Sitagliptin/Metformin hydrochloride Mylan is a medicine used to control blood glucose (sugar) levels in adults with type 2 diabetes. It is used together with diet and exercise in the following ways: • in patients whose blood glucose levels are not satisfactorily controlled with metformin (a diabetes medicine) used on its own; • in patients who are already taking a combination of sitagliptin and metformin as separate tablets; • in combination with a sulphonylurea, a PPAR\-gamma agonist such as a thiazolidinedione, or insulin (other types of diabetes medicines) in patients whose blood glucose levels are not satisfactorily controlled with either of these medicines and metformin. Sitagliptin/Metformin hydrochloride Mylan contains the active substances sitagliptin and metformin hydrochloride and is a ‘generic medicine’. This means that Sitagliptin/Metformin hydrochloride Mylan contains the same active substances and works in the same way as a ‘reference medicine’ already authorised in the EU called Janumet. For more information on generic medicines, see the question\-and\-answer document here.
Therapeutic Indication
| For adult patients with type 2 diabetes mellitus:<br>Sitagliptin/Metformin hydrochloride Mylan is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin.<br>Sitagliptin/Metformin hydrochloride Mylan is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.<br>Sitagliptin/Metformin hydrochloride Mylan is indicated as triple combination therapy with a peroxisome proliferator\-activated receptor gamma (PPARg) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPARg agonist.<br>Sitagliptin/Metformin hydrochloride Mylan is also indicated as add\-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control. | | --- |
Therapeutic Area (MeSH)
ATC Code
A10BD07
ATC Item
N/A
Pharmacotherapeutic Group
Drugs used in diabetes
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| sitagliptin hydrochloride monohydrate | N/A | sitagliptin hydrochloride monohydrate |
| metformin hydrochloride | N/A | metformin hydrochloride |
EMA Name
Sitagliptin / Metformin hydrochloride Mylan
Medicine Name
Sitagliptin / Metformin hydrochloride Mylan
Aliases
N/ANo risk management plan link.
