Acarbose 50mg 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
Category B
FDA Approved
Dec 1995
DEA Schedule
Not Controlled
Overview
What is this medicine?
Acarbose 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 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 with your doctor about how to take them in conjunction with this medication to ensure safe and effective use.
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 potency.
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 dose.
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 with your doctor about how to take them in conjunction with this medication to ensure safe and effective use.
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 potency.
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 dose.
Lifestyle & Tips
- Take acarbose with the first bite of each main meal. Do not skip meals or take it between meals.
- Continue to follow your prescribed diet and exercise plan. Acarbose works best when combined with a healthy lifestyle.
- If you experience low blood sugar (hypoglycemia) while taking acarbose with other diabetes medications (like insulin or sulfonylureas), you MUST treat it with pure glucose (dextrose) tablets or gel, NOT with table sugar or sugary foods/drinks. Acarbose prevents the breakdown of table sugar (sucrose) into glucose, so it won't raise your blood sugar quickly enough.
- Be prepared for potential gastrointestinal side effects like gas, bloating, and diarrhea, especially when starting the medication or increasing the dose. These usually lessen over time.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Initial: 25 mg three times daily with the first bite of each main meal. Maintenance: 50-100 mg three times daily with the first bite of each main meal.
Dose Range:
25 - 100 mg
Condition-Specific Dosing:
type2Diabetes:
Initial: 25 mg three times daily. Titrate gradually at 4-8 week intervals based on postprandial glucose and tolerability. Max dose: 50 mg three times daily for patients weighing â¤60 kg; 100 mg three times daily for patients weighing >60 kg.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (Safety and efficacy not established in pediatric patients <18 years of age)
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment needed (CrCl >50 mL/min)
Moderate:
Use with caution (CrCl 25-50 mL/min); consider lower doses and close monitoring.
Severe:
Contraindicated (CrCl <25 mL/min) due to increased systemic exposure.
Dialysis:
Contraindicated
Hepatic Impairment:
Mild:
No specific dose adjustment, but monitor liver enzymes periodically.
Moderate:
No specific dose adjustment, but monitor liver enzymes periodically.
Severe:
Not recommended due to potential for increased systemic exposure and lack of data.
Pharmacology
Mechanism of Action
Acarbose is an oral alpha-glucosidase inhibitor. It competitively inhibits alpha-glucosidase enzymes (sucrase, maltase, isomaltase, glucoamylase) in the brush border of the small intestine. This inhibition delays the digestion of complex carbohydrates (polysaccharides, oligosaccharides, and disaccharides) into absorbable monosaccharides (glucose). The delayed absorption of glucose leads to a reduction in postprandial blood glucose excursions.
Pharmacokinetics
Absorption:
Bioavailability:
<2% (systemic absorption of active drug is very low)
Tmax:
Approximately 1 hour (for the small amount absorbed)
FoodEffect:
Must be taken with the first bite of each main meal for optimal efficacy.
Distribution:
Vd:
Not available (due to minimal systemic absorption)
ProteinBinding:
Not applicable (minimal systemic absorption)
CnssPenetration:
Limited/No (due to minimal systemic absorption)
Elimination:
HalfLife:
Approximately 2 hours (for the absorbed portion)
Clearance:
Not precisely quantified due to minimal systemic absorption
ExcretionRoute:
Unabsorbed drug is excreted in feces. The small absorbed portion and its metabolites are primarily excreted renally.
Unchanged:
Approximately 50% of the administered dose is excreted unchanged in the feces.
Pharmacodynamics
OnsetOfAction:
Within minutes of ingestion (with the first bite of a meal)
PeakEffect:
Peak reduction in postprandial glucose occurs within 1-2 hours after a meal.
DurationOfAction:
Duration of effect is limited to the presence of food in the GI tract, typically 2-4 hours after a 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
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. Many people may not experience any side effects or may only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
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, 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
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. Many people may not experience any side effects or may only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
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 or persistent diarrhea, abdominal pain, or bloating.
- Symptoms of hypoglycemia (if on combination therapy): sweating, shakiness, dizziness, confusion, hunger, rapid heartbeat.
- Signs of liver problems: 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 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 acidosis or other diabetic complications
+ Digestion problems, such as difficulty absorbing nutrients
+ Inflammatory bowel disease, which includes conditions like Crohn's disease or ulcerative colitis
+ Bowel blockage or an increased risk of bowel blockage
+ Liver disease, which can impact the medication's metabolism
+ Malabsorption syndrome, a condition where your body has trouble absorbing nutrients
+ Ulcers in the colon, which can increase the risk of complications
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 drugs and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.
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.
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 acidosis or other diabetic complications
+ Digestion problems, such as difficulty absorbing nutrients
+ Inflammatory bowel disease, which includes conditions like Crohn's disease or ulcerative colitis
+ Bowel blockage or an increased risk of bowel blockage
+ Liver disease, which can impact the medication's metabolism
+ Malabsorption syndrome, a condition where your body has trouble absorbing nutrients
+ Ulcers in the colon, which can increase the risk of complications
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 drugs and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.
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.
Monitor your blood sugar levels as directed by your doctor to ensure they remain within a healthy range.
Regular blood tests will be necessary, as advised by your doctor. Be sure to discuss any concerns or questions you have with 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. Additionally, 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 inform 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 of this medication to both you and your baby.
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 to ensure they remain within a healthy range.
Regular blood tests will be necessary, as advised by your doctor. Be sure to discuss any concerns or questions you have with 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. Additionally, 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 inform 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 of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Transient increase in flatulence
- Diarrhea
- Abdominal discomfort
What to Do:
An overdose of acarbose will not cause systemic adverse effects. However, it may lead to increased flatulence, diarrhea, and abdominal discomfort. Avoid consuming carbohydrate-containing foods or drinks for 4-6 hours after an overdose. Symptomatic and supportive care. Call 1-800-222-1222 (Poison Control Center).
Drug Interactions
Moderate Interactions
- Intestinal adsorbents (e.g., charcoal, cholestyramine): May reduce the effect of acarbose.
- Digestive enzyme preparations (e.g., amylase, pancreatin): May reduce the effect of acarbose.
- Thiazide diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blockers, isoniazid: May cause hyperglycemia and lead to loss of glycemic control with acarbose.
Minor Interactions
- Digoxin: Acarbose may decrease digoxin bioavailability, requiring digoxin dose adjustment and monitoring.
Monitoring
Baseline Monitoring
HbA1c
Rationale: To establish baseline glycemic control and assess long-term efficacy.
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 establish baseline liver function, as transient elevations have been reported.
Timing: Prior to initiation
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 (1-hour or 2-hour PPG)
Frequency: Periodically, or as needed to assess efficacy and guide titration
Target: Individualized, typically <180 mg/dL (1-hour PPG) or <140 mg/dL (2-hour PPG)
Action Threshold: If consistently elevated, consider dose adjustment.
Liver enzymes (ALT, AST)
Frequency: Every 3 months during the first year of treatment, then periodically (e.g., annually) or as clinically indicated.
Target: Within normal limits
Action Threshold: If persistent elevations >3x ULN, consider dose reduction or discontinuation.
Symptom Monitoring
- Gastrointestinal side effects (flatulence, diarrhea, abdominal pain/cramping)
- Symptoms of hypoglycemia (if used with insulin or sulfonylureas): sweating, tremor, dizziness, confusion, hunger (note: treat with glucose, not sucrose)
- Symptoms of liver injury (unexplained nausea, vomiting, abdominal pain, fatigue, dark urine, jaundice)
Special Patient Groups
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. Acarbose is generally not recommended for use during pregnancy, as insulin is typically preferred for glycemic control in pregnant women with diabetes.
Trimester-Specific Risks:
First Trimester:
No specific increased risk identified in animal studies, but human data are lacking.
Second Trimester:
No specific increased risk identified in animal studies, but human data are lacking.
Third Trimester:
No specific increased risk identified in animal studies, but human data are lacking.
Lactation
L3 (Moderately safe). It is unknown if acarbose is excreted in human milk. Animal studies show excretion of radioactivity into milk after administration of radiolabeled acarbose. Due to the potential for adverse effects in the nursing infant, 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.
Infant Risk:
Potential for unknown effects due to minimal systemic absorption in mother, but caution advised.
Pediatric Use
Safety and efficacy have not been established in pediatric patients (<18 years of age). Therefore, its use is not recommended in this population.
Geriatric Use
No specific dose adjustment is required based on age alone. However, elderly patients are more likely to have impaired renal function, which necessitates careful monitoring of renal function (CrCl) and avoidance in severe renal impairment. Start with lower doses and titrate slowly to minimize GI side effects.
Clinical Information
Clinical Pearls
- Acarbose is most effective at reducing postprandial glucose excursions and is particularly useful for patients with significant post-meal hyperglycemia.
- The most common side effects are gastrointestinal (flatulence, diarrhea, abdominal pain) and tend to be dose-related. Starting with a low dose and titrating slowly can help improve tolerability.
- Instruct patients to take acarbose with the first bite of each main meal to ensure optimal efficacy.
- If hypoglycemia occurs when acarbose is used in combination with insulin or sulfonylureas, it must be treated with pure glucose (dextrose), as acarbose inhibits the breakdown of sucrose (table sugar) into absorbable glucose.
- Liver enzyme monitoring is recommended, especially during the first year of treatment, due to rare reports of transient elevations.
Alternative Therapies
- Metformin (first-line for most type 2 diabetes patients)
- Sulfonylureas (e.g., glipizide, glyburide, glimepiride)
- 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
- Meglitinides (e.g., repaglinide, nateglinide)
- Pramlintide
Cost & Coverage
Average Cost:
$15 - $50 per 30 tablets (generic 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 safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not 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 medication taken, the amount, and the time it occurred.