Lijenta 5

Indications

Lijenta 5 is indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults.

As monotherapy: in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to intolerance or contraindicated due to renal impairment.

As combination therapy: in combination with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.

 

Pharmacology

Linagliptin is indicated to improve glycemic control in patients with type 2 diabetes mellitus. Linagliptin is an inhibitor of DPP-4 (dipeptidyl peptidase-4), an enzyme that degrades the incretin hormones GLP-1 (glucagon like peptide-1) and GIP (glucose dependent insulinotropic polypeptide). Thus, Linagliptin increases the concentrations of active incretin hormones, stimulating the release of insulin from pancreatic beta (β) cells in a glucose-dependent manner and decreasing the secretion of glucagon from pancreatic alpha (α) cells in the circulation.

 

Dosage & Administration

Lijenta 5 mg once daily. If added to metformin, the dose of metformin should be maintained and linagliptin administered concomitantly. When used in combination with sulfonylurea, a lower dose of sulphonylurea may be considered to reduce the risk of hypoglycaemia.

Patients with renal impairment: No dose adjustment required. Linagliptin can be taken with or without a meal at any time of the day.

 

Interaction

Linagliptin is a weak competitive and a weak to moderate mechanism-based inhibitor of CYP isozyme CYP3A4, but does not inhibit other CYP isozymes. The risk for clinically meaningful interactions by other medicinal products on linagliptin is low and in clinical studies linagliptin had no clinically relevant effect on the pharmacokinetics of metformin, glyburide, simvastatin, warfarin, digoxin or oral contraceptives.

 

Contraindications

Hypersensitivity to the active substance or to any of the excipients.

 

Side Effects

There may be hypoglycemia, nasopharyngitis, cough and pancreatitis in combination with metformin and sulfonylurea.

 

Pregnancy & Lactation

Pregnancy category B. There are no adequate and well-controlled studies on pregnant women. So, Linagliptin tablets should be used during pregnancy only if clearly needed. It is not known whether Linagliptin passes into breast milk or not.

 

Precautions & Warnings

Hypersensitivity to the active substance or to any of the excipients.

 

 

Storage Conditions

Keep in a dry place away from light and heat. Keep out of the reach of children.

 

Pharmaceutical Name

NIPRO JMI Pharma Ltd

 

Generic

Linagliptin

 

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