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Drugs reference index «glimepiride and rosiglitazone»

glimepiride and rosiglitazone (Oral route)

glye-MEP-ir-ide, roe-zi-GLI-ta-zone MAL-ee-ate

Oral routeTablet
  • Congestive Heart Failure and Myocardial Ischemia
    • Thiazolidinediones, including rosiglitazone, cause or exacerbate congestive heart failure in some patients. After initiation of rosiglitazone maleate/glimepiride, 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 rosiglitazone maleate/glimepiride must be considered.
    • Rosiglitazone maleate/glimepiride is not recommended in patients with symptomatic heart failure. Initiation of rosiglitazone maleate/glimepiride in patients with established NYHA Class III or IV heart failure is contraindicated.
    • A meta-analysis of 42 clinical studies (mean duration 6 months; 14,237 total patients), most of which compared rosiglitazone to placebo, showed rosiglitazone to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction. Three other studies (mean duration 41 months; 14,067 total patients), comparing rosiglitazone to some other approved oral antidiabetic agents or placebo, have not confirmed or excluded this risk. In their entirety, the available data on the risk of myocardial ischemia are inconclusive .

May cause or worsen congestive heart failure, is not recommended in patients with symptomatic heart failure, and is contraindicated in patients with established NYHA Class III or IV heart failure. Monitor patients for signs and symptoms of heart failure after initiation or dose increases and if heart failure occurs, consider dose reducing or discontinuing rosiglitazone maleate and manage according to current standards of care. Overall, the available data on the risk of myocardial ischemia are inconclusive .

Commonly used brand name(s):

In the U.S.

  • Avandaryl

Available Dosage Forms:

  • Tablet

Therapeutic Class: Antidiabetic

Chemical Class: 2nd Generation Sulfonylurea

Uses For glimepiride and rosiglitazone

Glimepiride and rosiglitazone combination is used to treat high blood sugar levels that are caused by a type of diabetes mellitus or sugar diabetes called type 2 diabetes. Normally, after you eat, your pancreas releases insulin to help your body store excess sugar for later use. This process occurs during normal digestion of food. In type 2 diabetes, your body does not work properly to store the excess sugar and the sugar remains in your bloodstream. Chronic high blood sugar can lead to serious health problems in the future.

Proper diet is the first step in managing type 2 diabetes, but often medicines are needed to help your body. With two actions, the combination of glimepiride and rosiglitazone helps your body cope with high blood sugar. Glimepiride stimulates the release of insulin from the pancreas, directing your body to store blood sugar. Rosiglitazone helps your body use the insulin better and it reduces the amount of insulin in your body. .

glimepiride and rosiglitazone is available only with your doctor's prescription.

Before Using glimepiride and rosiglitazone

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For glimepiride and rosiglitazone, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to glimepiride and rosiglitazone or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of glimepiride and rosiglitazone combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of glimepiride and rosiglitazone combination in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and adjustment in the dose for patients receiving glimepiride and rosiglitazone combination.

Pregnancy

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

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.

Interactions with Medicines

Using glimepiride and rosiglitazone with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Alatrofloxacin
  • Balofloxacin
  • Ciprofloxacin
  • Clinafloxacin
  • Disopyramide
  • Enoxacin
  • Fleroxacin
  • Flumequine
  • Gatifloxacin
  • Gemifloxacin
  • Grepafloxacin
  • Levofloxacin
  • Lomefloxacin
  • Moxifloxacin
  • Norfloxacin
  • Ofloxacin
  • Pefloxacin
  • Prulifloxacin
  • Rufloxacin
  • Sparfloxacin
  • Temafloxacin
  • Tosufloxacin
  • Trovafloxacin Mesylate

Using glimepiride and rosiglitazone with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acebutolol
  • Aceclofenac
  • Acemetacin
  • Alclofenac
  • Alprenolol
  • Apazone
  • Atenolol
  • Benoxaprofen
  • Betaxolol
  • Bevantolol
  • Bisoprolol
  • Bitter Melon
  • Bromfenac
  • Bucindolol
  • Bufexamac
  • Carprofen
  • Carteolol
  • Carvedilol
  • Celiprolol
  • Clometacin
  • Clonixin
  • Clorgyline
  • Dexketoprofen
  • Diclofenac
  • Diflunisal
  • Dilevalol
  • Dipyrone
  • Droxicam
  • Esmolol
  • Etodolac
  • Etofenamate
  • Felbinac
  • Fenbufen
  • Fenofibrate
  • Fenoprofen
  • Fentiazac
  • Fenugreek
  • Floctafenine
  • Fluconazole
  • Flufenamic Acid
  • Flurbiprofen
  • Gemfibrozil
  • Glucomannan
  • Guar Gum
  • Ibuprofen
  • Indomethacin
  • Indoprofen
  • Iproniazid
  • Isocarboxazid
  • Isoxicam
  • Ketoprofen
  • Ketorolac
  • Labetalol
  • Levobunolol
  • Lornoxicam
  • Meclofenamate
  • Mefenamic Acid
  • Meloxicam
  • Mepindolol
  • Metipranolol
  • Metoprolol
  • Moclobemide
  • Nabumetone
  • Nadolol
  • Naproxen
  • Nebivolol
  • Nialamide
  • Niflumic Acid
  • Nimesulide
  • Oxaprozin
  • Oxprenolol
  • Oxyphenbutazone
  • Pargyline
  • Penbutolol
  • Phenelzine
  • Phenylbutazone
  • Pindolol
  • Pirazolac
  • Piroxicam
  • Pirprofen
  • Procarbazine
  • Propranolol
  • Propyphenazone
  • Proquazone
  • Psyllium
  • Rifampin
  • Selegiline
  • Sotalol
  • St John's Wort
  • Sulindac
  • Suprofen
  • Talinolol
  • Tenidap
  • Tenoxicam
  • Tertatolol
  • Tiaprofenic Acid
  • Timolol
  • Tolmetin
  • Toloxatone
  • Tranylcypromine
  • Trimethoprim
  • Zomepirac

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of glimepiride and rosiglitazone. Make sure you tell your doctor if you have any other medical problems, especially:

  • Alcohol intoxication or
  • Underactive adrenal glands or
  • Underactive pituitary gland or
  • Undernourished condition or
  • Weakened physical condition or
  • Any other condition that causes low blood sugar—Patients with these conditions may be more likely to develop low blood sugar while taking glimepiride and rosiglitazone.
  • Diabetic ketoacidosis (ketones in the blood) or
  • Kidney disease, severe or
  • Type 1 diabetes—glimepiride and rosiglitazone should not be used in patients with these conditions. Insulin is needed to control these conditions.
  • Diabetic macular edema (swelling of the back of the eye) or
  • Edema (fluid retention) or
  • Liver problems—Use with caution. May make these conditions worse.
  • Fever or
  • Infection or
  • Surgery or
  • Trauma—Patients with these conditions may need to temporarily use insulin to control blood sugar, and may need to test the blood sugar more often.
  • Fragile bones (especially women)—Use with caution. glimepiride and rosiglitazone may increase the risk of fractures.
  • Heart attacks, history of or
  • Heart disease or
  • Heart surgery in the past or
  • Other heart problems—glimepiride and rosiglitazone may increase the risk of heart attacks and make these conditions worse.
  • Heart failure, severe—glimepiride and rosiglitazone should not be used in patients with this condition.

Proper Use of glimepiride and rosiglitazone

Follow carefully the special meal plan your doctor gave you. This is the most important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

glimepiride and rosiglitazone should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

glimepiride and rosiglitazone should be taken with the first meal of the day.

You may notice improvement in your blood glucose control in 1 to 2 weeks, but the full effect of blood glucose control may take up to 2 to 3 months. Ask your doctor if you have any questions about this.

Dosing

The dose of glimepiride and rosiglitazone 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 glimepiride and rosiglitazone. 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 type 2 diabetes:
    • For oral dosage form (tablets):
      • For patients already taking glimepiride alone:
        • Adults—At first, 4 milligrams (mg) of rosiglitazone and 1 mg of glimepiride or 4 mg of rosiglitazone and 2 mg of glimepiride once a day, as directed by your doctor. Your doctor may gradually increase your dose until your blood sugar is controlled. However, the dose is usually not more than 8 mg of rosiglitazone and 4 mg of glimepiride.
        • Children—Use and dose must be determined by your doctor.
      • For patients already taking rosiglitazone alone:
        • Adults—At first, 4 milligrams (mg) of rosiglitazone and 1 mg of glimepiride or 4 mg of rosiglitazone and 2 mg of glimepiride once a day, as directed by your doctor. Your doctor may gradually increase your dose until your blood sugar is controlled. However, the dose is usually not more than 8 mg of rosiglitazone and 4 mg of glimepiride.
        • 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 gradually increase your dose until your blood sugar is controlled. However, the dose is usually not more than 8 mg of rosiglitazone and 4 mg of glimepiride.
        • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of glimepiride and rosiglitazone, 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.

Precautions While Using glimepiride and rosiglitazone

It is very important that your doctor check your progress at regular visits to make sure that glimepiride and rosiglitazone is working properly. Blood tests may be needed to check for unwanted effects.

Seek medical attention immediately if you have chest pain or discomfort; nausea; pain or discomfort in the arms, jaw, back, or neck; shortness of breath; sweating; or vomiting. These may be symptoms of a heart attack.

glimepiride and rosiglitazone may cause some women who do not have regular monthly periods to ovulate. This can increase the chance of pregnancy. If you are a woman of childbearing potential, you should discuss birth control options with your doctor.

Make sure your doctor knows if you are using insulin or nitrate medicines (e.g., Imdur®, Isordil®, or Sorbitrate®) before you start taking glimepiride and rosiglitazone. Using any of them together with glimepiride and rosiglitazone may increase your risk of having serious side effects.

Tell your doctor right away if you have a loss of appetite, nausea, vomiting, stomach pain, unusual tiredness or weakness, dark urine, or yellow eyes or skin. These may be signs of liver problems.

If you are rapidly gaining weight, having shortness of breath, chest pain or discomfort, extreme tiredness or weakness, irregular breathing, irregular heartbeat, or excessive swelling of the hands, wrist, ankles, or feet, check with your doctor immediately. These may be symptoms of heart problems or your body keeping too much water.

Glimepiride and rosiglitazone combination can cause hypoglycemia (low blood sugar). However, this can also occur if you delay or miss a meal or snack, exercise more than usual, drink alcohol, or when you take other types of diabetes medicine. Symptoms of low blood sugar may include anxiety; behavior change similar to being drunk; blurred vision; cold sweats; confusion; cool, pale skin; difficulty in thinking; drowsiness; excessive hunger; fast heartbeat; headache (continuing); nausea; nervousness; nightmares; restless sleep; shakiness; slurred speech; or unusual tiredness or weakness. Symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people feel different symptoms of low blood sugar. It is important that you learn which symptoms of low blood sugar you usually have so that you can treat it quickly.

If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes; or drink fruit juice, non-diet soft drink, or sugar dissolved in water to relieve the symptoms. Also, check your blood for low blood sugar. Glucagon is used in emergency situations when severe symptoms such as seizures (convulsions) or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. Members of your family also should know how to use it.

Hyperglycemia (high blood sugar) may also occur if you do not exercise as much as usual, have a fever or infection, do not take enough or skip a dose of your diabetes medicine, or overeat or do not follow your meal plan. Symptoms of hyperglycemia may include blurred vision; drowsiness; dry mouth; flushed, dry skin; fruit-like breath odor; increased urination (frequency and volume); ketones in the urine; loss of appetite; sleepiness; stomachache, nausea or vomiting; tiredness; troubled breathing (rapid and deep); unconsciousness; or unusual thirst.

If symptoms of high blood sugar occur, check your blood sugar level and then call your doctor for instructions.

It is very important to carefully follow any instructions from your health care team about:

  • Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.
  • Other medicines—Do not take other medicines during the time you are taking glimepiride and rosiglitazone combination unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.
  • Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, diabetic patients may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in patients with diabetes during pregnancy.
  • Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.
  • In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor will want you to have your eyes checked by an ophthalmologist (eye doctor).

It is important to tell your doctor that you are taking glimepiride and rosiglitazone if you are going to have any medical procedures or surgical procedures.

glimepiride and rosiglitazone may increase the risk of bone fractures in women. Ask your doctor about ways to keep your bones strong to help prevent fractures.

glimepiride and rosiglitazone 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
  • nervousness
  • nightmares
  • seizures
  • shakiness
  • shortness of breath
  • 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
  • wheezing
Incidence not known
  • Abdominal or stomach pain or tenderness
  • agitation
  • 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, sometimes with wheezing
  • fluid-filled skin blisters
  • hostility
  • increased sweating
  • increased thirst
  • irritability
  • itching
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • lethargy
  • light-colored stools
  • muscle pain or cramps
  • muscle twitching
  • pain or discomfort in the arms, jaw, back, or neck
  • redness of the skin
  • seizures
  • sensitivity to the sun
  • skin rash
  • 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 therapy
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.

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