Indication

Glimepiride and Metformin combination tablet is indicated as an adjunct to diet and exercise
to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both
Glimepiride and Metformin is appropriate or in cases where Glimepiride or Metformin
monotherapy does not result in adequate glycemic control.


Dosage & Administration

The initial recommended dose of Glimepiride and Metformin combination tablet is Glimepiride
1 mg and Metformin Hydrochloride 500 mg one extended release tablet once daily with
breakfast or first main meal of the day. Starting dose for patients inadequately controlled on
Glimepiride or Metformin monotherapy is Limaryl M 1/500 once daily, and gradually titrated
after assessing the therapeutic response. The maximum recommended dose per day is 8 mg
Glimepiride and 2000 mg Metformin. Due to the extended release formulation, Limaryl M must
be swallowed whole and not crushed or chewed.

Use in Pregnancy and Lactation
Pregnancy: The use of Glimepiride and Metformin combination is not recommended for use in
pregnancy. It is recommended that such patients change over to insulin. Lactation: The use of
Glimepiride and Metformin combination is not recommended for use in lactating mothers, and
if the diet alone is inadequate for controlling blood glucose, insulin therapy should be
considered. Pediatric use: Safety and effectiveness of Glimepiride and Metformin combination
in pediatric patients have not been established. Geriatric use: Metformin is substantially
excreted by the kidneys, and because aging is associated with reduced renal function,
Glimepiride and Metformin combination should be used with caution in the elderly.


Precautions

Glimepiride: In exceptional stress situations (e.g., trauma, surgery, febrile infections), blood
glucose regulation may deteriorate and a temporary change to insulin may be necessary to
maintain good metabolic control. Metformin: Lactic acidosis is a rare but serious complication
of Metformin accumulation which can be fatal. It is not recommended in hepatic/renal
impairment or hypoxic states.


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