Repaglinide and Metformin hydrochloride: Difference between revisions

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hypoglycemia, headache. diarrhea, nausea and vomiting


<!--Black Box Warning-->
<!--Black Box Warning-->


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Title
WARNING: LACTIC ACIDOSIS


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<i><span style="color:#FF0000;">ConditionName: </span></i>
<i><span style="color:#FF0000;">ConditionName: </span></i>


* Content
*Lactic acidosis can occur due to metformin accumulation. The risk increases with conditions such as sepsis, dehydration, excess alcohol intake, hepatic impairment, renal impairment, and acute congestive heart failure.
 
*Symptoms include malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress. Laboratory abnormalities include low pH, increased anion gap and elevated blood lactate.
 
*If acidosis is suspected, discontinue PrandiMet and hospitalize the patient immediately.


<!--Adult Indications and Dosage-->
<!--Adult Indications and Dosage-->

Revision as of 14:11, 17 November 2014

Repaglinide and Metformin hydrochloride
Black Box Warning
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: Vignesh Ponnusamy, M.B.B.S. [2]

Disclaimer

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Black Box Warning

WARNING: LACTIC ACIDOSIS
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Lactic acidosis can occur due to metformin accumulation. The risk increases with conditions such as sepsis, dehydration, excess alcohol intake, hepatic impairment, renal impairment, and acute congestive heart failure.
  • Symptoms include malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress. Laboratory abnormalities include low pH, increased anion gap and elevated blood lactate.
  • If acidosis is suspected, discontinue PrandiMet and hospitalize the patient immediately.

Overview

Repaglinide and Metformin hydrochloride is a meglitinide and biguanide combination that is FDA approved for the {{{indicationType}}} of type 2 diabetes mellitus. There is a Black Box Warning for this drug as shown here. Common adverse reactions include hypoglycemia, headache. diarrhea, nausea and vomiting.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Condition1
  • Dosing Information
  • Dosage
Condition2
  • Dosing Information
  • Dosage
Condition3
  • Dosing Information
  • Dosage
Condition4
  • Dosing Information
  • Dosage

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

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

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding FDA-Labeled Use of Repaglinide and Metformin hydrochloride in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

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

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Contraindications

  • Condition1

Warnings

WARNING: LACTIC ACIDOSIS
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Lactic acidosis can occur due to metformin accumulation. The risk increases with conditions such as sepsis, dehydration, excess alcohol intake, hepatic impairment, renal impairment, and acute congestive heart failure.
  • Symptoms include malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress. Laboratory abnormalities include low pH, increased anion gap and elevated blood lactate.
  • If acidosis is suspected, discontinue PrandiMet and hospitalize the patient immediately.
  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Repaglinide and Metformin hydrochloride in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Repaglinide and Metformin hydrochloride in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Repaglinide and Metformin hydrochloride in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

There is no FDA guidance on the use of Repaglinide and Metformin hydrochloride with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Repaglinide and Metformin hydrochloride with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Repaglinide and Metformin hydrochloride with respect to geriatric patients.

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Repaglinide and Metformin hydrochloride in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Repaglinide and Metformin hydrochloride in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Repaglinide and Metformin hydrochloride in the drug label.

Pharmacology

There is limited information regarding Repaglinide and Metformin hydrochloride Pharmacology in the drug label.

Mechanism of Action

Structure

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Repaglinide and Metformin hydrochloride in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Repaglinide and Metformin hydrochloride in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Repaglinide and Metformin hydrochloride in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Repaglinide and Metformin hydrochloride in the drug label.

How Supplied

Storage

There is limited information regarding Repaglinide and Metformin hydrochloride Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

{{#ask: Label Page::Repaglinide and Metformin hydrochloride |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Repaglinide and Metformin hydrochloride in the drug label.

Precautions with Alcohol

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

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

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

  1. ↑ Empty citation (help)
  2. ↑ "http://www.ismp.org". External link in |title= (help)


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