Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Acetaminophen Injection (10 mg/mL) is a clear, colorless solution and is supplied sterile and nonpyrogenic in 50 mL and 100 mL fill polypropylene bag container packaged 24 bags per case, as follows: NDC Strength Package Size 68083-647-01 500 mg/50 mL 6 Cartons (4 x 50 mL Single-Dose Bag in one carton) 68083-648-01 1,000 mg/100 mL 24 Monocartons (1 x 100 mL Single-Dose Bag in one carton) Do not remove unit from overwrap until ready for use. To open, tear outer wrap at the notch and remove solution bag. After removing the outer wrap, check the container for minute leaks by squeezing the solution bag firmly. If leaks are found, discard the solution because the sterility may be impaired. A small amount of moisture may be present inside the outer wrap. Acetaminophen Injection should be stored at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.] For single dose only. Use the product within 18 hours after opening. Do not freeze. Protect from light until use. Use only if prepared solution is clear and free from particulate matter. Manufactured by: Gland Pharma Limited D.P.Pally, Dundigal Post Hyderabad-500043, India. Revised: 03/2025; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Bag Label - 50 mL NDC 68083-647-01 Rx only Acetaminophen Injection 500 mg/50 mL (10 mg/mL) 50 mL fill Polypropylene Bag Container For Intravenous Use Only Protect from light until use Pouch Label - 50 mL NDC 68083-647-01 Rx only Acetaminophen Injection 500 mg/50 mL (10 mg/mL) 50 mL fill Polypropylene Bag Container For Intravenous Use Only Protect from light until use Carton Label - 50 mL NDC 68083-647-01 Rx only Acetaminophen Injection 500 mg/50 mL (10 mg/mL) For Intravenous Use Only Protect from light until use 4 x 50 mL fill Polypropylene Bag Container Bag Label - 100 mL NDC 68083-648-01 Rx only Acetaminophen Injection 1000 mg/100 mL (10 mg/mL) 100 mL fill Polypropylene Bag Container For Intravenous Use Only Protect from light until use Pouch Label - 100 mL NDC 68083-648-01 Rx only Acetaminophen Injection 1000 mg/100 mL (10 mg/mL) 100 mL fill Polypropylene Bag Container For Intravenous Use Only Protect from light until use Carton Label-100 mL NDC 68083-648-01 Rx only Acetaminophen Injection 1000 mg/100 mL (10 mg/mL) For Intravenous Use Only Protect from light until use one 100 mL fill Polypropylene Bag Container acetaminophen-spl-bag-label-50ml acetaminophen-spl-pouch-label-50ml acetaminophen-spl-carton-label-50ml acetaminophen-spl-bag-label-100ml acetaminophen-spl-pouch-label-100ml acetaminophen-spl-carton-label-100ml
- 16 HOW SUPPLIED/STORAGE AND HANDLING Acetaminophen Injection (10 mg/mL) is a clear, colorless solution and is supplied sterile and nonpyrogenic in 50 mL and 100 mL fill polypropylene bag container packaged 24 bags per case, as follows: NDC Strength Package Size 68083-647-01 500 mg/50 mL 6 Cartons (4 x 50 mL Single-Dose Bag in one carton) 68083-648-01 1,000 mg/100 mL 24 Monocartons (1 x 100 mL Single-Dose Bag in one carton) Do not remove unit from overwrap until ready for use. To open, tear outer wrap at the notch and remove solution bag. After removing the outer wrap, check the container for minute leaks by squeezing the solution bag firmly. If leaks are found, discard the solution because the sterility may be impaired. A small amount of moisture may be present inside the outer wrap. Acetaminophen Injection should be stored at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.] For single dose only. Use the product within 18 hours after opening. Do not freeze. Protect from light until use. Use only if prepared solution is clear and free from particulate matter. Manufactured by: Gland Pharma Limited D.P.Pally, Dundigal Post Hyderabad-500043, India. Revised: 03/2025
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Bag Label - 50 mL NDC 68083-647-01 Rx only Acetaminophen Injection 500 mg/50 mL (10 mg/mL) 50 mL fill Polypropylene Bag Container For Intravenous Use Only Protect from light until use Pouch Label - 50 mL NDC 68083-647-01 Rx only Acetaminophen Injection 500 mg/50 mL (10 mg/mL) 50 mL fill Polypropylene Bag Container For Intravenous Use Only Protect from light until use Carton Label - 50 mL NDC 68083-647-01 Rx only Acetaminophen Injection 500 mg/50 mL (10 mg/mL) For Intravenous Use Only Protect from light until use 4 x 50 mL fill Polypropylene Bag Container Bag Label - 100 mL NDC 68083-648-01 Rx only Acetaminophen Injection 1000 mg/100 mL (10 mg/mL) 100 mL fill Polypropylene Bag Container For Intravenous Use Only Protect from light until use Pouch Label - 100 mL NDC 68083-648-01 Rx only Acetaminophen Injection 1000 mg/100 mL (10 mg/mL) 100 mL fill Polypropylene Bag Container For Intravenous Use Only Protect from light until use Carton Label-100 mL NDC 68083-648-01 Rx only Acetaminophen Injection 1000 mg/100 mL (10 mg/mL) For Intravenous Use Only Protect from light until use one 100 mL fill Polypropylene Bag Container acetaminophen-spl-bag-label-50ml acetaminophen-spl-pouch-label-50ml acetaminophen-spl-carton-label-50ml acetaminophen-spl-bag-label-100ml acetaminophen-spl-pouch-label-100ml acetaminophen-spl-carton-label-100ml
Overview
Acetaminophen is a non-salicylate antipyretic and non-opioid analgesic agent. Its chemical name is N-acetyl-p-aminophenol. Acetaminophen has a molecular weight of 151.16. Its structural formula is: Acetaminophen Injection is a sterile, clear, colorless, non pyrogenic, isotonic formulation of acetaminophen intended for intravenous infusion. It has a pH of approximately 4.5 to 5.5 and an osmolality of approximately between 270 mOsm/kg and 310 mOsm/kg. Each 100 mL contains 1,000 mg Acetaminophen, USP, 3,800 mg Mannitol, USP, 30 mg Sodium Citrate Dihydrate USP, Water for Injection, USP qs. Each 50 mL contains 500 mg Acetaminophen, USP, 1,900 mg Mannitol, USP, 15 mg Sodium Citrate Dihydrate USP, Water for Injection, USP qs. pH is adjusted with glacial acetic acid. This container closure is not made with natural rubber latex, PVC or DEHP. acetamenophen-spl-structure
Indications & Usage
Acetaminophen Injection is indicated for • the management of mild to moderate pain in adult and pediatric patients 2 years and older • the management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older • the reduction of fever in adult and pediatric patients. Acetaminophen Injection is indicated for the • Management of mild to moderate pain in adult and pediatric patients 2 years and older ( 1 ) • Management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older ( 1 ) • Reduction of fever in adult and pediatric patients ( 1 )
Dosage & Administration
• Acetaminophen Injection may be given as a single or repeated dose. ( 2.1 ) • Acetaminophen Injection should be administered only as a 15-minute intravenous infusion. ( 2.5 ) Adults and Adolescents Weighing 50 kg and Over: • 1,000 mg every 6 hours or 650 mg every 4 hours to a maximum of 4,000 mg per day. Minimum dosing interval of 4 hours. ( 2.2 ) Adults and Adolescents Weighing Under 50 kg: • 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours to a maximum of 75 mg/kg per day. Minimum dosing interval of 4 hours. ( 2.2 ) Children : • Children 2 to 12 years of age: 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours to a maximum of 75 mg/kg per day. Minimum dosing interval of 4 hours. ( 2.3 ) Neonates and Infants: • Neonates including premature neonates born at greater than or equal to 32 weeks gestational age to 28 days chronological age, 12.5 mg/kg every 6 hours to a maximum of 50 mg/kg per day. Minimum dosing interval of 6 hours. ( 2.4 ) • Infants (29 days to 2 years of age): 15 mg/kg every 6 hours to a maximum of 60 mg/kg per day. Minimum dosing interval of 6 hours. ( 2.4 ) 2.1 Important Dosing and Administration Information • DO NOT ADD SUPPLEMENTARY MEDICATION. • Aseptic technique is required. • Before use, perform the following checks: Read the label. Ensure solution is the one ordered and is within the expiration date. • Inspect the solution in good light for cloudiness, haze or particulate matter; check the container for leakage or damage. Any container which is suspect should not be used. • Use only if solution is clear and container and seals are intact. Single-dose plastic container. Discard unused portion. Consult Package Insert for complete product information. • DO NOT USE PLASTIC CONTAINER IN SERIES CONNECTION. Acetaminophen Injection may be given as a single or repeated dose for the treatment of acute pain or fever. No dose adjustment is required when converting between oral acetaminophen and Acetaminophen Injection dosing in adults and adolescents who weigh 50 kg and above. Calculated maximum daily dose of acetaminophen is based on all routes of administration (i.e. intravenous, oral, and rectal) and all products containing acetaminophen. Exceeding the maximum mg/kg daily dose of acetaminophen as described in Tables 1-3 may result in hepatic injury, including the risk of liver failure and death. To avoid the risk of overdose, ensure that the total amount of acetaminophen from all routes and from all sources does not exceed the maximum recommended dose. 2.2 Recommended Dosage: Adults and Adolescents Adults and adolescents weighing 50 kg and over: the recommended dosage of Acetaminophen Injection is 1,000 mg every 6 hours or 650 mg every 4 hours, with a maximum single dose of Acetaminophen Injection of 1,000 mg, a minimum dosing interval of 4 hours, and a maximum daily dose of acetaminophen of 4,000 mg per day (includes all routes of administration and all acetaminophen-containing products including combination products). Adults and adolescents weighing under 50 kg: the recommended dosage of Acetaminophen Injection is 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours, with a maximum single dose of Acetaminophen Injection of 15 mg/kg, a minimum dosing interval of 4 hours, and a maximum daily dose of acetaminophen of 75 mg/kg per day (includes all routes of administration and all acetaminophen-containing products including combination products). Table 1. Dosing for Adults and Adolescents Age group Dose given every 4 hours Dose given every 6 hours Maximum single dose Maximum total daily dose of acetaminophen (by all routes) Adults and adolescents (13 years and older) weighing greater than or equal to 50 kg 650 mg 1,000 mg 1,000 mg 4,000 mg in 24 hours Adults and adolescents (13 years and older) weighing less than 50 kg 12.5 mg/kg 15 mg/kg 15 mg/kg (up to 750 mg) 75 mg/kg in 24 hours (up to 3,750 mg) 2.3 Recommended Dosage: Children Children 2 to 12 years of age: the recommended dosage of Acetaminophen Injection is 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours, with a maximum single dose of Acetaminophen Injection of 15 mg/kg, a minimum dosing interval of 4 hours, and a maximum daily dose of acetaminophen of 75 mg/kg per day. Table 2. Dosing for Children Age group Dose given every 4 hours Dose given every 6 hours Maximum single dose Maximum total daily dose of acetaminophen (by all routes) Children 2 to 12 years of age 12.5 mg/kg 15 mg/kg 15 mg/kg (up to 750 mg) 75 mg/kg in 24 hours (up to 3,750 mg) 2.4 Recommended Dosage for Treatment of Fever in Neonates and Infants Neonates, including premature neonates born at greater than or equal to 32 weeks gestational age, up to 28 days chronological age: the recommended dosage of Acetaminophen Injection is 12.5 mg/kg every 6 hours, to a maximum daily dose of acetaminophen of 50 mg/kg per day, with a minimum dosing interval of 6 hours. Infants 29 days to 2 years of age: the recommended dosage of Acetaminophen Injection is 15 mg/kg every 6 hours, to a maximum daily dose of acetaminophen of 60 mg/kg per day, with a minimum dosing interval of 6 hours. Table 3. Dosing for Treatment of Fever in Neonates and Infants Age Group Dose given every 6 hours Maximum total daily dose of acetaminophen (by all routes) Neonates (birth to 28 days) 12.5 mg/kg 50 mg/kg Infants (29 days to 2 years) 15 mg/kg 60 mg/kg 2.5 Instructions for Intravenous Administration from polypropylene bag container DO NOT ADD SUPPLEMENTARY MEDICATION. Aseptic technique is required. Before use, perform the following checks: Read the label. Ensure solution is the one ordered and is within the expiration date. Inspect the solution in good light for cloudiness, haze or particulate matter; check the container for leakage or damage. Any container which is suspect should not be used. Use only if solution is clear and container and seals are intact. Single dose plastic container. Discard unused portion. Consult Package Insert for complete product information. DO NOT USE PLASTIC CONTAINER IN SERIES CONNECTION. This solution is intended for intravenous administration over 15 minutes using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours. 1. Identify Twist-off Port (See Figure A). 2. To Attach Administration Set To aseptically remove the top portion of twist off port: hold container below the twist-off port and twist between the thumb and forefinger as shown in Figure B Steps 1 and 2. 3. Push spike through the diaphragm of the port ( See Figure C ). Hang container using hole on the lower flap. Prime set in accordance with the Directions for Use provided with the set in use. Polypropylene bag container can be safely transported in a standard 6-inch carrier through pneumatic tube system that is well maintained and running properly. acetamenophen-spl-figure-a acetamenophen-spl-figure-b acetamenophen-spl-figure-c 2.6 Instructions for Intravenous Administration of Doses Not Equivalent to 500 mg or 1,000 mg Doses that are not equivalent to 500 mg or 1,000 mg require aseptic transfer to a separate container prior to dispensing. Discard unused portion. Using aseptic technique, withdraw the appropriate dose (650 mg or weight-based) from an intact sealed polypropylene bag container and place the measured dose in a separate empty, sterile container (e.g., glass bottle, plastic intravenous container, or syringe) for intravenous infusion to avoid the inadvertent delivery and administration of the total volume of the commercially available container. The entire 100 mL container is not intended for use in patients weighing less than 50 kg. Acetaminophen injection is supplied in a single-dose container and the unused portion must be discarded. Place small volume pediatric doses up to 60 mL in volume in a syringe and administer over 15 minutes using a syringe pump.
Warnings & Precautions
• Risk of Hepatic Injury: Administration of acetaminophen in doses higher than recommended (by all routes of administration and from all acetaminophen-containing products including combination products) may result in hepatic injury, including the risk of liver failure and death. ( 5.1 ) • Use caution when administering acetaminophen in patients with the following conditions: hepatic impairment or active hepatic disease, in cases of alcoholism, chronic malnutrition, severe hypovolemia, or severe renal impairment (creatinine clearance less than or equal to 30 mL/min). ( 5.1 ) • Risk of Serious Skin or Hypersensitivity Reactions: Discontinue Acetaminophen Injection immediately at the first appearance of skin rash and if symptoms associated with allergy or hypersensitivity occur. Do not use in patients with acetaminophen allergy. ( 5.2 , 5.4 ) • Take care when prescribing, preparing, and administering Acetaminophen Injection to avoid dosing errors which could result in accidental overdose and death. ( 5.3 ) 5.1 Hepatic Injury Administration of acetaminophen in doses higher than recommended may result in hepatic injury, including the risk of liver failure and death [see Overdosage (10) ]. Do not exceed the maximum recommended daily dose of acetaminophen [see Dosage and Administration (2) ]. The maximum recommended daily dose of acetaminophen includes all routes of acetaminophen administration and all acetaminophen-containing products administered, including combination products. Use caution when administering acetaminophen in patients with the following conditions: hepatic impairment or active hepatic disease, alcoholism, chronic malnutrition, severe hypovolemia (e.g., due to dehydration or blood loss), or severe renal impairment (creatinine clearance less than or equal to 30 mL/min) [see Use In Specific Populations (8.6 , 8.7 )]. 5.2 Serious Skin Reactions Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity. 5.3 Risk of Medication Errors Take care when prescribing, preparing, and administering Acetaminophen Injection in order to avoid dosing errors which could result in accidental overdose and death. In particular, be careful to ensure that: • the dose in milligrams (mg) and milliliters (mL) is not confused; • the dosing is based on weight for patients under 50 kg; • infusion pumps are properly programmed; and • the total daily dose of acetaminophen from all sources does not exceed maximum daily limits [see Dosage and Administration (2) ]. 5.4 Allergy and Hypersensitivity There have been post-marketing reports of hypersensitivity and anaphylaxis associated with the use of acetaminophen. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, and pruritus. There were infrequent reports of life-threatening anaphylaxis requiring emergent medical attention. Discontinue Acetaminophen Injection immediately if symptoms associated with allergy or hypersensitivity occur. Do not use Acetaminophen Injection in patients with acetaminophen allergy.
Boxed Warning
RISK OF MEDICATION ERRORS AND HEPATOTOXICITY WARNING: RISK OF MEDICATION ERRORS AND HEPATOTOXICITY Take care when prescribing, preparing, and administering Acetaminophen Injection to avoid dosing errors which could result in accidental overdose and death. In particular, be careful to ensure that: • the dose in milligrams (mg) and milliliters (mL) is not confused; • the dosing is based on weight for patients under 50 kg; • infusion pumps are properly programmed; and • the total daily dose of acetaminophen from all sources does not exceed maximum daily limits. Acetaminophen Injection contains acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed the maximum daily limits, and often involve more than one acetaminophen-containing product [see Warnings and Precautions (5.1 )]. WARNING: RISK OF MEDICATION ERRORS AND HEPATOTOXICITY See full prescribing information for complete boxed warning. Take care when prescribing, preparing, and administering Acetaminophen Injection to avoid dosing errors which could result in accidental overdose and death. ( 5.3 ) Acetaminophen Injection contains acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed the recommended maximum daily limits, and often involve more than one acetaminophen-containing product. ( 5.1 )
Contraindications
Acetaminophen is contraindicated: • in patients with known hypersensitivity to acetaminophen or to any of the excipients in the intravenous formulation. • in patients with severe hepatic impairment or severe active liver disease [see Warnings and Precautions (5.1) ]. Acetaminophen is contraindicated: • In patients with known hypersensitivity to acetaminophen or to any of the excipients in the IV formulation. ( 4 ) • In patients with severe hepatic impairment or severe active liver disease. ( 4 )
Adverse Reactions
The following serious adverse reactions are discussed elsewhere in the labeling: • Hepatic Injury [see Warnings and Precautions (5.1) ] • Serious Skin Reactions [see Warnings and Precautions (5.2) ] • Allergy and Hypersensitivity [see Warnings and Precautions (5.4) ] The most common adverse reactions (incidence greater than or equal to 5%) in patients treated with Acetaminophen Injection were nausea, vomiting, headache, and insomnia in adult patients; nausea, vomiting, constipation and pruritus in pediatric patients. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Gland Pharma Limited, at 609-250-7990 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in practice. Adult Population A total of 1,020 adult patients have received Acetaminophen Injection in clinical trials, including 37.3% (n=380) who received 5 or more doses, and 17.0% (n=173) who received more than 10 doses. Most patients were treated with Acetaminophen Injection 1,000 mg every 6 hours. A total of 13.1% (n=134) received Acetaminophen Injection 650 mg every 4 hours. All adverse reactions that occurred in adult patients treated with either Acetaminophen Injection or placebo in repeated dose, placebo-controlled clinical trials at an incidence greater than or equal to 3% and at a greater frequency than placebo are listed in Table 4. The most common adverse events in adult patients treated with Acetaminophen Injection (incidence greater than or equal to 5% and greater than placebo) were nausea, vomiting, headache, and insomnia. Table 4. Treatment-Emergent Adverse Reactions Occurring in greater than or equal to 3% of Acetaminophen Injection-treated Adult Patients and at a Greater Frequency than Placebo in Placebo-Controlled, Repeated Dose Studies System Organ Class – Preferred Term Acetaminophen Injection (N=402) n (%) Placebo (N=379) n (%) Gastrointestinal Disorders Nausea Vomiting 138 (34) 62 (15) 119 (31) 42 (11) General Disorders and Administration Site Conditions Pyrexia* 22 (5) 52 (14) Nervous System Disorders Headache 39 (10) 33 (9) Psychiatric Disorders Insomnia 30 (7) 21 (5) *Pyrexia adverse reaction frequency data is included in order to alert healthcare practitioners that the antipyretic effects of Acetaminophen Injection may mask fever. Other Adverse Reactions Observed During Clinical Studies of Acetaminophen Injection in Adults The following additional treatment-emergent adverse reactions were reported by adult subjects treated with Acetaminophen Injection in all clinical trials (n=1,020) that occurred with an incidence of at least 1% and at a frequency greater than placebo (n=525). Blood and lymphatic system disorders: anemia General disorders and administration site conditions: fatigue, infusion site pain, edema peripheral Investigations : aspartate aminotransferase increased, breath sounds abnormal Metabolism and nutrition disorders: hypokalemia Musculoskeletal and connective tissue disorders: muscle spasms, trismus Psychiatric disorders: anxiety Respiratory, thoracic and mediastinal disorders: dyspnea Vascular disorders: hypertension, hypotension Pediatric Population A total of 483 pediatric patients (72 neonates, 167 infants, 171 children, and 73 adolescents) have received Acetaminophen Injection in active-controlled (n=250) and open-label clinical trials (n=225), including 43.9% (n=212) who received 5 or more doses and 31.2% (n=153) who received more than 10 doses. Pediatric patients received Acetaminophen Injection doses up to 15 mg/kg on an every 4 hours, every 6 hours, or every 8 hours schedule. The maximum exposure was 7.7, 6.4, 6.8, and 7.1 days in neonates, infants, children, and adolescents, respectively. The most common adverse events (incidence greater than or equal to 5%) in pediatric patients treated with Acetaminophen Injection were nausea, vomiting, constipation, and pruritus. Other Adverse Reactions Observed During Clinical Studies of Acetaminophen Injection in Pediatrics The following additional treatment-emergent adverse reactions were reported by pediatric subjects treated with Acetaminophen Injection (n=483) that occurred with an incidence of at least 1%. Blood and lymphatic system disorders: anemia Gastrointestinal disorders: diarrhea General disorders and administration site conditions : pyrexia, injection site pain Metabolism and nutrition disorders: hypokalemia, hypomagnesemia, hypoalbuminemia, hypophosphatemia Musculoskeletal and connective tissue disorders : muscle spasm Nervous system disorders: headache Psychiatric disorders: agitation Renal and urinary disorders: oliguria Respiratory, thoracic and mediastinal disorders : atelectasis, pleural effusion, pulmonary edema, stridor, wheezing Vascular disorders: hypotension, hypertension
Drug Interactions
• Substances that induce or regulate hepatic cytochrome enzyme CYP2E1 may alter the metabolism of acetaminophen and increase its hepatotoxic potential. ( 7.1 ) • Chronic oral acetaminophen use at a dose of 4,000 mg/day has been shown to cause an increase in international normalized ratio (INR) in some patients who have been stabilized on sodium warfarin as an anticoagulant. ( 7.2 ) 7.1 Effects of other Substances on Acetaminophen Substances that induce or regulate hepatic cytochrome enzyme CYP2E1 may alter the metabolism of acetaminophen and increase its hepatotoxic potential. The clinical consequences of these effects have not been established. Effects of ethanol are complex, because excessive alcohol usage can induce hepatic cytochromes, but ethanol also acts as a competitive inhibitor of the metabolism of acetaminophen. 7.2 Anticoagulants Chronic oral acetaminophen use at a dose of 4,000 mg/day has been shown to cause an increase in international normalized ratio (INR) in some patients who have been stabilized on sodium warfarin as an anticoagulant. As no studies have been performed evaluating the short-term use of Acetaminophen Injection in patients on oral anticoagulants, more frequent assessment of INR may be appropriate in such circumstances.
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