Adlina 5mg

Tablet
Linagliptin
Unimed Unihealth MFG. Ltd

Other Strength:
- Adlinameg 2.5mg+850mg
- Adlinameg 2.5mg+500mg

Alternative:
- Traneta 5mg
- Linatab 5mg
- Linita™ 5mg
- Linajen 5mg
- Linaglip 5mg



Adlina
Presentation
Adlina 5 tablet : Red, shield shaped, scored, film coated tablet; each tablet contains Linagliptin INN 5mg.

Indications
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

Dosage and 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.

Paediatric 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.

Contra-indications, warnings, etc
Contra-indications: Hypersensitivity to the active substance or to any of the excipients.

Precautions: Linagliptin should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. Hypoglycemia: Linagliptin alone showed a comparable incidence of hypoglycaemia to placebo. In clinical trials of Linagliptin as part of combination therapy with medicinal products not known to cause hypoglycaemia (metformin) rates of hypoglycaemia reported with Linagliptin were similar to rates in patients taking placebo. When Linagliptin was added to a sulphonylurea, the incidence of hypoglycaemia was increased over that of placebo. sulphonylureas and insulin are known to cause hypoglycaemia. Therefore, 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.

Use in 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.

Drug interactions: 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).

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.

Overdose : 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.

Pharmaceutical precautions
Store in a cool and dry place, protected from light.

Package quantities:
Adlina 5 tablet : Carton containing 10 tablets in Alu-Alu blister pack.

এই পাতাটি ১৮২ বার দেখা হয়েছে