Acarbose

Name: Acarbose

What brand names are available for acarbose?

  • Precose is the brand name available for acarbose.

WWhich drugs or supplements interact with acarbose?

  • Acarbose may interfere with digoxin (Lanoxin) absorption thereby decreasing digoxin blood levels and its effect. Therefore, the digoxin dose may need to be increased if acarbose is begun.
  • Since adding insulin or a sulfonylurea to acarbose therapy may lower blood glucose more than acarbose alone, the risk for developing hypoglycemia is greater when these drugs are combined. Caution should be used when combining these drugs. If mild to moderate hypoglycemia occurs while taking acarbose in combination with another anti-diabetic drug, the treatment for hypoglycemia is with with oral glucose (dextrose) instead of sucrose (table sugar) because acarbose blocks the digestion of sucrose to glucose, and hypoglycemia will not be corrected rapidly with sucrose. Acarbose alone does not produce hypoglycemia.
  • Charcoal may absorb acarbose and digestive enzyme preparations such as amylase or pancreatin may breakdown acarbose and should not be administered. with this diabetes drug.

What special dietary instructions should I follow?

Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. It is important to eat a healthful diet.

Alcohol may cause a decrease in blood sugar. Ask your doctor about the safe use of alcoholic beverages while you are taking acarbose.

What side effects can this medication cause?

When used in combination with insulin or other medications used to treat diabetes, acarbose may cause excessive lowering of blood sugar levels.

If you have any of these symptoms, glucose products (Insta-Glucose or B-D Glucose tablets) should be used and you should call your doctor. Because acarbose blocks the breakdown of table sugar and other complex sugars, fruit juice or other products containing these sugars will not help to increase blood sugar. It is important that you and other members of your household understand this difference between acarbose and other medications used to treat diabetes.

  • shakiness
  • dizziness or lightheadedness
  • sweating
  • nervousness or irritability
  • sudden changes in behavior or mood
  • headache
  • numbness or tingling around the mouth
  • weakness
  • pale skin
  • hunger
  • clumsy or jerky movements

If hypoglycemia is not treated, severe symptoms may develop. Be sure that your family, friends, and other people who spend time with you know that if you have any of the following symptoms, they should get medical treatment for you immediately.

  • confusion
  • seizures
  • loss of consciousness

Call your doctor immediately if you have any of the following symptoms of hyperglycemia (high blood sugar):

  • extreme thirst
  • frequent urination
  • extreme hunger
  • weakness
  • blurred vision

If high blood sugar is not treated, a serious, life-threatening condition called diabetic ketoacidosis could develop. Call your doctor immediately if you have any of the these symptoms:

  • dry mouth
  • upset stomach and vomiting
  • shortness of breath
  • breath that smells fruity
  • decreased consciousness

What should I know about storage and disposal of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

What is acarbose?

Acarbose slows the digestion of carbohydrates in the body, which helps control blood sugar levels.

Acarbose is used together with diet and exercise to treat type 2 diabetes. Acarbose is sometimes used in combination with insulin or other diabetes medications you take by mouth.

Acarbose may also be used for purposes not listed in this medication guide.

What is the most important information I should know about acarbose?

You should not use acarbose if you have inflammatory bowel disease, an ulcer or blockage in your intestines, or cirrhosis of the liver. Do not use acarbose if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

What other drugs will affect acarbose?

You may be more likely to have hyperglycemia (high blood sugar) if you take acarbose with other drugs that can raise blood sugar, such as:

  • isoniazid (for treating tuberculosis);

  • niacin (Advicor, Niaspan, Niacor, Simcor, Slo Niacin, and others), nicotine patches or gum;

  • birth control pills and other hormones;

  • a diuretic or "water pill";

  • heart or blood pressure medicine;

  • insulin or oral diabetes medicine;

  • diet pills, stimulants, or medicines to treat asthma, colds or allergies;

  • phenothiazines (Compazine and others);

  • seizure medications (Dilantin and others);

  • steroids (prednisone and others); or

  • thyroid medicine (Synthroid and others).

This list is not complete. Other drugs may interact with acarbose, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Uses For acarbose

Acarbose is used to treat type 2 diabetes. Normally, your pancreas releases insulin into the blood stream after you eat. Insulin is used by all the cells in your body to help turn the food you eat into energy. This is done by using glucose (sugar) in the blood as quick energy. When you have type 2 diabetes, insulin is still produced by your pancreas, but the amount of insulin produced may not be enough or your body may not be using it properly and you may still need more. Because of this, the insulin is not able to lower your blood sugar properly and you will have too much sugar in your blood. Acarbose lowers your blood sugar by preventing the breakdown of starch into sugar. It may be used alone or in combination with another type of oral diabetes medicine called a sulfonylurea.

acarbose is available only with your doctor's prescription.

What are some other side effects of Acarbose?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Belly pain.
  • Gas.
  • Loose stools (diarrhea).
  • Bloating.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Pharmacologic Category

  • Antidiabetic Agent, Alpha-Glucosidase Inhibitor

Use Labeled Indications

Diabetes mellitus, type 2: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (noninsulin dependent, NIDDM)

Guideline recommendations: Alpha-glucosidase inhibitors (eg, acarbose) are generally not used in patients with type 2 diabetes, but may be tried in specific situations ADA 2017a.

Dosing Hepatic Impairment

There are no dosage adjustments provided in the manufacturer's labeling; contraindicated in patients with cirrhosis.

Warnings/Precautions

Concerns related to adverse effects:

• Elevated serum transaminases: Treatment-emergent elevations of serum transaminases (AST and/or ALT) and hyperbilirubinemia may occur (dose-related). These elevations were asymptomatic, reversible, more common in females, and, in general, were not associated with other evidence of liver dysfunction. Fulminant hepatitis (may be fatal) has been reported. If elevations are observed, a reduction in dosage or withdrawal of therapy may be indicated, particularly if the elevations persist.

• Hypoglycemia: Hypoglycemia is unlikely to occur with acarbose monotherapy but may occur with combination therapy (eg, sulfonylureas, insulin, metformin). In patients taking acarbose, oral glucose (dextrose) should be used instead of sucrose (cane sugar) in the treatment of mild-to-moderate hypoglycemia since the hydrolysis of sucrose to glucose and fructose is inhibited by acarbose.

Disease-related concerns:

• Hepatic impairment: Use with caution in patients with hepatic impairment.

• Renal impairment: Not recommended in patients with significant impairment (serum creatinine >2 mg/dL or CrCl <25 mL/minute/1.73 m2).

• Stress-related states: It may be necessary to discontinue acarbose and administer insulin if the patient is exposed to stress (ie, fever, trauma, infection, surgery).

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Other warnings/precautions:

• Appropriate use: Diet: Increased intake of sucrose (cane sugar) and food that contains sucrose during treatment can lead to GI symptoms (eg, flatulence and bloating), loose stools, and occasionally diarrhea. If a diabetic diet is not followed, the GI side effects may be intensified. If severe symptoms develop in spite of adherence to a diabetic diet, temporarily or permanently reduce dose.

• Patient education: Diabetes self-management education (DSME) is essential to maximize the effectiveness of therapy.

Acarbose Dosage

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

  • the condition being treated
  • other medical conditions you have
  • other medications you are taking
  • how you respond to this medication

The recommended starting dose of acarbose for the treatment of type 2 diabetes is 25 mg three times daily. Dose increases should be individualized on the basis of effectiveness and tolerance. The maximum recommended dose of acarbose is 100 mg three times daily.

What should i discuss with my healthcare provider before taking acarbose (precose)?

Do not use this medication if you are allergic to acarbose, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin). You also should not use acarbose if you have:

  • inflammatory bowel disease;
  • a blockage in your intestines;
  • a digestive disorder affecting your intestines;
  • intestinal ulcer (of your colon); or
  • cirrhosis of the liver.

To make sure you can safely take acarbose, tell your doctor if you have any of these other conditions:

  • liver disease; or
  • a bowel or intestinal disorder; or
  • a stomach disorder.

FDA pregnancy category B. Acarbose is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether acarbose passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using acarbose.

For Healthcare Professionals

Applies to acarbose: oral tablet

General

The most frequently reported adverse events include abdominal pain, diarrhea, and flatulence.[Ref]

Gastrointestinal

Very common (10% or more): Abdominal pain (19%), diarrhea (31%), flatulence (74%)
Uncommon (0.1% to 1%): Nausea,, vomiting, dyspepsia
Postmarketing reports: Ileus/subileus, pneumatosis cystoides intestinalis[Ref]

In large-scale clinical trials, a majority of patients have complained of gastrointestinal (GI) side effects. GI side effects usually developed within the first few weeks of therapy, were usually mild to moderate in severity, and typically decreased over time. The most common GI side effects were due to the fermentation of unabsorbed carbohydrates and resultant gas production. The severity of GI symptoms may be decreased by dosage reduction and by avoidance of gas-producing foods and sucrose.

There have been rare postmarketing reports of pneumatosis cystoides intestinalis associated with alpha-glucosidase inhibitors including this drug. If suspected, discontinue therapy and perform appropriate diagnostic testing.[Ref]

Hepatic

Very common (10% or more): Serum transaminase elevations (14%)
Postmarketing reports: Fulminant hepatitis with fatal outcome, jaundice and/or hepatitis and associated liver damage[Ref]

Treatment-emergent elevations of AST and ALT to greater the upper limit of normal, greater than 1.8 x ULN) and greater than 3 x ULN have been observed in 14%, 6%, and 3% of patients in studies of up to 12 months with doses up to 300 mg 3 times a day. The elevations were more common in women and generally asymptomatic and reversible. Additionally, these elevations appear to be dose-related.

International postmarketing experience: There have been 62 reports of of serum transaminase elevations to greater than 500 international units/liter, 29 were associated with jaundice. Of these 62 cases, 41 were receiving treatment with 100 mg 3 times a day or greater, 33 of 45 patients for whom weight was reported weighed less than 60 kg. In the 59 cases for which follow-up was provided, 55 had improvement or resolution of hepatic abnormalities with drug discontinuation, in 2 cases the hepatic abnormalities remained unchanged. Five cases of fulminant hepatitis with fatal outcome have been reported in Japan.[Ref]

Hematologic

Frequency not reported: Small reductions in hematocrit
Postmarketing reports: Thrombocytopenia[Ref]

Dermatologic

Frequency not reported: Acute generalized exanthematous pustulosis[Ref]

Hypersensitivity

Postmarketing reports: Hypersensitivity skin reactions (e.g. rash, erythema, exanthema, urticaria)[Ref]

Cardiovascular

Postmarketing reports: Edema[Ref]

Metabolic

This drug when administered as monotherapy should not cause hypoglycemia, but when administered with other agents, it may increase the potential for hypoglycemia. Low serum calcium and low plasma vitamin B6 levels were associated with use of this drug, however, they are thought to be spurious or of no clinical significance.[Ref]

Frequency not reported: Hypoglycemia, low serum calcium, low plasma vitamin B6 levels[Ref]

Some side effects of acarbose may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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