Glyset 100mg 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 medicine used to help control high blood sugar in people with type 2 diabetes. It works by slowing down the digestion of carbohydrates (sugars and starches) in your gut, which helps prevent a big spike in blood sugar after meals. It's important to take it with the first bite of your main 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 well.

If you are taking charcoal or digestive enzyme preparations, consult with your doctor about the best way to take them in combination with this 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 location, out of the reach of children and pets, to prevent accidental ingestion.

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

  • Follow a balanced diet as recommended by your doctor or dietitian, focusing on consistent carbohydrate intake.
  • Engage in regular physical activity as advised by your healthcare provider.
  • Monitor your blood sugar levels regularly as instructed.
  • Understand that miglitol alone does not cause hypoglycemia (low blood sugar), but it can if taken with other diabetes medications like insulin or sulfonylureas. If hypoglycemia occurs, treat it with glucose (dextrose) tablets or gel, not table sugar or sugary foods, as miglitol will block their absorption.
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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:

initialDose: 25 mg three times daily with the first bite of each main meal for 4-8 weeks to minimize gastrointestinal side effects. Dose may be increased to 50 mg three times daily, then to 100 mg three times daily based on efficacy and tolerability.
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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)
Severe: Contraindicated (CrCl < 25 mL/min)
Dialysis: Contraindicated

Hepatic Impairment:

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

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. It reversibly inhibits membrane-bound intestinal alpha-glucosidase enzymes (e.g., sucrase, maltase, glucoamylase, isomaltase) that hydrolyze oligosaccharides, disaccharides, and polysaccharides into monosaccharides. This inhibition results in a delayed and reduced absorption of glucose, leading to a lower postprandial blood glucose rise.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 90-100% for 25 mg and 50 mg doses; decreases to 50-70% for 100 mg dose
Tmax: 2-3 hours
FoodEffect: Must be taken with the first bite of each main meal to exert its local effect on carbohydrate digestion.

Distribution:

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

Elimination:

HalfLife: 2-3 hours
Clearance: Not available (primarily renal excretion)
ExcretionRoute: Renal
Unchanged: Approximately 95% of absorbed dose
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Pharmacodynamics

OnsetOfAction: With first bite of meal (local action)
PeakEffect: Peak reduction in postprandial glucose occurs around 2-3 hours post-meal, correlating with Tmax.
DurationOfAction: Meal-dependent (duration of carbohydrate digestion)

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
+ 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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they bother you or do not go away:

Stomach pain
Diarrhea
* Gas

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:

  • Severe or persistent gastrointestinal side effects (e.g., diarrhea, abdominal pain, flatulence)
  • Symptoms of hypoglycemia (if on combination therapy): sweating, shakiness, dizziness, confusion, hunger
  • Signs of allergic reaction: rash, itching, swelling (especially of face/tongue/throat), severe dizziness, trouble breathing
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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.

Monitor 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 blood sugar control. Be aware that stress, such as fever, infection, injury, or surgery, can make it more challenging to manage your blood sugar levels. Changes in physical activity, exercise routines, 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:

  • Exacerbation of typical gastrointestinal side effects (e.g., flatulence, diarrhea, abdominal discomfort)

What to Do:

There is no specific antidote for miglitol overdose. Treatment should be symptomatic and supportive. If an overdose occurs, contact a poison control center immediately (e.g., Call 1-800-222-1222 in the US) or seek emergency medical attention.

Drug Interactions

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Major Interactions

  • Digoxin (decreased digoxin levels)
  • Intestinal adsorbents (e.g., charcoal) and digestive enzyme preparations (e.g., amylase, pancreatin) (may reduce miglitol's effect)
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Moderate Interactions

  • Other oral antidiabetic agents (increased risk of hypoglycemia)
  • Thiazide diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, isoniazid (may cause hyperglycemia, requiring dose adjustment of miglitol)

Monitoring

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Baseline Monitoring

HbA1c

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

Timing: Prior to initiation

Fasting Plasma Glucose (FPG)

Rationale: To establish baseline glycemic control.

Timing: Prior to initiation

Renal Function (CrCl or eGFR)

Rationale: Miglitol is renally excreted; contraindicated in severe renal impairment.

Timing: Prior to initiation

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Routine Monitoring

HbA1c

Frequency: Every 3-6 months

Target: < 7% (individualized)

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

Postprandial Plasma Glucose (PPG)

Frequency: Periodically, especially when titrating dose

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

Action Threshold: > 180 mg/dL (consider dose adjustment)

Renal Function (CrCl or eGFR)

Frequency: Annually or more frequently if clinically indicated

Target: > 25 mL/min

Action Threshold: < 25 mL/min (discontinue miglitol)

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Symptom Monitoring

  • Symptoms of hypoglycemia (if used with other antidiabetics): sweating, tremor, dizziness, confusion, hunger, irritability
  • Gastrointestinal side effects: flatulence, diarrhea, abdominal pain, bloating
  • Symptoms of allergic reaction: rash, itching, swelling

Special Patient Groups

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Pregnancy

Miglitol is Pregnancy Category B. Studies in animals have not shown harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed and the potential benefit outweighs the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: No specific increased risk identified in animal studies.
Second Trimester: No specific increased risk identified in animal studies.
Third Trimester: No specific increased risk identified in animal studies.
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Lactation

Miglitol is excreted into human milk. Due to the potential for hypoglycemia in the nursing infant and the lack of long-term safety data, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. Lactation risk is L3 (Moderately Safe).

Infant Risk: Potential for hypoglycemia, diarrhea, and other gastrointestinal effects in the infant. Monitor infant for adverse effects.
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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 on age alone. However, elderly patients are more likely to have decreased renal function, which should be assessed before initiating miglitol and monitored periodically. Miglitol is contraindicated in patients with severe renal impairment (CrCl < 25 mL/min).

Clinical Information

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Clinical Pearls

  • Miglitol must be taken with the first bite of each main meal to be effective in delaying carbohydrate absorption.
  • The most common side effects are gastrointestinal (flatulence, diarrhea, abdominal pain), which tend to be dose-related and often improve with continued therapy or by starting with a low dose and titrating slowly.
  • Unlike sulfonylureas or insulin, miglitol does not cause hypoglycemia when used as monotherapy. However, if used in combination with other agents that can cause hypoglycemia (e.g., insulin, sulfonylureas), hypoglycemia may occur. If hypoglycemia happens, it must be treated with glucose (dextrose) and NOT sucrose (table sugar) or complex carbohydrates, as miglitol will inhibit their breakdown and absorption.
  • Miglitol is primarily renally excreted and is contraindicated in severe renal impairment (CrCl < 25 mL/min).
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Alternative Therapies

  • Acarbose (another alpha-glucosidase inhibitor)
  • Metformin (biguanide)
  • Sulfonylureas (e.g., glipizide, glyburide, glimepiride)
  • Thiazolidinediones (TZDs) (e.g., pioglitazone, rosiglitazone)
  • DPP-4 inhibitors (e.g., sitagliptin, saxagliptin)
  • SGLT2 inhibitors (e.g., empagliflozin, canagliflozin)
  • GLP-1 receptor agonists (e.g., liraglutide, semaglutide)
  • Insulin
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Cost & Coverage

Average Cost: $30 - $100 per 30 tablets (generic 100mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic formulations)
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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 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 emergency medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.