D-Lina 5

Linagliptin INN 5mg

D-Lina 5 Tablet: Each film coated tablet contains Linagliptin INN 5 mg.

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.

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Linagliptin is indicated in the treatment of type-2 diabetes mellitus to improve glycemic 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 combined therapy:
•In combination with Metformin when diet and exercise plus Metformin alone do not provide adequate glycemic control.
•In combination with a sulfonylurea and Metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycemic control.
•In combination with insulin with or without Metformin, when this regimen alone, with diet and exercise does not provide adequate glycemic control.

Dosage & administration
Linagliptin may be taken with or without food 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.
The recommended dose is 5 mg once daily. 
For patients with renal insufficiency no dosage adjustment is required.
Pharmacokinetic studies suggest that no dose adjustment is required for patients with hepatic impairment.
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 hypoglycemia.

Linagliptin should not be prescribed for patients with a history of hypersensitivity reaction to Linagliptin such as urticaria, angioedema, or bronchial hyperreactivity.

The most common side effects of Linagliptin are stuffy or runny nose and sore throat. Hypoglycemia may occur when Linagliptin is combined with Insulin or Sulfonylurea and Metformin. Allergic reaction and muscle pain also may occur. Pancreatitis, angioedema (frequency rare) and urticaria (frequency rare) were identified as additional adverse reactions.

Linagliptin should not be used in patients with type-1 diabetes or for the treatment of diabetic ketoacidosis.
Linagliptin alone showed a comparable incidence of hypoglycemia to placebo. Caution is advised when Linagliptin is used in combination with a Sulphonylurea and/or Insulin. A dose reduction of the sulphonylurea or Insulin may be considered. 

In post-marketing experience of Linagliptin there have been spontaneously reported adverse reactions of acute pancreatitis. Patients should be informed of the characteristic symptom of acute pancreatitis: persistent, severe abdominal pain. Resolution of pancreatitis has been observed after discontinuation of Linagliptin. If pancreatitis is suspected, Linagliptin should be discontinued.

Use in pregnancy & lactation
Pregnancy: The use of Linagliptin has not been studied in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of Linagliptin during pregnancy.
Lactation: Available pharmacokinetic data in animals have shown excretion of Linagliptin/metabolites in milk. A risk to the breast-feed child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Linagliptin therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Symptoms: During controlled clinical trials in healthy subjects, single doses of up to 600 mg Linagliptin (equivalent to 120 times of recommended dose) were generally well tolerated. There is no experience with doses above 600 mg in humans. 
Therapy: In the event of an overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed materials from the gastrointestinal tract, employ clinical monitoring and institute measures if required.

Drug interactions
The efficacy of Linagliptin may be reduced when the drug is coadministered with a strong CYP3A4 or P-glycoprotein inducer (e.g., rifampin). Therefore, the use of alternative treatments is strongly recommended. Sulphonylureas should be used with caution during treatment with Linagliptin. The pharmacokinetic characteristics of Linagliptin were not altered by the concomitant administration of Simvastatin, Digoxin, Glyburide, Warfarin, Metformin or Pioglitazone.

Pharmaceutical precaution
Store in a cool, dry place and protect from light. Keep out of reach of children.

D-Lina 5 Tablet: Box containing 2 x 10 / 3 x 10 / 5 x 10 /10 x 10 tablets in blister pack.