AVAHASAN 2/500

Why is Rosiglitazone maleate, Metformin hydrochloride prescribed?

AVAHASAN 2/500 is an oral medication used to control blood sugar levels in people with type 2 (non-insulin-dependent) diabetes. It contains two drugs commonly used to lower blood sugar, rosiglitazone and metformin. AVAHASAN 2/500 replaces the need to take these two drugs separately. It is also used when treatment with metformin hydrochloride alone doesn't work. AVAHASAN 2/500 is not, however, meant to take the place of weight loss or diet and exercise. You should continue to follow the regimen your doctor recommends.

Blood sugar levels are ordinarily controlled by the body's natural supply of insulin, which helps sugar move out of the bloodstream and into the cells to be used for energy. People who have type 2 diabetes do not make enough insulin or do not respond normally to the insulin their bodies make, causing a buildup of unused sugar in the bloodstream. AVAHASAN 2/500 helps remedy this problem in two ways: by decreasing your body's production of sugar and making your body more sensitive to its own insulin supply. AVAHASAN 2/500 does not increase the body's production of insulin.

Most important fact about Rosiglitazone maleate, Metformin hydrochloride

AVAHASAN 2/500 could cause a very rare—but potentially fatal—side effect known as lactic acidosis. It is caused by a buildup of lactic acid in the blood. The problem is most likely to occur in people whose liver or kidneys are not working well, and in those who have multiple medical problems, take several medications, or have congestive heart failure. The risk also is higher if you are an older adult or drink alcohol. Lactic acidosis is a medical emergency that must be treated in a hospital. Notify your doctor immediately if you experience any of the following:

• Symptoms of lactic acidosis may include:
  Dizziness, extreme weakness or tiredness, light-headedness, low body temperature, slow or irregular heartbeat, rapid breathing or trouble breathing, sleepiness, unexpected or unusual stomach discomfort (especially after you have been taking AVAHASAN 2/500 for a while), unusual muscle pain

How should you take Rosiglitazone maleate, Metformin hydrochloride?

Do not take more or less of Rosiglitazone maleate, Metformin hydrochloride than directed by your doctor. AVAHASAN 2/500 should be taken in divided doses with meals to reduce the possibility of nausea or diarrhea, especially during the first few weeks of therapy. AVAHASAN 2/500 may start to work within the first week or two after you begin taking it, but it can take up to 3 months before the drug's full effects are seen. Be sure to check your blood sugar as your doctor recommends.

• If you miss a dose...
  Take the forgotten dose as soon as you remember. However, if it is almost time for your next dose, skip the one you missed and return to your regular schedule. Do not take two doses at once.

• Storage instructions...
  Store at room temperature in a tight, light-resistant container.

What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue using AVAHASAN 2/500.

• Side effects may include:
  Accidental injury, anemia, back pain, diarrhea, fatigue, headache, joint pain, nausea, sinus inflammation, swelling, upper respiratory infection, upset stomach, viral infection

Why should Rosiglitazone maleate, Metformin hydrochloride not be prescribed?

AVAHASAN 2/500 is processed primarily by the kidneys, and can build up to excessive levels in the body if the kidneys aren't working properly. It should be avoided if you have kidney disease or your kidney function has been impaired by a condition such as shock, blood poisoning, or a heart attack.

You should not use AVAHASAN 2/500 if you need to take medicine for congestive heart failure.

Do not take AVAHASAN 2/500 if you have ever had an allergic reaction to rosiglitazone or metformin.

Do not take AVAHASAN 2/500 if you have metabolic or diabetic ketoacidosis (a life-threatening medical emergency caused by insufficient insulin and marked by excessive thirst, nausea, fatigue, pain below the breastbone, and fruity breath).

You should not use AVAHASAN 2/500 if you have type 1 (insulin-dependent) diabetes, or if you are already taking insulin.

Special warnings about Rosiglitazone maleate, Metformin hydrochloride

Use AVAHASAN 2/500 with caution if you have a problem with fluid retention or swelling. The drug has been known to cause this problem, which in turn can lead to heart failure. Also use caution if you're at risk for heart failure. Call the doctor immediately if you develop symptoms of heart failure such as a sudden weight change, fatigue, shortness of breath, or swelling of the ankles or legs.

Before you start therapy with AVAHASAN 2/500, and at least once a year thereafter, your doctor will do a complete assessment of your kidney function. If you develop kidney problems while on AVAHASAN 2/500, your doctor will discontinue Rosiglitazone maleate, Metformin hydrochloride. If you are an older person, you will need to have your kidney function monitored more frequently, and your doctor may want to start you at a lower dosage.

Poor liver function could increase the risk of lactic acidosis. Therefore, your doctor will check to make sure your liver function is normal before prescribing AVAHASAN 2/500, then recheck it every 2 months for the first 12 months and periodically thereafter. Warning signs of liver damage include nausea, vomiting, abdominal pain, fatigue, loss of appetite, dark urine, and yellowing of the skin or whites of the eyes. If you develop any of these symptoms, tell your doctor immediately. You may need to discontinue treatment with AVAHASAN 2/500.

You should not take AVAHASAN 2/500 for 2 days before and after having an X-ray procedure (such as an angiogram) that uses an injectable dye. Also, if you are going to have surgery, except minor surgery, you should stop taking AVAHASAN 2/500. Once you have resumed normal food and fluid intake, your doctor will tell you when you can start drug therapy again.

Avoid drinking too much alcohol while taking AVAHASAN 2/500. Heavy drinking increases the danger of lactic acidosis and can also trigger an attack of low blood sugar.

AVAHASAN 2/500 occasionally causes a mild deficiency of vitamin B₁₂. Your doctor will check for this with yearly blood tests and may prescribe a supplement if necessary.

While taking AVAHASAN 2/500, you should check your blood or urine periodically for abnormal sugar levels. If you notice sudden changes after you've been stabilized for a while, tell your doctor immediately. It could be a sign you're developing lactic acidosis or ketoacidosis.

AVAHASAN 2/500 does not usually cause hypoglycemia (low blood sugar). However, it remains a possibility, especially in older, weak, and undernourished people and those with kidney, liver, adrenal, or pituitary gland problems. The risk of low blood sugar increases when AVAHASAN 2/500 is combined with other diabetes medications. The risk is also boosted by missed meals, alcohol, and excessive exercise. To avoid low blood sugar, you should closely follow the diet and exercise plan suggested by your doctor.

If your blood sugar becomes unstable due to the stress of a fever, injury, infection, or surgery, your doctor may temporarily take you off AVAHASAN 2/500 and ask you to take insulin instead.

You should stop taking AVAHASAN 2/500 if you become seriously dehydrated, since this increases the likelihood of developing lactic acidosis. Tell your doctor if you lose a significant amount of fluid due to vomiting, diarrhea, fever, or some other condition.

AVAHASAN 2/500 could trigger ovulation in premenopausal women who have stopped ovulating. It is important for all women who do not wish to get pregnant to use adequate birth control while taking Rosiglitazone maleate, Metformin hydrochloride.

Possible food and drug interactions when taking Rosiglitazone maleate, Metformin hydrochloride

If AVAHASAN 2/500 is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining AVAHASAN 2/500 with the following:

Amiloride
Calcium channel blockers (heart medications) such as nifedipine and verapamil hydrochloride
Cimetidine
Decongestant, airway-opening drugs such as Albuterol sulfate and pseudoephedrine hydrochloride
Digoxin
Estrogens such as conjugated estrogens
Furosemide
Isoniazid, a drug used for tuberculosis
Morphine
Niacin
Nifedipine
Oral contraceptives
Phenytoin
Procainamide
Quinidine
Quinine
Ranitidine
Steroids such as prednisone
Thyroid hormones such as levothyroxine
Tranquilizers such as chlorpromazine
Triamterene
Trimethoprim
Vancomycin
Water pills (diuretics) such as amiloride, hydrochlorothiazide, and triamterene

Do not drink too much alcohol, since excessive alcohol consumption can cause low blood sugar and increase the risk of developing lactic acidosis.

Special information if you are pregnant or breastfeeding

If you are pregnant or plan to become pregnant, tell your doctor immediately. AVAHASAN 2/500 has not been adequately studied in pregnant women and should not be taken during pregnancy unless the potential benefit outweighs the potential risk. Since studies suggest the importance of maintaining normal blood sugar levels during pregnancy, your doctor may prescribe insulin injections instead.

It is not known whether AVAHASAN 2/500 appears in human breast milk. Therefore, you should discuss with your doctor whether to discontinue the medication or to stop breastfeeding. If the medication is discontinued and if diet alone does not control blood sugar levels, your doctor may prescribe insulin injections.

Recommended dosage for Rosiglitazone maleate, Metformin hydrochloride

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 AVAHASAN 2/500 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 AVAHASAN 2/500 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 AVAHASAN 2/500, since the safety and effectiveness of the drug have not been studied in this group.

Overdosage

An overdose of AVAHASAN 2/500 can cause lactic acidosis. If you suspect an overdose, seek emergency treatment immediately.