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Linagliptin 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. In combination with insulin with or without metformin, when this regimen alone, with diet and exercise, does not provide adequate.


Empagliflozin: Sodium-glucose co-transporter 2 (SGLT2) is the predominant transporter responsible for the reabsorption of glucose from the glomerular filtrate back into the circulation. Empagliflozin is an inhibitor of SGLT2. By inhibiting SGLT2, empagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increasing urinary glucose excretion.
Linagliptin: Linagliptin is an inhibitor of DPP-4, an enzyme that degrades the incretin hormones glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). Thus, linagliptin increases the concentrations of active incretin hormones, stimulating the release of insulin in a glucose-dependent manner and decreasing the levels of glucagon in the circulation. Both incretin hormones are involved in the physiological regulation of glucose homeostasis. Incretin hormones are secreted at a low basal level throughout the day and levels rise immediately after meal intake. GLP-1 and GIP increase insulin biosynthesis and secretion from pancreatic beta cells in the presence of normal and elevated blood glucose levels. Furthermore, GLP-1 also reduces glucagon secretion from pancreatic alpha cells, resulting in a reduction in hepatic glucose output.

Dosage & Administration

The dose of Linagliptin is 5mg once daily. When Linagliptin is added to metformin, the dose of metformin should be maintained and Linagliptin administered concomitantly. When Linagliptin is used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin, may be considered to reduce the risk of hypoglycaemia.

Patients with renal impairment: For patients with renal impairment, no dose adjustment for Linagliptin is required.

Patients with hepatic impairment: Pharmacokinetic studies suggest that no dose adjustment is required for patients with hepatic impairment but clinical experience in such patients is lacking. Elderly patients: No dose adjustment is necessary based on age. However, clinical experience in patients >80 years of age is limited and caution should be exercised when treating this population.

Pediatric population: The safety and efficacy of Linagliptin in children and adolescents has not yet been established. Linagliptin can be taken with or without a meal at any time of the day. If a dose is missed, it should be taken as soon as the patient remembers. A double dose should not be taken on the same day.


Clinical data described suggest that the risk for clinically meaningful interactions by co-administered medicinal products is low.

Metformin: Co-administration of multiple three times daily doses of 850 mg metformin with 10 mg Linagliptin once daily did not clinical meaningfully alter the pharmacokinetics of Linagliptin in healthy volunteers.

Sulphonylureas: The steady-state pharmacokinetics of 5 mg Linagliptin was not changed by concomitant administration of a single 1.75 mg dose glibenclamide (glyburide). In clinical studies, Linagliptin had no clinically relevant effect on the pharmacokinetics of metformin, glyburide, simvastatin, warfarin, digoxin or oral contraceptives providing in vivo evidence of a low propensity for causing medicinal product interactions with substrates of CYP3A4, CYP2C9, CYP2C8, P-glycoprotein, and organic cationic transporter (OCT).


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

Side Effects

The most frequently reported adverse reaction was hypoglycaemia observed under the triple combination, Linagliptin plus metformin plus sulphonylurea 14.6% versus 7.6% in placebo. In the placebo-controlled studies 6.2% of patients experienced "hypoglycaemia" as an adverse reaction under Linagliptin. Of these, 5.1% were mild and 1.0% were moderate and 0.1% were classified as severe. Pancreatitis was reported more often in patients randomized to Linagliptin.

Pregnancy & Lactation

The use of Linagliptin has not been studied in pregnant women. As a precautionary measure, it is preferable to avoid the use of Linagliptin during pregnancy. A risk to the breast-feed child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue from Linagliptin therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Precautions & Warnings

Pancreatitis: There have been post marketing reports of acute pancreatitis, including fatal pancreatitis. If pancreatitis is suspected, promptly discontinue this tablet.

Hypotension: Before initiating this tablet assess and correct volume status in patients with renal impairment, the elderly, in patients with low systolic blood pressure, and in patients on diuretics. Monitor for signs and symptoms during therapy.

Impairment in Renal Function: Monitor renal function during therapy. More frequent monitoring is recommended in patients with eGFR below 60 mL/min/1.73 m2.

Hypoglycemia: Consider lowering the dose of insulin secretagogue or insulin to reduce the risk of hypoglycemia when initiating this tablet.

Genital Mycotic Infections: Monitor and treat as appropriate.

Urinary Tract Infections: Monitor and treat as appropriate.

Hypersensitivity: In such cases, promptly discontinue this tablet, assess for other potential causes, institute appropriate monitoring and treatment, and initiate alternative treatment for diabetes.

Increased LDL-C: Monitor and treat as appropriate.

Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with this tablet or any other antidiabetic drug.

Overdose Effects

During controlled clinical trials in healthy subjects, single doses of up to 600 mg Linagliptin were generally well tolerated. There is no experience with doses above 600 mg in humans. In the event of an overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring and institute clinical measures if required.

Storage Conditions

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
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