Mucomyst-10 inhalation

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not mix other medicines in a nebulizer with acetylcysteine inhalation, unless your doctor has told you to.

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 Mucomyst-10) 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:

• 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:

• Mild nausea
• stomach upset
• vomiting

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 Mucomyst-10 may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.