Miglitol 25mg Tablets

Miglitol reversibly inhibits membrane-bound intestinal alpha-glucosidase enzymes (sucrase, maltase, glucoamylase, dextranase) in the brush border of the small intestine. This inhibition delays the hydrolysis of oligosaccharides and disaccharides into absorbable monosaccharides, thereby delaying glucose absorption and lowering postprandial blood glucose concentrations.

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, follow your doctor's 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 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.

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 like 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.

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, consult your doctor to discuss the potential benefits and risks associated with using this medication during pregnancy.

• Diabetic ketoacidosis
• Inflammatory bowel disease
• Colonic ulceration
• Partial intestinal obstruction
• Chronic intestinal diseases associated with marked disorders of digestion or absorption
• Conditions that may worsen due to increased gas formation in the intestine (e.g., large hernias, significant intestinal adhesions)

• Intestinal adsorbents (e.g., charcoal): May reduce the effect of miglitol.
• Digestive enzyme preparations (e.g., amylase, pancreatin): May reduce the effect of miglitol.
• Sulfonylureas, Insulin, Metformin, other antidiabetic agents: Increased risk of hypoglycemia (especially if combined with sulfonylureas or insulin).

• Digoxin: Miglitol may decrease the bioavailability and plasma levels of digoxin.
• Propranolol: Miglitol may decrease the bioavailability of propranolol.
• Ranitidine: Miglitol may decrease the bioavailability of ranitidine.

• Not available

• Symptoms of hypoglycemia (sweating, tremor, dizziness, confusion, hunger, irritability) - especially if used with sulfonylureas or insulin.
• Gastrointestinal side effects (flatulence, diarrhea, abdominal pain, bloating).

Miglitol is Pregnancy Category B. Animal studies have shown no evidence of harm to the fetus. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed and the potential benefit justifies the potential risk to the fetus.

Miglitol is excreted into human milk. Due to the potential for hypoglycemia in the breastfed infant and the lack of data on long-term effects, 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.

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

No specific dose adjustment is required based on age alone. However, due to the higher prevalence of renal impairment in elderly patients, renal function should be monitored, and miglitol should be avoided in those with severe renal impairment (CrCl ≤ 25 mL/min).

• Miglitol must be taken with the first bite of each main meal to be effective in delaying carbohydrate absorption.
• If hypoglycemia occurs (especially when combined with sulfonylureas or insulin), it should be treated with glucose (dextrose) rather than sucrose (table sugar), as miglitol inhibits the breakdown of sucrose.
• Gastrointestinal side effects (flatulence, diarrhea, abdominal pain) are common, especially at the beginning of therapy or with dose escalation. These often diminish over time with continued use and dietary adherence.
• Dose titration should be gradual to minimize GI side effects.

• Metformin (biguanide)
• Sulfonylureas (e.g., glipizide, glyburide, glimepiride)
• Meglitinides (e.g., repaglinide, nateglinide)
• 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
• Acarbose (another alpha-glucosidase inhibitor)

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 this 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 overdose, including the medication taken, the amount, and the time it occurred.