VIPIDIA Film-coated tablet Ref.[6139] Active ingredients: Alogliptin

Posology

For the different dose regimens, Vipidia is available in strengths of 25 mg, 12.5 mg and 6.25 mg film-coated tablets.

Adults (≥18 years old)

The recommended dose of alogliptin is one tablet of 25 mg once daily as add-on therapy to metformin, a thiazolidinedione, a sulphonylurea, or insulin or as triple therapy with metformin and a thiazolidinedione or insulin.

When alogliptin is used in combination with metformin and/or a thiazolidinedione, the dose of metformin and/or the thiazolidinedione should be maintained, and Vipidia administered concomitantly.

When alogliptin is used in combination with a sulphonylurea or insulin, a lower dose of the sulphonylurea or insulin may be considered to reduce the risk of hypoglycaemia (see section 4.4).

Caution should be exercised when alogliptin is used in combination with metformin and a thiazolidinedione as an increased risk of hypoglycaemia has been observed with this triple therapy (see section 4.4). In case of hypoglycaemia, a lower dose of the thiazolidinedione or metformin may be considered.

Special populations

Elderly (≥65 years old)

No dose adjustment is necessary based on age. However, dosing of alogliptin should be conservative in patients with advanced age due to the potential for decreased renal function in this population.

Renal impairment

For patients with mild renal impairment (creatinine clearance (CrCl) >50 to ≤80 mL/min), no dose adjustment of alogliptin is necessary (see section 5.2).

For patients with moderate renal impairment (CrCl ≥30 to ≤50 mL/min), one-half of the recommended dose of alogliptin should be administered (12.5 mg once daily; see section 5.2).

For patients with severe renal impairment (CrCl <30 mL/min) or end-stage renal disease requiring dialysis, one-quarter of the recommended dose of alogliptin should be administered (6.25 mg once daily). Alogliptin may be administered without regard to the timing of dialysis. Experience in patients requiring renal dialysis is limited. Alogliptin has not been studied in patients undergoing peritoneal dialysis (see sections 4.4 and 5.2).

Appropriate assessment of renal function is recommended prior to initiation of treatment and periodically thereafter (see section 4.4).

Hepatic impairment

No dose adjustment is necessary for patients with mild to moderate hepatic impairment (Child-Pugh scores of 5 to 9). Alogliptin has not been studied in patients with severe hepatic impairment (Child-Pugh score >9) and is, therefore, not recommended for use in such patients (see sections 4.4 and 5.2).

Paediatric population

The safety and efficacy of alogliptin in children and adolescents < 18 years old have not been established. Currently available data are described in sections 4.8, 5.1 and 5.2, but no recommendation on a posology can be made. Alogliptin should not be used in the paediatric population because of lack of efficacy. Please refer to section 5.1.

Method of administration

Oral use.

Vipidia should be taken once daily with or without food. The tablets should be swallowed whole with water.

If a dose is missed, it should be taken as soon as the patient remembers. A double dose should not be taken on the same day.

The highest doses of alogliptin administered in clinical studies were single doses of 800 mg to healthy subjects and doses of 400 mg once daily for 14 days to patients with type 2 diabetes mellitus (equivalent to 32 times and 16 times the recommended daily dose of 25 mg alogliptin, respectively).

Management

In the event of an overdose, appropriate supportive measures should be employed as dictated by the patient’s clinical status.

Minimal quantities of alogliptin are removed by haemodialysis (approximately 7% of the substance was removed during a 3-hour haemodialysis session). Therefore, haemodialysis is of little clinical benefit in overdose. It is not known if alogliptin is removed by peritoneal dialysis.

4 years.

This medicinal product does not require any special storage conditions.

Polychlorotrifluoroethylene (PCTFE)/polyvinyl chloride (PVC) blisters with push through aluminium lidding foil. Pack sizes of 10, 14, 28, 30, 56, 60, 84, 90, 98 or 100 film-coated tablets.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.