Glimepiride 4mg Tablets
It is used to lower blood sugar in patients with high blood sugar (diabetes).
Drug Class
Antidiabetic Agent
Pharmacologic Class
Sulfonylurea
Pregnancy Category
C
FDA Approved
Dec 1995
DEA Schedule
Not Controlled
Overview
What is this medicine?
Glimepiride is a medication used to treat Type 2 Diabetes. It helps your body produce more insulin and use the insulin it already makes more effectively, which lowers your blood sugar levels. It's usually taken once a day with your first meal.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely.
Take your medication with a meal to help your body absorb it properly.
If you take your medication once a day, take it with your first meal of the day.
Establish a routine by taking your medication at the same time every day.
If you have a change in your eating habits, such as eating less than usual or skipping a meal, be sure to ask your doctor for guidance on how to adjust your medication schedule.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication:
Store it at room temperature in a dry place, avoiding bathrooms and areas with high humidity.
Keep all medications in a safe and secure location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist or healthcare provider.
Check with your pharmacist for guidance on the best way to dispose of your medication, and ask about potential drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose of your medication:
Take the missed dose as soon as you remember, with a meal.
If it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
* Do not take two doses at the same time or take extra doses to make up for a missed dose.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely.
Take your medication with a meal to help your body absorb it properly.
If you take your medication once a day, take it with your first meal of the day.
Establish a routine by taking your medication at the same time every day.
If you have a change in your eating habits, such as eating less than usual or skipping a meal, be sure to ask your doctor for guidance on how to adjust your medication schedule.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication:
Store it at room temperature in a dry place, avoiding bathrooms and areas with high humidity.
Keep all medications in a safe and secure location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist or healthcare provider.
Check with your pharmacist for guidance on the best way to dispose of your medication, and ask about potential drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose of your medication:
Take the missed dose as soon as you remember, with a meal.
If it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
* Do not take two doses at the same time or take extra doses to make up for a missed dose.
Lifestyle & Tips
- Follow a healthy diet plan recommended by your doctor or dietitian.
- Engage in regular physical activity as advised by your healthcare provider.
- Monitor your blood sugar levels regularly as instructed.
- Be aware of the symptoms of low blood sugar (hypoglycemia) and carry a source of fast-acting sugar (e.g., glucose tablets, fruit juice, hard candy) with you.
- Avoid excessive alcohol consumption, as it can increase the risk of hypoglycemia.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Initial: 1-2 mg orally once daily with breakfast or first main meal. Maintenance: 1-4 mg orally once daily. Max: 8 mg orally once daily.
Dose Range:
1 - 8 mg
Condition-Specific Dosing:
initial_dose:
1-2 mg once daily
maintenance_dose:
Titrate in increments of 1-2 mg at 1-2 week intervals based on blood glucose response.
maximum_dose:
8 mg once daily
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (Safety and efficacy not established in pediatric patients)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed, but monitor closely.
Moderate:
Initial dose 1 mg once daily. Titrate carefully. Max dose 4 mg once daily.
Severe:
Initial dose 1 mg once daily. Titrate carefully. Max dose 4 mg once daily.
Dialysis:
Not recommended for use in patients on dialysis due to risk of prolonged hypoglycemia. Insulin is generally preferred.
Hepatic Impairment:
Mild:
No specific adjustment needed, but monitor closely.
Moderate:
Initial dose 1 mg once daily. Titrate carefully. Max dose 4 mg once daily.
Severe:
Initial dose 1 mg once daily. Titrate carefully. Max dose 4 mg once daily. Use with caution due to increased risk of hypoglycemia.
Pharmacology
Mechanism of Action
Glimepiride primarily lowers blood glucose by stimulating the release of insulin from functioning pancreatic beta cells. It binds to a specific receptor on the beta cell membrane, leading to closure of ATP-sensitive potassium channels, depolarization of the membrane, and opening of voltage-gated calcium channels. The resulting calcium influx triggers insulin secretion. Glimepiride also appears to have extrapancreatic effects, including increasing peripheral glucose uptake and utilization, and decreasing hepatic glucose production.
Pharmacokinetics
Absorption:
Bioavailability:
100%
Tmax:
2-3 hours
FoodEffect:
Food does not significantly alter absorption, but administration with food may slow absorption slightly.
Distribution:
Vd:
Approximately 8.8 L
ProteinBinding:
Approximately 99.5% (primarily to albumin)
CnssPenetration:
Limited
Elimination:
HalfLife:
5-9 hours (terminal half-life)
Clearance:
Not available (highly protein bound, primarily metabolized)
ExcretionRoute:
Renal (60%) and Fecal (40%)
Unchanged:
<1% (renal)
Pharmacodynamics
OnsetOfAction:
Within 1 hour
PeakEffect:
2-4 hours
DurationOfAction:
Approximately 24 hours
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Severe dizziness or fainting
Shortness of breath
Low blood sugar (hypoglycemia), which may be more likely when taking this medication with other diabetes drugs. Symptoms of low blood sugar include:
+ Dizziness
+ Headache
+ Feeling sleepy or weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other severe skin reactions, characterized by:
- Red, swollen, blistered, or peeling skin
- Skin irritation (with or without fever)
- Red or irritated eyes
- Sores in the mouth, throat, nose, or eyes
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:
Upset stomach
Dizziness, tiredness, or weakness
Headache
Flu-like symptoms
Weight gain
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Severe dizziness or fainting
Shortness of breath
Low blood sugar (hypoglycemia), which may be more likely when taking this medication with other diabetes drugs. Symptoms of low blood sugar include:
+ Dizziness
+ Headache
+ Feeling sleepy or weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other severe skin reactions, characterized by:
- Red, swollen, blistered, or peeling skin
- Skin irritation (with or without fever)
- Red or irritated eyes
- Sores in the mouth, throat, nose, or eyes
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:
Upset stomach
Dizziness, tiredness, or weakness
Headache
Flu-like symptoms
Weight gain
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Symptoms of hypoglycemia (e.g., sweating, shaking, dizziness, confusion, extreme hunger, blurred vision, slurred speech, irritability)
- Symptoms of severe allergic reaction (e.g., rash, hives, swelling of face/lips/tongue, difficulty breathing)
- Symptoms of liver problems (e.g., yellowing of skin or eyes, dark urine, persistent nausea/vomiting, severe stomach pain)
- Unexplained weight gain or swelling (fluid retention)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
A known sulfa allergy.
Acidic blood conditions, such as acidosis.
Type 1 diabetes, as this medication is not intended to treat this condition.
Additionally, please note:
This medication is not suitable for children and should not be administered to pediatric patients.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist.
To ensure safe use, verify that it is acceptable to take this medication with your existing medications and health conditions.
Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
A known sulfa allergy.
Acidic blood conditions, such as acidosis.
Type 1 diabetes, as this medication is not intended to treat this condition.
Additionally, please note:
This medication is not suitable for children and should not be administered to pediatric patients.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist.
To ensure safe use, verify that it is acceptable to take this medication with your existing medications and health conditions.
Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Adhere to the diet and exercise plan recommended by your doctor to minimize the risk of low blood sugar, which can be a serious side effect of this drug. If left untreated, low blood sugar can lead to seizures, loss of consciousness, permanent brain damage, and even death. Consult with your doctor to discuss ways to manage this risk.
Regularly monitor your blood sugar levels as instructed by your doctor to ensure timely detection and treatment of any abnormalities. Individuals with low levels of the enzyme glucose-6-phosphate dehydrogenase (G6PD) may be at increased risk of developing anemia, particularly those of African, South Asian, Middle Eastern, or Mediterranean descent. Your doctor may recommend regular blood tests to monitor your condition, so be sure to follow their instructions and discuss any concerns with them.
Avoid driving if you have recently experienced low blood sugar, as it can significantly impair your ability to operate a vehicle safely, increasing the risk of accidents. Before consuming alcohol, consult with your doctor to understand the potential risks and interactions with this medication.
If you are also taking colesevelam, take it at least 4 hours after taking this drug to minimize potential interactions. Be aware that stress, such as fever, infection, injury, or surgery, can affect blood sugar control, as can changes in physical activity, exercise, or diet. This medication may increase the risk of heart disease-related death, so discuss this potential risk with your doctor.
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. Pregnant or breastfeeding women, or those planning to become pregnant, should consult with their doctor to weigh the benefits and risks of this medication to both themselves and their baby.
Regularly monitor your blood sugar levels as instructed by your doctor to ensure timely detection and treatment of any abnormalities. Individuals with low levels of the enzyme glucose-6-phosphate dehydrogenase (G6PD) may be at increased risk of developing anemia, particularly those of African, South Asian, Middle Eastern, or Mediterranean descent. Your doctor may recommend regular blood tests to monitor your condition, so be sure to follow their instructions and discuss any concerns with them.
Avoid driving if you have recently experienced low blood sugar, as it can significantly impair your ability to operate a vehicle safely, increasing the risk of accidents. Before consuming alcohol, consult with your doctor to understand the potential risks and interactions with this medication.
If you are also taking colesevelam, take it at least 4 hours after taking this drug to minimize potential interactions. Be aware that stress, such as fever, infection, injury, or surgery, can affect blood sugar control, as can changes in physical activity, exercise, or diet. This medication may increase the risk of heart disease-related death, so discuss this potential risk with your doctor.
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. Pregnant or breastfeeding women, or those planning to become pregnant, should consult with their doctor to weigh the benefits and risks of this medication to both themselves and their baby.
Overdose Information
Overdose Symptoms:
- Severe hypoglycemia (e.g., profound weakness, confusion, seizures, loss of consciousness, coma)
What to Do:
Seek immediate medical attention. Ingest fast-acting carbohydrates if conscious. If unconscious, glucagon injection or intravenous glucose may be required. Call 911 or your local emergency number. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Major Interactions
- Bosentan (increased risk of hepatotoxicity)
- Miconazole (oral, severe hypoglycemia)
- Fluconazole (increased glimepiride levels, hypoglycemia)
Moderate Interactions
- Beta-blockers (mask hypoglycemia symptoms, potentiate hypoglycemia)
- NSAIDs (e.g., ibuprofen, naproxen; potentiate hypoglycemia)
- Salicylates (e.g., aspirin; potentiate hypoglycemia)
- Sulfonamides (potentiate hypoglycemia)
- Warfarin (may potentiate or diminish anticoagulant effect)
- Chloramphenicol (potentiate hypoglycemia)
- Probenecid (potentiate hypoglycemia)
- MAOIs (potentiate hypoglycemia)
- Corticosteroids (decrease hypoglycemic effect)
- Thiazide diuretics (decrease hypoglycemic effect)
- Thyroid hormones (decrease hypoglycemic effect)
- Estrogens (decrease hypoglycemic effect)
- Phenytoin (decrease hypoglycemic effect)
- Rifampin (decrease hypoglycemic effect)
- Barbiturates (decrease hypoglycemic effect)
- Alcohol (potentiate or diminish hypoglycemic effect, disulfiram-like reaction)
Minor Interactions
- Chromium (may enhance hypoglycemic effect)
- Garlic (may enhance hypoglycemic effect)
Monitoring
Baseline Monitoring
Fasting Plasma Glucose (FPG)
Rationale: To establish baseline glycemic control and confirm diagnosis of Type 2 Diabetes.
Timing: Prior to initiation of therapy.
Hemoglobin A1c (HbA1c)
Rationale: To establish baseline long-term glycemic control.
Timing: Prior to initiation of therapy.
Renal Function (e.g., eGFR, serum creatinine)
Rationale: To assess kidney function, as glimepiride is renally excreted and dose adjustments are needed in renal impairment.
Timing: Prior to initiation of therapy.
Hepatic Function (e.g., ALT, AST)
Rationale: To assess liver function, as glimepiride is metabolized in the liver and dose adjustments may be needed in hepatic impairment.
Timing: Prior to initiation of therapy.
Routine Monitoring
Fasting Plasma Glucose (FPG)
Frequency: Daily (patient self-monitoring) or at each clinic visit (laboratory)
Target: <130 mg/dL (individualized)
Action Threshold: >130 mg/dL consistently, or signs of hypoglycemia (<70 mg/dL)
Postprandial Glucose (PPG)
Frequency: Periodically (patient self-monitoring)
Target: <180 mg/dL (individualized)
Action Threshold: >180 mg/dL consistently
Hemoglobin A1c (HbA1c)
Frequency: Every 3-6 months
Target: <7% (individualized)
Action Threshold: >7% (or individualized target) consistently
Signs/Symptoms of Hypoglycemia
Frequency: Ongoing (patient education and self-monitoring)
Target: N/A
Action Threshold: Any occurrence of symptoms (e.g., sweating, tremor, confusion, hunger)
Renal Function (e.g., eGFR, serum creatinine)
Frequency: Annually, or more frequently if impairment is present or suspected
Target: Stable, within normal limits or individualized for CKD stage
Action Threshold: Significant decline in eGFR or increase in creatinine
Hepatic Function (e.g., ALT, AST)
Frequency: Periodically, or if symptoms of liver dysfunction occur
Target: Stable, within normal limits
Action Threshold: Significant elevation of liver enzymes
Symptom Monitoring
- Symptoms of hypoglycemia (e.g., sweating, tremor, dizziness, confusion, hunger, irritability, blurred vision, headache, rapid heartbeat)
- Symptoms of hyperglycemia (e.g., increased thirst, increased urination, fatigue, blurred vision)
- Signs of allergic reaction (e.g., rash, itching, hives, swelling of face/lips/tongue)
- Symptoms of liver dysfunction (e.g., unusual fatigue, dark urine, yellowing of skin/eyes, abdominal pain)
Special Patient Groups
Pregnancy
Generally not recommended during pregnancy. Insulin is the preferred treatment for diabetes during pregnancy. Glimepiride is Pregnancy Category C, meaning animal studies have shown an adverse effect on the fetus, but there are no adequate and well-controlled studies in humans. Prolonged severe hypoglycemia has been reported in neonates born to mothers receiving sulfonylureas at the time of delivery.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though human data are limited and conflicting for sulfonylureas.
Second Trimester:
Risk of fetal hypoglycemia, especially if continued close to delivery.
Third Trimester:
High risk of severe and prolonged neonatal hypoglycemia if used near term. Discontinue at least 2 weeks prior to expected delivery.
Lactation
Not recommended during breastfeeding. Glimepiride is excreted into breast milk and has the potential to cause serious adverse effects, including hypoglycemia, in a nursing infant. Insulin is generally preferred for managing diabetes in lactating mothers.
Infant Risk:
High (L4 - Possible hazard)
Pediatric Use
Safety and effectiveness have not been established in pediatric patients. Use is generally not recommended.
Geriatric Use
Use with caution in elderly patients due to increased risk of hypoglycemia, particularly in those with impaired renal or hepatic function. Start with a low dose (1 mg) and titrate slowly. Monitor blood glucose closely.
Clinical Information
Clinical Pearls
- Always take glimepiride with breakfast or the first main meal of the day to minimize the risk of hypoglycemia.
- Educate patients thoroughly on the signs and symptoms of hypoglycemia and how to treat it.
- Patients should carry a source of fast-acting sugar (e.g., glucose tablets, hard candy, fruit juice) at all times.
- Be mindful of drug interactions, especially with other medications that can lower blood sugar or affect glimepiride metabolism (e.g., NSAIDs, fluconazole, beta-blockers).
- Renal and hepatic function should be monitored, and dose adjustments made accordingly to prevent drug accumulation and hypoglycemia.
- Weight gain is a common side effect of sulfonylureas; emphasize lifestyle modifications.
- Consider discontinuing glimepiride and switching to insulin at least 2 weeks prior to planned delivery in pregnant patients.
Alternative Therapies
- Metformin (first-line for most Type 2 Diabetes patients)
- Other Sulfonylureas (e.g., Glipizide, Glyburide)
- DPP-4 Inhibitors (e.g., Sitagliptin, Saxagliptin)
- SGLT2 Inhibitors (e.g., Canagliflozin, Dapagliflozin)
- GLP-1 Receptor Agonists (e.g., Liraglutide, Semaglutide)
- Thiazolidinediones (e.g., Pioglitazone)
- Insulin
Cost & Coverage
Average Cost:
$10 - $30 per 30 tablets (4mg generic)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Preferred Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.