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20 Cards in this Set
- Front
- Back
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Which of the following formulations has a method of hydromorphone delivery similar to EXALGO?
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Jurnista
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In patients with moderate to severe low back pain receiving EXALGO™, which of the following adverse reactions occurred in >=5% of patients and at an incidence greater than placebo?
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Nausea
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Respiratory depression occurs more frequently in:
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patients with conditions accompanied by hypoxia or hypercapnia
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According to the boxed warning in the EXALGO™ Package Insert, which of the following is a limitation of use of EXALGO™?
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Tablets should be swallowed whole and should not be broken, chewed, dissolved, crushed, or injected.
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Identify the correct statement regarding the conversion from oral opioids to EXALGO.
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The initial dose of EXALGO™ can be titrated until adequate pain relief with tolerable side effects has been achieved.
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In the double-blind phase of Study 301, which of the following adverse reactions occurred in >=5% of patients in the EXALGO™ group?
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Drug withdrawal syndrome
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EXALGO™ is only indicated for use in opioid-tolerant patients. Which of the following patients are considered opioid tolerant?
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Patients taking at least 60 mg/day of oral morphine for 1 week or longer
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Which of the following best describes the design of Study 301?
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A 4-week open-label conversion and titration phase followed by a 12-week double-blind treatment phase
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Steady state is reached after ___ to ____ days of once-daily dosing of EXALGO™.
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3, 4
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Hydromorphone is classified as a _____________ drug.
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Schedule II
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The administration of EXALGO™ causes which of the following effects in the CNS?
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Produces dose-related respiratory depression
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EXALGO™ is classified as Pregnancy Category ____.
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C
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The EXALGO™ OROS® delivery system comprises which of the following?
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A tablet core composed of an active drug layer and an osmotic layer
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In patients with chronic pain receiving EXALGO™, which of the following adverse reactions occurred in >=5% of patients?
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Somnolence
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Why should EXALGO™ not be used in patients with preexisting severe GI narrowing?
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The EXALGO™ tablet is nondeformable and might result in obstructive symptoms
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List contraindications associated with EXALGO™?
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- EXALGO™ is contraindicated in patients who have or are suspected of having a paralytic ileus.
- EXALGO™ is contraindicated in patients with a known hypersensitivity to any of its components. - EXALGO™ is contraindicated in patients with significant respiratory depression. |
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Dose increases of ____ to ____ should be considered for each titration step with EXALGO.
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25%, 50%
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EXALGO™ may be administered with or without food. (T or F)
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TRUE
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In Study 301, the median change from baseline to the end of the 12-week double-blind treatment phase or final visit in the mean pain intensity NRS scores was _______ for patients treated with EXALGO™ and ______ for patients treated with placebo.
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0.2; 1.6
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Patients with moderate renal impairment should be started on a reduced dose and closely monitored during dose titration. (T or F)
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TRUE
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