Acarbose 25mg Tablets
It is used to lower blood sugar in patients with high blood sugar (diabetes).
Drug Class
Antidiabetic Agent
Pharmacologic Class
Alpha-Glucosidase Inhibitor
Pregnancy Category
B
FDA Approved
Dec 1995
DEA Schedule
Not Controlled
Overview
What is this medicine?
Acarbose is a medicine that helps manage type 2 diabetes by slowing down the digestion of carbohydrates (sugars and starches) in your food. This means that sugar enters your bloodstream more slowly after meals, helping to keep your blood sugar levels from rising too high.
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 to you and follow the instructions closely. Take your medication with the first bite of each meal. Continue taking your medication as directed by your doctor or healthcare provider, 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 the lid tightly closed to maintain the medication's effectiveness.
What to Do If You Miss a Dose
If you miss a dose, skip it and resume your normal dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. Take your medication with the first bite of each meal. Continue taking your medication as directed by your doctor or healthcare provider, 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 the lid tightly closed to maintain the medication's effectiveness.
What to Do If You Miss a Dose
If you miss a dose, skip it and resume your normal dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Take acarbose with the first bite of each main meal. Do not skip meals or take it between meals.
- Follow a balanced diet as recommended by your doctor or dietitian, focusing on complex carbohydrates and limiting simple sugars.
- 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 acarbose (especially if also on insulin or sulfonylureas), treat it with pure glucose (dextrose) tablets or gel, not table sugar or fruit juice, as acarbose blocks the breakdown of table sugar.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
25 mg three times daily with the first bite of each main meal. Dose may be increased at 4-8 week intervals.
Dose Range:
25 - 100 mg
Condition-Specific Dosing:
maintenance_dose_less_than_60kg:
50 mg three times daily
maintenance_dose_greater_than_60kg:
50-100 mg three times daily
maximum_dose_less_than_60kg:
50 mg three times daily
maximum_dose_greater_than_60kg:
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 adjustment needed (CrCl > 50 mL/min)
Moderate:
Use with caution (CrCl 25-50 mL/min), consider lower doses
Severe:
Contraindicated (CrCl < 25 mL/min)
Dialysis:
Contraindicated
Hepatic Impairment:
Mild:
No specific adjustment, but monitor liver enzymes
Moderate:
No specific adjustment, but monitor liver enzymes
Severe:
Contraindicated (e.g., cirrhosis)
Pharmacology
Mechanism of Action
Acarbose is an oral alpha-glucosidase inhibitor that acts in the brush border of the small intestine to reversibly inhibit membrane-bound intestinal alpha-glucosidase enzymes (e.g., sucrase, maltase, isomaltase, glucoamylase). This inhibition delays the digestion of complex carbohydrates and disaccharides into absorbable monosaccharides (glucose), thereby slowing the rate of glucose absorption and reducing postprandial blood glucose excursions.
Pharmacokinetics
Absorption:
Bioavailability:
<2% (systemic absorption of active drug)
Tmax:
1 hour (for parent drug); 14-24 hours (for active metabolites)
FoodEffect:
Must be taken with the first bite of each main meal for optimal efficacy.
Distribution:
Vd:
Not well-defined due to minimal systemic absorption
ProteinBinding:
Negligible
CnssPenetration:
Limited
Elimination:
HalfLife:
2 hours (parent drug); 8 hours (active metabolites)
Clearance:
Not well-defined due to low systemic absorption
ExcretionRoute:
Renal (approximately 35% as metabolites), Fecal (approximately 51% as unabsorbed drug)
Unchanged:
Approximately 1-2% (systemically absorbed unchanged drug)
Pharmacodynamics
OnsetOfAction:
Within minutes of ingestion (with first bite of meal)
PeakEffect:
Approximately 1 hour post-meal (reduction in postprandial glucose)
DurationOfAction:
Duration of a meal (effects are localized to the GI tract during carbohydrate digestion)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor immediately or seek emergency 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
Follow your doctor's instructions for managing low blood sugar, which may include taking glucose tablets, liquid glucose, or some fruit juices.
Liver problems, which have rarely occurred with this medication and can be fatal. Seek medical help immediately if you experience:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
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 are bothered by any of the following side effects or if they persist, contact your doctor or seek medical attention:
Stomach pain
Diarrhea
Gas
Reporting Side Effects
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor immediately or seek emergency 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
Follow your doctor's instructions for managing low blood sugar, which may include taking glucose tablets, liquid glucose, or some fruit juices.
Liver problems, which have rarely occurred with this medication and can be fatal. Seek medical help immediately if you experience:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
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 are bothered by any of the following side effects or if they persist, contact your doctor or seek medical attention:
Stomach pain
Diarrhea
Gas
Reporting Side Effects
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact 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 abdominal pain
- Persistent or severe diarrhea
- Excessive flatulence (gas)
- Symptoms of hypoglycemia (shakiness, sweating, confusion, dizziness, hunger, rapid heartbeat) - if on other diabetes medications
- Unexplained nausea or vomiting
- Dark urine
- Yellowing of skin or eyes (jaundice)
Before Using This Medicine
Before taking this medication, it is essential to inform your doctor about the following:
Any allergies you have, including allergies to this drug, its components, or other substances, such as foods or medications. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have kidney disease, as this may affect how your body processes the medication.
* If you have any of the following health conditions:
+ Diabetic acid problems
+ Digestion problems
+ Inflammatory bowel disease
+ Bowel block or are at risk for bowel block
+ Liver disease
+ Malabsorption syndrome
+ Ulcers in the colon
It is crucial to disclose all your medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, as well as any health problems you are experiencing. This will enable your doctor and pharmacist to assess potential interactions and ensure it is safe for you to take this medication. Do not initiate, discontinue, or modify the dose of any medication without first consulting your doctor.
Any allergies you have, including allergies to this drug, its components, or other substances, such as foods or medications. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have kidney disease, as this may affect how your body processes the medication.
* If you have any of the following health conditions:
+ Diabetic acid problems
+ Digestion problems
+ Inflammatory bowel disease
+ Bowel block or are at risk for bowel block
+ Liver disease
+ Malabsorption syndrome
+ Ulcers in the colon
It is crucial to disclose all your medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, as well as any health problems you are experiencing. This will enable your doctor and pharmacist to assess potential interactions and ensure it is safe for you to take this medication. Do not initiate, discontinue, or modify the dose of any medication without first consulting your doctor.
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.
To monitor your condition effectively, check your blood sugar levels as directed by your doctor. Additionally, have your blood work checked as recommended by your doctor and discuss the results with them. Adhere to the diet and exercise plan outlined by your doctor to maintain optimal control over your blood sugar levels.
Be aware that stress, such as fever, infection, injury, or surgery, can make it more challenging to manage your blood sugar. Changes in physical activity, exercise, or diet can also impact your blood sugar control.
This medication may interfere with certain laboratory tests. Therefore, it is crucial to notify all your healthcare providers and laboratory personnel that you are taking this drug. If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks to you and your baby.
To monitor your condition effectively, check your blood sugar levels as directed by your doctor. Additionally, have your blood work checked as recommended by your doctor and discuss the results with them. Adhere to the diet and exercise plan outlined by your doctor to maintain optimal control over your blood sugar levels.
Be aware that stress, such as fever, infection, injury, or surgery, can make it more challenging to manage your blood sugar. Changes in physical activity, exercise, or diet can also impact your blood sugar control.
This medication may interfere with certain laboratory tests. Therefore, it is crucial to notify all your healthcare providers and laboratory personnel that you are taking this drug. If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks to you and your baby.
Overdose Information
Overdose Symptoms:
- Increased flatulence
- Diarrhea
- Abdominal discomfort/distension
What to Do:
Overdose of acarbose will not cause hypoglycemia in patients not also taking sulfonylureas or insulin. It may lead to transient increases in flatulence, diarrhea, and abdominal discomfort. Management is supportive. Avoid carbohydrate-containing meals for 4-6 hours. Call 1-800-222-1222 for poison control.
Drug Interactions
Contraindicated Interactions
- Intestinal adsorbents (e.g., charcoal)
- Digestive enzyme preparations (e.g., amylase, pancreatin)
Moderate Interactions
- Insulin (increased risk of hypoglycemia)
- Sulfonylureas (increased risk of hypoglycemia)
- Thiazide diuretics (may cause hyperglycemia)
- Corticosteroids (may cause hyperglycemia)
- Phenothiazines (may cause hyperglycemia)
- Thyroid products (may cause hyperglycemia)
- Estrogens (may cause hyperglycemia)
- Oral contraceptives (may cause hyperglycemia)
- Phenytoin (may cause hyperglycemia)
- Nicotinic acid (may cause hyperglycemia)
- Sympathomimetics (may cause hyperglycemia)
- Calcium channel blockers (may cause hyperglycemia)
- Isoniazid (may cause hyperglycemia)
Monitoring
Baseline Monitoring
HbA1c
Rationale: To establish baseline glycemic control.
Timing: Prior to initiation
Fasting Plasma Glucose (FPG)
Rationale: To establish baseline glycemic control.
Timing: Prior to initiation
Serum Creatinine / eGFR
Rationale: To assess renal function, as acarbose is contraindicated in severe renal impairment.
Timing: Prior to initiation
Liver Enzymes (ALT, AST)
Rationale: To assess baseline hepatic function, as acarbose can cause transient elevations and is contraindicated in cirrhosis.
Timing: Prior to initiation
Routine Monitoring
HbA1c
Frequency: Every 3-6 months
Target: <7% (individualized)
Action Threshold: Above target range, consider dose adjustment or additional therapy
Postprandial Plasma Glucose (PPG)
Frequency: Periodically (e.g., 1-2 hours after meals)
Target: <180 mg/dL (individualized)
Action Threshold: Consistently above target, consider dose adjustment
Liver Enzymes (ALT, AST)
Frequency: Every 3 months during the first year of treatment, then periodically
Target: Within normal limits
Action Threshold: Elevations >3x ULN, consider dose reduction or discontinuation
Renal Function (eGFR)
Frequency: Annually or as clinically indicated
Target: >25 mL/min
Action Threshold: eGFR <25 mL/min, discontinue acarbose
Symptom Monitoring
- Abdominal pain
- Flatulence
- Diarrhea
- Hypoglycemia (especially if used with insulin or sulfonylureas)
- Unexplained nausea, vomiting, dark urine, or jaundice (signs of liver injury)
Special Patient Groups
Pregnancy
Acarbose is Pregnancy Category B. While animal studies showed no harm, there are no adequate and well-controlled studies in pregnant women. Generally, insulin is preferred for glycemic control during pregnancy. Acarbose is not recommended during pregnancy.
Trimester-Specific Risks:
First Trimester:
Limited human data; generally not recommended.
Second Trimester:
Limited human data; generally not recommended.
Third Trimester:
Limited human data; generally not recommended.
Lactation
Acarbose is minimally absorbed, and its metabolites are excreted in breast milk. While the amount transferred to milk is low, potential for gastrointestinal effects in the infant cannot be excluded. Use is generally not recommended during breastfeeding.
Infant Risk:
Low to Moderate (L3 - Moderately Safe, but caution advised due to potential for GI effects in infant)
Pediatric Use
Safety and effectiveness have not been established in pediatric patients under 18 years of age. Use is not recommended.
Geriatric Use
No dosage adjustment is required based on age alone. However, due to potential for age-related decline in renal function, caution is advised, and renal function should be monitored. Start with the lowest dose (25 mg TID) and titrate slowly.
Clinical Information
Clinical Pearls
- Acarbose must be taken with the first bite of each main meal to be effective. If a meal is skipped, the dose for that meal should also be skipped.
- The most common side effects are gastrointestinal (flatulence, diarrhea, abdominal pain) due to undigested carbohydrates reaching the colon. These effects often diminish over time with continued use and dietary adherence.
- If hypoglycemia occurs (only when used with insulin or sulfonylureas), it must be treated with pure glucose (dextrose) because acarbose inhibits the breakdown of sucrose (table sugar) and other complex carbohydrates.
- Liver enzymes should be monitored, especially during the first year of treatment, as transient elevations have been reported.
Alternative Therapies
- Metformin (Biguanide)
- Sulfonylureas (e.g., Glipizide, Glyburide)
- Thiazolidinediones (e.g., Pioglitazone, Rosiglitazone)
- DPP-4 Inhibitors (e.g., Sitagliptin, Saxagliptin)
- GLP-1 Receptor Agonists (e.g., Liraglutide, Semaglutide)
- SGLT2 Inhibitors (e.g., Canagliflozin, Dapagliflozin)
- Insulin
Cost & Coverage
Average Cost:
$30 - $100 per 30 tablets (generic 25mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (Generic)
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 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 emergency medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.