Diastabol

Uses

Diastabol is used for an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Diastabol is also used to associated treatment for these conditions: Type 2 Diabetes Mellitus

How Diastabol works

In contrast to sulfonylureas, miglitol does not enhance insulin secretion. The antihyperglycemic action of miglitol results from a reversible inhibition of membrane-bound intestinal a-glucoside hydrolase enzymes. Membrane-bound intestinal a-glucosidases hydrolyze oligosaccharides and disaccharides to glucose and other monosaccharides in the brush border of the small intestine. In diabetic patients, this enzyme inhibition results in delayed glucose absorption and lowering of postprandial hyperglycemia.

Dosage

Diastabol dosage

There is no fixed dosage regimen for the management ofdiabetesmellitus with Diastabol Tablets or any other pharmacologic agent. Dosage of Diastabol must be individualized on the basis of both effectiveness and tolerance while not exceeding the maximum recommended dosage of 100 mg 3 times daily. Diastabol should be taken three times daily at the start of each main meal. Diastabol should be started at 25 mg, and the dosage gradually increased both to reducegastrointestinaladverse effects and to permit identification of the minimum dose required for adequate glycemic control of the patient. During treatment initiation and dose titration one-hourpostprandialplasma glucose may be used to determine the therapeutic response to Diastabol and identify the minimumeffective dosefor the patient.

Thereafter,glycosylated hemoglobinshould be measured at intervals of approximately 3 months. The therapeutic goal should be to decrease both postprandial plasma glucose and glycosylatedhemoglobinlevels to normal or near normal by using the lowest effective dose of Diastabol, either as monotherapy or in combination with asulfonylurea.

Initial Dosage: The recommended starting dosage of Diastabol is 25 mg, given orally three times daily at the start of each main meal. However, some patients may benefit by starting at 25 mg once daily to minimize gastrointestinal adverse effects, and gradually increasing the frequency of administration to 3 times daily.

Maintenance Dosage: The usual maintenance dose of Diastabol is 50 mg taken 3 times daily, although some patients may benefit from increasing the dose to 100 mg 3 times daily. To allow adaptation to potential gastrointestinal adverse effects, it is recommended that Diastabol therapy be initiated at a dosage of 25 mg 3 times daily, then gradually titrated upward to allow adaptation. After 4 to 8 weeks of the 25 mg 3 times daily regimen, the dosage should be increased to 50 mg 3 times daily for approximately three months, following which a glycosylated hemoglobin level should be measured to assess therapeutic response. If at that time, the glycosylated hemoglobin level is not satisfactory, the dosage may be further increased to 100 mg 3 times daily, the maximum recommended dosage.

Maximum Dosage: The maximum recommended dosage of Diastabol is 100 mg 3 times daily. In one clinical trial, 200 mg 3 times daily gave additional improved glycemic control but increased the incidence of the gastrointestinal symptoms described above.

Patients Receiving Sulfonylureas: Sulfonylurea agents may causehypoglycemia. There was no increased incidence of hypoglycemia in patients who took Diastabol in combination with sulfonylurea agents compared to the incidence of hypoglycemia in patients receiving sulfonylureas alone in any clinical trial. However, Diastabol given in combination with a sulfonylurea will cause a further lowering ofblood glucoseand may increase the risk of hypoglycemia due to the additive effects of the two agents. If hypoglycemia occurs, appropriate adjustments in the dosage of these agents should be made

Should be taken with food. Take with 1st bite of each main meal.

Side Effects

Abdominal pain or discomfort, diarrhoea, flatulence, skin rash.

Toxicity

Unlike sulfonylureas or insulin, an overdose will not result in hypoglycemia. An overdose may result in transient increases in flatulence, diarrhea, and abdomi-nal discomfort. Because of the lack of extra-intestinal effects seen with miglitol, no serious systemic reactions are expected in the event of an overdose.

Precaution

Patient exposed to stress (e.g. fever, trauma, infection, surgery). Renal impairment. Pregnancy and lactation.

Interaction

Concomitant use with insulin increases the risk of hypoglycaemia. Intestinal adsorbents (e.g. charcoal) and carbohydrate-splitting digestive enzyme supplements (e.g. amylase, pancreatin) may reduce glycaemic effects. May significantly reduce the bioavailability of ranitidine and propranolol.

Food Interaction

• Take with food. Take at the beginning of a meal.

[Moderate] GENERALLY AVOID: Alcohol may cause hypoglycemia or hyperglycemia in patients with diabetes.

Hypoglycemia most frequently occurs during acute consumption of alcohol.

Even modest amounts can lower blood sugar significantly, especially when the alcohol is ingested on an empty stomach or following exercise.

The mechanism involves inhibition of both gluconeogenesis as well as the counter-regulatory response to hypoglycemia.

Episodes of hypoglycemia may last for 8 to 12 hours after ethanol ingestion.

By contrast, chronic alcohol abuse can cause impaired glucose tolerance and hyperglycemia.

Moderate alcohol consumption generally does not affect blood glucose levels in patients with well controlled diabetes.

A disulfiram-like reaction (e.g., flushing, headache, and nausea) to alcohol has been reported frequently with the use of chlorpropamide and very rarely with other sulfonylureas.

MANAGEMENT: Patients with diabetes should avoid consuming alcohol if their blood glucose is not well controlled, or if they have hypertriglyceridemia, neuropathy, or pancreatitis.

Patients with well controlled diabetes should limit their alcohol intake to one drink daily for women and two drinks daily for men (1 drink = 5 oz wine, 12 oz beer, or 1.5 oz distilled spirits) in conjunction with their normal meal plan.

Alcohol should not be consumed on an empty stomach or following exercise.

Diastabol Drug Interaction

Moderate: contained in alcoholic beverages , glyburide, estradiol topical, ofloxacinUnknown: pioglitazone, ciclesonide, aspirin, teriflunomide, multivitamin, mupirocin topical, cyanocobalamin, chlorpheniramine, isotretinoin, losartan, acetaminophen / dextromethorphan / diphenhydramine, venlafaxine, fingolimod, isosorbide mononitrate, canagliflozin / metformin, metoprolol

Diastabol Disease Interaction

Major: diabetic ketoacidosis, intestinal disease, renal dysfunction

Volume of Distribution

• 0.18 L/kg

Elimination Route

Absorption of miglitol is saturable at high doses with 25 mg being completely absorbed while a 100-mg dose is only 50-70% absorbed. No evidence exists to show that systemic absorption of miglitol adds to its therapeutic effect.

Half Life

The elimination half-life of miglitol from plasma is approximately 2 hours.

Elimination Route

Diastabol is not metabolized in man or in any animal species studied. It is eliminated by renal excretion as an unchanged drug.

Pregnancy & Breastfeeding use

Category B: Either animal-reproduction studies have not demonstrated a fetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).

Contraindication

Patient with diabetic ketoacidosis, inflammatory bowel disease, colonic ulceration, partial intestinal obstruction or predisposition to this condition, chronic intestinal diseases associated with marked disorders of digestion or absorption and co-existing conditions that may deteriorate as a result of increased intestinal gas formation.

Storage Condition

Store at 25° C.

Innovators Monograph

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