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An overview of OFIRMEV

First and only IV acetaminophen in the US

  • Indicated for the management of mild to moderate pain; management of moderate to severe pain with adjunctive opioid analgesics; and reduction of fever
  • For adults and children ≥2 years old2

Comprehensive clinical dataset

  • The approval of OFIRMEV is supported by the results of 20 clinical trials involving 1375 patients1,2
  • IV acetaminophen has been studied in randomized clinical trials across a variety of surgical contexts and patient types1,3-5

Improved pain relief, reduced opioid consumption3

  • In total hip/knee replacement surgery, OFIRMEV 1 g + PCA* morphine demonstrated significant pain relief and reduced opioid consumption compared to placebo + PCA morphine3
  • The clinical benefit of reduced opioid consumption was not demonstrated

Patient satisfaction3

  • The hip/knee replacement study also showed that OFIRMEV 1 g + PCA morphine significantly improved patient satisfaction compared to placebo + PCA morphine†3

Significant fever reduction1

  • In adults with fever, antipyretic onset of action was significantly faster and duration of effect significantly longer with OFIRMEV than with placebo1

Established safety profile and well tolerated in clinical trials1-5

  • OFIRMEV was shown to be well tolerated in clinical trials1-5
  • The safety of IV acetaminophen has been monitored through a postmarketing surveillance program, with more than 400 million doses distributed since its European approval1
  • IV acetaminophen has been used outside the US since 2002 and is approved in over 60 countries1

Dosing for adults and children ≥2 years old2

  • OFIRMEV has a well-described pharmacokinetic profile2
  • Dosing guidelines have been established for children ≥2 years old through adults2
  • OFIRMEV is the first IV analgesic and antipyretic agent approved for children ≥2 years old2

Indication

OFIRMEV is indicated for the management of mild to moderate pain; the management of moderate to severe pain with adjunctive opioid analgesics; and the reduction of fever.

Important Safety Information

Do not exceed the maximum recommended daily dose of acetaminophen.

Administration of acetaminophen by any route in doses higher than recommended may result in hepatic injury, including the risk of severe hepatotoxicity and death.

OFIRMEV is contraindicated in patients with severe hepatic impairment, severe active liver disease or with known hypersensitivity to acetaminophen or to any of the excipients in the formulation.

Acetaminophen should be used with caution in patients with the following conditions: hepatic impairment or active hepatic disease, alcoholism, chronic malnutrition, severe hypovolemia, or severe renal impairment.

OFIRMEV should be administered only as a 15-minute infusion.

Discontinue OFIRMEV immediately if symptoms associated with allergy or hypersensitivity occur.

Do not use in patients with acetaminophen allergy.

The most common adverse reactions in patients treated with OFIRMEV were nausea, vomiting, headache, and insomnia in adult patients and nausea, vomiting, constipation, pruritus, agitation, and atelectasis in pediatric patients

The antipyretic effects of OFIRMEV may mask fever in patients treated for postsurgical pain.

To report SUSPECTED ADVERSE REACTIONS, contact Cadence Pharmaceuticals, Inc.
at 1-877-647-2239 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

References: 1. Data on file. Cadence Pharmaceuticals, Inc. 2. OFIRMEV™ (acetaminophen) injection prescribing information. 3. Sinatra RS, Jahr JS, Reynolds LW, Viscusi ER, Groudine SB, Payen-Champenois C. Efficacy and safety of single and repeated administration of 1 gram intravenous acetaminophen injection (paracetamol) for pain management after major orthopedic surgery. Anesthesiology. 2005;102:822-831. 4. Atef A, Fawaz AA. Intravenous paracetamol is highly effective in pain treatment after tonsillectomy in adults. Eur Arch Otorhinolaryngol. 2008;265:351-355. 5. Memis D, Inal MT, Kavalci G, Sezer A, Sut N. Intravenous paracetamol reduced the use of opioids, extubation time, and opioid-related adverse effects after major surgery in intensive care unit. J Crit Care. 2010;25:458-462.

*Patient-controlled analgesia.
†Subjects were asked to evaluate the study treatments, overall, using a 4-point categorical scale.

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Keeping Hydrated

by SCOTT & WHITE STAFF on JUNE 13, 2011in HEALTH AND WELLNESS 

Written By: Jenny Kidd, RD, LDThe Central Texas heat is well on its way so it’s that much more important to stay hydrated.  Water is crucial to physical health and makes up about 60% of body weight in adults and more in children. Body water balance is key for maintenance of body temperature, blood volume, and several metabolic processes. 

Most fluid recommendations suggest >3 liters per day for men and >2 liters per day for women. Other factors requiring additional fluid intake include:

  • Increased activity level
  • Increased sweat level
  • Living in a hot and humid environment
  • Living in high altitude
  • Pregnancy/Breastfeeding
  • Fever
  • Vomiting/diarrhea

While water is the most plain and obvious hydration source, other foods and beverages also contain significant amounts of water to contribute to overall hydration.  Many fruits and vegetables contain 70-90% water. Some of the best sources of water in food include:

  • Apples
  • Oranges
  • Grapes
  • Strawberries
  • Tomatoes
  • Watermelon (a summer favorite)
  • Potatoes
  • Corn
  • Broccoli
  • Spinach
  • Lettuce
  • Celery

Even many meats and cheeses contain more than 50% water. While water is typically the best choice, other beverages including skim milk and fruit juice are >90% water. Caffeinated beverages – tea, coffee, sodas and the like will also contribute to total fluid intake, but can contribute significantly to caloric intake. If you have a hard time drinking plain water, look for low calorie beverages to help you meet your fluid goals. Try water with lemon or lime juice, unsweetened tea or artificially sweetened drinks.

Without adequate fluid intake, there is risk of dehydration. The first sign of dehydration is thirst. But don’t wait until you’re thirsty to start drinking fluids. Thirst means your body isn’t keeping up with fluids adequately and needs replenishment. Other symptoms of dehydration include weakness, dizziness, dry mouth, decreased (and more concentrated) urine output, confusion and sometimes a feeling of a pounding heartbeat.

Some medical diagnoses should be cautious of drinking excess amounts of water. Talk to your physician or dietitian if you have questions about your fluid intake.

Northwest Anesthesia Seminars, Caribbean Cruise

February 2011.  A cruise is always a good place to combine meeting and vacation.  There were many good lectures.  The talk on the massive trauma protocol, blood replacement, (1:1:1  FFP, PRBC, 1 pk platelets) should be continued until blood loss is under control.  Overall, a good experience.

Submitted by HA in Texas

Hawaii Assn. of Nurse Anesthetists

I attended the HANA state meeting on Waikiki in Honolulu in February 2011.  The location was exceptional and the hospitality from the Hawaii CRNAs was warm and friendly.  One particular talk on the healing power of humor and Laughter, both for the provider and patient, will effect the way I relate to patients in the future.  Overall, it was a good meeting in a great place to vacation. The food was very good and I earned 17 CEUs.  I would give this meeting a 9 out of 10.

Submitted by YN in Texas

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