pharmacopeia
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/api/v1/drug/acarbose

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: alpha Glucosidase Inhibitors; Amylase Inhibitors.

Amylasealpha Glucosidase

Indications

Sourced from openFDA
  • Acarbose tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.ICD-10: E11.9

Contraindications

Sourced from openFDA
  • Acarbose tablets are contraindicated in patients with known hypersensitivity to the drug. Acarbose tablets are contraindicated in patients with diabetic ketoacidosis or cirrhosis.contraindicated

Dosage & administration

Sourced from openFDA

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. Acarbose tablets should be taken three times daily at the start (with the first bite) of each main meal. Acarbose tablets should be started at a low dose, with gradual dose escalation as described below, both to reduce gastrointestinal side effects and to permit identification of the minimum dose required for adequate glycemic control of the patient.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. During treatment initiation and dose titration (see below), one-hour postprandial plasma glucose may be used to determine the therapeutic response to acarbose tablets and identify the minimum effective dose for the patient. Thereafter, glycosylated hemoglobin should be measured at intervals of approximately three months. The therapeutic goal should be to decrease both postprandial plasma glucose and glycosylated hemoglobin levels to normal or near normal by using the lowest effective dose of acarbose tablets, either as monotherapy or in combination with sulfonylureas, insulin or metformin.

Adverse reactions

Sourced from openFDA

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.

Use in specific populations

Sourced from openFDA

Pregnancy Teratogenic Effects: Pregnancy Category B. The safety of acarbose tablets in pregnant women has not been established. Reproduction studies have been performed in rats at doses up to 480 mg/kg (corresponding to 9 times the exposure in humans, based on drug blood levels) and have revealed no evidence of impaired fertility or harm to the fetus due to acarbose. In rabbits, reduced maternal body weight gain, probably the result of the pharmacodynamic activity of high doses of acarbose in the intestines may have been responsible for a slight increase in the number of embryonic losses. However, rabbits given 160 mg/kg acarbose (corresponding to 10 times the dose in man, based on body surface area) showed no evidence of embryotoxicity and there was no evidence of teratogenicity at a dose 32 times the dose in man (based on body surface area). There are, however, no adequate and well-controlled studies of acarbose tablets in pregnant women. Because animal reproduction studies are not always predictive of the human response, this drug should be used during pregnancy only if clearly needed.

Overdosage

Sourced from openFDA

Unlike sulfonylureas or insulin, an overdose of acarbose tablets will not result in hypoglycemia. An overdose may result in transient increases in flatulence, diarrhea, and abdominal discomfort which shortly subside. 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.

Approval history

Sourced from openFDA
  • May 7, 2008ANDAANDA078470Hikma
  • Jul 27, 2011ANDAANDA090912Strides Pharma
  • Feb 7, 2012ANDAANDA202271Avet Lifesciences

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
3,795 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Hypoglycaemia2707.1%
  2. 2Nausea2045.4%
  3. 3Blood Glucose Increased2015.3%
  4. 4Dizziness1634.3%
  5. 5Diarrhoea1544.1%
  6. 6Vomiting1493.9%
  7. 7Drug Interaction1433.8%
  8. 8Acute Kidney Injury1413.7%
  9. 9Drug Ineffective1373.6%
  10. 10Off Label Use1373.6%
  11. 11Fall1273.3%
  12. 12Asthenia1123.0%
  13. 13Dyspnoea1082.8%
  14. 14Lactic Acidosis1072.8%
  15. 15Pneumonia1022.7%

Literature

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Recent PubMed references pinned to Acarbose as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 117 ClinicalTrials.gov registrations naming Acarbose as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Acarbose work?
Mechanism-of-action classes: alpha Glucosidase Inhibitors; Amylase Inhibitors.
What is Acarbose used for?
According to FDA labeling, Acarbose carries indications including: Acarbose tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Acarbose?
Acarbose is classified as Alpha glucosidase inhibitors, alpha-Glucosidase Inhibitor, alpha Glucosidase Inhibitors, Amylase Inhibitors, Inhibition Carbohydrate Digestion.
What are the brand names for Acarbose?
Acarbose is marketed under brand names including Precose.
What are the contraindications for Acarbose?
Acarbose labeling lists contraindications including: Acarbose tablets are contraindicated in patients with known hypersensitivity to the drug. Acarbose tablets are contraindicated in patients with diabetic ketoacidosis or cirrhosis.. Always consult the full prescribing information and a clinician.
Note. Data for acarbose is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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