Glyset 25mg 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
Oct 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 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 your blood sugar from rising too high right after you eat.
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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. Continue taking your medication as prescribed, even if you start to feel better.

If you are taking charcoal or digestive enzyme preparations, consult 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.

What to Do If You Miss a Dose

If you miss a dose, skip it and take your next dose at the usual time. 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. Do not skip meals or take the medication without food.
  • 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.
  • If you experience low blood sugar (hypoglycemia) while taking miglitol with other diabetes medications (like insulin or sulfonylureas), treat it with pure glucose (dextrose) tablets or gel, not table sugar or sugary drinks, as miglitol will prevent the breakdown of sucrose.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: Initially 25 mg three times daily with the first bite of each main meal. Dosage may be increased at 4-8 week intervals.
Dose Range: 25 - 100 mg

Condition-Specific Dosing:

maintenance: 50 mg three times daily, or 100 mg three times daily with the first bite of each main meal. Maximum recommended dose is 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 specific adjustment needed, but monitor renal function.
Moderate: No specific adjustment needed, but monitor renal function.
Severe: Contraindicated in patients with chronic renal dysfunction (creatinine clearance < 25 mL/min).
Dialysis: Contraindicated in patients on dialysis due to significant renal excretion.

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 delays the digestion of carbohydrates in the small intestine. It competitively inhibits alpha-glucosidase enzymes (sucrase, maltase, glucoamylase, dextranase) in the brush border of the small intestine, leading to a slower and lower rise in postprandial blood glucose levels.
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Pharmacokinetics

Absorption:

Bioavailability: Dose-dependent; nearly 100% at 25 mg, decreasing to 50-70% at 100 mg.
Tmax: Approximately 2-3 hours.
FoodEffect: Administered with the first bite of each main meal to exert its local effect on carbohydrate digestion.

Distribution:

Vd: Approximately 0.18 L/kg.
ProteinBinding: Negligible (<4%).
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 2 hours.
Clearance: Primarily renal clearance.
ExcretionRoute: Renal (urine).
Unchanged: Approximately 95% of the absorbed dose is excreted unchanged in the urine.
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Pharmacodynamics

OnsetOfAction: Rapid (with first bite of meal).
PeakEffect: Reduction in postprandial glucose peaks, typically within 1-2 hours after a meal.
DurationOfAction: Meal-dependent, primarily affecting postprandial glucose for the duration of carbohydrate digestion.

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:

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, bloating).
  • Symptoms of severe hypoglycemia (e.g., confusion, seizures, loss of consciousness) if used with insulin or sulfonylureas.
  • Signs of an allergic reaction (e.g., rash, hives, swelling of face/lips/tongue, difficulty 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 symptoms you experienced.
Certain health conditions, including:
+ Bowel obstruction or being at risk for bowel obstruction
+ Bowel problems, such as inflammatory bowel disease
+ Diabetic acidosis
+ Malabsorption syndrome
+ Issues with food digestion
+ 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 to ensure they remain within a healthy range. Additionally, have your blood work and other laboratory tests performed as scheduled by your doctor to closely monitor your condition.

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

If you are pregnant or planning to become pregnant, consult your doctor to discuss the potential benefits and risks associated with using this medication during pregnancy.
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Overdose Information

Overdose Symptoms:

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

What to Do:

In case of overdose, contact a poison control center or emergency medical services immediately. Management is primarily supportive, focusing on symptomatic relief of gastrointestinal symptoms. Do not administer carbohydrates as they will not be absorbed. Call 1-800-222-1222 for poison control.

Drug Interactions

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Moderate Interactions

  • Intestinal adsorbents (e.g., activated charcoal): May reduce the effect of miglitol.
  • Digestive enzyme preparations (e.g., amylase, pancreatin): May reduce the effect of miglitol.
  • Digoxin: Miglitol may decrease plasma concentrations of digoxin. Monitor digoxin levels.
  • Sulfonylureas/Insulin: Increased risk of hypoglycemia when co-administered. If hypoglycemia occurs, treat with oral glucose (dextrose), not sucrose (table sugar).

Monitoring

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Baseline Monitoring

HbA1c

Rationale: To establish baseline glycemic control.

Timing: Prior to initiation of therapy.

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

Rationale: To establish baseline glucose levels and assess initial response.

Timing: Prior to initiation of therapy.

Renal Function (Serum Creatinine, eGFR/CrCl)

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

Timing: Prior to initiation of therapy.

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Routine Monitoring

HbA1c

Frequency: Every 3-6 months (or more frequently if glycemic control is not achieved).

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

Action Threshold: If target HbA1c is not met, consider dose adjustment or addition of other antidiabetic agents.

Postprandial Glucose (PPG)

Frequency: Periodically, especially when titrating dose.

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

Action Threshold: Persistent elevation may indicate need for dose adjustment or alternative therapy.

Renal Function (eGFR/CrCl)

Frequency: Annually, or more frequently in patients with pre-existing renal impairment or risk factors.

Target: >25 mL/min (CrCl).

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

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Symptom Monitoring

  • Symptoms of hypoglycemia (e.g., sweating, tremor, dizziness, confusion, hunger) especially if used with insulin or sulfonylureas.
  • Gastrointestinal side effects (e.g., flatulence, diarrhea, abdominal pain, bloating), especially during dose titration.
  • Symptoms of allergic reaction (e.g., 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. 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 into human breast milk. Due to the potential for adverse effects on the nursing infant, 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 - some data, but potential for adverse effects). Potential for gastrointestinal effects or hypoglycemia in the infant, though systemic absorption in the infant is likely low.
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Pediatric Use

Safety and effectiveness of miglitol in pediatric patients 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, and miglitol is contraindicated in severe renal impairment. Renal function should be monitored.

Clinical Information

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Clinical Pearls

  • Miglitol is most effective at reducing postprandial glucose excursions, making it particularly useful for patients with prominent post-meal hyperglycemia.
  • 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. Start with a low dose and titrate slowly to minimize these effects.
  • Instruct patients to take miglitol with the first bite of each main meal to maximize its effectiveness.
  • If a patient experiences hypoglycemia while on miglitol (especially if also on insulin or sulfonylureas), they must treat it with pure glucose (dextrose) and not sucrose (table sugar), as miglitol inhibits the breakdown of sucrose.
  • Miglitol is not absorbed systemically to a significant extent and is not metabolized, making it a good option for patients with hepatic impairment, but it is contraindicated in severe renal impairment.
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Alternative Therapies

  • Other alpha-glucosidase inhibitors: Acarbose (Precose)
  • Other oral antidiabetic agents: Metformin, Sulfonylureas (e.g., glipizide, glyburide), Thiazolidinediones (e.g., pioglitazone), DPP-4 inhibitors (e.g., sitagliptin), SGLT2 inhibitors (e.g., empagliflozin), GLP-1 receptor agonists (e.g., liraglutide), Insulin.
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Cost & Coverage

Average Cost: Varies widely, typically $50-$200 per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (generic), Tier 3 (brand) depending on insurance plan.
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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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.