Pronunciation:

a-seet-il-SIS-teen

Brand Names:

• Acetadote

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Acetaminophen Antidote

Chemical—

Amino Acid

Uses of This Medicine:

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

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

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.

Children—

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

Older adults—

No information is available on the relationship of age to the effects of acetylcysteine injection in geriatric patients.

Breast-feeding—

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.

Other medicines—

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:

• Asthma or
• Bronchospasm, history of—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins.

This medicine works best when it is given as close to the time of overdose of acetaminophen as possible. The more time that goes by after the overdose, the less effective the medicine will be in protecting your liver.

Precautions While Using This Medicine:

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 tests may be needed to check for unwanted effects.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, trouble breathing, lightheadedness, dizziness, or fainting. Other signs may include feeling of warmth, redness of the face, neck, arms and occasionally, upper chest, very fast but irregular heartbeat or pulse, hive-like swellings on the skin, and puffiness or swellings of the eyelids or around the eyes. If these side effects occur, get emergency help at once.

Side Effects of This Medicine:

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:

More common

Fast heartbeat

feeling of warmth

fever

hives or welts, itching, or skin rash

hoarseness

irritation

joint pain, stiffness, or swelling

redness of the face, neck, arms, and occasionally, upper chest

redness of the skin

swelling of the eyelids, face, lips, hands, or feet

tightness in the chest

trouble breathing or swallowing

Less common

Cough

fast, pounding, or irregular heartbeat or pulse

noisy breathing

Rare

Confusion

dizziness

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

sweating

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

Nausea

vomiting

Less common

Body aches or pain

congestion

dryness or soreness of the throat

fever

hoarseness

runny nose

tender, swollen glands in the neck

voice changes

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.