Starlix

Starlix - an oral synthetic hypoglycemic drug. A medicine based on nateglinide for the treatment of diabetes, which helps to control blood sugar levels. This medicine helps your body to react better to the insulin produced by your pancreas. Starlix is used in conjunction with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

Product dosage: 120mg
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Synonyms Glinate Nateglinida Nateglinidum Incuria Meglitinide Fastic Nopik Nateglinid Senaglinide

Starlix (nateglinide) is a modern meglitinide-class antihyperglycemic agent specifically engineered for the management of type 2 diabetes mellitus. It functions as a rapid-onset, short-duration insulin secretagogue, primarily targeting the postprandial (after-meal) glucose excursions that are a significant contributor to overall glycemic control, as measured by HbA1c. By stimulating a swift and transient release of insulin from the pancreatic beta cells, Starlix offers a physiological insulin response that closely mimics the body’s natural reaction to food intake. This targeted mechanism provides a crucial therapeutic option for patients requiring focused intervention on postprandial hyperglycemia without a prolonged risk of hypoglycemia between meals.

Features

• Active Pharmaceutical Ingredient: Nateglinide.
• Pharmacologic Class: Meglitinide derivative; nonsulfonylurea insulin secretagogue.
• Mechanism of Action: Binds to and closes ATP-sensitive potassium channels on pancreatic beta-cell membranes, prompting a rapid but short-lived calcium influx that stimulates insulin secretion.
• Pharmacokinetics: Rapid absorption with peak plasma concentrations (Tmax) achieved within approximately 1 hour. Mean absolute bioavailability is around 73%.
• Half-life: Approximately 1.5 hours.
• Metabolism: Primarily metabolized in the liver by the cytochrome P450 isoenzymes CYP2C9 (70%) and CYP3A4 (30%).
• Excretion: Mainly via urine (83-88%) with approximately 10% excreted in feces.
• Available Formulations: Oral tablets in 60 mg and 120 mg strengths.
• Onset of Action: Begins within 20 minutes of oral administration.

Benefits

• Targeted Postprandial Glucose Control: Significantly reduces the sharp rise in blood sugar that occurs immediately after eating, a key factor in achieving optimal HbA1c levels.
• Physiological Insulin Response: Its rapid onset and short duration of action provide an insulin secretion profile that closely resembles the body’s natural post-meal insulin release, enhancing mealtime flexibility.
• Reduced Risk of Interprandial Hypoglycemia: Due to its short-acting nature, the insulin-stimulating effect subsides before the next meal, minimizing the potential for low blood sugar episodes during fasting periods.
• Complementary Therapy: Can be effectively used as monotherapy or in combination with other antihyperglycemic agents like metformin or thiazolidinediones, which have different mechanisms of action (e.g., reducing hepatic glucose production or improving insulin sensitivity).
• Suitable for Patients with Renal Impairment: Requires no dosage adjustment for patients with mild to severe renal impairment, unlike many other diabetes medications, offering a valuable option for this patient population.
• Supports Overall Glycemic Goals: By effectively managing postprandial spikes, it contributes directly to the reduction of HbA1c, thereby helping to lower the long-term risk of diabetic complications.

Common use

Starlix is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It is most effectively prescribed for patients who experience significant and problematic elevations in blood glucose levels following meals. It is particularly useful for individuals whose primary glycemic issue is postprandial hyperglycemia rather than fasting hyperglycemia. It can be used as a standalone (monotherapy) treatment when metformin is not tolerated or is contraindicated, or as part of a combination regimen with other oral antidiabetic agents that have complementary mechanisms, such as biguanides (e.g., metformin) or insulin sensitizers, when monotherapy does not provide adequate glycemic control.

Dosage and direction

• The recommended starting and maintenance dose is 120 mg taken three times daily, 1 to 30 minutes before each main meal (breakfast, lunch, and dinner).
• A dose of 60 mg three times daily may be used for patients who are near their HbA1c goal when treatment is initiated.
• The tablet should be swallowed whole with water.
• Administration is directly tied to meal consumption. If a meal is skipped, the corresponding dose of Starlix should also be skipped to prevent hypoglycemia. If a meal is added, a dose may be taken with that meal.
• Dosing should be individualized based on effectiveness and tolerability, as determined by the prescribing physician through regular blood glucose monitoring.

Precautions

• Hypoglycemia: As an insulin secretagogue, Starlix can cause hypoglycemia. Patients must be educated on the recognition, treatment, and prevention of low blood sugar. Risk is increased by skipped meals, strenuous exercise, alcohol consumption, and use of other antidiabetic drugs.
• Hepatic Impairment: Use with caution in patients with moderate to severe liver disease. Plasma levels of nateglinide may be significantly increased, potentiating the risk of hypoglycemia. More frequent blood glucose monitoring is advised.
• Loss of Glycemic Control: Under conditions of stress such as fever, trauma, infection, or surgery, a loss of glycemic control may occur, necessitating temporary discontinuation of Starlix and administration of insulin.
• Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Starlix or any other antidiabetic drug.
• Pregnancy and Lactation: Starlix is classified as FDA Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether nateglinide is excreted in human milk; caution is advised if administering to a nursing woman.

Contraindications

Starlix is contraindicated in patients with:

• Known hypersensitivity to nateglinide or any excipient in the formulation.
• Type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as these conditions require insulin therapy.
• Concomitant use with gemfibrozil, a strong CYP2C9 inhibitor, due to a significant interaction that increases nateglinide exposure and the risk of hypoglycemia.

Possible side effect

The most common adverse reactions are related to its pharmacologic effect (hypoglycemia) and the gastrointestinal system. Side effects include:

• Very Common (≥1/10): Hypoglycemia.
• Common (≥1/100 to <1/10): Dizziness, increased weight, flu-like symptoms, arthropathy, diarrhea, nausea, vomiting, constipation.
• Uncommon (≥1/1,000 to <1/100): Bronchitis, coughing, urticaria, pruritus (itching).
• As with all drugs, rare but serious allergic and hypersensitivity reactions can occur.

Drug interaction

Starlix is susceptible to numerous drug interactions due to its metabolism by CYP2C9 and CYP3A4.

• Drugs that Increase Risk of Hypoglycemia: NSAIDs, salicylates, monoamine oxidase inhibitors, non-selective beta-adrenergic blocking agents, ACE inhibitors, fibrates, sulfonamides, gemfibrozil (contraindicated), other CYP2C9 inhibitors (e.g., fluconazole).
• Drugs that May Lead to Hyperglycemia: Thiazides, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, isoniazid, other CYP2C9 inducers (e.g., rifampin).
• Beta-blockers may mask the tachycardic symptoms of hypoglycemia and impair counter-regulatory mechanisms.
• Alcohol may either potentiate or impair the glucose-lowering effect of Starlix and should be consumed with caution.

Missed dose

• If a dose is missed before a meal, it should be omitted.
• The patient should not take a double dose to make up for the missed one.
• The next dose should be taken at the usual time before the next scheduled meal.
• Blood glucose should be monitored.

Overdose

• Overdose of Starlix, like other insulin secretagogues, is expected to result in severe hypoglycemia.
• Symptoms include hunger, nausea, anxiety, cold sweats, drowsiness, tremor, blurred vision, and can progress to seizures, coma, and death.
• Management involves prompt administration of oral carbohydrates (glucose tablets, fruit juice, sugar). In severe cases (unconsciousness, seizures), immediate medical attention is required, and treatment includes intravenous glucose or glucagon injection.
• Close monitoring and possible hospitalization for observation for at least 24-48 hours is necessary, as hypoglycemia may recur after apparent clinical recovery.

Storage

• Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F).
• Keep the bottle tightly closed to protect from moisture and light.
• Keep out of reach of children.
• Do not use after the expiration date printed on the bottle.

Disclaimer

This information is for educational and informational purposes only and does not constitute medical advice. It is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or before starting any new treatment. Never disregard professional medical advice or delay in seeking it because of something you have read here. The information provided is based on the drug’s prescribing label but may not be exhaustive.

Reviews

Clinical studies have demonstrated the efficacy of nateglinide. In monotherapy trials, Starlix 120 mg tid provided significant reductions in HbA1c and fasting plasma glucose compared to placebo. In combination therapy with metformin, it provided additive glycemic control, particularly on postprandial glucose parameters. The safety profile is generally favorable, with hypoglycemia being the most frequently reported adverse event, typically mild to moderate in severity. Many clinicians report that its meal-contingent dosing offers a practical and effective tool for managing postprandial hyperglycemia in appropriate patient populations, enhancing both glycemic control and patient lifestyle flexibility.