HIGHLIGHTS OF PRESCRIBING INFORMATION products including combination products) may result in hepatic injury,. These highlights do not include all the
Missing: acetaminofen | Must include: acetaminofen
203 KB – 18 Pages
PAGE – 1 ============
_______________________________________________________________________________________________________________________________________ HIGHLIGHTS OF PRESCRIBING INFORMATION products including combination products) may result in hepatic injury, These highlights do not include all the information needed to use including the risk of liver failure and death. (5.1) Acetaminophen Injection safely and effectively. See full prescribing Do not exceed the maximum recommended daily dose of acetaminophen information for Acetaminophen Injection. (by all routes of administration and all acetaminophen -containing products including combination products). (5.1) Acetaminophen Injection , for intraveno us use Take care when prescribing, preparing, and administering Initial U.S. Approval: 1951 acetaminophen injectio n to avoid dosing errors which could result in accidental overdose and death. (5.3) WARNING: RISK OF MEDICATION ERRORS AND Use caution when administering acetaminophen in patients with the HEPATOTOXICITY following conditions: hepatic impairment or active hepatic disease, in See full prescribing information for complete boxed warning cases of alcoholism, chronic malnut rition, severe hypovolem ia, or severe Take care when prescribing, preparing, and administering Acetaminophen Discontinue acetaminophen immediately at the first appearance of skin Injection to avoid dosing errors which could result in accidental overdose rash and if symptoms associated with allergy or hypersensitivity occur. and death. (5.3) Do not use in patients with acetaminophen allergy. (5.2, 5.4) —————————— ADVERSE REACTIONS —————————- Acetaminophen Injection contains acetaminophen. Acetaminophen has The most common adverse reactions in patients treated with acetaminophen been associated with cases of acute liver failure, at times resulting in liver were nausea, vomiting, headache, and insomnia in adult patients and nausea, transplant and death. Most of the cases of liver injury are associated with vomit ing, constipation, pruritus, agitation, and atelectasis in pediatric patients. the use of acetaminophen at doses that exceed the recommended maximum (6.1) daily limits, and often involve more than one acetaminophen -containing product . (5.1) .To report SUSPECTED ADVERSE REACTIONS, contact —————————- INDICATIONS AND USAGE ————————— Fresenius Kabi USA, LLC, Vigilance & Medical Affairs at 1 -800 -551 Acetaminophen injection is indicated for the: 7176 or FDA at 1 -800 -FDA -1088 or www.fda.gov/medwatch. Management of mild to moderate pain. (1) Management of moderate to severe pain with adjunctive opioid —————————— DRUG INTERACTIONS —————————- analgesics. (1) Substances that induce or regulate hepatic cytochrome enzyme CYP2E1 Reduction of fever. (1) may alter the metabolism of acetaminophen and increase its hepatotoxic potential. (7.1) ———————- DOSAGE AND ADMINISTRATION ——————– Chronic oral acetamin ophen use at a dose of 4,000 mg/day has been Acetaminophen injection may be given as a single or repeated dose. shown to cause an increase in international normalized ratio (INR) in (2.1) some patients who have been stabilized on sodium warfarin as an Acetaminophen injection should be administered only as a 15 minute anticoagulant. (7.2) intravenous infusion. (2.4) ———————– USE IN SPECIFIC POPULATIONS ——————— Adults and Adolescents Weighing 50 kg and Over : Pregnancy: Category C. There are no studies of intravenous 1, 000 mg every 6 hours or 650 mg every 4 hours to a maximum of acetaminophen in pregnant women. Use only if clearly needed. (8.1) 4, 00 0 mg per day. Minimum dosing interval of 4 hours. (2.2) Nursing Mothers: Caution should be exercised when administered to a Adults and Adolescents Weighing Under 50 kg : nursing woman. (8.3) 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours to a maximum of Pediatric Use: Th e effectiveness of acetaminophen for the treatment of 75 mg/kg per day. Minimum dosing interva l of 4 hours. (2.2) acute pain and fever has not been studied in pediatric patients less than 2 Children: years of age. The safety and effectiveness of acetaminophen in pediatric Children 2 to 12 years of age: 15 mg/kg every 6 hours or 12.5 mg/kg patients older than 2 years is supported by evidence from adequate and every 4 hours to a maximum of 75 mg/kg per day. Minimum dosing well -controlled studies in adults with additional safety and interval of 4 hours. (2.3) pharmacokinetic data for this age group. (8.4) Geriatric Use: No overall differences in safety or effectiveness were ——————— DOSAGE FORMS AND STRENGTHS ——————– observed between geriatric and younger subjects. (8.5) Injection for intravenous infusion. Hep atic Impairment: Acetaminophen is contraindicated in patients with Each 100 mL flexible plastic container has 1,000 mg acetaminophen (10 severe hepatic impairment or severe active liver disease and should be mg/mL). (3) used with caution in patients with hepatic impairment or active liver disease. (4, 5.1, 8.6) Acetaminophen is contraindicated: Renal Impairment: In ca ses of severe renal impairment, longer dosing ——————————- CONTRAINDICATIONS ————————– In patients wit h known hypersensitivity to acetaminophen or to any of intervals and a reduced total daily dose of acetaminophen may be the excipients in the IV formulation. (4) warranted. (5.1, 8.7) In patients with severe hepatic impairment or severe active liver disease. Revised: 10 /2015 (4) ———————– WARNINGS AND PRECAUTIONS ——————— Adminis tration of acetaminophen in doses higher than recommended (by all routes of administration and from all acetaminophen -containing FULL PRESCRIBING INFORMATION: CONTENTS* 5.4 Allergy and Hypersensitivity 6 ADVERSE REACTIONS WARNING: RISK OF MEDICATION ERRORS AND HEPATOTOXICITY 6.1 Clinic al Trial Experience 1 INDICATIONS AND USAGE 7 DRUG INTERACTIONS 2 DOSAGE AND ADMINISTRATION 7.1 Effects of Other Substances on Acetaminophen 2.1 General Dosing Information 7.2 Anticoagulants 2.2 Recommended Dosage: Adults and Adolescents 2.3 Reco mmended Dosage: Children 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 2.4 Instructions for Intravenous Administration 8.2 Labor and Delivery 3 DOSAGE FORMS AND STRENGTHS 8.3 Nursing Mothers 4 CONTRAINDICATIONS 8.4 Pediatric Use 5 WARNINGS AND PRECAUTIONS 8.5 Geriatric Use 5.1 Hepatic Injury 8.6 Patients with Hepatic Impairment 5.2 Serious Skin Reactions 8.7 Patients with Renal Imp airment 5.3 Risk of Medication Errors 1Reference ID: 3839318
PAGE – 2 ============
_______________________________________________________________________________________________________________________________ 10 OVERDOSAGE 14.3 Pediatric Acute Pain and Fever 11 DESCRIPTION 16 HOW SUPPLIED/STORAGE AND HANDLING 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES *Sections or subsections omitted from the full prescribing information are not 14.1 Adult Acute Pain listed . 14.2 Adult Fever FULL PRESCRIBING INFORMATION 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 [see Warnings and Precautions (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 maximum daily limits, and often involve more than one acetaminophen-containing product [see Warnings and Precautions (5.1) ]. 1 INDICATIONS AND USAGE Acetaminophen injection is indicated for: Ł the management of mild to moderate pain Ł the management of moderate to severe pain with adjunctive opioid analgesics Ł the reduction of fever 2 DOSAGE AND ADMINIST RATION 2.1 General Dosing Information Acetaminophen injection, for intravenous use, may be given as a single or repeated dose for the treatment of acute pain or fever. No dose adjustment is required when converting 2 Reference ID: 3839318
PAGE – 3 ============
between oral acetaminophen and acetamino phen 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 and 2 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, wi th 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 an y routes) Adults and adolescents (13 years and older) 650 mg 1,000 mg 1,000 mg 4,000 mg in 24 hours Adults and adolescents (13 years and older) weighing < 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 3 Reference ID: 3839318
PAGE - 4 ============
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 Gro up Dose given every 4 hours Dose given every 6 hours Maximum single dose Maximum total daily dose of acetaminophen (by an y 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) 2.4Instructions for Intravenous Administration For adult and adolescent patients weig ,000 mg doses of acetaminophen injection , acetaminophen injection may be administered without further dilution. Examine the flexible plastic container contents before dose preparation or administering. DO NOT USE if particulate ma tter or discoloration is observed. Administer the contents of the flexible plastic container intravenously over 15minutes. Use aseptic technique when preparing acetaminophen injection for intravenous infusion. Do not add other medications to the acetami nophen injection flexible plastic container. For doses less than 1,000 mg, the appropriate dose must be withdrawn from the acetaminophen injection flexible plastic container and placed into a separate container prior to administration. Using aseptic tech nique, withdraw the appropriate dose (650 mg or weight- based) from an intact sealed acetaminophen injection flexible plastic 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 flexible plastic container of acetaminophen injection is not intended for use in patients weighing less than 50 kg. Acetaminophen injection is provided in a single- use flexible plastic 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. Monitor the end of the infusion in order to prevent the possibility of an air embolism, especially in cases where the acetaminophen injection infusion is the primary infusion. 4 Reference ID: 3839318
203 KB – 18 Pages