Amaryl 2mg Tablets
It is used to lower blood sugar in patients with high blood sugar (diabetes).
Drug Class
Antidiabetic Agent
Pharmacologic Class
Sulfonylurea
Pregnancy Category
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, a hormone that lowers blood sugar. It also helps your body use insulin more effectively. It's usually taken once a day with your first main meal.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow these guidelines:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
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 or skip a meal, be aware of how this may affect your medication and know what to do in these situations.
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 the bathroom.
Keep all medications in a 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.
If you are unsure about the best way to dispose of your medication, consult your pharmacist. You may also have access to 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 is close to the time for your next scheduled dose, skip the missed dose and continue with 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 ensure you get the most benefit from your medication, follow these guidelines:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
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 or skip a meal, be aware of how this may affect your medication and know what to do in these situations.
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 the bathroom.
Keep all medications in a 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.
If you are unsure about the best way to dispose of your medication, consult your pharmacist. You may also have access to 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 is close to the time for your next scheduled dose, skip the missed dose and continue with 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 balanced diet as 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.
- Do not skip meals, especially after taking your medication, to avoid low blood sugar (hypoglycemia).
- Carry a source of fast-acting sugar (e.g., glucose tablets, hard candy, fruit juice) to treat low blood sugar.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Initial: 1-2 mg once daily with breakfast or first main meal. Maintenance: 1-4 mg once daily. Max: 8 mg once daily.
Dose Range:
1 - 8 mg
Condition-Specific Dosing:
Type 2 Diabetes Mellitus:
Initial 1-2 mg once daily; titrate in increments of 1-2 mg at 1-2 week intervals based on blood glucose response. Max 8 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed, but monitor closely.
Moderate:
Initial 1 mg once daily; titrate carefully. Max 4 mg/day.
Severe:
Initial 1 mg once daily; titrate carefully. Max 4 mg/day.
Dialysis:
Use with caution; consider alternative agents or close monitoring due to increased risk of hypoglycemia.
Hepatic Impairment:
Mild:
No specific adjustment needed, but monitor closely.
Moderate:
Initial 1 mg once daily; titrate carefully. Increased risk of hypoglycemia.
Severe:
Initial 1 mg once daily; titrate carefully. Increased risk of hypoglycemia; consider alternative agents.
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 influx of calcium triggers insulin secretion. It also has extrapancreatic effects, including increased peripheral glucose uptake and decreased hepatic glucose production.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 100%
Tmax:
2-3 hours
FoodEffect:
Food delays absorption but does not significantly affect the extent of absorption (AUC).
Distribution:
Vd:
Approximately 11.3 L
ProteinBinding:
>99.5% (primarily to albumin)
CnssPenetration:
Limited
Elimination:
HalfLife:
5-9 hours (terminal elimination half-life)
Clearance:
Not available
ExcretionRoute:
Renal (approximately 60%) and fecal (approximately 40%)
Unchanged:
<1% (renal)
Pharmacodynamics
OnsetOfAction:
Approximately 1 hour
PeakEffect:
2-4 hours
DurationOfAction:
Up to 24 hours
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
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 immediate medical attention:
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 to occur 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
+ Signs of severe skin reactions include:
- Red, swollen, blistered, or peeling skin
- Other skin irritation (with or without fever)
- Red or irritated eyes
- Sores in your mouth, throat, nose, or eyes
Other Possible Side Effects
Most people taking this medication will not experience serious side effects, and some may not have any side effects at all. However, if you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
Upset stomach
Feeling dizzy, tired, or weak
Headache
Flu-like symptoms
Weight gain
Reporting Side Effects
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact 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 immediate medical attention:
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 to occur 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
+ Signs of severe skin reactions include:
- Red, swollen, blistered, or peeling skin
- Other skin irritation (with or without fever)
- Red or irritated eyes
- Sores in your mouth, throat, nose, or eyes
Other Possible Side Effects
Most people taking this medication will not experience serious side effects, and some may not have any side effects at all. However, if you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
Upset stomach
Feeling dizzy, tired, or weak
Headache
Flu-like symptoms
Weight gain
Reporting Side Effects
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact 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 low blood sugar (hypoglycemia): sweating, shakiness, dizziness, confusion, hunger, irritability, headache, blurred vision, rapid heartbeat. If these occur, consume a fast-acting sugar source immediately.
- Symptoms of high blood sugar (hyperglycemia): increased thirst, frequent urination, fatigue, blurred vision. Report these to your doctor.
- Signs of allergic reaction: rash, itching, hives, swelling of your face, lips, tongue, or throat, difficulty breathing. Seek immediate medical attention.
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 allergic reaction you experienced.
A known sulfa allergy.
A condition that affects the acidity of your blood.
If you have type 1 diabetes, as this medication is not intended to treat this condition.
Additionally, please note that:
This medication is not suitable for children and should not be administered to them.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist.
To ensure your safety, you must verify that it is acceptable to take this medication with all your other 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 allergic reaction you experienced.
A known sulfa allergy.
A condition that affects the acidity of your blood.
If you have type 1 diabetes, as this medication is not intended to treat this condition.
Additionally, please note that:
This medication is not suitable for children and should not be administered to them.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist.
To ensure your safety, you must verify that it is acceptable to take this medication with all your other 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 lead to severe consequences such as seizures, loss of consciousness, permanent brain damage, and even death. Regularly monitor your blood sugar levels as instructed by your doctor.
If you have a deficiency of the enzyme glucose-6-phosphate dehydrogenase (G6PD), you may be at a higher risk of developing anemia. This deficiency is more common in individuals of African, South Asian, Middle Eastern, and Mediterranean descent. Your doctor will likely 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 experienced low blood sugar, as it can significantly increase your risk of being involved in an accident. Additionally, consult your doctor before consuming alcohol, as it may interact with your medication.
If you are also taking colesevelam, take it at least 4 hours after taking this medication to avoid any potential interactions. Be aware that your blood sugar control may be affected during periods of stress, such as illness, infection, injury, or surgery, as well as changes in your physical activity, exercise routine, or diet.
This medication may increase the risk of death from heart disease, so discuss this potential risk with your doctor. If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as they will need to discuss the potential benefits and risks of this medication to both you and your baby.
If you have a deficiency of the enzyme glucose-6-phosphate dehydrogenase (G6PD), you may be at a higher risk of developing anemia. This deficiency is more common in individuals of African, South Asian, Middle Eastern, and Mediterranean descent. Your doctor will likely 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 experienced low blood sugar, as it can significantly increase your risk of being involved in an accident. Additionally, consult your doctor before consuming alcohol, as it may interact with your medication.
If you are also taking colesevelam, take it at least 4 hours after taking this medication to avoid any potential interactions. Be aware that your blood sugar control may be affected during periods of stress, such as illness, infection, injury, or surgery, as well as changes in your physical activity, exercise routine, or diet.
This medication may increase the risk of death from heart disease, so discuss this potential risk with your doctor. If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as they will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe hypoglycemia (extremely low blood sugar)
- Confusion
- Slurred speech
- Seizures
- Loss of consciousness
- Coma
What to Do:
Immediately consume a source of fast-acting sugar. If the person is unconscious or unable to swallow, call 911 or your local emergency number. Call 1-800-222-1222 (Poison Control Center) for further advice.
Drug Interactions
Major Interactions
- Bosentan (increased risk of hepatotoxicity)
- Miconazole (oral, IV, topical) - significantly enhances hypoglycemic effect
- Fluconazole (significantly enhances hypoglycemic effect)
Moderate Interactions
- Beta-blockers (may mask symptoms of hypoglycemia)
- NSAIDs (e.g., ibuprofen, naproxen - may enhance hypoglycemic effect)
- Sulfonamides (e.g., sulfamethoxazole/trimethoprim - may enhance hypoglycemic effect)
- Chloramphenicol (may enhance hypoglycemic effect)
- Coumarin derivatives (e.g., warfarin - may enhance or diminish anticoagulant effect)
- MAOIs (may enhance hypoglycemic effect)
- Corticosteroids (may decrease hypoglycemic effect)
- Thiazide diuretics (may decrease hypoglycemic effect)
- Thyroid hormones (may decrease hypoglycemic effect)
- Sympathomimetics (e.g., epinephrine, albuterol - may decrease hypoglycemic effect)
- Rifampin (may decrease hypoglycemic effect)
- Colesevelam (may decrease glimepiride absorption; administer glimepiride at least 4 hours before colesevelam)
Minor Interactions
- Alcohol (may potentiate or attenuate hypoglycemic effect)
Monitoring
Baseline Monitoring
HbA1c
Rationale: To establish baseline glycemic control and guide initial dosing.
Timing: Prior to initiation of therapy
Fasting Plasma Glucose (FPG)
Rationale: To establish baseline glycemic control and guide initial dosing.
Timing: Prior to initiation of therapy
Renal Function (e.g., eGFR, serum creatinine)
Rationale: To assess kidney function for appropriate dosing adjustments and to identify patients at higher risk for hypoglycemia.
Timing: Prior to initiation of therapy
Hepatic Function (e.g., ALT, AST)
Rationale: To assess liver function for appropriate dosing adjustments and to identify patients at higher risk for hypoglycemia.
Timing: Prior to initiation of therapy
Routine Monitoring
HbA1c
Frequency: Every 3-6 months (or more frequently if glycemic control is not at goal or therapy is changed)
Target: <7% (individualized based on patient factors)
Action Threshold: >7% (consider dose adjustment or addition of other agents)
Fasting Plasma Glucose (FPG)
Frequency: Daily (patient self-monitoring) or periodically in clinic
Target: 80-130 mg/dL
Action Threshold: <70 mg/dL (hypoglycemia, requires intervention); >180 mg/dL (hyperglycemia, consider dose adjustment)
Symptoms of Hypoglycemia
Frequency: Ongoing patient self-monitoring
Target: N/A
Action Threshold: Any occurrence of symptoms (e.g., sweating, tremor, confusion, hunger, dizziness) requires immediate action (consume fast-acting carbohydrate).
Renal Function
Frequency: Annually or more frequently if clinically indicated (e.g., in elderly or those with comorbidities)
Target: Stable eGFR
Action Threshold: Significant decline in eGFR (consider dose reduction or discontinuation)
Symptom Monitoring
- Symptoms of hypoglycemia: sweating, tremor, dizziness, confusion, hunger, irritability, headache, blurred vision, rapid heartbeat, anxiety, weakness, slurred speech, seizures, loss of consciousness.
- Symptoms of hyperglycemia (if control is poor): increased thirst, increased urination, fatigue, blurred vision.
- Signs of allergic reaction: rash, itching, hives, swelling of face/lips/tongue/throat, difficulty breathing.
Special Patient Groups
Pregnancy
Category C. Not recommended during pregnancy. Insulin is generally preferred for glycemic control in pregnant women with diabetes due to better safety profile and ability to cross the placenta.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though data are limited.
Second Trimester:
Risk of fetal hyperinsulinemia and hypoglycemia at birth.
Third Trimester:
Risk of fetal hyperinsulinemia and hypoglycemia at birth.
Lactation
Not recommended during breastfeeding. Sulfonylureas are excreted into breast milk and may cause hypoglycemia in the nursing infant.
Infant Risk:
High risk of hypoglycemia in the infant.
Pediatric Use
Safety and efficacy have not been established in pediatric patients. Use is generally not recommended.
Geriatric Use
Use with caution. Elderly patients are at increased risk for hypoglycemia due to potential for impaired renal/hepatic function, polypharmacy, and reduced counter-regulatory responses. Start with a low dose (1 mg) and titrate slowly with careful monitoring.
Clinical Information
Clinical Pearls
- Glimepiride should be taken with breakfast or the first main meal of the day to minimize the risk of hypoglycemia.
- Patients should be educated on the symptoms of hypoglycemia and how to treat it immediately.
- Alcohol consumption can increase the risk of hypoglycemia when taking glimepiride.
- Regular monitoring of blood glucose and HbA1c is crucial to assess efficacy and safety.
- Dose adjustments are necessary in patients with renal or hepatic impairment.
- Consider alternative agents or closer monitoring in elderly patients due to increased hypoglycemia risk.
Alternative Therapies
- Metformin (first-line for most Type 2 DM patients)
- Other sulfonylureas (e.g., glipizide, glyburide)
- DPP-4 inhibitors (e.g., sitagliptin, saxagliptin)
- GLP-1 receptor agonists (e.g., liraglutide, semaglutide)
- SGLT2 inhibitors (e.g., empagliflozin, dapagliflozin)
- Thiazolidinediones (e.g., pioglitazone, rosiglitazone)
- Insulin therapy
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 per 30 tablets (generic 2mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 (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's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't 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 medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.