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Investigations in pharmaceutical stocks of drugs have shown a non conformity with registred theorical stocks. This leads us to study the volatilisation of codeine stored in safety boxes suggest adding the mention "slightly efflorescent" to the usual characteristics of codeine found in the monography of the French Pharmacopoea as mentionned by LEBEAU and JANOT.
Pruritus is a common symptom associated with chronic renal failure (CRF). But increased plasma histamine levels and skin mast cell proliferation previously reported in these patients did not correlate with the intensity of the pruritus. Since increased mast cell releasability was described in chronic idiopathic urticaria, we attempted to examine whether this mechanism could explain pruritus in patients with CRF. Twenty-five patients with end stage renal failure were skin tested with histamine, codeine, and compound 48/80. There were nine patients on continuous ambulatory peritoneal dialysis, eight patients on hemodialysis, (tested both before and after dialysis) and eight patients with advanced CRF. Wheal area after intradermal injection of three concentrations of the above substances was measured. In general, the wheal areas in all patients with CRF were either similar to or smaller than those of the control group who were without renal impairment. In conclusion, patients with CRF with or without dialysis therapy demonstrated unchanged or decreased skin test responses to histamine, codeine, and compound 48/80. Increased mast cell releasability cannot explain the pruritus in patients with CRF.
The alteration of endogenous opiate alkaloids during fasting state was investigated in rats. The concentrations of morphine and codeine in the cortex, midbrain, pons plus medulla, cerebellum, adrenal gland and pancreas were measured using radioimmunoassay for the opiates following high pressure liquid chromatography. The morphine and codeine contents of fasting rats showed maximum elevated levels in cortex, pons plus medulla and pancreas after 2 days of fasting, but after 1 day in midbrain. The opiate content of the cerebellum showed a tendency for a continuous increase during the 4 days. Adrenal glands of fasting rats had elevated levels at days 3 and 4, although there were great fluctuations within the groups.
IgE antibodies that reacted with morphine and codeine were detected in the serum of a subject who experienced a life-threatening anaphylactic reaction following the administration of Omnopon-Scopolamine (papaveretum-hyoscine). Hapten inhibition studies with morphine and a number of structurally-related analogues revealed that morphine and codeine were the most potent inhibitors of IgE binding to a morphine-solid phase. Nalorphine, meperidine, and methadone were also good inhibitors of IgE binding, but naltrexone, buprenorphine, and fentanyl proved to be poor inhibitors. From a detailed examination of structure-activity relationships, the authors conclude that the important structural features of the morphine allergenic (that is, IgE binding) determinant comprises the cyclohexenyl ring with a hydroxyl group at C-6 and, most important of all, a methyl substituent attached to the N atom. The authors' findings suggest that morphine analogues administered to such a patient may provoke clinical anaphylaxis. Hyoscine reacted weakly with IgE antibodies in the subject's serum, but this was thought to be due to weak cross-reaction between this compound and morphine.
The case histories are presented of 6 patients with accidental poisoning by Spasmoplus suppositories. The main toxic constituents are codeine and the pyrazolone derivative, propyphenazone. All patients had symptoms of codeine intoxication with somnolence, miosis and oedema, 2 patients had also symptoms of prophyphenazone intoxication with hypotension, coma and convulsions. 1 patient died during the acute stage in a state of shock, with arrhythmia, and asystole.
Effective pain relief and patient tolerance and acceptance are essential in outpatient management of mild to moderate pain of acute low back strain. This study evaluated the efficacy, tolerability, and acceptability of diflunisal and acetaminophen with codeine in patients with mild to moderate pain after an initial or recurrent acute low back strain. Both drugs demonstrated equipotent analgesic efficacy; however, diflunisal was superior to acetaminophen with codeine for patient tolerability and acceptability. The results demonstrated that the study drugs were effective in treating mild to moderate pain caused by acute low back strain in an ambulatory care setting.
The purpose of this paper was to evaluate the contribution of low dosages of codeine and caffeine when added to acetaminophen. Subjects were dental outpatients undergoing oral surgery involving bone removal. This was a single-dose, parallel group, double-blind assay evaluting 99 subjects. The treatment groups were acetaminophen 1000 mg, acetaminophen 1000 mg + codeine 16 mg + caffeine 30 mg and placebo. The results demonstrated that both active treatments were superior to placebo. Overall, the combination was slightly better than acetaminophen alone. The advantage of the combination appeared more evident in the "severe" baseline pain group.
Fifty college athletes with acute sprains and strains from football-related activities were randomly assigned to treatment with either diflunisal or acetaminophen with codeine for seven days. Additional treatment in both groups included rest, elevation, local application of cold or heat, splinting, and physical therapy, as indicated. Both treatment groups exhibited clinically significant improvements in pain, tenderness, and swelling. The results of this study show that diflunisal, a peripherally acting nonnarcotic nonsteroidal anti-inflammatory agent with analgesic properties, was as effective as acetaminophen with codeine in relieving mild to moderate pain due to musculo-skeletal sprains and strains. The long duration of action of diflunisal permits less frequent dosing, an important consideration when prescribing medication for active young adults.
An open, randomized clinical study was performed to evaluate the efficacy of diflunisal versus acetaminophen with codeine in patients who underwent outpatient arthroscopy of the knee. Twenty patients were randomly assigned to each treatment group. Nineteen patients in each group successfully completed the study, which consisted of both objective and subjective evaluations. The results showed equal efficacy between the two drugs. However, a larger percentage of patients viewed diflunisal as providing good to excellent results overall compared with acetaminophen with codeine.
Toxicological findings are described in 16 medical examiner cases directly related to the combination of codeine and glutethimide. The cases described represent a six-month period, July through December 1982, showing the epidemic rate of abuse of this drug combination, most prominent in the Newark, NJ area since the late 1970s. Concentrations of codeine and glutethimide, measured by gas liquid chromatography (GLC), in the blood averaged 0.62 and 4.07 mg/L, respectively. Similarly determined urine concentrations averaged 38.06 and 12.68 mg/L, respectively. Specific concentrations of each drug in most cases were in the high therapeutic range, suggesting a possible toxic synergistic effect.
In this report-the fourth of a series on codeine and its alternates for pain and cough relief-an attempt is made to evaluate, on the basis of experimental and clinical data, and wherever possible in comparison with codeine, the effectiveness of a number of antitussive substances currently in clinical use. In the discussion of the undesired side-effects particular attention is paid to the risk of dependence and abuse.
This report-the second of a series on codeine and its alternates for pain and cough relief-contains a detailed evaluation of experimental and clinical data on newer substances having analgesic properties comparable to and in approximately the same range as those of codeine. The data are discussed under the headings: analgesic effects in animals; clinical usefulness; side-effects with particular reference to dependence and abuse liability.
This chapter concludes the survey of experimental and clinical data on the analgesic and antitussive properties of codeine and its potential therapeutic alternates. From an evaluation of their effectiveness on the one hand and the side-effects, including tolerance, dependence and abuse liability on the other, it would appear that the therapeutic goals of codeine could be achieved by other substances, except perhaps where analgesia, cough relief, and sedation are required simultaneously. The use of these other substances would, however, result in no particular gain and probably no particular loss.
Orally administered chenodeoxycholic acid (300 mg/kg) produced diarrhea and accumulation of gastro-intestinal fluid in rats. The fluid in the stomach and small intestine remained accumulated even after the accumulated colonic fluid and the diarrheal excretion decreased. When instilled into an intestinal closed-loop, chenodeoxycholic acid caused a marked inhibition of fluid absorption in the colon and jejunum but less effect in the ileum. On the contrary, an intravenous administration of chenodeoxycholic acid caused neither diarrhea nor impairment of colonic absorption of fluid. Atropine and codeine (10 mg/kg s.c.) blocked or at least delayed the diarrhea produced by oral administration of chenodeoxycholic acid. The antidiarrheal activity of codeine was found to be more potent and longer-lasting than that of atropine. Both drugs delayed the passage of chenodeoxycholic acid containing gastric fluid into the duodenum, but neither of them prevented chenodeoxycholic acid-induced jejunal secretion of fluid and electrolytes. These results indicate that the diarrheal excretion by chenodeoxycholic acid was ascribable to the impairment of fluid absorption in the colonic mucosa and partly to the activation of gastro-intestinal propulsive motility.
The reactivity of skin mast cells was tested in 86 probands. Introduction of various concentrations of codeine phosphate, either by intradermal injection or by prick test, produced an immediate wheal and flare response. Since the codeine skin test depends on both release of and response to histamine, it may be more useful than the conventional skin test with histamine for assessment of skin reactivity, and also for preliminary evaluation of anti-allergic agents in man.
The analgesic efficacy of single 500 and 1,000 mg doses of diflunisal, a new nonsteroidal antiinflammatory analgesic, was compared in a double-blind study with acetaminophen 600 mg, the combination of acetaminophen 600 mg with codeine 60 mg, and placebo in 132 inpatients with postoperative pain. Using a self-rating record, patients rated their pain and its relief hourly for up to 12 hours after medication. Diflunisal 500 and 1,000 mg were significantly superior to placebo for every measure of total and peak analgesia, and a significant analgesic effect persisted for 8 hours. Acetaminophen alone and the acetaminophen-codeine combination were significantly superior to placebo for most measures of analgesia, and their effects were significant for 4 and 5 hours respectively. Differences among the active medications were not statistically significant for measures of total or peak analgesia.
In this multicenter study a nonnarcotic analgesic available for moderate pain, naproxen sodium, 550 mg, was compared to a combination that is used extensively for moderate to severe pain, aspirin, phenacetin, caffeine and codeine phosphate (APC/C) (60 mg of codeine phosphate). Women with pain after major gynecologic surgery reported a similar pattern in pain reduction with the two medications except for a relatively sharper increase in pain intensity between four and six hours after administration of APC/C. A smaller number of patient complaints suggested that naproxen sodium was better tolerated than APC/C.
A report is given about a multicentric double-blind test for proof of effectiveness of two new suppository preparations with and without codeine against comparable remedies. Dolo Visano Supp. sine codeino showed a slight superiority over the reference preparation. This was proved above all for the influence upon pain and muscular overstrain. The better tolerability was marked. Dolo Visano Supp. (with codeine) showed advantages against the reference preparation. It was used in cases of severe pain, and in 88% it had a very good effect, whereas for the reference preparation this applied only in 67,9%. The assessments of physician and patients were almost alike. The myotonolytic effect has been proved equally for both of the new suppository preparations.