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Metformin / Pioglitazone Dosage

Applies to the following strength(s): 500 mg-15 mg ; 850 mg-15 mg ; 1000 mg-30 mg ; 1000 mg-15 mg

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

Usual Adult Dose for:

Additional dosage information:

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: metformin 500 mg-pioglitazone 15 mg orally twice a day OR metformin 850 mg-pioglitazone 15 mg orally once a day
Maintenance dose: Gradually titrate dose based on safety and efficacy
Maximum dose: Metformin 2550 mg-Pioglitazone 45 mg per day

Extended-release:
Initial dose: metformin 1000 mg-pioglitazone 15 mg OR metformin 1000 mg-pioglitazone 30 mg orally once a day
Maintenance dose: Gradually titrate dose based on safety and efficacy
Maximum dose: Metformin 2000 mg-Pioglitazone 45 mg per day

Comments:
-Initial doses for patients receiving combination therapy as separate tablets should be as close as possible to current regimen.
-Metformin doses above 2000 mg may be better tolerated given 3 times a day.

Use: 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

Moderate to severe renal impairment (eGFR less than 60 mL/min/1.73m2 or CrCl less than 60 mL/min) or ESRD: Use is contraindicated
Mild renal impairment (eGFR 60 mL/min/1.73 m2 or greater): No adjustment recommended

Liver Dose Adjustments

Not recommended in patients with hepatic impairment.

Precautions

New York Heart Association (NYHA) Class I or Class II Heart Failure:
-Initial therapy with immediate-release product should be metformin 500 mg-pioglitazone 15 mg orally once a day OR metformin 850 mg-pioglitazone 15 mg orally once a day; titrate as needed, after assessing adequacy of response and tolerability.

Concomitant use with Strong CYP450 2C8 Inhibitors:
-Immediate-release product: When administered with a strong CYP450 2C8 inhibitor, the maximum recommended dose is metformin 850 mg-pioglitazone 15 mg
-Extended-release product: When administered with a strong CYP450 2C8 inhibitor, the maximum recommended dose is metformin 1000 mg-pioglitazone 15 mg

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:
-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.
-This drug should not be used in patients with symptomatic heart failure.
-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.
-After initiation of pioglitazone, assess adequacy of response (HbA1c) after 3 to 6 months; patients who fail to show adequate response should have pioglitazone discontinued.
-Due to potential risks with prolonged pioglitazone therapy, prescribers should routinely confirm benefits of continued therapy.

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; 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.

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