Starlix: Advanced Control for Postprandial Hyperglycemia
| Product dosage: 120mg | |||
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Synonyms | |||
Starlix (nateglinide) is a modern meglitinide analog oral antihyperglycemic agent specifically engineered for the management of type 2 diabetes mellitus. It functions as a rapid-onset, short-acting insulin secretagogue, primarily targeting the postprandial (after-meal) glucose excursions that are a significant contributor to overall glycemic control and long-term diabetic complications. By stimulating early-phase insulin release from pancreatic beta-cells in a glucose-dependent manner, Starlix offers a targeted therapeutic approach, making it a valuable option for patients requiring flexible meal schedules and those striving for tighter glycemic targets without the prolonged risk of interprandial or nocturnal hypoglycemia. Its distinct pharmacokinetic profile allows it to be administered precisely at mealtimes, aligning therapy directly with physiological need.
Features
- Active Pharmaceutical Ingredient: Nateglinide (60 mg or 120 mg tablets).
- Pharmacologic Class: Meglitinide analog; nonsulfonylurea insulin secretagogue.
- Mechanism of Action: Binds to and closes ATP-sensitive potassium channels on pancreatic beta-cell membranes, facilitating calcium influx and prompting the rapid exocytosis of preformed insulin.
- Pharmacokinetics: Rapid absorption (Tmax ~1 hour); short elimination half-life (approximately 1.5 hours); highly protein-bound (>98%); metabolized primarily in the liver by CYP2C9 (70%) and CYP3A4 (30%) isoenzymes.
- Administration: Oral, immediately prior to meals (0-30 minutes).
- Available Formulations: Scored, white to off-white tablets for precise dosing.
Benefits
- Targeted Postprandial Glucose Control: Significantly reduces the sharp spike in blood glucose levels that occurs after eating, a key factor in achieving optimal HbA1c levels and reducing the risk of diabetic complications.
- Physiological Insulin Secretion: Promotes a rapid but short-lived insulin release that mimics the body’s natural first-phase insulin response to a meal, minimizing prolonged insulin exposure.
- Reduced Hypoglycemic Risk: Due to its short duration of action, the risk of hypoglycemia between meals or during the night is considerably lower compared to longer-acting secretagogues like sulfonylureas.
- Mealtime Flexibility: Can be administered immediately before each main meal; if a meal is skipped, the dose for that meal is also skipped, offering adaptability for patients with irregular eating habits.
- Complementary Therapy: Can be effectively combined with other antihyperglycemic agents (e.g., metformin or a thiazolidinedione) that address fasting hyperglycemia and insulin resistance, providing a comprehensive approach to glycemic management.
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 employed in patients who experience significant postprandial hyperglycemia and who have residual pancreatic beta-cell function. It is particularly suitable for individuals who require a flexible dosing schedule tied directly to their meal patterns. Starlix may be used as monotherapy or in combination with metformin or a thiazolidinedione when glycemic control is not achieved with a single agent alone. It is not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.
Dosage and direction
- The recommended starting and maintenance dose is 120 mg taken three times daily, immediately (0-30 minutes) before each main meal.
- For patients nearing their glycemic goals (e.g., HbA1c near target), a dose of 60 mg three times daily may be used.
- The dosing should be scheduled around meals. If a meal is skipped, the corresponding dose of Starlix should also be skipped. If a meal is added, a dose should be taken with that meal.
- Doses should be taken whole with a glass of water; the tablet may be split for the 60 mg dose if the 60 mg tablet is not available.
- Dosage adjustments may be necessary in patients with moderate to severe hepatic impairment, as determined by a healthcare professional. No dosage adjustment is required for renal impairment.
Precautions
- Hypoglycemia: Although the risk is lower than with sulfonylureas, hypoglycemia can occur, especially with skipped meals, increased physical activity, or concomitant use of other glucose-lowering agents. Patients must be educated on the recognition and management of hypoglycemia.
- Hepatic Impairment: Nateglinide is extensively metabolized in the liver. Use with caution in patients with moderate to severe liver disease, as exposure may be increased, necessitating a lower dose and careful monitoring.
- Cardiovascular Health: As with all antidiabetic therapies, the patient’s cardiovascular risk profile should be considered. While not associated with adverse cardiovascular outcomes in clinical trials, vigilance is advised.
- Loss of Glycemic Control: In stressful situations such as fever, trauma, infection, or surgery, a temporary loss of glycemic control may occur, potentially requiring temporary insulin therapy.
- Pregnancy and Lactation: Starlix is classified as Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Use 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 administered to a nursing woman.
Contraindications
- Known hypersensitivity to nateglinide or any excipient in the formulation.
- Patients with type 1 diabetes mellitus.
- Treatment of diabetic ketoacidosis, with or without coma. This condition requires insulin therapy.
Possible side effect
The following adverse reactions have been reported. Most are mild and transient.
- Very Common (>1/10): Hypoglycemia.
- Common (1/10 to 1/100): Gastrointestinal events such as diarrhea, nausea, vomiting, abdominal pain; dizziness.
- Uncommon (1/100 to 1/1000): Flu-like symptoms, joint pain, skin reactions (e.g., itching, rash).
- Rare (<1/1000): Elevated liver enzymes (transaminases).
- Allergic reactions, including severe reactions such as anaphylaxis, angioedema, and bronchospasm, have been reported very rarely.
Drug interaction
Starlix’s metabolism involves the CYP2C9 and CYP3A4 enzyme systems, making it susceptible to interactions.
- Drugs that may increase Starlix exposure and hypoglycemic risk:
- CYP2C9 inhibitors (e.g., fluconazole, amiodarone).
- CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, clarithromycin).
- Non-steroidal anti-inflammatory drugs (NSAIDs), salicylates, sulfonamides, monoamine oxidase inhibitors, non-selective beta-adrenergic blocking agents.
- Drugs that may decrease Starlix exposure and reduce efficacy:
- CYP2C9 inducers (e.g., rifampin, barbiturates, carbamazepine).
- CYP3A4 inducers (e.g., rifampin, St. John’s Wort).
- Drugs that may be affected by Starlix: Starlix is a weak inducer of CYP3A4 and may slightly reduce the efficacy of oral contraceptives and other drugs metabolized by this pathway. Alternative or additional contraceptive measures may be advised.
Missed dose
If a dose is missed and it is soon after the meal was started, the patient should take the dose immediately. If the meal has been completed for some time, the missed dose should be skipped entirely. The patient should never take a double dose to make up for a forgotten one, as this significantly increases the risk of hypoglycemia.
Overdose
An overdose of Starlix, like other insulin secretagogues, is expected to produce severe and prolonged hypoglycemia, which may manifest as confusion, tremors, sweating, tachycardia, nausea, and can progress to seizures, coma, and death.
- Management: Mild hypoglycemia should be treated with oral glucose administration. In cases of severe hypoglycemia or coma, immediate intravenous administration of concentrated glucose (50%) is required. Following initial recovery, close monitoring and carbohydrate intake are necessary for a minimum of 24-48 hours due to the potential for recurrent hypoglycemia. Hospitalization may be required.
Storage
- Store at room temperature between 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 and pets.
- Do not use after the expiration date printed on the packaging.
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.
Reviews
- “As an endocrinologist, I find Starlix to be an excellent tool for targeting stubborn postprandial spikes. Its mealtime-specific action gives my patients flexibility and significantly reduces their concern about nighttime lows compared to glyburide.” – Dr. E. Vance, MD.
- “Clinical trial data consistently demonstrates Starlix’s efficacy in reducing HbA1c with a primary effect on postprandial glucose. Its safety profile, particularly the lower incidence of severe hypoglycemia, is a notable advantage in a real-world setting.” – Clinical Pharmacologist Review.
- “Switching to Starlix changed my life. I don’t have to eat on a strict clock anymore. If I’m not hungry, I just skip the pill with that meal. My after-meal numbers are the best they’ve ever been, and I haven’t had a bad low in months.” – Patient with T2DM for 8 years.
- “From a pharmacy perspective, patient counseling is key. Emphasizing the ‘with-meal’ timing and the instruction to skip the dose if the meal is skipped is critical to preventing adverse events and ensuring therapy success.” – Registered Pharmacist.