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Drug Catalog - Product Detail

ACARBOSE TB 100MG 100

NDC Mfr Size Str Form
69543-0122-10 VIRTUS PHARMACEUTICALS 100 100MG TABLET
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Generic Name
ACARBOSE
Substance Name
ACARBOSE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA091343
Description
DESCRIPTION Acarbose Tablets are an oral alpha-glucosidase inhibitor for use in the management of type 2 diabetes mellitus. Acarbose is an oligosaccharide which is obtained from fermentation processes of a microorganism, Actinoplanes utahensis , and is chemically known as O-4,6-dideoxy-4-[[(1 S ,4 R ,5 S ,6 S )-4,5,6-trihydroxy-3-(hydroxymethyl)-2-cyclohexen-1-yl]amino]-α-D-glucopyranosyl-(1→4)- O -α-D-glucopyranosyl-(1→4)-D-glucose. It is a white to off-white powder with a molecular weight of 645.6. Acarbose is soluble in water and has a pK a of 5.1. Its empirical formula is C 25 H 43 NO 18 and its chemical structure is as follows: Acarbose Tablets are available as 25 mg, 50 mg and 100 mg tablets for oral use. The inactive ingredients are corn starch, magnesium stearate, microcrystalline cellulose and colloidal silicon dioxide. Chemical Structure
How Supplied
HOW SUPPLIED Acarbose Tablets 25 mg are white to yellowish, round biconvex tablets marked " 318 " on one face and " cor " on the other face. They are supplied as follows: Bottles of 100 NDC 69543-120-10 Bottles of 1000 NDC 69543-120-11 Acarbose Tablets 50 mg are white to yellowish, round biconvex tablets marked " 319 " on one face and " cor " on the other face. They are supplied as follows: Bottles of 100 NDC 69543-121-10 Bottles of 1000 NDC 69543-121-11 Acarbose Tablets 100 mg are white to yellowish, round biconvex tablets marked " 320 " on one face and " cor " on the other face. They are supplied as follows: Bottles of 100 NDC 69543-122-10 Bottles of 1000 NDC 69543-122-11 Store at 20° to 25 ° C (68° to 77 ° F) [See USP Controlled Room Temperature]. Protect from moisture. Keep container tightly closed. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Rev: May 2018 Distributed By: Virtus Pharmaceuticals, LLC Langhorne, PA 19047 1-888-848-3593 Manufactured By: Bluepharma Indústria Farmacêutica, S.A. S. Martinho do Bispo 3045-016 Coimbra, Portugal
Indications & Usage
INDICATIONS AND USAGE Acarbose Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Dosage and 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 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.