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ACETAMINOPHEN is a brand name for Acetaminophen (also known as Paracetamol), supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Adults ACETAMINOPHEN INJECTION (acetaminophen injection) is indicated for: the short-term management of mild to moderate pain when administration by IV route is deemed clinically necessary the management of moderate to severe pain with adjunctive opioid analgesics the treatment of fever. ACETAMINOPHEN INJECTION…
Verbatim from this product's HC label. Tap a section to expand.
). Do not exceed the maximum recommended single/daily doses of acetaminophen described in Table 1. Take care when prescribing and administering ACETAMINOPHEN INJECTION to avoid dosing errors due to confusion between milligram (mg) and millilitre (mL), which could result in accidental overdose and death.
Ensure the proper dose is communicated and dispensed. When writing prescriptions, include both the total dose in mg and the total dose in volume. Ensure the dose is measured and administered accurately. ACETAMINOPHEN INJECTION reduces the febrile temperature set-point.
Appropriate measures should be taken to allow adequate body heat dissipation. Serious Warnings and Precautions Medication Errors Caution is recommended when prescribing, preparing, and administering ACETAMINOPHEN INJECTION to avoid dosing errors which could result in accidental overdose and death (see DOSAGE AND ADMINISTRATION and OVERDOSAGE).
) does not exceed maximum daily limits. Hepatotoxicity 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 OVERDOSAGE and WARNINGS AND PRECAUTIONS, Hepatic/Biliary/ Pancreatic).
2 Recommended Dose and Dosage Adjustment No dose adjustment is required when converting between oral acetaminophen and ACETAMINOPHEN INJECTION dosing in adults and adolescents weighing 50 kg and above. , intravenous, oral, and rectal) and all products containing acetaminophen.
Dosing recommendations for different age groups are summarized in Table 1. 3 Administration For adult and adolescent patients weighing ≥ 50 kg requiring 1000 mg doses of ACETAMINOPHEN INJECTION, administer the dose by inserting a vented IV set through the septum of the bag.
ACETAMINOPHEN INJECTION may be administered without further dilution. The solution is clear and colorless. Examine the bag contents before dose preparation or administering. DO NOT USE if particulate matter, cloudiness or a change in color of solution is observed.
Administer the contents of the bag intravenously over 15-minutes. Use aseptic technique when preparing ACETAMINOPHEN INJECTION for intravenous infusion. Do not add other medications to the ACETAMINOPHEN INJECTION bag. The entire 100 mL bag of ACETAMINOPHEN INJECTION is not intended for use in patients weighing less than 50 kg.
0% (n = 173) who received more than 10 doses. 9%) were treated with acetaminophen injection 1000 mg every 6 hours following surgery. Approximately 69% of acetaminophen injection-treated and 71% of ACETAMINOPHEN INJECTION (Acetaminophen Injection) Product Monograph Page 11 of 31 placebo-treated patients experienced adverse events (AEs).
These AEs were predominantly of mild and moderate severity. The most common adverse events (incidence ≥ 5%) in adult patients treated with acetaminophen injection were nausea, vomiting, headache, and insomnia. 1% (n = 153) who received more than 10 doses.
Pediatric patients received acetaminophen injection doses up to 15 mg/kg on an every 4 hour, every 6 hour, or every 8 hour schedule. 1 days in children and adolescents, respectively. Approximately 48% of acetaminophen injection-treated patients experienced adverse events which were predominantly of mild and moderate severity.
The most common adverse events (incidence ≥ 5%) in pediatric patients treated with acetaminophen injection were nausea, vomiting, constipation, pruritus, agitation, and atelectasis. 2 Clinical Trial Adverse Reactions in Adults Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Treatment-emergent adverse events (TEAEs) reported in ≥ 1% of acetaminophen injection- treated post-operative adult patients in placebo-controlled, repeat-dose clinical trials are summarized in Table 4 if they occurred at a numerically higher rate with acetaminophen injection than with placebo.
These adverse events were included regardless of any causal relationship to acetaminophen injection. 3) AST = Aspartate aminotransferase; GGT = Gamma-glutamyl transferase These spontaneously reported TEAEs in adults, particularly the frequent gastrointestinal TEAEs such as nausea and vomiting, should be considered in the context of the patient population (post-operative patients) where numerous adverse events are expected.
Please see the Serious Warnings and Precautions Box at the beginning of Part I:
Health Professional Information. , due to dehydration or blood loss). Hematologic Chronic oral acetaminophen use at a dose of 4000 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- Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Intravenous Solution 1000 mg / 100 mL (10 mg/mL) mannitol, povidone K12, sodium dihydrogen phosphate dihydrate, sodium hydroxide (pH adjustment), water ACETAMINOPHEN INJECTION (Acetaminophen Injection) Product Monograph Page 9 of 31 term use of acetaminophen injection in patients on warfarin, more frequent assessment of INR may be appropriate.
Single doses of acetaminophen injection up to 3000 mg and repeated doses of 1000 mg every 6 hours for 48 hours have not been shown to cause a significant effect on platelet aggregation. Acetaminophen does not have any immediate or delayed effects on small-vessel hemostasis.
Clinical studies on both healthy subjects and patients with hemophilia showed no significant changes in bleeding time after receiving multiple doses of oral acetaminophen. Hepatic/Biliary/Pancreatic Administration of acetaminophen in doses higher than recommended may result in hepatic injury, including the risk of severe hepatotoxicity and death.
). Do not exceed the maximum recommended daily dose of acetaminophen (see DOSAGE AND ADMINISTRATION). Use caution when administering acetaminophen in patients with the following conditions: hepatic impairment or active hepatic disease, alcoholism, and chronic malnutrition (low reserves of hepatic gluthatione).
Acetylcysteine (N-acetyl-L-cysteine or NAC), the antidote for acetaminophen, may be considered in cases of overdose. Renal Use caution when administering acetaminophen in patients with severe renal impairment (creatinine clearance ≤ 30 mL/min).
ACETAMINOPHEN INJECTION is contraindicated in: patients who have previously demonstrated hypersensitivity to acetaminophen, to any ingredient in the formulation, or component of the container (see DOSAGE FORMS, COMPOSITION, AND PACKAGING).
patients with severe hepatic impairment or severe active liver disease. ACETAMINOPHEN INJECTION (Acetaminophen Injection) Product Monograph Page 5 of 31
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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For doses less than 1000 mg, the appropriate dose must be withdrawn from the bag and placed into a separate container prior to administration. 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.
If transferred to a rigid container, monitor the end of the infusion to ensure that air does not enter the system at the end of the infusion. ACETAMINOPHEN INJECTION is a single-use bag and the unused portion must be discarded. Table 2 lists commonly administered supportive care drugs and intravenous infusion solutions that are physically compatible for up to four hours at room temperature with ACETAMINOPHEN INJECTION and can therefore be administered in the same IV line.
ACETAMINOPHEN INJECTION (Acetaminophen Injection) Product Monograph Page 7 of 31 Diazepam and chlorpromazine hydrochloride are physically incompatible with acetaminophen injection in solution and should not be simultaneously administered in intravenous solution.
9% sodium chloride injection
3% to < 1% and were observed at a numerically higher incidence with acetaminophen injection than with placebo (n = 379). 4 Clinical Trial Adverse Reactions (Pediatrics) Common: Reported by ≥ 1% in Pediatrics Treatment-emergent adverse events reported in ≥ 1% of acetaminophen injection-treated post- operative hospitalized pediatric patients with pain or fever (n = 355) in active and/or open-label studies are summarized below.
These adverse events were included regardless of any causal relationship to acetaminophen injection. 2%), injection site pain […]
Longer dosing intervals and/or a reduced total daily dose of acetaminophen may be warranted in these patients. Hypersensitivity Reactions 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 have been infrequent reports of life- threatening anaphylaxis requiring emergent medical attention. ACETAMINOPHEN INJECTION should be immediately discontinued if symptoms associated with allergy or hypersensitivity occur (see CONTRAINDICATIONS).
Skin Rarely, acetaminophen can cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. It is important to recognize and react quickly to the initial symptoms of these reactions which may occur without warning but may be manifested by any serious skin reactions.
Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at their first appearance. 1 Pregnant Women There are no studies of intravenous acetaminophen in pregnant women and it is therefore not known whether ACETAMINOPHEN INJECTION can cause fetal harm when administered to a pregnant woman.
However, data on oral acetaminophen use in pregnant women show no increased risk of major congenital malformations. ACETAMINOPHEN INJECTION should be given to a pregnant woman only if the benefit to the mother clearly outweighs the risk to the fetus.
2 Breast-feeding While dedicated studies with acetaminophen injection in nursing women have not been conducted, acetaminophen is secreted in human milk after oral administration. Based on data from 32 nursing mothers, less than 2% of the weight-based dose given orally to the mother transfers through breast milk to the nursing child.
There is one well-documented report of a rash in a breast-fed infant that resolved when the mother stopped acetaminophen use and recurred when she resumed acetaminophen use. The benefits of breast feeding while on ACETAMINOPHEN INJECTION should therefore be weighed against the risks to the infant.
3 Pediatrics In pediatric patients younger than 2 years of age, the safety and efficacy of ACETAMINOPHEN INJECTION for the treatment of acute pain and fever has not been established. ACETAMINOPHEN INJECTION is not recommended for this age group.
The presence of hyperbilirubinaemia is associated with acetaminophen clearance reduction in neonates. ACETAMINOPHEN INJECTION contains povidone; there is limited data supporting its safe use in this age group (see ACTION AND CLINICAL PHARMACOLOGY, Pharmacokinetics).
In pediatric patients 2 years of age and older, the safety and efficacy of ACETAMINOPHEN INJECTION for the treatment of acute pain and fever is supported by evidence from adequate and well-controlled studies of acetaminophen injection in adults and from pharmacokinetic and controlled studies in pediatrics.
4 Geriatrics Of the total number of subjects in clinical studies with acetaminophen injection, 16% percent were aged 65 and over. No overall differences in safety or efficacy were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients.
As with other drugs, caution should be used in the treatment of elderly patients who are more […]