Tenelia

Tenelia

teneligliptin

Manufacturer:

Mitsubishi Tanabe Pharma

Distributor:

DKSH

Marketer:

Mitsubishi Tanabe Pharma
Concise Prescribing Info
Contents
Teneligliptin
Indications/Uses
Monotherapy as adjunct to diet & exercise to improve glycemic control in type 2 DM. In combination w/ metformin, sulfonylureas, peroxisome proliferator-activated receptor (PPAR) agonist (eg, thiazolidinediones), rapid insulin secretagogues, α-glucosidase inhibitors, Na glucose co-transporter 2 inhibitor, or insulin to improve glycemic control in type 2 DM when the single agent alone, w/ diet & exercise, does not provide adequate glycemic control.
Dosage/Direction for Use
Adult 20 mg once daily. May be increased to 40 mg once daily.
Administration
May be taken with or without food.
Contraindications
History of hypersensitivity. Severe ketosis, diabetic coma or precoma, type 1 DM. Severe infection, pre- or post-op patients, & patients w/ serious traumatic injury.
Special Precautions
Patients w/ cardiac failure (NYHA class III or IV); current or history of arrhythmia (eg, severe bradycardia), cardiac disease (eg, CHF), & hypokalaemia as they are prone to QT interval prolongation; history of abdominal operation or intestinal obstruction. Avoid in patients w/ current or history of QT interval prolongation (congenital long QT syndrome) or Torsades de Pointes. Concomitant use w/ sulfonylurea or insulin. Hypoglycaemia may occur in patients w/ pituitary or adrenal insufficiency; malnutrition, starvation, irregular diet, insufficient food intake or hyposthenia; extreme muscle exercise; excessive alcohol intake. Regularly monitor blood glucose & check drug effect during treatment. Acute pancreatitis. Severe hepatic impairment. May impair ability to drive & use machines caused by hypoglycemic symptoms. Pregnancy. Discontinue breastfeeding during treatment. Low-birth wt infants, neonate, nursing infants or childn. Elderly.
Adverse Reactions
Hypoglycaemia, intestinal obstruction, hepatic impairment, interstitial pneumonia, pemphigoid, acute pancreatitis. Constipation, abdominal distension, discomfort & pain, nausea, flatulence, stomatitis, gastric & colonic polyp, duodenal ulcer, reflux esophagitis, diarrhoea, decreased appetite, increased amylase & lipase; increased AST, ALT & γ-glutamyl transpeptidase (GTP); proteinuria, urine ketone body & blood urine present; eczema, rash, itching, allergic dermatitis; arthralgia; increased serum creatine kinase (CK), K & uric acid, malaise, allergic rhinitis.
Drug Interactions
Increased hypoglycemia w/ sulfonylurea, rapid-acting insulin secretagogues, α-glucosidase inhibitors, biguanides, thiazolidines, glucagon-like peptide-1 (GLP-1) receptor agonists, Na-glucose co-transporter-2 (SGLT2) inhibitors, insulin. Decreased blood glucose w/ β-blockers, salicylic acid, MAOIs. Antihyperglycaemic action may be reduced w/ adrenaline, adrenocortical & thyroid hormones. QT interval prolongation may occur w/ class IA (quinidine sulfate hydrate, procainamide HCl) & class III (amiodarone HCl, sotalol HCl) antiarrhythmics.
MIMS Class
Antidiabetic Agents
ATC Classification
A10BH08 - teneligliptin ; Belongs to the class of dipeptidyl peptidase 4 (DPP-4) inhibitors. Used in the treatment of diabetes.
Presentation/Packing
Form
Tenelia FC tab 20 mg
Packing/Price
3 × 10's
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