Pioglitazone + Glimepiride

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Generic Name: Pioglitazone + Glimepiride Brand Name(s): Generics only. No brands available.

Uses

What is Pioglitazone + Glimepiride used for?

This medication is a combination of 2 drugs, pioglitazone and glimepiride. It is used along with a proper diet and exercise program to control high blood sugar in patients 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.

Pioglitazone belongs to a class of drugs known as thiazolidinediones or “glitazones.” It works by helping to restore your body’s proper response to insulin, thereby lowering your blood sugar.

Talk to your doctor about the risks and benefits of using pioglitazone-containing products.

Glimepiride belongs to a class of drugs known as sulfonylureas. It works by causing the release of your body’s natural insulin.

How should I take Pioglitazone + Glimepiride?

Take this medication by mouth, usually once daily with the first main meal of the day or as directed by your doctor.

The dosage is based on your medical condition and response to treatment.

Colesevelam can decrease the absorption of glimepiride. If you are taking colesevelam, take this product at least 4 hours before taking colesevelam.

Use this medication regularly in order to get the most benefit from it. Remember to take it at the same time each day. Monitor your blood sugar on a regular basis, and share the results with your doctor.

It may take up to 2 to 3 months before you get the full benefit of this drug.

When switching from individual diabetes drugs to this combination product, your doctor may ask you to check your blood sugar more often to make sure you do not have a sudden attack of low blood sugar (hypoglycemic reaction) when starting this product. Follow your doctor’s directions carefully.

How do I store Pioglitazone + Glimepiride?

Pioglitazone + Glimepiride is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Pioglitazone + Glimepiride in the bathroom or the freezer. There may be different brands of Pioglitazone + Glimepiride 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 Pioglitazone + Glimepiride 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 Pioglitazone + Glimepiride?

Before taking this medication, tell your doctor or pharmacist if you are allergic to pioglitazone or glimepiride; or to other “glitazones” (e.g., rosiglitazone); or to other sulfonylureas (e.g., glipizide, tolbutamide); 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 taking this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (e.g., congestive heart failure), fluid in your lungs, swelling (edema, fluid retention), liver problems, kidney disease, thyroid problems, certain hormonal conditions (adrenal/pituitary insufficiency, syndrome of inappropriate secretion of antidiuretic hormone-SIADH), mineral imbalance (hyponatremia), anemia, eye (retina) problems, bladder cancer.

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 (hypoglycemia).

It may be harder to control your blood sugar when your body is stressed (e.g., due to fever, infection, injury, or surgery). In these cases, consult your doctor because you may require a change in your treatment plan, medications, or blood sugar testing.

This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.

This medication may increase the risk of bone fracture (e.g., upper arm, hand, foot, ankle) in female patients. To lower the chance of getting injured, use caution when doing activities such as contact sports.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, the elderly may be at greater risk for low blood sugar while using this drug.

This medication can cause changes in the menstrual cycle (promote ovulation) in women with certain fertility problems. Women of child-bearing age should use a reliable form of birth control while taking this medication. Consult your doctor for more details.

This medication is not recommended for use during pregnancy. Your doctor may direct you to switch to insulin treatment during your pregnancy. Use of pioglitazone/glimepiride close to the expected delivery date may increase the risk of low blood sugar in your newborn. Consult your doctor for more details, and follow all instructions carefully.

It is unknown if this medication passes into breast milk, and it may have undesirable effects on a nursing infant. Breast-feeding while using this drug is not recommended. 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 Pioglitazone + Glimepiride during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Pioglitazone + Glimepiride. Pioglitazone + Glimepiride is pregnancy risk category N 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 Pioglitazone + Glimepiride?

Headache, dizziness, diarrhea, nausea, muscle pain, sore throat, or tooth problems may 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: new/worsening vision problems (e.g., color or night vision problems), bone fracture, reddish-colored urine, urgent need to urinate, pain while urinating, loss of appetite, yellowing eyes/skin, dark urine, mental/mood changes (e.g., hallucinations, confusion), seizures, easy bruising/bleeding, signs of infection (e.g., fever, persistent sore throat).

This medication can cause low blood sugar (hypoglycemia). This may occur if you do not consume enough calories from food or if you do unusually heavy exercise. Symptoms include cold sweat, blurred vision, dizziness, drowsiness, shaking, fast heartbeat, headache, fainting, tingling of the hands/feet, and hunger. 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 about the reaction right away. 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.

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 Pioglitazone + Glimepiride?

Other medications can affect the removal of pioglitazone from your body, which may affect how pioglitazone works. Examples include gemfibrozil, rifamycins including rifampin, among others.

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 unaffected 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.

Pioglitazone + Glimepiride 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 Pioglitazone + Glimepiride?

Pioglitazone + Glimepiride 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 Pioglitazone + Glimepiride?

Pioglitazone + Glimepiride 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 Pioglitazone + Glimepiride.

What is the dose of Pioglitazone + Glimepiride for an adult?

Usual Adult Dose for Diabetes Type 2

Individualize dose based on safety, efficacy, and prior therapy

Initial dose: pioglitazone 30 mg-glimepiride 2 mg or pioglitazone 30 mg-glimepiride 4 mg orally once a day

-For patients inadequately controlled on glimepiride monotherapy: pioglitazone 30 mg-glimepiride 2 mg or pioglitazone 30 mg-glimepiride 4 mg orally once a day

-For patients inadequately controlled on pioglitazone monotherapy: pioglitazone 30 mg-glimepiride 2 mg orally once a day

-For patients receiving pioglitazone and glimepiride as individual components: Initiate with the combination product containing doses that are as close as possible to the dose of each component

-For patients currently on a different sulfonylurea monotherapy or switching from combination therapy of pioglitazone plus a different sulfonylurea: pioglitazone 30 mg-glimepiride 2 mg orally once a day

-For patients with systolic dysfunction, initiate with pioglitazone monotherapy and only initiate combination therapy after titration from pioglitazone 15 mg to 30 mg has been safely tolerated.

Maintenance Dose: Gradually titrate dose based on adequacy of therapeutic response and tolerability for each component

Comments:

-Take with first meal of the day.

-For patients switching from a different sulfonylurea, carefully monitor for hypoglycemia for 1 to 2 weeks due to a potential overlapping drug effect.

-If hypoglycemia occurs in a patient coadministered an insulin secretagogue, the dose of the insulin secretagogue should be reduced.

-If hypoglycemia occurs in a patient’s coadministered insulin, the insulin dose should be decreased by 10% to 25% with further adjustments based on glycemic response.

Use: As an adjunct to diet and exercise, to improve glycemic control in adult patients with type 2 diabetes mellitus who are already treated with a thiazolidinedione and sulfonylurea or who have inadequate glycemic control in a thiazolidinedione alone or a sulfonylurea alone.

Renal Dose Adjustments

Use with caution: Initial dosing, dose increments, and maintenance dosage should be conservative to minimize the risk of hypoglycemia.

Liver Dose Adjustments

Use with caution; Liver tests (ALT, AST, alkaline phosphatase, total bilirubin) should be obtained prior to initiating therapy.

-Routine monitoring of liver tests is not recommended in patients without liver disease.

– For patients who experience signs or symptoms indicative of liver injury, liver tests should be performed promptly.

-For ALT elevations greater than 3 times the upper limit of normal (3 x ULN), treatment should be interrupted and an investigation done for probable cause; this drug should not be started without another explanation for the liver test abnormality.

-For ALT elevations greater than 3 x ULN with total bilirubin of greater than 2 x ULN without alternative etiologies, this drug should not be restarted.

-For lesser elevations of ALT or bilirubin and with an alternate probable cause, treatment may proceed with caution.

Dose Adjustments

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

-Elderly, debilitated, or malnourished patients: Dose conservatively to avoid hypoglycemia

Concomitant Use with Insulin or Insulin Secretagogue

-If hypoglycemia occurs in a patient coadministered an insulin secretagogue, the dose of the insulin secretagogue should be reduced.

-If hypoglycemia occurs in a patient’s coadministered insulin, the insulin dose should be decreased by 10% to 25% with further adjustments based on glycemic response.

Concomitant Use with Strong CYP450 2C8 Inhibitors:

-If concomitantly administered with a strong CYP450 2C8 inhibitor, the maximum dose of pioglitazone should be 15 mg once a day; therefore, patients should be switched to individual components

Other Comments

Administration advice:

-Take orally once a day with first main meal of the day

-When coadministered with colesevelam, this drug should be taken at least 4 hours prior

General:

-This drug should be used with caution in patients with liver disease.

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

-Hypoglycemia may occur, especially in the elderly, debilitated, or malnourished patient, and/or those with renal, hepatic or adrenal insufficiency; dose reduction of glimepiride may be necessary.

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

-Hemolytic anemia may occur in glucose 6-phosphate dehydrogenase (G6PD) deficient patients; consider a non-sulfonylurea alternative.

Monitoring:

-Hepatic: ALT, AST, alkaline phosphatase, and total bilirubin should be obtained prior to starting therapy; routine monitoring in patients without liver disease is not recommended; however, repeat tests should be ordered promptly in patients showing signs or symptoms of liver injury.

-Observe closely for signs and symptoms of heart failure with initiation and with each dose increase.

-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 recommended if necessary.

-Patients should be told to stop taking this medication and seek medical attention for unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or dark urine as they may be a signs of hepatotoxicity.

-Patients should be instructed to report development or worsening of dysuria, urinary urgency, or any blood in the urine

-Patients should be informed about the risks of hypoglycemia, its symptoms, the conditions that might predispose them to develop it, and treatment.

-Patients should speak with their health care provider during periods of stress such as fever, trauma, infection, or surgery, as their diabetes management may need to be changed.

What is the dose of Pioglitazone + Glimepiride 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 Pioglitazone + Glimepiride available?

Pioglitazone + Glimepiride is available in the following dosage forms and strengths:

  • Oral tablet.

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 Pioglitazone + Glimepiride, 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.

Review Date: April 11, 2018 | Last Modified: April 11, 2018

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