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Does Starlix (nateglinide) cause side effects?
Type 2 diabetics have an inability to control blood glucose levels. This is caused by reduced secretion of insulin from the pancreas after meals and resistance of the body's cells to the effect of insulin which is to stimulate the cells to remove glucose from the blood. This leads to high levels of blood glucose.
However, Starlix appears to have a faster onset and a shorter duration of action than sulfonylureas. The benefit of this faster, shorter effect may be to prevent the rapid, transient rise in blood glucose that occurs in diabetics immediately following a meal.
Common side effects of Starlix include
- heart palpitations,
- numbness around the mouth,
- tingling in the fingers,
- muscle weakness,
- blurred vision,
- cold temperature,
- excessive yawning,
- confusion, and
- loss of consciousness.
Drug interactions of Starlix include nonsteroidal anti-inflammatory agents (NSAIDs), aspirin and aspirin-like compounds, monoamine oxidase inhibitors (MAOIs), and beta-blockers, because starting or stopping these drugs may increase the response to Starlix and may require the dose of Starlix to be lowered.
Starting or stopping the following drugs may decrease the response to Starlix and may require the dose of Starlix to be increased:
- thiazide diuretics,
- thyroid hormone, and
- drugs used in emergencies to regulate the heartbeat or restore breathing when airways are blocked such as epinephrine and albuterol.
What are the important side effects of Starlix (nateglinide)?
The most common side effects of nateglinide therapy are:
- Runny nose,
- upper respiratory infections,
- back pain,
- flu-like symptoms,
- dizziness, and
- joint pain are the most common side
Another important side effect of nateglinide therapy is hypoglycemia (low blood glucose levels with or without symptoms) can occur.
Some symptoms of hypoglycemia include:
Starlix (nateglinide) side effects list for healthcare professionals
The following serious adverse reaction is also described elsewhere in the labeling:
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In clinical trials, approximately 2,600 patients with type 2 diabetes mellitus were treated with Starlix. Of these, approximately 1,335 patients were treated for 6 months or longer and approximately 190 patients for one year or longer. Table 1 shows the most common adverse reactions associated with Starlix.
Table 1: Adverse Reactions other than Hypoglycemia (%) occurring Greater than or Equal to 2% in Starlix-Treated Patients from Pool of 12 to 64 week Placebo Controlled Trials
|Upper Respiratory Infection||8.1||10.5|
Episodes of severe hypoglycemia (plasma glucose less than 36 mg/dL) were reported in two patients treated with Starlix. Non-severe hypoglycemia occurred in 2.4 % of Starlix treated patients and 0.4 % of placebo treated patients.
Patients treated with Starlix had statistically significant mean increases in weight compared to placebo. In clinical trials, the mean weight increases with Starlix 60 mg (3 times daily) and Starlix 120 mg (3 times daily) compared to placebo were 1.0 kg and 1.6 kg respectively.
Increases in Uric Acid: There were increases in mean uric acid levels for patients treated with Starlix alone, Starlix in combination with metformin, metformin alone, and glyburide alone. The respective differences from placebo were 0.29 mg/dL, 0.45 mg/dL, 0.28 mg/dL, and 0.19 mg/dL.
The following adverse reactions have been identified during post-approval use of Starlix. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
What drugs interact with Starlix (nateglinide)?
Table 2 includes a list of drugs with clinically important drug interactions when concomitantly administered or withdrawn with Starlix and instructions for managing or preventing them.
Table 2: Clinically Significant Drug Interactions with Starlix
|Drugs That May Increase the Blood-Glucose-Lowering Effect of Starlix and Susceptibility to Hypoglycemia|
|Drugs:||Nonsteroidal anti-inflammatory drugs (NSAIDs), salicylates, monoamine oxidase inhibitors, non-selective beta-adrenergic-blocking agents, anabolic hormones (e.g. methandrostenolone), guanethidine, gymnema sylvestre, glucomannan, thioctic acid, and inhibitors of CYP2C9 (e.g. amiodarone, fluconazole, voriconazole, sulfinpyrazone), alcohol.|
|Intervention:||Dose reductions and increased frequency of glucose monitoring may be required when Starlix is coadministered with these drugs.|
|Drugs and Herbals That May Reduce the Blood-Glucose-Lowering Effect of Starlix and Increase Susceptibility to Hyperglycemia|
|Drugs:||Thiazides, corticosteroids, thyroid products, sympathomimetics, somatropin, somatostatin analogues (e.g. lanreotide, octreotide), and CYP inducers (e.g. rifampin, phenytoin and St John’s Wort).|
|Intervention:||Dose increases and increased frequency of glucose monitoring may be required when Starlix is coadministered with these drugs.|
|Drugs That May Blunt Signs and Symptoms of Hypoglycemia|
|Drugs:||beta-blockers, clonidine, guanethidine, and reserpine|
|Intervention:||Increased frequency of glucose monitoring may be required when Starlix is coadministered with these drugs.|
Starlix (nateglinide) is a meglitinide used to lower blood sugar (glucose) levels in type 2 diabetes. Common side effects of Starlix include runny nose, cough, upper respiratory infections, back pain, flu-like symptoms, dizziness, and joint pain. No safety and efficacy studies have been conducted in pregnant women taking Starlix. Starlix should not be used during pregnancy. Since many drugs are excreted in breast milk, the manufacturer recommends Starlix not be administered to breastfeeding mothers.
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Normal Blood Sugar Levels (Ranges) In Adults with Diabetes
People with diabetes can manage and prevent low or high blood sugar levels (hyperglycemia or hypoglycemia) by keeping a log of your blood sugar levels when you are eating and fasting and eat foods that are high in carbohydrates and sugar, for example, buttered potatoes, candy, sugary desserts, and fatty foods. Blood tests, for example, the hemoglobin A1c test (A1c test) and urinalysis can diagnose the type of diabetes the person has. Diabetes during pregnancy, called gestational diabetes, should be managed by you and your OB/GYN or another healthcare professional. Extremely high levels of blood glucose in the blood can be dangerous and life threatening if you have type 1, type 2, or gestational diabetes. If you or someone that you are with has extremely high blood glucose levels, call 911 or go to your nearest Urgent Care or Emergency Department immediately. To prevent and manage high blood glucose levels in people with diabetes keep a log of your blood sugar levels, eat foods that are high in carbohydrates sugar, for example, buttered potatoes, candy, sugary deserts, and fatty foods that you can share with your doctor and other healthcare professionals.
Type 2 Diabetes Diet Plan
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Diabetes (Type 1 and Type 2)
Diabetes is a chronic condition characterized by high levels of sugar (glucose) in the blood. The two types of diabetes are referred to as type 1 (insulin dependent) and type 2 (non-insulin dependent). Symptoms of diabetes include increased urine output, thirst, hunger, and fatigue. Treatment of diabetes depends on the type.
Diabetes Symptoms in Men
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Type 1 vs Type 2 Diabetes (Similarities and Differences)
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Type 2 Diabetes
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Eye Problems and Diabetes
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Diabetes and Kidney Disease
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Can Type 2 Diabetes be Cured?
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Tips for Managing Type 1 and 2 Diabetes at Home
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What Are the Early Signs of Type 2 Diabetes?
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.