Acetylcysteine 200 mg/mL Injection, Solution
Other active recalls for Acetylcysteine (different manufacturers) — 2 · tap to view
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Antidote class.
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🏭 Manufacturer & labeler
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🩺 Clinical
- Acetylcysteine is actually an FDA-approved prescription medicine with two main medical uses. In a hospital setting, it's used as a life-saving antidote when someone takes a dangero...
- Why am I being given acetylcysteine — isn't that a supplement people take for liver health?
- Timing matters a great deal. Acetylcysteine works best when started within 8 hours of the overdose — that's when it gives the strongest protection to your liver. After 8 hours, it'...
- How quickly does acetylcysteine work for an acetaminophen overdose, and does timing really matter?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Acetylcysteine (prescription drug) — tap one for details:
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $3.61 | $433.68 / 120 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J0132 | $0.389 / J0132 unit | — |
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🧾 Billing & reimbursement
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Acetylcysteine 200 mg/mL 00143-9433-04 | Hikma | 4 vials | — | AP | FDA listed | — |
| acetylcysteine 200 mg/mL 00574-0805-30 | Padagis | 4 vials | — | AP | FDA listed | — |
| Acetylcysteine 200 mg/mL 14445-0412-04 | Indoco | 4 vials | — | AP | FDA listed | — |
| Acetylcysteine 200 mg/mLthis 25021-0812-30 | Sagent | 4 vials | — | AP | FDA listed | — |
| Acetylcysteine 6 g/30mL 55150-0259-30 | Eugia | 4 vials | — | AP | FDA listed | — |
| Acetylcysteine 200 mg/mL 63323-0963-44 | Fresenius | 4 vials | — | AP | FDA listed | — |
| Acetadote 200 mg/mL 66220-0207-30 | Cumberland | 4 vials | — | AP | FDA listed | — |
| Acetylcysteine 200 mg/mL 68462-0946-12 | Glenmark | 4 vials | — | AP | FDA listed | — |
| Acetylcysteine 200 mg/mL 70069-0788-04 | Somerset | 4 vials | — | AP | FDA listed | — |
| Acetylcysteine 200 mg/mL 70594-0111-02 | Xellia | 4 vials | — | AP | FDA listed | — |
| Acetylcysteine 200 mg/mL 83270-0001-04 | ONESOURCE | 4 vials | — | AP | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
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Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 25021-0812-30 You're viewing this | 4 VIAL in 1 CARTON (25021-812-30) / 30 mL in 1 VIAL | 2018-04-15 | Active |
| 25021-0812-66 | 4 VIAL in 1 CARTON (25021-812-66) / 30 mL in 1 VIAL | 2022-02-15 | Active |
Pack size FAQ
What quantity is in NDC 25021-0812-30?
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🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | ✓ Available |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Acetylcysteine Injection is indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in adults and pediatric patients who weigh 5 kg or greater with acute ingestion or from repeated supratherapeutic ingestion (RSI). Acetylcysteine Injection is an antidote for acetaminophen overdose indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in adults and pediatric patients who weigh 5 kg or greater with acute ingestion or from repeated supratherapeutic ingestion (RSI) ( 1 ).
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Pre-Treatment Assessment Following Acute Ingestion ( 2.1 ) : Prior to initiating treatment with acetylcysteine injection, decide whether the three-bag or two-bag regimen will be used. Obtain a plasma or serum sample to assay for acetaminophen concentration at least 4 hours after ingestion. If the time of acetaminophen ingestion is unknown: Administer a loading dose of acetylcysteine injection immediately.
Obtain an acetaminophen concentration to determine need for continued treatment. If the acetaminophen concentration cannot be obtained (or is unavailable or uninterpretable) within the 8-hour time interval after acetaminophen ingestion or there is clinical evidence of acetaminophen toxicity: Administer a loading dose of acetylcysteine injection immediately and continue treatment for a total of two doses over 20 hours or three doses over 21 hours ( 2.5 ). If the patient presents more than 8 hours after ingestion and the time of acute acetaminophen ingestion is known: Administer a loading dose of acetylcysteine injection immediately.
Obtain acetaminophen concentration to determine need for continued treatment. If the patient presents less than 8 hours after ingestion and the time of acute acetaminophen ingestion is known and the acetaminophen concentration is known: Use the revised Rumack-Matthew nomogram ( Figure 1 ) to determine whether or not to initiate treatment with acetylcysteine injection ( 2.2 ). Nomogram for Estimating Potential for Hepatotoxicity from Acute Acetaminophen Ingestion ( 2.2 ): See Full Prescribing Information for instructions on how to use the nomogram to determine the need for dosing.
Preparation and Storage of Diluted Solution Prior to Administration ( 2.3 ) : Calculate the dose (mg) based on the patient's weight in kg; multiple vials of acetylcysteine injection may be required. Acetylcysteine injection is hyperosmolar (2,600 mOsmol/L), therefore acetylcysteine injection must be diluted in the recommended volume of sterile water for injection, 0.45% sodium chloride injection, or 5% dextrose in water injection prior to intravenous administration. In general, 0.45% normal saline is the preferred diluent because it provides a more consistent osmolarity profile, reduces the amount of free water delivered to the patient, and better approximates physiologic fluids.
See Full Prescribing Information for examples of osmolarity depending on the type of solution and acetylcysteine injection concentration. General Considerations for Selecting the Three-Bag or Two-Bag Regimen ( 2.4 ): It is not known whether the two-bag regimen is comparable to the three- bag regimen in preventing hepatotoxicity. Patients 40 kg or less should receive the three-bag regimen.
For patients weighing 41 kg or greater, the three-bag regimen may be preferred for those with early signs of severe liver injury or a large acetaminophen ingestion. Recommended Dosage for Acute Acetaminophen Ingestion ( 2.5 ): Acetylcysteine injection is for intravenous administration only. Total dosage of acetylcysteine injection is 300 mg/kg given intravenously as either: 3 separate doses infused over a total of 21 hours OR 2 separate doses infused over a total of 20 hours.
See Full Prescribing Information for weight-based dosage and weight-based dilution ( 2.5 ). See Full Prescribing Information for recommendations for continuing acetylcysteine injection treatment after 21 hours ( 2.2 ). Repeated Supratherapeutic Acetaminophen Ingestion ( 2.6 ) : Obtain acetaminophen concentration and other laboratory tests to guide treatment; revised Rumack-Matthew nomogram does not apply.
2.1Pre-Treatment Assessment and Testing Following Acute Acetaminophen Ingestion Prior to initiating treatment with acetylcysteine injection, decide whether the three-bag or two-bag regimen will be used [see Dosage and administration ( 2.4 )]. The following recommendations are related to acute acetaminophen ingestion. For recommendations related to repeated supra…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Acetylcysteine Injection: 6 grams per 30 mL (200 mg per mL) in a single-dose vial. Acetylcysteine Injection: 6 grams per 30 mL (200 mg per mL) in a single-dose vial ( 3 ).
⛔ Contraindications ▾
4 CONTRAINDICATIONS Acetylcysteine is contraindicated in patients with a previous hypersensitivity reaction to acetylcysteine [see Warnings and Precautions ( 5.1 )] . Patients with a previous hypersensitivity reaction to acetylcysteine ( 4 ).
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Fatal or life-threatening anaphylaxis, rash, hypotension, wheezing, shortness of breath, and/or bronchospasm have been observed. Observe patients during and after the infusion; immediately discontinue infusion if a serious reaction occurs and initiate appropriate treatment. Acetylcysteine infusion may be carefully restarted after treatment of hypersensitivity has been initiated and acute symptoms have resolved ( 5.1 ).
Fluid Overload: Total volume administered should be reduced for patients weighing less than 40 kg and for those requiring fluid restriction ( 5.2 ).
5.1Hypersensitivity Reactions Serious acute hypersensitivity reactions; including fatal or life-threatening anaphylaxis, rash, hypotension, wheezing, and/or shortness of breath; have been observed in patients receiving intravenous acetylcysteine for acetaminophen overdose and occurred soon after initiation of the infusion [see Adverse Reactions ( 6 )] . If a severe hypersensitivity reaction occurs, immediately stop the infusion of acetylcysteine and initiate appropriate treatment. Patients with asthma should be closely monitored during initiation of acetylcysteine therapy and throughout acetylcysteine therapy.
Acute flushing and erythema of the skin may occur in patients receiving acetylcysteine intravenously. These reactions usually occur 30 to 60 minutes after initiating the infusion and often resolve spontaneously despite continued infusion of acetylcysteine. If a reaction to acetylcysteine involves more than simply flushing and erythema of the skin, it should be treated as a hypersensitivity reaction.
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. The acetylcysteine infusion may be carefully restarted after treatment of the hypersensitivity symptoms has been initiated and acute symptoms have resolved; however, if the hypersensitivity reaction returns upon re-initiation of treatment or increases in severity, acetylcysteine should be discontinued and alternative patient management should be considered.
5.2Fluid Overload The total volume of acetylcysteine administered should be adjusted for patients less than 40 kg and for those requiring fluid restriction. To avoid fluid overload, the volume of diluent should be reduced as needed [see Dosage and Administration ( 2 )] . If volume is not adjusted fluid overload can occur, potentially resulting in hyponatremia, seizure and death.
Intravenous administration of acetylcysteine can cause fluid overload, potentially resulting in hyponatremia, seizure and death. To avoid fluid overload, use the recommended dilutions [see Dosage and Administration ( 2.5 )] .
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Most common adverse reactions (> 2%) are rash, urticaria/facial flushing and pruritus ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Sagent Pharmaceuticals at 1-866-625-1618 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Studies Experience The following clinically significant adverse reactions are described elsewhere in labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 .)] Fluid Overload [see Warnings and Precautions ( 5.2 )] Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In the literature, the most frequently reported adverse reactions attributed to intravenous acetylcysteine administration were rash, urticaria and pruritus.
The frequency of adverse reactions has been reported to be between 0.2% and 21%, and they most commonly occur during the initial loading dose of acetylcysteine. Loading Dose/Infusion Rate Study In a randomized, open-label, multi-center clinical study conducted in Australia in patients with acetaminophen poisoning, the rates of hypersensitivity reactions between a 15-minute and 60-minute intravenous infusion for the 150 mg/kg loading dose of acetylcysteine were compared. The incidence of drug-related adverse reactions occurring within the first 2 hours following acetylcysteine administration is presented in Table 4 .
Overall, 17% of patients developed an acute hypersensitivity reaction (18% in the 15-minute infusion group; 14% in the 60-minute infusion group) [see Warnings and Precautions ( 5.1 ), Clinical Studies ( 14 )] . Table 4. Incidence of Drug-Related Adverse Reactions Occurring Within the First 2 Hours Following Study Drug Administration by Preferred Term: Loading Dose/Infusion Rate Study Unkn=Unknown; NOS=not otherwise specified Treatment Group 15-minutes 60-minutes Number of Patients n=109 n=71 Cardiac disorders 5 (5%) 2 (3%) Severity: Unkn Mild Moderate Severe Unkn Mild Moderate Severe Tachycardia NOS 4 (4%) 1 (1%) 2 (3%) Gastrointestinal disorders 16 (15%) 7 (10%) Severity: Unkn Mild Moderate Severe Unkn Mild Moderate Severe Nausea 1 (1%) 6 (6%) 1 (1%) 1 (1%) Vomiting NOS 2 (2%) 11 (10%) 2 (3%) 4 (6%) Immune System Disorders 20 (18%) 10 (14%) Severity: Unkn Mild Moderate Severe Unkn Mild Moderate Severe Hypersensitivity reaction 2 (2%) 6 (6%) 11 (10%) 1 (1%) 4 (6%) 5 (7%) 1 (1%) Respiratory, thoracic and mediastinal disorders 2 (2%) 2 (3%) Severity: Unkn Mild Moderate Severe Unkn Mild Moderate Severe Pharyngitis 1 (1%) Rhinorrhea 1 (1%) Rhonchi 1 (1%) Throat tightness 1 (1%) Skin & subcutaneous tissue disorders 6 (6%) 5 (7%) Severity: Unkn Mild Moderate Severe Unkn Mild Moderate Severe Pruritus 1 (1%) 2 (3%) Rash NOS 3 (3%) 2 (2%) 3 (4%) Vascular disorders 2 (2%) 3 (4%) Severity: Unkn Mild Moderate Severe Unkn Mild Moderate Severe Flushing 1 (1%) 1 (1%) 2 (3%) 1 (1%) Safety Study A large multi-center study was performed in Canada where data were collected from patients who were treated with intravenous acetylcysteine for acetaminophen overdose between 1980 and 2005.
This study evaluated 4,709 adult cases and 1,905 pediatric cases. The incidence of hypersensitivity reactions in adult (overall incidence 8%) and pediatric (overall incidence 10%) patients is presented in Table 5 and Table 6 . Table 5.
Distribution of Reported Hypersensitivity Reactions in Adult Patients Receiving Intravenous Acetylcysteine * Respiratory symptoms are defined as presence of any of the following: cough, wheezing, stridor, shortness of breath, chest tightness, respiratory distress, or bronchospasm. Reaction Incidence (%) n=4,709 Urticaria/Facial Flushing 6.1% Pruritus 4.3% Respiratory Symptoms* 1.9% Edema 1.6% Hypotension 0.1% Anaphylaxis 0.1% Table 6. Distribution of Reported Hypersensitivity Reactions in Pediatric Patients Receiving Int…
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary Limited published case reports and case series of pregnant women exposed to acetylcysteine during various trimesters are not sufficient to inform any drug associated risk. Delaying treatment of acetaminophen overdose may increase the risk of maternal or fetal morbidity and mortality [see Clinical Considerations ]. Reproduction studies in rats and rabbits following oral administration of acetylcysteine during the period of organogenesis at doses similar to the total intravenous dose (based on the body surface area) did not cause any adverse effects to the fetus.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Acetaminophen and acetylcysteine cross the placenta.
Delaying treatment in pregnant women with acetaminophen overdose and potentially toxic acetaminophen plasma levels may increase the risk of maternal and fetal morbidity and mortality. Data Animal Data Reproduction studies have been performed following administration of acetylcysteine during the period of organogenesis in rats at oral doses up to 2,000 mg/kg/day (1.1 times the recommended total human intravenous dose of 300 mg/kg based on body surface area comparison) and in rabbits at oral doses up to 1,000 mg/kg/day (1.1 times the recommended total human intravenous dose of 300 mg/kg based on body surface area comparison).
No adverse developmental outcomes due to acetylcysteine were observed.
8.2Lactation Risk Summary There are no data on the presence of acetylcysteine in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for acetylcysteine and any potential adverse effects on the breastfed child from acetylcysteine or from the underlying maternal condition. Clinical Considerations Based on the pharmacokinetic data, acetylcysteine should be nearly completely cleared 30 hours after administration.
Breastfeeding women may consider pumping and discarding their milk for 30 hours after administration.
8.4Pediatric Use Safety and effectiveness of acetylcysteine in pediatric patients have not been established by adequate and well-controlled studies. Use of acetylcysteine in pediatric patients 5 kg and greater is based on clinical practice [see Dosage and Administration ( 2.5 )].
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Limited published case reports and case series of pregnant women exposed to acetylcysteine during various trimesters are not sufficient to inform any drug associated risk. Delaying treatment of acetaminophen overdose may increase the risk of maternal or fetal morbidity and mortality [see Clinical Considerations ]. Reproduction studies in rats and rabbits following oral administration of acetylcysteine during the period of organogenesis at doses similar to the total intravenous dose (based on the body surface area) did not cause any adverse effects to the fetus.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Acetaminophen and acetylcysteine cross the placenta.
Delaying treatment in pregnant women with acetaminophen overdose and potentially toxic acetaminophen plasma levels may increase the risk of maternal and fetal morbidity and mortality. Data Animal Data Reproduction studies have been performed following administration of acetylcysteine during the period of organogenesis in rats at oral doses up to 2,000 mg/kg/day (1.1 times the recommended total human intravenous dose of 300 mg/kg based on body surface area comparison) and in rabbits at oral doses up to 1,000 mg/kg/day (1.1 times the recommended total human intravenous dose of 300 mg/kg based on body surface area comparison).
No adverse developmental outcomes due to acetylcysteine were observed.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness of acetylcysteine in pediatric patients have not been established by adequate and well-controlled studies. Use of acetylcysteine in pediatric patients 5 kg and greater is based on clinical practice [see Dosage and Administration ( 2.5 )].
🆘 Overdosage ▾
10 OVERDOSAGE Fatal and life-threatening adverse events have been reported following acetylcysteine overdosage, including anaphylaxis, cerebral edema, and hemolytic-uremic syndrome (HUS). Stop acetylcysteine administration in the setting of suspected acetylcysteine overdosage and manage as clinically indicated. Anaphylaxis, including cases with a fatal outcome, has been reported following acetylcysteine overdosage.
Patients who experienced anaphylaxis following acetylcysteine overdosage often became symptomatic during the loading dose and experienced hypotension, rash, angioedema, bronchospasm, or respiratory distress. Cases of anaphylaxis with acetylcysteine overdosage also described coagulopathy, renal failure, or respiratory failure. Cerebral edema, including cases with a fatal outcome, has been reported following acetylcysteine overdosage.
Patients who experienced cerebral edema following acetylcysteine overdose presented with altered mental status, abnormal pupillary responses, seizures. Some cases of cerebral edema with acetylcysteine overdosage described brain herniation. HUS has been reported following acetylcysteine overdosage.
Patients who experienced HUS presented with microangiopathic hemolytic anemia, thrombocytopenia, and acute kidney injury. Removal of acetylcysteine via hemodialysis has been reported in the literature outside of the context of acetylcysteine overdosage. Studies of hemodialysis in acetaminophen overdose report significant extracorporeal removal of acetylcysteine during hemodialysis.
Contact the Poison Center (1-800-222-1222) for overdosage management recommendations for acetylcysteine including considerations for hemodialysis.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Acetylcysteine has been shown to reduce the extent of liver injury following acetaminophen overdose. Acetaminophen doses of 150 mg/kg or greater have been associated with hepatotoxicity. Acetylcysteine probably protects the liver by maintaining or restoring the glutathione levels, or by acting as an alternate substrate for conjugation with, and thus detoxification of, the reactive metabolite of acetaminophen.
12.3Pharmacokinetics After a single intravenous dose of acetylcysteine, the plasma concentration of total acetylcysteine declined in a poly-exponential decay manner with a mean terminal half-life (T 1/2 ) of 5.6 hours. The mean clearance (CL) for acetylcysteine was 0.11 liter/hr/kg and renal CL constituted about 30% of the total CL. Distribution The steady-state volume of distribution (Vd ss ) following administration of an intravenous dose of acetylcysteine was 0.47 liter/kg.
The protein binding of acetylcysteine ranges from 66 to 87%. Elimination Metabolism Acetylcysteine (i.e., N -acetylcysteine) is postulated to form cysteine and disulfides (N,N-diacetylcysteine and N- acetylcysteine). Cysteine is further metabolized to form glutathione and other metabolites.
Excretion After a single oral dose of [ 35 S]-acetylcysteine 100 mg, between 13 to 38% of the total radioactivity administered was recovered in urine within 24 hours. In a separate study, renal clearance was estimated to be approximately 30% of total body clearance. Specific Populations Hepatic Impairment Following a 600 mg intravenous dose of acetylcysteine to subjects with mild (Child Pugh Class A, n=1), moderate (Child-Pugh Class B, n=4) or severe (Child-Pugh Class C; n=4) hepatic impairment and 6 healthy matched controls, mean T1/2 increased by 80%.
Also, the mean CL decreased by 30% and the systemic acetylcysteine exposure (mean AUC) increased 1.6-fold in subjects with hepatic impairment compared to subjects with normal hepatic function. These changes are not considered to be clinically meaningful. Renal Impairment Hemodialysis may remove some of total acetylcysteine.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Acetylcysteine has been shown to reduce the extent of liver injury following acetaminophen overdose. Acetaminophen doses of 150 mg/kg or greater have been associated with hepatotoxicity. Acetylcysteine probably protects the liver by maintaining or restoring the glutathione levels, or by acting as an alternate substrate for conjugation with, and thus detoxification of, the reactive metabolite of acetaminophen.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Acetylcysteine Injection is supplied as a 20% solution (200 mg per mL) as follows: NDC Acetylcysteine Injection (200 mg per mL) Package Factor 25021-812-30 6 grams per 30 mL Single-Dose Vial 4 vials per carton Do not use previously opened vials for intravenous administration. Note: The color of Acetylcysteine Injection may turn from essentially colorless to a slight pink or purple once the stopper is punctured. The color change does not affect the quality of the product.
Storage Conditions Store unopened vials at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Discard unused portion. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.
📦 Storage and Handling ▾
Storage Conditions Store unopened vials at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Discard unused portion. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.
📋 Description ▾
11 DESCRIPTION Acetylcysteine Injection is an intravenous antidote for the treatment of acetaminophen overdose. Acetylcysteine is the nonproprietary name for the N-acetyl derivative of the naturally occurring amino acid, L-cysteine (N-acetyl-L-cysteine,). The compound is a white crystalline powder, which melts in the range of 104° to 110°C and has a very slight odor.
The molecular formula of the compound is C 5 H 9 NO 3 S, and its molecular weight is 163.2. Acetylcysteine has the following structural formula: Acetylcysteine Injection is supplied as a sterile solution in vials containing 20% w/v (200 mg per mL) acetylcysteine. The pH of the solution ranges from 6.0 to 7.5.
Acetylcysteine Injection contains the following inactive ingredients: 0.5 mg per mL disodium edetate, sodium hydroxide (used for pH adjustment), and Water for Injection, USP. The amount of sodium in Acetylcysteine Injection is approximately 30 mg per mL. Because Acetylcysteine Injection is administered based on a patient's weight, the amount of sodium administered in a course of treatment will vary from approximately 225 mg to 4,500 mg.
The use of ½ normal saline will contribute approximately an additional 1,770 mg of sodium per liter of diluent. Structural Formula
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Hypersensitivity Reactions Advise patients and caregivers that hypersensitivity reactions related to administration and infusion may occur during and after acetylcysteine treatment, including hypotension, wheezing, shortness of breath and bronchospasm [see Warnings and Precautions ( 5.1 )] . For specific treatment information regarding the clinical management of acetaminophen overdose, please contact your regional poison center at 1-800-222-1222, or alternatively, a special health professional assistance line for acetaminophen overdose at 1-800-525-6115. sagent® Mfd. for SAGENT Pharmaceuticals Schaumburg, IL 60173 (USA) Made in Italy ©2024 Sagent Pharmaceuticals Revised: December 2024