Antidiabetic (DPP-4 Inhibitor)
GENERIC NAME WITH SPECIFICATION:Linagliptin INN
SB-Lina 5 Tablet: Each Film Coated Tablet contains Linagliptin INN 5 mg.
SB-Lina 5 is indicated for the treatment of type-2 diabetes mellitus to improve glycemic control.
- 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 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
- The recommended dose of SB-Lina is 5 mg once daily.
- SB-Lina can 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.
- No dosage adjustment is required for hepatic or kidney impaired patients.
- When SB-Lina is added to Metformin, the dose of Metformin should be maintained, and SB-Lina administered concomitantly.
- When SB-Lina is used in combination with a Sulfonylurea or with Insulin, a lower dose of the Sulphonylurea or Insulin,may be considered to reduce the risk of hypoglycemia.
Side effects includes: Hypoglycemia, headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heart beat, sweating,
stuffy or runny nose and sore throat. Pancreatitis, angioedema (frequency rare) and urticaria (frequency rare) were identified as
additional adverse reactions.
Linagliptin should not be prescribed for patients with a history of hypersensitivity reaction to this drug, such as urticaria,angioedema,
or bronchial hyper-reactivity.
PREGNANCY & LACTATION
Pregnancy: Pregnancy Category B
There are no adequate and well-controlled studies in pregnant women. Linagliptin tablets should be used during pregnancy only
if clearly needed. It is preferable to avoid the use of Linagliptin during pregnancy.
It is not known if whether Linagliptin passes into breast milk or not. Caution should be exercised when Linitagliptin is administered
to a nursing woman.
SB-Lina 5 Tablet: Each box contains 20 Film Coated Tablets in Alu-Alu blister pack.
SB-LINA 5 mg MRP 300 TK.