Combunox For acute, moderate to severe pain
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Efficacy
Safety and Tolerability
Dosing
Patient Education Material
Safety and Tolerability Profile
In a single-dose, postoperative dental pain study
Incidence of Adverse Events
Nausea occurred in only 6.5% of patients receiving COMBUNOX
Vomiting was reported in just 3.2% of patients treated with COMBUNOX
Incidence of Adverse Events
In single-dose studies
With COMBUNOX, nausea and vomiting occurred at approximately one half the rate reported in patients treated with oxycodone1
Constipation and dyspepsia occurred in fewer than 1% of patients receiving COMBUNOX1
In a multiple-dose study
The most frequently reported adverse events (≥2% of patients) with COMBUNOX were nausea (25.4%), dizziness (19.2%), somnolence (17.4%), headache (10.2%), constipation (4.5%), vomiting (4.5%), asthenia (3.3%), fever (3.0%), vasodilation (3.0%), diarrhea (2.1%), and dyspepsia (2.1%)†
† The multiple-dose study included only patients treated with COMBUNOX. Patients were treated for up to 7 days.
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References:
1. COMBUNOX® (Oxycodone HCl and Ibuprofen) Tablets Prescribing Information. Forest Pharmaceuticals, Inc., St Louis, Mo.
2. Singla N, Pong A, Newman K, for the MD-10 Study Group. Combination oxycodone 5 mg/ibuprofen 400 mg for the treatment of pain after abdominal or pelvic surgery in women: a randomized, double-blind, placebo- and active-controlled parallel-group study. Clin Ther. 2005;27:45–57.
3. Newman K, Zheng H. Combination of oxycodone HCl and ibuprofen, compared to ibuprofen or oxycodone HCl alone, is more rapid and effective in alleviating postoperative pain. Presented at: 22nd Annual Scientific Meeting of the American Pain Society; March 20–23, 2003; Chicago, Ill.
4. Data on file, Forest Laboratories, Inc.
5. Litkowski LJ, Christensen SE, Adamson DN, Van Dyke T, Han S-H, Newman K. Analgesic efficacy and tolerability of oxycodone 5 mg/ibuprofen 400 mg compared with those of oxycodone 5 mg/acetaminophen 325 mg and hydrocodone 7.5 mg/acetaminophen 500 mg in patients with moderate to severe postoperative pain: a randomized, double-blind, placebo-controlled, single-dose, parallel-group study in a dental pain model. Clin Ther. 2005;27:418–429.