaction is suspected, the medication should be discontinued, other potential causes of the event should be assessed, and alternative treatment for diabetes should be instituted.
Change in clinical status of patients with previously controlled type 2 diabetes: A patient with type 2 diabetes previously well controlled on Teneligliptin plus Pioglitazone combination that develops laboratory abnormalities or clinical illness (especially vague and poorly defined illness) should be evaluated promptly for evidence of ketoacidosis or lactic acidosis. Evaluation should include serum electrolytes and ketones, blood glucose and if indicated, blood pH, lactate, pyruvate levels. If acidosis of either form occurs, Teneligliptin plus Pioglitazone tablet must be stopped immediately and other appropriate corrective measures initiated.
QT prolongation: QT prolongation has been observed with very high doses of Teneligliptin (160 mg). Special caution is required in the administration of Teneligliptin to patients who are prone to QT prolongation. In addition, the coadministration of Teneligliptin with drugs known to cause QT prolongation on their own, such as class IA or class III antiarrhythmic drugs should be performed with caution.
Fluid retention and cardiac failure: Pioglitazone can cause fluid retention, which may exacerbate or precipitate heart failure. When treating patients who have at least one risk factor for development of congestive heart failure (e.g. prior myocardial infarction or symptomatic coronary artery disease or the elderly), physicians should start with the lowest available dose and increase the dose gradually. Patients should be observed for signs and symptoms of heart failure, weight gain or edema; particularly those with reduced cardiac reserve. Since insulin and Pioglitazone are both associated with fluid retention, concomitant administration of insulin may increase the risk of edema. Therapy should be discontinued if any deterioration in cardiac status occurs.
Bladder cancer: Cases of bladder cancer were reported more frequently in clinical trials with Pioglitazone. A possible risk after short-term treatment cannot be excluded. Risk factors for bladder cancer should be assessed before initiating Pioglitazone treatment (risks include age, smoking history, exposure to some occupational or chemotherapy agents e.g. cyclophosphamide or prior radiation treatment in the pelvic region). Any macroscopic hematuria should be investigated before starting Pioglitazone therapy.
Patients should be advised to promptly seek the attention of their physician if macroscopic hematuria or other symptoms such as dysuria or urinary urgency develop during treatment.
Monitoring of liver function: There have been rare reports of elevated liver enzymes and hepatocellular dysfunction during post-marketing experience with Pioglitazone. It is recommended, therefore, that patients treated with Teneligliptin plus Pioglitazone tablet undergo periodic monitoring of liver enzymes. Liver enzymes should be checked prior to the initiation of therapy in all patients. Therapy should not be initiated in patients with increased baseline liver enzyme levels (ALT > 2.5 times upper limit of normal) or with any other evidence of liver disease.
Following initiation of therapy, it is recommended that liver enzymes be monitored periodically according to clinical judgement. If ALT levels are increased to 3 times upper limit of normal during therapy, therapy should be discontinued. If any patient develops symptoms suggesting hepatic dysfunction, which may include unexplained nausea, vomiting, abdominal pain, fatigue, anorexia and/or dark urine, liver enzymes should be checked. The decision whether to continue the patient on therapy with Teneligliptin plus Pioglitazone tablet should be guided by clinical judgement pending laboratory evaluations. If jaundice is observed, the medicinal product should be discontinued.
Weight gain: In clinical trials with Pioglitazone there was evidence of dose related weight gain, which may be due to fat accumulation and in some cases associated with fluid retention. In some cases weight increase may be a symptom of cardiac failure, therefore weight should be closely monitored.
Hematology: There was a small reduction in mean hemoglobin (4% relative reduction) and hematocrit (4.1% relative reduction) during therapy with Pioglitazone, consistent with hemodilution.
Hypoglycemia: Patients receiving Pioglitazone with a sulphonylurea may be at risk for dose-related hypoglycemia, and a reduction in the dose of the sulphonylurea may be necessary.
Eye disorders: Post-marketing reports of new-onset or worsening diabetic macular edema with decreased visual acuity have been reported with thiazolidinediones, including Pioglitazone. Many of these patients reported concurrent peripheral edema. It is unclear whether or not there is a direct association between Pioglitazone and macular edema but prescribers should be alert to the possibility of macular edema if patients report disturbances in visual acuity; an appropriate ophthalmological referral should be considered.
Polycystic ovarian syndrome: As a consequence of enhancing insulin action, Pioglitazone treatment in patients with polycystic ovarian syndrome may result in resumption of ovulation. These patients may be at risk of pregnancy. Patients should be aware of the risk of pregnancy and if a patient wishes to become pregnant or if pregnancy occurs, the treatment should be discontinued.
Others: An increased incidence in bone fractures in women was seen in clinical trials with Pioglitazone. The risk of fractures should be considered in the long term care of patients treated with Pioglitazone.
Pioglitazone should be used with caution during concomitant administration of cytochrome P450 2C8 inhibitors (e.g. gemfibrozil) or inducers (e.g. rifampicin). Glycemic control should be monitored closely. Pioglitazone dose adjustment within the recommended posology or changes in diabetic treatment should be considered.
Effects On Ability to Drive and Use Machines: When driving or using machines, it should be taken into account that dizziness and somnolence has been reported with DPP-4 inhibitors. In addition, patients should be alerted to the risk of hypoglycemia when Teneligliptin plus Pioglitazone tablet is used in combination with a sulphonylurea or with insulin.
Use in the Elderly: Combination use with insulin should be considered with caution in the elderly because of increased risk of serious heart failure. In light of age-related risks (especially bladder cancer, fractures and heart failure), the balance of benefits and risks should be considered carefully both before and during treatment in the elderly.
