Avandaryl

Name: Avandaryl

Description

AVANDARYL contains 2 oral antidiabetic drugs used in the management of type 2 diabetes: rosiglitazone maleate and glimepiride.

Rosiglitazone maleate is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. Rosiglitazone maleate is not chemically or functionally related to the sulfonylureas, the biguanides, or the alpha-glucosidase inhibitors. Chemically, 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:

Glimepiride is an oral antidiabetic drug of the sulfonylurea class. Chemically, glimepiride is 1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido)ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea with a molecular weight of 490.62. The molecular formula for glimepiride is C24H34N4O5S. Glimepiride is a white to yellowish-white, crystalline, odorless to practically odorless powder and is practically insoluble in water. The structural formula of glimepiride is:

AVANDARYL is available for oral administration as tablets containing rosiglitazone maleate and glimepiride, respectively, in the following strengths (expressed as rosiglitazone maleate/glimepiride): 4 mg/1 mg, 4 mg/2 mg, 4 mg/4 mg, 8 mg/2 mg, and 8 mg/4 mg. Each tablet contains the following inactive ingredients: hypromellose 2910, lactose monohydrate, macrogol (polyethylene glycol), magnesium stearate, microcrystalline cellulose, sodium starch glycolate, titanium dioxide, and 1 or more of the following: yellow, red, or black iron oxides.

Avandaryl FDA Warning

WARNING: CONGESTIVE HEART FAILURE 

Thiazolidinediones, including rosiglitazone, cause or exacerbate congestive heart failure in some patients. After initiation of AVANDARYL®, and after dose increases, observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain, dyspnea, and/or edema). If these signs and symptoms develop, the heart failure should be managed according to current standards of care. Furthermore, discontinuation or dose reduction of AVANDARYL must be considered.AVANDARYL is not recommended in patients with symptomatic heart failure. Initiation of AVANDARYL in patients with established NYHA Class III or IV heart failure is contraindicated.

Proper Use of Avandaryl

Take this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

This medicine should come with a Medication Guide. It is very important that you read and understand this information. Ask your doctor if you have any questions.

This medicine should be taken with the first meal of the day.

Carefully follow the special diet your doctor gave you. This is the most important part of controlling your diabetes and will help the medicine work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

If you are also taking colesevelam (Welchol®), take Avandaryl® at least 4 hours before taking colesevelam.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For type 2 diabetes:
      • For patients already taking glimepiride or rosiglitazone alone:
        • Adults—At first, rosiglitazone 4 milligrams (mg) plus glimepiride 1 mg or rosiglitazone 4 mg plus glimepiride 2 mg once a day, as directed by your doctor. Your doctor may adjust your dose as needed. However, the dose is usually not more than rosiglitazone 8 mg plus glimepiride 4 mg per day.
        • Children—Use and dose must be determined by your doctor.
      • For patients switching from a combination of glimepiride and rosiglitazone as separate tablets:
        • Adults—The dose is the same as the dose you are already taking. Your doctor may adjust your dose as needed. However, the dose is usually not more than rosiglitazone 8 mg plus glimepiride 4 mg per day.
        • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Avandaryl Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
  • Body aches or pain
  • chills
  • cough
  • difficulty with breathing
  • ear congestion
  • fever
  • headache
  • injury
  • loss of voice
  • nasal congestion
  • runny nose
  • sneezing
  • sore throat
  • unusual tiredness or weakness
Less common
  • Anxiety
  • blurred vision
  • chest pain or discomfort
  • cold sweats
  • coma
  • confusion
  • cool, pale skin
  • decreased urine output
  • depression
  • dilated neck veins
  • dizziness
  • extreme fatigue
  • fast heartbeat
  • increased hunger
  • irregular breathing
  • irregular heartbeat
  • nausea
  • nightmares
  • seizures
  • shakiness
  • slurred speech
  • swelling of the face, fingers, feet, or lower legs
  • tightness in the chest
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • weight gain
Incidence not known
  • Abdominal or stomach pain or tenderness
  • agitation
  • back, leg, or stomach pains
  • bleeding gums
  • bloody, black, or tarry stools
  • blue lips and fingernails
  • coughing that sometimes produces a pink frothy sputum
  • dark urine
  • decreased appetite
  • difficult, fast, or noisy breathing
  • fluid-filled skin blisters
  • general body swelling
  • hostility
  • increased sweating
  • increased thirst
  • irritability
  • itching or skin rash
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • light-colored stools
  • loss of appetite
  • muscle pain or cramps
  • muscle twitching
  • nosebleeds
  • pain or discomfort in the arms, jaw, back, or neck
  • redness of the skin
  • seizures
  • sensitivity to the sun
  • skin thinness
  • sores, ulcers, or white spots on the lips or in the mouth
  • stupor
  • sweating
  • swollen glands
  • vomiting
  • yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
  • Lack or loss of strength
Rare
  • Burning, stinging, itching, or redness of the skin not present before treatment
Incidence not known
  • Diarrhea

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

What do I need to tell my doctor BEFORE I take Avandaryl?

  • If you have an allergy to glimepiride, rosiglitazone, or any other part of this medicine.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have any of these health problems: Acidic blood problem or type 1 diabetes.
  • If you are using insulin.

This is not a list of all drugs or health problems that interact with Avandaryl.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some other side effects of Avandaryl?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Signs of a common cold.
  • Headache.
  • Weight gain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Dosage Forms and Strengths

Each rounded triangular tablet contains rosiglitazone maleate and glimepiride as follows:

• 4 mg/1 mg – yellow, gsk debossed on one side and 4/1 on the other. • 4 mg/2 mg – orange, gsk debossed on one side and 4/2 on the other. • 4 mg/4 mg – pink, gsk debossed on one side and 4/4 on the other. • 8 mg/2 mg – pale pink, gsk debossed on one side and 8/2 on the other. • 8 mg/4 mg – red, gsk debossed on one side and 8/4 on the other.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Where can i get more information?

Your pharmacist can provide more information about glimepiride and rosiglitazone.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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How should I take Avandaryl?

Take Avandaryl exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take Avandaryl with your first meal of the day.

Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, confusion, irritability, dizziness, or feeling shaky. Always keep a source of sugar with you in case you have low blood sugar. Sugar sources include fruit juice, hard candy, crackers, raisins, and non-diet soda. Be sure your family and close friends know how to help you in an emergency.

If you have severe hypoglycemia and cannot eat or drink, use a glucagon injection. Your doctor can prescribe a glucagon emergency injection kit and tell you how to use it.

Check your blood sugar carefully during times of stress, travel, illness, surgery or medical emergency, vigorous exercise, or if you drink alcohol or skip meals. These things can affect your glucose levels and your dose needs may also change. Do not change your Avandaryl dose or dosing schedule without your doctor's advice.

Use Avandaryl regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

This medicine is only part of a treatment program that may also include diet, exercise, weight control, blood sugar testing, vision exams, and special medical care. Follow your doctor's instructions very closely.

Store Avandaryl at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

Avandaryl side effects

Get emergency medical help if you have signs of an allergic reaction to Avandaryl: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • shortness of breath (even with mild exertion), swelling, rapid weight gain;

  • chest pain or heavy feeling, pain spreading to the arm or jaw, nausea, sweating, general ill feeling;

  • pale skin, easy bruising or bleeding, weakness;

  • upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • changes in your vision; or

  • severe skin reaction - fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common Avandaryl side effects may include:

  • headache; or

  • cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Avandaryl?

Tell your doctor if you use insulin. Taking Avandaryl while you are using insulin may increase your risk of serious heart problems.

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • insulin;

  • heart or blood pressure medicine; or

  • cholesterol-lowering medicine.

This list is not complete. Many other medicines can increase or decrease the effects of Avandaryl on lowering your blood sugar. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

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