Acarbose

What is Acarbose?

• Acarbose (Precose; Prandase), a pseudotetrasaccharide and inhibitor of alpha-glucosidase and pancreatic alpha-amylase with antihyperglycemic activity used to treat diabetes mellitus type 2 and, in some countries, prediabetes.

Acarbose structure

Acarbose-3D-balls

Acarbose

What are the uses of this medicine?

• Acarbose (Precose; Prandase) is an oral alpha-glucosidase inhibitor used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

How does this medicine work?

• Acarbose (ay' kar bose) is an inhibitor of intestinal alpha-glucosidase, an enzyme responsible for digestion and absorption of starch, disaccharides and dextrin.
• The inhibition of the glucosidase activity in the intestinal brush border blocks the breakdown of starch and disaccharides to absorbable monosaccharides, leading to carbohydrate malabsorption and blunting of the postprandial rise in blood glucose.
• In addition, acarbose inhibits pancreatic alpha-amylase which hydrolyzes complex starches to oligosaccharides in the small intestines.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• with known hypersensitivity to the drug
• with diabetic ketoacidosis or cirrhosis
• with inflammatory bowel disease, colonic ulceration, partial intestinal obstruction or in patients predisposed to intestinal obstruction
• chronic intestinal diseases with marked disorders of digestion or absorption and in patients who have conditions that may deteriorate as a result of increased gas formation in the intestine.

What drug interactions can this medicine cause?

Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following:

• medications for diabetes

digoxin (Lanoxin) diuretics ('water pills') estrogens isoniazid medications for high blood pressure or colds oral contraceptives pancreatic enzymes phenytoin (Dilantin) steroids thyroid medications vitamins

Is this medicine FDA approved?

• Acarbose was approved for use in the United States in 1995 and was the first alpha-glucosidase inhibitor introduced into clinical practice.
• A similar alpha glucosidase inhibitor, miglitol, was approved the following year.
• The current indications for acarbose are for management of glycemic control in type 2 diabetes used in combination with diet and exercise, with or without other oral hypoglycemic agents or insulin.

How should this medicine be used?

• There is no fixed dosage regimen for the management of diabetes mellitus with Acarbose Tablets or any other pharmacologic agent.
• Dosage of Acarbose Tablets must be individualized on the basis of both effectiveness and tolerance while not exceeding the maximum recommended dose of 100 mg t.i.d.

Recommended dosage:

• The recommended starting dosage of Acarbose Tablets is 25 mg given orally three times daily at the start (with the first bite) of each main meal.
• Once a 25 mg t.i.d. dosage regimen is reached, dosage of Acarbose Tablets should be adjusted at 4-8 week intervals based on one-hour postprandial glucose or glycosylated hemoglobin levels, and on tolerance.
• The dosage can be increased from 25 mg t.i.d. to 50 mg t.i.d.
• The maximum recommended dose for patients ≤ 60 kg is 50 mg t.i.d.
• The maximum recommended dose for patients > 60 kg is 100 mg t.i.d.

Administration:

• Acarbose comes as a tablet to take by mouth.
• It is usually taken three times a day.
• It is very important to take each dose with the first bite of each main meal.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Acarbose Tablets are available as 25 mg, 50 mg and 100 mg for oral use.

This medicine is available in fallowing brand namesː

• Precose; Prandase

What side effects can this medication cause?

The most common side effects of this medicine include:

• abdominal pain
• diarrhea
• flatulence
• Elevated Serum Transaminase
• hepatitis
• hypersensitive skin reactions
• edema
• ileus/subileus
• thrombocytopenia
• pneumatosis cystoides intestinalis

What special precautions should I follow?

• Because of their mechanism of action, Acarbose Tablets when administered alone should not cause hypoglycemia. Because Acarbose Tablets given in combination with a sulfonylurea or insulin will cause a further lowering of blood glucose, it may increase the potential for hypoglycemia. Severe hypoglycemia may require the use of either intravenous glucose infusion or glucagon injection.
• When diabetic patients are exposed to stress such as fever, trauma, infection, or surgery, a temporary loss of control of blood glucose may occur. At such times, temporary insulin therapy may be necessary.
• Patients should be told to take Acarbose Tablets orally three times a day at the start (with the first bite) of each main meal. It is important that patients continue to adhere to dietary instructions, a regular exercise program, and regular testing of urine and/or blood glucose.
• Measurement of glycosylated hemoglobin levels is recommended for the monitoring of long-term glycemic control.
• Acarbose Tablets, particularly at doses in excess of 50 mg t.i.d., may give rise to elevations of serum transaminases and, in rare instances, hyperbilirubinemia. It is recommended that serum transaminase levels be checked every 3 months during the first year of treatment with Acarbose Tablets and periodically thereafter. If elevated transaminases are observed, a reduction in dosage or withdrawal of therapy may be indicated, particularly if the elevations persist.
• Monitoring glycemic control with 1,5-AG assay is not recommended as measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking acarbose. Use alternative methods to monitor for glycemic control.
• Treatment of patients with Renal Impairment with Acarbose Tablets is not recommended.
• Because many drugs are excreted in human milk, Acarbose Tablets should not be administered to a nursing woman.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• flatulence
• diarrhea
• abdominal discomfort

Management of overdosage:

• In cases of overdosage the patient should not be given drinks or meals containing carbohydrates (polysaccharides, oligosaccharides and disaccharides) for the next 4-6 hours.

Can this medicine be used in pregnancy?

• Pregnancy Category B.
• The safety of Acarbose Tablets in pregnant women has not been established.

Can this medicine be used in children?

• Safety and effectiveness of Acarbose Tablets in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active Ingredient:

• ACARBOSE

Inactive Ingredients:

• STARCH, CORN
• CELLULOSE, MICROCRYSTALLINE
• MAGNESIUM STEARATE
• SILICON DIOXIDE

Who manufactures and distributes this medicine?

Manufactured by:

• Strides Pharma Science Limited
• Bengaluru, India.

Distributed by:

• Strides Pharma Inc.
• East Brunswick, NJ

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

• Store at 20˚ to 25˚C (68˚ to 77˚F).
• Protect from moisture.
• Keep container tightly closed.

Antidiabetics

•  Alpha-Glucosidase Inhibitors
  • Acarbose
  • Miglitol
• Incretin-Based Drugs
  • Dipeptidyl Peptidase-4 (DPP-4) Inhibitors
    • Alogliptin
    • Linagliptin
    • Saxagliptin
    • Sitagliptin
  • Glucagon-Like Peptide-1 (GLP-1) Analogues
    • Albiglutide
    • Dulaglutide
    • Exenatide
    • Liraglutide
    • Lixisenatide
•  Insulin
• Metformin
• Metiglinide Analogues
  • Nateglinide
  • Repaglinide
• Pramlintide
• Sodium Glucose Cotransporter-2 (SGLT-2) Inhibitors
  • Canagliflozin
  • Dapagliflozin
  • Empagliflozin
• Sulfonylureas
  • First Generation Sulfonylureas
    • Acetohexamide
    • Chlorpropamide
    • Tolazamide
    • Tolbutamide
  • Second Generation Sulfonylureas
    • Gliclazide
    • Glimepiride
    • Glipizide
    • Glyburide (Glibenclamide)
• Thiazolidinediones
  • Pioglitazone
  • Rosiglitazone
  • Troglitazone

• Dailymed label info on Acarbose
• FDA Acarbose

Acarbose Resources
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