Acetaminophen Injection, Solution
Product Images NDC 51662-1540

This is a description of a medication called VR made by Auromedics Pharma LLC. VR is an intravenous injection that comes in a single-dose vial. The 100 mL vial contains 1000 mg of acetaminophen, 3850 mg of mannitol, 25 mg of cysteine hydrochloride monohydrate, and 10.4 mg dibasic sodium phosphate. The pH of the medication may be adjusted with hydrochloric acid and/or sodium hydroxide. The recommended dosage and prescribing information can be found on the label. The medication should be stored at a controlled room temperature between 20°C to 25°C and should not be refrigerated or frozen. The medication is for intravenous use only and doses less than 1000 mg require aseptic transfer to a proper container. Unused portions need to be discarded.*

The text describes a table (Table 4) that shows the treatment-emergent adverse reactions occurring in over 3% of adult patients treated with acetaminophen and at a greater frequency than placebo in placebo-controlled, repeated dose studies. The table lists these reactions by system organ class and preferred term, such as gastrointestinal disorders (nausea, vomiting), general disorders and administration site conditions (pyrexia), nervous system disorders (headache), and psychiatric disorders (insomnia). The note at the end warns healthcare practitioners that the antipyretic effects of acetaminophen may mask fever and includes information about pyrexia adverse reaction frequency data.*

The text is a warning about the risks of medication errors and hepatotoxicity associated with Acetaminophen Injection, a medication that contains acetaminophen. Healthcare professionals are advised to be cautious in prescribing, preparing, and administering the medication to avoid dosing errors, which could result in accidental overdose and death. The warning highlights the importance of ensuring that the dose is based on weight for patients under 50 kg, that infusion pumps are programmed properly, and that the total daily dose of acetaminophen from all sources does not exceed maximum limits. The text also notes that acetaminophen has been associated with cases of acute liver failure, which can result in liver transplant and death, especially at doses that exceed the maximum daily limits and often involve more than one acetaminophen-containing product.*

This is a table presenting the acetaminophen pharmacokinetic parameters for different subpopulations. The subpopulations and their corresponding values are Children (AUCo.gn: 38; Conse.megmt: 30), Adolescents (AUCo.gn: 519; Conse.megmt: 2907), and Adults (AUCo.gn: 2408; Conse.megmt: 27008).*

This is a dosing table for adults and adolescents showing the maximum daily dose of acetaminophen for different weight categories. The maximum total daily dose is 4000mg in 24 hours for adults and adolescents weighing 250kg or more, while for those weighing less than 50kg the maximum dose ranges from 650mg to 1500mg per day depending on their weight.*

This is a table showing dosing guidelines for children based on age and weight using acetaminophen. It includes the maximum single-dose and daily dose for a given age group. The table is not legible in some parts and not enough information is available to provide a complete and accurate description.*

This is a dosage table for the treatment of fever in neonates and infants. The table provides the recommended dosages of acetaminophen for two age groups: neonates (birth to 28 days) and infants (29 days to 2 years). The dosages are given in milligrams per kilogram (ma/ka) and the maximum total daily dose of acetaminophen is provided in milligrams (makg).*

The text describes a warning for healthcare professionals regarding the use of Acetaminophen Injection. The warning highlights the risk of medication errors that can result in accidental overdose and death. It advises healthcare professionals to take care when prescribing, preparing, and administering the injection to avoid dosing errors. The risk of hepatotoxicity (acute liver failure) associated with acetaminophen use is also mentioned, particularly at doses that exceed maximum daily limits and involve multiple acetaminophen-containing products. The warning emphasizes the importance of ensuring the correct dose, based on the patient's weight, and the careful programming of infusion pumps.*