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Sepioglin

Active Substance: pioglitazone hydrochloride
Common Name: pioglitazone
ATC Code: A10BG03
Marketing Authorisation Holder: Vaia S.A.
Active Substance: pioglitazone hydrochloride
Status: Withdrawn
Authorisation Date: 2012-03-09
Therapeutic Area: Diabetes Mellitus, Type 2
Pharmacotherapeutic Group: Drugs used in diabetes

Therapeutic Indication

Pioglitazone is indicated as second- or third-line treatment of type-2 diabetes mellitus as described below:

as monotherapy:

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

as triple oral therapy in combination with:

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

Pioglitazone is also indicated for combination with insulin in type-2-diabetes-mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance (see section 4.4).

After initiation of therapy with pioglitazone, patients should be reviewed after three to six months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained (see section 4.4).

The marketing authorisation for Sepioglin has been withdrawn at the request of the marketing-authorisation holder.

Source: European Medicines Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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