Cetylev (Oral)

Acetylcysteine helps to prevent or reduce liver damage from an overdose of acetaminophen.

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

Your doctor will monitor your progress closely while you are taking this medicine. This will help your doctor determine if the medicine is working correctly and if you should continue using it. Blood and urine tests may be required to check for side effects.

Serious allergic reactions may happen after taking this medicine. Inform your doctor immediately if you experience difficulty breathing or swallowing, fever, hives, itchy skin, rash, nausea, redness of the skin, especially around the ears, swelling of the eyes, face, or inside the nose, or unusual tiredness or weakness.

This medicine may raise the risk of bleeding in your esophagus and stomach. Let your doctor know if you have severe or persistent vomiting after taking this medicine.

In deciding to use a medicine, you and your doctor will weigh the risks against the benefits. For this medicine, consider the following:

Allergies

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

Pediatric

There have not been appropriate studies on how acetylcysteine affects children. However, there are no specific problems documented for children so far.

Geriatric

Although there have not been appropriate studies on how acetylcysteine affects older adults, no specific problems have been documented for them so far. However, older patients are more likely to have age-related kidney, liver, or heart issues, which may require caution and an adjustment in the dose for patients receiving acetylcysteine.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if there might be an interaction. In these situations, your doctor may want to adjust the dose, or other precautions may be needed. When receiving this medicine, it is very important that your healthcare professional knows if you are taking any of the following medicines. The interactions listed below are significant but may not be all-inclusive.

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be the best treatment for you. If both are prescribed together, your doctor may adjust the dose or how often you take one or both.

• Carbamazepine
• Nitroglycerin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around the time of eating food or certain types of food due to potential interactions. Using alcohol or tobacco with some medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect how you can use this medicine. Be sure to tell your doctor if you have any other medical problems, especially:

• Bleeding in the esophagus or
• Stomach ulcers, or a history of these—may increase the risk of more serious side effects.

• Congestive heart failure or
• Hypertension (high blood pressure) or
• Kidney disease—This medicine contains sodium, which can worsen these conditions.

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

• Difficulty with breathing or swallowing
• fever
• hives or itching
• nausea
• rash with or without a fever
• reddening of the skin, especially around the ears
• severe or ongoing vomiting
• 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.

In the U.S.

• Acys-5
• Cetylev

In Canada

• Acetylcysteine

Available Dosage Forms:

• Solution
• Capsule
• Tablet

Therapeutic Class: Acetaminophen Antidote

Chemical Class: Amino Acid

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.

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.

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