Teneligliptin is indicated for the treatment of Type 2 Diabetes Mellitus as a mono-therapy, adjunct to diet and exercise.
20 mg tablets.
The usual adult dosage is 20 mg of teneligliptin administered orally once daily. If efficacy is insufficient, the dose may be increased up to 40 mg once daily while closely monitoring the clinical course.
Teneligliptin is contraindicated in the following:
- Any patient with a known hypersensitivity to teneligliptin or any of the components in the formulation,
- Severe ketosis, diabetic coma or history of diabetic coma, type 1 diabetic patients,
- Patients with severe infection, surgery, severe trauma (blood sugar control should preferably be done by insulin).
Teneligliptin should be administered carefully in the following:
- Patients with advanced liver failure (safety has not been established),
- Patients with congestive heart failure (NYHA category III-IV) (safety has not been established),
- Patients with pituitary insufficiency or adrenal insufficiency, poor nutritional state, starvation, an irregular dietary intake, or debilitating condition, intense muscle movement or excessive alcohol intake (may cause low blood sugar),
- Patients with history of abdominal surgery or with a history of bowel obstruction (may cause bowel obstruction),
- Patients with arrhythmia, severe bradycardia or its history, patients with heart disease such as congestive heart failure or patients with low serum potassium, congenital prolonged QT syndrome, history of Torsades de pointes or patients using antiarrhythmic drugs (may cause QT prolongation),
- Patients using an insulin secretagogue (e.g., sulfonylurea) (risk of severe hypoglycaemia).
Teneligliptin should be used with caution with drugs that can enhance the blood glucose lowering effect (like β blockers, MAO inhibitors, etc.) and attenuate the blood glucose lowering effect (like steroids, thyroid hormones, etc).
On concomitant therapy with ketoconazole, the geometric least squares mean ratio (concomitant therapy/teneligliptin monotherapy) of Cmax and AUC0-t of unchanged plasma teneligliptin with their two-sided 90% CI is 1.37 [1.25, 1.50] and 1.49 [1.38, 1.60], respectively.
Teneligliptin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Safe use of teneligliptin during pregnancy has not been established. Teneligliptin should be avoided by breastfeeding mothers (transition to milk has been reported in laboratory animals).
Safety and effectiveness of teneligliptin in pediatric patients have not been established.
The most common adverse reactions reported with teneligliptin are hypoglycemia and constipation. Other adverse reactions reported with teneligliptin are:
Gastrointestinal Disorders: Intestinal obstruction, abdominal bloating, abdominal discomfort, nausea, abdominal pain, flatulence, stomatitis, gastric polyps, colon polyps, duodenal ulcer, reflux esophagitis, diarrhea, loss of appetite, increased amylase, lipase increased, acute pancreatitis.
Kidney and Urinary system: Proteinuria, urine ketone-positive.
Skin and Subcutaneous Tissue Disorders: Eczema, rash, itching, allergic dermatitis.
Investigations: Increase in AST, ALT, γ-GTP and ALP.
Others: Increased CPK, increased serum potassium, fatigue, allergic rhinitis, elevation of serum uric acid