Acys-5

Name: Acys-5

Commonly used brand name(s)

In the U.S.

  • Acys-5
  • Cetylev

In Canada

  • Acetylcysteine

Available Dosage Forms:

  • Powder
  • Tablet, Effervescent
  • Capsule
  • Capsule, Extended Release
  • Tablet
  • Solution

Therapeutic Class: Amino Acid Supplement

Chemical Class: Amino Acid

Before Using Acys-5

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.

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.

Interactions with 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

Interactions with Food/Tobacco/Alcohol

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 of acetylcysteine

This section provides information on the proper use of a number of products that contain acetylcysteine. It may not be specific to Acys-5. Please read with care.

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.

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

For the Consumer

Applies to acetylcysteine: oral capsule, oral capsule extended release, oral powder, oral solution, oral tablet, oral tablet effervescent

Other dosage forms:

  • inhalation solution
  • intravenous solution

Along with its needed effects, acetylcysteine (the active ingredient contained in Acys-5) 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 while taking acetylcysteine:

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 of acetylcysteine 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

For Healthcare Professionals

Applies to acetylcysteine: compounding powder, inhalation solution, intravenous solution, oral capsule, oral tablet, oral tablet effervescent

General

The most common adverse events were anaphylactoid reaction, nausea, vomiting, flushing, and skin rash.[Ref]

Hypersensitivity

Anaphylactoid symptoms include airway obstruction (bronchospasm), angioedema, dyspnea, hypotension, shock, tachycardia, urticaria, and injection site reaction (including rash). These are most common either during, or at the end of the loading dose infusion, and may be dose related. Careful monitoring is recommended.[Ref]

Very common (10% or more): Anaphylactoid reaction (18%)
Uncommon (0.1% to 1%): Anaphylaxis
Rare (less than 0.1%): Acquired sensitization
Frequency not reported: Dermal eruptions[Ref]

Gastrointestinal

Very common (10% or more): Vomiting NOS (12%)
Common (1% to 10%): Nausea
Frequency not reported: Stomatitis[Ref]

Respiratory

Common (1% to 10%): Respiratory symptoms, pharyngitis, rhinorrhea, rhonchi, throat tightness
Frequency not reported: Bronchoconstriction, bronchospasm, irritation to tracheal and bronchial tract (inhalation route), hemoptysis, dyspnea, respiratory arrest, coughing, stridor[Ref]

Respiratory symptoms were defined as presence of any of the following: cough, wheezing, stridor, shortness of breath, chest tightness, respiratory distress, or bronchospasm.[Ref]

Cardiovascular

Common (1% to 10%): Tachycardia
Uncommon (0.1% to 1%): Hypotension
Frequency not reported: Cyanosis, tachycardia, bradycardia, cardiac arrest, extrasystoles, flushing, hypertension, vasodilation, ECG changes[Ref]

Dermatologic

Common (1% to 10%): Urticaria/facial flushing, rash NOS, pruritus, flushing
Frequency not reported: Angioedema, sweating, edema periorbital, clamminess[Ref]

Metabolic

Common (1% to 10%): Edema
Frequency not reported: Acidosis, hypokalemia[Ref]

Other

Rare (less than 0.1%): Death
Frequency not reported: Fever, malaise, rigors, chest pain, facial pain, facial edema, raised temperature[Ref]

Nervous system

Frequency not reported: Syncope, generalized seizure, drowsiness[Ref]

Local

Frequency not reported: Injection site reaction[Ref]

Musculoskeletal

Frequency not reported: Arthralgia, arthropathy[Ref]

Hepatic

Frequency not reported: Deterioration of liver function[Ref]

Hematologic

Frequency not reported: Thrombocytopenia[Ref]

Ocular

Frequency not reported: Blurred vision, eye pain, puffy eyes, itching/redness/irritation in eyes (ophthalmic formulation)[Ref]

Psychiatric

Frequency not reported: Anxiety[Ref]

Some side effects of Acys-5 may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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