📌 COMPOSITION

• Each F/C caplet of Janutab 50 mg/500 mg contains: Sitagliptin (as phosphate monohydrate) 50 mg – Metformin hydrochloride 500 mg.
• Each F/C caplet of Janutab 50 mg/850 mg contains: Sitagliptin (as phosphate monohydrate) 50 mg – Metformin hydrochloride 850 mg.
• Each F/C caplet of Janutab plus 50 mg/1000 mg contains: Sitagliptin (as phosphate monohydrate) 50 mg – Metformin hydrochloride 1000 mg.

📌 DESCRIPTION

Janutab is a combination of two antihyperglycaemic agents (sitagliptin and metformin) with complementary mechanisms 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, and this enzyme in turn inhibits the hormones GLP-1 and GIP 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, a member of the biguanide class, lowers basal and postprandial plasma glucose. It acts by reduction of hepatic glucose production, increasing insulin sensitivity in muscles and delaying intestinal glucose absorption.

📌 INDICATIONS

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

📌 DOSAGE & ADMINISTRATION

• The recommended initial dose is 50 mg sitagliptin / 500 mg metformin HCl twice daily with a meal. Patients with inadequate glycaemic control on this dose can be titrated up to 50 mg sitagliptin / 1000 mg metformin HCl twice daily with a meal, with gradual dose escalation to reduce gastrointestinal side effects due to metformin.
• Dosage adjustment for patients with mild, moderate, severe and end‑stage renal disease, or patients receiving insulin and/or insulin secretagogues (e.g., sulfonylureas).
• Dosage adjustment is recommended in patients with renal diseases:
• Creatinine clearance rate (45-59) ml/min: the maximum daily dose of metformin is 2000 mg and the initial dose is half the daily dose; sitagliptin does not require dose adjustment (maximum daily dose 100 mg).
• Creatinine clearance rate (30-44) ml/min: the maximum daily dose of metformin is 1000 mg and the initial dose is half the daily dose; sitagliptin (maximum daily dose 50 mg).
• Creatinine clearance < 30 ml/min: metformin is contraindicated; sitagliptin maximum daily dose 25 mg.

Do not exceed the maximum recommended daily dose of 100 mg sitagliptin and 2000 mg metformin.

In patients at increased risk of further progression of renal impairment or with 30-40 ml/min GFR, and in the elderly, renal function should be assessed every 3-6 months.

Children: The safety and efficacy of Janutab in children and adolescents under 18 years of age have not been established.

📌 RESTRICTIONS ON USE

Contraindications

• Hypersensitivity to sitagliptin or metformin.
• Acute or chronic metabolic acidosis (e.g., lactic acidosis, ketoacidosis).
• Conditions with potential to alter renal function such as: dehydration, severe infection, shock, IV administration of iodine contrast for X‑ray examination.
• Cardiac or respiratory failure, recent myocardial infarction.
• Patients with hepatic disease.
• Severe renal impairment (creatinine clearance rate below 30 ml/min).
• Patients with type 1 diabetes, diabetic precoma.

Precautions

• Treatment with Janutab should be stopped immediately and the doctor consulted if symptoms of lactic acidosis appear, which include vomiting, abdominal pain with muscle cramps, fatigue and difficulty in breathing. This condition occurs due to metformin accumulation, especially in patients with renal impairment.
• If pancreatitis or bullous pemphigoid is suspected, promptly discontinue Janutab.
• Janutab should be temporarily suspended for any surgical procedure and should not be restarted until the patient becomes able to eat and renal function is confirmed to be normal.
• Caution should be taken in cases of impaired renal or hepatic function, hypoglycaemia, vitamin B12 deficiency, erosions and blisters, or patients who use insulin secretagogue medicines (sulfonylureas) or have a history of pancreatic disease or elderly 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 drugs (e.g., sulfonylureas) or insulin increases the risk of hypoglycaemia.
• Co‑administration of Janutab with carbonic anhydrase inhibitors increases the risk of lactic acidosis.
• Thiazide and other diuretics, corticosteroids, phenothiazines, thyroid products, oestrogens, oral contraceptives, phenytoin, nicotinic acid, calcium channel blockers and isoniazid lead to loss of glycaemic control when used with Janutab.
• Caution should be taken when using Janutab with furosemide or nifedipine, NSAIDs, drugs that reduce metformin clearance such as ranolazine, vandetanib, dolutegravir and cimetidine.

📌 ADVERSE EFFECTS

Common adverse effects: stuffy or runny nose and sore throat, diarrhoea, nausea and vomiting, gas, stomach discomfort, indigestion, weakness, headache, allergic reaction, upper respiratory infections, hypoglycaemia. Taking Janutab with meals can help reduce the common stomach side effects of metformin.

📌 OVERDOSAGE

In case of overdosage, gastric lavage and ECG monitoring should be performed and supportive therapy instituted. Haemodialysis may be useful for removal of metformin overdosage. Sitagliptin may be removed by prolonged haemodialysis.

📌 STORAGE INSTRUCTIONS

Store below 30°C in a dry place.

📌 PHARMACEUTICAL FORMS

• Janutab plus 1000/50 caplets: Pack of 30 caplets and hospital packs of different sizes.
• Janutab 850/50 caplets: Pack of 30 caplets and hospital packs of different sizes.
• Janutab 500/50 caplets: Pack of 30 caplets and hospital packs of different sizes.