Oxycodone and Acetaminophen (Oxycodone / Acetaminophen) - Summary

SUMMARY

OXYCODONE AND ACETAMINOPHEN CAPSULES USP

Each capsule, for oral administration, contains:

Oxycodone hydrochloride USP 5 mg (equivalent to 4.4815 mg of oxycodone)

Acetaminophen USP 500 mg

The oxycodone component is 14-hydroxydihydrocodeinone, an opiate analgesic.

Acetaminophen, 4’-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic.

Oxycodone and acetaminophen capsules are indicated for the relief of moderate to moderately severe pain.

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NEWS HIGHLIGHTS

Published Studies Related to Oxycodone and Acetaminophen (Oxycodone / Acetaminophen)

Within-subject comparison of the psychopharmacological profiles of oral hydrocodone and oxycodone combination products in non-drug-abusing volunteers. [2009.04.01]
BACKGROUND: Non-medical use and abuse of prescription opioids is a significant problem in the United States. Little attention has been paid to assessing the relative psychopharmacological profile (including abuse liability-related effects) of specific prescription opioids. The purpose of this study was to directly compare the psychopharmacological profile of two widely prescribed and abused oral opioid combination products within the same subject... CONCLUSIONS: Consistent with a recent study published in this journal using identical doses of HYD and OXY (without ACET) in prescription opioid abusers (Walsh, S.L., Nuzzo, P.A., Lofwall, M.R., Holtman Jr., J.R., 2008. The relative abuse liability of oral oxycodone, hydrocodone and hydromorphone assessed in prescription drug abusers. Drug Alcohol Depend. 198, 191-202), we found little difference in the pharmacodynamic effects of HYD/ACET and OXY/ACET in non-drug-abusing volunteers.

Effect of delayed activated charcoal on acetaminophen concentration after simulated overdose of oxycodone and acetaminophen. [2009.02]
OBJECTIVE: To determine the effect of activated charcoal (AC) on acetaminophen (APAP) absorption kinetics when administered at 1, 2, or 3 h after combined oral overdose with oxycodone... CONCLUSION: The effect of AC rapidly declines between 1 and 3 h after combined oral overdose of APAP and oxycodone. AC is unlikely to be beneficial at or beyond 2 h after an overdose of acetaminophen and oxycodone.

The effect of single-dose tramadol on oxycodone clearance. [2007.11]
We have noticed increased prescribing of tramadol by emergency physicians for breakthrough pain in patients chronically taking oxycodone. Both oxycodone and tramadol undergo oxidative metabolism by CYP2D6 and CYP3A4, suggesting the possibility that tramadol may compete with oxycodone for metabolism...

Postoperative intravenous morphine consumption, pain scores, and side effects with perioperative oral controlled-release oxycodone after lumbar discectomy. [2007.07]
BACKGROUND: Oral opioid formulations contribute to postoperative analgesia. In this study, we evaluated the perioperative application of oral controlled-release oxycodone to reduce postoperative IV morphine consumption and opioid side effects after lumbar discectomy... CONCLUSIONS: Perioperative oral controlled-release oxycodone reduces postoperative IV morphine consumption after lumbar discectomy while providing good analgesia with fewer side effects compared with placebo.

Efficacy and tolerability of once-daily OROS hydromorphone and twice-daily extended-release oxycodone in patients with chronic, moderate to severe osteoarthritis pain: results of a 6-week, randomized, open-label, noninferiority analysis. [2007.05]
OBJECTIVE: This study compared the efficacy and tolerability of a once-daily controlled-release formulation of hydromorphone (OROS) hydromorphone, Janssen-Cilag, Beerse, Belgium) and twice-daily extended-release (ER) oxycodone in patients with chronic, moderate to severe osteoarthritis (OA) pain. OROS hydromorphone is currently available only in Europe... CONCLUSIONS: Once-daily OROS hydromorphone and twice-daily ER oxycodone provided similar pain relief in these patients with OA of the knee or hip. The tolerability profiles of the 2 agents were similar.

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Clinical Trials Related to Oxycodone and Acetaminophen (Oxycodone / Acetaminophen)

Oxycodone-Naloxone in Relieving Opioid-Related Constipation [Active, not recruiting]
The primary objective of this study is to demonstrate that subjects with moderate to severe non-malignant pain taking oxycodone/naloxone prolonged release tablets have improvement in symptoms of constipation compared to subjects taking oxycodone prolonged release tablets alone.

Oxycodone-Naloxone Prolonged Release Tablets in Relieving Opioid-Related Constipation [Active, not recruiting]

OXY-1: The Pharmacogenetics of Oxycodone Analgesia in Postoperative Pain [Completed]
Patients undergoing surgery (thyroidectomy and hysterectomy) will postoperatively receive oxycodone intravenously (IV) as pain management with morphine as an escape medicine, if there is insufficient pain relief with oxycodone. Patients' pain and side effects will be registered and after 24 hours they will answer a questionnaire. All included patients will be genotyped accordingly to CYP2D6 and relevant single nucleotide polymorphisms (SNPs), and measures of plasma levels of oxycodone will be performed.

OXY-2: The Pharmacogenetics of Oxycodone Analgesia in Human Experimental Pain Models [Completed]
Thirty-two healthy volunteers will be submitted to experimental pain and on the 2 study days receive Oxycodone 20 mg po vs. placebo. Half of the volunteers will be poor metabolizers according to CYP2D6 genotype and half will be extensive metabolizers (EM) and have an enzyme with normal function. The study hypothesis is that PM will experience less pain relief than EM.

Safety/Efficacy Study of Oxycodone HCl/Niacin to Treat Pain After Bunionectomy [Completed]
The purpose of this study is to determine whether oxycodone HCl and niacin are effective in the treatment of pain following bunionectomy surgery.

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PATIENT REVIEWS / RATINGS / COMMENTS

Oxycodone and Acetaminophen review by 49 year old male patient
		Rating
Overall rating:
Effectiveness:		Moderately Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		NECK AND BACK PAIN
Dosage & duration:		5 / 325 TAB MCK - FOUR TIMES PER DAY. taken 4 tablets per day- every six hours for the period of FOR 2 & 1/2 MONTHS AND STILL TAKING IT.
Other conditions:		NONE
Other drugs taken:		NAPROXEN SODIUM
		Reported Results
Benefits:		IT WORKED FOR RELIEVING SOME OF MY NECK AND BACK PAIN. PLEASE NOTE, MY CAUSE OF PAIN WAS DUE TO SURGERY PAIN AND NOT YOUR NORMAL KIND OF BACK PAIN. I MUST SAY THAT IT JUST KIND OF TOOK THE EDGE OFF OF THE SEVERE PAIN I WAS FEELING. AS TIME WENT ON I BEGAN TO HEAL AND FEEL MUCH BETTER AND NOW IT TENDS TO WORK MUCH BETTER.
Side effects:		SOMETIMES TROUBLE BREATHING AND TROUBLE URINATING. ALSO, FELT DROWSY DURING THE DAY. THE BREATHING AND THE URINATING PROBLEMS STOPPED AFTER ABOUT A WEEK ON THIS MEDICATION. AS FOR THE DROWSY FEELING, I STILL EXPERIENCE THAT AND TRY NOT TO DRIVE WHILE ON THIS MEDICATION. I EXPERIENCE NO OTHER SIDE EFFECT EVEN THOUGH I AM STILL TAKING THE MEDICATION.
Comments:		DUE TO A SLIP AND FALL ACCIDENT, I NEEDED TO GET BACK SURGERY FOR MY CONDITION. THE TYPE OF SURGERY I HAD WAS CALLED ANTERIOR CERVICAL DISKECTOMY AND FUSION FOR CERVICAL DISC DISPLACEMENT. THE DOCTOR PRESCRIBED OXYCODONE ALONG WITH NAPROXEN. I RARELY TOOK THE NAPROXEN BUT TOOK THE OXYCODONE FOUR TIMES A DAY FOR TWO MONTHS. AT THIS TIME, I STILL TAKE THE MEDICATION ONLY WHEN I FEEL I NEED IT - APPROXIMATELY ONCE OR TWICE A DAY.