Each film coated tablet contains:
Linagliptin 5 mg Tablet
| Light pink colored, round biconvex film coated tablet with breakline on one side and plain surface on other.
Pharmacotherapeutic Group: Anti-Diabetic Drug
Pharmacodynamic properties: LINTAB-5 is a competitive and reversible dipeptidyl peptidase (DPP)-4 enzyme inhibitor that slows the breakdown of insulinotropic hormone glucagon-like peptide (GLP)-1 for better glycemic control in diabetes patients. GLP and glucose-dependent insulinotropic polypeptide (GIP) are incretin hormones that increase the production and release of insulin from pancreatic beta cells and decrease the release of glucagon from pancreatic alpha cells. This results in a overall decrease in glucose production in the liver and increase an of insulin in a glucose-dependent manner.
Absorption The absolute bioavailability of linagliptin is approximately 30%. High-fat meal reduced Cmax by 15% and increased AUC by 4%.
Distribution The mean apparent volume of distribution at is approximately 1110 L, indicating that linagliptin extensively distributes to the tissues.
Metabolism Following oral administration, the majority (about 90%) of linagliptin is excreted unchanged, indicating that metabolism represents a minor elimination pathway. A small fraction of absorbed linagliptin is metabolized to a pharmacologically inactive metabolite, which shows a steady-state exposure of 13.3% relative to linagliptin.
Excretion : approximately 85% of the administered radioactivity was eliminated via the enterohepatic system (80%) or urine (5%) within 4 days of dosing. Renal clearance at steady state was approximately 70 mL/min.
Management of Type 2 Diabetes Mellitus.
Once a day dosing, no dose adjustment required in renal failure.
Can be taken with or without food.
- LINTAB-5 may be taken with or without food.
- Pregnancy Category : B
- Nursing mother: Linagliptin is excreted in milk . Caution should be exercised.
- Paediatric: Safety and effectiveness have not been established.
- Geriatric Use : No dose adjustment is recommended in this population.
- Renal Impairment No dose adjustment is recommended for patients with renal impairment.
- Hepatic Impairment No dose adjustment is recommended for patients with hepatic impairment
Storage: Store in a cool and dry place; Protect from light, heat and moisture; Keep away from the reach of children.
- Missed dose: Take the missed dose as soon as you remember
- Skip the missed dose if it is almost time for your next scheduled dose
- Do not take extra medicine to make up the missed dose.
Pregnancy;lactation; Diabetic Ketoacidosis ,Pancreatitis
ADVERSE DRUG REACTIONS
Nasopharygitis, GI upsets, rashes, nausea, vomiting, loss of appetite
The serum concentration of Linagliptin can be increased when it is combined with Acetaminophen whereas decreased when is combined with Aldosterone.
The metabolism of Albendazole can be decreased when combined with Linagliptin.
Rifampicin decreased the efficacy of Linagliptin
LINTAB-5 : Each box contains 5 X3 X 10 strips ie 5 cc in 1 duplex box with 3 strips in 1 cc