Acetaminophen Injection (B. Braun Melsungen): Uses, Side Effects and Dosage

Serious Warnings and Precautions

What is ACETAMINOPHEN INJECTION used for?

ACETAMINOPHEN INJECTION is used in adults and children (2 years of age and older) to manage and treat short term:

• mild to moderate pain;
• moderate to severe pain when given with medicines known as opioids; and
• fevers.

ACETAMINOPHEN INJECTION should be given when it is necessary to give acetaminophen through a vein (“intravenously” or “IV”).

How does ACETAMINOPHEN INJECTION work?

ACETAMINOPHEN INJECTION belongs to a group of medicines known as analgesics (pain relievers) and antipyretics (fever reducer). The way ACETAMINOPHEN INJECTION works is not known. However, it is thought to work by blocking chemical messengers in the brain that cause pain and fever.

What are the ingredients in ACETAMINOPHEN INJECTION?

Medicinal ingredient: acetaminophen.

Non-medicinal ingredients: glacial acetic acid, mannitol, sodium citrate and water for injections.

ACETAMINOPHEN INJECTION comes in the following dosage forms:

Solution for Infusion: 10 mg/mL of acetaminophen.

Do not use ACETAMINOPHEN INJECTION if:

• you are allergic to acetaminophen or to any other ingredients in ACETAMINOPHEN INJECTION;
• you have severe kidney problems;
• you have severe liver problems.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ACETAMINOPHEN INJECTION. Talk about any health conditions or problems you may have, including if you:

• have taken other medications containing acetaminophen in the past 24 hours;
• have liver problems;
• have kidney problems;

• have alcohol dependence or regularly drink alcohol (three or more drinks per day);

• suffer from malnutrition;
• have low blood or fluids in your body (hypovolemia). This can be happen from dehydration or blood loss;

• are breastfeeding or planning to breastfeed. ACETAMINOPHEN INJECTION can pass into breast milk;

• are pregnant or planning to become pregnant. It is not known if ACETAMINOPHEN INJECTION can cause harm to your unborn baby;
• are 65 years of age or older, especially if you also have kidney, liver, and/or heart problems.
• are taking warfarin (a drug to prevent clotting of blood).

Other warnings you should know about:

ACETAMINOPHEN INJECTION can cause the following:

• Allergic reactions: ACETAMINOPHEN INJECTION can cause an allergic reaction. The symptoms can include swelling of the face, mouth, and throat, breathing problems, hives, rashes, and itchiness. If you notice any symptoms of an allergic reaction, stop taking ACETAMINOPHEN INJECTION right away and tell your healthcare professional.
• Severe skin reactions: ACETAMINOPHEN INJECTION can cause severe skin reactions. This can include acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN). If you notice any signs of a skin reaction, stop taking ACETAMINOPHEN INJECTION right away and tell your healthcare professional.

See the Serious side effects and what to do about them table, below, for more information on these and other serious side effects.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with ACETAMINOPHEN INJECTION:

• alcohol;
• barbiturates, a medicine used to cause a sleeping and calming effect;
• busulfan, a medicine used to treat cancer;
• carbamazepine, a medicine used to treat and manage seizures;
• isoniazid, a medicine used to treat tuberculosis;
• probenecid, a medicine used to treat gout or gouty arthritis;
• zidovudine, a medicine used to prevent and treat HIV;
• medicines used to thin the blood and prevent blood clots (e.g., warfarin);
• medicines used to treat pain and reduce fever (e.g., salicylamide and diflunisal);
• medicines known as tyrosine kinase inhibitors (e.g., imatinib and sorafenib).

How to take ACETAMINOPHEN INJECTION:

Your healthcare professional will prepare and give you ACETAMINOPHEN INJECTION. You will receive ACETAMINOPHEN INJECTION through your veins (i.e., “intravenously” or “IV”) by slow injection over 15 minutes.

Usual dose:

Your healthcare professional will decide the right dose for your treatment and how long you should be treated with ACETAMINOPHEN INJECTION. Your dose may depend on your condition, weight, and if you are taking other medicines that contain acetaminophen.

Overdose:

The symptoms of an overdose with ACETAMINOPHEN INJECTION can include:

• kidney problems;
• liver problems;
• encephalopathy (a disease that affects the brain function or structure);
• low blood sugar levels;
• coma;
• low blood platelet levels;
• nausea;
• vomiting;
• excessive or abnormal sweating; or
• not feeling well.

Missed Dose:

If a dose is missed, the dose should be given to you by your healthcare professional as soon as it is recognized. If it is almost time for the next dose, the missed dose will be skipped and the next scheduled dose will be given.

What are possible side effects from using ACETAMINOPHEN INJECTION?

These are not all the possible side effects you may have when taking ACETAMINOPHEN INJECTION. If you experience any side effects not listed here, tell your healthcare professional.

The side effects in adults include:

• difficulty sleeping;
• headache;
• nausea;
• vomiting.

The side effects in children include:

• agitation;
• constipation;
• itchy skin;
• lung collapse;
• nausea;
• vomiting.

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

ACETAMINOPHEN INJECTION will be stored by your healthcare professional between 15°C to 25°C. Do not refrigerate or freeze. Keep the container in the outer carton in order to protect from light. Keep out of reach and sight of children.

If you want more information about ACETAMINOPHEN INJECTION:

• Talk to your healthcare professional

• Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-

  • canada/services/drugs-health-products/drug-products/drug-product-database.html); or by calling 1-800-854-6851.

Last Revised: February 24, 2023