Diabetes mellitus type 2

Active Ingredient: Rosiglitazone

Indication for Rosiglitazone

Population group: only adults (18 years old or older)
Therapeutic intent: Curative procedure

Rosiglitazone is indicated in the treatment of type 2 diabetes mellitus:

as monotherapy:

  • in patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance

as dual oral therapy in combination with:

  • metformin, in patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin
  • a sulphonylurea, only in patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite monotherapy with a sulphonylurea

as triple oral therapy in combination with:

  • metformin and a sulphonylurea, in patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy.

For this indication, competent medicine agencies globally authorize below treatments:

4 mg daily in 1 or 2 divided doses and after 8 weeks 4-8 mg daily in 1 or 2 divided doses


Dosage regimens

Oral, 4 milligrams rosiglitazone, divided daily, 1 to 2 doses in total, over the duration of 8 weeks. Afterwards, oral, between 4 milligrams rosiglitazone and 8 milligrams rosiglitazone, divided daily, 1 to 2 doses in total.

Detailed description

Rosiglitazone therapy is usually initiated at 4 mg/day. This dose can be increased to 8 mg/day after eight weeks if greater glycaemic control is required.

In patients administered rosiglitazone in combination with a sulphonylurea, an increase in rosiglitazone to 8 mg/day should be undertaken cautiously following appropriate clinical evaluation to assess the patient’s risk of developing adverse reactions relating to fluid retention.

Rosiglitazone may be given once or twice a day.

Dosage considerations

Rosiglitazone may be taken with or without food.

Active ingredient


Rosiglitazone is a selective agonist at the PPARγ (peroxisomal proliferator activated receptor gamma) nuclear receptor and is a member of the thiazolidinedione class of anti-diabetic agents. It reduces glycaemia by reducing insulin resistance at adipose tissue, skeletal muscle and liver.

Read more about Rosiglitazone

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