Combogesic IV: Uses, Side Effects and Dosage

Serious Warnings and Precautions

What is COMBOGESIC IV used for?

COMBOGESIC IV is used in adults (18 years of age and older) to manage short-term:

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

COMBOGESIC IV should be given when an intravenous (IV) route of administration is necessary.

How does COMBOGESIC IV work?

COMBOGESIC IV belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). It is a combination of two medicinal ingredients, ibuprofen (as ibuprofen sodium dihydrate) and acetaminophen. These work together to relieve pain and inflammation (swelling, redness, or soreness).

What are the ingredients in COMBOGESIC IV?

Medicinal ingredients:

• Acetaminophen;
• Ibuprofen, as ibuprofen sodium.

Non-medicinal ingredients:

• Cysteine hydrochloride monohydrate;
• Disodium phosphate dihydrate;
• Hydrochloric acid (for pH adjustment);
• Mannitol;
• Sodium hydroxide (for pH adjustment);
• Water for injection.

COMBOGESIC IV comes in the following dosage forms:

Solution: 10 mg/mL of acetaminophen and 3 mg/mL of ibuprofen (as ibuprofen sodium dihydrate).

Do not use COMBOGESIC IV if:

• you are planning to have or have recently had heart bypass surgery.
• you have severe, uncontrolled heart failure.
• you are in the third trimester of pregnancy (28 weeks or later).
• you are allergic to acetaminophen, ibuprofen, or any of the other ingredients in COMBOGESIC IV.
• you have had asthma, hives, or an allergic reaction in the past after taking acetylsalicylic acid (ASA) or other NSAIDs.
• you have an autoimmune disease known as lupus.
• you have any bleeding disorders (e.g., bleeding in the brain or active bleeding from the stomach or gut).
• you have active stomach or intestinal ulcers.
• you have inflammatory bowel disease (e.g., Crohn’s disease or ulcerative colitis).
• you have liver disease (active or severe).
• you have kidney disease (severe or worsening).
• you have high potassium levels in the blood (hyperkalemia).
• you are under the age of 18 years of age.

• you regularly drink large quantities of alcohol (active alcoholism).

• you have a blood disorder that affects the formation of red blood cells, white blood cells, and/or platelets.
• you are breastfeeding or planning to breastfeed. COMBOGESIC IV can pass into your breast milk.

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

• have or had heart problems.
• have or had kidney problems.

• are at a higher risk of having heart, blood vessel, or kidney problems. This can include if you:

  • have high blood pressure.
  • have high cholesterol.
  • have diabetes.
  • have heart failure (heart is unable to pump blood normally).
  • have narrowed or blocked blood vessels (e.g., coronary artery disease or peripheral arterial disease).
  • are a smoker or previous smoked.
  • are dehydrated.
  • on a salt restricted diet
• have liver problems.
• have blood clotting or platelet problems.
• have a history of ulcers or bleeding from the stomach or intestines or are at a higher risk of these problems.
• have a condition known as ASA-triad (i.e., if you have asthma, growths inside the nose (nasal polyps), and are allergic to acetylsalicylic acid).
• have are allergic to another NSAID medicine. If you are unsure ask your healthcare professional.
• have immune system problems (e.g., autoimmune disorders).
• are in your first or second trimester of pregnancy or planning to become pregnant. It is not recommended for use during your first or second trimester of pregnancy.
• have a condition that causes weakness or frailty.
• are 65 years of age or older.

Other warnings you should know about:

COMBOGESIC IV can cause the following:

• Bleeding problems: You are at a higher risk of bleeding problems if you:

  • have a stomach infection;
  • drink alcohol;
  • smoke;
  • have poor general health;
  • have a platelet disorder;
  • take anticoagulants (medicines used to thin blood or prevent blood clotting);
  • take corticosteroids (medicines used to treat inflammation);
  • take non-steroidal anti-inflammatory drugs (NSAIDs; medicines used to treat pain, fever and inflammation);
  • take selective serotonin reuptake inhibitors (SSRIs; medicines used to treat depression);
  • are older in age; or
  • have a condition that causes weakness or frailty.

Stop use and tell your healthcare professional right away if you have any signs of bleeding.

• Severe skin reactions: This can include reactions known as acute generalized exanthematous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), exfoliative dermatitis, or erythema multiforme. These are more likely to happen during the first month of treatment. Tell your healthcare professional right away if you notice any changes to your skin both during and after treatment.

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

Check-ups and testing: Your healthcare professional will regularly monitor your health throughout your treatment. This may include:

• checking your blood pressure.
• monitoring for potential ulcers and bleeding.
• monitoring your eyesight and vision.
• testing your blood and urine to check your liver, kidney, and blood profile.

Driving and using machines: COMBOGESIC IV can cause drowsiness, dizziness, blurred vision, vertigo, tinnitus, hearing loss, insomnia, or depression. Before you do tasks which may require your attention, you should wait until you know how you react to COMBOGESIC IV.

Fertility in women: COMBOGESIC IV may affect your fertility. This means that it may be difficult for you to have a child. COMBOGESIC IV is not recommended if you are planning to become pregnant. Talk to your healthcare professional if you have any questions about this.

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 COMBOGESIC IV:

• anticoagulants, medicines used to thin blood or prevent blood clotting (e.g., warfarin).
• medicines used to treat high blood pressure or other heart conditions (e.g., angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), and beta-blockers).
• carbamazepine, a medicine used to treat epilepsy and seizures (fits).
• probenecid, a medicine used to treat gout.
• zidovudine, a medicine used to prevent and treat human immunodeficiency virus (HIV).
• isoniazid, a medicine used to treat tuberculosis.
• other non-steroidal anti-inflammatory drugs (NSAIDs), medicines used to treat pain, fever and inflammation (e.g., acetylsalicylic acid (ASA), naproxen, and salicylates).
• diuretics also known as the “water pill”, medicines used to lower fluid levels (e.g., furosemide and thiazides).
• medicines used to treat depression (e.g., lithium, selective serotonin reuptake inhibitors (SSRIs), and serotonin and norepinephrine reuptake inhibitors (SNRIs)).
• medicines used to treat different cancers (e.g., methotrexate, busulfan, and tyrosine kinase inhibitors).
• corticosteroids, medicines used to treat inflammation (e.g., glucocorticoids).
• cyclosporin or tacrolimus, medicines used to lower the risk of organ transplant rejection.
• digoxin, a medicine used to treat heart failure and irregular heart rhythms.
• barbiturates, medicines used to relax the body and help with sleeping.
• alcohol.

If you are unsure ask your healthcare professional.

How to take COMBOGESIC IV:

Your healthcare professional will prepare and give you COMBOGESIC IV in a hospital or medical setting. You will receive COMBOGESIC IV through your veins (i.e., “intravenously” or “IV”) by slow infusion over 15 minutes.

Usual dose:

Your healthcare professional will decide the right dose of COMBOGESIC IV for you. This will be the lowest dose possible for your treatment for the shortest time needed. Your dose may depend on your condition, weight, and if you are taking other medicines.

Overdose:

Missed Dose:

If a dose is missed, the dose will 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 COMBOGESIC IV?

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

The side effects of COMBOGESIC IV may include:

• feeling gassy,
• feeling ill,
• feeling tired,
• headache,
• nervousness,
• pain or aggravation at the injection site,
• ringing in the ears.

Serious side effects and what to do about them

Serious side effects and what to do about them

Serious side effects and what to do about them

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:

Store COMBOGESIC IV at controlled room temperature, 15°C to 25°C.

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

Keep out of reach and sight of children.

If you want more information about COMBOGESIC IV:

•

• 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); the manufacturer’s website (www.aftpharm.com), or by calling 1-855-611-2724

Last Revised: JAN 22, 2025