Rosiglitazone

Generic name: Rosiglitazone
Drug class: Thiazolidinediones

Usage of Rosiglitazone

Rosiglitazone is used to treat a type of diabetes mellitus called type 2 diabetes. It may be used alone or with other medicines such as metformin or sulfonylurea agents. Rosiglitazone is used together with a proper diet and exercise to help control blood sugar levels. It does this by helping your body use insulin better.

This medicine is available only with your doctor's prescription.

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:

Less common

Abdominal or stomach pain

blurred vision

chest pain or discomfort

decrease in the amount of urine

dry mouth

flushed, dry skin

fruit-like breath odor

increased hunger

increased thirst

increased urination

irregular heartbeat

nausea

noisy, rattling breathing

pain in the shoulders, arms, jaw, or neck

pale skin

rapid or unusual weight gain

sweating

swelling of the fingers, hands, feet, or lower legs

trouble breathing

unexplained weight loss

unusual bleeding or bruising

unusual tiredness or weakness

vomiting

Rare

Anxiety

chills

cold sweats

coma

confusion

dark urine

depression

dizziness

fast heartbeat

headache

loss of appetite

nightmares

seizures

shakiness

slurred speech

Incidence not known

Blue lips and fingernails

changes in vision

coughing that sometimes produces a pink frothy sputum

hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

itching or skin rash

light-colored stools

redness of the skin

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:

More common

Ear congestion

fever

general feeling of discomfort or illness

hoarseness or other voice changes

injury

joint pain

muscle aches and pains

runny or stuffy nose

shivering

sneezing

sore throat

trouble sleeping

Less common

Back pain

cough

diarrhea

lightheadedness

pain or tenderness around the eyes and cheekbones

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.

Before taking 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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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 rosiglitazone 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 rosiglitazone in the elderly.

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

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine 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.

Abiraterone Acetate

Ceritinib

Chloroquine

Chlorothiazide

Chlorthalidone

Ciprofloxacin

Delafloxacin

Enoxacin

Entacapone

Furosemide

Gatifloxacin

Gemfibrozil

Gemifloxacin

Grepafloxacin

Hydrochlorothiazide

Hydroflumethiazide

Hydroxychloroquine

Indapamide

Insulin

Insulin Aspart, Recombinant

Insulin Bovine

Insulin Degludec

Insulin Detemir

Insulin Glargine, Recombinant

Insulin Glulisine

Insulin Lispro, Recombinant

Lanreotide

Letermovir

Levofloxacin

Lomefloxacin

Metolazone

Moxifloxacin

Norfloxacin

Octreotide

Ofloxacin

Omaveloxolone

Pasireotide

Phenobarbital

Pixantrone

Polythiazide

Primidone

Somatrogon-ghla

Sparfloxacin

Thioctic Acid

Triamterene

Trovafloxacin

Using this medicine 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

Atenolol

Betaxolol

Bisoprolol

Bitter Melon

Carteolol

Carvedilol

Celiprolol

Esmolol

Fenofibrate

Fenofibric Acid

Fenugreek

Glucomannan

Guar Gum

Labetalol

Levobunolol

Metipranolol

Metoprolol

Nadolol

Nebivolol

Oxprenolol

Penbutolol

Pindolol

Practolol

Propranolol

Psyllium

Rifampin

Sotalol

Timolol

Trimethoprim

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.

Relate drugs

How to use Rosiglitazone

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 may be taken with or without food.

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.

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:

Adults—At first, 4 milligrams (mg) per day, taken as a single dose or divided into two doses. Your doctor may adjust your dose as needed. However, the dose is usually not more than 8 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.

Warnings

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

Call your doctor right away 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.

If you are rapidly gaining weight or 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 right away. These may be symptoms of a heart problem or edema (fluid retention).

If you have abdominal or stomach pain, dark urine, a loss of appetite, nausea or vomiting, unusual tiredness or weakness, or yellow eyes or skin, check with your doctor right away. These may be symptoms of a serious liver problem.

Check with your doctor right away if blurred vision, difficulty in reading, or any other change in vision occurs while you are taking this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

This medicine may increase the risk for bone fractures in women. Ask your doctor about ways to keep your bones strong to help prevent fractures.

Certain women may be at an increased risk for pregnancy while taking this medicine. If you had problems ovulating and had irregular periods in the past, this medicine may cause you to ovulate. This could increase your chance of becoming pregnant. If you are a woman of childbearing potential, you should discuss birth control options with your doctor.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

It is very important to carefully follow any instructions from your doctor about:

Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your doctor.

Other medicines—Do not take other medicines 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.

Symptoms of fluid retention—Know what to do if you start to retain fluid. Fluid retention may worsen or lead to heart problems.

This medicine does not cause hypoglycemia (low blood sugar). However, low blood sugar can occur if you delay or miss a meal or snack, exercise more than usual, drink alcohol, cannot eat because of nausea or vomiting, or take rosiglitazone with another type of diabetes medicine. The 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.

Symptoms of low blood sugar 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.

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 drinks, 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 occur if you do not take enough or skip a dose of your medicine, overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual.

Symptoms of high blood sugar include blurred vision, drowsiness, dry mouth, flushed, dry skin, fruit-like breath odor, increased urination (frequency and amount), ketones in the urine, loss of appetite, sleepiness, stomachache, nausea, or vomiting, tiredness, troubled breathing (rapid and deep), unconsciousness, or unusual thirst.

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

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