Tenelizone

Tenelizone

Manufacturer:

Ajanta Pharma Phil

Distributor:

Ajanta Pharma Phil
Concise Prescribing Info
Contents
Per 20 mg/15 mg FC tab Teneligliptin HBr hydrate 20 mg, pioglitazone HCl 15 mg. Per 20 mg/30 mg FC tab Teneligliptin HBr hydrate 20 mg, pioglitazone HCl 30 mg
Indications/Uses
Adjunct to diet & exercise, to improve glycemic control in patients w/ type II diabetes inadequately controlled on pioglitazone monotherapy.
Dosage/Direction for Use
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Patients w/ diabetic ketoacidosis, diabetic pre-coma; moderate & severe renal impairment (CrCl <60 mL/min); acute conditions w/ potential to alter renal function eg, dehydration, severe infection, shock, intravascular administration of iodinated contrast agents, current/history of bladder cancer & uninvestigated macroscopic hematuria. Not suitable for severe infection, before & after surgery, glycemic control by insulin inj. Acute or chronic disease which may cause tissue hypoxia eg, cardiac or resp failure, recent MI, shock, hepatic impairment, acute alcohol intoxication, alcoholism. Pregnancy & lactation.
Special Precautions
NYHA (class III-IV) heart failure patients. Hypoglycemia. Concomitant use w/ insulin formulations or sulfonylurea drugs. Adrenal insufficiency or pituitary gland dysfunction; debilitating condition, malnourishment, starvation, irregular or lack of dietary intake; intense muscular exercise; excessive alcohol intake. Patients w/ history of bowel obstruction or abdominal surgery. Acute or history of pancreatitis. Discontinue if hypersensitivity reactions are suspected. Change in clinical status of patients w/ previously controlled type 2 diabetes; evaluate promptly for evidence of ketoacidosis or lactic acidosis. Periodic monitoring of liver function; discontinue if jaundice is observed. May affect ability to drive & use machines. Severe hepatic impairment. Elderly. Teneligliptin: Patients prone to QT prolongation (patients w/ heart disease eg, CHF, having hypokalemia, w/ or w/ history of arrhythmia eg, bradycardia). Concomitant use w/ drugs known to cause QT prolongation eg, class IA or III antiarrhythmic drugs. Pioglitazone: Fluid retention & cardiac failure. Discontinue therapy if any deterioration in cardiac status occurs. Assess risk factors for bladder cancer (including age, smoking history, exposure to some occupational or chemotherapy agents eg, cyclophosphamide or prior radiation treatment in the pelvic region) & investigate any macroscopic hematuria before initiating treatment. Wt gain. New-onset or worsening diabetic macular edema w/ decreased visual acuity. Polycystic ovarian syndrome. Bone fractures in women. Concomitant use w/ cytochrome P4502C8 inhibitors (eg, gemfibrozil) or inducers (eg, rifampicin).
Adverse Reactions
Teneligliptin: Hypoglycemia & constipation. Intestinal obstruction. Pioglitazone: Upper resp tract infection; hypo-aesthesia; visual disturbance; fracture bone; increased wt.
Drug Interactions
Teneligliptin: Enhanced blood glucose lowering effect w/ diabetes & sulfonylurea drugs, rapid acting secretagogue, α-glucosidase inhibitor, biguanides, thiazolidinediones, GLP-1 analog formulation, insulin prep; β-blocker agent, salicylic acid, MAOIs. Attenuated blood glucose lowering effect w/ adrenaline & adrenal cortical hormone. May cause QT prolongation w/ class IA (eg, quinidine sulfate hydrate, procainamide HCl) & class III (eg, amiodarone HCl, sotalol HCl) antiarrhythmic drugs. Pioglitazone: Increased AUC w/ gemfibrozil. Decreased AUC w/ rifampicin.
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.
A10BG03 - pioglitazone ; Belongs to the class of thiazolidinediones. Used in the treatment of diabetes.
Presentation/Packing
Form
Tenelizone 20 mg/15 mg FC tab
Packing/Price
30's
Form
Tenelizone 20 mg/30 mg FC tab
Packing/Price
30's
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