Posts Tagged ‘Actoplus Met (Pioglitazone/Metformin)’

Actoplus Met (Pioglitazone/Metformin) Pharmacokinetics

Saturday, November 3rd, 2007

Absorption
In bioequivalence studies of Actoplus Met 15 mg/500 mg and 15 mg/850 mg, the area under the curve (AUC) and maximum concentration (Cmax) of both the pioglitazone and the metformin component following a single dose of the combination tablet were bioequivalent to ACTOS� 15 mg concomitantly administered with Glucophage� (500 mg or 850 mg, respectively) tablets under fasted conditions in healthy subjects.
Administration of Actoplus Met 15 mg/850 mg with food resulted in no change in overall exposure of pioglitazone. With metformin there was no change in AUC; however mean peak serum concentration of metformin was decreased by 28% when administered with food. A delayed time to peak serum concentration was observed for both components (1.9 hours for pioglitazone and 0.8 hours for metformin) under fed conditions. These changes are not likely to be clinically significant.

Pioglitazone hydrochloride
Following oral administration, in the fasting state, pioglitazone is first measurable in serum within 30 minutes, with peak concentrations observed within 2 hours. Food slightly delays the time to peak serum concentration to 3 to 4 hours, but does not alter the extent of absorption.

Metformin hydrochloride
The absolute bioavailability of a 500 mg metformin tablet given under fasting conditions is approximately 50% – 60%. Studies using single oral doses of metformin tablets of 500 mg to 1500 mg, and 850 mg to 2550 mg, indicate that there is a lack of dose proportionality with increasing doses, which is due to decreased absorption rather than an alteration in elimination. Food decreases the extent of and slightly delays the absorption of metformin, as shown by approximately a 40% lower mean peak plasma concentration, a 25% lower AUC in plasma concentration versus time curve, and a 35 minute prolongation of time to peak plasma concentration following administration of a single 850 mg tablet of metformin with food, compared to the same tablet strength administered fasting. The clinical relevance of these decreases is unknown.

Distribution
Pioglitazone hydrochloride
The mean apparent volume of distribution (V/F) of pioglitazone following single-dose administration is 0.63 � 0.41 (mean � SD) L/kg of body weight. Pioglitazone is extensively protein bound (> 99%) in human serum, principally to serum albumin. Pioglitazone also binds to other serum proteins, but with lower affinity. Metabolites M-III and M-IV also are extensively bound (> 98%) to serum albumin.

Metformin hydrochloride
The apparent volume of distribution (V/F) of metformin following single oral doses of 850 mg averaged 654 � 358 L. Metformin is negligibly bound to plasma proteins. Metformin partitions into erythrocytes, most likely as a function of time. At usual clinical doses and dosing schedules of metformin, steady-state plasma concentrations of metformin are reached within 24 – 48 hours and are generally <1 �g/mL. During controlled clinical trials, maximum metformin plasma levels did not exceed 5 �g/mL, even at maximum doses.

Metabolism
Pioglitazone hydrochloride
Pioglitazone is extensively metabolized by hydroxylation and oxidation; the metabolites also partly convert to glucuronide or sulfate conjugates. Metabolites M-II and M-IV (hydroxy derivatives of pioglitazone) and M-III (keto derivative of pioglitazone) are pharmacologically active in animal models of type 2 diabetes. In addition to pioglitazone, M-III and M-IV are the principal drug-related species found in human serum following multiple dosing. At steady-state, in both healthy volunteers and in patients with type 2 diabetes, pioglitazone comprises approximately 30% to 50% of the total peak serum concentrations and 20% to 25% of the total AUC.
In vitro data demonstrate that multiple CYP isoforms are involved in the metabolism of pioglitazone. The cytochrome P450 isoforms involved are CYP2C8 and, to a lesser degree, CYP3A4 with additional contributions from a variety of other isoforms including the mainly extrahepatic CYP1A1. In vivo studies of pioglitazone in combination with P450 inhibitors and substrates have been performed. Urinary 6?-hydroxycortisol/cortisol ratios measured in patients treated with pioglitazone showed that pioglitazone is not a strong CYP3A4 enzyme inducer.

Metformin hydrochloride
Intravenous single-dose studies in normal subjects demonstrate that metformin is excreted unchanged in the urine and does not undergo hepatic metabolism (no metabolites have been identified in humans) nor biliary excretion. Renal clearance is approximately 3.5 times greater than creatinine clearance which indicates that tubular secretion is the major route of metformin elimination. Following oral administration, approximately 90% of the absorbed drug is eliminated via the renal route within the first 24 hours, with a plasma elimination half-life of approximately 6.2 hours. In blood, the elimination half-life is approximately 17.6 hours, suggesting that the erythrocyte mass may be a compartment of distribution.

Excretion
Following oral administration, approximately 15% to 30% of the pioglitazone dose is recovered in the urine. Renal elimination of pioglitazone is negligible and the drug is excreted primarily as metabolites and their conjugates. It is presumed that most of the oral dose is excreted into the bile either unchanged or as metabolites and eliminated in the feces.
The mean serum half-life of pioglitazone and total pioglitazone ranges from 3 to 7 hours and 16 to 24 hours, respectively. Pioglitazone has an apparent clearance, CL/F, calculated to be 5 to 7 L/hr.

Special Populations

Geriatric
Pioglitazone hydrochloride
In healthy elderly subjects, peak serum concentrations of pioglitazone and total pioglitazone are not significantly different, but AUC values are slightly higher and the terminal half-life values slightly longer than for younger subjects. These changes were not of a magnitude that would be considered clinically relevant.

Metformin hydrochloride
Limited data from controlled pharmacokinetic studies of metformin in healthy elderly subjects suggest that total plasma clearance is decreased, the half-life is prolonged, and Cmax is increased, compared to healthy young subjects. From these data, it appears that the change in metformin pharmacokinetics with aging is primarily accounted for by a change in renal function.
Actoplus Met treatment should not be initiated in patients ? 80 years of age unless measurement of creatinine clearance demonstrates that renal function is not reduced.

Pediatric
Pioglitazone hydrochloride
Pharmacokinetic data in the pediatric population are not available.

Metformin hydrochloride
After administration of a single oral metformin 500 mg tablet with food, geometric mean metformin Cmax and AUC differed less than 5% between pediatric type 2 diabetic patients (12 to 16 years of age) and gender- and weight-matched healthy adults (20 to 45 years of age), and all with normal renal function.

Gender
Pioglitazone hydrochloride
As monotherapy and in combination with sulfonylurea, metformin, or insulin, pioglitazone improved glycemic control in both males and females. The mean Cmax and AUC values were increased 20% to 60% in females. In controlled clinical trials, hemoglobin A1C(A1C) decreases from baseline were generally greater for females than for males (average mean difference in A1C 0.5%). Since therapy should be individualized for each patient to achieve glycemic control, no dose adjustment is recommended based on gender alone.

Metformin hydrochloride
Metformin pharmacokinetic parameters did not differ significantly between normal subjects and patients with type 2 diabetes when analyzed according to gender (males = 19, females = 16). Similarly, in controlled clinical studies in patients with type 2 diabetes, the antihyperglycemic effect of metformin was comparable in males and females.

Race
Pioglitazone hydrochloride
Pharmacokinetic data among various ethnic groups are not available.

Metformin hydrochloride
No studies of metformin pharmacokinetic parameters according to race have been performed. In controlled clinical studies of metformin in patients with type 2 diabetes, the antihyperglycemic effect was comparable in whites (n=249), blacks (n=51), and Hispanics (n=24).

Renal Insufficiency
Pioglitazone hydrochloride
The serum elimination half-life of pioglitazone, M-III and M-IV remains unchanged in patients with moderate (creatinine clearance 30 to 60 mL/min) to severe (creatinine clearance < 30 mL/min) renal impairment when compared to normal subjects.

Metformin hydrochloride
In patients with decreased renal function (based on creatinine clearance), the plasma and blood half-life of metformin is prolonged and the renal clearance is decreased in proportion to the decrease in creatinine clearance. Since metformin is contraindicated in patients with renal impairment, Actoplus Met is also contraindicated in these patients.

Hepatic Impairment
Pioglitazone hydrochloride
Compared with normal controls, subjects with impaired hepatic function (Child-Pugh Grade B/C) have an approximate 45% reduction in pioglitazone and total pioglitazone mean peak concentrations but no change in the mean AUC values.
Therapy with Actoplus Met should not be initiated if the patient exhibits clinical evidence of active liver disease or serum transaminase levels (ALT) exceed 2.5 times the upper limit of normal.

Metformin hydrochloride
No pharmacokinetic studies of metformin have been conducted in subjects with hepatic insufficiency.

Product Description

Most important information about Actos

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

  • Share/Bookmark

Actoplus Met (Pioglitazone/Metformin) Most Important Information

Friday, November 2nd, 2007

What is the most important information I should know about ActoPlus Met?
Lactic acidosis, which can be fatal, may occur while taking ActoPlus Met.
Symptoms include:

  • general body discomfort,
  • muscle pain,
  • breathing problems,
  • increasing drowsiness,
  • upset stomach,
  • cold skin,
  • dizziness,
  • tiredness,
  • lightheadedness,
  • and slowed heartbeat.

If any of these symptoms occur, seek medical attention at once.
Lactic acidosis is more likely to occur in patients who have heart failure, kidney or liver problems, a lack of body fluids or dehydration, x-ray or scanning procedures that require an injectable iodinated contrast drug, surgery, serious infection, heart attack, stroke, or who use alcohol excessively. Also at higher risk are the elderly, especially those older than 80 years of age who have not had kidney and liver function tests.
Thiazolidinedione antidiabetics such as ActoPlus Met may cause or worsen heart failure in some patients. Tell your doctor if you have a history of heart failure. ActoPlus Met should not be used to treat patients with moderate to severe heart failure. You will be monitored for signs of heart failure when you start ActoPlus Met and when your dose increases. Contact your doctor at once if you develop swelling of the hands, ankles, or feet; shortness of breath; or sudden unexplained weight gain. Your doctor may need to stop your medicine or change your dose.
Avoid excessive alcohol intake while taking metformin and pioglitazone. Together, alcohol and metformin and pioglitazone may increase the risk of lactic acidosis and hypoglycemia.
Metformin and pioglitazone does not usually cause hypoglycemia (low blood sugar). Nevertheless, hypoglycemia may occur, as a result of skipped meals, excessive exercise, or alcohol consumption. Know the signs and symptoms of low blood sugar, which include:

  • hunger,
  • headache,
  • drowsiness,
  • weakness,
  • dizziness,
  • a fast heartbeat,
  • sweating,
  • tremor,
  • and nausea.

Carry a non-dietetic candy or glucose tablets to treat episodes of low blood sugar.

What should I discuss with my doctor before taking ActoPlus Met?
Do not take metformin and pioglitazone without first talking to your doctor if you:

  • have type 1 diabetes;
  • have liver or kidney disease;
  • have acute or chronic metabolic acidosis, including diabetic ketoacidosis;
  • have congestive heart failure;
  • have had a heart attack or a stroke;
  • have a serious infection, illness, or injury;
  • need to have surgery;
  • need to have x-rays or other procedures using injectable contrast agents;
  • are dehydrated (have lost water from your body) due to diarrhea, vomiting, fever, heat stroke, decreased fluid intake, or any other cause;
  • have edema (water retention or swelling);
  • drink alcohol; or
  • are 80 years of age or older and have not had your kidney function tested.

You may not be able to take metformin and pioglitazone, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
Treatment with metformin and pioglitazone may cause resumption of fertility by allowing the return of ovulation (production of eggs) in certain women with insulin resistance who were not ovulating before treatment with metformin and pioglitazone. Talk to your doctor about adequate forms of birth control while taking metformin and pioglitazone if birth control is desired.
Contact your doctor if you develop a fever or an infection, require surgery, or if you experience a serious injury. Illness or injury may cause a loss of blood sugar control and insulin (or an adjustment of a current insulin dose) may be required for a period of time.
Metformin and pioglitazone is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Generally, insulin is the drug of choice for controlling diabetes during pregnancy. Do not take metformin and pioglitazone without first talking to your doctor if you are pregnant or could become pregnant during treatment.
It is not known whether metformin and pioglitazone passes into breast milk. Do not take metformin and pioglitazone without first talking to your doctor if you are breast-feeding a baby.
If you are over the age of 65 years, there may be an slight increase in the risk of developing lactic acidosis due to a natural decline in kidney function with advancing age. A lower dose or special monitoring may be necessary during treatment.

Product Description

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

  • Share/Bookmark

Actoplus Met (Pioglitazone/Metformin) Description

Thursday, November 1st, 2007

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:
[Image]
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:
[Image]
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

  • Share/Bookmark