Drug Name
Actos (Pioglitazone)
Generic Name
Manufacturer / Distributor
Pioglitazone (PYE-oh-GLI-ta-zone)
Takeda Pharmaceutical Company Limited
Looks like
Pioglitazone is available with a prescription under the brand name Actos. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.
- Actos 15 mg-white, round tablets
- Actos 30 mg-white, round tablets
- Actos 45 mg-white, round tablets
Dosage Form
Tablets
Route Of Administration
ORAL
Imprint Code
Actos;15 / Actos;30 / Actos;45
Size
7mm / 7mm / 8mm
Alternatives
Actoplus Met
Drug Uses
Actos is used for the treatment of type II diabetes along with a healthy diabetic diet, regular exercise, weight control, smoking reduction, and careful monitoring of blood glucose.
Actos may be used alone or in combination with metformin, a drug in a different class of anti-diabetic drugs, that also lowers blood glucose.
Actos is approved for treating type II diabetes in combination with insulin as well as another class of anti-diabetic drugs, the sulfonylureas.
Drug class
Actos is a drug that reduces the amount of glucose (sugar) in the blood. It is in a class of anti-diabetic drugs, called “thiazolidinediones”, that are used in the treatment of type II diabetes.
Actos also lowers the level of glucose in the blood by reducing the production and secretion of glucose into the blood by the liver. In addition, actos may alter the blood concentrations of lipids (fats) in the blood. Specifically, it decreases triglycerides and increases the “good” (HDL) cholesterol.
Contains
Actos is available as a tablet for oral administration containing 15 mg, 30 mg, or 45 mg of pioglitazone (as the base) formulated with the following excipients: lActose monohydrate NF, hydroxypropylcellulose NF, carboxymethylcellulose calcium NF, and magnesium stearate NF.
Chemical formula
Pioglitazone [(�)-5-[[4-[2-(5-ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-] thiazolidinedione monohydrochloride belongs to a different chemical class and has a different pharmacological action than the sulfonylureas, metformin, or the ?-glucosidase inhibitors. The molecule contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo. No differences were found in the pharmacologic activity between the two enantiomers.
Pioglitazone hydrochloride is an odorless white crystalline powder that has a molecular formula of C19H20N2O3S�HCl and a molecular weight of 392.90 daltons. It is soluble in N,N-dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether.
Mechanism of Action
Actos is a thiazolidinedione antidiabetic agent that depends on the presence of insulin for its mechanism of action. Actos decreases insulin resistance in the periphery and in the liver resulting in increased insulin-dependent glucose disposal and decreased hepatic glucose output. Unlike sulfonylureas, pioglitazone is not an insulin secretagogue. Pioglitazone is a potent and highly selective agonist for peroxisome proliferator-activated receptor-gamma (PPAR?). PPAR receptors are found in tissues important for insulin action such as adipose tissue, skeletal muscle, and liver. Activation of PPAR? nuclear receptors modulates the transcription of a number of insulin responsive genes involved in the control of glucose and lipid metabolism.
In animal models of diabetes, pioglitazone reduces the hyperglycemia, hyperinsulin-emia, and hypertriglyceridemia characteristic of insulin-resistant states such as type 2 diabetes. The metabolic changes produced by pioglitazone result in increased responsiveness of insulin-dependent tissues and are observed in numerous animal models of insulin resistance.
Since pioglitazone enhances the effects of circulating insulin (by decreasing insulin resistance), it does not lower blood glucose in animal models that lack endogenous insulin.
How Taken
Take pioglitazone exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.
Take each dose with a full glass of water.
Pioglitazone is usually taken once daily. You may take the medicine with or without food.
Pioglitazone is only part of a complete program of treatment that also includes diet, exercise, and weight control. Your doctor may also recommend other medicines to treat your diabetes.
It is important to use this medicine regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Your liver function may also need to be tested, and you may need regular eye exams. It is important that you not miss any scheduled visits to your doctor.
Your medication needs may change if you become sick or injured, if you have a serious infection, or if you have any type of surgery. Your doctor may want you to stop taking pioglitazone for a short time if any of these situations affect you.
Take care not to let your blood sugar get too low, causing hypoglycemia. You may have hypoglycemia if you skip a meal, exercise too long, drink alcohol, or are under stress.
Know the signs of low blood sugar (hypoglycemia) and how to recognize them:
- hunger, headache, confusion, irritability;
- drowsiness, weakness, dizziness, tremors;
- sweating, fast heartbeat;
- seizure (convulsions); or
- fainting, coma (severe hypoglycemia can be fatal).
Always keep a source of sugar available in case you have symptoms of low blood sugar. Sugar sources include orange juice, glucose gel, candy, or milk. If you have severe hypoglycemia and cannot eat or drink, use an injection of glucagon. Your doctor can give you a prescription for a glucagon emergency injection kit and tell you how to give the injection.
Dosage and Administration
Actos should be taken once daily without regard to meals.
The management of antidiabetic therapy should be individualized. Ideally, the response to therapy should be evaluated using HbA1c which is a better indicator of long-term glycemic control than FPG alone. HbA1c reflects glycemia over the past two to three months. In clinical use, it is recommended that patients be treated with Actos for a period of time adequate to evaluate change in HbA1c (three months) unless glycemic control deteriorates.
Monotherapy
Actos monotherapy in patients not adequately controlled with diet and exercise may be initiated at 15 mg or 30 mg once daily. For patients who respond inadequately to the initial dose of Actos, the dose can be increased in increments up to 45 mg once daily. For patients not responding adequately to monotherapy, combination therapy should be considered.
Combination Therapy
Sulfonylureas: Actos in combination with a sulfonylurea may be initiated at 15 mg or 30 mg once daily. The current sulfonylurea dose can be continued upon initiation of Actos therapy. If patients report hypoglycemia, the dose of the sulfonylurea should be decreased.
Metformin: Actos in combination with metformin may be initiated at 15 mg or 30 mg once daily. The current metformin dose can be continued upon initiation of Actos therapy. It is unlikely that the dose of metformin will require adjustment due to hypoglycemia during combination therapy with Actos.
Insulin: Actos in combination with insulin may be initiated at 15 mg or 30 mg once daily. The current insulin dose can be continued upon initiation of Actos therapy. In patients receiving Actos and insulin, the insulin dose can be decreased by 10% to 25% if the patient reports hypoglycemia or if plasma glucose concentrations decrease to less than 100 mg/dL. Further adjustments should be individualized based on glucose-lowering response.
Usual Starting Dose
The recommended starting dose of Actos is 15 to 30 milligrams once a day.
If this fails to bring your blood sugar under control, the dose can be increased to a maximum of 45 milligrams a day. If your blood sugar still remains high, the doctor may add a second medication.
Usual Maintenance Dose
When Actos is added to other diabetes medications, your doctor may need to lower their dosage if you develop low blood sugar. If you are taking insulin, the dose should be lowered when blood sugar readings fall below 100.
Missed Dose
Take the missed dose as soon as you remember. If you do not remember until the next day, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose.
Overdose
Seek emergency medical attention if you think you have used too much of this medicine. Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org/findyour.htm ), or emergency room immediately.
You may have signs of low blood sugar, such as:
- hunger,
- headache,
- confusion,
- irritability,
- drowsiness,
- weakness,
- dizziness,
- tremors,
- sweating,
- fast heartbeat,
- seizure (convulsions),
- fainting, or coma.
Storage
Store at 77 degrees F (25 degrees C) in a tightly closed container. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light.
Keep container tightly closed.
Do not store in the bathroom.
Keep Actos out of the reach of children and away from pets.
How Supplied
Actos is available in 15 mg, 30 mg, and 45 mg tablets as follows:
15 mg Tablet: white to off-white, round, convex, non-scored tablet with �Actos� on one side, and �15� on the other, available in:
NDC 64764-151-04 Bottles of 30
NDC 64764-151-05 Bottles of 90
NDC 64764-151-06 Bottles of 500
30 mg Tablet: white to off-white, round, flat, non-scored tablet with �Actos� on one side, and �30� on the other, available in:
NDC 64764-301-14 Bottles of 30
NDC 64764-301-15 Bottles of 90
NDC 64764-301-16 Bottles of 500
45 mg Tablet: white to off-white, round, flat, non-scored tablet with �Actos� on one side, and �45� on the other, available in:
NDC 64764-451-24 Bottles of 30
NDC 64764-451-25 Bottles of 90
NDC 64764-451-26 Bottles of 500
What is the most important information I should know about Actos?
Most important information about Actos
Pharmacokinetics
Side Effects
More information about ACTOS (Pioglitazone):
FDA Alert
Actos Benefits Recent Heart-Attack Patients with Diabetes
Actos found to improve glucose control and lipid profiles
Takeda Revises Actos (pioglitazone HCl) Prescribing Label
New Analyses Show Actos Reduced Risk of Secondary Stroke by Almost 50 Percent
ACTOS (Pioglitazone) Combination Therapy
Submission of an Application for an additional Indication of Actos in Japan; Concomitant Therapy with Biguanides for Type 2 Diabetes
Termination of Development of Fixed Dose Combination Product of Actos + TAK-536
Takeda Wins Patent Infringement Litigation on Appeal Against ANDA Filers for Generic Actos
Diabetes Drugs Increase Risk of Heart Failure, Research Shows
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