Pioglitazone + Metformin

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

Uses

What is Pioglitazone + Metformin used for?

This combination medication is used along 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.

Pioglitazone belongs to a class of drugs known as thiazolidinediones or “glitazones”. Metformin and pioglitazone work by helping to restore your body’s proper response to the insulin you naturally produce. Metformin also decreases the amount of sugar that your liver makes and that your stomach/intestines absorb.

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

How should I take Pioglitazone + Metformin?

Take this medication by mouth as directed by your doctor, usually once or twice daily with meals to decrease stomach upset. Drink plenty of fluids while taking this medication unless otherwise directed by your doctor.

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.

Take this medication regularly in order to get the most benefit from it. Remember to use it at the same time(s) each day.

If you are already taking another diabetes medication, follow your doctor’s directions carefully for stopping/continuing the old drug and starting this medication.

Check your blood sugar regularly as directed by your doctor. Keep track of the results, and share them with your doctor. Tell your doctor if your blood sugar measurements are too high or too low. Your dosage/treatment may need to be changed. It may take up to 2 to 3 months before the full benefit of this drug takes effect.

How do I store Pioglitazone + Metformin?

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

Before taking this medication, tell your doctor or pharmacist if you are allergic to pioglitazone or metformin; 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: severe breathing problems (such as obstructive lung disease, severe asthma), blood problems (such as anemia, vitamin B12 deficiency), kidney disease, liver disease, heart disease (such as congestive heart failure, chest pain), fluid in your lungs, swelling (edema), a certain eye problem (macular edema), bladder cancer.

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 using this medication because it can increase your risk of lactic acidosis and 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 increased stress may require a change in your treatment plan, medications, or blood sugar testing.

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

Older adults may be at greater risk for side effects such as low blood sugar or lactic acidosis.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Your doctor may direct you to use insulin instead of this product during your pregnancy. Follow your doctor’s instructions carefully.

This medication can cause changes in the menstrual cycle (promote ovulation) and increase the risk of becoming pregnant. Consult your doctor or pharmacist about the use of reliable birth control while using this medication.

Metformin passes into breast milk in small amounts. It is unknown if pioglitazone 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 Pioglitazone + Metformin during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Pioglitazone + Metformin. Pioglitazone + Metformin 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 + Metformin?

Nausea, vomiting, stomach upset, diarrhea, weakness, sore throat, muscle pain, weight gain, tooth problems or a metallic taste in the mouth may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. If stomach symptoms return later (after taking the same dose for several days or weeks), tell your doctor right away. Stomach symptoms that occur after the first days of your treatment may be signs of lactic acidosis.

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 (such as blurred vision), bone fracture, reddish-colored urine, urgent need to urinate, pain while urinating.

Pioglitazone may rarely cause liver disease. Tell your doctor right away if you develop symptoms of liver disease, including: dark urine, yellowing of eyes/skin, persistent nausea/vomiting, stomach/abdominal pain.

This medication usually does not cause low blood sugar (hypoglycemia). Low blood sugar may occur if this drug is prescribed with other diabetes medications (such as insulin or a sulfonylurea). Low blood sugar is more likely if you drink large amounts of alcohol, do unusually heavy exercise, or do not consume enough calories from food. 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 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.

Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, or 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 of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), 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 + Metformin?

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 + 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 Pioglitazone + Metformin?

Pioglitazone + 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 Pioglitazone + Metformin?

Pioglitazone + 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 Pioglitazone + Metformin.

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

Usual Adult Dose for Diabetes Type 2

Individualize dose based on safety, efficacy, and prior therapy

-All doses provided as pioglitazone/metformin

Immediate-release (IR):

Initial dose: 15 mg/500 mg IR orally twice a day or 15 mg/850 mg IR orally once a day

-For patients inadequately control on metformin monotherapy: May initiate with 15 mg/850 mg IR orally twice a day (depending on previous metformin dose)

-For patients with NYHA Class I or Class II CHF: Initial dose: 15 mg/500 mg IR or 15 mg/850 mg IR orally once a day

Maintenance dose: Gradually titrate dose based on safety and efficacy

Maximum dose: Pioglitazone 45 mg/Metformin 2550 mg per day

Extended-release (XR):

Initial dose: 15 mg/1000 mg XR or 30 mg/1000 mg XR orally once a day

-For patients inadequately control on pioglitazone or metformin monotherapy: 15 mg/1000 mg XR twice a day (depending on previous metformin dose) or 30 mg/1000 mg XR orally once a day

Maintenance dose: Gradually titrate dose based on safety and efficacy

Maximum dose: Pioglitazone 45 mg/Metformin 2000 mg per day

Comments:

-Initial doses for patients receiving combination therapy as separate tablets should be as close as possible to current regimen.

-Take with meals and gradually titrate metformin doses to reduce gastrointestinal side effects; metformin doses above 2000 mg may be better tolerated given 3 times a day.

-After initiation of therapy, and with each dose increase, carefully monitor for adverse reactions related to fluid retention.

-If hypoglycemia occurs with concomitant use of insulin or insulin secretagogue, the insulin or insulin secretagogue dose should be reduced.

Use: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both pioglitazone and metformin is appropriate.

Renal Dose Adjustments

-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 therapy at the time of, or before iodinated contrast imaging procedure; re-evaluate eGFR 48 hours after procedure; restart therapy only if renal function is stable.

-For patients receiving intra-arterial iodinated contrast, this drug should be stopped and restarted only if renal function is stable.

Liver Dose Adjustments

Avoid use in patients with clinical or laboratory evidence of hepatic disease

Liver function tests (ALT, AST, alkaline phosphatase, and total bilirubin) should be obtained prior to therapy

-If ALT is greater than 3 times the upper limit of normal (ULN) and total bilirubin greater than 2 x ULN without alternative etiologies: Therapy should not be initiated

-For lesser elevations or in patients with an alternate probable cause, may initiate with caution

-Promptly measure liver tests in patients reporting symptoms indicative of liver injury; if abnormal, interrupt therapy and investigate cause; therapy should not be restarted without another explanation for liver test abnormalities.

Dose Adjustments

Elderly: Renal function should be assessed more frequently in elderly patients.

New York Heart Association (NYHA) Class I or Class II Heart Failure:

-Initial dose (IR): pioglitazone 15 mg/metformin 500 mg immediate-release (IR) or pioglitazone 15 mg/metformin 850 mg IR orally once a day; titrate as needed, after assessing adequacy of response and tolerability.

-Initial dose (XR): pioglitazone 15 mg/metformin 1000 mg extended-release (XR) or pioglitazone 30 mg/metformin 1000 mg XR orally once a day; titrate as needed, after assessing adequacy of response and tolerability.

IODINATED CONTRAST PROCEDURES:

-Stop therapy at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR between 30 and 60 mL/min/1.73 m2; in patients with a history of liver disease, alcoholism or heart failure; or in patients who will be administered intra-arterial iodinated contrast.

-Re-evaluate eGFR 48 hours after procedure; restart therapy only if renal function is stable.

Concomitant use with Strong CYP450 2C8 Inhibitors:

-Immediate-release (IR): Maximum dose: pioglitazone 15 mg/metformin 850 mg IR orally once a day

-Extended-release (XR): Maximum dose: pioglitazone 15 mg/metformin 1000 mg XR orally once a day

Hypoglycemia:

-If hypoglycemia occurs in a patient concomitantly receiving an insulin secretagogue such as a sulfonylurea: the dose of the insulin secretagogue should be reduced.

-If hypoglycemia occurs in a patient concomitantly receiving insulin: decrease the insulin dose by 10% to 25%, further adjustments to the insulin dose should be based on glycemic response.

Therapeutic drug monitoring/range: Steady-state plasma concentrations of metformin are achieved within 24 to 48 hours and are generally less than 1 mcg/mL. Metformin levels greater than 5 mcg/mL have been implicated as the cause of lactic acidosis.

Dialysis

-Metformin is contraindicated in patients with renal failure.

-Metformin may be removed from the system following prolonged hemodialysis;venovenous hemofiltration has been used successfully following metformin overdose.

Other Comments

Administration advice:

-Take with food

-Swallow whole with a glass of water

-Extended-release product should not be chewed, cut, or crushed; the tablet shell may be seen in the stool

General:

-This drug may need to be temporarily stopped 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.

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

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

-Pioglitazone exerts its antihyperglycemic effect only in the presence of endogenous insulin and therefore would not be effective in patients with type 1 diabetes or diabetic ketoacidosis and should not be used in treat these conditions.

Monitoring:

-Observe closely for signs and symptoms of heart failure especially at therapy initiation and with each increase in dose

-Hepatic: Liver function tests (ALT, AST, total bilirubin, and alkaline phosphatase) should be obtained prior to initiating therapy and promptly if signs or symptoms of liver injury develop; routine monitoring in patients without liver disease is not recommended.

-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:

-Patients should understand the importance of diet and exercise in the management of their diabetes; they should understand during periods of stress, medication requirements may change and they should seek medical advice promptly.

-Patients should understand the management of low and high blood sugars, especially if they are on insulin or other medications that may affect blood sugars.

-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; while gastrointestinal symptoms might be common when initiating treatment, gastrointestinal problems after initiation should be reported.

-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.

-Patients should be instructed to report hematuria, dysuria, or urinary urgency promptly.

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

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

  • Oral tablet,
  • Oral tablet, extended release.

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 + 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.

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

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