Rosiglitazone + Metformin

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Generic Name: Rosiglitazone + Metformin Brand Name(s): Generics only. No brands available.

Uses

What is Rosiglitazone + Metformin used for?

Rosiglitazone + Metformin is a combination of 2 drugs: rosiglitazone and metformin. It is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. Rosiglitazone belongs to a class of drugs known as glitazones. Rosiglitazone and metformin lower blood sugar by helping to restore your body’s proper response to insulin. Metformin also decreases the amount of sugar that your liver makes and that your stomach/intestines absorb.

How should I take Rosiglitazone + Metformin?

Take this medication by mouth as directed by your doctor, usually once or twice daily with a meal.

The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). To reduce your risk of side effects (such as upset stomach), your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor’s instructions carefully.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.

Tell your doctor if your condition does not improve or if it worsens (your blood sugar is too high or too low).

How do I store Rosiglitazone + Metformin?

Rosiglitazone + Metformin is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Rosiglitazone + Metformin in the bathroom or the freezer. There may be different brands of Rosiglitazone + Metformin that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Rosiglitazone + Metformin down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Rosiglitazone + Metformin?

Before taking this medication, tell your doctor or pharmacist if you are allergic to rosiglitazone or metformin; or to other glitazones such as pioglitazone; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, breathing problems (such as obstructive lung disease, severe asthma), heart disease (such as congestive heart failure, heart attack, angina), blood problems (such as anemia, vitamin B-12 deficiency), swelling (edema), fluid in the lungs, eye (retina) problems, bone problems (such as osteoporosis, osteopenia).

Before having surgery or any X-ray/scanning procedure using iodinated contrast, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). You may need to stop this medication for a short time for the surgery/procedure. Ask your doctor or dentist for instructions before your surgery/procedure.

You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely.

Limit alcohol while taking this medication because it can increase your risk of developing low blood sugar.

High fever, “water pills” (diuretics such as hydrochlorothiazide), too much sweating, diarrhea, or vomiting may cause loss of too much body water (dehydration) and increase your risk of lactic acidosis. Stop taking this medication and tell your doctor right away if you have prolonged diarrhea or vomiting. Be sure to drink enough fluids to prevent dehydration unless your doctor directs you otherwise.

It may be harder to control your blood sugar when your body is stressed (such as due to fever, infection, injury, or surgery). Consult your doctor because this may require a change in your treatment plan, medications, or blood sugar testing.

This medication may increase the risk of bone fracture (usually in the upper arm, hand, or foot), especially in women.

Older adults may be more sensitive to the side effects of this medication, especially low blood sugar and lactic acidosis.

This medication can cause changes in a woman’s menstrual cycle (promote ovulation) and increase the chance of pregnancy. Consult your doctor or pharmacist about using reliable birth control while taking this medication.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

Pregnancy may cause or worsen diabetes. Discuss a plan with your doctor for managing your blood sugar while pregnant. Your doctor may change your diabetes treatment during your pregnancy (such as diet and medications including insulin).

Metformin passes into breast milk. It is unknown if rosiglitazone passes into breast milk. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Rosiglitazone + Metformin during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Rosiglitazone + Metformin. Rosiglitazone + Metformin is pregnancy risk category C according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Rosiglitazone + Metformin?

Nausea, stomach upset, diarrhea, or metallic taste may occur at the beginning of treatment as your body adjusts to the medication. If stomach symptoms return later (after you are on the same dose for several days or more), tell your doctor right away. Returning stomach symptoms may be due to lactic acidosis.

Headache, joint pain, weight gain, loss of appetite, cough, or fever may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: bone fracture, vision changes (such as color changes or night vision problems).

Rosiglitazone has rarely caused very serious liver disease. Tell your doctor right away if you develop symptoms of liver disease, including: nausea/vomiting that doesn’t stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine.

This medication does not usually cause low blood sugar (hypoglycemia). Low blood sugar may occur if this drug is prescribed with other diabetes medications, or if you do not consume enough calories from food, or if you do unusually heavy exercise. Talk with your doctor or pharmacist about whether the dose of your other diabetes medication(s) needs to be lowered. Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don’t have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor right away about the reaction and the use of this product. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist to find out what you should do if you miss a meal.

Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor right away. Your dosage may need to be increased.

Get medical help right away if you have any very serious side effects, including: symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Rosiglitazone + Metformin?

A product that may interact with this drug is: insulin.

Beta-blocker medications (such as metoprolol, propranolol, glaucoma eye drops such as timolol) may prevent the fast/pounding heartbeat you would usually feel when your blood sugar falls too low (hypoglycemia). Other symptoms of low blood sugar, such as dizziness, hunger, or sweating, are not affected by these drugs.

Many drugs can affect your blood sugar, making it harder to control. Before you start, stop, or change any medication, talk with your doctor or pharmacist about how the medication may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high or low blood sugar. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Rosiglitazone + Metformin may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Rosiglitazone + Metformin?

Rosiglitazone + Metformin may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Rosiglitazone + Metformin?

Rosiglitazone + Metformin may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Rosiglitazone + Metformin.

What is the dose of Rosiglitazone + Metformin for an adult?

Usual Adult Dose for Diabetes Type 2

Individualize dose based on safety, efficacy, and prior therapy; asses the risk versus benefit of initiating with combination therapy versus monotherapy

-Initial dose: rosiglitazone 2 mg/metformin 500 mg orally once or twice a day

-If glycosylated hemoglobin (HbA1c) is greater than 11% or fasting plasma glucose (FPG) is greater than 270 mg/dL: consider a starting dose of rosiglitazone 2 mg/metformin 500 mg orally twice a day

Titration: Increase in increments of rosiglitazone 2 mg/metformin 500 mg per day in divided doses if not adequately controlled after 4 weeks

Patients Inadequately Controlled on Rosiglitazone Monotherapy:

-Initial dose: Current rosiglitazone dose plus metformin 1000 mg per day orally in 2 divided doses

Patients Inadequately Controlled on Metformin Monotherapy:

-Initial dose: Current metformin dose plus rosiglitazone 4 mg per day orally in 2 divided doses

Patients currently receiving rosiglitazone and metformin as individual components:

-Switch to combination product containing the same dose of each component

-Titration: Allow sufficient time to assess adequacy of response; increase in increments of rosiglitazone 4 mg/metformin 500 mg per day in divided doses; allow 1 to 2 weeks to assess metformin dose increase; allow 8 to 12 weeks to assess rosiglitazone dose increase

-Maximum dose: rosiglitazone 8 mg/metformin 2000 mg per day

Comments:

-This drug should be given in divided doses with meals.

-Gradual dose escalation is recommended in order to reduce the gastrointestinal side effects of metformin and allow for determination of the minimum effective dose.

-Coadministration with insulin is not recommended.

Use: To improve glycemic control in adult patients with type 2 diabetes mellitus as an adjunct to diet and exercise.

Renal Dose Adjustments

Obtain eGFR prior to initiating therapy:

-eGFR less than 30 mL/min/1.73 m2: Use is contraindicated

-eGFR 30 to 45 mL/min/1.73 m2: Initiating therapy is not recommended

-eGFR that falls below 30 mL/min/1.73 m2 during therapy: Discontinue therapy

-eGFR that falls below 45 mL/min/1.73 m2 during therapy: Assess risks versus benefit of continued therapy

-eGFR greater than 45 mL/min/1.73 m2: No dose adjustments recommended

IODINATED CONTRAST PROCEDURE:

-For patients with eGFR between 30 and 60 mL/min/1.73 m2: Stop this drug at the time of, or before imaging procedure; re-evaluate eGFR 48 hours after procedure; restart therapy only if renal function is stable.

Liver Dose Adjustments

Not recommended in patients with active liver disease or in patients with ALT elevations 2.5 times the upper limit of normal (2.5 x ULN).

-If ALT elevations greater than 3 x ULN develop during therapy, recheck liver enzymes as soon as possible; if ALT remains greater than 3 x ULN, treatment should be discontinued.

-If symptoms suggestive of liver dysfunction develop, liver enzymes should be checked; if jaundice develops, treatment should be discontinued

-In the presence of hepatic disease or hepatic dysfunction of sufficient magnitude to predispose patient to lactic acidosis, treatment should be discontinued.

Dose Adjustments

Elderly: Initial and maintenance dose should be conservative due to the potential for decreased renal function; dose adjustments should be based on renal function which should be routinely monitored.

If signs or symptoms of heart failure develop, dose reduction or drug discontinuation should be considered.

Other Comments

Administration advice:

-Take twice a day with food

General:

-Temporarily stop treatment prior to radiologic studies utilizing iodinated contrast materials and for surgical procedures when restricted food or fluid intake is expected; may resume once adequate renal function is confirmed.

-Coadministration with insulin is not recommended.

-This drug should not be used in patients with symptomatic heart failure.

-For rosiglitazone, reductions in fasting blood glucose may be seen after 1 week, however, it may take 6 to 8 weeks for full therapeutic effect to be realized.

-Hypoglycemia may occur if used in combination with other hypoglycemic agents; dose reduction of concomitant drug may be necessary.

-This drug should not be used in patients with type 1 diabetes or diabetic ketoacidosis.

Monitoring:

-Observe closely for signs and symptoms of heart failure

-Hepatic: Monitor liver enzymes baseline and periodically

-Renal: Assess renal function baseline, repeat at least annually and more often as clinically indicated.

-Hematologic: Measure hematologic parameters at baseline, and annually

-Monitor glycemic control

Patient advice:

-This drug may cause edema; patients experiencing rapid weight gain, shortness of breath or other symptoms of heart failure should notify their health care professional promptly.

-Premenopausal anovulatory women may be at risk for pregnancy while on this drug; pregnancy risk should be discussed with patient and adequate contraception offered.

-Patients with unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or dark urine should be advised to report these symptoms to their health care professional.

-Inform patients about the risk of lactic acidosis, conditions that might predispose them to its occurrence, and symptoms to watch for and report.

– Advise patient that this drug will need to be temporarily stopped if undergoing radiologic studies with intravascular iodinated contrast materials or surgical procedures that will limit food or fluid intake.

-Advise patients on the risks of excessive alcohol intake.

-Tell patients that while gastrointestinal symptoms might be common when initiating treatment, gastrointestinal problems after initiation should be reported

What is the dose of Rosiglitazone + Metformin for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Rosiglitazone + Metformin available?

Rosiglitazone + Metformin is available in the following dosage forms and strengths:

  • Oral

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Rosiglitazone + Metformin, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: April 26, 2018 | Last Modified: April 26, 2018

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