Miglitol 100mg Tablets

Miglitol is an oral alpha-glucosidase inhibitor that delays the digestion of carbohydrates (e.g., starch, dextrin, maltose, sucrose) in the small intestine. It competitively inhibits alpha-glucosidase enzymes (sucrase, maltase, glucoamylase, dextranase) located in the brush border of the small intestine, leading to a slower and lower rise in postprandial blood glucose concentrations.

Urgent Side Effects: Seek Medical Attention Immediately

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:

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 low blood sugar, follow your doctor's instructions for treatment, 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 not everyone will experience them. If you have any of the following side effects or any other concerns, contact your doctor or seek medical help:

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.

Reporting Side Effects

To report side effects, you can:

Call your doctor for medical advice
Contact the FDA at 1-800-332-1088
Visit the FDA's MedWatch website at https://www.fda.gov/medwatch

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. Be sure to describe the allergic reaction you experienced, including any symptoms.
Certain health conditions, such as:
+ Bowel obstruction or being at risk for bowel obstruction
+ Bowel problems, including 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 consulting your doctor first.

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, 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 benefits and risks of using this medication during pregnancy to make an informed decision.

• Intestinal adsorbents (e.g., charcoal): May reduce the effect of miglitol.
• Digestive enzyme preparations (e.g., amylase, pancreatin): May reduce the effect of miglitol.
• Other antidiabetic agents (e.g., sulfonylureas, insulin): Increased risk of hypoglycemia.

• Symptoms of hypoglycemia (if used with sulfonylurea or insulin): sweating, tremor, dizziness, confusion, hunger, rapid heartbeat.
• Gastrointestinal side effects: flatulence, diarrhea, abdominal pain, bloating.

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. Insulin is generally preferred for glycemic control during pregnancy.

Miglitol is excreted into breast milk in small amounts in animal studies. It is unknown if it is excreted in human milk. Caution should be exercised when miglitol is administered to a nursing woman. The potential for hypoglycemia in the infant is a concern if the mother is also on other antidiabetic agents.

Safety and effectiveness in pediatric patients have not been established. Not recommended for use in children.

No overall differences in safety or effectiveness were observed between elderly and younger patients. However, due to the higher prevalence of renal impairment in the elderly, renal function should be monitored, and dose adjustments made as necessary.

• Miglitol primarily targets postprandial hyperglycemia, making it useful for patients whose fasting glucose is well-controlled but post-meal glucose spikes are problematic.
• The most common side effects are GI-related (flatulence, diarrhea, abdominal pain) due to undigested carbohydrates reaching the colon. These often improve with continued use and gradual dose titration.
• It does not cause hypoglycemia when used as monotherapy. If hypoglycemia occurs, it's usually when combined with insulin or sulfonylureas, and must be treated with glucose (dextrose) as sucrose (table sugar) absorption will be inhibited.
• Patients should be advised to take it with the first bite of each main meal for optimal efficacy.
• Contraindicated in patients with severe renal impairment (CrCl < 25 mL/min) and inflammatory bowel disease, colonic ulceration, or partial intestinal obstruction.

• 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

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 medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.