Acarbose
Alpha-glucosidase inhibitor antidiabetic
What it is used for
INDICATIONS AND USAGE Acarbose tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Clinical selection for Acarbose should follow culture results where relevant, Kenya STG/EML recommendations, and the current product SmPC. Class context: Alpha-glucosidase inhibitor antidiabetic. Confirm site-specific dose, duration and monitoring before prescribing.
Warnings
Monitor serum hepatic transaminase in patients on 200mg/day for the first six months; may enhance hypoglycaemic effect of insulin and sulphonylureas. Due to its MOA, hypoglycaemic episodes should be treated with oral glucose not sucrose. B
Possible side effects
ADVERSE REACTIONS 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 and are related to the presence of undigested carbohydrate in the lower GI tract. If the prescribed diet is not observed, the intestinal side effects may be intensified. If strongly distressing symptoms develop in spite of adherence to the diabetic diet prescribed, the doctor must be consulted and the dose temporarily or permanently reduced. Elevated Serum Transaminase Levels See PRECAUTIONS . Other Abnormal Laboratory Findings Small reductions in hematocrit occurred more often in acarbose-treated patients than in placebo-treated patients but were not associated with reductions in hemoglobin. Low serum calcium and low plasma vitamin B 6 levels were associated with acarbose tablets therapy but are thought to be either spurious or of no clinical significance. Postmarketing Adverse Event Reports Additional adverse events reported from worldwide postmarketing experience include fulminant hepatitis with fatal outcome, hypersensitive skin reactions (for example rash, erythema, exanthema and uticaria), edema, ileus/subileus, jaundice and/or hepatitis and associated liver damage, thrombocytopenia, and pneumatosis cystoides intestinalis (see PRECAUTIONS ). Pneumatosis Cystoides Intestinalis There have been rare postmarketing reports of pneumatosis cystoides intestinalis associated with the use of alpha-glucosidase inhibitors, including acarbose tablets.Pneumatosis cystoides intestinalis may present with symptoms of diarrhea, mucus discharge, rectal bleeding, and constipation.Complications may include pneumoperitoneum, volvulus, intestinal obstruction, intussusception, intestinal hemorrhage, and intestinal perforation. If pneumatosis cystoides intestinalis is suspected, discontinue acarbose tablets and perform the appropriate diagnostic imaging. To report SUSPECTED ADVERSE REACTIONS, contact Avet Pharmaceuticals Inc. at 1-866-901-DRUG (3784) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Storage
HOW SUPPLIED Acarbose Tablets, USP are supplied as follows: For 50 mg: White to yellow-tinged, round, biconvex tablets, debossed with "HP" and "148" on one side and plain on other side. NDC: 71335-9725-1: 30 Tablets in a BOTTLE NDC: 71335-9725-2: 90 Tablets in a BOTTLE NDC: 71335-9725-3: 100 Tablets in a BOTTLE Store at 20o to 25oC (68oto 77oF) [see USP Controlled Room Temperature]. Protect from moisture. For bottles, keep container tightly closed. Repackaged/Relabeled by: Bryant Ranch Prepack Burbank, CA 91504
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