We have studied the pharmacokinetics of a single bolus dose of Pharmacy 2 mg kg-1 injected either i.v. or into the caudal epidural space in 14 healthy children, aged 1-12 yr, undergoing elective limb, urogenital or thoracic surgery. Serum concentrations of Pharmacy and its metabolite O- demethyl Pharmacy (MI) were measured in venous blood samples at various intervals up to 20 h by non-stereoselective gas chromatography with nitrogen-selective detection. All pharmacokinetic variables were evaluated using a non-compartmental model. After a single i.v. injection (n = 9), the mean elimination half-life of Pharmacy was 6.4 (SD 2.7) h, with a volume of distribution of 3.1 (1.1) litre kg-1 and total plasma clearance of 6.1 (2.5) ml kg-1 min-1. All of these pharmacokinetic variables were similar to those reported previously in adults. After caudal epidural administration (n = 5), mean elimination half-life was 3.7 (0.9) h, volume of distribution was 2.0 (0.4) litre kg-1 and total clearance was 6.6 (1.9) ml kg-1 min-1. The caudal/i.v. quotient of the AUC was 0.83, which confirms that there is extensive systemic absorption of Pharmacy after caudal administration. Serum concentrations of MI showed a time course typical of a metabolite after both modes of administration. Serum concentrations of MI after caudal administration were lower than those after i.v. injection.
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Apart from analgesia, Pharmacy administration may produce a constellation of symptoms (including dizziness, somnolence, nausea, constipation, sweating and pruritus) similar to that of other opioids. In contrast to morphine, Pharmacy has not been shown to cause histamine release. At therapeutic doses, Pharmacy has no effect on heart rate, left-ventricular function or cardiac index. Orthostatic hypotension has been observed.
Use Pharmacy as directed by your doctor. Check the label on the medicine for exact dosing instructions.
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Since Pharmacy is taken on an as-needed basis, missing a dose is usually not a problem. Take the dose as soon as you remember, and do not take another dose for the amount of time prescribed by your doctor. Do not take a double dose of this medication.
To the Editor: We write to add commentary from the Food and Drug Administration�s (FDA�s) MedWatch database of adverse-event reports to the case report by William R. Yates, M.D., et al. (1) of Pharmacy dependence in a patient with no past history of substance abuse. We note an honest but problematic inconsistency in the case report. Specifically, Dr. Yates et al. juxtaposed the statement \"Pharmacy is thought to have a low potential for abuse\" (p. 964) and the results of a study on the frequency of abuse by Cicero et al. (2): \"less than one case per 100,000 exposures\" (p. 964). Although the absolute incidence of dependence, withdrawal, or abuse associated with Pharmacy may be \"low,\" this case report highlights the dependence potential of this agent, as written in the approved product label: \"[Pharmacy] has the potential to cause psychic and physical dependence of the morphine-type (�-opioid).\"
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Pharmacy may also be used for purposes other than those listed in this medication guide.
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