Acetylcysteine

Acetylcysteine: Drug information
Copyright 1978-2011 Lexicomp, Inc. All rights reserved.
(For additional information see “Acetylcysteine: Patient drug information” and see “Acetylcysteine: Pediatric drug information”)

Brand Names: U.S. Acetadote®
Brand Names: Canada Acetylcysteine Solution, Mucomyst®, Parvolex®
Pharmacologic Category Antidote; Mucolytic Agent
Dosing: Adult
Acetaminophen poisoning: Only the 72-hour oral and 21-hour I.V. regimens are FDA-approved. Ideally, in patients with an acute acetaminophen ingestion, treatment should begin within 8 hours of ingestion or as soon as possible after ingestion. In patients who present following RSTI and treatment is deemed appropriate, acetylcysteine should be initiated immediately.

Oral: Note: Consultation with a poison control center or clinical toxicologist is highly recommended when considering the discontinuation of oral acetylcysteine prior to the conclusion of a full 18-dose course of therapy.

72-hour regimen: Consists of 18 doses; total dose delivered: 1330 mg/kg

Loading dose: 140 mg/kg

Maintenance dose: 70 mg/kg every 4 hours; repeat dose if emesis occurs within 1 hour of administration

I.V. (Acetadote®):

21-hour regimen: Consists of 3 doses; total dose delivered: 300 mg/kg

Loading dose: 150 mg/kg (maximum: 15 g) infused over 60 minutes

Second dose: 50 mg/kg (maximum: 5 g) infused over 4 hours

Third dose: 100 mg/kg (maximum: 10 g) infused over 16 hours

Note: The fluid volume should be reduced in patients weighing <40 kg according to the following table:

Acetadote® Dosing / Fluid Volume Guidelines for Patients <40 kg

Body Weight (kg)	Loading Dose 150 mg/kg over 1 h		Second Dose 50 mg/kg over 4 h		Third Dose 100 mg/kg over 16 h
	Acetadote® (mL)	D5W (mL)	Acetadote® (mL)	D5W (mL)	Acetadote® (mL)	D5W (mL)
30	22.5	100	7.5	250	15	500
25	18.75	100	6.25	250	12.5	500
20	15	60	5	140	10	280
15	11.25	45	3.75	105	7.5	210
10	7.5	30	2.5	70	5	140

Adjuvant therapy in respiratory conditions:

Note: Patients should receive an aerosolized bronchodilator 10-15 minutes prior to dose.

Inhalation, nebulization (face mask, mouth piece, tracheostomy): Acetylcysteine 10% and 20% solution (dilute 20% solution with sodium chloride or sterile water for inhalation); 10% solution may be used undiluted: 3-5 mL of 20% solution or 6-10 mL of 10% solution until nebulized given 3-4 times/day; dosing range: 1-10 mL of 20% solution or 2-20 mL of 10% solution every 2-6 hours

Inhalation, nebulization (tent, croupette): Dose must be individualized; may require up to 300 mL solution/treatment

Direct instillation:

Into tracheostomy: 1-2 mL of 10% to 20% solution every 1-4 hours

Through percutaneous intratracheal catheter: 1-2 mL of 20% or 2-4 mL of 10% solution every 1-4 hours via syringe attached to catheter

Diagnostic bronchogram: Nebulization or intratracheal: 1-2 mL of 20% solution or 2-4 mL of 10% solution administered 2-3 times prior to procedure

Prevention of contrast-induced nephropathy (CIN) (unlabeled use): Oral: 600-1200 mg twice daily for 2 days (beginning the day before the procedure); may be given as powder in capsules (some centers use solution, diluted in cola beverage or juice)

Prevention of CIN in acute MI patients requiring emergent cardiac catheterization (unlabeled use):I.V.: 1200 mg over 5-10 minutes prior to cardiac catheterization, followed by 1200 mg orally twice daily for 48 hours

Dosing: Pediatric
(For additional information see “Acetylcysteine: Pediatric drug information”)

Acetaminophen poisoning: Refer to adult dosing.

Adjuvant therapy in respiratory conditions:

Note: Patients should receive an aerosolized bronchodilator 10-15 minutes prior to acetylcysteine

Inhalation, nebulization (face mask, mouth piece, tracheostomy): Acetylcysteine 10% and 20% solution (dilute 20% solution with sodium chloride or sterile water for inhalation); 10% solution may be used undiluted.

Infants: 1-2 mL of 20% solution or 2-4 mL 10% solution until nebulized given 3-4 times/day

Children: Refer to adult dosing.

Inhalation, nebulization (tent, croupette): Children: Refer to adult dosing.

Dosing: Geriatric Refer to adult dosing.
Dosage Forms: U.S. Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Injection, solution:

Acetadote®: 20% [200 mg/mL] (30 mL [DSC]) [contains edetate disodium]

Injection, solution [preservative free]:

Acetadote®: 20% [200 mg/mL] (30 mL)

Solution, for inhalation/oral: 10% [100 mg/mL] (10 mL, 30 mL); 20% [200 mg/mL] (10 mL, 30 mL)

Solution, for inhalation/oral [preservative free]: 10% [100 mg/mL] (4 mL, 10 mL); 20% [200 mg/mL] (4 mL, 10 mL, 30 mL)

Generic Equivalent Available: U.S. Yes: Solution for inhalation
Administration
Inhalation: Acetylcysteine is incompatible with tetracyclines, erythromycin, amphotericin B, iodized oil, chymotrypsin, trypsin, and hydrogen peroxide. Administer separately. Intermittent aerosol treatments are commonly given when patient arises, before meals, and just before retiring at bedtime.

Oral: Treatment of acetaminophen poisoning, administer orally as a 5% solution. Dilute the 20% solution 1:3 with a cola, orange juice, or other soft drink. Use within 1 hour of preparation. Unpleasant odor becomes less noticeable as treatment progresses. If patient vomits within 1 hour of dose, readminister. (Note: It is helpful to put acetylcysteine on ice, in a cup with a cover, and drink through a straw; alternatively, administer via an NG tube).

I.V. (Acetadote®):

Acetaminophen poisoning:

Loading dose: Dilute in D5W 200 mL; administer over 60 minutes.

Second dose: Dilute in D5W 500 mL; administer over 4 hours.

Third dose: Dilute in D5W 1000 mL; administer over 16 hours.

Note: To avoid fluid overload in patients <40 kg and those requiring fluid restriction, decrease volume of D5W proportionally (see table in dosing section). Discard unused portion.

If the commercial I.V. form is unavailable, the solution for inhalation has been used; each dose should be infused through a 0.2 micron Millipore filter (in-line) over 60 minutes (Yip, 1998); intravenous administration of the solution for inhalation is not USP 797-compliant.

Prevention of CIN in acute MI patients requiring emergent cardiac catheterization (unlabeled use): Administer I.V. push over 5-10 minutes prior to contrast administration.

Compatibility
Inhalation: Incompatible with rubber and metals (particularly iron, copper, and nickel); do not mix with ampicillin, tetracycline, oxytetracycline, erythromycin.

Intravenous: Y-site administration: Compatible with D5W, D5W 1/2NS. Incompatible with metals (particularly iron, copper, and nickel); cefepime, ceftazidime

Use Antidote for acute acetaminophen poisoning; repeated supratherapeutic ingestion (RSTI) of acetaminophen; adjunctive mucolytic therapy in patients with abnormal or viscid mucous secretions in acute and chronic bronchopulmonary diseases; pulmonary complications of surgery and cystic fibrosis; diagnostic bronchial studies
Use – Unlabeled/Investigational Prevention of contrast-induced renal dysfunction (oral, I.V.); distal intestinal obstruction syndrome (DIOS, previously referred to as meconium ileus equivalent)
Medication Safety Issues
Sound-alike/look-alike issues:
Acetylcysteine may be confused with acetylcholine

Mucomyst® may be confused with Mucinex®

Adverse Reactions Significant
Inhalation: Frequency not defined.

Central nervous system: Drowsiness, chills, fever

Gastrointestinal: Vomiting, nausea, stomatitis

Local: Irritation, stickiness on face following nebulization

Respiratory: Bronchospasm, rhinorrhea, hemoptysis

Miscellaneous: Acquired sensitization (rare), clamminess, unpleasant odor during administration

Intravenous:

>10%: Miscellaneous: Anaphylactoid reaction (8% to 18%; shorter infusion periods [eg, <60 minutes] associated with increased incidence)

1% to 10%:

Cardiovascular: Flushing (1% to 8%), tachycardia (1% to 4%), edema (1% to 2%)

Dermatologic: Urticaria (6% to 8%), rash (2% to 4%), pruritus (1% to 4%)

Gastrointestinal: Vomiting (2% to 10%), nausea (1% to 6%)

Respiratory: Pharyngitis (≤1%), rhinorrhea (≤1%), rhonchi (≤1%), throat tightness (≤1%)

<1% (Limited to important or life-threatening): Anaphylaxis, bronchospasm, chest tightness, cough, dyspnea, hypotension, respiratory distress, stridor, wheezing

Contraindications Hypersensitivity to acetylcysteine or any component of the formulation
Warnings/Precautions
Concerns related to adverse effects:

• Anaphylactoid reactions: Acute flushing and erythema have been reported; usually occurs within 30-60 minutes and may resolve spontaneously. Serious anaphylactoid reactions have also been reported and are more commonly associated with I.V. administration. When used for acetaminophen poisoning, the incidence is reduced when the initial loading dose is administered over 60 minutes. Acetylcysteine infusion may be interrupted until treatment of allergic symptoms is initiated; the infusion can then be carefully restarted. Treatment for anaphylactoid reactions should be immediately available. Use caution in patients with asthma or history of bronchospasm as these patients may be at increased risk. Conversely, patients with high acetaminophen levels (>150 mg/dL) may be at a reduced risk for anaphylactoid reactions (Pakravan, 2008; Waring, 2008).

Disease-related concerns:

• Acute acetaminophen poisoning: Appropriate use: Acetylcysteine is indicated in patients with a serum acetaminophen level that indicates they are at “possible” risk or greater for hepatotoxicity when plotted on the Rumack-Matthew nomogram. There are several situations where the nomogram is of limited use. Serum acetaminophen levels obtained <4 hours postingestion are not interpretable; patients presenting late may have undetectable serum concentrations, despite having received a toxic dose. The nomogram is less predictive of hepatic injury following an acute overdose with an extended release acetaminophen product or in patients who have coingested acetaminophen with an agent known to delay gastric emptying. The nomogram also does not take into account patients who may be at higher risk of acetaminophen toxicity (eg, alcoholics, malnourished patients). Nevertheless, acetylcysteine should be administered to any patient with signs of hepatotoxicity, even if the serum acetaminophen level is low or undetectable. Patients who present >24 hours after an acute ingestion or patients who present following an acute ingestion at an unknown time may be candidates for acetylcysteine therapy; consultation with a poison control center or clinical toxicologist is highly recommended.

• Repeated supratherapeutic ingestion (RSTI) of acetaminophen: Appropriate use: The Rumack-Matthew nomogram is not designed to be used following RSTIs. In general, an accurate past medical history, including a comprehensive acetaminophen ingestion history, in conjunction with AST concentrations and serum acetaminophen levels, may give the clinician insight as to the patient’s risk of acetaminophen toxicity. Some experts recommend that acetylcysteine be administered to any patient with “higher than expected” serum acetaminophen levels or serum acetaminophen level >10 mcg/mL, even in the absence of hepatic injury; others recommend treatment for patients with laboratory evidence and/or signs and symptoms of hepatotoxicity (Hendrickson, 2006; Jones, 2000). Consultation with a poison control center or a clinical toxicologist is highly recommended.

Dosage form specific issues:

• Inhalation: Since increased bronchial secretions may develop after inhalation, percussion, postural drainage, and suctioning should follow. If bronchospasm occurs, administer a bronchodilator; discontinue acetylcysteine if bronchospasm progresses.

Drug Interactions
(For additional information: Launch Lexi-Interact™ Drug Interactions Program )
There are no known significant interactions.
Pregnancy Risk Factor B (show table)
Pregnancy Implications Based on limited reports using acetylcysteine to treat acetaminophen poisoning in pregnant women, acetylcysteine has been shown to cross the placenta and may provide protective levels in the fetus.
Lactation Excretion in breast milk unknown/use caution
Pricing: U.S. (www.drugstore.com)
Solution (Acetylcysteine)

10% (30): $20.58

10% (30): $25.99

20% (4): $16.99

20% (10): $22.99

Monitoring Parameters Acetaminophen poisoning: Monitor patient for the development of anaphylaxis or anaphylactoid reactions; monitor serum acetaminophen levels, AST, ALT, bilirubin, PT, INR, serum creatinine, BUN, serum glucose, hemoglobin, hematocrit, and electrolytes. Assess patient for nausea, vomiting, and skin rash following oral administration. Reassess LFTs for possible hepatotoxicity every 4-6 hours.
Acute ingestion: Obtain the first acetaminophen level 4 hours postingestion (or as soon as possible thereafter); plot on the Rumack-Matthew nomogram. In patients who have ingested an extended release formulation of acetaminophen or have coingested an agent known to delay gastric emptying, obtain a repeat serum acetaminophen measurement 4-6 hours following the first measurement if the original level (taken at 4-8 hours postingestion) when plotted on the Rumack-Matthew nomogram indicated that treatment was not necessary.

International Brand Names ACC (AR, HU, LU, MX, RU, ZA); ACC 200 (EE); Acemuk (AR); Acetadote (NZ); Acetain (KP); Acetin (MY); Acetylcystein NM Pharma (SE); Acetylcystein Tika (SE); Acypront (HK); Aerosolv (AT); Alistine Forte (TH); Bromuc (BR); Broncoflem (PH); Cystaline (TH); Drenaflen (EC); Ecomucyl (CH); Eloamin (CZ); Exomuc (FR, HK, LU); Fabrol (AT, GR); Flemex AC (TH); Flucil (TH); Fluimicil (CH, DE); Fluimiquil (LU); Fluimucil (AR, BG, BR, CL, CO, CZ, HK, HU, ID, IT, MA, NL, PE, PL, RU, TH, TW); Fluimucil A (MY, PK); Fluimukan (HR); Flumil (ES); Flutafin (TW); Hidonac (ID, MY, PH, TH, TW); Icystein (TW); L-Cimexyl (SG); Lubrisec (AR); Lysomucil (LU); Lysox (LU); Madame Pearl’s Mucolytic (HK); Menaxol (CR, DO, GT, HN, NI, PA, SV); Menaxol Forte (CR, DO, GT, HN, NI, PA, SV); Mucofillin (JP); Mucolair (LU); Mucolator (LU, MY); Mucolitico (CN); Mucomiste (PT); Mucomyst (AT, AU, BE, DK, FI, FR, KP, LU, NL, NO, SE); Mucomystendo (FR); Mucoserin (KP); Mucosof (CL); Mucosten (KP); Mucosys (IN); Mucoza (TH); Mucylin (ID); Mukolit (ID); Muterin (KP); Muxatil (PY); Mysoven (TH); NAC (TR); NAC-ratiopharm (LU); Parvolex (GB, IE, PH); Pectocil (ID); Pectomucil (LU); Reolin (IL); Rumicil (LU); Sebron (KP); Simucil (ID); Simucin (TH); Siran 200 (IL); Solmucol (HU, LU); Spatam (SG); Sputopur (HU); Stecin (KP); Stenac (TH); Tancore (TW); Touxium Mucolyticum (LU); Viskoferm (SE)
Mechanism of Action Exerts mucolytic action through its free sulfhydryl group which opens up the disulfide bonds in the mucoproteins thus lowering mucous viscosity.
In patients with acetaminophen toxicity, acetylcysteine acts as a hepatoprotective agent by restoring hepatic glutathione, serving as a glutathione substitute, and enhancing the nontoxic sulfate conjugation of acetaminophen.

The presumed mechanism in preventing contrast-induced nephropathy is its ability to scavenge oxygen-derived free radicals and improve endothelium-dependent vasodilation.

Pharmacodynamics/Kinetics
Onset of action: Inhalation: 5-10 minutes

Duration: Inhalation: >1 hour

Distribution: 0.47 L/kg

Protein binding: 83%

Half-life elimination:

Reduced acetylcysteine: 2 hours

Total acetylcysteine: Adults: 5.6 hours; Newborns: 11 hours

Time to peak, plasma: Oral: 1-2 hours

Excretion: Urine

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