Adjunct to diet and exercise to improve glycemic control in adults w/ type 2 diabetes mellitus.
Type 2 Diabetes Mellitus
Monotherapy or in Combination w/ Sulfonylureas, Insulin, or Metformin:
Initial: 25mg tid w/ 1st bite of each main meal; may also initiate at 25mg qd to minimize GI side effects and gradually increase to 25mg tid
Titrate: After reaching 25mg tid, dose may be adjusted at 4- to 8-week intervals, to 50 mg tid, and then further to 100mg tid in some patients
Maint Range: 50-100mg tid
≤60kg: 50mg tid
>60kg: 100mg tid
If no further reduction in postprandial glucose or HbA1c observed w/ 100mg tid, consider reducing dose
Patients Receiving Sulfonylureas or Insulin:
If hypoglycemia occurs, make appropriate dosage adjustments of these agents
SrCr >2mg/dL: Not recommended
Take tid w/ 1st bite of each main meal
Tab: 25mg, 50mg, 100mg
Diabetic ketoacidosis, cirrhosis, inflammatory bowel disease, colonic ulceration, partial intestinal obstruction or predisposition to it, chronic intestinal diseases w/ marked disorders of digestion or absorption, and conditions that may deteriorate from increased intestinal gas formation.
Inhibits hydrolysis of sucrose to glucose and fructose; use oral glucose (dextrose) instead of sucrose (cane sugar) in treatment of mild to moderate hypoglycemia. Elevated serum transaminase levels, fulminant hepatitis, and hyperbilirubinemia reported. Reduce dose or d/c if elevated serum transaminases persist. A temporary loss of control of blood glucose may occur when exposed to stress; temporary insulin therapy may be necessary. Monitoring of glycemic control w/ 1,5-AG assay is not recommended; use alternative methods to monitor for glycemic control. Pneumatosis cystoides intestinalis reported; d/c and perform appropriate diagnostic imaging if this is suspected. Reduce dose temporarily or permanently if strongly distressing symptoms develop in spite of adherence to the diabetic diet.
Flatulence, diarrhea, abdominal pain.
See Dose Modification. Closely observe for loss of blood glucose control w/ thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blockers, and isoniazid. Intestinal adsorbents (eg, charcoal) and digestive enzyme preparations containing carbohydrate-splitting enzymes (eg, amylase, pancreatin) may reduce effect; avoid concomitant use. May affect digoxin bioavailability; may require dose adjustment of digoxin.
PREGNANCY AND LACTATION
Category B, not for use in nursing.
MECHANISM OF ACTION
α-glucosidase inhibitor; competitively and reversibly inhibits pancreatic α-amylase and membrane-bound intestinal α-glucoside hydrolase enzymes.
Absorption: Active Drug: Bioavailability (<2%); Tmax=approx 1 hr. Metabolism: GI tract by intestinal bacteria and digestive enzymes; 4-methylpyrogallol derivatives (major metabolites). Elimination: Urine (<2%), feces (51%, unabsorbed); T1/2=approx 2 hrs.
Assess for hypersensitivity to the drug, renal dysfunction, diabetic ketoacidosis, cirrhosis, inflammatory bowel disease, colonic ulceration, partial intestinal obstruction or predisposition to it, chronic intestinal diseases w/ marked disorders of digestion or absorption, conditions that may deteriorate from increased intestinal gas formation, pregnancy/nursing status, and possible drug interactions.
Monitor for signs/symptoms of hypoglycemia, pneumatosis cystoides intestinalis, and other adverse reactions. Monitor FPG, HbA1c, LFTs, and renal function. Monitor serum transaminases every 3 months for 1st yr, then periodically.
Instruct to take tid at the start of each main meal. Inform about importance of adhering to dietary instructions, a regular exercise program, and regular testing of urine and/or blood glucose. Counsel about risks, signs/symptoms, and treatment of hypoglycemia, and conditions that predispose to its development. Instruct to have readily available source of glucose (dextrose, D-glucose) to treat symptoms of low blood sugar. Inform that side effects (GI effects such as flatulence, diarrhea, abdominal discomfort) usually develop during the 1st few weeks of therapy and generally diminish in frequency and intensity w/ time.
≤25°C (≤77°F). Protect from moisture.
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