Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489 Greifswald, Germany
Pioglitazone is indicated as second or third line treatment of type 2 diabetes mellitus as described below:
as monotherapy:
as dual oral therapy in combination with:
as triple oral therapy in combination with:
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 3 to 6 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).
Pioglitazone treatment may be initiated at 15 mg or 30 mg once daily. The dose may be increased in increments up to 45 mg once daily.
In combination with insulin, the current insulin dose can be continued upon initiation of pioglitazone therapy. If patients report hypoglycaemia, the dose of insulin should be decreased.
No dose adjustment is necessary for elderly patients (see section 5.2). Physicians should start treatment with the lowest available dose and increase the dose gradually, particularly when pioglitazone is used in combination with insulin (see section 4.4 Fluid retention and cardiac failure).
No dose adjustment is necessary in patients with impaired renal function (creatinine clearance >4 mL/min) (see section 5.2). No information is available from dialysed patients therefore pioglitazone should not be used in such patients.
Pioglitazone should not be used in patients with hepatic impairment (see sections 4.3 and 4.4).
The safety and efficacy of Actos in children and adolescents under 18 years of age have not been established. No data are available.
Pioglitazone tablets are taken orally once daily with or without food. Tablets should be swallowed with a glass of water.
In clinical studies, patients have taken pioglitazone at higher than the recommended highest dose of 45 mg daily. The maximum reported dose of 120 mg/day for four days, then 180 mg/day for seven days was not associated with any symptoms.
Hypoglycaemia may occur in combination with sulphonylureas or insulin. Symptomatic and general supportive measures should be taken in case of overdose.
3 years.
This medicinal product does not require any special storage conditions.
Aluminium/aluminium blisters, packs of 28, 56, 98 and 112 tablets.
Not all pack sizes may be marketed.
No special requirements for disposal.
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