Acetadote

Name: Acetadote

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Shortness of breath.
  • Very bad dizziness or passing out.

What are some other side effects of Acetadote?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Upset stomach or throwing up.
  • Flushing.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Warnings and Precautions

Hypersensitivity Reactions

Serious acute hypersensitivity reactions during acetylcysteine administration including rash, hypotension, wheezing, and/or shortness of breath, have been observed in patients receiving intravenous acetylcysteine for acetaminophen overdose and occurred soon after initiation of the infusion [see Adverse Reactions (6.1)]. If a severe hypersensitivity reaction occurs, immediately stop the infusion of Acetadote and initiate appropriate treatment.

One patient with asthma developed bronchospasm and died after intravenous administration of acetylcysteine. Acetadote should be used with caution in patients with asthma, or where there is a history of bronchospasm. Patients with asthma should be closely monitored during initiation of Acetadote therapy and throughout Acetadote therapy.

Acute flushing and erythema of the skin may occur in patients receiving acetylcysteine intravenously. These reactions usually occur 30 to 60 minutes after initiating the infusion and often resolve spontaneously despite continued infusion of acetylcysteine. If a reaction to acetylcysteine involves more than simply flushing and erythema of the skin, it should be treated as a hypersensitivity reaction.

Management of less severe hypersensitivity reactions should be based upon the severity of the reaction and include temporary interruption of the infusion and/or administration of antihistaminic drugs. The Acetadote infusion may be carefully restarted after treatment of the hypersensitivity symptoms has been initiated; however, if the hypersensitivity reaction returns upon re-initiation of treatment or increases in severity, Acetadote should be discontinued and alternative patient management should be considered.

Fluid Overload

The total volume of Acetadote administered should be adjusted for patients less than 40 kg and for those requiring fluid restriction. To avoid fluid overload, the volume of diluent should be reduced as needed [see Dosage and Administration (2)]. If volume is not adjusted fluid overload can occur, potentially resulting in hyponatremia, seizure and death.

Intravenous administration of Acetadote can cause fluid overload, potentially resulting in hyponatremia, seizure and death. To avoid fluid overload, use the recommended dilution shown in Tables 2, 3 and 4 [see Dosage and Administration (2.4)].

Acetadote Drug Class

Acetadote is part of the drug classes:

  • Antidotes

  • Mucolytics

  • OTHER OPHTHALMOLOGICALS

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 Acetadote) 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 Acetadote 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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