Pioglitazone And Metformin hydrochloride
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];
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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)
There is limited information regarding Pioglitazone And Metformin hydrochloride FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
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
There is limited information regarding Pioglitazone And Metformin hydrochloride Contraindications in the drug label.
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.