Acetylcysteine inhalation

You should not use acetylcysteine inhalation if you are allergic to it.

To make sure this medicine is safe for you, tell your doctor if you have asthma.

FDA pregnancy category B. Acetylcysteine inhalation is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether acetylcysteine inhalation passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

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

The viscosity of pulmonary mucous secretions depends on the concentrations of mucoprotein and, to a lesser extent, deoxyribonucleic acid (DNA). The latter increases with increasing purulence owing to the presence of cellular debris. The mucolytic action of acetylcysteine is related to the sulfhydryl group in the molecule. This group probably ``opens′′ disulfide linkages in mucus thereby lowering the viscosity. The mucolytic activity of acetylcysteine is unaltered by the presence of DNA, and increases with increasing pH. Significant mucolysis occurs between pH 7 and 9.

Acetylcysteine undergoes rapid deacetylation in vivo to yield cysteine or oxidation to yield diacetylcystine.

Occasionally, patients exposed to the inhalation of an acetylcysteine aerosol respond with the development of increased airways obstruction of varying and unpredictable severity. Those patients who are reactors cannot be identified a priori from a random patient population. Even when patients are known to have reacted previously to the inhalation of an acetylcysteine aerosol, they may not react during a subsequent treatment. The converse is also true; patients who have had inhalation treatments of acetylcysteine without incident may still react to subsequent inhalation with increased airways obstruction. Most patients with bronchospasm are quickly relieved by the use of a bronchodilator given by nebulization. If bronchospasm progresses, the medication should be discontinued immediately.

Acetylcysteine is indicated as adjuvant therapy for patients with abnormal, viscid, or inspissated mucous secretions in such conditions as:

Chronic bronchopulmonary disease (chronic emphysema, emphysema with bronchitis, chronic asthmatic bronchitis, tuberculosis, bronchiectasis and primary amyloidosis of the lung)
Acute bronchopulmonary disease (pneumonia, bronchitis, tracheobronchitis)
Pulmonary complications of cystic fibrosis
Tracheostomy care
Pulmonary complications associated with surgery
Use during anesthesia
Post-traumatic chest conditions
Atelectasis due to mucous obstruction
Diagnostic bronchial studies (bronchograms, bronchospirometry, and bronchial wedge catheterization)

Acetylcysteine is contraindicated in those patients who are sensitive to it.

The acute ingestion of acetaminophen in quantities of 150 mg/kg or greater may result in hepatic toxicity. However, the reported history of the quantity of a drug ingested as an overdose is often inaccurate and is not a reliable guide to therapy of the overdose. THEREFORE, PLASMA OR SERUM ACETAMINOPHEN CONCENTRATIONS, DETERMINED AS EARLY AS POSSIBLE, BUT NO SOONER THAN 4 HOURS FOLLOWING AN ACUTE OVERDOSE, ARE ESSENTIAL IN ASSESSING THE POTENTIAL RISK OF HEPATOTOXICITY. IF AN ASSAY FOR ACETAMINOPHEN CANNOT BE OBTAINED, IT IS NECESSARY TO ASSUME THAT THE OVERDOSE IS POTENTIALLY TOXIC.

INTERPRETATION OF ACETAMINOPHEN ASSAYS

1. When results of the plasma acetaminophen assay are available refer to the nomogram below to determine if plasma concentration is in the potentially toxic range. Values above the solid line connecting 200 mcg/mL at 4 hours with 50 mcg/mL at 12 hours are associated with a possibility of hepatic toxicity if an antidote is not administered. (Do not wait for assay results to begin acetylcysteine treatment.)
2. If the predetoxification plasma level is above the broken line continue with maintenance doses of acetylcysteine. It is better to err on the safe side and thus the broken line is placed 25% below the solid line which defines possible toxicity.
3. If the predetoxification plasma level is below the broken line described above, there is minimal risk of hepatic toxicity and acetylcysteine treatment can be discontinued.

Assay procedures most suitable for determining acetaminophen concentrations utilize high pressure liquid chromatography (HPLC) or gas liquid chromatography (GLC). The assay should measure only parent acetaminophen and not conjugated. The assay procedures listed below fulfill this requirement:

NDC 0517-7510-03

ACETYLCYSTEINE
SOLUTION, USP

10% (100 mg/mL)

For Inhalation (Mucolytic Agent)
or Oral Administration
(Acetaminophen Antidote)

NOT FOR INJECTION
10 mL VIAL
PRESERVATIVE FREE

Rx Only

AMERICAN REGENT, INC.
SHIRLEY, NY  11967

ACETYLCYSTEINE
SOLUTION, USP

10% (100 mg/mL)

NDC 0517-7510-03
3 x 10 mL VIALS

Rx Only

For Inhalation (Mucolytic Agent) or Oral Administration (Acetaminophen Antidote)

NOT FOR INJECTION        PRESERVATIVE FREE

Each mL contains: Acetylcysteine 100 mg (10%), Edetate Disodium 0.025%, Water for Injection q.s. pH adjusted with Sodium Hydroxide and, if necessary, Hydrochloric Acid is added. pH (range 6.0 to 7.5).  CONTAINS ONE PLASTIC DROPPER FOR DISPENSING.
WARNING: DISCARD OPENED CONTAINER AFTER 96 HOURS. Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30° (59°-86°F) (See USP Controlled Room Temperature).
STORE IN REFRIGERATOR 2° to 8°C (36° to 46°F) AFTER OPENING. A change in color may occur after opening, this does not change the efficacy of the drug. Acetylcysteine may be diluted to a lesser concentration with an appropriate solution.
Directions for Use: See Package Insert.

AMERICAN REGENT, INC.
SHIRLEY, NY 11967

Rev. 11/11

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

Data not available