Precose 25mg 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
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 medicine used to help control high blood sugar in people with type 2 diabetes. It works by slowing down the digestion of carbohydrates (sugars and starches) in your gut, which helps prevent your blood sugar from rising too high right after you eat.
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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 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 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 dose.
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Lifestyle & Tips

  • Take acarbose with the first bite of each main meal to ensure it works effectively.
  • 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 by your doctor.
  • If you experience hypoglycemia (low blood sugar) while taking acarbose with insulin or a sulfonylurea, treat it with glucose (dextrose) tablets or gel, as table sugar (sucrose) or complex carbohydrates may not be absorbed quickly enough due to acarbose's action.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

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

Condition-Specific Dosing:

Type 2 Diabetes Mellitus: Initial: 25 mg TID. Titrate gradually at 4-8 week intervals based on postprandial glucose and tolerability. Max dose: 50 mg TID for patients weighing ≤ 60 kg; 100 mg TID for patients weighing > 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 specific adjustment needed (CrCl > 50 mL/min)
Moderate: Use with caution (CrCl 25-50 mL/min), monitor closely.
Severe: Contraindicated (CrCl < 25 mL/min) due to increased systemic exposure of active metabolites.
Dialysis: Contraindicated (CrCl < 25 mL/min); not dialyzable.

Hepatic Impairment:

Mild: No specific adjustment needed, but monitor liver enzymes periodically.
Moderate: No specific adjustment needed, but monitor liver enzymes periodically.
Severe: No specific adjustment needed, but monitor liver enzymes periodically. Use with caution in patients with severe hepatic impairment.

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% (as active drug); approximately 35% of the dose is absorbed as metabolites.
Tmax: 1 hour (for metabolites)
FoodEffect: Must be taken with the first bite of each main meal for optimal efficacy.

Distribution:

Vd: Not available (due to minimal systemic absorption of parent drug)
ProteinBinding: Not significant
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 2 hours (for absorbed metabolites)
Clearance: Not available
ExcretionRoute: Fecal (unabsorbed drug and metabolites); Renal (absorbed metabolites)
Unchanged: Approximately 50% of the administered dose is excreted in the feces as unabsorbed drug within 96 hours.
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Pharmacodynamics

OnsetOfAction: Within minutes of ingestion (with first bite of meal)
PeakEffect: Approximately 1 hour post-meal (reduction in postprandial glucose)
DurationOfAction: Corresponds to the presence of food in the GI tract (meal-dependent)

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following signs or 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
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 attention 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. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:

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 flatulence, diarrhea, or abdominal pain (especially when starting or increasing dose)
  • Symptoms of hypoglycemia (if used with other diabetes medications: sweating, shakiness, dizziness, confusion, hunger, rapid heartbeat)
  • Signs of liver problems (unusual tiredness, dark urine, yellowing of skin or eyes, nausea, vomiting, stomach pain)
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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 symptoms you experienced.
If you have kidney disease.
* If you have any of the following health conditions:
+ Diabetic acidosis or other diabetic complications
+ Digestion problems
+ Inflammatory bowel disease
+ Bowel obstruction or are at risk for bowel obstruction
+ Liver disease
+ Malabsorption syndrome
+ Ulcers in the colon

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.
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Precautions & Cautions

It is essential to inform all of 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 can significantly increase your risk of being involved in an accident.

To ensure effective management of your condition, it is crucial to 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.

Adhering to the diet and exercise plan outlined by your doctor is vital for maintaining control over your blood sugar levels. Be aware that certain situations, such as fever, infection, injury, or surgery, can make it more challenging to manage your blood sugar. Similarly, changes in physical activity, exercise, or diet can also impact your blood sugar levels.

This medication may interfere with the accuracy of certain laboratory tests. Therefore, it is essential to inform all of your healthcare providers and laboratory personnel that you are taking this drug. If you are pregnant, planning to become pregnant, or are breastfeeding, consult with 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:

  • Increased flatulence
  • Diarrhea
  • Abdominal discomfort/distension

What to Do:

Overdose of acarbose will not cause hypoglycemia unless taken with sulfonylureas or insulin. Overdose symptoms are primarily exaggerated gastrointestinal effects. Management is symptomatic and supportive. Avoid food and drinks containing carbohydrates for 4-6 hours. Call 1-800-222-1222 (Poison Control Center) for advice.

Drug Interactions

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Major Interactions

  • Intestinal adsorbents (e.g., charcoal): 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 decrease plasma concentrations of digoxin. Monitor digoxin levels.
  • Thiazides, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blockers, isoniazid: These drugs may cause hyperglycemia and could reduce the glucose-lowering effect of acarbose. Monitor blood glucose closely.
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Confidence Interactions

Monitoring

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Baseline Monitoring

HbA1c

Rationale: To establish baseline glycemic control and guide initial therapy.

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.

Liver Enzymes (ALT, AST)

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

Timing: Prior to initiation of therapy.

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Routine Monitoring

HbA1c

Frequency: Every 3-6 months

Target: Individualized, typically <7% for most adults

Action Threshold: If target not met, consider dose adjustment or addition of other agents.

Postprandial Blood Glucose

Frequency: Periodically, especially during dose titration

Target: <180 mg/dL (1-2 hours post-meal)

Action Threshold: Persistent elevation may indicate need for dose adjustment or therapy change.

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: Significant or persistent elevations may warrant dose reduction or discontinuation.

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Symptom Monitoring

  • Abdominal discomfort (flatulence, diarrhea, abdominal pain)
  • Symptoms of hypoglycemia (if used with insulin or sulfonylureas: sweating, tremor, confusion, hunger)
  • Symptoms of liver injury (unexplained nausea, vomiting, abdominal pain, fatigue, dark urine, jaundice)

Special Patient Groups

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Pregnancy

Category B. Studies in animals have shown no evidence of harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. Generally, insulin is preferred for glycemic control during pregnancy.

Trimester-Specific Risks:

First Trimester: No known increased risk based on animal data, but human data are limited.
Second Trimester: No known increased risk based on animal data, but human data are limited.
Third Trimester: No known increased risk based on animal data, but human data are limited.
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Lactation

It is not known whether acarbose is excreted in human milk. However, small amounts of acarbose and its metabolites have been found in the milk of lactating rats. Due to potential for adverse effects in the 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: Not available (potential for unknown risk due to lack of human data and animal excretion).
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Pediatric Use

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

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Geriatric Use

No dosage adjustment is required based on age alone. However, due to the higher prevalence of renal impairment in elderly patients, renal function should be assessed before initiating therapy and monitored periodically. Start with the lowest dose (25 mg TID) and titrate slowly to minimize gastrointestinal side effects.

Clinical Information

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Clinical Pearls

  • Acarbose must be taken with the first bite of each main meal to be effective in delaying carbohydrate absorption.
  • The most common side effects are gastrointestinal (flatulence, diarrhea, abdominal pain), which tend to decrease over time with continued use and slow dose titration.
  • Hypoglycemia is rare when acarbose is used as monotherapy but can occur if combined with insulin or sulfonylureas. If hypoglycemia occurs, it must be treated with glucose (dextrose) and NOT sucrose (table sugar) or complex carbohydrates, as acarbose will prevent their rapid absorption.
  • Liver enzyme monitoring is recommended, especially during the first year of treatment, due to rare reports of transient elevations.
  • Contraindicated in patients with diabetic ketoacidosis, inflammatory bowel disease, colonic ulceration, partial intestinal obstruction, or in patients predisposed to intestinal obstruction, and in patients with chronic intestinal diseases associated with marked disorders of digestion or absorption.
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Alternative Therapies

  • Metformin (Biguanide)
  • Sulfonylureas (e.g., Glipizide, Glyburide)
  • Thiazolidinediones (e.g., Pioglitazone, Rosiglitazone)
  • DPP-4 Inhibitors (e.g., Sitagliptin, Saxagliptin)
  • SGLT2 Inhibitors (e.g., Canagliflozin, Dapagliflozin)
  • GLP-1 Receptor Agonists (e.g., Liraglutide, Semaglutide)
  • Insulin
  • Meglitinides (e.g., Repaglinide, Nateglinide)
  • Pramlintide (Amylin analog)
  • Miglitol (another alpha-glucosidase inhibitor)
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 30 tablets (generic)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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's a good idea to check with your pharmacist for more information. 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 emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.