Actose15 mg

Actose 15 mg is indicated as an adjunct to diet and exercise to improve glycaemic control in patients with type II diabetes (NIDDM). Actose 15 mg is indicated for monotherapy and also indicated for use in combination with sulphonylurea, Metformin or Insulin when diet and exercise plus the single agent does not result in adequate glycaemic control.

Thiazolidinedione Group

Actose 15 mg is a preparation of Actose 15 mg which is a member of the newest class of oral antidiabetic agent called thiazolidinediones. It depends on the presence of Insulin for its mechanism of action. Actose 15 mg decreases Insulin resistance in the periphery and in the liver, resulting in increased Insulin dependent glucose disposal and decreased hepatic glucose output. It also improves abnormality in lipid metabolism by activating peroxisome proliferator activated receptor gamma (PPAR-γ).

Actose 15 mg can be taken once daily without regard to meals. The management of antidiabetic therapy should be individualized. Actose 15 mg monotherapy may be initiated at 15 mg or 30 mg once daily dosages in patients not adequately controlled with diet and exercise alone. For patients who respond inadequately to the initial dose of Actose 15 mg, the dose can be increased up to 45 mg once daily. For patients not responding adequately to monotherapy, combination therapy should be considered.Maximum recommended daily dose of Actose 15 mg should not exceed 45 mg since doses higher than 45 mg have not been studied in placebo controlled clinical studies. Besides, no placebo controlled clinical studies of more than 30 mg once daily have been conducted in combination therapy.

Actose 15 mg can be taken once daily without regard to meals. The management of antidiabetic therapy should be individualized. Actose 15 mg monotherapy may be initiated at 15 mg or 30 mg once daily dosages in patients not adequately controlled with diet and exercise alone. For patients who respond inadequately to the initial dose of Actose 15 mg, the dose can be increased up to 45 mg once daily. For patients not responding adequately to monotherapy, combination therapy should be considered.Maximum recommended daily dose of Actose 15 mg should not exceed 45 mg since doses higher than 45 mg have not been studied in placebo controlled clinical studies. Besides, no placebo controlled clinical studies of more than 30 mg once daily have been conducted in combination therapy.

Administration of thiazolidinediones with an oral contraceptive containing ethinyl oestradiol and norethindrone reduces the plasma concentration of both hormones by approximately 30% which could result in loss of contraception.

Actose 15 mg is contraindicated in patients with known hypersensitivity to any of its components.

The overall incidence and types of adverse events reported in placebo controlled clinical trials of Actose 15 mg monotherapy at doses of 7.5 mg, 15 mg, 30 mg or 45 mg once daily are upper respiratory tract infection (13.2%), headache (9.1%), sinusitis (6.3%), myalgia (5.4%), tooth disorder (5.3%), and pharyngitis (5.1%).

Pregnancy: There are no adequate and well controlled studies in pregnant women. Actose 15 mg should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.Lactation: It is not known whether Actose 15 mg is secreted in human milk. As many drugs are excreted in human milk, it should not be administered to a lactating women.

Actose 15 mg exerts its antihyperglycaemic effect only in the presence of Insulin. Therefore, it should not be used in Type 1 diabetes or for the treatment of diabetic ketoacidosis. Actose 15 mg should be used with caution in case of combination antidiabetic therapy and hepatic insufficiency. Liver enzyme should be monitored regularly.

Store at 25° C.

Thiazolidinedione Group

Actose 15 mg is a preparation of Actose 15 mg which is a member of the newest class of oral antidiabetic agent called thiazolidinediones. It depends on the presence of Insulin for its mechanism of action. Actose 15 mg decreases Insulin resistance in the periphery and in the liver, resulting in increased Insulin dependent glucose disposal and decreased hepatic glucose output. It also improves abnormality in lipid metabolism by activating peroxisome proliferator activated receptor gamma (PPAR-γ).

Pregnancy: There are no adequate and well controlled studies in pregnant women. Actose 15 mg should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.Lactation: It is not known whether Actose 15 mg is secreted in human milk. As many drugs are excreted in human milk, it should not be administered to a lactating women.