Glimepiride 2mg 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
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 help people with type 2 diabetes control their blood sugar. It works by helping your pancreas release more insulin, which is a natural hormone that lowers blood sugar. 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 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 effectiveness and safety of your medication:

Store it at room temperature in a dry place, avoiding bathrooms and areas prone to moisture.
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 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 by your doctor.
  • Carry a source of fast-acting sugar (e.g., glucose tablets, hard candy, fruit juice) to treat mild to moderate low blood sugar.
  • 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: Initial: 1-2 mg orally once daily with breakfast or first main meal. Maintenance: 1-4 mg orally once daily. Maximum: 8 mg orally once daily.
Dose Range: 1 - 8 mg

Condition-Specific Dosing:

initial_therapy: Start with 1-2 mg once daily. Increase dose by 1-2 mg at 1-2 week intervals based on blood glucose response.
maintenance_therapy: Typical maintenance dose is 1-4 mg once daily. Doses above 4 mg daily result in only modest additional effect.
maximum_dose: Do not exceed 8 mg once daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not generally recommended. Safety and efficacy not established for children under 18 years of age. Some studies have explored use in adolescents (8-17 years), but it is not a first-line agent.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment required, but monitor closely.
Moderate: Initial dose of 1 mg once daily. Titrate carefully based on blood glucose response and renal function. Avoid if GFR < 22 mL/min.
Severe: Initial dose of 1 mg once daily. Titrate carefully. Avoid if GFR < 22 mL/min. Increased risk of hypoglycemia.
Dialysis: Not recommended for use in dialysis patients due to increased risk of hypoglycemia and prolonged half-life of active metabolites.

Hepatic Impairment:

Mild: Initial dose of 1 mg once daily. Titrate carefully.
Moderate: Initial dose of 1 mg once daily. Titrate carefully. Increased risk of hypoglycemia.
Severe: Initial dose of 1 mg once daily. Titrate carefully. Increased risk of hypoglycemia. Use with extreme caution or avoid.

Pharmacology

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Mechanism of Action

Glimepiride lowers blood glucose by stimulating the release of insulin from the beta cells of the pancreatic islets. It binds to the sulfonylurea receptor (SUR1) on the pancreatic beta-cell membrane, leading to the closure of ATP-sensitive potassium channels. This depolarization of the beta-cell membrane opens voltage-gated calcium channels, resulting in an influx of calcium and subsequent exocytosis of insulin.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 100%
Tmax: 2-3 hours
FoodEffect: Food slightly delays absorption 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: Not readily available as a single rate; primarily hepatic metabolism and renal/fecal excretion.
ExcretionRoute: Approximately 60% via urine (as metabolites) and 40% via feces (as metabolites).
Unchanged: <1%
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Pharmacodynamics

OnsetOfAction: Within 1 hour
PeakEffect: 2-4 hours
DurationOfAction: Up to 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 when taking this medication. If you notice any of the following signs or 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 when this medication is used with other diabetes medications. Symptoms may 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, such as:
- 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 attention:

Upset stomach
Dizziness, tiredness, or weakness
Headache
Flu-like symptoms
Weight gain

Reporting Side Effects

This list is not exhaustive, and you may experience other 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.
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Seek Immediate Medical Attention If You Experience:

  • Symptoms of low blood sugar (hypoglycemia): sweating, shakiness, dizziness, confusion, hunger, irritability, rapid heartbeat, blurred vision, headache, weakness, slurred speech. If these occur, consume a quick source of sugar and notify your doctor.
  • Symptoms of allergic reaction: rash, itching, hives, swelling of the face, lips, tongue, or throat, difficulty 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:

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 safe use, verify that it is acceptable to take this medication with all your other medications and health conditions.
Do not initiate, discontinue, or adjust the dosage of any medication without first 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. Adhere to the diet and exercise plan recommended by your doctor to minimize the risk of low blood sugar, which can be a side effect of this drug. If left untreated, low blood sugar can lead to severe complications, including seizures, loss of consciousness, permanent brain damage, and even death. Consult with your doctor to discuss ways to manage this risk.

Regularly check your blood sugar levels as instructed by your doctor to monitor your condition. Additionally, if you have a deficiency of the enzyme glucose-6-phosphate dehydrogenase (G6PD), you may be at a higher risk of developing anemia. This enzyme deficiency is more common in individuals of African, South Asian, Middle Eastern, and 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 increase your risk of being involved in an accident. Also, consult with your doctor before consuming alcohol, as it may interact 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 certain situations, such as fever, infection, injury, or surgery, can make it more challenging to control your blood sugar levels. Changes in your physical activity, exercise routine, or diet can also affect your blood sugar levels. Inform your doctor if you experience any of these situations, as they may need to adjust your treatment plan.

This medication may increase the risk of death from heart disease, 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 discuss the potential benefits and risks of this medication to both the mother and the baby.
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Overdose Information

Overdose Symptoms:

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

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. If the person is conscious, administer oral glucose (e.g., glucose tablets, sugary drink). If unconscious, do NOT give anything by mouth; emergency medical personnel may administer intravenous glucose or glucagon. Monitor blood glucose levels closely for at least 24-48 hours due to the potential for recurrent hypoglycemia.

Drug Interactions

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Contraindicated Interactions

  • Oral miconazole (due to severe hypoglycemia risk)
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Major Interactions

  • Alcohol (potentiates hypoglycemic effect)
  • Beta-blockers (mask symptoms of hypoglycemia, prolong recovery)
  • Nonsteroidal Anti-inflammatory Drugs (NSAIDs) e.g., ibuprofen, naproxen (increase hypoglycemic effect)
  • Salicylates (high-dose aspirin) (increase hypoglycemic effect)
  • Sulfonamides (e.g., sulfamethoxazole/trimethoprim) (increase hypoglycemic effect)
  • Chloramphenicol (increase hypoglycemic effect)
  • Coumarins (e.g., warfarin) (potentiates hypoglycemic effect, monitor INR)
  • Probenecid (increase hypoglycemic effect)
  • Monoamine Oxidase Inhibitors (MAOIs) (increase hypoglycemic effect)
  • Fluconazole (potent CYP2C9 inhibitor, significantly increases glimepiride levels)
  • Cimetidine (increase hypoglycemic effect)
  • Clarithromycin (increase hypoglycemic effect)
  • Gemfibrozil (increase hypoglycemic effect)
  • Thiazide diuretics (decrease hypoglycemic effect)
  • Corticosteroids (e.g., prednisone) (decrease hypoglycemic effect)
  • Phenothiazines (decrease hypoglycemic effect)
  • Thyroid products (decrease hypoglycemic effect)
  • Estrogens/Oral Contraceptives (decrease hypoglycemic effect)
  • Phenytoin (decrease hypoglycemic effect)
  • Nicotinic acid (decrease hypoglycemic effect)
  • Sympathomimetics (e.g., epinephrine) (decrease hypoglycemic effect)
  • Calcium channel blockers (decrease hypoglycemic effect)
  • Isoniazid (decrease hypoglycemic effect)
  • Rifampin (CYP2C9 inducer, decreases glimepiride levels)
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Moderate Interactions

  • ACE inhibitors (e.g., enalapril, lisinopril) (may enhance hypoglycemic effect)
  • Fibrates (e.g., fenofibrate) (may enhance hypoglycemic effect)
  • Quinolones (e.g., ciprofloxacin) (may cause dysglycemia, including hypoglycemia)
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Minor Interactions

  • Chromium supplements (may enhance insulin sensitivity)

Monitoring

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Baseline Monitoring

Hemoglobin A1c (HbA1c)

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

Timing: Prior to initiation of therapy.

Fasting Plasma Glucose (FPG)

Rationale: To establish baseline glucose levels.

Timing: Prior to initiation of therapy.

Renal Function (Serum Creatinine, eGFR)

Rationale: To assess kidney function as glimepiride is partially renally cleared and dose adjustment may be needed in impairment.

Timing: Prior to initiation of therapy.

Hepatic Function (ALT, AST)

Rationale: To assess liver function as glimepiride is primarily metabolized in the liver and dose adjustment may be needed in impairment.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Hemoglobin A1c (HbA1c)

Frequency: Every 3-6 months

Target: <7% for most adults (individualized targets based on patient factors)

Action Threshold: If HbA1c remains above target, consider dose adjustment or addition of other agents.

Fasting Plasma Glucose (FPG)

Frequency: Daily to weekly (self-monitoring) or as clinically indicated

Target: 80-130 mg/dL (individualized targets)

Action Threshold: Persistent readings outside target range warrant dose adjustment or re-evaluation of therapy.

Self-Monitoring of Blood Glucose (SMBG)

Frequency: As directed by healthcare provider (e.g., once daily, pre-meals, post-meals)

Target: Individualized, typically 80-130 mg/dL pre-meal, <180 mg/dL 1-2 hours post-meal

Action Threshold: Frequent hypoglycemic episodes or persistent hyperglycemia require immediate attention.

Renal Function (Serum Creatinine, eGFR)

Frequency: Annually or more frequently if clinically indicated (e.g., with concomitant nephrotoxic drugs or worsening renal function)

Target: Stable eGFR

Action Threshold: Significant decline in eGFR may necessitate dose reduction or discontinuation.

Hepatic Function (ALT, AST)

Frequency: Annually or more frequently if clinically indicated (e.g., with signs of liver dysfunction)

Target: Normal limits

Action Threshold: Elevated liver enzymes may require re-evaluation of therapy.

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Symptom Monitoring

  • Symptoms of hypoglycemia: sweating, tremor, dizziness, hunger, confusion, irritability, rapid heartbeat, blurred vision, headache, weakness, slurred speech.
  • Symptoms of hyperglycemia (less common with glimepiride alone): increased thirst, frequent urination, increased hunger, fatigue, blurred vision.
  • Symptoms of allergic reactions: rash, itching, hives, swelling of face/lips/tongue/throat, difficulty breathing.

Special Patient Groups

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Pregnancy

Generally not recommended during pregnancy. Insulin is the preferred agent for glycemic control in pregnant women with diabetes due to the risk of neonatal hypoglycemia and the lack of sufficient safety data for glimepiride.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity, though data are limited. Insulin is preferred.
Second Trimester: Risk of fetal hyperinsulinemia and subsequent neonatal hypoglycemia. Insulin is preferred.
Third Trimester: Increased risk of severe neonatal hypoglycemia due to transplacental passage of glimepiride. Insulin is preferred.
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Lactation

Not recommended during breastfeeding. Glimepiride is excreted into breast milk and may cause hypoglycemia in the nursing infant. Insulin or other agents with better safety profiles in lactation are preferred.

Infant Risk: Risk of hypoglycemia in the infant.
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Pediatric Use

Not recommended for children under 18 years of age due to lack of established safety and efficacy. Increased risk of hypoglycemia in this population.

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Geriatric Use

Use with caution in elderly patients due to increased susceptibility to hypoglycemia, especially in those with impaired renal or hepatic function. Start with a low dose (1 mg) and titrate slowly with careful monitoring of blood glucose.

Clinical Information

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Clinical Pearls

  • Glimepiride should be taken with the first main meal of the day to optimize its effect and reduce the risk of hypoglycemia.
  • Educate patients thoroughly on the symptoms of hypoglycemia and how to manage them (e.g., carrying glucose tablets).
  • Patients should be advised about the potential for weight gain with sulfonylureas.
  • Monitor for signs of secondary failure, where the drug loses its effectiveness over time, necessitating a change in therapy.
  • Caution is advised when combining glimepiride with other medications that can affect blood glucose levels (e.g., beta-blockers, alcohol, certain antibiotics).
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Alternative Therapies

  • Metformin (first-line for most Type 2 Diabetes patients)
  • Dipeptidyl Peptidase-4 (DPP-4) Inhibitors (e.g., sitagliptin, saxagliptin)
  • Sodium-Glucose Cotransporter-2 (SGLT2) Inhibitors (e.g., empagliflozin, canagliflozin)
  • Glucagon-Like Peptide-1 (GLP-1) Receptor Agonists (e.g., liraglutide, semaglutide)
  • Thiazolidinediones (TZDs) (e.g., pioglitazone)
  • Insulin therapy
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Cost & Coverage

Average Cost: Check current market prices; typically inexpensive as a generic. per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (preferred generic) on most commercial and Medicare Part D plans.
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 for more information. 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 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.