Pioglitazone And Metformin hydrochloride

Pioglitazone And Metformin hydrochloride
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Deepika Beereddy, MBBS [2]

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Overview

Pioglitazone And Metformin hydrochloride is a hypoglycemic agent that is FDA approved for the treatment of diabetes mellitus type 2. Common adverse reactions include upper respiratory tract infection, edema, diarrhea, headache and weight gain.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Diabetes mellitus type 2

• ACTOPLUS MET XR is indicated 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.

Important Limitations of Use

Pioglitazone exerts its antihyperglycemic effect only in the presence of endogenous insulin. ACTOPLUS MET XR should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings.

Use caution in patients with liver disease.

Dosage

Recommendations for All Patients

ACTOPLUS MET XR should be taken with meals to reduce the gastrointestinal side effects associated with metformin.

If therapy with a combination tablet containing pioglitazone and extended-release metformin is considered appropriate the recommended starting dose is:

• 15 mg/1000 mg or 30 mg/1000 mg once daily and gradually titrated as needed, after assessing adequacy of therapeutic response and tolerability,
• for patients with NYHA Class I or Class II congestive heart failure: 15 mg/1000 mg or 30 mg/1000 mg once daily and gradually titrated as needed, after assessing adequacy of therapeutic response and tolerability.
• for patients inadequately controlled on metformin monotherapy: 15 mg/1000 mg twice daily or 30 mg/1000 mg once daily (depending on the dose of metformin already being taken) and gradually titrated, as needed, after assessing adequacy of therapeutic response and tolerability,
• for patients inadequately controlled on pioglitazone monotherapy: 15 mg/1000 mg twice daily or 30 mg/1000 mg once daily and gradually titrated, as needed, after assessing adequacy of therapeutic response and tolerability.
• for patients who are changing from combination therapy of pioglitazone plus metformin as separate tablets: ACTOPLUS MET XR should be taken at doses that are as close as possible to the dose of pioglitazone and metformin already being taken.

ACTOPLUS MET XR may be titrated up to a maximum daily dose of 45 mg/2000 mg of pioglitazone/extended-release metformin.

Metformin doses above 2000 mg may be better tolerated given three times a day.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Pioglitazone And Metformin hydrochloride in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Pioglitazone And Metformin hydrochloride in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

The safety and effectiveness of pioglitazone/metformin combination have not been established in pediatric patients and the product is not recommended for use in this population because of the risk of serious adverse effects.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Pioglitazone And Metformin hydrochloride in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Pioglitazone And Metformin hydrochloride in pediatric patients.

Contraindications

• Initiation in patients with established NYHA Class III or IV heart failure [see BoxedWarning].
• Renal impairment (e.g., serum creatinine levels ≥1.5 mg/dL [males], ≥1.4 mg/dL [females], or abnormal creatinine clearance) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia.
• Use in patients with known hypersensitivity to pioglitazone, metformin or any other component of ACTOPLUS MET XR.
• Metabolic acidosis, including diabetic ketoacidosis. Diabetic ketoacidosis should be treated with insulin.

Warnings

There is limited information regarding Pioglitazone And Metformin hydrochloride Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Pioglitazone And Metformin hydrochloride Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Pioglitazone And Metformin hydrochloride Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Pioglitazone And Metformin hydrochloride Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Pioglitazone And Metformin hydrochloride in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Pioglitazone And Metformin hydrochloride in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Pioglitazone And Metformin hydrochloride during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Pioglitazone And Metformin hydrochloride in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Pioglitazone And Metformin hydrochloride in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Pioglitazone And Metformin hydrochloride in geriatric settings.

Gender

There is no FDA guidance on the use of Pioglitazone And Metformin hydrochloride with respect to specific gender populations.

Race

There is no FDA guidance on the use of Pioglitazone And Metformin hydrochloride with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Pioglitazone And Metformin hydrochloride in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Pioglitazone And Metformin hydrochloride in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Pioglitazone And Metformin hydrochloride in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Pioglitazone And Metformin hydrochloride in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Pioglitazone And Metformin hydrochloride Administration in the drug label.

Monitoring

There is limited information regarding Pioglitazone And Metformin hydrochloride Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Pioglitazone And Metformin hydrochloride and IV administrations.

Overdosage

There is limited information regarding Pioglitazone And Metformin hydrochloride overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Pioglitazone And Metformin hydrochloride Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Pioglitazone And Metformin hydrochloride Mechanism of Action in the drug label.

Structure

There is limited information regarding Pioglitazone And Metformin hydrochloride Structure in the drug label.

Pharmacodynamics

There is limited information regarding Pioglitazone And Metformin hydrochloride Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Pioglitazone And Metformin hydrochloride Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Pioglitazone And Metformin hydrochloride Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Pioglitazone And Metformin hydrochloride Clinical Studies in the drug label.

How Supplied

There is limited information regarding Pioglitazone And Metformin hydrochloride How Supplied in the drug label.

Storage

There is limited information regarding Pioglitazone And Metformin hydrochloride Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Pioglitazone And Metformin hydrochloride Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Pioglitazone And Metformin hydrochloride interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Pioglitazone And Metformin hydrochloride Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Pioglitazone And Metformin hydrochloride Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.