ACTOS

Brand Names

Pioglitazone Hydrochloride

What is ACTOS

ACTOS is a medicine used to improve the action of the body's naturally produced insulin. ACTOS is used in the management of Type 2 diabetes not controlled by diet. ACTOS helps to control the level of glucose in your blood when you have Type 2 diabetes. This is the 'adult onset' type of diabetes and is controlled by diet, certain oral medications and occasionally insulin.

It is also called pioglitazone hydrochloride and belongs to a group of medicines called glitazones which decrease insulin resistance.

Side effects of ACTOS

These are the common ACTOS side effects, you may experience:

• a small increase in weight
• low blood sugar levels (hypoglycaemia). This occurs more often when ACTOS is taken with a sulfonylurea or insulin
• heart failure which may show as localised swelling of the ankles, feet and hands (oedema) and/or fluid in the lungs (pulmonary oedema). This has been reported in clinical trials mainly in patients who are taking ACTOS in combination with insulin
• increased risk of fracture in women
• macular oedema (an eye disorder that can affect vision)
• altered or impaired liver function

You should inform your doctor immediately if you have noticed:

• weight gain
• signs of hypoglycaemia which may include weakness, trembling or shaking, sweating, light-headedness, headache, Dizziness, lack of concentration, tearfulness or crying, irritability, hunger, numbness around the lips and fingers
• eye problems including blurred or double vision

Indication

ACTOS is intended as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes (non-insulin-dependent diabetes mellitus, NIDDM). ACTOS is intended for monotherapy. It is also used in combination with a sulfonyl-urea, metformin, or insulin when diet and exercise plus the single tablet does not result in adequate glycemic control.

Treatment of type 2 diabetes should also include nutritional counseling, weight reduction as needed, and exercise. These efforts are important not only in the primary treatment of type 2 diabetes, but also to maintain the efficacy of drug therapy.

Precautions

• General warnings:



This medication should not be used in cases of type 1 diabetes or for the treatment of ketoacidosis induced by diabetes, as the drug (ACTOS) exerts antihypeglycemic effects only if used together with insulin.

• Hypoglycemia:



Patients taking ACTOS in combination with insulin or oral hypoglycemic agents may be at risk for hypoglycemia, and a reduction in the dose of the concomitant agent may be necessary.

• Cardiovascular:



In clinical trials the incidence of serious cardiac adverse events related to volume expansion was not increased in patients treated with ACTOS as monotherapy or in combination with sulfonylureas or metformin vs. placebo-treated patients. In insulin combination studies, a small number of patients with a history of previously existing cardiac disease developed congestive heart failure when treated with ACTOS in combination with insulin. ACTOS is not indicated in patients with NYHA Class III or IV cardiac status. In post marketing experience with ACTOS, cases of congestive heart failure have been reported in patients both with and without previously known heart disease.

• Edema:



ACTOS should be used with caution in patients with edema. In clinical trials, edema was reported more frequently in patients treated with ACTOS than in placebo-treated patients. In post marketing experience, reports of initiation or worsening of edema have been received.

• Weight Gain:



Dose related weight gain was seen with ACTOS alone and in combination with other hypoglycemic agents. The mechanism of weight gain is unclear but probably involves a combination of fluid retention and fat accumulation.

Dosage forms

The dosage of ACTOS that your doctor prescribes will depend on factors, including:

• How well your diabetes is controlled
• Other medical conditions you may have
• Other medications you may be currently taking.

You should not change your dosage form until your doctor instructs you to do so.

Actos Dosing for Type 2 Diabetes

The starting dose for Actos is 15 mg or 30 mg once daily. If necessary, your healthcare provider may increase your dosage up to 45 mg once daily to control your blood sugar.