Actos: Advanced Type 2 Diabetes Management with Pioglitazone
Actos
| Product dosage: 15mg | |||
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| Product dosage: 30mg | |||
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Synonyms | |||
Similar products
Actos (pioglitazone hydrochloride) is a thiazolidinedione-class oral antidiabetic agent indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. By enhancing insulin sensitivity in peripheral tissues, it addresses core pathophysiological defects associated with the disease. This medication is designed for long-term management, helping to stabilize blood glucose levels and potentially reduce the risk of diabetic complications when used as part of a comprehensive treatment plan under medical supervision.
Features
- Contains pioglitazone hydrochloride as the active pharmaceutical ingredient
- Available in 15 mg, 30 mg, and 45 mg film-coated tablets
- Functions as a selective agonist for peroxisome proliferator-activated receptor-gamma (PPAR-γ)
- Administered orally, once daily, with or without food
- Manufactured under strict pharmaceutical quality control standards
- Requires prescription and regular monitoring during therapy
Benefits
- Significantly reduces hemoglobin A1c (HbA1c) levels by improving insulin sensitivity in muscle, adipose tissue, and the liver
- May help preserve pancreatic beta-cell function, potentially slowing disease progression
- Demonstrates favorable effects on lipid profiles, typically increasing HDL cholesterol while decreasing triglycerides
- Provides sustained glycemic control with once-daily dosing, supporting treatment adherence
- Can be used as monotherapy or in combination with other antidiabetic agents including metformin, sulfonylureas, or insulin
- Offers potential cardiovascular benefits in appropriate patient populations when used as directed
Common use
Actos is primarily prescribed for the management of type 2 diabetes mellitus in adults when glycemic control cannot be achieved through diet and exercise alone. It is commonly used as second-line therapy after metformin or as part of combination regimens with other oral antidiabetic medications or insulin. The medication may be particularly beneficial for patients with significant insulin resistance. Clinical use extends to patients who require additional glycemic control while minimizing the risk of hypoglycemia when used as monotherapy. Healthcare providers may consider Actos for patients who have not achieved target HbA1c levels with other antidiabetic agents, especially those with dyslipidemia concerns.
Dosage and direction
The recommended starting dose for Actos is 15 mg or 30 mg once daily. Dosage may be increased gradually, up to a maximum of 45 mg once daily, based on glycemic response as measured by HbA1c levels. Dose adjustments should typically occur at intervals of 12-16 weeks to allow adequate time for therapeutic response assessment. Administration is oral, with tablets swallowed whole with water, and may be taken with or without food. For patients receiving concomitant insulin therapy, the insulin dose may need reduction if patients report hypoglycemia or if plasma glucose concentrations fall below 100 mg/dL. Renal impairment does not significantly affect pharmacokinetics, but hepatic impairment requires caution and possible dose adjustment. Regular monitoring of liver enzymes is recommended before initiation and periodically during treatment.
Precautions
Before initiating Actos therapy, perform liver function tests; discontinue if ALT levels exceed 2.5 times the upper limit of normal. Monitor for signs and symptoms of heart failure, as fluid retention may occur and could exacerbate or lead to heart failure. Use with caution in patients with edema, particularly when used with insulin. Regular ophthalmologic examinations are recommended due to potential risk of diabetic macular edema. Monitor weight gain, which may be significant in some patients. Hemoglobin/hematocrit levels may decrease during therapy, typically during the first 4-12 weeks of treatment. Use with caution in premenopausal anovulatory women, as ovulation may resume, potentially requiring contraception. Bone fracture risk increases, particularly in women; consider bone density assessment in patients with fracture risk factors. Monitor glycemic control regularly through HbA1c testing every 3-6 months.
Contraindications
Actos is contraindicated in patients with known hypersensitivity to pioglitazone or any component of the formulation. It must not be used in patients with established New York Heart Association (NYHA) Class III or IV heart failure. The medication is contraindicated in patients with active bladder cancer or a history of bladder cancer. Use is prohibited in patients with severe hepatic impairment (Child-Pugh Class C) or active liver disease. Actos is not indicated for use in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. The medication is contraindicated in combination with gemfibrozil due to significant drug interaction that increases pioglitazone exposure. It should not be used during pregnancy unless potential benefit justifies potential risk to the fetus.
Possible side effect
Common adverse reactions (≥5%) include upper respiratory tract infection, headache, sinusitis, myalgia, tooth disorder, diabetes mellitus aggravated, and pharyngitis. Hypoglycemia may occur when used in combination with insulin or insulin secretagogues. Weight gain of 2-4 kg occurs frequently, related to fluid retention and fat accumulation. Edema (4-6%) and anemia (1-2%) may develop, typically within the first few months of treatment. Less frequent but potentially serious side effects include congestive heart failure (0.5-1%), bladder cancer (increased incidence in long-term users), fractures (particularly in distal upper and lower limbs in women), macular edema, and hepatic enzyme elevations. Rare cases of hypersensitivity reactions including angioedema and urticaria have been reported. Postmarketing reports include new onset or worsening diabetic macular edema, pulmonary edema, and hepatitis.
Drug interaction
Gemfibrozil significantly increases pioglitazone exposure and is contraindicated. Rifampin decreases pioglitazone exposure by approximately 54%; consider alternative therapy or dose adjustment. Atorvastatin slightly decreases pioglitazone concentrations. Ketoconazole increases pioglitazone AUC by approximately 40%; monitor glycemic control. Oral contraceptives containing ethinyl estradiol and norethindrone may have decreased efficacy when coadministered with Actos. CYP2C8 inhibitors (trimethoprim, montelukast) may increase pioglitazone exposure. Insulin and insulin secretagogues increase risk of hypoglycemia; dose reduction may be necessary. Other medications that cause fluid retention (NSAIDs, corticosteroids) may exacerbate this effect. Actos may potentially decrease the efficacy of cyclosporine; monitor cyclosporine levels.
Missed dose
If a dose of Actos is missed, it should be taken as soon as remembered on the same day. However, if it is almost time for the next scheduled dose, the missed dose should be skipped and the regular dosing schedule resumed. Patients should not take a double dose to make up for a missed dose. Consistent daily administration at approximately the same time each day is recommended to maintain stable drug levels and optimal glycemic control. If multiple doses are missed, patients should contact their healthcare provider for guidance, as glycemic control may be compromised. Keeping a medication diary or using pill organizers can help prevent missed doses.
Overdose
Cases of overdose with Actos have been reported with doses up to 120 mg daily. The most common manifestations expected would be those related to the pharmacologic effects of the drug, including hypoglycemia, although this is unlikely when used as monotherapy. Other potential effects include excessive fluid retention leading to heart failure exacerbation, dizziness, weakness, and gastrointestinal disturbances. There is no specific antidote for pioglitazone overdose. Management should include supportive and symptomatic treatment, with close monitoring of blood glucose, electrolyte balance, cardiac function, and hepatic status. Hemodialysis is unlikely to be effective due to high protein binding. Gastric lavage may be considered if presentation is early after ingestion. Patients should seek immediate medical attention if overdose is suspected.
Storage
Store Actos tablets at controlled room temperature, 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C and 30°C (59°F and 86°F). Keep the medication in its original container with the lid tightly closed to protect from moisture and light. Do not store in bathroom cabinets where humidity levels fluctuate. Keep out of reach of children and pets. Do not use tablets that are discolored, damaged, or beyond the expiration date printed on the packaging. Proper disposal of unused medication through take-back programs is recommended to prevent accidental ingestion or environmental contamination. Do not flush medications down the toilet unless specifically instructed to do so.
Disclaimer
This information is provided for educational purposes only and does not constitute medical advice. Actos is a prescription medication that should be used only under the supervision of a qualified healthcare professional. Individual patient responses may vary, and treatment decisions should be based on professional medical judgment considering the patient’s complete medical history, current medications, and specific health status. The prescribing physician should be consulted for specific dosing instructions and monitoring requirements. This information is not exhaustive and does not replace the approved product labeling. Patients should report any adverse effects to their healthcare provider and adhere to recommended monitoring schedules.
Reviews
Clinical studies demonstrate Actos effectively reduces HbA1c by 1.0-1.5% when used as monotherapy and provides additional glycemic control when combined with other antidiabetic agents. The PROactive study showed significant reduction in secondary composite endpoints including myocardial infarction and stroke in high-risk patients. Many endocrinologists appreciate its mechanism of action targeting insulin resistance, though most recommend careful patient selection due to safety considerations. Patient reviews often mention improved energy levels and stable blood glucose readings, though some report dissatisfaction with weight gain and edema. The American Diabetes Association guidelines include thiazolidinediones as treatment options, particularly noting their durability of effect. Long-term observational studies continue to evaluate the benefit-risk profile in various patient populations.