Assessment of the safety and efficacy of extended-release oxycodone/acetaminophen, for 14 days postsurgery

Singla, Neil; Barrett, Thomas; Sisk, Lisa; Kostenbader, Kenneth; Young, Jack

doi:10.1185/03007995.2014.957824

Cited by 9 publications

(5 citation statements)

References 24 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…In an open-label extension study of the above trial lasting at least 14 days, tolerability of XARTEMIS™ XR was consistent with that of an opioid product and AEs occurred in 43.8% of patients [ 42 ]. The most common AEs reported in this extension study were nausea (17.8%), vomiting (7.5%), and constipation (6.2%).…”

Section: Efficacy and Safety Of The Oxycodone/acetaminophen Fixed-dosmentioning

confidence: 85%

The Potential Role of an Extended-Release, Abuse-Deterrent Oxycodone/Acetaminophen Fixed-Dose Combination Product for the Treatment of Acute Pain

2015

View full text Add to dashboard Cite

Acute pain, prevalent as part of postoperative and traumatic pain, is often sub-optimally or inadequately treated. Fixed-dose combination analgesic products that combine a reduced amount of opioid with a nonopioid analgesic such as acetaminophen (paracetamol) in a single tablet offer potential pharmacodynamic and/or pharmacokinetic benefits, and may also result in an opioid-sparing effect. A new analgesic product (XARTEMIS™ XR, Mallinckrodt Brand Pharmaceuticals, Dublin, Ireland) combines oxycodone (7.5 mg) with acetaminophen (325 mg) in an immediate-release/extended-release (ER) formulation that is indicated for the treatment of acute pain. The ER formulation of this product provides stable serum drug concentrations that in this case lasts 12 h. Oxycodone/acetaminophen is a drug combination that offers safe and effective pain relief in a variety of acute pain syndromes such as postoperative pain. The combination formulation allows a smaller amount of oxycodone per tablet and the biphasic-layered matrix of the pill for ER may present obstacles to potential abusers. No opioid is totally abuse resistant, but the lower opioid content and tamper-resistant formulation of this product might discourage abuse. Clinicians must still be mindful of the acetaminophen part of this product in the patient’s overall daily intake (in light of acetaminophen hepatotoxicity). The new product appears to provide an important new choice in the armamentarium against acute pain.Electronic supplementary materialThe online version of this article (doi:10.1007/s12325-015-0213-5) contains supplementary material, which is available to authorized users.

show abstract

Section: Efficacy and Safety Of The Oxycodone/acetaminophen Fixed-dosmentioning

confidence: 85%

The Potential Role of an Extended-Release, Abuse-Deterrent Oxycodone/Acetaminophen Fixed-Dose Combination Product for the Treatment of Acute Pain

2015

View full text Add to dashboard Cite

show abstract

“…Patients were administered these drugs every 12 hours over 14 days. Both products demonstrated good pain control with side effects consistent with opioid products, which occurred in 43.8% of patients [30].…”

Section: Oxycodone and Acetaminophenmentioning

confidence: 86%

Fixed Dose Versus Loose Dose: Analgesic Combinations

Pergolizzi¹,

Varrassi²,

LeQuang³

et al. 2023

Cureus

View full text Add to dashboard Cite

Combinations of drugs may be fixed (two or more entities in a single product) or loose (two or more agents taken together but as individual agents) to help address multimechanistic pain. The use of opioids plus nonopioids can result in lower opioid consumption without sacrificing analgesic benefits. Drug combinations may offer additive or synergistic benefits. A variety of fixed-dose combination products are available on the market such as diclofenac plus thiocolchicoside, acetaminophen and caffeine, acetaminophen and opioid, ibuprofen and acetaminophen, tramadol and acetaminophen, and others. Fixeddose combination products offer predictable pharmacokinetics and pharmacodynamics, known adverse events, and can reduce the pill burden. However, they are limited to certain drug combinations and doses; loose dosing allows prescribers the versatility to meet individual patient requirements as well as the ability to titrate as needed. Not all drug combinations offer synergistic benefits, which depend on the drugs and their doses. Certain drugs offer dual mechanisms of action in a single molecule, such as tapentadol, and these may further be used in combination with other analgesics. New technology allows for co-crystal productions of analgesic agents which may further improve drug characteristics, such as bioavailability. Combination analgesics are important additions to the analgesic armamentarium and may offer important benefits at lower doses than monotherapy.

show abstract

“…The use of a combination of analgesics (NSAIDs, glucocorticoids, and opioids) could have many advantages, such as the induction of analgesia by different mechanisms of action, improved rapid recovery after surgery, less general toxicity, and adverse effects because the combination of drugs allows reducing the doses, particularly how much synergistic analgesic effects can be obtained using a combination of two or more drugs [ 24 , 25 , 26 , 27 , 28 , 29 , 30 ]. It is important to mention that evidence can also be found in clinical trials on the use of other opioid analgesics alone, or in combination with other types of drugs, to treat postoperative pain after a bunionectomy, such as tramadol [ 31 , 32 ], oxycodone [ 7 , 33 , 34 , 35 ], and morphine [ 33 , 36 , 37 ].…”

Section: Discussionmentioning

confidence: 99%

Analgesic Efficacy and Safety of Tapentadol Immediate Release in Bunionectomy: A Meta-Analysis

Franco-de la Torre,

Gómez-Sánchez,

Aragon-Martinez

et al. 2023

Pharmaceuticals

View full text Add to dashboard Cite

The aim of this systematic review and meta-analysis was to evaluate the analgesic effect of different doses of tapentadol immediate release (IR) and its adverse effects after a bunionectomy. Pubmed, Cochrane, Lilacs, Medline, and Imbiomed were used to identify abstracts of scientific publications related to the keywords of this systematic review (PROSPERO ID CRD42023437295). Moreover, the risk of bias in all included articles was assessed using the Cochrane Collaboration risk of bias tool. Data on the sum of pain intensity, total pain relief, global assessment, and adverse effects were extracted. The statistical method of inverse variance with means difference was used to evaluate the numerical data and the Mantel–Haenszel and Odd Ratio test to analyze the dichotomous data. In addition, the number needed to treat, the number needed to harm, and the 95% confidence intervals were calculated. A qualitative evaluation (n = 2381) was carried out according to the conclusions of the authors. Tapentadol (n = 1772) was more effective in relieving postoperative pain than the placebo (n = 609) after a bunionectomy. In addition, the analgesic efficacy of IR tapentadol (n = 1323) versus the placebo (n = 390) was evaluated in a total of 1713 patients using a global evaluation of the treatments. All three doses of IR tapentadol showed better results compared to the placebo after a bunionectomy. Finally, the adverse effects have a direct relationship with the dose, and the greatest number of adverse effects are most observed with tapentadol IR 100 mg (n = 2381). It is concluded that tapentadol IR (100 mg) leads to the best satisfaction score in this meta-analysis.

show abstract

Assessment of the safety and efficacy of extended-release oxycodone/acetaminophen, for 14 days postsurgery

Abstract: These results show that ER OC/APAP demonstrated an expected safety and tolerability profile and good patient satisfaction in a postsurgical model of acute pain.

Cited by 9 publications

References 24 publications

The Potential Role of an Extended-Release, Abuse-Deterrent Oxycodone/Acetaminophen Fixed-Dose Combination Product for the Treatment of Acute Pain

The Potential Role of an Extended-Release, Abuse-Deterrent Oxycodone/Acetaminophen Fixed-Dose Combination Product for the Treatment of Acute Pain

Fixed Dose Versus Loose Dose: Analgesic Combinations

Analgesic Efficacy and Safety of Tapentadol Immediate Release in Bunionectomy: A Meta-Analysis

Contact Info

Product

Resources

About