Archive for the ‘Actoplus Met’ Category

FROM THE BEGINING…

Saturday, October 4th, 2008

Do you have diabetes? Are you struggling to live with diabetes? Are you looking for information online about diabetes? Are you unsure as to what types of foods you should now be eating to help keep a check on your glucose levels? If you have answered yes to any of these questions this article may well be of interest and benefit to you.

Diabetes is a disease in which the body does not produce or properly use insulin. Insulin is a hormone that is needed to convert sugar, starches and other food into energy needed for daily life. The cause of diabetes continues to be a mystery, although both genetics and environmental factors such as obesity and lack of exercise appear to play roles.

There are 20.8 million children and adults in the United States, or 7% of the population, who have diabetes. While an estimated 14.6 million have been diagnosed with diabetes, unfortunately, 6.2 million people (or nearly one-third) are unaware that they have the disease.

In order to determine whether or not a patient has pre-diabetes or diabetes, health care providers conduct a Fasting Plasma Glucose Test (FPG) or an Oral Glucose Tolerance Test (OGTT). Either test can be used to diagnose pre-diabetes or diabetes.

With the FPG test, a fasting blood glucose level between 100 and 125 mg/dl signals pre-diabetes. A person with a fasting blood glucose level of 126 mg/dl or higher has diabetes.

In the OGTT test, a person’s blood glucose level is measured after a fast and two hours after drinking a glucose-rich beverage. If the two-hour blood glucose level is between 140 and 199 mg/dl, the person tested has pre-diabetes. If the two-hour blood glucose level is at 200 mg/dl or higher, the person tested has diabetes.

Major Types of Diabetes

Type 1 diabetes
Results from the body’s failure to produce insulin, the hormone that “unlocks” the cells of the body, allowing glucose to enter and fuel them. It is estimated that 5-10% of Americans who are diagnosed with diabetes have type 1 diabetes.

Type 2 diabetes
Results from insulin resistance (a condition in which the body fails to properly use insulin), combined with relative insulin deficiency. Most Americans who are diagnosed with diabetes have type 2 diabetes.

Medications for Type 2 Diabetes

Sulfonylureas:
- GLUCOTROL XL (Glipizide)
- AMARYL (Glimepiride)

Meglitinides:
- PRANDIN (Repaglinide)
- STARLIX (Nateglinide)

Biguanides:
- GLUCOPHAGE (Metformin)

Thiazolidinediones:
- ACTOS (Pioglitazone)
- ACTOPLUS MET (Pioglitazone/Metformin)
- AVANDIA (Rosiglitazone)
- AVANDAMET (Rosiglitazone/Metformin)

Other medications:
- KARELA and DIABECON

Gestational diabetes
Gestational diabetes affects about 4% of all pregnant women – about 135,000 cases in the United States each year.

Pre-diabetes
Pre-diabetes is a condition that occurs when a person’s blood glucose levels are higher than normal but not high enough for a diagnosis of type 2 diabetes. There are 54 million Americans who have pre-diabetes, in addition to the 20.8 million with diabetes.

Additional Information

Recently Diagnosed
You or someone you love has just been diagnosed with diabetes — chances are you have a million questions running through your head. This area of our Web site can help ease your fears and teach you more about living with diabetes or caring for someone with diabetes, and connect you with others affected by diabetes who will listen and share their own experiences.

Diabetes Symptoms
Often diabetes goes undiagnosed because many of its symptoms seem so harmless. Learn what they are in this section.

Diabetes Risk Test
More than 20 million Americans have diabetes — nearly one in three does not know it! Take our diabetes risk test to see if you are at risk for having diabetes. Diabetes is more common in African Americans, Latinos, Native Americans, Asian Americans and Pacific Islanders.

Diabetes Myths
Find the truth about some of the most common myths about diabetes.

The Genetics of Diabetes
You’ve probably wondered how you got diabetes. You may worry that your children will get it too. Unlike some traits, diabetes does not seem to be inherited in a simple pattern. Yet clearly, some people are born more likely to get diabetes than others.

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Actoplus Met (Pioglitazone/Metformin)

Saturday, November 10th, 2007

Thiazolidinediones

Rosiglitazone (Avandia) and pioglitazone (ACTOS) are in a group of drugs called thiazolidinediones. These drugs help insulin work better in the muscle and fat and also reduce glucose production in the liver. The first drug in this group, troglitazone (Rezulin), was removed from the market because it caused serious liver problems in a small number of people. So far rosiglitazone and pioglitazone have not shown the same problems, but users are still monitored closely for liver problems as a precaution. Both drugs appear to increase the risk for heart failure in some individuals, and there is debate about whether rosiglitazone may contribute to an increased risk for heart attacks. Both drugs are effective at reducing A1C and generally have few side effects.

Product Description

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 get more information about Actoplus Met:  ACTOPLUS MET MEDICATION.

To buy ACTOPLUS MET click HERE: My Family Drugstore

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Actoplus Met (Pioglitazone/Metformin) ACTOplus met Approved by the FDA for Type 2 Diabetes

Wednesday, November 7th, 2007

LINCOLNSHIRE, Ill., August 29, 2005 — Takeda Pharmaceuticals North America, Inc. (TPNA) today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for ACTOplus met for the treatment of type 2 diabetes.
ACTOplus met combines Actos (pioglitazone HCl) and metformin, two widely used diabetes medications, in a single tablet. Actos directly targets insulin resistance, a condition where the body does not efficiently use the insulin it produces, and metformin acts primarily by reducing the amount of glucose produced by the liver. These medications work in combination to help patients with type 2 diabetes manage their blood glucose levels.
To offer physicians greater flexibility in treating their patient�s needs, ACTOplus met will be available in two dosages of pioglitazone/metformin — 15 mg/500 mg and 15 mg/850 mg — both of which are to be given once a day or in divided doses not exceeding the maximum recommended daily doses of pioglitazone 45 mg and metformin 2,550 mg as mentioned in the approved labeling.
“To reach target blood glucose levels, many people with type 2 diabetes will have to take a combination of therapies. In fact, within three years of being prescribed their first medication, approximately 50 percent of patients will need to add additional therapies to manage their condition,” said Ralph DeFronzo, M.D., professor of Medicine and chief of the Diabetes Division at the University of Texas Health Science Center at San Antonio. “ACTOplus met may help patients reduce the number of pills they take each day, and offers a new and convenient treatment option.”
According to the American Diabetes Association, diabetes affects more than 18 million people, and type 2 diabetes is the most common form of the disease. Both Actos and metformin are widely used medications in the treatment of type 2 diabetes and both have a known safety profile. Combining these medications may provide patients with an easier way to take the two drugs, as they are already often prescribed together to help manage the disease.
Takeda Global Research & Development Center, Inc. submitted the ACTOplus met NDA in October 2004. Takeda expects the medication to be available to patients by October 2005.
“Takeda is committed to developing appropriate treatment options for healthcare providers and their patients,” said Mark Booth, president of Takeda Pharmaceuticals North America, Inc. “ACTOplus met reflects that commitment by offering a convenient option for people with type 2 diabetes and an important new addition to the Actos portfolio.”

About ACTOplus met & Actos
ACTOplus met is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes who are already treated with a combination of pioglitazone and metformin or whose diabetes is not adequately controlled with metformin or pioglitazone alone.
Actos is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. Actos may be used alone or in combination with metformin, sulfonylureas, or insulin.
A small number of people who have taken metformin, a component of ACTOplus met, have developed a rare, serious condition called lactic acidosis. Lactic acidosis, a buildup of lactic acid in the blood, can be fatal in about half the cases. Because lactic acidosis occurs most frequently in people with kidney problems, ACTOplus met should not be used in people with kidney disease or in people 80 years of age and older whose kidneys do not work properly. ACTOplus met should not be taken by people with metabolic acidosis, congestive heart failure requiring treatment, or with hypersensitivity to pioglitazone, metformin or any other component of ACTOplus met. ACTOplus met should not be taken by people who drink excessive amounts of alcohol. ACTOplus met should be discontinued in patients with severe infection or in patients undergoing x-ray studies using intravenous contrast dye. Talk to your health professional before discontinuing any medications.
Actos and ACTOplus met can cause fluid retention (swelling) that may lead to or worsen heart failure, so tell your health professional if you have a history of these conditions. Talk to your doctor immediately if you experience rapid weight gain, fluid retention, or shortness of breath while taking either drug. If you have moderate to severe heart failure, Actos or ACTOplus met is not recommended. Your health professional should perform a blood test to check for liver problems before you start Actos or ACTOplus met and periodically thereafter. Do not take Actos or ACTOplus met if you have active liver disease.
Talk to your doctor immediately if you experience nausea, vomiting, stomach pain, tiredness, loss of appetite, dark urine, or yellowing of the skin. If you are of childbearing age, talk to your doctor before taking Actos or ACTOplus met, as it could increase your chance of becoming pregnant.
Actos or ACTOplus met should not be used in patients with type 1 diabetes.
Source: Takeda Pharmaceuticals North America, Inc.

Product Description

Most important information about Actos

Pharmacokinetics

Side Effects

More information about ACTOPLUS MET (Pioglitazone/Metformin):

Laboratory Abnormalities

FDA MedWatch Alerts

To buy ACTOPLUS MET click HERE: My Family Drugstore

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Actoplus Met (Pioglitazone/Metformin) FDA MedWatch Alerts

Tuesday, November 6th, 2007

[Posted 03/09/2007]
Takeda and FDA notified healthcare professionals of recent safety data concerning pioglitazone-containing products. The results of an analysis of the manufacturer’s clinical trial database of pioglitazone showed more reports of fractures in female patients taking pioglitazone than those taking a comparator (either placebo or active). The majority of fractures observed in female patients were in the distal upper limb (forearm, hand and wrist) or distal lower limb (foot, ankle, fibula and tibia). There were more than 8100 patients in the pioglitazone-treated groups and over 7400 patients in the comparator-treated groups. The duration of pioglitazone treatment was up to 3.5 years. Healthcare professionals should consider the risk of fracture when initiating or treating female patients with type 2 diabetes mellitus with pioglitazone-containing products.

Product Description

Most important information about Actos

Pharmacokinetics

Side Effects

More information about ACTOPLUS MET (Pioglitazone/Metformin):

Laboratory Abnormalities

ACTOplus met Approved by the FDA for Type 2 Diabetes

To buy ACTOPLUS MET click HERE: My Family Drugstore

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Actoplus Met (Pioglitazone/Metformin) Laboratory Abnormalities

Monday, November 5th, 2007

Hematologic
Pioglitazone may cause decreases in hemoglobin and hematocrit. The fall in hemoglobin and hematocrit with pioglitazone appears to be dose related. Across all clinical studies, mean hemoglobin values declined by 2% to 4% in patients treated with pioglitazone. These changes generally occurred within the first 4 to 12 weeks of therapy and remained relatively stable thereafter. These changes may be related to increased plasma volume associated with pioglitazone therapy and have rarely been associated with any significant hematologic clinical effects.
In controlled clinical trials of metformin at 29 weeks’ duration, a decrease to subnormal levels of previously normal serum vitamin B12 levels, without clinical manifestations, was observed in approximately 7% of patients. Such decrease, possibly due to interference with B12 absorption from the B12 -intrinsic factor complex, is, however, very rarely associated with anemia and appears to be rapidly reversible with discontinuation of metformin or vitamin B12 supplementation.

Serum Transaminase Levels
During all clinical studies in the U.S., 14 of 4780 (0.30%) patients treated with pioglitazone had ALT values ? 3 times the upper limit of normal during treatment. All patients with follow-up values had reversible elevations in ALT. In the population of patients treated with pioglitazone, mean values for bilirubin, AST, ALT, alkaline phosphatase, and GGT were decreased at the final visit compared with baseline. Fewer than 0.9% of patients treated with pioglitazone were withdrawn from clinical trials in the U.S. due to abnormal liver function tests.
In pre-approval clinical trials, there were no cases of idiosyncratic drug reactions leading to hepatic failure.
CPK Levels: During required laboratory testing in clinical trials with pioglitazone, sporadic, transient elevations in creatine phosphokinase levels (CPK) were observed. An isolated elevation to greater than 10 times the upper limit of normal was noted in 9 patients (values of 2150 to 11400 IU/L). Six of these patients continued to receive pioglitazone, two patients had completed receiving study medication at the time of the elevated value and one patient discontinued study medication due to the elevation. These elevations resolved without any apparent clinical sequelae. The relationship of these events to pioglitazone therapy is unknown.

Product Description

Most important information about Actos

Pharmacokinetics

Side Effects

More information about ACTOPLUS MET (Pioglitazone/Metformin):

FDA MedWatch Alerts

ACTOplus met Approved by the FDA for Type 2 Diabetes

To buy ACTOPLUS MET click HERE: My Family Drugstore

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