Glyset 100mg Tablets
Overview
What is this medicine?
How to Use This Medicine
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.
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.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
Side Effects
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.
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
Before Using This Medicine
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.
Precautions & Cautions
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.
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
Major Interactions
- Digoxin (decreased digoxin levels)
- Intestinal adsorbents (e.g., charcoal) and digestive enzyme preparations (e.g., amylase, pancreatin) (may reduce miglitol's effect)
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
Baseline Monitoring
Rationale: To establish baseline glycemic control and guide initial therapy.
Timing: Prior to initiation
Rationale: To establish baseline glycemic control.
Timing: Prior to initiation
Rationale: Miglitol is renally excreted; contraindicated in severe renal impairment.
Timing: Prior to initiation
Routine Monitoring
Frequency: Every 3-6 months
Target: < 7% (individualized)
Action Threshold: > 7% (consider dose adjustment or additional therapy)
Frequency: Periodically, especially when titrating dose
Target: < 180 mg/dL (1-2 hours post-meal)
Action Threshold: > 180 mg/dL (consider dose adjustment)
Frequency: Annually or more frequently if clinically indicated
Target: > 25 mL/min
Action Threshold: < 25 mL/min (discontinue miglitol)
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
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:
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).
Pediatric Use
Safety and effectiveness in pediatric patients (under 18 years of age) have not been established. Use is generally not recommended.
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
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).
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