Precose 100mg Tablets

Manufacturer BAYER HEALTHCARE PHARMA Active Ingredient Acarbose(AY car bose) Pronunciation AY-car-bose
It is used to lower blood sugar in patients with high blood sugar (diabetes).
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Drug Class
Antidiabetic agent
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Pharmacologic Class
Alpha-glucosidase inhibitor
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Pregnancy Category
B
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FDA Approved
Dec 1995
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DEA Schedule
Not Controlled

Overview

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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.
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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 precisely. 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 better.

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 one.
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Lifestyle & Tips

  • Take acarbose with the first bite of each main meal (breakfast, lunch, and dinner). This is crucial for it to work effectively.
  • Continue to follow your prescribed diet and exercise plan as recommended by your doctor.
  • If you experience low blood sugar (hypoglycemia) while taking acarbose (especially if also on insulin or sulfonylureas), you MUST treat it with pure glucose (dextrose) tablets or gel. Table sugar (sucrose) or fruit juice will NOT work quickly enough because acarbose blocks its breakdown.
  • Be aware of potential gastrointestinal side effects like gas, bloating, and diarrhea, especially when starting the medication or increasing the dose. These often lessen over time.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 50 mg three times daily with the first bite of each main meal
Dose Range: 25 - 100 mg

Condition-Specific Dosing:

initial: 25 mg three times daily with the first bite of each main meal for 4-8 weeks
maintenance: Titrate gradually based on efficacy and tolerability, typically 50-100 mg three times daily. Max 100 mg TID for patients >60 kg, 50 mg TID for patients <=60 kg.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (Safety and efficacy not established in pediatric patients <18 years of age)
Adolescent: Not established (Safety and efficacy not established in pediatric patients <18 years of age)
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (CrCl >50 mL/min)
Moderate: No adjustment needed (CrCl 25-50 mL/min), but caution advised due to increased systemic exposure.
Severe: Contraindicated (CrCl <25 mL/min) due to significant increase in systemic exposure.
Dialysis: Contraindicated

Hepatic Impairment:

Mild: No specific adjustment, but monitor liver enzymes.
Moderate: No specific adjustment, but monitor liver enzymes.
Severe: Not recommended due to potential for liver enzyme elevation and lack of data.

Pharmacology

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Mechanism of Action

Acarbose is an oral alpha-glucosidase inhibitor. It competitively inhibits alpha-glucosidase enzymes (e.g., sucrase, maltase, glucoamylase, dextranase) in the brush border of the small intestine. This inhibition delays the digestion of complex carbohydrates (polysaccharides, oligosaccharides, and disaccharides) into absorbable monosaccharides (glucose). This results in a slower and lower rise in postprandial blood glucose levels.
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Pharmacokinetics

Absorption:

Bioavailability: <2% (systemic)
Tmax: 1 hour (for absorbed drug)
FoodEffect: Must be taken with the first bite of each main meal to exert its local effect in the intestine.

Distribution:

Vd: Not available (due to minimal systemic absorption)
ProteinBinding: Not available (due to minimal systemic absorption)
CnssPenetration: Limited (minimal systemic absorption)

Elimination:

HalfLife: Approximately 2 hours (for absorbed drug)
Clearance: Not available
ExcretionRoute: Renal (absorbed drug and metabolites), Fecal (unabsorbed drug)
Unchanged: Approximately 34% of an oral dose is excreted in feces as unabsorbed drug.
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Pharmacodynamics

OnsetOfAction: Within minutes of ingestion (local effect)
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.
Confidence: High

Safety & Warnings

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Side Effects

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 signs or symptoms, contact your doctor or seek medical attention immediately:

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

Most people do not experience significant side effects, but some may occur. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical attention:

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.
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Seek Immediate Medical Attention If You Experience:

  • Severe or persistent diarrhea or abdominal pain.
  • Symptoms of liver problems: unusual tiredness, dark urine, yellowing of skin or eyes (jaundice), nausea, vomiting, loss of appetite.
  • Symptoms of severe hypoglycemia (if on other diabetes meds): confusion, seizures, loss of consciousness.
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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. Be sure to describe the allergic reaction and its symptoms.
If you have kidney disease or any of the following health conditions: diabetic acidosis, digestive problems, inflammatory bowel disease, bowel obstruction or risk of bowel obstruction, liver disease, malabsorption syndrome, or colonic ulcers.

It is crucial to note that this list is not exhaustive, and you should disclose all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems to your doctor and pharmacist. This will help ensure that it is safe to take this medication in conjunction with your other treatments. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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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. 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. 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.

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 of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Temporary increase in flatulence
  • Diarrhea
  • Abdominal discomfort

What to Do:

An overdose of acarbose will not cause hypoglycemia in patients not also taking sulfonylureas or insulin. Overdose symptoms are primarily gastrointestinal. Avoid food and drink containing carbohydrates for 4-6 hours. Symptomatic and supportive care. Call 1-800-222-1222 (Poison Control).

Drug Interactions

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Major Interactions

  • Intestinal adsorbents (e.g., activated charcoal, cholestyramine): May reduce the effect of acarbose.
  • Digestive enzyme preparations (e.g., amylase, pancreatin): May reduce the effect of acarbose.
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Moderate Interactions

  • Digoxin: Acarbose may alter the bioavailability of digoxin, potentially decreasing digoxin levels. Monitor digoxin levels.
  • Sulfonylureas/Insulin: Increased risk of hypoglycemia when co-administered. Dose adjustment of sulfonylurea/insulin may be required. Hypoglycemia should be treated with oral glucose (dextrose), not sucrose (table sugar).

Monitoring

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Baseline Monitoring

HbA1c

Rationale: To establish baseline glycemic control.

Timing: Prior to initiation of therapy.

Fasting Plasma Glucose (FPG)

Rationale: To establish baseline glycemic control.

Timing: Prior to initiation of therapy.

Postprandial Glucose (PPG)

Rationale: Acarbose primarily targets postprandial glucose.

Timing: Prior to initiation of therapy.

Serum Transaminases (ALT, AST)

Rationale: To establish baseline liver function, as liver enzyme elevations have been reported.

Timing: Prior to initiation of therapy.

Serum Creatinine / eGFR

Rationale: To assess renal function, as acarbose is contraindicated in severe renal impairment.

Timing: Prior to initiation of therapy.

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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 Glucose (PPG)

Frequency: Periodically, or as needed for titration

Target: Individualized, typically <180 mg/dL 2 hours post-meal

Action Threshold: If target not met, consider dose adjustment.

Serum Transaminases (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 elevations occur, especially >3x ULN, consider dose reduction or discontinuation and investigate other causes.

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Symptom Monitoring

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

Special Patient Groups

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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.

Trimester-Specific Risks:

First Trimester: Limited human data, animal studies show no harm.
Second Trimester: Limited human data, animal studies show no harm.
Third Trimester: Limited human data, animal studies show no harm.
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Lactation

L3 (Moderate risk). It is not known whether acarbose is excreted in human milk. Due to the potential for serious adverse reactions in nursing infants, 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: Unknown, but potential for gastrointestinal effects or hypoglycemia in infant if excreted in milk.
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Pediatric Use

Safety and effectiveness have not been established in pediatric patients under 18 years of age.

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Geriatric Use

No specific dose adjustment is required based on age alone. However, due to potential for decreased renal function in elderly patients, renal function should be assessed. Start with a low dose and titrate slowly due to potential for increased sensitivity to side effects.

Clinical Information

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Clinical Pearls

  • Acarbose is most effective at reducing postprandial glucose excursions, making it a good choice for patients with predominantly high post-meal blood sugars.
  • The most common side effects are gastrointestinal (flatulence, diarrhea, abdominal pain), which tend to be dose-related and often improve with continued use or slower titration.
  • It is crucial to instruct patients to take acarbose with the first bite of each main meal for optimal efficacy.
  • Hypoglycemia, if it occurs (usually when combined with insulin or sulfonylureas), must be treated with glucose (dextrose) as acarbose prevents 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 reversible liver enzyme elevations.
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Alternative Therapies

  • 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
  • Meglitinides (e.g., repaglinide, nateglinide)
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Cost & Coverage

Average Cost: Varies widely, typically $15-$50 per 30 tablets (generic 100mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (for generic)
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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 your 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 taken, the amount, and the time it happened.