Combogesic IV

Pronunciation: kom-boh-JEE-zik
Generic name: acetaminophen 1000mg/100mL and ibuprofen 300mg/100mL
Dosage form: injectable injection
Drug class: Analgesic combinations

Medically reviewed by Carmen Pope, BPharm. Last updated on Nov 1, 2023.

What is Combogesic IV?

Combogesic IV is a prescription pain medication for adults that contains acetaminophen and ibuprofen which may be given when an intravenous route of administration is considered clinically necessary to:

• relieve mild to moderate pain
• manage moderate to severe pain in addition to opioid analgesics.

The active ingredients in Combogesic IV, acetaminophen, and ibuprofen, both work together to relieve pain. The precise way acetaminophen works is not known but it is thought to work in the brain. It is not an opioid and it does not contain salicylates. The precise way ibuprofen works is not completely understood either but is thought to involve the inhibition of cyclooxygenase enzymes (COX-1 and COX-2). COX enzymes help create inflammatory substances such as prostaglandin and clotting substances such as thromboxane (TxA2). Ibuprofen is a potent inhibitor of prostaglandin synthesis and belongs to the class of medicines known as nonsteroidal anti-inflammatory drugs (NSAIDs).

Combogesic IV was FDA-approved on 18 October 2023.

Warnings

Do not administer to people with a history of hypersensitivity reactions to acetaminophen, ibuprofen, other NSAIDs, or any of the other ingredients in the IV formulation. Discontinue immediately if allergic-type symptoms occur.

Do not administer to people who have experienced asthma, urticaria (hives), or allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients. Combogesic is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity).

Not for patients with severe hepatic impairment, severe active liver disease, or kidney disease.

Should not be given to people undergoing coronary artery bypass graft (CABG) surgery.

Combogesic IV is indicated for short-term use of five days or less.

Excessive use can be harmful and associated with an increased risk of liver toxicity, cardiovascular events, and gastrointestinal damage.

Contains acetaminophen, which 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 doses of acetaminophen that exceed 4000 mg per day and often involve more than one acetaminophen-containing product. Do not exceed the maximum stated dose and take into account other sources of acetaminophen when reviewing the total daily dosage.

Healthcare providers should take care when prescribing, preparing, and administering Combogesic IV to avoid dosing errors which could result in accidental overdose and death.

Nonsteroidal anti-inflammatory drugs (NSAIDs), which include ibuprofen found in Combogesic, are associated with an increased risk of

• serious cardiovascular blood clotting events, including heart attack and stroke, which can be fatal. This increased risk may occur early in treatment and may increase with longer use
• serious gastrointestinal (GI) side effects such as gastrointestinal bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These may occur at any time during use and without any warning symptoms. Elderly patients and those with a prior history of peptic ulcer disease or GI bleeding are more at risk.

Combogesic IV should also be avoided in people with severe heart failure unless the benefits outweigh the risks. People taking blood pressure medications may not respond to this medication as well as others. Blood pressure should be monitored during treatment.

Serious skin reactions may occur and may cause hematologic toxicity. Discontinue immediately if a skin rash or other signs of hypersensitivity occur.

Related/similar drugs

acetaminophen, tramadol, cyclobenzaprine, naproxen, oxycodone, Tylenol

Before taking

Before being administered Combogesic IV, tell your healthcare provider about all of your medical conditions, including if you:

• have liver or kidney problems
• have high blood pressure
• have asthma
• have heart problems
• have bleeding problems
• have or have had ulcers
• drink alcohol
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy and breastfeeding

Being administered Combogesic IV at about 20 weeks of pregnancy or later may harm your unborn baby. Cases of oligohydramnios/fetal renal dysfunction have been reported with NSAIDs given during this time. Premature closure of the fetal ductus arteriosus can occur from week 30 onwards.

NSAID-containing products, including Combogesic, may cause reversible fertility problems in females, which may temporarily affect your ability to become pregnant during treatment. Talk to your healthcare provider if this is a concern for you.

Ibuprofen can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with Combogesic.

How is Combogesic IV administered?

Combogesic IV is administered into a vein as a 15-minute infusion, every 6 hours, as necessary.

The lowest effective dose should be used for the shortest duration needed for pain relief. Administering Combogesic IV for longer than 5 days is not recommended.

Do not exceed the maximum total daily dose of Combogesic IV (4,000 mg acetaminophen and 1 200 mg ibuprofen) in 24 hours. Do not exceed a total daily dose of 4,000 mg (4 g) of acetaminophen from all sources.

Do not administer at the same time as other acetaminophen-containing products.

Dosage

Adults weighing greater than or equal to 50 kg (actual body weight)

• Acetaminophen 1000mg/ibuprofen 300mg (one vial) of acetaminophen administered as a 15-minute infusion, every 6 hours, as necessary.

Adults weighing less than 50 kg (actual body weight)

• 15 mg/kg acetaminophen and 4.5 mg/kg ibuprofen administered as a 15-minute infusion, every 6 hours, as necessary.

What happens if I miss a dose?

Combogesic IV is just given as necessary for pain relief, so it does not matter if you miss a dose.

What happens if I overdose?

If your healthcare provider administers too much Combogesic IV, you may be at greater risk of side effects and acetaminophen toxicity. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What are the side effects of Combogesic IV?

Combogesic IV may cause serious side effects, including:

• new or worse high blood pressure
• heart failure
• liver problems including liver failure
• kidney problems including kidney failure
• low potassium levels in your blood (hyperkalemia)
• life-threatening allergic reactions
• life-threatening skin reactions
• low red blood cells (anemia)
• changes in your vision.

Get emergency help right away if you get any of the following symptoms:

• shortness of breath or trouble breathing
• slurred speech
• chest pain
• swelling of the face or throat
• weakness in one part or side of your body.

Tell your healthcare provider right away if you get any of the following symptoms:

• nausea
• vomit blood
• more tired or weaker than usual
• there is blood in your bowel movement or it is black and sticky like tar
• diarrhea
• itching
• unusual weight gain
• your skin or eyes look yellow
• skin rash or blisters with fever (including rash with hives, sores in your mouth or eyes, or your skin blisters and peels)
• indigestion or stomach pain
• swelling of the arms, legs, hands, and feet
• flu-like symptoms.

The most common side effects occurring in 3% or more of patients include

• infusion site pain
• nausea
• constipation
• dizziness
• leakage (extravasation) from the infusion site
• vomiting
• headache
• sleepiness.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Combogesic IV. You can report suspected side effects to AFT Pharmaceuticals at toll-free phone #1-877-845-0689 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

What should I avoid while taking Combogesic?

You should avoid drinking alcohol during treatment with Combogesic. Drinking alcohol during treatment may increase your risk of serious side effects.

What other drugs will affect Combogesic IV?

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Medications that may interact with Combogesic include:

• Anticoagulants, such as warfarin
• Aspirin
• Cyclosporine
• Digoxin
• Diuretics
• Heart medications, such as ACE inhibitors, Angiotensin Receptor Blockers, and Beta-blockers
• Methotrexate
• Other NSAIDs and salicylates
• Pemetrexed
• SSRIs and other drugs that affect serotonin reuptake.

This is not a full list of interactions. Refer to the prescribing information.

Storage

Store at 20°C to 25°C (68°F to 77°F). Excursions are permitted between 15°C to 30°C (59°F to 86°F).

Do not refrigerate or freeze. Store in the original carton to protect from light. Protect from heat.

Ingredients

Active: acetaminophen 1,000 mg/100 mL (10 mg/mL), ibuprofen 300 mg/100 mL (3 mg/mL).

Other: Cysteine hydrochloride monohydrate, disodium phosphate dihydrate, mannitol, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), and water for injections.

Available as a single-dose vial for injection that contains 1,000 mg/100 mL (10 mg/mL) of acetaminophen and 300 mg/100 mL (3 mg/mL) of ibuprofen.

Manufacturer

S.M. Farmaceutici SRL. Distributed by AFT Pharmaceuticals Ltd.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer