Monotherapy, as indicated as an adjunct to diet to lower blood glucose in patients with noninsulin-dependent diabetes mellitus (NIDDM) whose hyperglycemia cannot be managed on diet alone. Combination with a sulfonylurea, metformin, or insulin in patients with NIDDM when diet plus acarbose do not result in adequate glycemic control
Pregnancy & Lactation :
Risk Factor - B
Warnings & Precautions:
Hypoglycemia: Acarbose may increase the hypoglycemic potential of sulfonylureas. Oral glucose (dextrose) should be used in the treatment of mild to moderate hypoglycemia. Severe hypoglycemia may require the use of either intravenous glucose infusion or glucagon injection. Elevated serum transaminase levels:
Treatment-emergent elevations of serum transaminases (AST and/or ALT) occurred in 15% of acarbose-treated patients in long-term studies. These serum transaminase elevations appear to be dose related. At doses >100 mg 3 times/day, the incidence of serum transaminase elevations greater than 3 times the upper limit of normal was 2-3 times higher in the acarbose group than in the placebo group. These elevations were asymptomatic, reversible, more common in females, and, in general, were not associated with other evidence of liver dysfunction. 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.
Contraindication:
Known hypersensitivity to the drug and in patients with diabetic ketoacidosis or cirrhosis; patients with inflammatory bowel disease, colonic ulceration, partial intestinal obstruction or in patients predisposed to intestinal obstruction; 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
Adverse Reactions :
>10%: Gastrointestinal: Abdominal pain (21%) and diarrhea (33%) tend to return to pretreatment levels over time, and the frequency and intensity of flatulence (77%) tend to abate with time Hepatic: Elevated liver transaminases <1%: Sleepiness, headache, vertigo, erythema, urticaria, severe gastrointestinal distress, weakness
Over Dose / Poisoning : An overdose will not result in hypoglycemia; an overdose may result in transient increases in flatulence, diarrhea, and abdominal discomfort which shortly subside
Dosage :
Adults: Dosage must be individualized on the basis of effectiveness and tolerance while not exceeding the maximum recommended dose Initial dose: 25 mg 3 times/day with the first bite of each main meal Maintenance dose: Should be adjusted at 4- to 8-week intervals based on 1-hour postprandial glucose levels and tolerance.
Dosage may be increased from 25 mg 3 times/day to 50 mg 3 times/day. Some patients may benefit from increasing the dose to 100 mg 3 times/day. Maintenance dose ranges: 50-100 mg 3 times/day. Maximum dose: < or =60 kg: 50 mg 3 times/day >60 kg: 100 mg 3 times/day
Patients receiving sulfonylureas: Acarbose given in combination with a sulfonylurea will cause a further lowering of blood glucose and may increase the hypoglycemic potential of the sulfonylurea. If hypoglycemia occurs, appropriate adjustments in the dosage of these agents should be made.
Dosing adjustment in renal impairment: Clcr <25 mL/minute: Peak plasma concentrations were 5 times higher and AUCs were 6 times larger than in volunteers with normal renal function; however, long term clinical trials in diabetic patients with significant renal dysfunction have not been conducted and treatment of these patients with acarbose is not recommended
Patient Information :
Take this medication exactly as directed, with the first bite of each main meal. Do not change dosage or discontinue without first consulting prescriber. Do not take other medications with or within 2 hours of this medication unless so advised by prescriber. It is important to follow dietary and lifestyle recommendations of prescriber.
You will be instructed in signs of hypo-/hyperglycemia by prescriber or diabetic educator. If combining acarbose with other diabetic medication (eg, sulfonylureas, insulin), keep source of glucose (sugar) on hand in case hypoglycemia occurs. You may experience mild side effects during first weeks of acarbose therapy (eg, bloating, flatulence, diarrhea, abdominal discomfort); these should diminish over time. Report severe or persistent side effects, fever, extended vomiting or flu, or change in color of urine or stool. Breast-feeding precautions: Consult prescriber if breast-feeding.
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