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PubMed2000

Combination hydrocodone and ibuprofen versus combination codeine and acetaminophen for the treatment of chronic pain.

OBJECTIVE: The objective of this study was to compare the effectiveness of combination hydrocodone 7.5 mg and ibuprofen 200 mg with that of combination codeine 30 mg and acetaminophen 300 mg for the treatment of chronic pain. BACKGROUND: Hydrocodone 7.5 mg with ibuprofen 200 mg is the only approved fixed-dose combination analgesic containing an opioid and ibuprofen. METHODS: In this randomized, parallel-group, double-blind, repeated-dose, active-comparator, 4-week, multicenter study, 469 patients were randomly assigned to receive a 1-tablet (n = 156) or 2-tablet (n = 153) dose of combination hydrocodone 7.5 mg and ibuprofen 200 mg (HI1 and HI2, respectively) or a 2-tablet dose of combination codeine 30 mg and acetaminophen 300 mg (CA, n = 160), the active comparator, every 6 to 8 hours as needed for pain. Efficacy was measured through pain relief scores, number of daily doses of study medication, number of daily doses of supplemental analgesics, number of patients who discontinued therapy due to an unsatisfactory analgesic response, and global assessment scores. RESULTS: Of the 469 patients, 255 (54.4%) were female and 214 (45.6%) were male. The mean age was 51.1 years. Types of chronic pain included back (214; 45.6%), arthritic (145; 30.9%), other musculoskeletal (65; 13.9%), cancer (6; 1.3%), diabetic neuropathic (3; 0.6%), postherpetic neuralgic (5; 1.1%), other neurologic (21; 4.5%), and other unclassified chronic pain (10; 2.1%). During the 48 hours prior to the study, 351 (74.8%) patients had been treated with opioid or opioid-nonopioid combination analgesics. The overall mean daily pain relief score was significantly greater in the HI2 group (2.25+/-0.89) than in the HI1 group (1.98+/-0.87) (P = 0.003) or the CA group (1.85+/-0.96) (P < 0.001). The overall mean number of daily doses of study medication was significantly less in the HI2 group (2.94+/-0.99) than in the HI1 group (3.23+/-0.76) (P = 0.036) or the CA group (3.26+/-0.75) (P = 0.014). The overall mean number of daily doses of supplemental analgesics was significantly less in the HI2 group (0.24+/-0.49) than in the HI1 group (0.34+/-0.58) (P = 0.021) or CA group (0.49+/-0.85) (P = 0.010). The number of patients who discontinued treatment due to an unsatisfactory analgesic response was significantly less in the HI2 group (2; 1.3%) than in the CA group (12; 7.5%) (P = 0.008). HI2 was more effective than HI1 and CA as measured by pain relief scores for week 1 (P < 0.001 vs HI1 and CA), week 2 (P < 0.001 vs HI1 and CA), and week 3 (P = 0.008 vs HI1 and P < 0.001 vs CA); daily doses of study medication for week 1 (P = 0.019 vs HI1 and P = 0.011 vs CA); daily doses of supplemental analgesics for week 1 (P = 0.010 vs HI1 and CA); and global assessment scores for week 1 (P = 0.018 vs HI1 and P < 0.001 vs CA), week 2 (P = 0.005 vs HI1 and P < 0.001 vs CA), and week 4 (P = 0.013 vs HI1 and P = 0.023 vs CA). There were no significant differences between HI1 and CA in any efficacy variable. There were no significant differences in the number of patients experiencing adverse events in the HI2 (127; 83%), HI1 (124; 79.5%), and CA (129; 80.6%) groups. However, the mean number of patients who discontinued treatment due to adverse events was significantly greater in the HI2 group (40; 26.1%) than in the HI1 group (23; 14.7%) (P = 0.013). CONCLUSIONS: The results of this study suggest that 2-tablet doses of combination hydrocodone 7.5 mg and ibuprofen 200 mg may be more effective than either 1-tablet doses of this combination or 2-tablet doses of combination codeine 30 mg and acetaminophen 300 mg. Moreover, 1-tablet doses of combination hydrocodone 7.5 mg and ibuprofen 200 mg may be as effective as 2-tablet doses of combination codeine 30 mg and acetaminophen 300 mg.

Acetaminophen↗
PubMed2000

Dose-response effect of combination hydrocodone with ibuprofen in patients with moderate to severe postoperative pain.

OBJECTIVE: The objective of this study was to demonstrate a dose-response effect with 1- and 2-tablet doses of combination hydrocodone 7.5 mg with ibuprofen 200 mg and placebo in patients with moderate to severe postoperative abdominal or gynecologic pain. BACKGROUND: Hydrocodone 7.5 mg with ibuprofen 200 mg is the only approved fixed-dose combination analgesic containing an opioid and ibuprofen. Previous studies with this combination have demonstrated that the components have an additive analgesic effect as well as efficacy compared with other fixed-dose combination analgesics. METHODS: This randomized, parallel-group, double-blind, single-dose, placebo-controlled study compared 1 tablet of hydrocodone 7.5 mg with ibuprofen 200 mg (n = 60), 2 tablets of hydrocodone 7.5 mg with ibuprofen 200 mg (n = 60), and placebo (n = 60) in patients with moderate or severe pain after abdominal or gynecologic surgery. Analgesia was evaluated over 8 hours. RESULTS: Mean pain relief (PR) scores were significantly greater for the 2-tablet dose than for the 1-tablet dose at 80 (P = 0.027) and 100 (P = 0.017) minutes and at 2 (P = 0.013), 2.5 (P = 0.012), 3 (P = 0.006), 4 (P = 0.029), 5 (P = 0.002), 6 (P = 0.032), 7 (P = 0.036), and 8 (P = 0.01) hours. Mean pain intensity difference scores were significantly greater for the 2-tablet dose than for the 1-tablet dose at 80 (P = 0.013) and 100 (P = 0.007) minutes and at 2 (P = 0.003), 2.5 (P = 0.002), 3 (P = 0.002), 4 (P = 0.009), 5 (P < 0.001), 6 (P = 0.004), 7 (P = 0.009), and 8 (P = 0.001) hours. Mean total PR scores were significantly greater for the 2-tablet dose than for the 1-tablet dose for all measured time intervals (0 to 3 hours, P = 0.01; 0 to 4 hours, P = 0.006; 0 to 6 hours, P = 0.003; 0 to 8 hours, P = 0.003). Mean sum of pain intensity differences was significantly greater for the 2-tablet dose than for the 1-tablet dose for all measured time intervals (0 to 3 hours, P = 0.004; 0 to 4 hours, P < 0.001; 0 to 6 hours, P < 0.001; 0 to 8 hours, P < 0.001). Mean peak PR score and median time-to-remedication were significantly greater for the 2-tablet dose than for the 1-tablet dose (P < 0.029 and P = 0.017, respectively). Both doses were superior to placebo. There were no significant differences in the number of patients experiencing adverse events between the 2-tablet dose (n = 6 [10.0%]), the 1-tablet dose (n = 4 [6.7%]), and placebo (n = 1 11.7%]). Adverse events were not serious, and none of the patients discontinued therapy because of side effects. CONCLUSIONS: This study demonstrated that a 2-tablet dose of hydrocodone with ibuprofen provided significantly more analgesia than a 1-tablet dose (a positive dose-response effect) and that both doses were superior to placebo.

Dose-Response Relationship, Drug↗
PubMed1991

Hydrocodone versus codeine in acute musculoskeletal pain.

STUDY OBJECTIVES: To evaluate the efficacy and prevalence of side effects of hydrocodone versus codeine in acute pain syndromes. TYPE OF PARTICIPANTS/SETTING: Sixty-two consecutive adult emergency department patients 18 to 70 years old with acute musculoskeletal pain. Patients using other analgesics or having any contraindication to opioid therapy were excluded. In addition, 12 patients were excluded because of insufficient data or study dropout. DESIGN/INTERVENTIONS: In a randomized, double-blind prospective manner, patients received either 5 mg hydrocodone with 500 mg acetaminophen or 30 mg codeine with 500 mg acetaminophen to take on discharge from the ED and every four hours thereafter as needed for pain. MEASUREMENTS: Pain intensity was evaluated by a visual analog scale at zero, one, two, four, eight, 24, and 48 hours. Specific side effects were sought, along with the number of patients reporting inadequate analgesia. MAIN RESULTS: Data were obtained on 50 subjects (25 per group). Mean and median pain scores did not differ significantly at time zero (x vs y, 6.03 vs 5.99 and 6.8 vs 6.1, respectively) or subsequent intervals. Side effects were noted in eight hydrocodone/acetaminophen and 18 codeine/acetaminophen patients (P = .005). No significant differences in gastrointestinal side effects were reported; however, less nausea or vomiting was reported in the hydrocodone group (P = .23). Central nervous system side effects (sedation or lightheadedness) were reported in six hydrocodone/acetaminophen patients compared with 16 codeine/acetaminophen patients (P less than .005). In addition, no hydrocodone/acetaminophen patients reported inadequate analgesia compared with six codeine/acetaminophen patients (P less than .05). CONCLUSION: Although pain scores were not significantly different, hydrocodone may be a more effective analgesic than codeine in acute musculoskeletal pain, as demonstrated by significantly fewer treatment failures. Central nervous system side effects are less common with hydrocodone than with codeine.

Acetaminophen↗
PubMed1997

A comparison of oral ketorolac and hydrocodone-acetaminophen for analgesia after ambulatory surgery: arthroscopy versus laparoscopic tubal ligation.

This multicenter study compared the analgesic efficacy and side effects of ketorolac and hydrocodone-acetaminophen when administered orally after ambulatory arthroscopic or laparoscopic tubal ligation procedures. After awakening from general anesthesia, 252 patients experiencing moderate or severe postoperative pain were randomly assigned to receive one of three analgesic treatments according to a placebo-controlled, double-blind protocol. Group 1 (n = 83) received oral ketorolac 10 mg every 6 h for up to 3 days, Group 2 (n = 82) received hydrocodone 7.5 mg plus acetaminophen 750 mg every 6 h for up to 3 days, and Group 3 (n = 87) received placebo capsules followed by ketorolac 10 mg every 6 h for up to 3 days. Severity of pain was recorded using a 4-point categorical score and visual analog scale (VAS) at 0.5 h and subsequently at hourly intervals for 6 h, as well as daily for up to 3 days. Pain relief was recorded using a 5-point categorical scale at the same time points. In the patients undergoing arthroscopic surgery, both ketorolac and hydromorphone-acetaminophen provided superior pain relief compared with the placebo. Although the categorical summed pain intensity difference (SPID), VAS SPID, and total pain relief scores were higher in the ketorolac group compared with the hydrocodone-acetaminophen group, the differences were not statistically significant. In the patients undergoing laparoscopic tubal ligation surgery, the three treatment groups displayed similar responses to the study medications. However, the ketorolac group scored higher in terms of overall tolerability than the hydrocodone-acetaminophen group. In conclusion, there was no difference in the efficacy between oral ketorolac and hydrocodone-acetaminophen combination in controlling pain after outpatient arthroscopic surgery procedures. Neither oral analgesic proved to be very effective after laparoscopic tubal ligation.

Acetaminophen↗
PubMed2004

Cough suppression during flexible bronchoscopy using combined sedation with midazolam and hydrocodone: a randomised, double blind, placebo controlled trial.

BACKGROUND: Current British Thoracic Society guidelines do not recommend routinely the combined use of a benzodiazepine and opiate during flexible bronchoscopy (FB). A randomised, placebo controlled, double blind study was undertaken to determine whether hydrocodone in combination with midazolan improves cough suppression during FB without increasing the risk of desaturation. METHODS: 120 patients were randomised to receive midazolam and 5 mg i.v. hydrocodone or midazolam and placebo with topical anaesthesia. Pulse oximetry was recorded continuously during FB. Bronchoscopists and nurses charted their perception of cough and the patients rated their discomfort during the procedure on a 10 cm visual analogue scale (VAS). RESULTS: There was no significant difference between the two groups with regard to the indication for FB, duration of procedure (21 (11) min v 22 (10) min, p = 0.570), doses of supplemental lignocaine (171 (60) mg v 173 (66) mg, p = 0.766) and midazolam (4.5 (2.3) mg v 4.9 (2.7) mg, p = 0.309), lowest oxygen saturation (94.8 (2.7) v 94.9 (2.7), p = 0.433), and desaturations < or =90%. Perception of cough by both the bronchoscopist and the nurse was significantly lower in the hydrocodone group (3 (0-10) and 3 (0-10)) than in the placebo group (6 (0-10) and 6 (0-10)), respectively (p = 0.001). According to the VAS scale, patients' tolerance was also significantly better with hydrocodone than with placebo (2 (0-8) v 3 (0-9), p = 0.043). CONCLUSION: The combination of midazolam and hydrocodone markedly reduces cough during FB without causing significant desaturation, especially when invasive diagnostic procedures are performed.

Antitussive Agents↗
PubMed2005

Evaluation of abuse of prescription and illicit drugs in chronic pain patients receiving short-acting (hydrocodone) or long-acting (methadone) opioids.

BACKGROUND: Multiple studies have documented the incidence of illicit drug use and abuse of opioids. Over the years, several hypotheses have been proposed. Short-acting opioids such as hydrocodone are generally considered to predispose patients to poor pain management, dependency, misuse, or abuse; whereas long-acting opioids such as methadone are thought to provide sustained pain management without dependency or abuse. OBJECTIVES: To evaluate and identify the prevalence of illicit drug use and prescription drug abuse or misuse in patients receiving hydrocodone or methadone. STUDY DESIGN: A prospective, comparative evaluation. METHODS: A total of 200 patients from an interventional pain management setting, divided into two groups of 100 consecutive patients receiving either hydrocodone (Group I) or methadone (Group II) were evaluated with urine testing for illicit drug use, and/or misuse or abuse of opioids. Drug testing was carried out by Rapid Drug Screen(R). RESULTS: Results of this study showed that 22% (95% CI, 13% - 30%) of Group I patients receiving hydrocodone used illicit drugs as compared with 24% (95% CI, 15% - 32%) of those in Group II who were receiving methadone. The misuse or abuse of a prescription opioid was seen in 3% (95% CI, 0% - 6%) of the patients in Group I and 12% (95% CI, 5% - 18%) in Group II. In a significant proportion of patients in both groups, the drug prescribed for them was not detected on testing. The combined use of illicit drugs and misuse of prescription drugs was noted in 24% (95% CI, 15% - 32%) in Group I and 33% (95% CI, 23% - 42%) in Group II. CONCLUSIONS: There were no significant differences as to illicit drug use and/or misuse of opioids in patients treated with hydrocodone or methadone. These findings suggest that the use of a long acting opioid formulation by patients with chronic pain does not reduce the risk of drug abuse or improve compliance with medical therapy.

Journal Article↗
PubMed1982

Simultaneous assay of hydrocodone bitartrate and acetaminophen in a tablet formulation.

A reversed-phase pressurized liquid chromatographic procedure is presented for the simultaneous quantitation of hydrocodone bitartrate and acetaminophen in a tablet formulation. The separation method was based on an octadecylsilane column with a buffered (pH 4.5) methanol-water mobile phase. Measurement was with a UV spectrophotometer set at 283 nm, compared to external standards. Assays for the active ingredients in tablet samples averaged 99.7% of the label claim for hydrocodone bitartrate and 100.3% for acetaminophen. The respective relative standard deviations of the retention time and precision were 2.2 and 1.75% for hydrocodone and 3.3 and 0.95% for acetaminophen. The range of interest studied was 0.035 to 0.065 mg/ml for hydrocodone bitartrate and 3.50 to 6.50 mg/ml for acetaminophen. The assay method was also compared to colorimetric and USP procedures for the active ingredients. The method was suitable for control, content uniformity, and stability-indicating use.

Acetaminophen↗
PubMed1983

Capillary GLC assay for carbinoxamine and hydrocodone in human serum using nitrogen-sensitive detection.

Capillary gas chromatography using an open tubular fused silica column and NP-FID was applied to the simultaneous analysis of the antihistamine, carbinoxamine, and the antitussive, hydrocodone, in human serum. Carbinoxamine and hydrocodone were extracted into methylene chloride-2-propanol (9:1) under alkaline conditions along with their respective internal standards, brompheniramine and N-ethylhydrocodone. The basic drugs were back-extracted into 0.1 N sulfuric acid and reextracted into benzene after making the aqueous phase alkaline with potassium hydroxide. The benzene extracts were evaporated to dryness and the residues were reconstituted with 40 microliter of n-nonyl alcohol-methanol (19:1). Samples (1-2 microliter) were injected onto the capillary column in the splitless mode (solvent effect) at 185 degrees and the temperature programmed to 250 degrees. Calibration curves using spiked serum standards were linear to at least 20 ng/ml for both drugs. Coefficients of variation averaged +/- 6.1% for carbinoxamine and +/- 5.0% for hydrocodone in the 2-15 ng/ml range. Sensitivity was estimated to be approximately 0.2 ng/ml for a 2-ml serum sample. Serum levels of carbinoxamine and hydrocodone were determined in a human volunteer administered these drugs.

Administration, Oral↗
PubMed1977

Gas chromatographic determination of hydrocodone in serum.

A procedure for the determination of hydrocodone (dihydrocodeinone) in serum has been developed. Hydrocodone and N-isobutyldihydronorcodeinone, the internal standard, are extracted from serum by chloroform-isopropyl alcohol (9:1, v/v). The extracts are purified by back-extraction into 0.1 N sulfuric acid and a final basic extraction into benzene. The pentafluorophenylhydrazone derivatives are formed and determined using electron capture gas chromatography. As little as 1 ng/ml of hydrocodone in serum can be determined. A closely related compound and potential metabolite, dihydronorcodeinone, does not interfere. Serum hydrocodone levels were determined in dogs after oral and intravenous doses of 0.5 mg/kg, and in humans after a 10-mg oral dose of the bitartrate. A mean peak serum drug concentration of 23.6 ng/ml and a terminal half-life of 3.8 h resulted from the human study. The terminal half-life in serum was 1.8 h after the intravenous dose in dogs.

Administration, Oral↗
PubMed1993

CYP2D6 phenotype determines the metabolic conversion of hydrocodone to hydromorphone.

The contribution of cytochrome P450 2D6 (CYP2D6) to the formation of hydrocodone's active metabolite, hydromorphone, was examined in vitro and in vivo. Human liver microsomes prepared from an individual homozygous for the D6-B mutation of the CYP2D6 gene catalyzed this reaction at a negligible rate. Urinary metabolic ratios of hydrocodone/hydromorphone were highly correlated with O-demethylation ratios for dextromethorphan, an established marker drug of CYP2D6 activity (rs = 0.85; n = 18). The kinetics of hydrocodone after a single oral dose and its partial metabolic clearance to hydromorphone were investigated in five extensive metabolizers of dextromethorphan, six poor metabolizers, and four extensive metabolizers after pretreatment with quinidine, a selective inhibitor of CYP2D6 activity. The mean values for partial metabolic clearance by O-demethylation in the three groups were 28.1 +/- 10.3, 3.4 +/- 2.4, and 5.0 +/- 3.6 ml/hr/kg, respectively. No statistically significant phenotypic differences in physiologic measures were observed. However, over the first hour after dosing, the extensive metabolizers reported more "good opiate effects" and fewer "bad opiate effects" than poor metabolizers and extensive metabolizers in whom CYP2D6 was inhibited by quinidine. These data establish the importance of CYP2D6 in the formation of hydromorphone from hydrocodone and suggest that the activity of this enzyme may limit the abuse liability of hydrocodone.

Cytochrome P-450 CYP2D6↗
PubMedDate not supplied

Disposition of hydrocodone in hair.

The use of prescription drugs, including synthetic opiates, is increasing in the U.S., with emergency room reports showing a dramatic rise in prescription opiate abuse. As part of an ongoing study, the hair of admitted opiate users was analyzed for hydrocodone and hydromorphone, as well as codeine, morphine, and 6-acetylmorphine in order to determine if there was any correlation between self-reported frequency of opiate intake and the concentration of drug detected in hair. The hairs were confirmed using gas chromatography-mass spectrometry following screening by enzyme linked immunosorbent assay (ELISA). Twenty-four hair specimens collected from volunteers showed the presence of hydrocodone (130-15,933 pg/mg); four of those also contained hydromorphone (59-504 pg/mg). The specimens were also analyzed for morphine, codeine, and 6-acetylmorphine. Hair specimens from five self-reported codeine users showed concentrations of hydrocodone between 592 and 15,933 pg/mg. In addition, codeine was present at concentrations of 575-20,543 pg/mg, but neither morphine nor hydromorphone were present in any of those hair specimens. Though the analysis of some opiates in hair has been previously published, this is the first study where the hydrocodone and hydromorphone concentrations have been measured following self-reported opiate intake.

Codeine↗
PubMedDate not supplied

Comparative metabolism of hydrocodone in man, rat, guinea pig, rabbit, and dog.

The metabolism of hydrocodone was studied in man, rat, guinea pig, rabbit, and dog. Routes of metabolism included O-demethylation, N-dealkylation, and 6-keto-reduction to the corresponding 6-alpha- and 6-beta-hydroxy metabolites, where each metabolic pathway produces an active metabolite. Mean total recovery of drug and metabolites as percentage of administered dose ranged from a low of 10.6% for the rabbit to a high of 46.8% for the guinea pig; man was intermediate at 25.7%. For man, approximately 70% of the total drug recovered was excreted in the first 24 hr, and the remainder by 72 hr. Considerable species differences were observed in the patterns of metabolism of hydrocodone. Also, stereoselectivity of 6-keto reduction to the beta-form was observed for all species in the reduction of hydrocodone and hydromorphone with the exception of the reduction of hydrocodone by man.

Adult↗
PubMed1980

Methodological considerations in the evaluation of analgesic combinations: acetaminophen (paracetamol) and hydrocodone in postpartum pain.

1 In a double-blind study, 108 postpartum patients received single oral doses of either placebo, acetaminophen (paracetamol) 1000 mg, hydrocodone 10 mg, the combination of acetaminophen plus hydrocodone, or codeine 60 mg. 2 In the 2X2 factorial analysis, both the acetaminophen and hydrocodone effects were statistically significant, whereas the interaction contrast was not. This indicates that the analgesic effect of the combination represents the additive effect of its constituents and is consistent with the assumption that these constituents are producing analgesia by different mechanisms. 3 Although significantly superior to placebo, codeine seemed to be inferior to the other treatments. 4 Compared with placebo, both codeine and hydrocodone (centrally acting narcotics) seemed relatively more effective in uterine cramp than episiotomy pain; the reverse seemed true with acetaminophen (a peripherally acting analgesic). 5 Some methodological implications for the evaluation of analgesic combinations are discussed.

Acetaminophen↗
PubMed2002

Characterizing the subjective, psychomotor, and physiological effects of a hydrocodone combination product (Hycodan) in non-drug-abusing volunteers.

RATIONALE: The subjective, psychomotor, and physiological effects of prescription compounds containing the opioid hydrocodone have not been studied in a population of non-drug-abusing people who might be prescribed these compounds for cough or pain relief. OBJECTIVES: To characterize the effects of a hydrocodone combination product, Hycodan, which contains hydrocodone and a peripherally-acting anticholinergic, homatropine, in non-drug-abusing volunteers. METHODS: Eighteen volunteers participated in a crossover, double-blind study in which they received placebo; 5 mg hydrocodone/1.5 mg homatropine, 10 mg hydrocodone/3 mg homatropine, 20 mg hydrocodone/6 mg homatropine (all PO); 40 mg morphine (PO); and 2 mg lorazepam (PO). Measures were assessed before and for 300 min after drug administration. End-of-session and 24-h measures were taken to assess residual drug effects and overall subjects' assessment of the drug effects. RESULTS. Subjective effects of the hydrocodone/homatropine combination were dose-related, although the majority of statistically significant effects were limited to the highest dose combination tested. A combination of 20 mg hydrocodone/6 mg homatropine and morphine had a similar profile of subjective effects, which included both pleasant and unpleasant effects. Peak liking ratings were increased by 20 mg hydrocodone/6 mg homatropine and morphine, and trough ratings of liking (dislike) were lower in the 20 mg hydrocodone/6 mg homatropine condition, relative to the placebo condition. Post-session ratings of overall liking were not significant, either at the end of the session or 24 h later. Cognitive and psychomotor impairment were more marked with lorazepam than with hydrocodone/homatropine and morphine. Miosis and exophoria were increased in a dose-related manner by hydrocodone/homatropine. CONCLUSIONS: Hycodan at the highest dose tested had effects similar to that of a prototypic mu agonist, morphine. Both drugs produced pleasant (including drug liking) as well as unpleasant subjective effects. Post-session ratings of overall liking and "want to take drug again" were not significant.

Adult↗
PubMed1999

Analgesic efficacy of a combination of hydrocodone with ibuprofen in postoperative pain.

Two randomized, double-blind, parallel-group single-dose 2 x 2 factorial analgesic studies compared a single-dose or a 2-tablet dose of a combination of 7.5 mg hydrocodone bitartrate with 200 mg ibuprofen with each constituent alone and with a placebo in women with moderate or severe postoperative pain from abdominal or gynecologic surgery. A nurse-observer recorded patient reports of pain intensity and pain relief periodically for 8 hours. In both studies, the combination was significantly superior to placebo for sum of the pain intensity differences (SPID), total pain relief (TOTPAR), peak pain intensity difference (PID) and pain relief, global evaluation, and time to remedication. The combination was likewise significantly superior to both hydrocodone and ibuprofen for most of these summary measures of analgesia. In a factorial analysis, both the hydrocodone and ibuprofen effects were significant for most summary measures of analgesia, whereas results of the interaction contrast were consistent with the concept that the analgesic effect of the combination represents the additive analgesia of its 2 constituents.

Adult↗
PubMed1997

[Studies on the analysis of hydrocodone and its metabolite in human urine by GC/MS].

The method for the analysis of hydrocodone and its metabolite in urine by GC/MSD is reported. The urine was hydrolysed with HCl and extracted with diethyl ether/isopropanol. The gas chromatography/mass spectrometric properties of trimethylsilyl ether of hydrocodone, first reacted with methoxyamine to protect the carbonyl group, were studied. This method is sensitive and rapid for the determination of hydrocodone, codeine and dihydrocodeine.

Analgesics, Opioid↗
PubMed1982

Hydromorphone detected in bile following hydrocodone ingestion.

Two similar cases are reported here in which Tussionex, a preparation containing hydrocodone and phenyltoloxamine, caused or contributed to death. Toxicological analyses revealed a high concentration ratio of hydromorphone to hydrocodone in the bile in both cases. It is postulated that the finding of hydromorphone is due to the metabolism of hydrocodone.

Adult↗
PubMed1997

Simultaneous identification and quantitation of codeine, morphine, hydrocodone, and hydromorphone in urine as trimethylsilyl and oxime derivatives by gas chromatography-mass spectrometry.

Following enzymatic hydrolysis of urine, a gas chromatography-mass spectrometry method for the simultaneous determination of codeine, morphine, hydrocodone, and hydromorphone uses hydroxylamine to form oxime derivatives of the keto-opiates (i.e., hydrocodone, hydromorphone, oxycodone, and oxymorphone). These trimethylsilyl-derivatized forms no longer interfere with the detection and quantitation of codeine and morphine. Samples are extracted on solid-phase columns and quantitated by deuterated internal calibrations of each analyte with selected ion monitoring. Codeine, morphine, hydrocodone, and hydromorphone are completely separated, allowing simultaneous quantitation without interference and a chromatographic analysis time < 9 min.

Codeine↗