Acarbose: uses, appearance and warnings

Acarbose Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Acarbose Tablets are available as 25 mg, 50 mg or 100 mg, circular biconvex tablets. Each tablet strength is white to yellow-tinged in color. The 25 mg tablet is engraved with 'P210' on one side and '25' on the other side. The 50 mg tablet is engraved with 'P211' on one side and '50' on the other side. The 100 mg tablet is engraved with 'P212' on one side and '100' on the other side. Acarbose Tablets are available in bottles of 100 and bottles of 1000. Strength NDC Tablet Identification 25 mg 64380-758-06 P210 25 Bottles of 100 50 mg 64380-759-06 P211 50 100 mg 64380-760-06 P212 100 Store at 20˚ to 25˚C (68˚ to 77˚F) [see USP Controlled Room Temperature]. Protect from moisture. Keep container tightly closed.

Acarbose Tablets are contraindicated in patients with known hypersensitivity to the drug. Acarbose Tablets are contraindicated in patients with diabetic ketoacidosis or cirrhosis. Acarbose Tablets are also contraindicated in patients with inflammatory bowel disease, colonic ulceration, partial intestinal obstruction or in patients predisposed to intestinal obstruction. In addition, Acarbose Tablets are contraindicated in patients who have chronic intestinal diseases associated 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.

Digestive Tract Gastrointestinal symptoms are the most common reactions to Acarbose Tablets. In U.S. placebo-controlled trials, the incidences of abdominal pain, diarrhea, and flatulence were 19%, 31%, and 74% respectively in 1255 patients treated with Acarbose Tablets 50-300 mg t.i.d., whereas the corresponding incidences were 9%, 12%, and 29% in 999 placebo-treated patients. In a one-year safety study, during which patients kept diaries of gastrointestinal symptoms, abdominal pain and diarrhea tended to return to pretreatment levels over time, and the frequency and intensity of flatulence tended to abate with time. The increased gastrointestinal tract symptoms in patients treated with Acarbose Tablets are a manifestation of the mechanism of action of Acarbose Tablets and are related to the presence of undigested carbohydrate in the lower GI tract. …

Certain drugs tend to produce hyperglycemia and may lead to loss of blood glucose control. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicolinic acid, sympathomimetics, calcium channel-blocking drugs, and isoniazid. When such drugs are administered to a patient receiving Acarbose Tablets, the patient should be closely observed for loss of blood glucose control. When such drugs are withdrawn from patients receiving Acarbose Tablets in combination with sulfonylureas or insulin, patients should be observed closely for any evidence of hypoglycemia. Patients Receiving Sulfonylureas or Insulin: Sulfonylurea agents or insulin may cause hypoglycemia. …