30, 45 mg
30, 45 mg
Actozone® 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.Posology and method of administration
Posology: Pioglitazone 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.
Elderly: No dose adjustment is necessary for elderly patients .
Renal impairment: No dose adjustment is necessary in patients with impaired renal function (creatinine clearance > 4 ml/min). No information is available from dialysed patients therefore pioglitazone should not be used in such patients.
Hepatic impairment: Pioglitazone should not be used in patients with hepatic impairment .
Paediatric population : The safety and efficacy of Actozone® in children and adolescents under 18 years of age have not been established. No data are available.
Effects on ability to drive and use machines: Actozone® has no or negligible effect on the ability to drive and use machines. However patients who experience visual disturbance should be cautious when driving or using machines.
Recommendations For prescribers:Do not use pioglitazone in patients with active bladder cancer. Use pioglitazone with patients with a prior history of bladder cancer. The benefits of glycemic control versus unknown risks for cancer recurrence with pioglitazone should be considered in patients with a prior history of bladder cancer. Counsel patients to report any signs or symptoms of blood in urine, urinary urgency, Pain, on urination, or back or abdominal pain, as these may be due to bladder cancer. Encourage patients to read the Medication Guide they get with their pioglitazone medicine. Report adverse events involving pioglitazone medicines.
Pregnancy: Pioglitazone should not be used in pregnancy.
Breastfeeding: Pioglitazone should not be administered to breast-feeding women.
Amoun Pharmaceutical Company S.A.E. (“Amoun”) is an Egyptian “closed” Joint-Stock Company established in 1998 under the laws of the Arab Republic of Egypt, with a fully paid-up capital of 1.4 billion Egyptian Pounds. Amoun’s main business includes development, manufacturing, marketing, distribution, and export of a wide range of human pharmaceutical and animal health products.