Generic Name: Actos
What is Actos?
Breast-feedingPioglitazone has been shown to be present in the milk of lactating rats. However patients who experience visual disturbance should be cautious when driving or using machines. Within each system organ class, adverse reactions are presented in order of decreasing incidence followed by decreasing seriousness.
Adverse reaction Frequency of adverse reactions of pioglitazone by treatment regimen Monotherapy Combination with metformin with sulpho-nylurea with metformin and sulpho-nylurea with insulin Infections and infestations upper respiratory tract infection common common common common common bronchitis common sinusitis uncommon uncommon uncommon uncommon uncommon Neoplasms benign, malignant and unspecified including cysts and polyps bladder cancer uncommon uncommon uncommon uncommon uncommon Blood and lymphatic system disorders anaemia common Immune System Disorders hypersensitivity and allergic reactions1 not known not known not known not known not known Metabolism and nutrition disorders hypoglycaemia uncommon very common common appetite increased uncommon Nervous system disorders In an outcome study of patients with pre-existing major macrovascular disease, the incidence of serious heart failure was 1.
However, this did not lead to an increase in mortality in this study. In patients on insulin with no pioglitazone the incidence of heart failure was 8. Heart failure has been reported with marketing use of pioglitazone, and more frequently when pioglitazone was used in combination with insulin or in patients with a history of cardiac failure.
A higher rate of fractures was observed in women taking pioglitazone 2.
Because they lower insulin resistance, they also increase fertility in younger women who have polycystic ovary disease, called PCOS. If pregnancy is not desired, a premenopausal woman using one of these drugs should be careful to use birth control. Although they have been shown to rarely cause liver damage, the FDA requires that liver tests be done before treatment start, every two months for the first year and periodically thereafter. If the liver enzyme ALT shows a value more than three times the upper limit of normal, the drug must be stopped.
The glitazones work well in Type 2 diabetes only when insulin resistance is present. People with Type 1. The presence of excess abdominal weight, a low HDL level, high triglycerides, or high blood pressure, all associated with insulin resistance, are good indicators that glitazones may be worth trying.
For more easy-to-understand information on diabetes medications to use with or without insulin, see this clear, up-to-date book written for the person with diabetes. Written by Gary Scheiner, MS, CDE. Medical Management ofType 1 DiabetesPublished by the American Diabetes Association in 2012, this highly detailed professional book edited by Francine R. Kaufman, MD provides the most current information about all aspects of Type 1 diabetes.
How should I take Actos?
Therapy with ACTOS should not be initiated if the patient exhibits clinical evidence of active liver disease or the ALT levels exceed 2. Patients with mildly elevated liver enzymes ALT levels at 1 to 2. Initiation or continuation of therapy with ACTOS in patients with mildly elevated liver enzymes should proceed with caution and include appropriate clinical follow-up which may include more frequent liver enzyme monitoring.
If ALT levels exceed 3 times the upper limit of normal, the test should be repeated as soon as possible. Macular Edema: Macular edema has been reported in post-marketing experience in diabetic patients who were taking pioglitazone or another thiazolidinedione. Some patients presented with blurred vision or decreased visual acuity, but some patients appear to have been diagnosed on routine ophthalmologic examination.
What should I avoid while taking Actos?
In the first trial, 566 patients were randomized to receive either 15 mg or 30 mg of ACTOS or placebo once daily for 16 weeks in addition to their insulin regimen. Treatment with ACTOS as add-on to insulin produced statistically significant improvements in HbA1c and FPG at endpoint compared to placebo add-on to insulin see Table 24.
The mean daily insulin dose at baseline in each treatment group was approximately 70 units. The mean change from baseline in daily dose of insulin including patients with no insulin dose modifications was -3 units in the patients treated with ACTOS 15 mg, -8 units in the patients treated with ACTOS 30 mg, and -1 unit in patients treated with placebo.
The mean daily insulin dose at baseline in both treatment groups was approximately 70 units. The mean change from baseline in daily dose of insulin including patients with no insulin dose modifications was -5 units in the patients treated with ACTOS 30 mg and -8 units in the patients treated with ACTOS 45 mg.
Actos side effects
Actos is supplied as tablet containing 15, 30, and 45 mg. Pioglitazone is also available as combination drugs that include Actosplus Met pioglitazone and metforminActoplus Met XR pioglitazone and metformin extended-release formulationand Duetact pioglitazone and glimeperide. Actos UsesActos is mainly prescribed for the treatment of type-2 diabetes together with weight management, regular exercise, healthy diet, smoking reduction, and careful monitoring of blood sugar levels.
This medication may be used alone or in combination with other anti-diabetic drugs belonging to a different drug class, such as metformin Glucophage and insulin. The drug is not used to treat patients with type 1 diabetes whose bodies produce no insulin whatsoever.
Pioglitazone works in regulating the production of naturally-produced insulin. Since it requires insulin to be effective, it is not effective in patients with type-1 diabetes where the body is not able to produce its own insulin or insulin is very low.
Common Actos ide effects may include:
Patients who take pioglitazone also should do a couple of simple self-checks every day.
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Therapy with ACTOS should not be initiated if the patient exhibits clinical evidence of active liver disease or increased serum transaminase levels ALT greater than 2.
A similar pattern of results was seen in a 24-week combination therapy study with ACTOS with insulin.
All other antidiabetic agents were withdrawn prior to starting study treatment. In the first trial, 566 patients were randomized to receive either 15 mg or 30 mg of ACTOS or placebo once daily for 16 weeks in addition to their insulin regimen. Treatment with ACTOS as add-on to insulin produced statistically significant improvements in HbA1c and FPG at endpoint compared to placebo add-on to insulin see Table 24.
Where can I get more information?
Pediatric Use Safety and effectiveness of ACTOS in pediatric patients have not been established.
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