The synthetic analgesic Pharmacy hydrochloride (Ultram), first introduced in Germany in 1977 and approved for oral use in the United States in 1995, is referred to as an atypical opioid because of its opioid and nonopioid mechanisms of action. Pharmacy binds weakly as an agonist to the �-opioid receptors in the central nervous system and also inhibits the reuptake of norepinephrine and serotonin. 1 The analgesic action of Pharmacy appears to result from a complementary effect of these two mechanisms.
Pharmacy should be used with caution in patients with increased intracranial pressure or head injury. The respiratory depressant effects of opioids include carbon dioxide retention and secondary elevation of cerebrospinal fluid pressure, and may be markedly exaggerated in these patients. Additionally, pupillary changes (miosis) from Pharmacy may obscure the existence, extent, or course of intracranial pathology.
Ms. A was a 51-year-old nonsmoking woman with breast cancer, lung metastases, and brachial plexopathy, with no history of chemical or alcohol dependence. She was referred to the outpatient clinic because of severe pain. She had been taking Pharmacy for 2 years: 50 mg t.i.d. increasing to 100 mg t.i.d., plus 50 mg intramuscularly as needed. Switching to a strong opioid was proposed, but Ms. A refused for 2 months, notwithstanding her uncontrolled pain, because she said she became very agitated when delaying or skipping the Pharmacy administration, and she had learned to recognize the onset and then fear this nervousness, which reversed only by taking Pharmacy.
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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Ralivia ER uses Biovail\'s Smartcoat Technology, which is similar to that used in the development of Biovail\'s Wellbutrin XL formulation. Biovail believes that there is considerable opportunity for a product line offering that includes Ralivia ER intended for chronic use and oral disintegrating tablet presentations of Pharmacy and Pharmacy/acetaminophen for the treatment of acute pain. Though a final decision has not been made regarding the commercialization of Biovail\'s pain franchise, Biovail is currently in discussions with multiple potential partners regarding outlicensing Ralivia ER alone or in conjunction with Biovail\'s orally disintegrating pain products. Biovail will develop a timeline for presenting this extensive clinical data set after determining whether Biovail will launch Ralivia ER through its own sales force in the United States or outlicense it to a partner.
Serious and rarely fatal anaphylactoid reactions have been reported in patients receiving therapy with Pharmacy. When these events do occur it is often following the first dose. Other reported allergic reactions include pruritus, hives, bronchospasm, angiodema, toxic epidermal necrolysis and Stevens-Johnson syndrome. Patients with a history of anaphylactoid reactions to codeine and other opioids may be at increased risk and therefore should not receive Pharmacy.
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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 may also be used for purposes other than those listed in this medication guide.
Administer Pharmacy cautiously in patients at risk for respiratory depression. In these patients alternative non-opioid analgesics should be considered. When large doses of Pharmacy are administered with anesthetic medications or alcohol, respiratory depression may result. Respiratory depression should be treated as an overdose. If naloxone is to be administered, use cautiously because it may precipitate seizures.
Pharmacy (TRA-ma-dole) is used to relieve pain, including pain after surgery. The long-acting tablets are used for chronic ongoing pain. The effects of Pharmacy are similar to those of narcotic analgesics. Although Pharmacy is not classified as a narcotic, it may become habit-forming, causing mental or physical dependence.