Diaset50 mg

Diaset is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

• Monotherapy: FDA-approved for use alone, together with dietary modification and exercise, to lower postprandial (after-meal) blood glucose spikes. Its glucose-lowering effect as monotherapy is generally modest compared with other antidiabetic classes and is usually insufficient for patients with significant hyperglycemia.
• Combination therapy: May be used together with a sulfonylurea when diet, exercise, and either agent alone do not provide adequate glycemic control, for an additive effect on blood glucose.

Diaset is not indicated for type 1 diabetes mellitus or diabetic ketoacidosis.

Each film-coated tablet of Miglitol typically contains Miglitol as the active ingredient, commonly available in strengths of 25 mg, 50 mg, and 100 mg, along with pharmaceutically inert excipients.

Diaset is an oral antidiabetic agent belonging to the alpha-glucosidase inhibitor class. Chemically it is a desoxynojirimycin derivative that acts locally in the small intestine rather than being absorbed and metabolized systemically to a significant degree. It is used alongside diet and exercise to help manage blood glucose levels in adults with type 2 diabetes mellitus.

Diaset belongs to the alpha-glucosidase inhibitor class of oral antidiabetic drugs.

Mechanism of Action

Miglitol works by reversibly inhibiting membrane-bound intestinal alpha-glucosidase enzymes (including sucrase, maltase, and glucoamylase) in the brush border of the small intestine. This delays the digestion and absorption of complex carbohydrates and disaccharides, blunting the rise in blood glucose that normally follows a meal. Unlike sulfonylureas, Miglitol does not stimulate insulin secretion from the pancreas and does not cause hypoglycemia when used alone.

Pharmacokinetics

• Absorption: Absorption is dose-dependent and becomes saturated at higher doses; peak plasma concentrations occur roughly 2-3 hours after dosing.
• Distribution: Minimal plasma protein binding (under 4%).
• Metabolism: Miglitol is not metabolized in the body.
• Excretion: Eliminated almost entirely unchanged via the kidneys, with an elimination half-life of approximately 2 hours.

Diaset should be swallowed with the first bite of each main meal, three times a day, so that the drug is present in the intestine when carbohydrates are being digested. It should not be taken on an empty stomach or well after a meal has started.

Clinically Significant Interactions

• Insulin or sulfonylureas: Combined use with Diaset increases the risk of hypoglycemia. If hypoglycemia occurs, it must be treated with oral glucose (dextrose), not table sugar (sucrose), because Diaset blocks the breakdown of complex sugars needed for rapid glucose absorption.
• Digoxin: Diaset may reduce plasma digoxin concentrations; monitoring of digoxin levels/effect is advised if co-administered.
• Ranitidine and propranolol: Bioavailability of these drugs may be reduced when taken with Diaset.
• Digestive enzyme preparations and activated charcoal: May reduce the effectiveness of Diaset and should generally be avoided in combination.
• Metformin and glyburide: Minor reductions in bioavailability have been observed with concurrent Diaset use but are not considered clinically significant.

Gastrointestinal effects are by far the most common adverse effects of Diaset and tend to lessen with continued use and gradual dose titration.

Very Common

• Flatulence
• Diarrhea
• Abdominal pain

Less Common

• Skin rash
• Low serum iron levels

Rare

• Pneumatosis cystoides intestinalis (a rare bowel condition), with possible complications such as intestinal obstruction or perforation, reported post-marketing.

See Precautions and Warnings and Interactions for management of hypoglycemia when Diaset is combined with insulin or sulfonylureas.

Pregnancy

Diaset has not been established as safe for use in pregnant women. Animal reproduction studies did not show fetal harm at doses several times the human dose, but adequate, well-controlled studies in pregnant women are lacking. Diaset should be used during pregnancy only if clearly needed and the potential benefit justifies the potential risk to the fetus; consult a physician before use.

Lactation

Small amounts of Diaset pass into breast milk. Because of the potential for adverse effects in a nursing infant, it is generally recommended that Diaset not be used by a nursing mother; a physician should be consulted to weigh alternatives.

• Hypoglycemia with combination therapy: When Diaset is used with insulin or a sulfonylurea, hypoglycemia can occur and must be treated with oral glucose (dextrose), not sucrose (see Interactions).
• Not effective alone for marked hyperglycemia: Diaset produces a comparatively modest glucose-lowering effect and is generally not sufficient as monotherapy for patients with significant hyperglycemia.
• Gastrointestinal tolerability: Flatulence, diarrhea, and abdominal pain are common with Diaset, especially early in treatment; gradual dose titration improves tolerability, and symptoms often diminish with continued use.
• Renal impairment: Diaset is not recommended in patients with creatinine clearance below 25 mL/min (see Dosage and Administration).
• Loss of glycemic control during stress: During periods of stress such as fever, trauma, infection, or surgery, temporary insulin therapy may be required, and Diaset may need to be withheld.

Because Diaset does not stimulate insulin release, an overdose is not expected to cause hypoglycemia by itself. Overdose may cause transient increases in gastrointestinal symptoms such as flatulence, diarrhea, and abdominal discomfort. There is no specific antidote for Diaset overdose. In case of a suspected overdose, seek immediate medical attention or contact a poison control center/emergency services; supportive care should be provided as needed, and if Diaset was combined with insulin or a sulfonylurea, blood glucose should be monitored closely for hypoglycemia from the other agent(s).

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children.

Pediatric Use

Safety and effectiveness of Diaset in pediatric patients have not been established; its use in children is not recommended.

Geriatric Use

No overall differences in safety or effectiveness of Diaset have been observed between elderly and younger adult patients; however, elderly patients are more likely to have reduced renal function, so renal status should be assessed before starting treatment (see Dosage and Administration).

Renal Impairment

Diaset is not recommended when creatinine clearance is below 25 mL/min (see Dosage and Administration).

Hepatic Impairment

No dose adjustment is required, as Diaset is not hepatically metabolized.

Diaset is generally used long-term, as part of ongoing management of type 2 diabetes mellitus alongside diet and exercise. Treatment duration and continued need should be reviewed periodically by the prescribing physician based on blood glucose control, HbA1c levels, and tolerability.

Miglitol is classified as an oral antidiabetic agent, specifically an alpha-glucosidase inhibitor.

Miglitol reversibly inhibits intestinal brush-border alpha-glucosidase enzymes, delaying the breakdown of complex carbohydrates into absorbable monosaccharides. This slows carbohydrate absorption and reduces the postprandial rise in blood glucose, without stimulating insulin secretion.

B

Safety and effectiveness of Diaset have not been established in pediatric patients. Diaset is therefore not recommended for use in children and adolescents.