Possible side effects
Stop taking nateglinide and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives). Other, less serious side effects from nateglinide result mostly from blood sugar levels that are either too high or too low. You should be familiar with the symptoms of both high and low blood sugar levels and know how to treat both conditions. Also, be sure your family and close friends know how to help you in an emergency situation.
Low blood sugar may occur when too much nateglinide is taken; when meals are missed or delayed; if you exercise more than usual; during illness, especially with vomiting or diarrhea; if you take other medications; after drinking alcohol; and in other situations.
Hypoglycemia or Low blood sugar has the following symptoms:
- shaking;
- headache;
- cold sweats;
- pale, cool skin;
- anxiety; and
- difficulty concentrating.
Keep hard, sugary candy; chocolate; fruit juice; or glucose tablets on hand to treat episodes of low blood sugar.
Increased blood sugar may occur when not enough glimepiride is taken; if you eat significantly more food than usual; if you exercise less than usual; if you take other medications; during fever or other illness; and in other situations.
Hyperglycemia or High blood sugar has the following symptoms:
- increased thirst,
- increased hunger,
- and increased urination.
There may be an increased risk of death due to cardiovascular (heart and blood vessels) complications with the use of glimepiride when compared to the treatment of diabetes with diet or diet plus insulin. The long-term use of glimepiride should be discussed with your doctor.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
What other drugs will affect Starlix?
Before taking nateglinide, tell your doctor if you are taking any of the following medicines:
- a nonsteroidal anti-inflammatory drug (NSAID) such as diclofenac (Voltaren, Cataflam), etodolac (Lodine), fenoprofen (Nalfon), flurbiprofen (Ansaid), ibuprofen (Advil, Motrin, Nuprin, others), indomethacin (Indocin), ketoprofen (Orudis KT, Orudis, Oruvail), nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprosyn, others), piroxicam (Feldene), sulindac (Clinoril), tolmetin (Tolectin), and others;
- aspirin (Bayer Aspirin, Ecotrin, Easprin, others) or another salicylate such as salsalate (Disalcid, Salflex, Salsitab, others), choline magnesium trisalicylate (Tricosal, Trilisate), and others;
- a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate);
- a beta-blocker such as atenolol (Tenormin), metoprolol (Lopressor, Toprol XL), or propranolol (Inderal);
- a steroid medication such as prednisone (Deltasone, Orasone, others), methylprednisolone (Medrol), dexamethasone (Decadron), prednisolone (Prelone, others), and others;
- a diuretic (water pill) such as hydrochlorothiazide (HCTZ, HydroDiuril, Esidrix, Microzide, Oretic, others), chlorothiazide (Diuril), chlorthalidone (Thalitone, Hygroton), metolazone (Mykrox, Zaroxolyn), indapamide (Lozol), and others;
- a thyroid supplement such as Levoxyl, Synthroid, Levothroid, Levotabs, Thyrolar, Cytomel, and others; or
- a respiratory medication such as albuterol (Ventolin, Proventil, others), bitolterol (Tornalate), metaproterenol (Alupent, Metaprel), pirbuterol (Maxair), terbutaline (Brethaire, Brethine, Bricanyl), and others.
The medicines listed above may interact with nateglinide or affect blood sugar control. You may require dosage adjustments or special monitoring during treatment.
Drugs other than those listed here may also interact with nateglinide or affect your condition. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.
What should I avoid while taking Starlix?
Follow your diet, medication, and exercise routines very closely. Changing any of these routines can affect blood sugar levels.
Avoid alcohol. It lowers blood sugar and may interfere with diabetes treatment.
Tell your doctor and dentist that you are taking this medication before you undergo any surgery.
Do not take any over-the-counter cough, cold, allergy, pain, or weight-loss medications without first talking to your doctor or pharmacist.
Contraindications
Starlix� (nateglinide) is contraindicated in patients with:
- Known hypersensitivity to the drug or its inactive ingredients.
- Type 1 diabetes.
- Diabetic ketoacidosis. This condition should be treated with insulin.
Warnings
You should periodically test your blood or urine for abnormal sugar (glucose) levels. Even people with well-controlled diabetes may find that injury, infection, surgery, or fever results in a temporary loss of blood sugar control. At such times, the doctor may recommend that you take insulin instead of Starlix.
The effectiveness of any antidiabetic drug, including Starlix, may decrease with time. This may occur because of either a diminished responsiveness to the medication or a worsening of the diabetes.
If you have liver disease, use Starlix with caution. Also, be aware that dialysis treatments may reduce the effectiveness of the drug.
The safety and effectiveness of Starlix in children have not been established.
If you have type 1 (insulin-dependent) diabetes, you cannot use Starlix. The drug also cannot be used for diabetic ketoacidosis (a life-threatening medical emergency caused by insufficient insulin and marked by excessive thirst, nausea, fatigue, pain below the breastbone, and fruity-smelling breath).
If you are already taking a drug that promotes insulin secretion, such as Micronase, you should not switch to Starlix or add it to your current drug. In addition, Starlix is not for you if you have been taking other antidiabetic drugs for a long time, or if Starlix gives you an allergic reaction.
Precautions
Hypoglycemia
All oral blood glucose lowering drugs that are absorbed systemically are capable of producing hypoglycemia. The frequency of hypoglycemia is related to the severity of the diabetes, the level of glycemic control, and other patient characteristics. Geriatric patients, malnourished patients, and those with adrenal or pituitary insufficiency or severe renal impairment are more susceptible to the glucose lowering effect of these treatments. The risk of hypoglycemia may be increased by strenuous physical exercise, ingestion of alcohol, insufficient caloric intake on an acute or chronic basis, or combinations with other oral antidiabetic agents. Hypoglycemia may be difficult to recognize in patients with autonomic neuropathy and/or those who use beta-blockers. Starlix� (nateglinide) should be administered prior to meals to reduce the risk of hypoglycemia. Patients who skip meals should also skip their scheduled dose of Starlix to reduce the risk of hypoglycemia.
Hepatic Impairment
Starlix should be used with caution in patients with moderate-to-severe liver disease because such patients have not been studied.
Hypoglycemia
Transient loss of glycemic control may occur with fever, infection, trauma, or surgery. Insulin therapy may be needed instead of Starlix therapy at such times. Secondary failure, or reduced effectiveness of Starlix over a period of time, may occur.
Information For Patients
Carcinogenesis/ Mutagenesis/ Impairment of Fertility
Carcinogenicity: A two-year carcinogenicity study in Sprague-Dawley rats was performed with oral doses of nateglinide up to 900 mg/kg/day, which produced AUC exposures in male and female rats approximately 30 and 40 times the human therapeutic exposure respectively with a recommended Starlix dose of 120 mg, three times daily before meals. A two-year carcinogenicity study in B6C3F1 mice was performed with oral doses of nateglinide up to 400 mg/kg/day, which produced AUC exposures in male and female mice approximately 10 and 30 times the human therapeutic exposure with a recommended Starlix dose of 120 mg, three times daily before meals. No evidence of a tumorigenic response was found in either rats or mice.
Mutagenesis: Nateglinide was not genotoxic in the in vitro Ames test, mouse lymphoma assay, chromosome aberration assay in Chinese hamster lung cells, or in the in vivo mouse micronucleus test. Impairment of Fertility: Fertility was unaffected by administration of nateglinide to rats at doses up to 600 mg/kg (approximately 16 times the human therapeutic exposure with a recommended Starlix dose of 120 mg three times daily before meals).
Pregnancy
Pregnancy Category C
Nateglinide was not teratogenic in rats at doses up to 1000 mg/kg (approximately 60 times the human therapeutic exposure with a recommended Starlix dose of 120 mg, three times daily before meals). In the rabbit, embryonic development was adversely affected and the incidence of gallbladder agenesis or small gallbladder was increased at a dose of 500 mg/kg (approximately 40 times the human therapeutic exposure with a recommended Starlix dose of 120 mg, three times daily before meals). There are no adequate and well-controlled studies in pregnant women. Starlix should not be used during pregnancy.
Nursing Mothers
Studies in lactating rats showed that nateglinide is excreted in the milk; the AUC0-48h ratio in milk to plasma was approximately 1:4. During the peri- and postnatal period body weights were lower in offspring of rats administered nateglinide at 1000 mg/kg (approximately 60 times the human therapeutic exposure with a recommended Starlix dose of 120 mg, three times daily before meals). It is not known whether Starlix is excreted in human milk. Because many drugs are excreted in human milk, Starlix should not be administered to a nursing woman.
Pediatric Use
The safety and effectiveness of Starlix in pediatric patients have not been established.
Geriatric Use
No differences were observed in safety or efficacy of Starlix between patients age 65 and over, and those under age 65. However, greater sensitivity of some older individuals to Starlix therapy cannot be ruled out.
Product Description
Most important information about Starlix
Pharmacokinetics
More information about STARLIX (Nateglinide) :
Starlix Combination Therapy
Starlix approved for use in combination with thiazolidinedione class of antidiabetic drugs
Study: Starlix enhances glucose control in people with impaired tolerance
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