I am diabetic

Drug Name
Avandamet (Rosiglitazone/Metformin)

Generic Name
Rosiglitazone/Metformin (roe-sih-GLIH-tah-sone/MET-fore-min)

Manufacturer / Distributor
GlaxoSmithKline

Looks like
Metformin and rosiglitazone is available with a prescription under the brand name Avandamet. 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.

• Avandamet 1 mg/500 mg (rosiglitazone/metformin) – yellow, oval, film-coated tablets
• Avandamet 2 mg/500 mg (rosiglitazone/metformin) – pale pink, oval, film-coated tablets
• Avandamet 4 mg/500 mg (rosiglitazone/metformin) – orange, oval, film-coated tablets

Dosage Form
Tablets

Route Of Administration
ORAL

Imprint Code
gsk;2/500 / gsk;4/500 / gsk;2/1000 / gsk;4/1000

Size
15mm / 15mm / 19mm / 19mm

Alternatives
Actos, Actoplus Met, Avandia

Drug Uses
Improving blood sugar levels, with diet and exercise, in patients with type 2 diabetes who are already being treated with both of these medicines or who are not adequately controlled on metformin alone.
Avandamet is a combination of an insulin resistance reducer and a biguanide. This combination medicine works in 2 ways to improve blood glucose levels (sugar). Rosiglitazone 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

Avandamet combines two medicines to treat type 2 diabetes – rosiglitazone and metformin – in one convenient pill. Along with eating healthy and staying active, Avandamet can help you control your blood sugar.

Contains
Avandamet (rosiglitazone maleate and metformin HCl) tablets contain 2 oral antihyperglycemic drugs used in the management of type 2 diabetes: Rosiglitazone maleate and metformin hydrochloride.
Rosiglitazone maleate is an oral antidiabetic agent, which acts primarily by increasing insulin sensitivity. Rosiglitazone improves glycemic control while reducing circulating insulin levels. Pharmacologic studies in animal models indicate that rosiglitazone improves sensitivity to insulin in muscle and adipose tissue and inhibits hepatic gluconeogenesis. Rosiglitazone maleate is not chemically or functionally related to the sulfonylureas, the biguanides, or the ?-glucosidase inhibitors.

Chemical formula
Rosiglitazone maleate is (�)-5-[[4-[2-(methyl-2-pyridinylamino)ethoxy]phenyl] methyl]-2,4-thiazolidinedione, (Z)-2-butenedioate (1:1) with a molecular weight of 473.52 (357.44 free base). The molecule has a single chiral center and is present as a racemate. Due to rapid interconversion, the enantiomers are functionally indistinguishable. The molecular formula is C18H19N3O3S�C4H4O4. Rosiglitazone maleate is a white to off-white solid with a melting point range of 122� to 123�C. The pKa values of rosiglitazone maleate are 6.8 and 6.1. It is readily soluble in ethanol and a buffered aqueous solution with pH of 2.3; solubility decreases with increasing pH in the physiological range. The structural formula of rosiglitazone maleate is:

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 to off-white crystalline compound with a molecular formula of C4H11N5�HCl and a molecular weight of 165.63. 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 of metformin hydrochloride is:

Avandamet is available for oral administration as tablets containing rosiglitazone maleate and metformin hydrochloride equivalent to: 2 mg rosiglitazone with 500 mg metformin hydrochloride (2 mg/500 mg), 4 mg rosiglitazone with 500 mg metformin hydrochloride (4 mg/500 mg), 2 mg rosiglitazone with 1,000 mg metformin hydrochloride (2 mg/1,000 mg), and 4 mg rosiglitazone with 1,000 mg metformin hydrochloride (4 mg/1,000 mg). In addition, each tablet contains the following inactive ingredients: Hypromellose 2910, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, povidone 29-32, sodium starch glycolate, titanium dioxide, and 1 or more of the following: Red and yellow iron oxides.

Mechanism of Action

Avandamet combines 2 antidiabetic agents with different mechanisms of action to improve glycemic control in patients with type 2 diabetes: Rosiglitazone maleate, 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.

Rosiglitazone maleate
Rosiglitazone, a member of the thiazolidinedione class of antidiabetic agents, improves glycemic control by improving insulin sensitivity while reducing circulating insulin levels. Rosiglitazone is a highly selective and potent agonist for the peroxisome proliferator-activated receptor-gamma (PPAR?). In humans, PPAR receptors are found in key target tissues for insulin action such as adipose tissue, skeletal muscle, and liver. Activation of PPAR? nuclear receptors regulates the transcription of insulin-responsive genes involved in the control of glucose production, transport, and utilization. In addition, PPAR?-responsive genes also participate in the regulation of fatty acid metabolism.
Insulin resistance is a common feature characterizing the pathogenesis of type 2 diabetes. The antidiabetic activity of rosiglitazone has been demonstrated in animal models of type 2 diabetes in which hyperglycemia and/or impaired glucose tolerance is a consequence of insulin resistance in target tissues. Rosiglitazone reduces blood glucose concentrations and reduces hyperinsulinemia in the ob/ob obese mouse, db/db diabetic mouse, and fa/fa fatty Zucker rat.
In animal models, rosiglitazone�s antidiabetic activity was shown to be mediated by increased sensitivity to insulin’s action in the liver, muscle, and adipose tissue. The expression of the insulin-regulated glucose transporter GLUT-4 was increased in adipose tissue. Rosiglitazone did not induce hypoglycemia in animal models of type 2 diabetes and/or impaired glucose tolerance.

Metformin hydrochloride
Metformin hydrochloride is an antihyperglycemic agent, which improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Its pharmacologic mechanisms of action are different from other classes of oral antihyperglycemic agents. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and increases peripheral glucose uptake and utilization. Unlike sulfonylureas, metformin does not produce hypoglycemia in either patients with type 2 diabetes or normal subjects 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 rosiglitazone 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 rosiglitazone with meals to reduce nausea, diarrhea, and upset stomach that may occur with metformin and rosiglitazone therapy. These symptoms may be more likely to occur during the first few weeks of therapy.
It is important to take metformin and rosiglitazone regularly to get the most benefit.
A decrease in vitamin B12 may also occur during metformin and rosiglitazone 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 doctor may want to monitor your blood sugar control and other factors with blood tests during treatment.
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 rosiglitazone. 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
ADULTS
Your doctor will start therapy at a low dose and increase it until your blood sugar levels are under control.

For patients who are inadequately controlled on metformin therapy alone
The recommended daily starting dose is 4 milligrams of rosiglitazone plus the dose of metformin you are already taking.

For patients who are inadequately controlled on rosiglitazone therapy alone
The recommended daily starting dose is 1,000 milligrams of metformin plus the dose of rosiglitazone you are already taking.

For patients on combination therapy taking separate doses of rosiglitazone and metformin
The usual starting dose of Avandamet is based on your current doses of rosiglitazone and metformin.

For patients who need to increase their current dose of Avandamet
The daily dose of Avandamet may be increased by increments of 4 milligrams of rosiglitazone and/or 500 milligrams of metformin, up to a maximum daily dose of 8 milligrams of rosiglitazone and 2,000 milligrams of metformin.

CHILDREN
Children should not take Avandamet, since the safety and effectiveness of the drug have not been studied in this group.

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.
You may have signs of low blood sugar, such as:

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

An overdose of metformin and rosiglitazone 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 at room temperature at 77 degrees F (25 degrees C). Keep in a tightly closed, light-resistant container away from heat and moisture. Brief storage between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Do not store in bathroom. Keep Avandamet out of the reach of children and away from pets.

How Supplied
Tablets: Each tablet contains rosiglitazone as the maleate and metformin hydrochloride as follows:

2 mg/500 mg – pale pink, film-coated oval tablet, debossed with gsk on one side and 2/500 on the other.
4 mg/500 mg – orange, film-coated oval tablet, debossed with gsk on one side and 4/500 on the other.
2 mg/1,000 mg – yellow, film-coated oval tablet, debossed with gsk on one side and 2/1000 on the other.
4 mg/1,000 mg – pink, film-coated oval tablet, debossed with gsk on one side and 4/1000 on the other.

2 mg/500 mg bottles of 60 -DC 0007-3167-18
4 mg/500 mg bottles of 60 – C 0007-3168-18
2 mg/1,000 mg bottles of 60 – NDC 0007-3163-18
4 mg/1,000 mg bottles of 60 – NDC 0007-3164-18

Most important information about Avandamet

Pharmacokinetics

Possible Side Effects

More information about AVANDAMET (Rosiglitazone/Metformin):

FDA MedWatch Alerts

Combination with Insulin

FDA Approves Avandamet as Initial Therapy for Type 2 Diabetes

FDA Alert

Too Many Meds: Try Combinations

New Avandamet dosage strengths approved for treatment of type 2 diabetes

EMEA Statement on Recent Publication on Cardiac Safety of Rosiglitazone (Avandia, Avandamet, Avaglim)

To buy AVANDAMET (Rosiglitazone/Metformin) click HERE: My Family Drugstore