Acarbose

Name: Acarbose

IIs acarbose available as a generic drug?

  • Yes. This diabetes drug is available as generic, and is as an oral tablet.

Do I need a prescription for acarbose?

  • Yes. A prescription is necessary to obtain this diabetes drug.

WWhat are the side effects of acarbose?

The most common side effects of include:

  • Abdominal pain
  • Diarrhea
  • Flatulence (gas)
  • An increase in liver enzymes

There is a rare possibility that these gastrointestinal side effects may become severe and progress to intestinal obstruction caused by paralysis of the intestinal muscles (paralytic ileus).

Possible serious, but rare side effects of include:

  • Decreases in hematocrit, calcium or vitamin B6 levels
  • Liver failure
  • Jaundice
  • Hepatitis
  • Ileus
  • A reduction in the number of platelets (thrombocytopenia)
  • Severe skin reactions (rash, erythema, exantherma, and hives [urticaria])
  • Pneumatosis cystoides intestinalis infection

Is acarbose safe to use during pregnancy or while breastfeeding?

  • There are no studies of acarbose treatment during pregnancy in humans. Insulin therapy is recommended in pregnancy.
  • Acarbose is excreted in the milk of lactating animals, but no human studies have been conducted. Precose use is not recommended for women who are breastfeeding.

What should I discuss with my healthcare provider before taking acarbose?

You should not use acarbose if you are allergic to it, or if you have:

  • inflammatory bowel disease;

  • a blockage in your intestines;

  • a digestive disorder affecting your intestines;

  • intestinal ulcer (of your colon);

  • cirrhosis of the liver; or

  • diabetic ketoacidosis (call your doctor for treatment with insulin).

To make sure acarbose is safe for you, tell your doctor if you have:

  • liver disease;

  • kidney disease;

  • a bowel or intestinal disorder; or

  • a stomach disorder.

This medicine is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

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.

Acarbose is not approved for use by anyone younger than 18 years old.

Introduction

Antidiabetic agent; an α-glucosidase inhibitor.1 6 30 52

Interactions for Acarbose

Digestive Enzyme Supplements

Possible reduction in the glycemic effects of acarbose.1 Avoid concomitant use.1

Intestinal Adsorbents

Possible reduction in the glycemic effects of acarbose.1 Avoid concomitant use.1

Specific Drugs

Drug

Interaction

Comments

Amylase (digestive enzyme preparation)

Possible reduction in glycemic effects of acarbose1

Avoid concomitant use1

Calcium-channel blocking agents

Potential to exacerbate hyperglycemia, resulting in loss of glycemic control1

No effect of acarbose on the pharmacokinetic or pharmacodynamics of nifedipine1

Monitor for loss of glycemic control1

When calcium-channel blocking agents are withdrawn in patients receiving concurrent sulfonylureas or insulin, monitor for evidence of hypoglycemia1

Charcoal (intestinal adsorbent)

Possible reduction in glycemic effects of acarbose1

Avoid concomitant use1

Corticosteroids

Potential to exacerbate hyperglycemia, resulting in loss of glycemic control1

Monitor for loss of glycemic control1

When corticosteroids are withdrawn in patients receiving concurrent sulfonylureas or insulin, monitor for evidence of hypoglycemia1

Contraceptives, oral

Potential exacerbation of hyperglycemia/loss of glycemic control1

Monitor for loss of glycemic control1

When oral contraceptives are withdrawn in patients receiving concurrent sulfonylureas or insulin, observe for evidence of hypoglycemia1

Digoxin

Decreased blood concentrations of digoxin1

May require increased digoxin dosage1

Diuretics (e.g., thiazides)

Potential exacerbation of hyperglycemia, resulting in loss of glycemic control1

Monitor for loss of glycemic control1

When diuretics are withdrawn in patients receiving concurrent sulfonylureas or insulin, observe for evidence of hypoglycemia1

Estrogens

Potential to exacerbate hyperglycemia, resulting in loss of glycemic control1

Monitor for loss of glycemic control1

When estrogens are withdrawn in patients receiving concurrent sulfonylureas or insulin, observe for evidence of hypoglycemia1

Glyburide

No effect on absorption or disposition of concomitant glyburide1

Pharmacokinetic interaction with glyburide unlikely1

Insulin

Increased risk of hypoglycemia, rarely hypoglycemic shock, with concomitant insulin1

If hypoglycemia occurs, reduce insulin dosage1

Isoniazid

Potential to exacerbate hyperglycemia, resulting in loss of glycemic control1

Monitor for loss of glycemic control1

When isoniazid is withdrawn in patients receiving concurrent sulfonylureas or insulin, monitor for evidence of hypoglycemia1

Metformin

Possible decreased peak plasma concentration of metformin1

Pharmacokinetic interaction not considered clinically important1

Nicotinic acid

Potential to exacerbate diabetes mellitus, resulting in loss of glycemic control1

Monitor for loss of glycemic control1

When nicotinic acid is withdrawn in patients receiving concurrent sulfonylureas or insulin, observe for evidence of hypoglycemia1

Pancreatin (digestive enzyme preparation; no longer commercially available in the US)

Possible reduction in glycemic effects of acarbose1

Avoid concomitant use1

Phenothiazines

Potential to exacerbate hyperglycemia, resulting in loss of glycemic control1

Monitor for loss of glycemic control1

When phenothiazines are withdrawn in patients receiving concurrent sulfonylureas or insulin, monitor for evidence of hypoglycemia1

Phenytoin

Potential to exacerbate hyperglycemia, resulting in loss of glycemic control1

Monitor for loss of glycemic control1

When phenytoin is withdrawn in patients receiving concurrent sulfonylureas or insulin, monitor for evidence of hypoglycemia1

Pramlintide

Delayed gastric emptying caused by α-glucosidase inhibitors may alter effects of pramlintide on GI absorption of nutrients112

Avoid concomitant pramlintide; safety/efficacy of combination therapy not established112

Propranolol

Pharmacokinetic or pharmacodynamic interaction unlikely1

Ranitidine

Pharmacokinetic or pharmacodynamic interaction unlikely1

Rosiglitazone

Reduced extent of absorption and prolonged half-life of rosiglitazone113

Potential for altered glycemic control is uncertain114

Pharmacokinetic interaction not considered clinically important113

Sulfonylureas

Increased risk of hypoglycemia, hypoglycemic shock with sulfonylureas1

If hypoglycemia occurs, reduce sulfonylurea dosage1

Sympathomimetic agents

Potential to exacerbate hyperglycemia, resulting in loss of glycemic control1

Monitor for loss of glycemic control1

When sympathomimetic agents are withdrawn in patients receiving concurrent sulfonylureas or insulin, monitor for evidence of hypoglycemia.1

Thyroid agents

Potential to exacerbate hyperglycemia, resulting in loss of glycemic control1

Monitor for loss of glycemic control1

When thyroid agents are withdrawn in patients receiving concurrent sulfonylureas or insulin, monitor for evidence of hypoglycemia1

Commonly used brand name(s)

In the U.S.

  • Precose

Available Dosage Forms:

  • Tablet

Therapeutic Class: Antidiabetic

Pharmacologic Class: Alpha-Glucosidase Inhibitor

Before Using acarbose

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For acarbose, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to acarbose or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on acarbose have been done only in adult patients, and there is no specific information comparing use of acarbose in children with use in other age groups.

Geriatric

acarbose has been tested in a limited number of elderly people and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

Pregnancy Category Explanation
All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking acarbose, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using acarbose with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acetohexamide
  • Aspirin
  • Balofloxacin
  • Besifloxacin
  • Chlorpropamide
  • Ciprofloxacin
  • Digoxin
  • Enoxacin
  • Fleroxacin
  • Flumequine
  • Gatifloxacin
  • Gemifloxacin
  • Gliclazide
  • Glipizide
  • Glyburide
  • Lanreotide
  • Levofloxacin
  • Lomefloxacin
  • Moxifloxacin
  • Nadifloxacin
  • Norfloxacin
  • Octreotide
  • Ofloxacin
  • Pasireotide
  • Pazufloxacin
  • Pefloxacin
  • Pioglitazone
  • Prulifloxacin
  • Rufloxacin
  • Sparfloxacin
  • Thioctic Acid
  • Tolazamide
  • Tolbutamide
  • Tosufloxacin

Using acarbose with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acebutolol
  • Atenolol
  • Betaxolol
  • Bisoprolol
  • Bitter Melon
  • Carteolol
  • Carvedilol
  • Celiprolol
  • Esmolol
  • Fenugreek
  • Furazolidone
  • Glucomannan
  • Guar Gum
  • Iproniazid
  • Isocarboxazid
  • Labetalol
  • Levobunolol
  • Linezolid
  • Methylene Blue
  • Metipranolol
  • Metoprolol
  • Moclobemide
  • Nadolol
  • Nebivolol
  • Nialamide
  • Oxprenolol
  • Penbutolol
  • Phenelzine
  • Pindolol
  • Practolol
  • Procarbazine
  • Propranolol
  • Psyllium
  • Rasagiline
  • Safinamide
  • Selegiline
  • Sotalol
  • Timolol
  • Tranylcypromine
  • Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of acarbose. Make sure you tell your doctor if you have any other medical problems, especially:

  • Diabetic ketoacidosis or
  • Fever or
  • Infection or
  • Surgery or
  • Trauma—Insulin is needed to control these conditions
  • Digestion problems or
  • Inflammatory bowel disease or
  • Intestinal blockage or
  • Other intestinal problems—Acarbose should not be used
  • Kidney disease (severe)—Higher blood levels of acarbose may occur; acarbose should not be used
  • Liver disease—Acarbose may make this condition worse

What do I need to tell my doctor BEFORE I take Acarbose?

  • If you have an allergy to acarbose or any other part of acarbose.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have kidney disease.
  • If you have any of these health problems: Diabetic acid problems, problems with food break down, inflammatory bowel disease, bowel block or at risk for bowel block, liver disease, malabsorption syndrome, or ulcers in the colon.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take acarbose with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Acarbose?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • Check your blood sugar as you have been told by your doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Talk with your doctor before you drink alcohol.
  • Follow the diet and workout plan that your doctor told you about.
  • It may be harder to control your blood sugar during times of stress like when you have a fever, an infection, an injury, or surgery. A change in level of physical activity or exercise and a change in diet may also affect your blood sugar. Talk with your doctor.
  • This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take acarbose.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Low blood sugar can happen. The chance of low blood sugar may be raised when this medicine is used with other drugs for high blood sugar (diabetes). Signs may be dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating. Call your doctor right away if you have any of these signs. Follow what you have been told to do if you get low blood sugar. This may include taking glucose tablets, liquid glucose, or some fruit juices.
  • Very bad and sometimes deadly liver problems have happened with acarbose. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.

How is Acarbose Supplied

Acarbose Tablets 25 mg are white to yellowish, round biconvex tablets marked "318" on one face and "cor" on the other face. They are supplied as follows:

Bottles of 100 NDC 69543-120-10
Bottles of 1000 NDC 69543-120-11

Acarbose Tablets 50 mg are white to yellowish, round biconvex tablets marked "319" on one face and "cor" on the other face. They are supplied as follows:

Bottles of 100 NDC 69543-121-10
Bottles of 1000 NDC 69543-121-11

Acarbose Tablets 100 mg are white to yellowish, round biconvex tablets marked "320" on one face and "cor" on the other face. They are supplied as follows:

Bottles of 100 NDC 69543-122-10
Bottles of 1000 NDC 69543-122-11

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Protect from moisture. Keep container tightly closed.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Rev: August 2016

Distributed By:
Virtus Pharmaceuticals, LLC
Tampa, FL 33619
1-888-848-3593

Manufactured By:
Bluepharma Indústria Farmacêutica, S.A.
S. Martinho do Bispo
3045-016 Coimbra, Portugal

PRINCIPAL DISPLAY PANEL - 25 mg Tablet Bottle Label

NDC 69543-120-10

Acarbose
Tablets 25 mg

Rx only

100 Tablets

VIRTUS
PHARMACEUTICALS

PRINCIPAL DISPLAY PANEL - 100 mg Tablet Bottle Label

NDC 69543-122-10

Acarbose
Tablets 100 mg

Rx only

100 Tablets

VIRTUS
PHARMACEUTICALS

Acarbose 
Acarbose tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:69543-120
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acarbose (Acarbose) Acarbose 25 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN  
MICROCRYSTALLINE CELLULOSE  
MAGNESIUM STEARATE  
SILICON DIOXIDE  
Product Characteristics
Color WHITE (White to yellowish) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code cor;318
Contains     
Packaging
# Item Code Package Description
1 NDC:69543-120-10 100 TABLET in 1 BOTTLE
2 NDC:69543-120-11 1000 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091343 02/01/2015
Acarbose 
Acarbose tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:69543-121
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acarbose (Acarbose) Acarbose 50 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN  
MICROCRYSTALLINE CELLULOSE  
MAGNESIUM STEARATE  
SILICON DIOXIDE  
Product Characteristics
Color WHITE (White to yellowish) Score no score
Shape ROUND Size 7mm
Flavor Imprint Code cor;319
Contains     
Packaging
# Item Code Package Description
1 NDC:69543-121-10 100 TABLET in 1 BOTTLE
2 NDC:69543-121-11 1000 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091343 02/01/2015
Acarbose 
Acarbose tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:69543-122
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acarbose (Acarbose) Acarbose 100 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN  
MICROCRYSTALLINE CELLULOSE  
MAGNESIUM STEARATE  
SILICON DIOXIDE  
Product Characteristics
Color WHITE (white to yellowish) Score no score
Shape ROUND Size 9mm
Flavor Imprint Code cor;320
Contains     
Packaging
# Item Code Package Description
1 NDC:69543-122-10 100 TABLET in 1 BOTTLE
2 NDC:69543-122-11 1000 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091343 02/01/2015
Labeler - Virtus Pharmaceuticals LLC (079659493)
Revised: 07/2017   Virtus Pharmaceuticals LLC

Dosing Geriatric

Refer to adult dosing.

Description

PRECOSE® (acarbose tablets) is an oral alpha-glucosidase inhibitor for use in the management of type 2 diabetes mellitus. Acarbose is an oligosaccharide which is obtained from fermentation processes of a microorganism, Actinoplanes utahensis, and is chemically known as O-4,6-dideoxy4-[[(1S,4R,5S,6S)-4,5,6-trihydroxy-3-(hydroxymethyl)-2-cyclohexen-1-yl]amino] α-D-glucopyranos yl-(1 → 4)-O-α-D-glucopyranosyl-(1 →4)-D-glucose. It is a white to off-white powder with a molecular weight of 645.6. Acarbose is soluble in water and has a pKa of 5.1. Its empirical formula is C25H43NO18 and its chemical structure is as follows:

PRECOSE is available as 25 mg, 50 mg and 100 mg tablets for oral use. The inactive ingredients are starch, microcrystalline cellulose, magnesium stearate, and colloidal silicon dioxide.

Uses of Acarbose

Acarbose is a prescription medication used to treat type 2 diabetes along with diet and exercise.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Acarbose Drug Class

Acarbose is part of the drug class:

  • Alpha glucosidase inhibitors

Acarbose and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Acarbose falls into category B.

There are no well-done studies that have been done in humans with acarbose. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

Dosing & Uses

Dosage Forms & Strengths

tablet

  • 25mg
  • 50mg
  • 100mg

Type 2 Diabetes Mellitus

Initially 25 mg PO q8hr, at meals (with first bite)

Can increase to 50 or 100 mg PO q8hr at 4- to 8-wk intervals based on 1 hour postprandial glucose or glycosylated hemoglobin levels, and on tolerance

Maximum Dose

<60 kg: 50 mg q8hr

>60 kg: 100 mg q8hr

Other Indications & Uses

Type 2 DM, mono treatment or with sulfonylurea

Safety & efficacy not established

What is acarbose (precose)?

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

Acarbose is used 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 happens if i miss a dose (precose)?

Take the missed dose as soon as you remember (be sure to take it with a meal). If it has been longer than 15 minutes since you started your meal, you may still take acarbose but it may be less effective than taking it with the first bite of the meal. Do not take acarbose between meals, and do not take extra medicine to make up a missed dose.

  • Diabetes (Type 1 and Type 2)
  • Diabetes Treatment (Type 1 and Type 2 Medications and Diet)
  • Oral Diabetes Prescription Medications

Usual Adult Dose for Diabetes Type 2

Individualize dose based on efficacy and tolerability:

Initial dose: 25 mg orally 3 times a day
-Adjust dose at 4 to 8 week intervals based on efficacy and tolerability
Maintenance dose: 50 mg to 100 mg orally 3 times a day
Maximum dose: Weight 60 kg or less: 50 mg orally 3 times a day; Weight greater than 60 kg: 100 mg orally 3 times a day

Comments:
-Take at the start (with first bite) of each main meal; patients should be adhering to a diabetic diet to minimize GI side effects.
-Some patients benefit from starting at 25 mg orally once a day with subsequent titration to 3 times a day to minimize GI side effects.
-If no further reduction in postprandial glucose or HbA1c is observed with titration to 100 mg three times a day, consider lowering the dose.

Use: As an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.

Dose Adjustments

Significant renal dysfunction (serum creatinine greater than 2 mg/dL): Use is not recommended

Acarbose Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug. Excreted into human milk: Unknown Excreted into animal milk: Yes The effects in the nursing infant are unknown.

This drug and/or its metabolites have been found in the milk of lactating rats with levels reaching 10 times the maternal plasma levels. Less than 2% of a dose is absorbed from the mother's gastrointestinal tract making the likelihood of it reaching the infant through breast milk unlikely. However since there is no information in women using this drug while breastfeeding, alternate therapy should be considered.

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