Description

    Probucol is used to lower levels of cholesterol (a fat-like substance) in the blood. This may help prevent medical problems caused by cholesterol clogging the blood vessels.

    Probucol was available only with your doctor's prescription.

    Probucol was voluntarily removed from the market in the United States during 1995. The withdrawal from the market was due to safety concerns .


    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

    There is no specific information about the use of probucol in children. However, use is not recommended in children under 2 years of age since cholesterol is needed for normal development.

    Geriatric

    Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of probucol in the elderly with use in other age groups.

    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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

    • Bepridil
    • Cisapride
    • Dronedarone
    • Foscarnet
    • Levoketoconazole
    • Levomethadyl
    • Mesoridazine
    • Pimozide
    • Piperaquine
    • Sparfloxacin
    • Terfenadine
    • Thioridazine
    • Ziprasidone

    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.

    • Acecainide
    • Adagrasib
    • Ajmaline
    • Amiodarone
    • Amisulpride
    • Anagrelide
    • Apomorphine
    • Aprindine
    • Aripiprazole
    • Aripiprazole Lauroxil
    • Arsenic Trioxide
    • Astemizole
    • Atazanavir
    • Azimilide
    • Azithromycin
    • Bedaquiline
    • Bretylium
    • Buprenorphine
    • Buserelin
    • Ceritinib
    • Chloral Hydrate
    • Chloroquine
    • Chlorpromazine
    • Citalopram
    • Clarithromycin
    • Clofazimine
    • Clothiapine
    • Clozapine
    • Crizotinib
    • Dabrafenib
    • Dasatinib
    • Degarelix
    • Delamanid
    • Deslorelin
    • Deutetrabenazine
    • Dexmedetomidine
    • Disopyramide
    • Dofetilide
    • Dolasetron
    • Domperidone

    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.

    • Cyclosporine

    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:

    • Gallbladder disease or gallstones or
    • Heart disease—Probucol may make these conditions worse.
    • Liver disease—Higher blood levels of probucol may result, which may increase the chance of side effects.

    Proper Use

    Many patients who have high cholesterol levels will not notice any signs of the problem. In fact, many may feel normal. Take this medicine exactly as directed by your doctor, even though you may feel well. Try not to miss any doses and do not take more medicine than your doctor ordered.

    Remember that this medicine will not cure your condition but it does help control it. Therefore, you must continue to take it as directed if you expect to keep your cholesterol levels down.

    Follow carefully the special diet your doctor gave you. This is the most important part of controlling your condition, and is necessary if the medicine is to work properly.

    This medicine works better when taken with meals.

    Before prescribing medicine for your condition, your doctor will probably try to control your condition by prescribing a personal diet for you. Such a diet may be low in fats, sugars, and/or cholesterol. Many people are able to control their condition by carefully following their doctor's orders for proper diet and exercise. Medicine is prescribed only when additional help is needed and is effective only when a schedule of diet and exercise is properly followed.

    Also, this medicine is less effective if you are greatly overweight. It may be very important for you to go on a reducing diet. However, check with your doctor before going on any diet.

    Make certain your health care professional knows if you are on a low-sodium, low-sugar, or any other special diet.

    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.

    • The number of tablets that you take depends on the strength of the medicine.
    • For oral dosage form (tablets):
      • Adults: 500 milligrams two times a day taken with the morning and evening meals.
      • Children:
        • Up to 2 years of age—Use is not recommended.
        • 2 years of age and over—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.


    Precautions

    It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly to lower your cholesterol levels and to decide if you should continue to take it.

    Do not stop taking this medicine without first checking with your doctor. When you stop taking this medicine, your blood fat levels may increase again. Your doctor may want you to follow a special diet to help prevent this.


    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 as soon as possible if any of the following side effects occur:

    More common

    • Dizziness or fainting
    • fast or irregular heartbeat

    Rare

    • Swellings on face, hands, or feet, or in mouth
    • unusual bleeding or bruising
    • unusual tiredness or weakness

    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:

    More common

    • Bloating
    • diarrhea
    • nausea and vomiting
    • stomach pain

    Less common

    • Headache
    • numbness or tingling of fingers, toes, or face

    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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