Combogesic® IV

Paracetamol 1000 mg and ibuprofen 300 mg in 100 mL solution for infusion

A new treatment for postoperative pain management

Combogesic IV Prescription Medicine Box Pack

Combogesic® IV’s patented 3.3 to 1 paracetamol to ibuprofen ratio has been proven to provide significantly better pain relief than the same dose of either paracetamol IV or ibuprofen IV alone.1

Combogesic® IV was developed to provide a combination analgesic therapy with the administration of a single formulation in postoperative patients unable to receive oral analgesics

Effective treatment for
postoperative pain management

  • New clinical data demonstrates that Combogesic® IV provides significantly more analgesia than comparable doses of paracetamol IV, ibuprofen IV and placebo.1
  • All study medicines were administered to patients intravenously over 15 minutes every 6 hours over a 48-hour period, for a total of 8 doses.
  • Combogesic® IV provided significantly superior pain relief than comparable doses of ibuprofen or paracetamol, and placebo.1

The amount of pain relief provided by Combogesic® IV was approximately DOUBLE that of paracetamol IV and ibuprofen IV alone*,1

Combogesic® provided the greatest amount of pain relief, far exceeding the amount required for a clinically significant difference, with all pairwise comparisons being highly significant.*

*Based on time-adjusted SPID48, calculated from VAS pain intensity scores recorded up until the time of consumption of the first dose of rescue.

Combogesic® IV provided greater pain relief over the first 6, 12, 24 and 48 hours treatment period than all three comparators**,1

Combogesic® IV is an effective, opioid-free, pain management tool, with significantly greater pain relief than either of its mono components over the first 6, 12, 24 and 48 hours.**

**As measured by Total Pain Relief (TOTPAR) calculated from the area under the curve of pain relief scores over a specified time interval calculated by the linear trapezoidal rule, up until the first pre-rescue pain relief. There is no time adjustment for TOTPAR.

Combogesic® IV provided significantly greaterpain relief than all three treatment groups at the majority of scheduled time points*,1

Providing sustained pain relief over the first dose

*According to VAS pain intensity, Pain Intensity Differences and Pain Relief scores.

Combogesic® IV provided significantly greaterpain relief than all three treatment groups at the majority of scheduled time points*,1

Providing sustained pain relief over 48 hours

No compromise in safety

  • The postoperative safety profile of Combogesic® IV is equivalent with that of paracetamol IV or ibuprofen IV and no novel adverse events were reported.1
  • Combogesic® IV can be given after surgery and continued in the postoperative period as a component of multimodal pain management.1

From hospital to home
– easy IV to tablet switch

Combogesic Iv To Combogesic Tablet 30 Percent Less
*Based on the total oral Morphine Milligram Equivalent (MME) dose of all rescue medication consumed over the full 48 hour study period.

The Combogesic® IV treatment group was found to have:

  • Significantly reduced odds of requiring opioid analgesia for breakthrough pain than all three comparators.1
  • A longer time to the first dose of breakthrough analgesia than all three comparators.1
  • Significantly lower consumption of oxycodone breakthrough analgesia than all three comparators.1

Why is this important?

  • Immediate-release formulations of prescription opioids have been described as a gateway to addiction.2
  • The potential harm from extended opioid treatments and escalating usage of opioid based treatments has been a strong focus of pain medicine research and forums.
  • Effective pain solutions are needed that allow for an easy opioid-free IV to tablet switch for pain management in the clinic and at home.

Resources

Prescribing information

United Kingdom

Download (PDF)

Northern Ireland

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Combogesic IV Article

Download (PDF)

Patient resources

United Kingdom

Download (PDF)

Northern Ireland

Download (PDF)

References

1. Daniels, S.E, Playne, R., Stanescu, I., Zhang, J., Gottlieb, I.J, Atkinson, H.C. (2019). Efficacy and safety of an intravenous acetaminophen/ibuprofen fixed-dose combination after bunionectomy: A randomized, double-blind, factorial, placebo controlled trial. Clinical Therapeutics 41 (10): 1952-1965. Research sponsored by AFT Pharmaceuticals.

2. FDA Commissioner Scott Gottlieb. September 28, 2017. “FDA Takes Important Steps to Stem the Tide of Opioid Misuse and Abuse | FDA Voice.”. Retrieved https://www.fda.gov/news-events/fda-voices-perspectives-fda-leadership-and-experts/fda-takesimportant-steps-stem-tide-opioid-misuse-and-abuse

Reporting adverse events

Adverse events should be reported. Reporting form and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to AFT Pharma UK Ltd on 01934 838820.

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