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Black Box Warning
Title
See full prescribing information for complete Boxed Warning.
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Content
Overview
Glimepiride is a hypoglycemic agent that is FDA approved for the treatment of type 2 diabetes mellitus. There is a Black Box Warning for this drug as shown here. Common adverse reactions include hypoglycemia, headache, nausea, and dizziness.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Type 2 Diabetes Mellitus
Glimepiride is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Important Limitations of Use
Glimepiride tablets should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.
Dosing Information
Glimepiride tablets should be administered with breakfast or the first main meal of the day.
The recommended starting dose of glimepiride tablet is 1 mg or 2 mg once daily. Patients at increased risk for hypoglycemia (e.g., the elderly or patients with renal impairment) should be started on 1 mg once daily.
After reaching a daily dose of 2 mg, further dose increases can be made in increments of 1 mg or 2 mg based upon the patient’s glycemic response. Uptitration should not occur more frequently than every 1 to 2 weeks. A conservative titration scheme is recommended for patients at increased risk for hypoglycemia.
The maximum recommended dose is 8 mg once daily.
Patients being transferred to glimepiride from longer half-life sulfonylureas (e.g., chlorpropamide) may have overlapping drug effect for 1 to 2 weeks and should be appropriately monitored for hypoglycemia.
When colesevelam is coadministered with glimepiride, maximum plasma concentration and total exposure to glimepiride is reduced. Therefore, glimepiride should be administered at least 4 hours prior to colesevelam.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
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Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Glimepiride in adult patients.
Non–Guideline-Supported Use
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Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Glimepiride 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 Glimepiride 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 Glimepiride in pediatric patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Glimepiride in pediatric patients.
Contraindications
Glimepiride tablet is contraindicated in patients with a history of a hypersensitivity reaction to:
Glimepiride or any of the product’s ingredients [see Warnings and Precautions ( 5.2 )].
Sulfonamide derivatives: Patients who have developed an allergic reaction to sulfonamide derivatives may develop an allergic reaction to glimepiride. Do not use glimepiride in patients who have a history of an allergic reaction to sulfonamide derivatives.
Reported hypersensitivity reactions include cutaneous eruptions with or without pruritus as well as more serious reactions (e.g. anaphylaxis, angioedema, Stevens-Johnson Syndrome, dyspnea) [see Warnings and Precautions (5.2) and Adverse Reactions (6.2)].
Warnings
Title
See full prescribing information for complete Boxed Warning.
ConditionName:
Content
Description
Precautions
Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Glimepiride 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 Glimepiride in the drug label.
Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Glimepiride in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Glimepiride during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Glimepiride with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Glimepiride with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Glimepiride with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Glimepiride with respect to specific gender populations.
Race
There is no FDA guidance on the use of Glimepiride with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Glimepiride in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Glimepiride in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Glimepiride in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Glimepiride in patients who are immunocompromised.
Administration and Monitoring
Administration
Recommended Dosing
Glimepiride tablets should be administered with breakfast or the first main meal of the day.
The recommended starting dose of glimepiride tablet is 1 mg or 2 mg once daily. Patients at increased risk for hypoglycemia (e.g., the elderly or patients with renal impairment) should be started on 1 mg once daily.
After reaching a daily dose of 2 mg, further dose increases can be made in increments of 1 mg or 2 mg based upon the patient’s glycemic response. Uptitration should not occur more frequently than every 1 to 2 weeks. A conservative titration scheme is recommended for patients at increased risk for hypoglycemia.
The maximum recommended dose is 8 mg once daily.
Patients being transferred to glimepiride from longer half-life sulfonylureas (e.g., chlorpropamide) may have overlapping drug effect for 1 to 2 weeks and should be appropriately monitored for hypoglycemia.
When colesevelam is coadministered with glimepiride, maximum plasma concentration and total exposure to glimepiride is reduced. Therefore, glimepiride should be administered at least 4 hours prior to colesevelam.
Dosage forms and strengths
Glimepiride tablet is formulated as tablets of:
1 mg tablets (pink coloured, oval shaped, biconvex, uncoated tablets debossed with ‘AHI 1’ on one side and break line on the other)
2 mg tablets (green coloured, oval shaped, biconvex, uncoated tablets debossed with ‘AHI 2’ on one side and break line on the other)
4 mg tablets (blue coloured, oval shaped, biconvex, uncoated tablets debossed with ‘AHI 4’ on one side and break line on the other)
Monitoring
There is limited information regarding Monitoring of Glimepiride in the drug label.
Description
IV Compatibility
There is limited information regarding IV Compatibility of Glimepiride in the drug label.
Overdosage
Acute Overdose
Signs and Symptoms
Description
Management
Description
Chronic Overdose
There is limited information regarding Chronic Overdose of Glimepiride in the drug label.
Pharmacology
There is limited information regarding Glimepiride Pharmacology in the drug label.
The usual starting dose of Glimepiride as initial therapy is 1 to 2 mg once daily, administered with breakfast or the first main meal. Those patients who may be more sensitive to hypoglycemic drugs should be started at 1 mg once daily, and should be titrated carefully.
No exact dosage relationship exists between Glimepiride and the other oral hypoglycemic agents. The maximum starting dose of Glimepiride should be no more than 2 mg.
Failure to follow an appropriate dosage regimen may precipitate hypoglycemia. Patients who do not adhere to their prescribed dietary and drug regimen are more prone to exhibit unsatisfactory response to therapy.
