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 used to relieve moderate to moderately severe pain.
RESULTS: Then mean pain intensity (� SD) on a verbal rating scale (0 = none, 4 = unbearable) was similar with morphine (1.6 � 1.2, n = 17) and with Pharmacy (1.5 � 1.3, n = 16) on the fourth day of dosing. The mean daily doses on day 4 were 101 � 58 mg of morphine and 375 � 135 mg of Pharmacy, indicating a relative potency of 4:1 with oral dosing. The total number of side-effects per person was lower on the fourth day with Pharmacy (p � 0.05), as was the severity of nausea (p � 0.05) and constipation decreased with Pharmacy (p � 0.05). Three patients dropped out of the morphine group due to side-effects and 4 out of the Pharmacy group due to inadequate analgesia. Overall, 8 patients (40%) preferred morphine, 3 (15%) favoured Pharmacy and 9 (45%) expressed no distinct choice. Nurses rated pain control better with morphine (p � 0.03), but the tolerability of Pharmacy was judged superior (p � 0.002).
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Most of these 912 reports included a history of drug/substance abuse. However, some reports specifically stated no such history, as in the case described by Dr. Yates et al. Additional reports described compelling clinical summaries that suggest, but do not state, that there was no past history of drug/substance abuse. (No percentages are presented because of the multiple possibilities afforded by differential report inclusion/exclusion criteria.)
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).\" Suhagra online No prescription
Avoid alcohol while taking Pharmacy. Alcohol may cause a dangerous decrease in breathing and/ or liver problems when used during treatment with Pharmacy. Use caution when engaging in driving, operating machinery, or performing other hazardous activities. Pharmacy may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Do not take sleeping pills, tranquilizers, sedatives, and antihistamines except under the supervision of your doctor. These drugs may increase drowsiness caused by Pharmacy.
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Do not take Pharmacy without first talking to your doctor if you have kidney disease; liver disease; or a history of alcohol or drug dependence. You may not be able to take Pharmacy, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above. Pharmacy is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Do not take this medicine without first talking to your doctor if you are pregnant. It is also not known whether Pharmacy appears in breast milk. Do not take Pharmacy without first talking to your doctor if you are breast-feeding. If you are over 75 years of age, you may be more likely to experience side effects from Pharmacy. The maximum daily dose of Pharmacy for people over 75 years of age is 300 mg. Pharmacy is not approved by the FDA for use by children younger than 16 years of age.
Impaired renal function results in a decreased rate and extent of excretion of Pharmacy and its active metabolite, M1. In patients with creatinine clearances of less than 30 mL/min, adjustment of the dosing regimen is recommended (see DOSAGE AND ADMINISTRATION). The total amount of Pharmacy and M1 removed during a 4-hour dialysis period is less than 7% of the administered dose.
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