GLYPTEN-M®/ GLYPTEN-M®FORTE Tablets

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Composition:

GLYPTEN-M®

  • Each uncoated bilayered tablet contains:
  • Teneligliptin Hydrobromide Hydrate equivalent to Teneligliptin ………………………….……….…………………….……….. 20 mg
  • Metformin Hydrochloride I.P. ….. 500 mg (in sustained-release form)
  • Excipients …………………………….…………….... q.s.
  • Colour: Ferric oxide yellow USP/NF (In Teneligliptin layer)

 

GLYPTEN-M®FORTE

  • Each uncoated bilayered tablet contains:
  • Teneligliptin Hydrobromide Hydrate equivalent to Teneligliptin…………………………………..... 20 mg
  • Metformin Hydrochloride I.P. … 1000 mg (in sustained-release form)
  • Excipients …………………………………………. q.s.
  • Colour: Ferric oxide yellow USP/NF (In Teneligliptin layer)

Description

  • Teneligliptin is an orally-active inhibitor of the Dipeptidyl Peptidase-4 (DPP-4) enzyme, which is believed to exert its actions in patients with Type 2 Diabetes by slowing the inactivation of incretin hormones. Concentrations of the active intact hormones are increased by teneligliptin, thereby increasing and prolonging the action of these hormones. By increasing and prolonging active incretin levels, teneligliptin increases insulin release and decreases glucagon levels in the circulation in a glucose-dependent manner.
  • Metformin is an oral antidiabetic drug belonging to the biguanide group. Metformin hydrochloride improves glucose tolerance by decreasing hepatic glucose production, decreasing intestinal absorption of glucose and improving insulin sensitivity by increasing peripheral glucose uptake and utilization. Metformin is not chemically or pharmacologically related to sulphonylureas, thiazolidinediones, gliptins, glinides, SGLT 2 inhibitors or alpha-glucosidase inhibitors.

Indications

  • GLYPTEN-M®/ GLYPTEN-M FORTE® is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with Type 2 Diabetes when treatment with both teneligliptin and metformin sustained-release is appropriate

Dosage

  • The usual adult starting dose of GLYPTEN-M®/ GLYPTEN-M®FORTE is 20 mg of teneligliptin and 500 mg or 1000 mg of metformin sustained release administered once daily. If efficacy is insufficient, the dose may be increased up to 40 mg and 2000 mg once daily while closely monitoring the clinical course.
  • GLYPTEN-M®/ GLYPTEN-M®FORTE should be administered with food to reduce the gastrointestinal side effects associated with the metformin component.
  • GLYPTEN-M®/ GLYPTEN-M®FORTE should be swallowed whole. The tablet must not be split, crushed or chewed before swallowing.