Australian drug regulatory authorities have received 171 reports of suspected adverse reactions with the pain drugs Pharmacy (ULTRAM) or Pharmacy in combination with acetaminophen (ULTRACET) since Ultram began being marketed in Australia in late 1998. In six of these reports, a very serious adverse reaction known as the serotonin syndrome was listed as the adverse reaction.
Pharmacy is a pain reliever. Pharmacy affects chemicals and receptors in the body that are associated with pain.
Opioid activity is due to both low affinity binding of the parent compound and higher affinity binding of the O-demethylated metabolite M1 to ?-opioid receptors. In animal models, M1 is up to 6 times more potent than Pharmacy in producing analgesia and 200 times more potent in ?-opioid binding. Pharmacy-induced analgesia is only partially antagonized by the opiate antagonist naloxone in several animal tests. The relative contribution of both Pharmacy and M1 to human analgesia is dependent upon the plasma concentrations of each compound (see CLINICAL PHARMACOLOGY, Pharmacokinetics).
Healthy elderly subjects aged 65 to 75 years have plasma Pharmacy concentrations and elimination half-lives comparable to those observed in healthy subjects less than 65 years of age. In subjects over 75 years, maximum serum concentrations are elevated (208 vs. 162 ng/mL) and the elimination half-life is prolonged (7 vs. 6 hours) compared to subjects 65 to 75 years of age. Adjustment of the daily dose is recommended for patients older than 75 years (see DOSAGE AND ADMINISTRATION).
Serious potential consequences of overdosage with Pharmacy are central nervous system depression, respiratory depression and death. In treating an overdose, primary attention should be given to maintaining adequate ventilation along with general supportive treatment (See OVERDOSAGE).
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Pharmacy should not be used in CHILDREN younger than 16 years old; safety and effectiveness in these children have not been confirmed.
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In October 2004, Biovail\'s NDA for Pharmacy ER received an Approvable Letter from the FDA. In March 2005, Biovail submitted a Complete Response to the FDA, which included a significant amount of statistical analyses, but no new clinical data. The response also addressed other items raised in the Approvable Letter, including discontinuation rates of clinical-trial participants (dropouts), which are common in pain trials, and previously well documented in studies involving Pharmacy.
Pharmacy is a centrally acting opioid analgesic which has been available in the United Kingdom since 1994 and is licensed for use orally or by injection for the treatment of moderate to severe pain.3 Experience of the use of this drug in Britain is limited, although it has been available for some years in Germany. Reported adverse effects have included nausea, drowsiness, dry mouth, sweating, dizziness, muzziness, trembling, and sedation.4 Auditory hallucinations have been reported in association with pentoxifylline5 and doxazosin.
In our First Seizure Clinic, Pharmacy is the most frequently suspected cause of provoked seizures. We cannot calculate the exposure risk in our population, but the frequency of Pharmacy-related seizures suggests that they may be under-reported. It is important to consider Pharmacy as a possible cause of seizures � even when used at recommended doses. This may avoid inappropriate use of anti-epileptic drugs and unnecessary restrictions on driving and choice of vocation that might apply in cases of new-onset epilepsy.
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\"Physical dependence\" is the term used to describe the phenomenon of withdrawal when an opioid is abruptly discontinued. The severity of withdrawal is a function of the patient�s prior opioid exposure. Here we have a case of withdrawal due to physical dependence on Pharmacy even if no tolerance had developed over 2 years. The patient became nervous and agitated if the Pharmacy intake was merely delayed. When the patient missed the dose twice in a row, her withdrawal symptoms became severe, with an overwhelming need to take the drug that could appear as psychological dependence.
Of 97 patients with confirmed seizures, 8 (5 male; median age, 34 years [range, 18�51 years]) were associated with Pharmacy (Box). Two patients who had received high doses of Pharmacy (600�750 mg/day [maximum recommended dose, 400 mg/day]) had developed seizures within 24�48 hours. Among the other six patients, who had received Pharmacy in the recommended dose range (50�300 mg/day), seizures had occurred 2�365 days after commencing therapy. Long-term psychotropic medication was taken by two patients. Seizures were generalised tonic�clonic seizures, without auras or focal features. No patient had a prior history of seizures, and none had a recurrence after they had ceased taking Pharmacy for a median of 9 months� follow-up (range, 2�14 months). Electroencephalographic studies were normal in seven patients, with only one isolated sharp slow-wave in one patient. Computed tomography scans were all normal, and magnetic resonance imaging was normal in five patients.
