Brand Name

    US Brand Name

    Starlix


    Description

    Nateglinide is used together with diet and exercise to control blood sugar levels in patients with type 2 diabetes. It works by causing your pancreas to release more insulin into the blood stream. This medicine does not help patients who have insulin-dependent or type 1 diabetes.

    This medicine is available only with your doctor's prescription.

    This product is available in the following dosage forms:

    • Tablet

    Before Using

    In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

    Allergies

    Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

    Pediatric

    Appropriate studies have not been performed on the relationship of age to the effects of nateglinide in the pediatric population. Safety and efficacy have not been established.

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of nateglinide in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

    Breastfeeding

    There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

    Drug Interactions

    Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Abametapir
    • Abiraterone Acetate
    • Abiraterone Acetate, Micronized
    • Alogliptin
    • Aspirin
    • Avacopan
    • Bexagliflozin
    • Capecitabine
    • Carbamazepine
    • Ceftobiprole Medocaril
    • Ceritinib
    • Chloroquine
    • Chlorothiazide
    • Chlorthalidone
    • Ciprofloxacin
    • Conivaptan
    • Darolutamide
    • Delafloxacin
    • Elexacaftor
    • Eltrombopag
    • Enoxacin
    • Entacapone
    • Fedratinib
    • Fexinidazole
    • Fosnetupitant
    • Furosemide
    • Gatifloxacin
    • Gemifloxacin
    • Grepafloxacin
    • Hydrochlorothiazide
    • Hydroflumethiazide
    • Hydroxychloroquine
    • Indapamide
    • Insulin
    • Insulin Aspart, Recombinant
    • Insulin Bovine
    • Insulin Degludec
    • Insulin Detemir
    • Insulin Glargine, Recombinant
    • Insulin Glulisine

    Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Acebutolol
    • Atenolol
    • Betaxolol
    • Bisoprolol
    • Bitter Melon
    • Carteolol
    • Carvedilol
    • Celiprolol
    • Esmolol
    • Glecaprevir
    • Glucomannan
    • Guar Gum
    • Isocarboxazid
    • Labetalol
    • Levobunolol
    • Linezolid
    • Methylene Blue
    • Metipranolol
    • Metoprolol
    • Nadolol
    • Nebivolol
    • Oxprenolol
    • Ozanimod
    • Penbutolol
    • Phenelzine
    • Pibrentasvir
    • Pindolol
    • Practolol
    • Procarbazine
    • Propranolol
    • Psyllium
    • Rasagiline
    • Safinamide
    • Selegiline
    • Sotalol
    • Timolol
    • Tirzepatide
    • Tranylcypromine

    Other Interactions

    Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

    Other Medical Problems

    The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

    • Diabetic ketoacidosis (ketones in the blood) or
    • Type 1 diabetes—Should not be used in patients with these conditions. Insulin is needed to control these conditions.
    • Hypoglycemia (low blood sugar), recurrent or
    • Nerve problems (eg, diabetic neuropathy)—Patients with these conditions may not be able to notice the symptoms of low blood sugar right away.
    • Kidney disease or
    • Liver disease—Use with caution. May increase the risk of low blood sugar.

    Proper Use

    Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

    Carefully follow the special meal plan your doctor gave you. This is a very important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

    Take this medicine 1 to 30 minutes before a meal. If you skip a meal, then you should also skip your dose of nateglinide.

    Dosing

    The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

    The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

    • For oral dosage form (tablets):
      • For type 2 diabetes:
        • Adults—60 to 120 milligrams (mg) 3 times a day.
        • Children—Use and dose must be determined by your doctor.

    Missed Dose

    If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

    Storage

    Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

    Keep out of the reach of children.

    Do not keep outdated medicine or medicine no longer needed.

    Ask your healthcare professional how you should dispose of any medicine you do not use.


    Precautions

    It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

    It is very important to follow carefully any instructions from your health care team about:

    • Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.
    • Other medicines—Do not take other medicines during the time you are taking nateglinide unless they have been discussed with your doctor. This especially includes nonprescription medicines for appetite control, asthma, colds, cough, hay fever, pain relief, or sinus problems.
    • Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, including changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in patients with diabetes during pregnancy.
    • Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.

    In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines.

    This medicine may cause hypoglycemia (low blood sugar). This is more common when this medicine is taken together with certain medicines. Low blood sugar must be treated before it causes you to pass out (unconsciousness). People feel different symptoms of low blood sugar. It is important that you learn which symptoms you usually have so you can treat it quickly. Talk to your doctor about the best way to treat low blood sugar.

    Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your medicine, overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual. High blood sugar can be very serious and must be treated right away. It is important that you learn which symptoms you have in order to treat it quickly. Talk to your doctor about the best way to treat high blood sugar.

    This medicine may make you dizzy or drowsy. Do not drive, use machines, or do anything else that could be dangerous until you know how this medicine affects you.

    Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.


    Side Effects

    Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

    Check with your doctor immediately if any of the following side effects occur:

    More common

    • Ear congestion
    • cough
    • difficulty in breathing
    • loss of voice
    • sneezing
    • sore throat
    • stuffy or runny nose

    Less common

    • Chest tightness
    • cough producing mucus
    • diarrhea
    • general discomfort or illness
    • shivering
    • sweating
    • trouble sleeping
    • vomiting

    Incidence not known

    • Anxiety
    • blurred vision
    • chills
    • clay-colored stools
    • cold sweats
    • coma
    • confusion
    • cool, pale skin
    • dark urine
    • depression
    • dizziness
    • fast heartbeat
    • fever
    • headache
    • increased hunger
    • loss of appetite
    • nausea
    • nervousness
    • nightmares
    • seizures
    • shakiness
    • slurred speech
    • stomach pain
    • unusual tiredness or weakness
    • unpleasant breath odor
    • vomiting of blood
    • yellow eyes or skin

    Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

    Less common

    • Back pain
    • dizziness
    • joint pain
    • muscle aches and pains

    incidence not known

    • Hives, itching, skin rash
    • redness of the skin

    Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

    Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.






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