Brand Name

    US Brand Name

    Acys-5

    Cetylev

    Legubeti

    Canadian Brand Name

    Acetylcysteine


    Description

    Acetylcysteine is used to help prevent or lessen liver damage caused by an overdose of acetaminophen.

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

    This product is available in the following dosage forms:

    • Solution
    • Capsule
    • 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 on the relationship of age to the effects of acetylcysteine have not been performed in the pediatric population. However, no pediatric-specific problems have been documented to date.

    Geriatric

    Although appropriate studies on the relationship of age to the effects of acetylcysteine have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving acetylcysteine.

    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 receiving 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 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.

    • Carbamazepine
    • Nitroglycerin

    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:

    • Bleeding in the esophagus or
    • Stomach ulcers, or history of—May increase risk for more serious side effects.
    • Congestive heart failure or
    • Hypertension (high blood pressure) or
    • Kidney disease—This medicine contains sodium, which can make these conditions worse.

    Proper Use

    This medicine will be given to you by a nurse or other healthcare professional while you are in the hospital. It works best when it is given as close to the time of overdose as possible. The more time that goes by after the overdose, the less effective the medicine will be in protecting your liver.

    This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

    The effervescent tablets should be dissolved in water before taking. Follow the instructions provided by your doctor. The mixed solution should be taken within 2 hours.

    Mix the oral liquid with caffeine-free diet cola or other diet soft drink and drink it within 1 hour after mixing.

    There is usually a total of 17 doses of this medicine, taken about 4 hours apart. If you vomit within 1 hour after you take your medicine, you will need to take another dose to make up for it.


    Precautions

    Your doctor will check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood and urine tests may be needed to check for unwanted effects.

    This medicine may cause serious allergic reactions, including angioedema. Tell your doctor right away if you have blurred vision, confusion, difficulty with breathing or swallowing, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, fever, hives, itching skin, rash, large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, nausea, reddening of the skin, especially around the ears, sweating, swelling of the eyes, face, or inside of the nose, or unusual tiredness or weakness.

    This medicine may increase risk of bleeding in your esophagus and stomach. Tell your doctor if you have severe or ongoing vomiting after taking this medicine.


    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 or nurse immediately if any of the following side effects occur:

    Incidence not known

    • Blurred vision
    • confusion
    • difficulty with breathing or swallowing
    • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
    • feeling of warmth
    • fever
    • hives or itching
    • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
    • nausea
    • rash with or without a fever
    • reddening of the skin, especially around the ears
    • redness of the face, neck, arms and occasionally, upper chest
    • severe or ongoing vomiting
    • sweating
    • swelling of the eyes, face, or inside of the nose
    • 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

    • Mild nausea
    • stomach upset
    • vomiting

    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.






    CON-XXXXXXXX

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