Nateglinide

Nateglinide is a prescription medication used to treat the symptoms of  type 2 diabetes mellitus. 

• Nateglinide is available under the following different brand names: Starlix

Common side effects of Nateglinide include:

• Upper respiratory tract infection,
• Back pain,
• Flu symptoms,
• Dizziness,
• Joint pain or inflammation,
• Diarrhea,
• Bronchitis,
• Coughing,
• Weight gain, and
• Symptoms of low blood sugar (sweating, trembling, dizziness, increased appetite, palpitations, nausea, fatigue, and weakness).

Serious side effects of Nateglinide include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat,
• Seizure, and
• Yellowing of the skin or eyes

Rare side effects of Nateglinide include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Tablet

• 60 mg
• 120 mg

Type 2 diabetes mellitus Monotherapy, or With Metformin

Adult dosage

• 120 mg orally every 8 hours
• 60 mg orally every 8 hours if the patient is near goal HbA1C
• Take the dose 1-30 minutes before the meal

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Nateglinide has severe interactions with no other drugs.
• Nateglinide has serious interactions with the following drugs
  • baricitinib
  • efavirenz
  • ethanol
  • ivosidenib
• Nateglinide has moderate interactions with at least 126 other drugs.
• Nateglinide has minor interactions with at least 82 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Documented hypersensitivity

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Nateglinide?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Nateglinide?”

Cautions

• Not to be used in combination with an insulin secretagogue (. g, glyburide)
• Not to be used as a substitute for metformin monotherapy but as adjunctive
• There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with therapy
• Hypoglycemia
  • Use caution in patients with a risk of severe hypoglycemia: elderly, malnourished, adrenal or pituitary insufficiency, hepatic insufficiency
  • Glinides can cause hypoglycemia; severe hypoglycemia can cause seizures, may be life-threatening or cause death
  • Hypoglycemia can impair concentration ability and reaction time; this may place an individual and others at risk in situations where these abilities are important (. g, driving or operating other machinery)
  • Hypoglycemia can happen suddenly, and symptoms may differ in each individual and change over time in the same individual
  • Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes, in patients with diabetic neuropathy (nerve disease), in patients using medications that block the sympathetic nervous system (. g, beta-blockers), or in patients who experience recurrent hypoglycemia
  • Factors that may increase the risk of hypoglycemia include changes in meal pattern (. g, macronutrient content), changes in the level of physical activity, changes to coadministered medication, and concomitant use with other antidiabetic agents
  • Patients with renal or hepatic impairment may be at higher risk of hypoglycemia; clinical Pharmacology; patients should take the medication before meals and be instructed to skip the dose if a meal is skipped
  • Patients and caregivers must be educated to recognize and manage hypoglycemia; self-monitoring of blood glucose plays an essential role in the prevention and management of hypoglycemia; in patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia, increased frequency of blood glucose monitoring recommended

Pregnancy and Lactation

• Available data from published literature and applicant’s pharmacovigilance in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes
• There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy
• Therapy should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus
• Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications
• Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity
• Lactation
  • There are no data on presence of nateglinide in human milk, effects on breastfeeding infants, or on milk production
  • The drug is present in animal milk; when a drug is present in animal milk, it is likely that the drug will be present in human milk
  • Because of the potential for hypoglycemia in breast-fed infants, advise women that the use of the drug is not recommended while breastfeeding