I am diabetic

Drug Name
Actoplus Met (Pioglitazone/Metformin)

Generic Name
Pioglitazone hydrochloride and Metformin hydrochloride (Pye-oh-GLI-ta-zone/ MET-fore-min)

Manufacturer / Distributor
Takeda

Looks like
Metformin and pioglitazone is available with a prescription under the brand name Actoplus Met. 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.

• Actoplus Met 15 mg/500 mg (pioglitazone/metformin)-off white oval, film-coated tablets
• Actoplus Met 15 mg/850 mg (pioglitazone/metformin)-off white pink, oval, film-coated tablets

Dosage Form
Tablets

Route Of Administration
ORAL

Imprint Code
4833M;15/500 / 4833M;15/850

Size
14mm / 18mm

Alternatives
Actos, Avandia, Avandamet

Drug Uses
Actoplus Met is a combination of two oral diabetes medicines (Metformin and Pioglitazone) that help control blood sugar levels with diet and exercise, in patients with type 2 diabetes who are already being treated with both of these medications, who are not adequately controlled on metformin alone, or who have responded to pioglitazone alone but require additional control.
ActoPlus Met is a combination of an insulin resistance reducer and a biguanide. This combination medicine works in 2 ways to improve blood glucose levels (sugar). Pioglitazone helps the cells use glucose, and metformin slows the liver’s production of glucose. Controlling high blood sugar helps prevent heart disease, strokes, kidney disease, blindness, circulation problems, and sexual function problems (impotence).

Drug class
Actoplus Met is a combination of an insulin resistance reducer and a biguanide, used along with a diet and exercise program to control high blood sugar in certain diabetic patients.

Contains
Actoplus Met� (pioglitazone hydrochloride and metformin hydrochloride) tablets contain two oral antihyperglycemic drugs used in the management of type 2 diabetes:

• pioglitazone hydrochloride
• and metformin hydrochloride.

The concomitant use of pioglitazone and metformin has been previously approved based on clinical trials in patients with type 2 diabetes inadequately controlled on metformin. Additional efficacy and safety information about pioglitazone and metformin monotherapies may be found in the prescribing information for each individual drug.

Inactive ingredients:

• povidone
• microcrystalline cellulose
• croscarmellose sodium
• magnesium stearate
• hypromellose 2910
• polyethylene glycol 8000
• titanium dioxide
• talc

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, biguanides, or the ?-glucosidase inhibitors. The molecule contains one asymmetric center, and the synthetic compound is a racemate. The two enantiomers of pioglitazone interconvert in vivo. The structural formula is as shown:

Pioglitazone hydrochloride is an odorless white crystalline powder that has a molecular formula of C19H20N2O3S�HCl and a molecular weight of 392.90. 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.

Metformin hydrochloride (N,N -dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. Metformin hydrochloride is a white crystalline powder with a molecular formula of C4H11N5�HCl and a molecular weight of 165.62. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula is as shown:

Actoplus Met is available as a tablet for oral administration containing 15 mg pioglitazone hydrochloride (as the base) with 500 mg metformin hydrochloride (15 mg/500 mg) or 15 mg pioglitazone hydrochloride (as the base) with 850 mg metformin hydrochloride (15 mg/850 mg) formulated with the following excipients: povidone USP, microcrystalline cellulose NF, croscarmellose sodium NF, magnesium stearate NF, hypromellose 2910 USP, polyethylene glycol 8000 NF, titanium dioxide USP, and talc USP.

Mechanism of Action
Actoplus Met combines two antihyperglycemic agents with different mechanisms of action to improve glycemic control in patients with type 2 diabetes: pioglitazone hydrochloride, a member of the thiazolidinedione class, and metformin hydrochloride, a member of the biguanide class. Thiazolidinediones are insulin-sensitizing agents that act primarily by enhancing peripheral glucose utilization, whereas biguanides act primarily by decreasing endogenous hepatic glucose production.

Pioglitazone hydrochloride
Pioglitazone depends on the presence of insulin for its mechanism of action. Pioglitazone 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, hyperinsulinemia, 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.

Metformin hydrochloride
Metformin hydrochloride improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. Unlike sulfonylureas, metformin does not produce hypoglycemia in either patients with type 2 diabetes or normal subjects (except in special circumstances) and does not cause hyperinsulinemia. With metformin therapy, insulin secretion remains unchanged while fasting insulin levels and day-long plasma insulin response may actually decrease.

How Taken
Take metformin and pioglitazone exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain the instructions to you.
Take each dose with a full glass of water.
Take metformin and pioglitazone with meals to reduce nausea, diarrhea, and upset stomach that may occur with metformin and pioglitazone therapy. These symptoms may be more likely to occur during the first few weeks of therapy.
It is important to take metformin and pioglitazone regularly to get the most benefit.
A decrease in vitamin B12 may also occur during metformin and pioglitazone therapy. Your doctor may want to monitor blood levels of vitamin B12 and you may need to take a B12 supplement. A vitamin B12 deficiency may rarely cause anemia.
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 metformin and 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.
Usually, liver function is monitored with blood tests at the start of treatment, every two months for the first year of treatment, and periodically thereafter during treatment with pioglitazone. Notify your doctor immediately if you develop nausea, vomiting, abdominal pain, unusual fatigue, loss of appetite, yellow skin or eyes, or dark urine. These symptoms may be early signs of liver problems.

Dosage and Administration
The use of antihyperglycemic therapy in the management of type 2 diabetes should be individualized on the basis of effectiveness and tolerability while not exceeding the maximum recommended daily dose of pioglitazone 45 mg and metformin 2550 mg.

Usual Starting Dose
Selecting the starting dose of Actoplus Met should be based on the patient’s current regimen of pioglitazone and/or metformin. After initiation of Actoplus Met or with dose increase, patients should be carefully monitored for adverse events related to fluid retention. Actoplus Met should be given in divided daily doses with meals to reduce the gastrointestinal side effects associated with metformin.
Starting dose for patients inadequately controlled on metformin monotherapy
Based on the usual starting dose of pioglitazone (15-30 mg daily), Actoplus Met may be initiated at either the 15 mg/500 mg or 15 mg/850 mg tablet strength once or twice daily, and gradually titrated after assessing adequacy of therapeutic response.
Starting dose for patients who initially responded to pioglitazone monotherapy and require additional glycemic control
Based on the usual starting doses of metformin (500 mg twice daily or 850 mg daily), Actoplus Met may be initiated at either the 15 mg/500 mg twice daily or 15 mg/850 mg tablet strength once daily, and gradually titrated after assessing adequacy of therapeutic response.
Starting dose for patients switching from combination therapy of pioglitazone plus metformin as separate tablets.

Usual Maintenance Dose
Actoplus Met may be initiated with either the 15 mg/500 mg or 15 mg/850 mg tablet strengths based on the dose of pioglitazone and metformin already being taken.
No studies have been performed specifically examining the safety and efficacy of Actoplus Met in patients previously treated with other oral hypoglycemic agents and switched to Actoplus Met. Any change in therapy of type 2 diabetes should be undertaken with care and appropriate monitoring as changes in glycemic control can occur.
Sufficient time should be given to assess adequacy of therapeutic response. Ideally, the response to therapy should be evaluated using A1C, which is a better indicator of long-term glycemic control than FPG alone. A1C reflects glycemia over the past two to three months. In clinical use, it is recommended that patients be treated with Actoplus Met for a period of time adequate to evaluate change in A1C (8-12 weeks) unless glycemic control as measured by FPG deteriorates.

Missed Dose
Take the missed dose as soon as you remember (be sure to take the medicine with food). If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time.
Do not take extra medicine to make up the missed 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.
Symptoms may include:

• hunger,
• headache,
• confusion,
• irritability,
• drowsiness,
• weakness,
• dizziness,
• tremors,
• sweating,
• fast heartbeat,
• seizure (convulsions),
• fainting, or coma.

An overdose of metformin and pioglitazone may cause a life-threatening condition called lactic acidosis. Get emergency medical help if you have any of these symptoms of lactic acidosis:

• weakness,
• increasing sleepiness,
• slow heart rate,
• cold feeling,
• muscle pain,
• shortness of breath,
• stomach pain,
• feeling light-headed,
• and fainting.

Storage
Store ActoPlus Met at 77 degrees F (25 degrees C) in a tightly closed container. Store away from heat, moisture, and light. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted.
Do not store in bathroom.
Keep ActoPlus Met out of the reach of children and away from pets.

How Supplied

Actoplus Met is available in 15 mg pioglitazone hydrochloride (as the base)/500 mg metformin hydrochloride and 15 mg pioglitazone hydrochloride (as the base)/850 mg metformin hydrochloride tablets as follows:

15 mg/500 mg tablet: white to off-white, oblong, film-coated tablet with “4833M” on one side, and “15/500″ on the other, available in:
Bottles of 60 – NDC 64764-155-60
Bottles of 180 – NDC 64764-155-18

15 mg/850 mg tablet: white to off-white, oblong, film-coated tablet with “4833M” on one side, and “15/850″ on the other, available in:
Bottles of 60 – NDC 64764-158-60
Bottles of 180 – NDC 64764-158-18

Most important information about Actos

Pharmacokinetics

Side Effects

More information about ACTOPLUS MET (Pioglitazone/Metformin):

Laboratory Abnormalities

FDA MedWatch Alerts

ACTOplus met Approved by the FDA for Type 2 Diabetes

To buy ACTOPLUS MET click HERE: My Family Drugstore

Tags: Actoplus Met (Pioglitazone/Metformin), Conditions & Treatments, Medications, Type 2 Diabetes

This entry was posted on Thursday, November 1st, 2007 at 1:19 pm and is filed under Actoplus Met, Medications, Type 2 Diabetes. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.