Acarbose

Name: Acarbose

WWhat else should I know about acarbose?

What preparations are available?
  • Tablets: 25, 50 and 100 mg.
How should I keep this drug stored?
  • Precose should be stored at room temperature, 15 C - 30 C (59 F - 86 F) in a tight container.
WWhen was acarbose approved by the FDA?
  • The FDA approved acarbose in September 1995.
Reviewed on 1/6/2017 References REFERENCE: FDA Prescribing Information

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

In case of overdose, do not eat or drink anything containing carbohydrates for the next 4 to 6 hours.

Acarbose side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • severe constipation;

  • severe stomach pain, diarrhea that is watery or bloody;

  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin; or

  • liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • stomach discomfort, gas, bloating;

  • mild diarrhea; or

  • mild skin rash or itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Acarbose dosing information

Usual Adult Dose for Diabetes Type 2:

Individualize dose based on efficacy and tolerability:

Initial dose: 25 mg orally 3 times a day
-Adjust dose at 4 to 8 week intervals based on efficacy and tolerability
Maintenance dose: 50 mg to 100 mg orally 3 times a day
Maximum dose: Weight 60 kg or less: 50 mg orally 3 times a day; Weight greater than 60 kg: 100 mg orally 3 times a day

Comments:
-Take at the start (with first bite) of each main meal; patients should be adhering to a diabetic diet to minimize GI side effects.
-Some patients benefit from starting at 25 mg orally once a day with subsequent titration to 3 times a day to minimize GI side effects.
-If no further reduction in postprandial glucose or HbA1c is observed with titration to 100 mg three times a day, consider lowering the dose.

Use: As an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.

Advice to Patients

  • Importance of adherence to diet and exercise regimen.1 23 54

  • Importance of adherence to dietary precautions designed to minimize adverse GI effects.1 108 Importance of consulting a clinician for dosage adjustments if adverse GI effects occur despite adherence to such dietary precautions.1 (See Adherence to Prescribed Diet under Cautions.)

  • Importance of regular monitoring of blood glucose concentrations.1 14 23 52 62

  • Importance of avoiding infection.23

  • Provide instruction on the management of hyperglycemia or hypoglycemia.23 62 Advise of the risk of hypoglycemia, its symptoms, and conditions that predispose to the development of hypoglycemia.1 Importance of keeping a readily available source of glucose (dextrose) to treat symptoms of hypoglycemia when used in combination with a sulfonylurea agent or insulin.1

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

  • Importance of advising patients of other important precautionary information.1 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Acarbose

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets

25 mg

Precose

Bayer

50 mg

Precose

Bayer

100 mg

Precose

Bayer

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take acarbose or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to acarbose. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Acarbose - Clinical Pharmacology

Acarbose is a complex oligosaccharide that delays the digestion of ingested carbohydrates, thereby resulting in a smaller rise in blood glucose concentration following meals. As a consequence of plasma glucose reduction, Acarbose Tablets reduce levels of glycosylated hemoglobin in patients with type 2 diabetes mellitus. Systemic non-enzymatic protein glycosylation, as reflected by levels of glycosylated hemoglobin, is a function of average blood glucose concentration over time.

Mechanism of Action

In contrast to sulfonylureas, Acarbose Tablets do not enhance insulin secretion. The antihyperglycemic action of Acarbose results from a competitive, reversible inhibition of pancreatic alpha-amylase and membrane-bound intestinal alpha-glucoside hydrolase enzymes. Pancreatic alpha-amylase hydrolyzes complex starches to oligosaccharides in the lumen of the small intestine, while the membrane-bound intestinal alpha-glucosidases hydrolyze oligosaccharides, trisaccharides, and disaccharides to glucose and other monosaccharides in the brush border of the small intestine. In diabetic patients, this enzyme inhibition results in a delayed glucose absorption and a lowering of postprandial hyperglycemia.

Because its mechanism of action is different, the effect of Acarbose Tablets to enhance glycemic control is additive to that of sulfonylureas, insulin or metformin when used in combination. In addition, Acarbose Tablets diminish the insulinotropic and weight-increasing effects of sulfonylureas.

Acarbose has no inhibitory activity against lactase and consequently would not be expected to induce lactose intolerance.

Pharmacokinetics

Absorption

In a study of 6 healthy men, less than 2% of an oral dose of Acarbose was absorbed as active drug, while approximately 35% of total radioactivity from a 14C-labeled oral dose was absorbed. An average of 51% of an oral dose was excreted in the feces as unabsorbed drug-related radioactivity within 96 hours of ingestion. Because Acarbose acts locally within the gastrointestinal tract, this low systemic bioavailability of parent compound is therapeutically desired. Following oral dosing of healthy volunteers with 14C-labeled Acarbose, peak plasma concentrations of radioactivity were attained 14 to 24 hours after dosing, while peak plasma concentrations of active drug were attained at approximately 1 hour. The delayed absorption of Acarbose-related radioactivity reflects the absorption of metabolites that may be formed by either intestinal bacteria or intestinal enzymatic hydrolysis.

Metabolism

Acarbose is metabolized exclusively within the gastrointestinal tract, principally by intestinal bacteria, but also by digestive enzymes. A fraction of these metabolites (approximately 34% of the dose) was absorbed and subsequently excreted in the urine. At least 13 metabolites have been separated chromatographically from urine specimens. The major metabolites have been identified as 4 –methylpyrogallol derivatives (that is, sulfate, methyl, and glucuronide conjugates). One metabolite (formed by cleavage of a glucose molecule from Acarbose) also has alpha-glucosidase inhibitory activity. This metabolite, together with the parent compound, recovered from the urine, accounts for less than 2% of the total administered dose.

Excretion

The fraction of Acarbose that is absorbed as intact drug is almost completely excreted by the kidneys. When Acarbose was given intravenously, 89% of the dose was recovered in the urine as active drug within 48 hours. In contrast, less than 2% of an oral dose was recovered in the urine as active (this is, parent compound and active metabolite) drug. This is consistent with the low bioavailability of the parent drug. The plasma elimination half-life of Acarbose activity is approximately 2 hours in healthy volunteers. Consequently, drug accumulation does not occur with three times a day (t.i.d.) oral dosing.

Special Populations

The mean steady-state area under the curve (AUC) and maximum concentrations of Acarbose were approximately 1.5 times higher in elderly compared to young volunteers; however, these differences were not statistically significant. Patients with severe renal impairment (Clcr < 25 mL/min/1.73m2) attained about 5 times higher peak plasma concentrations of Acarbose and 6 times larger AUCs than volunteers with normal renal function. No studies of Acarbose pharmacokinetic parameters according to race have been performed. In U.S. controlled clinical studies of Acarbose Tablets in patients with type 2 diabetes mellitus, reductions in glycosylated hemoglobin levels were similar in Caucasians (n=478) and African-Americans (n=167), with a trend toward a better response in Latinos (n=132).

Drug-Drug Interactions

Studies in healthy volunteers have shown that Acarbose Tablets have no effect on either the pharmacokinetics or pharmacodynamics of nifedipine, propranolol, or ranitidine. Acarbose Tablets did not interfere with the absorption or disposition of the sulfonylurea glyburide in diabetic patients. Acarbose Tablets may affect digoxin bioavailability and may require dose adjustment of digoxin by 16% (90% confidence interval: 8 to 23%), decrease mean Cmax of digoxin by 26% (90% confidence interval: 16 to 34%) and decreases mean trough concentrations of digoxin by 9% (90% confidence limit: 19% decrease to 2% increase). (See PRECAUTIONS, Drug Interactions).

The amount of metformin absorbed while taking Acarbose Tablets was bioequivalent to the amount absorbed when taking placebo, as indicated by the plasma AUC values. However, the peak plasma level of metformin was reduced by approximately 20% when taking Acarbose Tablets due to a slight delay in the absorption of metformin. There is little if any clinically significant interaction between Acarbose Tablets and metformin.

Contraindications

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.

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 to 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.

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 Tablets-treated patients than in placebo-treated patients but were not associated with reductions in hemoglobin. Low serum calcium and low plasma vitamin B6 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 (e.g. rash, erythema, exanthema and urticaria), edema, ileus/subileus, jaundice and/or hepatitis and associated liver damage, thrombocytopenia, and pneumatosis cystoids 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.

Overdosage

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 to 6 hours.

Acarbose Dosage and Administration

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.

Initial Dosage

The recommended starting dosage of Acarbose Tablets is 25 mg given orally three times daily at the start (with the first bite) of each main meal. However, some patients may benefit from more gradual dose titration to minimize gastrointestinal side effects. This may be achieved by initiating treatment at 25 mg once per day and subsequently increasing the frequency of administration to achieve 25 mg t.i.d.

Maintenance Dosage

Once a 25 mg t.i.d. dosage regimen is reached, dosage of Acarbose Tablets should be adjusted at 4 to 8 week intervals based on one-hour postprandial glucose or glycosylated hemoglobin levels, and on tolerance. The dosage can be increased from 25 mg t.i.d. to 50 mg t.i.d. Some patients may benefit from further increasing the dosage to 100 mg t.i.d. The maintenance dose ranges from 50 mg t.i.d. to 100 mg t.i.d. However, since patients with low body weight may be at increased risk for elevated serum transaminases, only patients with body weight > 60 kg should be considered for dose titration above 50 mg t.i.d. (see PRECAUTIONS). If no further reduction in postprandial glucose or glycosylated hemoglobin levels is observed with titration to 100 mg t.i.d., consideration should be given to lowering the dose. Once an effective and tolerated dosage is established, it should be maintained.

Maximum Dosage

The maximum recommended dose for patient's ≤ 60 kg is 50 mg t.i.d. The maximum recommended dose for patients > 60 kg is 100 mg t.i.d.

Patients Receiving Sulfonylureas or Insulin

Sulfonylurea agents or insulin may cause hypoglycemia. Acarbose Tablets given in combination with a sulfonylurea or insulin will cause a further lowering of blood glucose and may increase the potential for hypoglycemia. If hypoglycemia occurs, appropriate adjustments in the dosage of these agents should be made.

Special Populations Elderly

AUC and Cmax are approximately 1.5 times higher in the elderly.

Dosing Adult

Diabetes mellitus, type 2: Oral: Note: Dosage must be individualized on the basis of effectiveness and tolerance.

Initial dose: 25 mg 3 times daily with the first bite of each main meal (may also initiate at 25 mg once daily with gradual titration to 25 mg 3 times daily as tolerated); increase dose at 4- to 8-week intervals based on 1-hour postprandial glucose or glycosylated hemoglobin levels and tolerance until maintenance dose of 50 to 100 mg 3 times daily is reached (maximum dose: ≤60 kg: 50 mg 3 times daily; >60 kg: 100 mg 3 times daily)

Drug Interactions

Alpha-Lipoic Acid: May enhance the hypoglycemic effect of Antidiabetic Agents. Monitor therapy

Androgens: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Exceptions: Danazol. Monitor therapy

Digoxin: Acarbose may decrease the serum concentration of Digoxin. Monitor therapy

Guanethidine: May enhance the hypoglycemic effect of Antidiabetic Agents. Monitor therapy

Hyperglycemia-Associated Agents: May diminish the therapeutic effect of Antidiabetic Agents. Monitor therapy

Hypoglycemia-Associated Agents: Antidiabetic Agents may enhance the hypoglycemic effect of Hypoglycemia-Associated Agents. Monitor therapy

MAO Inhibitors: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy

Neomycin: May enhance the adverse/toxic effect of Acarbose. Neomycin may decrease the metabolism of Acarbose. Monitor therapy

Pegvisomant: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy

Prothionamide: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy

Quinolone Antibiotics: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Quinolone Antibiotics may diminish the therapeutic effect of Blood Glucose Lowering Agents. Specifically, if an agent is being used to treat diabetes, loss of blood sugar control may occur with quinolone use. Monitor therapy

Salicylates: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy

Selective Serotonin Reuptake Inhibitors: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy

Thiazide and Thiazide-Like Diuretics: May diminish the therapeutic effect of Antidiabetic Agents. Monitor therapy

Adverse Reactions

>10%: Gastrointestinal: Frequency and intensity of flatulence (74%) tend to abate with time; diarrhea (31%) and abdominal pain (19%) tend to return to pretreatment levels over time

1% to 10%: Hepatic: Increased serum transaminases (≤4%)

<1% (Limited to important or life-threatening): Edema, erythema, hepatic injury, hepatitis, intestinal obstruction, jaundice, pneumatosis cystoides intestinalis, skin rash, thrombocytopenia, urticaria

Acarbose Precautions

Serious side effects have been reported with acarbose including the following:

 

  • Hypoglycemia. When used in combination with other medications to treat type 2 diabetes, acarbose can cause hypoglycemia (low blood sugar). Tell your healthcare provider right away if you have some or all of the following symptoms of hypoglycemia:
    • shakiness
    • dizziness or lightheadedness
    • sweating
    • nervousness or irritability
    • sudden changes in behavior or mood
    • headache
    • numbness or tingling around the mouth
    • weakness
    • pale skin
    • hunger or thirst
    • clumsy or jerky movements
    • confusion
    • weakness
    • blurred vision

 

Do not take acarbose if you:

  • are allergic to acarbose or to any of its ingredients
  • have diabetic ketoacidosis
  • have cirrhosis
  • have inflammatory bowel disease, colonic ulceration, or partial intestinal obstruction
  • have chronic intestinal diseases or disorders of digestion or absorption
  • have conditions that may deteriorate as a result of increased gas formation in the intestine

 

Acarbose Overdose

If you take too much acarbose, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If acarbose is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Pregnancy & Lactation

Pregnancy Category: B

Lactation: not known if crosses into breast milk, avoid using in nursing women

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

What should i avoid while taking acarbose (precose)?

Avoid drinking alcohol. It can lower your blood sugar.

Avoid taking a digestive enzyme such as pancreatin, amylase, or lipase at the same time you take acarbose. These enzymes can make it harder for your body to absorb acarbose. Products that contain digestive enzymes include Arco-Lase, Cotazym, Donnazyme, Pancrease, Creon, and Ku-Zyme.

Side effects

Digestive Tract

Gastrointestinal symptoms are the most common reactions to PRECOSE. 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 PRECOSE 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 PRECOSE are a manifestation of the mechanism of action of PRECOSE 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 PRECOSE-treated patients than in placebo-treated patients but were not associated with reductions in hemoglobin. Low serum calcium and low plasma vitamin B6 levels were associated with PRECOSE 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 Precose. 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 Precose and perform the appropriate diagnostic imaging.

Read the entire FDA prescribing information for Precose (Acarbose)

Read More »

Acarbose Pregnancy Warnings

Use is not recommended. AU TGA pregnancy category: B3 US FDA pregnancy category: B

Animal studies in rats and rabbits have failed to reveal evidence of embryotoxicity or teratogenicity; however, in rabbits, resorptions were observed, and in rats, increases in prenatal losses occurred during organogenesis at doses up to 9 times the exposure in humans. There are no controlled data in human pregnancy. Because abnormal blood glucose levels during pregnancy are associated with a higher incidence of congenital anomalies as well as increased neonatal morbidity and mortality, most experts recommend that insulin be used during pregnancy to maintain blood glucose levels as close to normal as possible. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Acarbose Identification

Substance Name

Acarbose

CAS Registry Number

56180-94-0

Drug Class

Hypoglycemic Agents

Administrative Information

LactMed Record Number

1

Last Revision Date

20150310

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

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