Reprexain® (hydrocodone
bitartrate 5 mg and ibuprofen
200 mg tablets) is indicated for the short-term (generally
less than 10 days) management of acute pain.
Reprexain® is not indicated
for the treatment of such conditions as osteoarthritis or rheumatoid
arthritis.
Reprexain® – Dual
Analgesic Action Without Liver Toxicity Risk1
Reprexain® contains no acetaminophen
Acetaminophen is the most common drug associated with intentional
and accidental hepatoxicity2,3
Percentage of fatal acute liver failures caused by
acetaminophen increased by nearly 30% within a five-year
time period3
Hydrocodone and ibuprofen do not include
Constitutive Androstane Receptor (CAR), which has been
shown to regulate liver toxicity1
Reprexain® combines two analgesics and works in two
ways
Ibuprofen's central analgesic action reduces inflammation
and pain and demonstrates greater efficacy than acetaminophen4
Hydrocodone
blocks pain impulse generation and is about six times more
potent than codeine5
Has been shown to significantly reduce pain compared
to either ingredient alone or placebo7,8
Has a well-established
safety profile9
Provides physicians prescription-dosing convenience
for class three drugs
Effect of Hydrocodone / lbuprofen Combination*
Comparative pain-relief scores of hydrocodone/ibuprofen combination,
hydrocodone, ibuprofen, and placebo in a single-dose study
of patients with moderate to severe postoperative pain (N=240)7
Safety Information
Reprexain is indicated for the short-term (generally less
than 10 days) management of acute pain. It is not indicated
for the treatment of conditions such as osteoarthritis or
rheumatoid arthritis. Reprexain should not be given to patients
who have experienced asthma, urticaria, or allergic-type
reactions after taking aspirin or other nonsteroidal anti-inflammatory
drugs (NSAIDs). Serious gastrointestinal toxicity, such as
inflammation, bleeding, ulceration and perforation of the
stomach, small intestine, or large intestine, with or without
warning symptoms, can occur in patients taking NSAIDs. All
NSAIDs have been associated with an increase in cardiovascular
adverse events. The most commonly reported side effects with
Reprexain include headache, somnolence, constipation, nausea,
dizziness, and dyspepsia. Hydrocodone may impair mental and/or
physical abilities when ingested with alcohol and other CNS
depressants.
Zang, W. Huang, S. S. Chua, P. Wei, D. D. Moore, Modulation
of acetaminophen-induced hepatotoxicity by the xenobiotic
receptor CAR. Science 2002;298:422-424.
Larson AM, Polson J. Fontana RJ, et. al. Acetaminophen-Induced
Acute Liver Failure: Results of a United States Multicenter.
Prospective Study. Hepatology; December 2005.
Sachs CJ. Oral analgesics for acute nonspecific pain. Am
Fam Physician. 2005;715.
Sunshine, et al. Analgesic efficacy of a hydrocodone with
ibuprofen combination compared with ibuprofen alone for the
treatment of acute postoperative pain. J Clin Pharmacol.
37 (10): 908.
Wideman GL, Keffer M, Morris E, et al. Analgesic efficacy
of a combination of hydrocodone with ibuprofen in postoperative
pain. Clin Pharmacol Ther. 1999;65:66-76.
Betancourt JW. Efficacy of ibuprofen-hydrocodone for the
treatment of postoperative pain after periodontal surgery.
J Periodontology. 2004;75:872-876.