Amaryl 1mg 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 make more insulin, a hormone that lowers blood sugar. It's usually taken once a day with your first main 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, preferably with the first meal of the day if you are taking it once daily. Establish a routine by taking your medication at the same time every day. It's also important to know what to do if you don't eat as much as usual or if you skip a meal.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe 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're unsure about the best way to dispose of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember, with a meal. However, 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 the missed one.
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, preferably with the first meal of the day if you are taking it once daily. Establish a routine by taking your medication at the same time every day. It's also important to know what to do if you don't eat as much as usual or if you skip a meal.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe 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're unsure about the best way to dispose of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember, with a meal. However, 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 the missed one.
Lifestyle & Tips
- Take glimepiride exactly as prescribed, usually once daily with your first main meal.
- Do not skip meals while taking this medication, as it can increase the risk of low blood sugar (hypoglycemia).
- 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.
- Carry a source of fast-acting sugar (e.g., glucose tablets, hard candy, fruit juice) to treat mild hypoglycemia.
- Limit or avoid alcohol consumption, as it can increase the risk of low blood sugar.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Initial dose 1-2 mg once daily with breakfast or first main meal. Maintenance dose typically 1-4 mg once daily. Maximum dose 8 mg once daily.
Dose Range:
1 - 8 mg
Condition-Specific Dosing:
initial:
1-2 mg once daily
maintenance:
1-4 mg once daily
maximum:
8 mg once daily
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Safety and efficacy not established in pediatric patients)
Adolescent:
Not established (Safety and efficacy not established in pediatric patients)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment for mild impairment, but monitor closely.
Moderate:
Initial dose 1 mg once daily. Titrate carefully based on blood glucose response. Maximum dose 4 mg once daily.
Severe:
Initial dose 1 mg once daily. Titrate carefully based on blood glucose response. Maximum dose 4 mg once daily. Use with caution due to increased risk of hypoglycemia.
Dialysis:
Not recommended for use in patients on dialysis due to prolonged half-life and increased risk of hypoglycemia. Insulin is generally preferred.
Hepatic Impairment:
Mild:
Initial dose 1 mg once daily. Titrate carefully based on blood glucose response.
Moderate:
Initial dose 1 mg once daily. Titrate carefully based on blood glucose response. Use with caution due to increased risk of hypoglycemia.
Severe:
Not recommended due to increased risk of hypoglycemia and lack of data. Insulin is generally preferred.
Pharmacology
Mechanism of Action
Glimepiride is a sulfonylurea antidiabetic agent that lowers blood glucose by stimulating the release of insulin from the beta cells of the pancreatic islets. It also appears to increase the sensitivity of peripheral tissues to insulin and decrease hepatic glucose production.
Pharmacokinetics
Absorption:
Bioavailability:
Nearly 100%
Tmax:
2-3 hours
FoodEffect:
Food delays absorption (Tmax increased) but does not significantly affect the extent of absorption (AUC).
Distribution:
Vd:
Approximately 8.8 L
ProteinBinding:
>99.5% (primarily to albumin)
CnssPenetration:
Limited
Elimination:
HalfLife:
5-9 hours (terminal half-life)
Clearance:
Approximately 48 mL/min (total body clearance)
ExcretionRoute:
Renal (approximately 60%) and Fecal (approximately 40%)
Unchanged:
<1%
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
+ Difficulty 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
If you experience any of these symptoms, contact your doctor right away and follow their instructions for managing low blood sugar, which may include taking glucose tablets, liquid glucose, or some fruit juices.
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other severe skin reactions
Seek medical help immediately if you notice:
+ 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
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:
Upset stomach
Feeling dizzy, tired, or weak
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, 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
+ Difficulty 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
If you experience any of these symptoms, contact your doctor right away and follow their instructions for managing low blood sugar, which may include taking glucose tablets, liquid glucose, or some fruit juices.
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other severe skin reactions
Seek medical help immediately if you notice:
+ 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
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:
Upset stomach
Feeling dizzy, tired, or weak
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, 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, shaking, fast heartbeat, dizziness, hunger, confusion, irritability, blurred vision. If these occur, consume a quick source of sugar.
- Symptoms of high blood sugar (hyperglycemia): increased thirst, frequent urination, fatigue, blurred vision. Report these to your doctor.
- Signs of allergic reaction: rash, itching, swelling (especially of face/tongue/throat), severe dizziness, trouble breathing. Seek immediate medical attention.
- Unusual bruising or bleeding, signs of infection (fever, sore throat), yellowing of skin or eyes (jaundice), dark urine, pale stools (signs of liver problems).
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 those that affect your blood's pH balance.
Type 1 diabetes, as this medication is not intended to treat this condition.
Additionally, consider the following:
This medication is not suitable for children. Do not administer it to a child.
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 all your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without 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 those that affect your blood's pH balance.
Type 1 diabetes, as this medication is not intended to treat this condition.
Additionally, consider the following:
This medication is not suitable for children. Do not administer it to a child.
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 all your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without 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 recently 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 minimize 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.
There is evidence suggesting that this medication may increase the risk of death from heart disease. Discuss this potential risk with your doctor to determine the best course of treatment for your specific situation. 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 with you to ensure the best possible outcome for 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 recently 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 minimize 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.
There is evidence suggesting that this medication may increase the risk of death from heart disease. Discuss this potential risk with your doctor to determine the best course of treatment for your specific situation. 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 with you to ensure the best possible outcome for both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe hypoglycemia (prolonged and severe low blood sugar)
- Loss of consciousness
- Seizures
- Coma
What to Do:
Immediately consume a source of sugar. If the person is unconscious or having seizures, do NOT give anything by mouth. Call 911 or emergency medical services. Emergency treatment may include intravenous glucose or glucagon injection. Call 1-800-222-1222 (Poison Control Center) for advice.
Drug Interactions
Contraindicated Interactions
- Bosentan (increased risk of hepatotoxicity)
Major Interactions
- Beta-blockers (mask hypoglycemia symptoms, enhance hypoglycemic effect)
- Fluconazole (increases glimepiride AUC and Cmax, leading to increased risk of hypoglycemia)
- Warfarin (may potentiate or weaken anticoagulant effect)
- Rifampin (decreases glimepiride exposure, reducing efficacy)
- Thiazide diuretics and other diuretics (may cause hyperglycemia, reducing glimepiride efficacy)
- Corticosteroids (may cause hyperglycemia, reducing glimepiride efficacy)
- Sympathomimetics (may cause hyperglycemia, reducing glimepiride efficacy)
- Phenytoin (may alter glucose control)
- Sulfonamides (potentiate hypoglycemic effect)
- NSAIDs (potentiate hypoglycemic effect)
- Salicylates (potentiate hypoglycemic effect)
- MAOIs (potentiate hypoglycemic effect)
- Chloramphenicol (potentiate hypoglycemic effect)
- Probenecid (potentiate hypoglycemic effect)
- Coumarin derivatives (potentiate hypoglycemic effect)
- Anabolic steroids (potentiate hypoglycemic effect)
- Cyclophosphamide (potentiate hypoglycemic effect)
- Disopyramide (potentiate hypoglycemic effect)
- Fibrates (potentiate hypoglycemic effect)
- Tetracyclines (potentiate hypoglycemic effect)
- Quinolones (may cause dysglycemia)
Moderate Interactions
- Alcohol (potentiates hypoglycemic effect)
- Cimetidine (may increase glimepiride levels)
- Ranitidine (may increase glimepiride levels)
- Digoxin (glimepiride may increase digoxin levels)
- Oral contraceptives (may reduce glimepiride efficacy)
- Thyroid hormones (may reduce glimepiride efficacy)
- Laxatives (chronic use may reduce glimepiride efficacy)
- Nicotinic acid (may reduce glimepiride efficacy)
- Estrogens (may reduce glimepiride efficacy)
- Phenothiazines (may reduce glimepiride efficacy)
Minor Interactions
- Not available (most interactions are moderate to major due to hypoglycemia risk)
Monitoring
Baseline Monitoring
Fasting Plasma Glucose (FPG)
Rationale: To establish baseline glycemic control and confirm diagnosis of Type 2 Diabetes Mellitus.
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., SCr, eGFR)
Rationale: To assess kidney function as glimepiride is partially 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 primarily metabolized in the liver and dose adjustments are needed in hepatic impairment.
Timing: Prior to initiation of therapy.
Routine Monitoring
Fasting Plasma Glucose (FPG)
Frequency: Daily (self-monitoring) or at each clinic visit
Target: 80-130 mg/dL (individualized)
Action Threshold: <70 mg/dL (hypoglycemia) or consistently >180 mg/dL (hyperglycemia)
Postprandial Glucose (PPG)
Frequency: Periodically (self-monitoring) or as directed by physician
Target: <180 mg/dL (individualized)
Action Threshold: Consistently >200 mg/dL
Hemoglobin A1c (HbA1c)
Frequency: Every 3-6 months
Target: <7% (individualized)
Action Threshold: >7% (consider dose adjustment or additional therapy)
Renal Function (e.g., SCr, eGFR)
Frequency: Annually or more frequently if clinically indicated (e.g., in elderly or with comorbidities)
Target: Stable, within normal limits for age/sex
Action Threshold: Significant decline in eGFR (consider dose adjustment or discontinuation)
Hepatic Function (e.g., ALT, AST)
Frequency: Annually or more frequently if clinically indicated
Target: Stable, within normal limits
Action Threshold: Significant elevation (consider discontinuation)
Symptom Monitoring
- Symptoms of hypoglycemia (e.g., sweating, tremor, dizziness, confusion, hunger, irritability, blurred vision, rapid heartbeat)
- Symptoms of hyperglycemia (e.g., increased thirst, increased urination, fatigue, blurred vision)
- Signs of allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing)
- Unexplained weight gain or swelling (fluid retention)
Special Patient Groups
Pregnancy
Category C. Not recommended for use during pregnancy. Insulin is generally preferred for glycemic control in pregnant women with diabetes due to the potential for prolonged severe hypoglycemia in the neonate with sulfonylureas.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity not definitively established, but generally avoided.
Second Trimester:
Risk of neonatal hypoglycemia if used near term.
Third Trimester:
High risk of severe neonatal hypoglycemia if used near term, due to prolonged half-life and placental transfer.
Lactation
L3 (Probably Compatible). Glimepiride is excreted into breast milk. Due to the potential for hypoglycemia in the nursing infant, use is generally not recommended. Insulin is preferred for glycemic control in lactating women.
Infant Risk:
Risk of hypoglycemia in the infant. Monitor infant for signs of hypoglycemia (e.g., lethargy, poor feeding, jitteriness).
Pediatric Use
Safety and efficacy have not been established in pediatric patients. Use is 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 and titrate slowly. Monitor blood glucose closely.
Clinical Information
Clinical Pearls
- Always take glimepiride with the first main meal of the day to minimize the risk of hypoglycemia.
- Educate patients thoroughly on the symptoms and management of hypoglycemia.
- Consider lower starting doses and slower titration in elderly patients or those with renal/hepatic impairment.
- Glimepiride has a relatively long duration of action (up to 24 hours), allowing for once-daily dosing.
- Be aware of drug interactions, especially with other medications that can affect blood glucose levels (e.g., beta-blockers, corticosteroids, fluconazole).
- Regular monitoring of HbA1c, FPG, and renal/hepatic function is crucial.
Alternative Therapies
- Metformin (first-line for most Type 2 DM patients)
- DPP-4 inhibitors (e.g., sitagliptin, saxagliptin)
- SGLT2 inhibitors (e.g., empagliflozin, canagliflozin)
- GLP-1 receptor agonists (e.g., liraglutide, semaglutide)
- Thiazolidinediones (e.g., pioglitazone)
- Insulin therapy
Cost & Coverage
Average Cost:
$10 - $30 per 30 tablets (generic 1mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's 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 be sure to check with your pharmacist for more details. If you have any questions or concerns about this medication, don't hesitate to reach out to 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 seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.