Glyset 50mg Tablets

Manufacturer PFIZER Active Ingredient Miglitol(MIG li tol) Pronunciation MIG-li-tol
It is used to help control blood sugar in people with type 2 diabetes.
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Drug Class
Antidiabetic agent
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Pharmacologic Class
Alpha-glucosidase inhibitor
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Pregnancy Category
Category B
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FDA Approved
Dec 1996
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Miglitol is a medication used to help manage type 2 diabetes. It works by slowing down the digestion of carbohydrates (sugars and starches) in your gut, which helps to prevent your blood sugar from rising too high after meals.
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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 the first bite of each meal, as directed by your doctor or healthcare provider. Continue taking your medication as prescribed, even if you start to feel better.

If you are taking charcoal or digestive enzyme preparations, consult with your doctor about the best way to take them in combination with your medication.

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 and secure location, out of the reach of children and pets.

What to Do If You Miss a Dose

If you miss a dose, skip it 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 dose.
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Lifestyle & Tips

  • Take miglitol with the first bite of each main meal to ensure it works effectively.
  • 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.
  • If you experience low blood sugar (hypoglycemia) while taking miglitol, treat it with glucose (dextrose) tablets or gel, not regular sugar or sugary drinks, as miglitol can block the breakdown of table sugar.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 50 mg three times daily with the first bite of each main meal
Dose Range: 25 - 100 mg

Condition-Specific Dosing:

Initial Dose: 25 mg three times daily with the first bite of each main meal for 4-8 weeks to minimize gastrointestinal side effects.
Maintenance Dose: Increase to 50 mg three times daily. If glycemic control is inadequate, dose may be increased to 100 mg three times 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 adjustment needed (CrCl > 50 mL/min)
Moderate: No adjustment needed (CrCl 25-50 mL/min), but caution advised due to increased plasma concentrations.
Severe: Contraindicated (CrCl < 25 mL/min) due to significant accumulation.
Dialysis: Not recommended; contraindicated in severe renal impairment.

Hepatic Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed

Pharmacology

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Mechanism of Action

Miglitol is an oral alpha-glucosidase inhibitor that acts in the small intestine to delay the digestion of carbohydrates (e.g., starch, dextrin, maltose, sucrose) into monosaccharides (e.g., glucose). This delays glucose absorption, resulting in a lower and more prolonged postprandial blood glucose rise.
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Pharmacokinetics

Absorption:

Bioavailability: 50-70% (dose-dependent)
Tmax: 2-3 hours
FoodEffect: Food delays absorption but does not significantly alter the extent of absorption. Should be taken with the first bite of a meal for optimal effect.

Distribution:

Vd: 0.18 L/kg
ProteinBinding: <4%
CnssPenetration: Limited

Elimination:

HalfLife: 2 hours
Clearance: Not available
ExcretionRoute: Renal
Unchanged: 95% (renal)
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Pharmacodynamics

OnsetOfAction: Rapid (with first bite of meal)
PeakEffect: 2-3 hours post-meal
DurationOfAction: Dependent on meal size and composition, generally for the duration of carbohydrate digestion in the small intestine.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when 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
Low blood sugar (hypoglycemia), which can occur when this medication is used with other diabetes medications. Symptoms may include:
+ Dizziness
+ Headache
+ Feeling sleepy or weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating

If you experience any of these symptoms, call 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.

Other Possible Side Effects

Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help if they bother you or do not go away:

Stomach pain
Diarrhea
* Gas

This is not a comprehensive list of all 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.
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Seek Immediate Medical Attention If You Experience:

  • Symptoms of hypoglycemia (low blood sugar): sweating, shakiness, dizziness, confusion, hunger, rapid heartbeat. Seek immediate medical attention if severe.
  • Severe gastrointestinal discomfort: persistent or severe flatulence, diarrhea, or abdominal pain. These are common but should be reported if severe or persistent.
  • Allergic reaction: rash, itching, swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. Seek immediate medical attention.
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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 allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Bowel obstruction or being at risk for bowel obstruction
+ Bowel problems, such as inflammatory bowel disease
+ Diabetic acidosis
+ Malabsorption syndrome
+ Difficulty breaking down food
+ Ulcers in the colon
Kidney disease
If you are breastfeeding, as you should not breastfeed while taking this medication

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose 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.

If you experience low blood sugar, do not operate a vehicle, as this increases your risk of being involved in an accident.

To monitor your condition effectively, check your blood sugar levels as directed by your doctor. Additionally, have your blood work and other laboratory tests performed as scheduled by your doctor.

Adhere to the diet and exercise plan recommended by your doctor to maintain optimal control over your blood sugar levels. Be aware that stress, such as fever, infection, injury, or surgery, can make it more challenging to manage your blood sugar. Similarly, changes in physical activity, exercise, or diet can also impact your blood sugar control.

If you are pregnant or planning to become pregnant, notify your doctor. It is crucial to discuss the potential benefits and risks associated with using this medication during pregnancy to make an informed decision.
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Overdose Information

Overdose Symptoms:

  • Increased flatulence
  • Diarrhea
  • Abdominal discomfort

What to Do:

Overdose of miglitol is not expected to cause hypoglycemia unless taken with other hypoglycemic agents. Management is primarily supportive, focusing on symptomatic relief of gastrointestinal symptoms. Call 1-800-222-1222 (Poison Control Center) for advice.

Drug Interactions

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Major Interactions

  • Insulin and Sulfonylureas: Increased risk of hypoglycemia when used concomitantly. If hypoglycemia occurs, treat with glucose (dextrose), not sucrose (table sugar), as miglitol inhibits sucrose breakdown.
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Moderate Interactions

  • Intestinal Adsorbents (e.g., charcoal): May reduce the effect of miglitol by adsorbing it.
  • Digestive Enzyme Preparations (e.g., amylase, pancreatin): May reduce the effect of miglitol by counteracting its mechanism of action.

Monitoring

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Baseline Monitoring

HbA1c

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

Timing: Prior to initiation of therapy.

Fasting Plasma Glucose (FPG) and Postprandial Glucose (PPG)

Rationale: To assess baseline glucose levels and guide initial therapy.

Timing: Prior to initiation of therapy.

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

Rationale: Miglitol is renally excreted; severe renal impairment is a contraindication.

Timing: Prior to initiation of therapy.

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Routine Monitoring

HbA1c

Frequency: Every 3-6 months

Target: <7% (individualized)

Action Threshold: If target not met, consider dose adjustment or addition of other agents.

Postprandial Glucose (PPG)

Frequency: Periodically, or as needed for glycemic control assessment

Target: <180 mg/dL (1-2 hours post-meal, individualized)

Action Threshold: If consistently elevated, consider dose adjustment.

Renal Function

Frequency: Annually, or more frequently in patients with risk factors for renal impairment

Target: CrCl > 25 mL/min

Action Threshold: If CrCl falls below 25 mL/min, discontinue miglitol.

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Symptom Monitoring

  • Symptoms of hypoglycemia (e.g., sweating, tremor, confusion, hunger, dizziness) especially if used with insulin or sulfonylureas.
  • Gastrointestinal side effects (e.g., flatulence, diarrhea, abdominal pain, bloating), especially during initiation and dose titration.

Special Patient Groups

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Pregnancy

Miglitol is Pregnancy Category B. Studies in animals have shown no evidence of harm to the fetus. However, there are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if clearly needed.

Trimester-Specific Risks:

First Trimester: No known specific risks identified from animal studies.
Second Trimester: No known specific risks identified from animal studies.
Third Trimester: No known specific risks identified from animal studies.
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Lactation

Miglitol is excreted in human milk. Due to the potential for hypoglycemia in the nursing infant and the lack of long-term data, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Infant Risk: L3 (Moderately Safe) - Potential for hypoglycemia in the infant; monitor infant for signs of hypoglycemia.
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Pediatric Use

Safety and effectiveness in pediatric patients (under 18 years of age) have not been established. Use is generally not recommended.

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Geriatric Use

No specific dose adjustment is required based solely on age. However, due to the higher likelihood of decreased renal function in elderly patients, renal function should be assessed before initiating miglitol and monitored periodically. Contraindicated in severe renal impairment.

Clinical Information

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Clinical Pearls

  • Miglitol primarily targets postprandial hyperglycemia, making it particularly useful for patients with elevated post-meal glucose levels.
  • The most common side effects are gastrointestinal (flatulence, diarrhea, abdominal pain), which tend to be dose-related and often diminish over time with continued use. Starting with a low dose and titrating slowly can help mitigate these effects.
  • Unlike sulfonylureas or insulin, miglitol does not cause hypoglycemia when used as monotherapy. However, it can increase the risk of hypoglycemia when combined with these agents.
  • If hypoglycemia occurs while on miglitol, it must be treated with glucose (dextrose) as miglitol inhibits the breakdown of sucrose (table sugar) and complex carbohydrates.
  • Patients should be advised to take miglitol with the first bite of each main meal for optimal efficacy.
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Alternative Therapies

  • Metformin (Biguanide)
  • Acarbose (another Alpha-glucosidase inhibitor)
  • Sulfonylureas (e.g., Glipizide, Glyburide)
  • Thiazolidinediones (e.g., Pioglitazone, Rosiglitazone)
  • DPP-4 Inhibitors (e.g., Sitagliptin, Saxagliptin)
  • SGLT2 Inhibitors (e.g., Canagliflozin, Dapagliflozin)
  • GLP-1 Receptor Agonists (e.g., Liraglutide, Semaglutide)
  • Insulin
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Cost & Coverage

Average Cost: Varies widely, typically $30-$100 per 30 tablets (50mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic)
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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 information. If you have any questions or concerns about your 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 medication taken, including the amount and time of ingestion.