Dosing & Uses
Dosage Forms and Strengths
injectable solution
- 20% (200mg/mL)
effervescent tablets for oral solution (Cetylev)
- 500mg (DSC)
- 2.5g (DSC)
Acetaminophen Overdose
May administer injectable orally
Continuous IV infusion recommended for acute ingestion (ideally within 8-10 hr following ingestion, but may administer if >10 hr)
Intermittent IV infusion may be considered for late presenting or chronic ingestion (more than 10 hr after ingestion)
Oral administration
- May administer injectable orally
- Loading dose: 140 mg/kg PO
- Maintenance dose: 4 hr after loading dose, start 70 mg/kg PO q4hr for a total 17 doses; repeat dose if emesis occurs within 1 hr of administration
IV continuous infusion
- Acute ingestion (within 8-10 hr after ingestion)
- Administer as 3 doses
- Loading dose: 150 mg/kg IV; mix in 200 mL of D5W and infuse over 1 hr
- Dose 2: 50 mg/kg IV in 500 mL D5W over 4 hr, THEN
- Dose 3: 100 mg/kg IV in 1000 mL D5W over 16 hr
- >100 kg: No specific studies have conducted; limited data suggest a loading dose of 15,000 mg infused IV over 1 hr, then a first maintenance dose of 5,000 mg IV over 4 hr and a second maintenance dose of 10,000 mg over 16 hr
Intermittent IV administration (off-label)
- Total treatment time 48 hr
- Late presenting or chronic ingestion (>10 hr after ingestion) in patients >40 kg
- Loading dose: 140 mg/kg IV infused over 1 hr (dilute in 500 mL D5W), THEN
- Maintenance dose: 70 mg/kg IV q4h for at least 12 doses (dilute each dose in 250 mL of D5W and infuse over minimum 1 hr)
Acute Hepatic Failure (Orphan)
Orphan sponsor
- Cumberland Pharmaceuticals, Inc, 2525 West End Ave, Suite 950, Nashville, TN 37203
Other Indications and Uses
Delayed presentation of acetaminophen-induced hepatic failure
Dosage Forms and Strengths
injectable solution
- 200mg/mL
effervescent tablets for oral solution (Cetylev)
- 500mg (DSC)
- 2.5g (DSC)
Acetaminophen Overdose
May administer injectable orally
Continuous IV infusion recommended for acute ingestion (ideally within 8-10 hr following ingestion, but may administer if >10 hr)
Intermittent IV infusion may be considered for late presenting or chronic ingestion (>10 hr after ingestion)
Oral administration (Cetylev)
- Loading dose: 140 mg/kg PO
- Maintenance dose: 4 hr after loading dose, give 70 mg/kg PO q4hr for a total of 17 doses; repeat dose if emesis occurs within 1 hr of administration
IV continuous infusion (Acetadote) weight ≤20 kg
- Loading Dose: 150 mg/kg IV in 3 mL diluent/kg body-weight over 1 hr
- Dose 2: 50 mg/kg IV in 7 mL diluent/kg body-weight over 4 hr
- Dose 3: 100 mg/kg in 14 mL diluent/kg body-weight over 16 hr
IV continuous infusion (Acetadote) >20 kg to <40 kg
- Loading Dose: 150 mg/kg IV in 100 mL of diluent administered over 1hr
- Dose 2: 50 mg/kg IV in 250 mL of diluent administered over 4 hr
- Dose 3: 100 mg/kg IV in 500 mL of diluent administered over 16 hr
IV continuous infusion (Acetadote) weight ≥40 kg
- As adults
- Loading dose: 150 mg/kg IV; mix in 200 mL of D5W and infuse over 1 hr
- Dose 2: 50 mg/kg IV in 500 mL D5W over 4 hr, THEN
- Dose 3: 100 mg/kg IV in 1000 mL D5W over 16 hr
Intermittent infusion (Off-label)
- Total treatment time 48 hr
- Late presenting or chronic (more than 10 hr after ingestion) in patients >40 kg
- Loading dose: 140 mg/kg IV infused over 1 hr (dilute in 200 mL D5W), THEN
- Maintenance dose: 70 mg/kg IV q4h for at least 12 doses (dilute each dose in 250 mL of D5W and infuse over minimum 1 hr)
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (0)
Monitor Closely (1)
- activated charcoal
activated charcoal decreases effects of acetylcysteine (Antidote) by Other (see comment). Use Caution/Monitor. Comment: Conflicting reports exist; however, charcoal administration does not preclude acetylcysteine administration for acetaminophen overdose .
Minor (9)
- isosorbide dinitrate
acetylcysteine (Antidote) increases effects of isosorbide dinitrate by Other (see comment). Minor/Significance Unknown. Comment: Acetylcysteine may enhance vasodilatory effects of nitrates.
- isosorbide mononitrate
acetylcysteine (Antidote) increases effects of isosorbide mononitrate by Other (see comment). Minor/Significance Unknown. Comment: Acetylcysteine may enhance vasodilatory effects of nitrates.
- nitroglycerin IV
acetylcysteine (Antidote) increases effects of nitroglycerin IV by Other (see comment). Minor/Significance Unknown. Comment: Acetylcysteine may enhance vasodilatory effects of nitroglycerin.
- nitroglycerin PO
acetylcysteine (Antidote) increases effects of nitroglycerin PO by Other (see comment). Minor/Significance Unknown. Comment: Acetylcysteine may enhance vasodilatory effects of nitroglycerin.
- nitroglycerin rectal
acetylcysteine (Antidote) increases effects of nitroglycerin rectal by Other (see comment). Minor/Significance Unknown. Comment: Acetylcysteine may enhance vasodilatory effects of nitroglycerin.
- nitroglycerin sublingual
acetylcysteine (Antidote) increases effects of nitroglycerin sublingual by Other (see comment). Minor/Significance Unknown. Comment: Acetylcysteine may enhance vasodilatory effects of nitroglycerin.
- nitroglycerin topical
acetylcysteine (Antidote) increases effects of nitroglycerin topical by Other (see comment). Minor/Significance Unknown. Comment: Acetylcysteine may enhance vasodilatory effects of nitroglycerin.
- nitroglycerin transdermal
acetylcysteine (Antidote) increases effects of nitroglycerin transdermal by Other (see comment). Minor/Significance Unknown. Comment: Acetylcysteine may enhance vasodilatory effects of nitroglycerin.
- nitroglycerin translingual
acetylcysteine (Antidote) increases effects of nitroglycerin translingual by Other (see comment). Minor/Significance Unknown. Comment: Acetylcysteine may enhance vasodilatory effects of nitroglycerin.
Adverse Effects
Frequency Not Defined
Oral administration
- Nausea
- Vomiting
- Drowsiness
- Chills
- Fever
IV administration
- Anaphylactoid reaction due to pyrogens
- Flushing
- Edema
- Urticaria
- Pruritus
- Nausea
- Pharyngitis
- Rhinorrhea
Warnings
Contraindications
Hypersensitivity
Cautions
Obtain serum acetaminophen concentration at least 4 hr postingestion to determine if toxic levels present before treatment or whether full course necessary
IV used if persistent vomiting precludes PO administration in 1st 8 hr
Consult local regional PCC or medical toxicologist for assistance
Asthma patient reported to develop bronchospasm and die after intravenous administration of drug; 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 therapy and throughout therapy
Total volume administered should be adjusted for patients <40 kg and for those requiring fluid restriction; to avoid fluid overload, volume of diluent should be reduced as needed; if volume not adjusted fluid overload can occur, potentially resulting in hyponatremia, seizure and death
Hypersensitivity reactions
- Serious acute hypersensitivity reactions during acetylcysteine administration including rash, hypotension, wheezing, and/or shortness of breath reported in patients receiving intravenous acetylcysteine for acetaminophen overdose; occurred soon after initiation
- Acute flushing and erythema of skin may occur in patients receiving drug intravenously; these reactions usually occur 30 to 60 minutes after initiating the infusion and often resolve spontaneously despite continued infusion of the drug; If a reaction to acetylcysteine involves more than simply flushing and erythema of the skin, it should be treated as a hypersensitivity reaction
- IV may cause severe anaphylactic reactions, however, new 2011 IV formulation (replaces original 2004 IV formulation) does not contain ethylene diamine tetracetic acid or any other stabilization and chelating agents and is free of preservatives
- 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; infusion may be carefully restarted after treatment of hypersensitivity symptoms initiated; however, if hypersensitivity reaction returns upon re-initiation of treatment or increases in severity, the drug should be discontinued and alternative patient management considered
Pregnancy & Lactation
Pregnancy Category: B
Delaying treatment in pregnant women with acetaminophen overdose and potentially toxic acetaminophen plasma levels may increase risk of maternal and fetal morbidity and mortality
Lactation: Developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and potential adverse effects on the breastfed child from therapy or from underlying maternal condition
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Acts as sulfhydryl group donor to restore liver glutathione; may also scavenge free radicals to prevent delayed hepatotoxicity as antioxidant; encourages sulfation pathway of metabolism for acetaminophen
Might be useful against free radicals or reactive metabolites formed by chloroform, carbon tetrachloride, 1,2-dichloropropane, acrylonitrite, doxyrubicin and cyclophosphamide
Administration
Instructions
May pretreat with diphenhydramine, hydrocortisone, cimetidine
Should be given within 8 hr of acetaminophen ingestion for maximum benefit; however effective even after 24 hr of ingestion
Acetadote is hyperosmolar (2600 mOsm/L) and is compatible with 5% dextrose (D5W), 0.45% NaCl injection, and sterile water for injection
Decrease total IV volume for patients who weigh <40 kg or if fluid restriction is required
See adult and pediatric dosing for detailed information on oral, intermittent IV infusion, or continuous IV infusion
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| N-A-C Sustain oral - | 600 mg tablet |  | |
| acetylcysteine oral - | 600 mg capsule |  | |
| acetylcysteine - | 100 mg/mL (10 %) vial |  | |
| acetylcysteine - | 200 mg/mL (20 %) vial |  | |
| acetylcysteine - | 200 mg/mL (20 %) vial |  | |
| acetylcysteine - | 200 mg/mL (20 %) vial |  | |
| acetylcysteine - | 100 mg/mL (10 %) vial |  | |
| acetylcysteine - | 200 mg/mL (20 %) vial |  | |
| acetylcysteine - | 100 mg/mL (10 %) vial |  | |
| acetylcysteine - | 100 mg/mL (10 %) vial |  | |
| acetylcysteine - | 200 mg/mL (20 %) vial |  | |
| acetylcysteine - | 100 mg/mL (10 %) vial |  | |
| acetylcysteine - | 200 mg/mL (20 %) vial |  | |
| acetylcysteine - | 200 mg/mL (20 %) vial |  | |
| acetylcysteine - | 100 mg/mL (10 %) vial |  | |
| acetylcysteine - | 100 mg/mL (10 %) vial |  | |
| acetylcysteine - | 200 mg/mL (20 %) vial |  | |
| acetylcysteine - | 100 mg/mL (10 %) vial |  | |
| Acetadote intravenous - | 200 mg/mL (20 %) vial |  | |
| NAC oral - | 600 mg capsule |  | |
| acetylcysteine intravenous - | 200 mg/mL (20 %) vial |  | |
| acetylcysteine intravenous - | 200 mg/mL (20 %) vial |  | |
| acetylcysteine intravenous - | 200 mg/mL (20 %) vial |  | |
| acetylcysteine intravenous - | 200 mg/mL (20 %) vial |  | |
| acetylcysteine intravenous - | 200 mg/mL (20 %) vial |  | |
| acetylcysteine intravenous - | 200 mg/mL (20 %) vial |  | |
| acetylcysteine intravenous - | 200 mg/mL (20 %) vial |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
acetylcysteine oral
NO MONOGRAPH AVAILABLE AT THIS TIME
USES: Consult your pharmacist.
HOW TO USE: Consult your pharmacist.
SIDE EFFECTS: Consult your pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Consult your pharmacist.
DRUG INTERACTIONS: Consult your pharmacist.Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: No monograph available at this time.
MISSED DOSE: Consult your pharmacist.
STORAGE: Consult your pharmacist.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised July 2016. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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