ACETAMINOPHEN INJECTION 10 MG — DIN 02483343

What is ACETAMINOPHEN INJECTION?

ACETAMINOPHEN INJECTION 10 MG contains ACETAMINOPHEN : 10 MG. It is listed in the Health Canada Drug Product Database under DIN 02483343, held by AVIR PHARMA INC., supplied as SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as marketed, status dated 13-Sep-2019. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is ACETAMINOPHEN INJECTION used for?

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 may be given in single or repeated doses when an intravenous route of administration is considered clinically appropriate. Pediatrics ≥ 2 years of age 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 may be given in single or repeated doses when an intravenous route of administration is considered clinically appropriate.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

How is it administered?

The maximum daily dose of acetaminophen includes all routes of administration (i.e., intravenous, oral, and rectal) and all products containing acetaminophen. Do not exceed the maximum recommended single/daily doses of acetaminophen described in Table 1. Table 1 Dosing Recommendations Age group | Dose given every 6 hours | Volume given every 6 hours | Maximum total daily dose of acetaminophen (by any route) Children, 2 years – 12 years | 15 mg/kg | 1.5mL solution per kg | 75 mg/kg in 24 hours Adults and adolescents weighing < 50 kg | 15 mg/kg | 1.5mL solution per kg | 75 mg/kg in 24 hours (up to 3750 mg) Adults and adolescents weighing ≥ 50 kg | 1000 mg | one 100mL bag | 4000 mg in 24 hours 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. For doses less than 1000 mg, the appropriate dose must be withdrawn from the bag and placed into a separate container prior to administration. Using aseptic technique, withdraw the appropriate dose (weight-based) from an intact sealed ACETAMINOPHEN INJECTION bag 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. 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.

Included because it drives pack selection and wastage. Consult the monograph.

Contraindications

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.

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. 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 routes of administration 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 cases of liver injury are associated with doses exceeding maximum daily limits, often involving more than one acetaminophen-containing product. Hypersensitivity Reactions: Post-marketing reports of hypersensitivity and anaphylaxis, including life-threatening cases, have been associated with acetaminophen use. Discontinue immediately if symptoms occur. Skin Reactions: Rarely, serious skin reactions such as AGEP, SJS, and TEN, which can be fatal, have occurred. Patients should be informed about these signs and discontinue the drug at first appearance.