Acarbose 50 mg/1
acarbose · TABLET · Strides Pharma Science Limited
Acarbose is a tablet containing acarbose at 50 mg/1, taken oral. Manufactured by Strides Pharma Science Limited.
Key Facts
- Brand Name
- Acarbose
- Generic Name
- acarbose
- NDC Code (Product)
64380-759- Manufacturer
- Strides Pharma Science Limited
- Strength
- 50 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA090912
- Drug Class
- alpha-Glucosidase Inhibitor [EPC]
- Marketing Start
- 12/10/2016
Recall History
Teva Pharmaceuticals USA
Labeling: Incorrect or Missing Lot and/or Exp Date: An incorrect expiration date of July 2018 is printed on the product labeling rather than the correct expiration date of July 2017.
Boehringer Ingelheim Roxane Inc
Subpotent Drug: The firm received an out of specification result for Assay (potency was below specification) at the 9 month stability time point.
Aidapak Services, LLC
Labeling: Label Mixup: ACARBOSE, Tablet, 25 mg may be potentially mislabeled as one of the following drugs: ZINC GLUCONATE, Tablet, 50 mg, NDC 00904319160, Pedigree: AD60240_57, EXP: 5/22/2014; TOLTERODINE TARTRATE ER, Capsule, 2 mg, NDC 00009519001, Pedigree: W002724, EXP: 6/6/2014; SILDENAFIL CITRATE, Tablet, 25 mg, NDC 00069420030, Pedigree: W003646, EXP: 6/25/2014; SEVELAMER CARBONATE, Tab
Aidapak Services, LLC
Labeling: Label Mixup; ACARBOSE Tablet, 25 mg may be potentially mislabeled as LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: AD39588_4, EXP: 5/13/2014.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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.
Dosage & Administration
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…
Contraindications
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.
Drug Interactions
Drug Interactions Certain drugs tend to produce hyperglycemia and may lead to loss of blood glucose control. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel-blocking drugs, and isoniazid. When such drugs are administered to a patient receiving acarbose tablets, the patient should be closely observed for loss of blood glucose control. When such drugs are withdrawn from patients receiving acarbose tablets in combination with sulfonylureas or insulin, patients should be observed closely for any evidence of hypoglycemia. Patients Receiving Sulfonylureas or Insulin: Sulfonylurea agents or insulin may cause hypoglycemia. Acarbose tablets given in combination with a sulfonylurea or insulin may 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. Very rarely, individual cases of hypoglycemic shock have been reported in patients receiving acarbose tablets therapy in combination with sulfonylureas and/or insulin. …
Adverse Reactions
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 Abnorma…
Frequently Asked Questions
What is Acarbose used for?
Acarbose contains acarbose. It is a tablet taken oral. Consult your doctor for specific uses.
Is Acarbose a controlled substance?
Acarbose is not classified as a controlled substance by the DEA.
What is the generic name for Acarbose?
The generic name for Acarbose is acarbose. There are no other listed brand versions of acarbose.
What is the NDC code for Acarbose 50 mg/1?
The NDC (National Drug Code) for Acarbose 50 mg/1 is 64380-759, listed by Strides Pharma Science Limited.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)