Repaglinide
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Vignesh Ponnusamy, M.B.B.S. [2]
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Overview
Repaglinide is an antidiabetic agent that is FDA approved for the {{{indicationType}}} of type 2 diabetes mellitus. Common adverse reactions include hypoglycemia, diarrhea, arthralgia, headache, sinusitis, upper respiratory infection.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Type 2 Diabetes Mellitus
- Starting Dose
- For patients not previously treated or whose HbA1c is < 8%, the starting dose should be 0.5 mg with each meal. For patients previously treated with blood glucose-lowering drugs and whose HbA1c is ≥ 8%, the initial dose is 1 or 2 mg with each meal preprandially.
- Dose Adjustment
- Dosing adjustments should be determined by blood glucose response, usually fasting blood glucose. Postprandial glucose levels testing may be clinically helpful in patients whose pre-meal blood glucose levels are satisfactory but whose overall glycemic control (HbA1c) is inadequate. The preprandial dose should be doubled up to 4 mg with each meal until satisfactory blood glucose response is achieved. At least one week should elapse to assess response after each dose adjustment.
- The recommended dose range is 0.5 mg to 4 mg taken with meals. PRANDIN may be dosed preprandially 2, 3, or 4 times a day in response to changes in the patient’s meal pattern. The maximum recommended daily dose is 16 mg.
- Patient Management
- Long-term efficacy should be monitored by measurement of HbA1c levels approximately every 3 months. Failure to follow an appropriate dosage regimen may precipitate hypoglycemia or hyperglycemia. Patients who do not adhere to their prescribed dietary and drug regimen are more prone to exhibit unsatisfactory response to therapy including hypoglycemia. When hypoglycemia occurs in patients taking a combination of PRANDIN and a thiazolidinedione or PRANDIN and metformin, the dose of PRANDIN should be reduced.
- Patients Receiving Other Oral Hypoglycemic Agents
- When PRANDIN is used to replace therapy with other oral hypoglycemic agents, PRANDIN may be started on the day after the final dose is given. Patients should then be observed carefully for hypoglycemia due to potential overlapping of drug effects. When transferred from longer half-life sulfonylurea agents (e.g., chlorpropamide) to repaglinide, close monitoring may be indicated for up to one week or longer.
- Combination Therapy
- If PRANDIN monotherapy does not result in adequate glycemic control, metformin or a thiazolidinedione may be added. If metformin or thiazolidinedione monotherapy does not provide adequate control, PRANDIN may be added. The starting dose and dose adjustments for PRANDIN combination therapy is the same as for PRANDIN monotherapy. The dose of each drug should be carefully adjusted to determine the minimal dose required to achieve the desired pharmacologic effect. Failure to do so could result in an increase in the incidence of hypoglycemic episodes. Appropriate monitoring of FPG and HbA1c measurements should be used to ensure that the patient is not subjected to excessive drug exposure or increased probability of secondary drug failure.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Repaglinide in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Repaglinide in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Repaglinide in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Repaglinide in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Repaglinide in pediatric patients.
Contraindications
- Diabetic ketoacidosis, with or without coma. This condition should be treated with insulin.
- Type 1 diabetes.
- Co-administration of gemfibrozil.
- Known hypersensitivity to the drug or its inactive ingredients.
Warnings
- Description
Precautions
- Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Repaglinide 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 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
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Repaglinide in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Repaglinide during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Repaglinide with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Repaglinide with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Repaglinide with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Repaglinide with respect to specific gender populations.
Race
There is no FDA guidance on the use of Repaglinide with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Repaglinide in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Repaglinide in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Repaglinide in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Repaglinide in patients who are immunocompromised.
Administration and Monitoring
Administration
- Oral
- Intravenous
Monitoring
There is limited information regarding Monitoring of Repaglinide in the drug label.
- Description
IV Compatibility
There is limited information regarding IV Compatibility of Repaglinide in the drug label.
Overdosage
Acute Overdose
Signs and Symptoms
- Description
Management
- Description
Chronic Overdose
There is limited information regarding Chronic Overdose of Repaglinide in the drug label.
Pharmacology
There is limited information regarding Repaglinide Pharmacology in the drug label.
Mechanism of Action
Structure
Pharmacodynamics
There is limited information regarding Pharmacodynamics of Repaglinide in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Repaglinide in the drug label.
Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Repaglinide in the drug label.
Clinical Studies
There is limited information regarding Clinical Studies of Repaglinide in the drug label.
How Supplied
Storage
There is limited information regarding Repaglinide 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 Patient Counseling Information of Repaglinide in the drug label.
Precautions with Alcohol
- Alcohol-Repaglinide interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
- ®[1]
Look-Alike Drug Names
- A® — B®[2]
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
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