Miglitol 50mg Tablets
It is used to help control blood sugar in people with type 2 diabetes.
Drug Class
Antidiabetic agent
Pharmacologic Class
Alpha-glucosidase inhibitor
Pregnancy Category
Category B
FDA Approved
Oct 1996
DEA Schedule
Not Controlled
Overview
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. This helps to prevent your blood sugar from rising too high right after you eat a meal.
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 your doctor for guidance on how to take them in conjunction 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.
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 your doctor for guidance on how to take them in conjunction 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.
Lifestyle & Tips
- Take miglitol with the first bite of each main meal to ensure it works effectively.
- Continue to 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 with other diabetes medications (like insulin or sulfonylureas), treat it with glucose (dextrose) tablets or gel, NOT with table sugar or complex carbohydrates, as miglitol will prevent their breakdown and absorption.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
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, then increase to 50 mg three times daily. May be further increased to 100 mg three times daily if needed and tolerated.
maximumDose:
100 mg three times daily
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed (CrCl > 50 mL/min)
Moderate:
No specific 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:
Contraindicated, as miglitol is renally eliminated and accumulates in severe renal impairment.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
Miglitol is an oral alpha-glucosidase inhibitor. It competitively inhibits alpha-glucosidase enzymes (e.g., sucrase, maltase, glucoamylase, dextranase) in the brush border of the small intestine. This inhibition delays the digestion of complex carbohydrates and disaccharides into absorbable monosaccharides (glucose), thereby delaying and reducing the rise in postprandial blood glucose levels.
Pharmacokinetics
Absorption:
Bioavailability:
Dose-dependent; approximately 50-70% at 25 mg, decreasing to 25-35% at 100 mg
Tmax:
2-3 hours
FoodEffect:
Taken with the first bite of each main meal to maximize therapeutic effect on postprandial glucose. Food delays absorption but does not significantly affect the extent of absorption.
Distribution:
Vd:
Approximately 81 L
ProteinBinding:
<4%
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 2 hours
Clearance:
Not available (primarily renal excretion)
ExcretionRoute:
Renal
Unchanged:
>95%
Pharmacodynamics
OnsetOfAction:
Within minutes of ingestion (with first bite of meal)
PeakEffect:
Peak reduction in postprandial glucose occurs within 1-2 hours after a meal.
DurationOfAction:
Corresponds to the presence of food in the GI tract and drug concentration, typically 2-3 hours post-meal.
Safety & Warnings
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, 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 an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor for advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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, 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 an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor for advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe or persistent diarrhea, flatulence, or abdominal discomfort.
- Symptoms of severe hypoglycemia (if used with other diabetes medications): severe sweating, confusion, seizures, loss of consciousness.
- Symptoms of liver problems (rare): unusual tiredness, dark urine, yellowing of skin or eyes (jaundice), persistent nausea or vomiting, severe stomach pain.
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 blockage or being at risk for bowel blockage
+ Bowel problems, such as inflammatory bowel disease
+ Diabetic acidosis
+ Malabsorption syndrome
+ Problems 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 consulting your doctor first.
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 blockage or being at risk for bowel blockage
+ Bowel problems, such as inflammatory bowel disease
+ Diabetic acidosis
+ Malabsorption syndrome
+ Problems 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 consulting your doctor first.
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 can significantly increase your risk of being involved in an accident.
To ensure effective management of your condition, it is crucial to monitor your blood sugar levels as directed by your doctor. Additionally, adhere to the schedule recommended by your doctor for regular blood work and other laboratory tests.
Follow the personalized diet and exercise plan that your doctor has outlined for you. Be aware that your blood sugar control may be more challenging during periods of stress, such as when you have a fever, infection, injury, or are undergoing surgery. Changes in your physical activity, exercise routine, or diet can also impact your blood sugar levels.
If you are pregnant or planning to become pregnant, it is vital to discuss the potential benefits and risks of using this medication during pregnancy with your doctor.
If you experience low blood sugar, do not operate a vehicle, as this can significantly increase your risk of being involved in an accident.
To ensure effective management of your condition, it is crucial to monitor your blood sugar levels as directed by your doctor. Additionally, adhere to the schedule recommended by your doctor for regular blood work and other laboratory tests.
Follow the personalized diet and exercise plan that your doctor has outlined for you. Be aware that your blood sugar control may be more challenging during periods of stress, such as when you have a fever, infection, injury, or are undergoing surgery. Changes in your physical activity, exercise routine, or diet can also impact your blood sugar levels.
If you are pregnant or planning to become pregnant, it is vital to discuss the potential benefits and risks of using this medication during pregnancy with your doctor.
Overdose Information
Overdose Symptoms:
- Exaggerated gastrointestinal symptoms such as flatulence, diarrhea, and abdominal discomfort.
What to Do:
In case of overdose, contact a poison control center immediately (e.g., 1-800-222-1222) or seek emergency medical attention. Overdose of miglitol alone is unlikely to cause hypoglycemia. Treatment is supportive and symptomatic.
Drug Interactions
Major Interactions
- Intestinal adsorbents (e.g., charcoal): May reduce the effect of miglitol.
- Digestive enzyme preparations (e.g., amylase, pancreatin): May reduce the effect of miglitol.
Moderate Interactions
- Sulfonylureas/Insulin: Increased risk of hypoglycemia when used concomitantly. Dose adjustment of sulfonylurea/insulin may be required.
- Digoxin: Miglitol may decrease plasma concentrations of digoxin. Monitor digoxin levels.
- Propranolol, Ranitidine: Miglitol may decrease the bioavailability of these drugs. Clinical significance is generally minor.
Monitoring
Baseline Monitoring
HbA1c
Rationale: To establish baseline glycemic control and guide therapy initiation.
Timing: Prior to initiation of therapy
Fasting Plasma Glucose (FPG)
Rationale: To establish baseline glycemic control.
Timing: Prior to initiation of therapy
Renal Function (CrCl or eGFR)
Rationale: Miglitol is renally excreted; assess for contraindications or need for caution.
Timing: Prior to initiation of therapy
Routine Monitoring
HbA1c
Frequency: Every 3-6 months
Target: Individualized, typically <7%
Action Threshold: If target not met, consider dose adjustment or additional therapy.
Postprandial Plasma Glucose (PPG)
Frequency: Periodically, especially when titrating dose
Target: Individualized, typically <180 mg/dL 1-2 hours post-meal
Action Threshold: If target not met, consider dose adjustment.
Renal Function (CrCl or eGFR)
Frequency: Annually or more frequently if clinically indicated (e.g., in elderly or those with risk factors for renal decline)
Target: >25 mL/min
Action Threshold: If CrCl falls below 25 mL/min, discontinue miglitol.
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) - common, especially during initiation and dose titration.
- Symptoms of liver injury (rare) (e.g., unexplained nausea, vomiting, abdominal pain, fatigue, dark urine, jaundice).
Special Patient Groups
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 specific increased risk identified in animal studies; human data lacking.
Second Trimester:
No specific increased risk identified in animal studies; human data lacking.
Third Trimester:
No specific increased risk identified in animal studies; human data lacking.
Lactation
Miglitol is excreted into breast milk in animals. It is unknown if it is excreted in human milk. Due to poor oral absorption in adults, infant exposure is likely low, but caution is advised, especially in newborns or preterm infants. Consider the benefits of breastfeeding versus the potential risks to the infant.
Infant Risk:
L3 (Moderately Safe) - Potential for low infant exposure due to poor absorption, but lack of human data warrants caution.
Pediatric Use
Safety and effectiveness in pediatric patients (under 18 years of age) have not been established. Not recommended for use in this population.
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 and during therapy, as miglitol is renally eliminated. Monitor for gastrointestinal side effects, which may be less tolerated in the elderly.
Clinical Information
Clinical Pearls
- Miglitol should be taken with the first bite of each main meal to be most effective in delaying carbohydrate absorption.
- Common side effects are gastrointestinal (flatulence, diarrhea, abdominal pain) and tend to be dose-related and decrease over time. Start with a low dose and titrate slowly to improve tolerability.
- If hypoglycemia occurs while on miglitol (especially when combined with sulfonylureas or insulin), it must be treated with glucose (dextrose) and not sucrose (table sugar) or complex carbohydrates, as miglitol inhibits their breakdown.
- Miglitol does not cause weight gain and may even lead to modest weight loss.
- Contraindicated in patients with chronic intestinal diseases (e.g., inflammatory bowel disease, colonic ulceration, partial intestinal obstruction) or conditions that may worsen due to increased gas formation (e.g., large hernias).
Alternative Therapies
- Acarbose (another alpha-glucosidase inhibitor)
- Metformin (biguanide)
- Sulfonylureas (e.g., glipizide, glyburide)
- Thiazolidinediones (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
Cost & Coverage
Average Cost:
Varies, typically $30-$100 per 30 tablets (50mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic)
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 detailed information about the overdose, including the substance taken, the amount, and the time it occurred.