Acarbose (Oral Route)

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.

This medicine is available only with your doctor`s prescription.

This product is available in the following dosage forms:

• Tablet

Before Using

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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 this medicine 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

This medicine 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

Breastfeeding

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.

Drug Interactions

Using this medicine 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


• Alatrofloxacin


• Balofloxacin


• Chlorpropamide


• Ciprofloxacin


• Clinafloxacin


• Enoxacin


• Fleroxacin


• Flumequine


• Gatifloxacin


• Gemifloxacin


• Gliclazide


• Glipizide


• Glyburide


• Grepafloxacin


• Levofloxacin


• Lomefloxacin


• Moxifloxacin


• Norfloxacin


• Ofloxacin


• Pefloxacin


• Prulifloxacin


• Rufloxacin


• Sparfloxacin


• Temafloxacin


• Tolazamide


• Tolbutamide


• Tosufloxacin


• Trovafloxacin Mesylate

Using this medicine 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


• Alprenolol


• Atenolol


• Betaxolol


• Bevantolol


• Bisoprolol


• Bitter Melon


• Bucindolol


• Carteolol


• Carvedilol


• Celiprolol


• Clorgyline


• Digoxin


• Dilevalol


• Esmolol


• Fenugreek


• Glucomannan


• Guar Gum


• Iproniazid


• Isocarboxazid


• Labetalol


• Levobunolol


• Mepindolol


• Metipranolol


• Metoprolol


• Moclobemide


• Nadolol


• Nebivolol


• Nialamide


• Oxprenolol


• Pargyline


• Penbutolol


• Phenelzine


• Pindolol


• Procarbazine


• Propranolol


• Psyllium


• Selegiline


• Sotalol


• St John`s Wort


• Talinolol


• Tertatolol


• Timolol


• Toloxatone


• Tranylcypromine


• Warfarin

Other Interactions

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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Diabetic ketoacidosis or


• Fever or


• Infection or


• Surgery or


• Traumaa€”Insulin is needed to control these conditions

• Digestion problems or


• Inflammatory bowel disease or


• Intestinal blockage or


• Other intestinal problemsa€”Acarbose should not be used

• Kidney disease (severe)a€”Higher blood levels of acarbose may occur; acarbose should not be used

• Liver diseasea€”Acarbose may make this condition worse

Proper Use

Follow carefully the special meal plan your doctor gave you. This is the most important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed .

For this medicine to work properly it must be taken at the beginning of each main meal .

Dosing

The dose of this medicine will be different for different patients. Follow your doctor`s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  
  
  
  • For type 2 diabetes:
    
    
    
    • Adultsa€”At first the dose is 25 milligrams (mg) three times a day, at the start of each main meal . Your dose may then be adjusted by your doctor .
    
    
    • Childrena€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  
  

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you finish a meal and you have forgotten to take the medicine, do not take the missed dose . Instead, take the next dose at the beginning of your next meal, as scheduled.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions

Your doctor will want to check your progress at regular visits , especially during the first few weeks you take this medicine.

It is very important to follow carefully any instructions from your health care team about:

• Alcohola€”Drinking alcohol may cause severe low blood sugar . Discuss this with your health care team.


• Other medicinesa€”Do not take other medicines during the time you are taking acarbose unless they have been discussed with your doctor . This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems .


• Counselinga€”Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in patients with diabetes during pregnancy.


• Travela€”Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.

In case of emergencya€”There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines.

Acarbose does not cause hypoglycemia (low blood sugar). However, low blood sugar can occur if you take acarbose with another type of diabetes medicine, delay or miss a meal or snack, exercise more than usual, drink alcohol, or cannot eat because of nausea or vomiting . Symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people may feel different symptoms of low blood sugar . It is important that you learn which symptoms of low blood sugar you usually have so that you can treat it quickly.

Symptoms of low blood sugar include anxiety; behavior change similar to being drunk; blurred vision; cold sweats; confusion; cool, pale skin; difficulty in thinking; drowsiness; excessive hunger; fast heartbeat; headache (continuing); nausea; nervousness; nightmares; restless sleep; shakiness; slurred speech; or unusual tiredness or weakness.

If symptoms of low blood sugar occur, eat glucose tablets or gel or honey, or drink fruit juice to relieve the symptoms . Table sugar (sucrose) or regular (nondiet) soft drinks will not work. Also, check your blood for low blood sugar . Glucagon is used in emergency situations when severe symptoms such as seizures (convulsions) or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. Members of your household also should know how to use it.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your antidiabetic medicine, overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual.

Symptoms of high blood sugar include blurred vision; drowsiness; dry mouth; flushed, dry skin; fruit-like breath odor; increased urination; ketones in urine; loss of appetite; stomachache, nausea, or vomiting; tiredness; troubled breathing (rapid and deep); unconsciousness; or unusual thirst.

If symptoms of high blood sugar occur, check your blood sugar level and then call your doctor for instructions.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention .

Check with your doctor as soon as possible if any of the following side effects occur:

Rare

• Yellow eyes or skin

Some side effects may occur that usually do not need medical attention . These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Abdominal or stomach pain


• Bloated feeling or passing of gas


• Diarrhea

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional .

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.