Brand names: Acetadote ;, Legubeti
Drug class: Acetaminophen antidote

Medically reviewed by Drugs.com on Jun 10, 2024. Written by ASHP.

Introduction

Antidote for acetaminophen overdosage; mucolytic agent and sulfhydryl donor.^{102 108 120}

Uses for Acetylcysteine, Acetylcysteine Lysine(Local, Systemic)

Antidote for Acetaminophen Overdosage

Treatment of acetaminophen overdosage following acute ingestion or repeated supratherapeutic ingestion.^{102 103 108} IV acetylcysteine designated an orphan drug by FDA for this use.¹²¹ Optimal if given within 8 hours of acute acetaminophen ingestion;¹⁰⁹ may be effective when given ≥24 hours after ingestion.^{105 106}

Mucolytic Uses

Adjunctive treatment for patients with abnormal, viscid, or inspissated mucous secretions associated with conditions such as acute and chronic bronchopulmonary disorders (e.g., pneumonia, bronchitis, emphysema, tracheobronchitis, chronic asthmatic bronchitis, tuberculosis, bronchiectasis, primary amyloidosis of the lung); atelectasis caused by mucus obstruction; pulmonary complications of cystic fibrosis; pulmonary complications of surgery; and post-traumatic chest conditions.¹⁰²

Used during anesthesia and in the preparation of patients for bronchograms, bronchospirometry, bronchial wedge catheterization, and other diagnostic bronchial studies.¹⁰²

Tracheostomy care.¹⁰²

Prevention of Nephropathy Associated with Radiographic Contrast Media

Has been used to prevent radiographic contrast media-induced nephropathy^{† [off-label]}.^{100 101 110 111 112 113 114 116 117 122 123 124 125 126 127} Efficacy for this indication not supported by the results of large, randomized clinical trials;^{126 127} use not recommended in some current clinical guidelines.^{115 130 131}

Acetylcysteine, Acetylcysteine Lysine(Local, Systemic) Dosage and Administration

General

Pretreatment Screening

Acetaminophen Overdosage

• Because the reported or estimated amount of acetaminophen ingestion often is inaccurate and is not a reliable guide to the therapeutic management of the overdose, the preferred method to assess the risk of toxicity after acute acetaminophen ingestion usually is measurement of plasma or serum acetaminophen concentrations.^{105 106 108}

• Determine plasma or serum acetaminophen concentrations as soon as possible (but no sooner than 4 hours) after ingestion. ^{102 103 108} May be appropriate to obtain an additional sample at 4–6 hours after initial sample (or 8–10 hours after ingestion) if an extended-release acetaminophen preparation was ingested.^{102 108}

• Also obtain baseline liver transaminases, bilirubin, INR/PT, creatinine, BUN, blood glucose, and electrolytes.^{102 103 108}

• Use plasma or serum acetaminophen concentrations in conjunction with a nomogram ([Web]) to estimate potential for hepatotoxicity and necessity of acetylcysteine therapy.^{105 108} A full course of acetylcysteine therapy is indicated if initial plasma or serum acetaminophen concentrations fall on or above the dashed line on the nomogram.^{105 106 108}

• Assistance is available from a regional poison center at 800-222-1222 or an assistance line for acetaminophen overdosage at 800-525-6115.¹⁰⁸

• If plasma or serum acetaminophen concentrations cannot be obtained, assume that the overdosage is potentially toxic and initiate acetylcysteine therapy.^{102 108}

• Regardless of the quantity of acetaminophen reported to have been ingested, administer acetylcysteine immediately if ≤24 hours have elapsed from the reported time of ingestion of an overdose of acetaminophen.¹⁰² Do not await results of assays for acetaminophen levels before initiating treatment with acetylcysteine.¹⁰²

• In the event that a loading dose of acetylcysteine is administered before plasma or serum acetaminophen concentrations are available, the initial plasma or serum concentration (obtained ≥4 hours after ingestion) is used in conjunction with the nomogram to determine the necessity of completing a full course of acetylcysteine therapy.^{105 108} In such situations, administration of a full course of therapy is indicated if the initial plasma or serum acetaminophen concentration falls on or above the dashed line on the nomogram; acetylcysteine therapy is discontinued if the initial acetaminophen concentration falls below the dashed line on the nomogram.^{102 105 108}

• Because acetylcysteine therapy may be useful even when instituted >24 hours after an overdose, a full course of acetylcysteine therapy is recommended for patients presenting ≥24 hours postingestion with measurable plasma or serum acetaminophen concentrations or biochemical evidence of hepatic injury.

• The nomogram may underestimate the hepatotoxicity risk in patients with chronic alcoholism or malnutrition and in those receiving CYP2E1 enzyme-inducing drugs (e.g., isoniazid); consider treating such patients even if the acetaminophen concentrations are in the nontoxic range.¹⁰⁸

• Since oral administration of acetylcysteine may result in vomiting or aggravate vomiting associated with acetaminophen overdosage, evaluate patients at risk of gastric hemorrhage (e.g., those with esophageal varices or peptic ulcers) with regard to the relative risks of upper GI hemorrhage and acetaminophen-induced hepatotoxicity and treat with acetylcysteine accordingly.¹⁰²

Multiple Supratherapeutic Acetaminophen Doses

• Guidelines for the treatment of ingestions involving multiple, higher-than-recommended acetaminophen doses over an extended period of time currently are not available.¹¹⁸ Plasma transaminase concentrations (along with other laboratory tests to monitor hepatic and renal function and electrolyte and fluid balance, e.g., bilirubin, INR, creatinine, BUN, blood glucose, electrolytes) and plasma or serum acetaminophen concentrations have been used to estimate potential for hepatotoxicity and necessity of acetylcysteine therapy.^{108 118}

• Assistance is available from a regional poison center at 800-222-1222 or an assistance line for acetaminophen overdosage at 800-525-6115.¹⁰⁸

Patient Monitoring

• Closely monitor patients with asthma during initiation of and throughout acetylcysteine therapy.^{102 108}

Acetaminophen Overdose

• Monitor hepatic and renal function and electrolytes throughout the detoxification process in patients receiving acetylcysteine as an antidote for acetaminophen overdosage.^{102 108}

• If the initial acetaminophen concentration was in the non-toxic range, but time of ingestion was unknown or <4 hours, obtain a second sample for acetaminophen concentration and consider the patient's clinical status to decide whether or not to continue acetylcysteine treatment beyond the loading dose.^{102 108}

• In cases of suspected massive overdose, or with concomitant ingestion of other substances, or in patients with preexisting liver disease, the absorption and/or the half-life of acetaminophen may be prolonged.¹⁰⁸ In such cases, consider the need for continued treatment with IV acetylcysteine beyond a total of 3 separate doses over a 21-hour infusion period.¹⁰⁸ Obtain acetaminophen levels, ALT/AST, and INR following the last maintenance dose.¹⁰⁸ If acetaminophen levels are still detectable, or if the ALT/AST are still increasing or the INR remains elevated, continue dosing and consult a regional poison center at 800-222-1222 or an assistance line for acetaminophen overdosage at 800-525-6115.¹⁰⁸

Administration

Administer orally (as a solution) or by IV infusion as an antidote for acetaminophen overdosage; administer by oral inhalation or intracheal instillation for mucolytic uses.^{102 103 108}

Has been administered orally^{100 110 117} or IV^{110 117} for prevention of radiographic contrast media-induced nephropathy^{† [off-label]}.

Oral Administration

May administer as a 5% solution for acetaminophen overdose.¹⁰² To prepare the 5% solution, dilute commercially available 20% solution 1:3 with diet soft drink.¹⁰²

Alternatively, may use oral solution prepared from commercially available packets containing 500 mg or 2.5 g of acetylcysteine (available as acetylcysteine lysine [Legubeti]).¹⁰³ To prepare oral solution, dissolve the appropriate number of packets in the volume of caffeine-free diet cola or other diet soft drink, as indicated in dosing tables provided in the prescribing information.¹⁰³ The Legubeti preparation is for oral administration only and should not be used for nebulization or intratracheal instillation.¹⁰³

May administer via duodenal or nasoduodenal tube if persistently unable to retain orally administered drug; also may consider IV formulation.^{102 103}

IV Administration

Injection concentrate must be diluted prior to IV administration.¹⁰⁸

Acetylcysteine solution for inhalation or oral administration should not be administered by injection.¹⁰²

Dilution

Dilute dose with an appropriate volume of 5% dextrose injection, 0.45% sodium chloride injection, or sterile water for injection(see Table 1).¹⁰⁸

Adjust total volume for patients who weigh <40 kg (see Table 1) or for those requiring fluid restriction.¹⁰⁸ In patients weighing ≤20 kg, the recommended volume of diluent is 3, 7, and 14 mL/kg for the loading, second, and third doses, respectively.¹⁰⁸

Dilution in the 3 compatible diluents results in different osmolarity of the solution for IV administration (see Table 2).¹⁰⁸ Adjust osmolarity to a physiologically safe level (generally ≥150 mOsmol/L in pediatric patients).¹⁰⁸

Rate of Administration

Loading dose: Infuse over 1 hour.^{108 109}

First maintenance dose: Infuse over 4 hours.¹⁰⁸

Second maintenance dose: Infuse over 16 hours.¹⁰⁸

Oral Inhalation and Intratracheal Instillation

For use as a mucolytic agent, administer 20% acetylcysteine solution undiluted or dilute with sodium chloride injection, sodium chloride inhalation solution, sterile water for injection, or sterile water for inhalation solution.¹⁰²

May use 10% acetylcysteine solution undiluted.¹⁰²

Dosage

Pediatric Patients

Antidote for Acetaminophen Overdosage

Oral

Loading dose: 140 mg/kg, administered as soon as possible.^{102 103} Maintenance dosage, if indicated: 70 mg/kg every 4 hours for 17 doses.^{102 103}

If patient vomits a loading or maintenance dose within 1 hour of administration, repeat the dose.^{102 103}

IV

Loading dose: 150 mg/kg, administered as soon as possible. ¹⁰⁸

First maintenance dose: 50 mg/kg. ¹⁰⁸

Second maintenance dose: 100 mg/kg. ¹⁰⁸

Recommended dosage for patients weighing <5 kg not studied.¹⁰⁸

Mucolytic Uses

Nebulization

Face mask, mouthpiece, or tracheostomy: 3–5 mL of the 20% solution or 6–10 mL of the 10% solution 3 or 4 times daily; alternatively, 1–10 mL of the 20% solution or 2–20 mL of the 10% solution every 2–6 hours.¹⁰²

Tent or croupette: Volume of acetylcysteine solution should be sufficient to maintain a very heavy mist in the tent or croupette for the desired period; maintenance of heavy mist may require up to 300 mL of the 10 or 20% solution for a single, continuous treatment.¹⁰² Administer intermittently or for continuous prolonged periods.¹⁰²

Direct Instillation

1–2 mL of a 10–20% solution as often as every hour.¹⁰²

Intratracheal Instillation

Instillation through a percutaneous intratracheal catheter: 1–2 mL of the 20% solution or 2–4 mL of the 10% solution every 1–4 hours via a syringe attached to the catheter.¹⁰²

Instillation through a catheter into the trachea: 2–5 mL of the 20% solution via a syringe attached to the catheter.¹⁰²

Diagnostic Bronchial Studies

Nebulization

2 or 3 doses of 1–2 mL of the 20% solution or 2–4 mL of the 10% solution prior to the procedure.¹⁰²

Intratracheal Instillation

2 or 3 doses of 1–2 mL of the 20% solution or 2–4 mL of the 10% solution prior to the procedure.¹⁰²

Tracheostomy Care

Intratracheal Instillation

1–2 mL of a 10–20% solution into the tracheostomy every 1–4 hours.¹⁰²

Adults

Antidote for Acetaminophen Overdosage

Oral

Loading dose: 140 mg/kg, administered as soon as possible.^{102 103} Maintenance dosage, if indicated: 70 mg/kg every 4 hours for 17 doses.^{102 103}

If patient vomits a loading or maintenance dose within 1 hour of administration, repeat the dose.^{102 103}

IV

Loading dose: 150 mg/kg, administered as soon as possible.¹⁰⁸

First maintenance dose: 50 mg/kg.¹⁰⁸

Second maintenance dose: 100 mg/kg.¹⁰⁸

Limited information available regarding dosing requirements of patients weighing >100 kg.¹⁰⁸

Mucolytic Uses

Nebulization

Face mask, mouthpiece, tracheostomy: 3–5 mL of the 20% solution or 6–10 mL of the 10% solution 3 or 4 times daily; alternatively, 1–10 mL of the 20% solution or 2–20 mL of the 10% solution every 2–6 hours.¹⁰²

Tent or croupette: Volume of acetylcysteine solution should be sufficient to maintain a very heavy mist in the tent or croupette for the desired period; maintenance of heavy mist may require up to 300 mL of the 10 or 20% solution for a single, continuous treatment.¹⁰² Administer intermittently or for continuous prolonged periods.¹⁰²

Direct Instillation

1–2 mL of a 10–20% solution as often as every hour.¹⁰²

Intratracheal Instillation

Instillation through a percutaneous intratracheal catheter: 1–2 mL of the 20% solution or 2–4 mL of the 10% solution every 1–4 hours via a syringe attached to the catheter.¹⁰²

Instillation through a catheter into the trachea: 2–5 mL of the 20% solution via a syringe attached to the catheter.¹⁰²

Diagnostic Bronchial Studies

Nebulization

For diagnostic bronchial studies: 2 or 3 doses of 1–2 mL of the 20% solution or 2–4 mL of the 10% solution prior to the procedure.¹⁰²

Intratracheal Instillation

For diagnostic bronchial studies: 2 or 3 doses of 1–2 mL of the 20% solution or 2–4 mL of the 10% solution prior to the procedure.¹⁰²

Tracheostomy Care

Intratracheal Instillation

1–2 mL of a 10–20% solution into the tracheostomy every 1–4 hours.¹⁰²

Prevention of Nephropathy Associated with Radiographic Contrast Media† [off-label]

Oral

600 mg twice daily, given the day before and the day of contrast media administration (total of 4 doses), has been used.^{100 110 117 122} Other dosage regimens have been investigated.^{110 117 126 127}

Special Populations

Hepatic Impairment

Limited data in hepatic impairment suggest no clinically meaningful effects on acetylcysteine pharmacokinetics.¹⁰⁸ No specific dosage recommendations for hepatic impairment.¹⁰⁸

Renal Impairment

No specific dosage recommendations for renal impairment;^{102 108} hemodialysis may remove some acetylcysteine.¹⁰⁸

Cautions for Acetylcysteine, Acetylcysteine Lysine(Local, Systemic)

Contraindications

• Acetylcysteine injection contraindicated in patients with known hypersensitivity or previous anaphylactoid reaction to acetylcysteine or any ingredient in the formulation.¹⁰⁸

• Acetylcysteine solution for oral inhalation or intratracheal instillation contraindicated in patients with known hypersensitivity to the drug.¹⁰²

• When administered orally as an antidote, no contraindications.¹⁰²

Warnings/Precautions

Encephalopathy Due to Hepatic Failure

If encephalopathy resulting from hepatic failure occurs during oral acetylcysteine therapy, discontinue the drug to avoid further administration of nitrogenous substances.¹⁰²

No data indicating that acetylcysteine influences hepatic failure; however, this remains a theoretical possibility.¹⁰²

Respiratory Effects

An increased volume of liquefied bronchial secretions may develop following oral inhalation or intratracheal instillation; airway may become occluded.¹⁰² If cough is inadequate to maintain an open airway, institute mechanical suction or endotracheal aspiration (with or without bronchoscopy).¹⁰²

Irritation of tracheal and bronchial tracts and hemoptysis have occurred following administration; however, such findings are not uncommon in patients with bronchopulmonary disease and a causal relationship not established.¹⁰²

Chest tightness and bronchoconstriction reported.¹⁰² Clinically overt acetylcysteine-induced bronchospasm occurs rarely and unpredictably, even in patients with asthmatic bronchitis or bronchitis complicating bronchial asthma.¹⁰² Occasionally, patients receiving oral inhalation of acetylcysteine develop increased airway obstruction of varying and unpredictable severity.¹⁰² Patients who have had such reactions to previous therapy with acetylcysteine may not react during subsequent therapy with the drug, and patients who have had inhalation treatments with acetylcysteine without incident may react to subsequent therapy.¹⁰²

If bronchospasm occurs, give a bronchodilator by nebulization.¹⁰² If bronchospasm progresses, discontinue acetylcysteine immediately.¹⁰² When administered by IV infusion, use with caution in patients with asthma or history of bronchospasm.¹⁰⁸

Hypersensitivity Reactions

Serious hypersensitivity reactions (e.g., rash, hypotension, wheezing, dyspnea), including death in a patient with asthma, reported in patients receiving IV acetylcysteine.¹⁰⁸

Acute flushing and erythema also reported; generally occur 30–60 minutes after initiation of infusion and resolve despite continued infusion.¹⁰⁸ Reactions to acetylcysteine that involve symptoms other than flushing and erythema should be considered anaphylactoid reactions and treated accordingly.¹⁰⁸

If a severe hypersensitivity reaction occurs during IV therapy, immediately discontinue IV acetylcysteine and initiate appropriate treatment.¹⁰⁸ If less severe hypersensitivity reactions occur, manage according to severity; management may include temporary interruption of infusion and/or administration of antihistamines.¹⁰⁸

Once treatment of hypersensitivity reaction has been initiated, carefully reinstitute IV acetylcysteine.¹⁰⁸ If hypersensitivity reaction recurs or increases in severity, discontinue IV acetylcysteine and consider alternative management.¹⁰⁸ Closely monitor patients with asthma during initiation of and throughout IV therapy.¹⁰⁸

Generalized urticaria reported rarely in patients receiving oral acetylcysteine for acetaminophen overdosage.¹⁰² If urticaria or other allergic symptoms occur during oral therapy, discontinue the drug unless it is considered essential and allergic symptoms can be otherwise controlled.¹⁰²

Acquired sensitization to acetylcysteine reported rarely.¹⁰² Sensitization not confirmed by patch testing.¹⁰² Sensitization to acetylcysteine and dermal eruptions reported by several inhalation therapists after frequent and extended exposure to the drug.¹⁰²

GI Effects

Oral administration may result in vomiting or may aggravate vomiting associated with acetaminophen overdosage.¹⁰² Dilution of acetylcysteine prior to oral administration may minimize effects.¹⁰²

Evaluate patients at risk of gastric hemorrhage (e.g., those with esophageal varices or peptic ulcers) with regard to relative risks of upper GI hemorrhage and acetaminophen-induced hepatotoxicity; provide acetylcysteine treatment accordingly.¹⁰²

Fluid Overload

IV administration of acetylcysteine can cause fluid overload, possibly resulting in hyponatremia, seizures, and death.¹⁰⁸ To avoid fluid overload, follow recommendations for dilution and reduce the volume of diluent as needed.¹⁰⁸

Nebulization Administration Precautions

A slight disagreeable odor that tends to become unnoticeable and stickiness on the face with use of a face mask (easily removed with water) can occur with administration by nebulization.¹⁰²

An increased concentration of the drug in the nebulizer due to evaporation of the solvent occurs with continued nebulization of acetylcysteine solution with a dry gas.¹⁰² If extreme concentration impedes nebulization and efficient delivery of the drug, dilute the nebulizing solution with appropriate amounts of sterile water for injection as concentration occurs to resolve this problem.¹⁰²

Specific Populations

Pregnancy

Limited published case reports and case series of pregnant women exposed to acetylcysteine during various trimesters insufficient to inform any drug-associated risk.¹⁰⁸ Delaying treatment of acetaminophen overdose may increase risk of maternal or fetal morbidity and mortality.¹⁰⁸

Lactation

Not known whether acetylcysteine is distributed into human milk;^{102 108} effects on breast-fed infant or on milk production also not known.¹⁰⁸ Consider the developmental and health benefits of breast-feeding along with the mother’s need for acetylcysteine and any potential adverse effects on the breast-fed child from acetylcysteine or from the underlying maternal condition.¹⁰⁸ Use acetylcysteine with caution in nursing women.¹⁰²

Based on pharmacokinetic data, acetylcysteine should be nearly completely cleared 30 hours after IV administration.¹⁰⁸ Breast-feeding women may consider pumping and discarding their milk for 30 hours after administration.¹⁰⁸

Pediatric Use

Efficacy of IV acetylcysteine as an antidote for acetaminophen overdosage appears to be similar to that in adults.¹⁰⁸ Safety and efficacy of IV acetylcysteine in pediatric patients not established by adequate and well-controlled studies; use of IV acetylcysteine as an antidote for acetaminophen overdosage in pediatric patients ≥5 kg is based on clinical practice.¹⁰⁸

Geriatric Use

Insufficient experience with IV acetylcysteine in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.¹⁰⁸

Common Adverse Effects

Oral administration: Nausea, vomiting, other GI symptoms.¹⁰²

IV administration (reported in >2% of patients): Rash, urticaria/facial flushing, pruritus.¹⁰⁸

Oral inhalation/intratracheal instillation: Stomatitis, nausea, vomiting, fever, rhinorrhea, drowsiness, clamminess, chest tightness, bronchoconstriction.¹⁰²

Drug Interactions

Activated Charcoal

Possible interference with absorption of oral acetylcysteine;^{102 119} however, usual dosage of acetylcysteine is appropriate in patients given activated charcoal (higher dosages not necessary).^{105 106} Manufacturer recommends that if activated charcoal has been administered, lavage should be performed before administering oral acetylcysteine treatment.¹⁰²

Acetylcysteine, Acetylcysteine Lysine(Local, Systemic) Pharmacokinetics

Absorption

Bioavailability

Absorbed following oral administration, with peak plasma concentrations achieved within 1–2 hours.¹¹⁹

Distribution

Extent

Crosses the placenta.¹⁰⁸

Plasma Protein Binding

50–87%.^{108 119}

Elimination

Metabolism

Deacetylated to cysteine and oxidized to yield diacetylcysteine.^{102 108} Cysteine is further metabolized to form glutathione and other metabolites.¹⁰⁸

Elimination Route

Principally (70%) nonrenal.^{108 119}

Half-life

6.25 hours after oral administration.¹¹⁹

5.6 hours after IV administration in adults.¹⁰⁸

Special Populations

Following IV administration of acetylcysteine in subjects with mild (Child-Pugh class A), moderate (Child-Pugh class B), or severe (Child-Pugh class C) hepatic impairment, mean elimination half-life is increased by 80% compared with normal subjects.¹⁰⁸ Mean clearance is decreased by 30% and systemic exposure increased 1.6-fold in subjects with hepatic impairment compared to subjects with normal hepatic function.¹⁰⁸ These changes are not considered clinically meaningful.¹⁰⁸

Hemodialysis may remove some of total acetylcysteine.¹⁰⁸

Stability

Storage

Oral, Oral Inhalation, Intratracheal Instillation

Solution

20–25°C (excursions permitted to 15–30°C).¹⁰² Use diluted solutions within 1 hour.¹⁰² Store undiluted solution in opened vials in refrigerator; use within 96 hours.¹⁰² Presence of a light purple color in the solution does not appreciably affect drug potency.¹⁰² Do not store admixtures.¹⁰²

Packets for Oral Solution

20–25°C (excursions permitted to 15–30°C).¹⁰³ Use prepared solution within 1 hour after preparation.¹⁰³

Parenteral

Injection Concentrate for IV Infusion

20–25°C.¹⁰⁸

Presence of light pink to purple color in diluted solution does not affect the quality of the product.¹⁰⁸

Do not use previously opened vials for IV administration.¹⁰⁸

Following dilution with 5% dextrose, 0.45% sodium chloride, or sterile water for injection, stable at controlled room temperature for 24 hours.¹⁰⁸

Actions

• N-acetyl derivative of the naturally occurring amino acid, L-cysteine.^{102 108}

• May protect the liver following acetaminophen overdosage by maintaining or restoring glutathione levels or by acting as an alternate substrate for conjugation with (and detoxification of) a toxic intermediate metabolite of acetaminophen.^{102 108}

• Reduces viscosity of purulent and nonpurulent pulmonary secretions and facilitates their removal by coughing, postural drainage, or mechanical means.¹⁰² Mucolytic effect depends on the free sulfhydryl group, which appears to reduce disulfide linkages of mucoproteins.¹⁰²

• Thiol-containing antioxidant.¹⁰⁰ May act as an oxygen free-radical scavenger to prevent radiographic contrast media-induced renal toxicity;^{100 123 125 129} also may increase the biologic effects of nitric oxide by combining with the oxide to form S-nitrosothiol, a potent vasodilator.^{101 123 129}

Advice to Patients

• Advise patients and caregivers that hypersensitivity reactions, including hypotension, wheezing, shortness of breath, and bronchospasm, may occur during or after acetylcysteine treatment.¹⁰⁸

• Advise women to inform their clinician if they are or plan to become pregnant or plan to breast-feed.^{102 108} Breast-feeding women may consider pumping and discarding their milk for 30 hours after administration.¹⁰⁸

• Advise patients to inform their clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs.^{102 108}

• Inform patients of other important precautionary information.^{102 108}

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

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