Glimepiride 1mg Tablets

Manufacturer DR.REDDY'S Active Ingredient Glimepiride(GLYE me pye ride) Pronunciation GLYE me pye ride
It is used to lower blood sugar in patients with high blood sugar (diabetes).
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Drug Class
Antidiabetic agent
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Pharmacologic Class
Sulfonylurea
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Pregnancy Category
Category C
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FDA Approved
Dec 1995
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Glimepiride is a medication used to treat type 2 diabetes. It helps your body produce more insulin from your pancreas, which then helps lower your blood sugar levels. It's usually taken once a day with your first main meal.
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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 skipping a meal or not eating as much as usual, be sure to ask your doctor for guidance on how to adjust your medication schedule.

Storing and Disposing of Your Medication

To maintain the effectiveness 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 by your pharmacist or healthcare provider.
Check with your pharmacist for guidance on the best way to dispose of your medication. You may also want to explore 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.
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 a missed dose.
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Lifestyle & Tips

  • Take glimepiride exactly as prescribed, usually once daily with breakfast or the first main meal.
  • Do not skip meals, as this 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 glucose levels regularly as instructed by your doctor.
  • Carry a source of fast-acting sugar (e.g., glucose tablets, hard candy, fruit juice) to treat mild to moderate hypoglycemia.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking, as they can interact with glimepiride.
  • Limit or avoid alcohol consumption, as it can increase the risk of hypoglycemia.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 1-2 mg orally once daily with breakfast or first main meal
Dose Range: 1 - 8 mg

Condition-Specific Dosing:

initial_dose: 1-2 mg once daily
maintenance_dose: 1-4 mg once daily
maximum_dose: 8 mg once daily
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
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Dose Adjustments

Renal Impairment:

Mild: No initial dose adjustment required, but monitor closely.
Moderate: Initial dose 1 mg once daily, titrate carefully. Max 4 mg/day.
Severe: Initial dose 1 mg once daily, titrate carefully. Max 4 mg/day. Avoid if GFR < 22 mL/min.
Dialysis: Not recommended for use in dialysis patients due to risk of hypoglycemia and lack of data.

Hepatic Impairment:

Mild: No specific adjustment, but monitor closely.
Moderate: Initial dose 1 mg once daily, titrate carefully. Increased risk of hypoglycemia.
Severe: Initial dose 1 mg once daily, titrate carefully. Increased risk of hypoglycemia. Use with caution or avoid.

Pharmacology

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Mechanism of Action

Glimepiride 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 influx of calcium triggers insulin secretion. Glimepiride also appears to have extrapancreatic effects, including increased peripheral glucose uptake and utilization, and decreased hepatic glucose production.
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Pharmacokinetics

Absorption:

Bioavailability: 100%
Tmax: 2-3 hours
FoodEffect: Food does not significantly alter absorption, but administration with food is recommended to minimize gastrointestinal upset and reduce the risk of hypoglycemia.

Distribution:

Vd: Approximately 8.8 L
ProteinBinding: Approximately 99.5% (primarily to albumin)
CnssPenetration: Limited

Elimination:

HalfLife: 5-9 hours (terminal half-life)
Clearance: Approximately 22 mL/min
ExcretionRoute: Renal (60%) and Fecal (40%)
Unchanged: <1% (renal)
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Pharmacodynamics

OnsetOfAction: Within 1 hour
PeakEffect: 2-4 hours
DurationOfAction: Approximately 24 hours

Safety & Warnings

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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
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. If you notice any of the following side effects, or if they bother you or do not go away, contact your doctor:

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.
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Seek Immediate Medical Attention If You Experience:

  • Symptoms of low blood sugar (hypoglycemia): sweating, shakiness, dizziness, confusion, hunger, irritability, headache, blurred vision, rapid heartbeat, anxiety, weakness. If these occur, consume a quick source of sugar and notify your doctor.
  • Symptoms of allergic reaction: rash, itching, swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. Seek immediate medical attention.
  • Symptoms of liver problems: yellowing of skin or eyes (jaundice), dark urine, persistent nausea/vomiting, severe stomach pain. Contact your doctor immediately.
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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 problems, such as acidosis.
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 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 issues 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 consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. To manage your condition effectively, follow the diet and exercise plan recommended by your doctor.

Be aware that this drug can cause low blood sugar, which may lead to severe complications, including seizures, loss of consciousness, permanent brain damage, and even death. Consult your doctor to discuss ways to prevent and manage low blood sugar. Regularly check 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. Individuals of African, South Asian, Middle Eastern, and Mediterranean descent are more likely to have low G6PD levels. Your doctor will monitor your condition through regular blood tests, 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 increase your risk of being involved in an accident. Before consuming alcohol, consult your doctor to understand the potential risks and interactions with this medication.

If you are 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 your blood sugar control. Changes in physical activity, exercise, or diet can also impact your blood sugar levels.

This medication may increase the risk of death from heart disease. Discuss this potential risk with your doctor to understand the benefits and risks associated with this medication. If you are 65 or older, use this drug with caution, as you may be more susceptible to side effects.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. They will help you weigh the benefits and risks of taking this medication to ensure the best possible outcome for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe hypoglycemia (extremely low blood sugar)
  • Confusion
  • Slurred speech
  • Seizures
  • Loss of consciousness
  • Coma

What to Do:

In case of suspected overdose, immediately seek emergency medical attention. Call 911 or your local poison control center (e.g., 1-800-222-1222 in the US). Treatment involves administering glucose (oral for conscious patients, IV dextrose or glucagon for unconscious patients) and close monitoring of blood glucose levels for an extended period due to the prolonged action of glimepiride.

Drug Interactions

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Major Interactions

  • Bosentan (increased risk of hepatotoxicity)
  • Miconazole (oral, severe hypoglycemia)
  • Fluconazole (increased glimepiride levels, severe hypoglycemia)
  • Other sulfonylureas (additive effects, increased hypoglycemia risk)
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Moderate Interactions

  • Beta-blockers (mask hypoglycemia symptoms, impair glucose recovery)
  • NSAIDs (enhance hypoglycemic effect)
  • Salicylates (enhance hypoglycemic effect)
  • Warfarin (potential for altered INR)
  • Corticosteroids (hyperglycemic effect, may require dose adjustment of glimepiride)
  • Thiazide diuretics (hyperglycemic effect, may require dose adjustment of glimepiride)
  • Alcohol (potentiates hypoglycemic effect, disulfiram-like reaction possible)
  • Chloramphenicol (enhances hypoglycemic effect)
  • Clofibrate (enhances hypoglycemic effect)
  • Probenecid (enhances hypoglycemic effect)
  • Sulfonamides (enhances hypoglycemic effect)
  • MAO inhibitors (enhances hypoglycemic effect)
  • ACE inhibitors (enhances hypoglycemic effect)
  • Sympathomimetics (e.g., epinephrine, albuterol - hyperglycemic effect)
  • Thyroid hormones (hyperglycemic effect)
  • Oral contraceptives (hyperglycemic effect)
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Minor Interactions

  • Certain herbal supplements (e.g., ginseng, fenugreek, bitter melon - may have additive hypoglycemic effects)

Monitoring

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Baseline Monitoring

HbA1c (Glycated Hemoglobin)

Rationale: To establish baseline glycemic control and guide initial therapy.

Timing: Prior to initiation of therapy

Fasting Plasma Glucose (FPG)

Rationale: To establish baseline glycemic control and guide initial therapy.

Timing: Prior to initiation of therapy

Renal Function (e.g., eGFR, creatinine)

Rationale: To assess kidney function as glimepiride is renally excreted and dose adjustments are needed in 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 are needed in impairment.

Timing: Prior to initiation of therapy

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Routine Monitoring

HbA1c

Frequency: Every 3-6 months

Target: <7% (individualized based on patient factors)

Action Threshold: >7% (consider dose adjustment or additional therapy)

Fasting Plasma Glucose (FPG)

Frequency: Daily (patient self-monitoring) or periodically in clinic

Target: 80-130 mg/dL (individualized)

Action Threshold: <70 mg/dL (hypoglycemia), >180 mg/dL (hyperglycemia)

Postprandial Glucose (PPG)

Frequency: Periodically (patient self-monitoring)

Target: <180 mg/dL (1-2 hours after meal)

Action Threshold: >180 mg/dL

Signs and Symptoms of Hypoglycemia

Frequency: Ongoing patient education and monitoring

Target: N/A

Action Threshold: Any occurrence of symptoms (e.g., sweating, tremor, confusion, hunger)

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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 glycemic control is poor): increased thirst, increased urination, fatigue, blurred vision.

Special Patient Groups

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Pregnancy

Glimepiride is classified as Pregnancy Category C. It is generally not recommended for use during pregnancy due to the potential for fetal hypoglycemia. Insulin is typically the preferred treatment for diabetes during pregnancy.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity, though data are limited. Risk of hypoglycemia in mother.
Second Trimester: Risk of maternal hypoglycemia. Fetal hyperinsulinemia and hypoglycemia are concerns, especially if used near term.
Third Trimester: High risk of severe neonatal hypoglycemia if used near term, as glimepiride can cross the placenta and stimulate fetal insulin secretion.
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Lactation

Glimepiride is not recommended during breastfeeding. It is excreted into breast milk and has the potential to cause hypoglycemia in the breastfed infant. Insulin or other antidiabetic agents with better safety profiles during lactation are preferred.

Infant Risk: Moderate risk (L3). Potential for hypoglycemia in the infant. Monitor infant for signs of hypoglycemia (e.g., lethargy, poor feeding, jitteriness).
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Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Use is generally not recommended in children due to increased risk of hypoglycemia and lack of long-term data.

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Geriatric Use

Use with caution in elderly patients. They may be more susceptible to the hypoglycemic effects of glimepiride due to impaired renal function, polypharmacy, and reduced counter-regulatory responses. Start with a low dose (1 mg) and titrate slowly, monitoring closely for hypoglycemia.

Clinical Information

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Clinical Pearls

  • Always take glimepiride with breakfast or the first main meal to reduce the risk of hypoglycemia.
  • Educate patients thoroughly on the symptoms of hypoglycemia and how to treat it immediately.
  • Patients should carry a source of fast-acting sugar at all times.
  • Renal and hepatic function should be assessed before starting therapy and monitored periodically.
  • Be aware of drug interactions, especially with other medications that can affect blood glucose levels (e.g., beta-blockers, NSAIDs, corticosteroids).
  • Glimepiride has a long duration of action (24 hours), allowing for once-daily dosing, but also means hypoglycemia can be prolonged.
  • Consider switching to insulin during pregnancy or lactation due to risks to the fetus/infant.
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Alternative Therapies

  • Other Sulfonylureas (e.g., Glipizide, Glyburide)
  • Biguanides (e.g., Metformin)
  • 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, Rosiglitazone)
  • Meglitinides (e.g., Repaglinide, Nateglinide)
  • Insulin therapy
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets (generic 1mg)
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic)
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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 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.