COMPOSITION

DESCRIPTION

Janutab is a combination of two antihyperglycemic agents (sitagliptin and metformin) with complementary mechanism to improve blood sugar control in type 2 diabetics. Sitagliptin increases insulin secretion and decreases glucagon secretion through selective inhibition of the enzyme (DPP-4) dipeptidyl peptidase 4, and this enzyme in turn inhibits the hormones (GLP-1) glucagon like peptide-1 and (GIP) glucose dependent insulinotropic polypeptide that are released from the intestine which are responsible for regulating the levels of glucose in the blood by increasing the production and secretion of insulin from the pancreas when blood glucose levels are high, as the hormone (GLP-1) reduces the secretion of glucagon from the pancreatic alpha cells, and thus the production of glucose from the liver decreases. While metformin, is a member of the biguanide class, lowering basal and postprandial plasma glucose. It acts by reduction of hepatic glucose production, increasing insulin sensitivity in muscles and delay intestinal glucose absorption.

INDICATION

Janutab is indicated to glycemic control in adult patients with type 2 diabetes mellitus as an adjunct to proper diet and exercise.

DOSAGE & ADMINISTRATION

RESTRICTIONS ON USE

Contraindications

• Hypersensitivity to sitagliptin or metformin.
• Acute or chronic metabolic acidosis (as: lactic acidosis, ketoacidosis).
• Conditions with potential to alter renal function such as: dehydration, sever infection, shock, IV administration of iodine contrast for X-ray examination.
• Cardiac or respiratory failure, recent myocardial infarction.
• Patients with hepatic discasc.
• Severe renal impairment: (creatinine clearance rate below 30 mL/min).
• patients with typel diabetes, diabetic precoma.

Precautions

• If pancreatitis or Bullous Pemphigoid are suspected, promptly discontinue Janutab.
• Janutab should be temporarity suspended for any surgical procedure and should not be restarted until the patient becomes able to eat and confirm the renal function is normal.
• The caution should be taken in case of impairment of renal or hepatic function, hypoglycemia, Vitamin B12 deficiency, erosions and blisters or patients who use insulin secretagogue medicines (sulfonylurea) or have history of pancreas disease or eldery patients.

Effects on the ability to drive vehicles or use machines

There is no information to suggest that Janutab affects the ability to drive or use machines.

Use in pregnancy and lactation

Janutab should not be used during pregnancy and lactation.

DRUG INTERACTIONS

• Co-administration of Janutab with digoxin should be monitored.
• Co-administration of Janutab with insulin secretagogue drug (e.g., sulfonylurea) or insulin increase the risk of hypoglycemia.
• Co-administration of Janutab with Carbonic anhydrase inhibitors increase risk of lactic acidosis.
• Thiazide and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, calcium channel blockers and isoniazid leads to loss of glycemic control when use with janutab.
• Caution should be taken when use Janutab with furosemide or nifedipine, NSAIDs, Drugs that reduce metformin clearance such as ranolazine, vandctanib, dolutegravir, and cimetidine.

ADVERSE EFFECTS

OVERDOSAGE

In case of overdosage, gastric lavage and monitor ECG should be done and institute supporting therapy. Hemodialysis may be useful for removal of overdosage of metformine. Sitagliptin may be removed by prolonged hemodialysis.

STORAGE INSTRUCTIONS

Store below 30°C, in a dry place.

PRESENTATIONS