iNTRAFEN®

Intrafen® (Ibuprofen) is an injectable for the management of Pain and Fever. It is indicated in adults and pediatric patients for the for the management of mild to moderate pain and moderate to severe pain as an adjunct to opioid analgesics.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Every 6 ml vial contains 4 ml solution containing 400 mg ibuprofen.
Every 10 ml vial contains 8 ml solution containing 800 mg ibuprofen.

INDICATIONS

• Management of mild to moderate pain,
• Management of moderate to severe pain as an adjunct to opioid analgesics,
• Reduction of fever.

PHARMACEUTICAL FORM

INTRAFEN 400 mg/4 ml – 800 mg/8 ml 1 vial at a box.

POSOLOGY

Analgesia (Pain) treatment:
Administer 400 mg to 800 mg intravenously every 6 hours as necessary. Infusion time must be no less than 30 minutes.
Antipyretic (Fever) treatment:
Administer 400 mg intravenously, followed by 400 mg every 4 to 6 hours or 100-200 mg every 4 hours as necessary. Infusion time must be no less than 30 minutes.
INTRAFEN must be diluted with an appropriate solution prior to intravenous infusion. In order to prevent possible incompatibilities, INTRAFEN should be diluted with only a 0.9% Sodium Chloride Solution, 5% Glucose Solution, or Lactated Ringers Solution.

Produced by Gen Pharmaceuticals Inc, Turkey.

List of Clinical Studies for Intrafen:

1.Ahiskalioglu, E. O., Ahiskalioglu, A., Aydin, P., Yayik, A. M., & Temiz, A. (2017). Effects of single-dose preemptive intravenous ibuprofen on postoperative opioid consumption and acute pain after laparoscopic cholecystectomy. Medicine, 96(8), e6200.

2.Arpacı, H et al (2016) Effects of lornoxicam and intravenous ibuprofen on erythrocyte deformability and hepatic and renal blood flow in rats. Drug Design, Development and Therapy. 10: 2477-2481

3.Pınar, H.U. et al (2017) Effects of Addition of Preoperative Intravenous Ibuprofen to Pregabalin on Postoperative Pain in Posterior Lumbar Interbody Fusion Surgery. Pain Research and Management. https://doi.org/10.1155/2017/1030491.

4.Cenker, E., Serinken, M. & Uyanık, E (2017) Intravenous paracetamol vs ibuprofen in renal colic: a randomised, double-blind, controlled clinical trial. Urolithiasis. https://doi.org/10.1007/s00240-017-0997-7

On intravenous Ibuprofen:

1.Southworth, S., Peters, J., Rock, A., & Pavliv, L. (2009). A multicenter, randomized, double-blind, placebo-controlled trial of intravenous ibuprofen 400 and 800 mg every 6 hours in the management of postoperative pain. Clinical therapeutics, 31(9), 1922-1935.

2.Krudsood, S., Tangpukdee, N., Wilairatana, P., Pothipak, N., Duangdee, C., Warrell, D. A., & Looareesuwan, S. (2010). Intravenous ibuprofen (IV-ibuprofen) controls fever effectively in adults with acute uncomplicated Plasmodium falciparum malaria but prolongs parasitemia. The American journal of tropical medicine and hygiene, 83(1), 51-55.

3.Morris, P. E., Promes, J. T., Guntupalli, K. K., Wright, P. E., & Arons, M. M. (2010). A multi-center, randomized, double-blind, parallel, placebo-controlled trial to evaluate the efficacy, safety, and pharmacokinetics of intravenous ibuprofen for the treatment of fever in critically ill and non-critically ill adults. Critical Care, 14(3), R125.

4.Singla, N., Rock, A., & Pavliv, L. (2010). A multi-center, randomized, double-blind placebo-controlled trial of intravenous-ibuprofen (IV-ibuprofen) for treatment of pain in post-operative orthopedic adult patients. Pain Medicine, 11(8), 1284-1293.

5.Metwalli, O. S., Abotaleb, U. I., & Nasr, H. M. (2013). Comparative study between intravenous ibuprofen, intravenous tramadol alone and in combination after arthroscopic reconstruction surgery. Ain-Shams Journal of Anaesthesiology, 6(2), 171.

6.Shrestha, A., & Huang, D. (2015). Intravenous ibuprofen as an adjunct in acute postoperative pain: A Review. Journal of Society of Anesthesiologists of Nepal, 2(1), 21-24.

7.Gupta, A., Abubaker, H., Demas, E., & Ahrendtsen, L. (2016). A randomized trial comparing the safety and efficacy of intravenous ibuprofen versus ibuprofen and acetaminophen in knee or hip arthroplasty. Pain physician, 19(6), 349-356.

8.Southworth, S. R., Woodward, E. J., Peng, A., & Rock, A. D. (2015). An integrated safety analysis of intravenous ibuprofen (Caldolor®) in adults. Journal of pain research, 8, 753.

9.Smith, H. S., & Voss, B. (2012). Pharmacokinetics of Intravenous Ibuprofen. Drugs, 72(3), 327-337.

10.Kroll, P. B., Meadows, L., Rock, A., & Pavliv, L. (2011). A Multicenter, Randomized, Double‐Blind, Placebo‐Controlled Trial of Intravenous Ibuprofen (IV‐Ibuprofen) in the Management of Postoperative Pain Following Abdominal Hysterectomy. Pain Practice, 11(1), 23-32.

11.Moss, J. R., Watcha, M. F., Bendel, L. P., McCarthy, D. L., Witham, S. L., & Glover, C. D. (2014). A multicenter, randomized, double‐blind placebo‐controlled, single dose trial of the safety and efficacy of intravenous ibuprofen for treatment of pain in pediatric patients undergoing tonsillectomy. Pediatric Anesthesia, 24(5), 483-489.

12.Le, V., Kurnutala, L., Schiano Di Cola, J., Ahmed, K., Yarmush, J., Daniel Eloy, J., … & Bekker, A. (2016). Premedication with intravenous ibuprofen improves recovery characteristics and stress response in adults undergoing laparoscopic cholecystectomy: a randomized controlled trial. Pain Medicine, 17(6), 1163-1173.

13.Promes, J. T., Safcsak, K., Pavliv, L., Voss, B., & Rock, A. (2011). A prospective, multicenter, randomized, double-blind trial of IV ibuprofen for treatment of fever and pain in burn patients. Journal of Burn Care & Research, 32(1), 79-90.