Preparation
Linastar-M 2.5/500: Each film coated tablet contains Linagliptin INN 2.5 mg and Metformin Hydrochloride BP 500 mg.
Linastar-M 2.5/850:Each film coated tablet contains Linagliptin INN 2.5 mg and Metformin Hydrochloride BP 850 mg.
Indication
Linastar-M is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both Linagliptin and Metformin Hydrochloride is appropriate.
Contraindication
Although Linagliptin undergoes minimal renal excretion, Metformin Hydrochloride is known to be substantially excreted by the kidney. The risk of Metformin Hydrochloride accumulation and lactic acidosis increases with the degree of renal impairment. Therefore, this combination is contraindicated in patients with renal impairment. It is also contraindicated in acute or chronic metabolic acidosis (diabetic ketoacidosis) and in hypersensitivity to Linagliptin or Metformin Hydrochloride.
Dosage & Administration
The dosage of Linastar-M should be individualized on the basis of both effectiveness and tolerability. Maximum recommended dose of 2.5 mg Linagliptin and 1000 mg Metformin Hydrochloride twice daily with meals. Dose escalation should be gradual to reduce the gastrointestinal (GI) side effects associated with Metformin use.
Recommended starting dose:
In patients currently not treated with Metformin Hydrochloride, initiate treatment with 2.5 mg Linagliptin and 500 mg Metformin Hydrochloride twice daily.
In patients already treated with Metformin Hydrochloride, start with 2.5 mg Linagliptin and the current dose of Metformin Hydrochloride twice daily.
Patients already treated with Linagliptin and Metformin Hydrochloride, individual components may be switched to this combination containing the same doses of each component.
Side Effect
Most common side effects are nasopharyngitis and diarrhea. Hypoglycemia is more common in patients treated with this combination and sulfonylureas.
Use in Pregnancy and Lactation: There are no adequate and well-controlled studies in pregnant women with this combination or its individual component; so it should be used during pregnancy only if clearly needed. Caution should also be exercised when it is administered to a lactating mother.
Precaution
In a patient with lactic acidosis who is taking Metformin Hydrochloride, the drug should be discontinued immediately and supportive therapy promptly instituted. There have been postmarketing reports of acute pancreatitis. If pancreatitis is suspected, promptly discontinue Linastar-M. Temporarily discontinue Linastar-M in patients undergoing radiologic studies with intravascular administration of iodinated contrast materials or any surgical procedures necessitating restricted intake of food and fluids. Metformin Hydrochloride may lower Vitamin B12 levels; so hematologic parameters should be monitored annually.
Drug Interaction
Cationic drugs (Amiloride, Digoxin, Morphine, Ranitidine, Trimethoprim etc.): May reduce Metformin Hydrochloride elimination. P-glycoprotien/CYP3A4 inducer (i.e. rifampin): The efficacy of Linastar-M may be reduced when administered in combination.
Presentation
Linastar-M 2.5/500: Each box contains 3X10 tablets in Alu-Alu blister pack.
Linastar-M 2.5/850: Each box contains 3X10 tablets in Alu-Alu blister pack.
Use Children
This combination is not recommended for use in children & adolescent under 18 years.
Use Pregnancy Lactation
There are no adequate and well-controlled studies in pregnant women with this combination or its individual component; so it should be used during pregnancy only if clearly needed. Caution should also be exercised when it is administered to a lactating mother.
Storage
Store below 30 °C, keep in a dry place and protected from light. Keep all medicines out of the reach of children.