Ofirmev injection is used to treat pain in adults and children at least 2 years old.

Ofirmev injection is sometimes given with opioid pain medication to treat moderate to severe pain in adults and children at least 2 years old.

Ofirmev injection is also used to reduce fever in adults and children 2 years and older .

You should not use Ofirmev if you have severe liver disease.

Do not use more Ofirmev than is recommended. An overdose of acetaminophen can damage your liver or cause death.

Call your doctor at once if you have nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).

Be very careful when measuring your dose. Ofirmev contains 10 milligrams (mg) of acetaminophen in each milliliter (mL) of the solution.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. Stop using Ofirmev and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

Before taking this medicine

You should not be treated with Ofirmev if you are allergic to acetaminophen or if you have severe liver disease.

To make sure Ofirmev is safe for you, tell your doctor if you have:

• bleeding problems;

• liver disease, cirrhosis, alcoholism, or more than 3 alcoholic beverages per day;

• kidney disease; or

• if you've recently been sick with vomiting or diarrhea;

• if you are malnourished.

Tell your doctor if you are pregnant or breastfeeding.

Pregnancy may be less likely to occur while the mother or the father is using this medicine.

Ofirmev is given as an infusion into a vein, usually once every 4 to 6 hours. A healthcare provider will give your first dose and may teach you how to properly use the medication by yourself.

Be very careful when measuring your dose. Ofirmev injection contains 10 milligrams (mg) of acetaminophen in each milliliter (mL) of the solution. If your dose is 1000 mg, for example, you would use only 100 mL of solution.

If you are using an infusion pump, take care to properly program the machine to deliver the correct amount of medicine for your dose.

Tell your doctor if you have any changes in weight while using this medicine. Lower doses are used in people who weigh less than 110 pounds (50 kilograms).

Do not use more Ofirmev than is recommended. An overdose of acetaminophen can damage your liver or cause death.

Each Ofirmev vial (bottle) is for one use only. Throw it away after one use, even if there is still medicine left inside.

Store at room temperature away from heat and moisture. Do not refrigerate or freeze.

You must use the medicine within 6 hours after opening a vial.

You should not be treated with Ofirmev if you are allergic to acetaminophen or if you have severe liver disease.

To make sure Ofirmev is safe for you, tell your doctor if you have:

• bleeding problems;

• liver disease, cirrhosis, alcoholism, or more than 3 alcoholic beverages per day;

• kidney disease; or

• if you've recently been sick with vomiting or diarrhea;

• if you are malnourished.

Tell your doctor if you are pregnant or breastfeeding.

Pregnancy may be less likely to occur while the mother or the father is using this medicine.

Since Ofirmev is used when needed, you may not be on a dosing schedule. Skip any missed dose if it's almost time for your next dose. Do not use two doses at one time.

Do not use Ofirmev injection more often than every 4 hours.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen can damage your liver or cause death.

Early signs of acetaminophen overdose include loss of appetite, nausea, vomiting, sweating, or weakness. Later symptoms may include upper stomach pain, dark urine, and yellowing of your skin or eyes.

Overdose symptoms may also include hunger with irritability, fast heart rate, tremors, feeling jittery, trouble concentrating, easy bruising, unusual bleeding, or purple or red pinpoint spots under your skin.

Avoid using other medicines that may contain acetaminophen (sometimes abbreviated as APAP).

Drinking alcohol may increase your risk of liver damage.

Get emergency medical help if you have signs of an allergic reaction to Ofirmev: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal, even if you took acetaminophen in the past and had no reaction. Tell your caregivers or call your doctor if you have skin redness or a rash that spreads and causes blistering and peeling.

Stop using Ofirmev and call your doctor at once if you have:

• fever, cough, chest pain, trouble breathing; or

• liver problems - nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common Ofirmev side effects may include:

• cough, breathing problems;

• nausea, vomiting;

• constipation;

• agitation;

• itching;

• headache; or

• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor if you also use a blood thinner (warfarin, Coumadin, Jantoven)

Other drugs may interact with acetaminophen, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.