Complete SPL Sections#
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
For Oral Use
DESCRIPTION
DESCRIPTION SECTION
Miglitol Tablets, an oral alpha-glucosidase inhibitor for use in the management of non-insulin-dependent diabetes mellitus (NIDDM). Miglitol is a desoxynojirimycin derivative, and is chemically known as 3,4,5-piperidinetriol, 1-(2-hydroxyethyl) -2-(hydroxymethyl)-, [2R-(2a,3ß,4a, 5ß)]-. It is a white to pale-yellow powder with a molecular weight of 207.2. Miglitol is soluble in water and has a pK a of 5.9. Its empirical formula is C 8 H 17 NO 5 and its chemical structure is as follows: Miglitol tablets are available as 25 mg, 50 mg, and 100 mg tablets for oral use. The inactive ingredients are corn starch, microcrystalline cellulose, magnesium stearate, hypromelloses, polyethylene glycols, titanium dioxide, and polysorbate 80.
CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY SECTION
Miglitol is a desoxynojirimycin derivative 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, miglitol tablets reduce levels of glycosylated hemoglobin in patients with Type II (non-insulin-dependent) diabetes mellitus. Systemic nonenzymatic protein glycosylation, as reflected by levels of glycosylated hemoglobin, is a function of average blood glucose concentration over time.
CLINICAL STUDIES
CLINICAL STUDIES SECTION
INDICATIONS AND USAGE
INDICATIONS & USAGE SECTION
Miglitol tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
CONTRAINDICATIONS
CONTRAINDICATIONS SECTION
Miglitol tablets are contraindicated in patients with: Diabetic ketoacidosis Inflammatory bowel disease, colonic ulceration, or partial intestinal obstruction, and in patients predisposed to intestinal obstruction Chronic intestinal diseases associated with marked disorders of digestion or absorption, or with conditions that may deteriorate as a result of increased gas formation in the intestine Hypersensitivity to the drug or any of its components
PRECAUTIONS
PRECAUTIONS SECTION
ADVERSE REACTIONS
ADVERSE REACTIONS SECTION
OVERDOSAGE
OVERDOSAGE SECTION
Unlike sulfonylureas or insulin, an overdose of miglitol tablets will not result in hypoglycemia. An overdose may result in transient increases in flatulence, diarrhea, and abdominal discomfort. Because of the lack of extra-intestinal effects seen with miglitol tablets, no serious systemic reactions are expected in the event of an overdose.
DOSAGE AND ADMINISTRATION
DOSAGE & ADMINISTRATION SECTION
There is no fixed dosage regimen for the management of diabetes mellitus with miglitol tablets or any other pharmacologic agent. Dosage of miglitol tablets must be individualized on the basis of both effectiveness and tolerance while not exceeding the maximum recommended dosage of 100 mg 3 times daily. Miglitol tablets should be taken three times daily at the start of each main meal. Miglitol tablets should be started at 25 mg, and the dosage gradually increased both to reduce gastrointestinal adverse effects and to permit identification of the minimum dose required for adequate glycemic control of the patient. During treatment initiation and dose titration, one-hour postprandial plasma glucose may be used to determine the therapeutic response to miglitol tablets and identify the minimum effective dose for the patient. Thereafter, glycosylated hemoglobin should be measured at intervals of approximately 3 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 miglitol tablets, either as monotherapy or in combination with a sulfonylurea.
HOW SUPPLIED
HOW SUPPLIED SECTION
Miglitol tablets are available as 25 mg, 50 mg, and 100 mg white to off-white, circular, biconvex film-coated tablets, debossed with the logo-mark "OP" on one side and the product code on the other side, as indicated below. Tablet Identification Strength NDC Front Back Bottles of 100: 25 mg 69367-303-01 OP 25 50 mg 69367-304-01 OP 26 100 mg 69367-305-01 OP 27
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Manufactured by: Orient Pharma Co., Ltd. Yunlin, Taiwan Distributed by: Westminster Pharmaceuticals, LLC Nashville, TN 37217 Rev. 10/2020
PRINCIPAL DISPLAY PANEL - 25 mg Tablet Bottle Label
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 69367-303-01 Miglitol Tablets 25 mg Rx only 100 Tablets
PRINCIPAL DISPLAY PANEL - 50 mg Tablet Bottle Label
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 69367-304-01 Miglitol Tablets 50 mg Rx only 100 Tablets
PRINCIPAL DISPLAY PANEL - 100 mg Tablet Bottle Label
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 69367-305-01 Miglitol Tablets 100 mg Rx only 100 Tablets
