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Administration of Xanax XR tablets results in a slower rate of absorption and decreased peak plasma concentration levels (which occur in 5-11 hours vs.
The labeling also contains a stateihent indicating that steady-state peak and trough concentrations for equivalent doses of Xanax XR every 12 hours and Xanax four times a day are detox to quit oxycontin the same. Based on the data provided, DMETS cannot determine the clinical effect a switch, as listed above, would have on a patient.
Although patients would still receive equal amounts of alprazolam (e.g., 1 mg extended release vs. 1 mg immediate release), DMETS is unsure if the effects of the extended release formulation will contribute to an increase in adverse events such as sedation, somnolence, and memory impairment. LABELING, PACKAGING, AND SAFETY RELATED ISSUES In the review of the container labels, carton and non fda tramadol insert labeling of Xanax XR, DMETS has attempted to focus on safety issues relating to possible medication errors. DMETS has reviewed the current container labels, carton and insert labeling and has identified several areas of possible improvement, which might minimize potential user error.
Revise the established name to read "Alprazolam Extended-release no prescription xanax hydrocodone overnight delivery Tablets." Additionally, increase the prominence of the established name so that it is at least half as large as the proprietary name.
DMETS acknowledges the sponsor's attempt to distinguish the proprietary name, Xanax XR from Xanax by placing the modifier 'XR' in a contrasting background.
However, the current presentation of the modifier does not necessarily help to distinguish the two product;. The current presentation of 'XR' looks similar to a logo and thus, it may not help to distinguish the product. We recommend that the format (font, color, and background contrast) of the modifier 'XR' be the same as the format of the proprietary name. DMETS recommends that each strength of the immediate release and extended release formulations be non fda tramadol distinguished by a different color. This differentiation may help to decrease selection errors between the two formulations and is particularly important in the 0.5 mg, 1 mg, and 2 mg strengths, since the two formulations have overlapping strengths. [In the current presentation, the strength (0.5 mg) on the carton labeling for Xanax sind Xanax XR is presented in the same color (i.e., green).non fda tramadol ] A. DMETS has no objections to non fda tramadol the use of the proprietary name Xanax XR. This is considered a tentative decision and the firm should be notified that this name with its associated labels and labeling must be re-evaluated approximately 90 days prior to the expected approval of the NDA. A re-review of the name prior to NDA approval will rule out any objections based upon approvals of other proprietary or established names from this date forward. DMETS recommends the above labeling revisions that might lead to safer use of the product.
We would be willing to revisit these issues if the Division receives another draft of the labeling from the manufacturer. DMETS would appreciate feedback of the final outcome of this consult. We would be willing to meet with the Division for further discussion, if needed. If you have further questions or need clarifications, please contact Sammie Beam, project manager, at 301-827-3242. Team Leader Division of Medication Errors and Technical Support / Office of Drug Safety IfHARS THIS'KM ON ORIGINAL igssHSgste ESlSmtll Actual Error. A prescription for Effexor XR 75 mg was dispensed with Effexor 75 mg. The patient discovered the error prior to ingestion. Actual Error. A patient received Effexor XR 75 mg instead of Effexor 75 mg.
She experienced dizziness, diarrhea, and fell down without any muscle coordination. Actual Error. A patient received Effexor XR 150 mg instead of Effexor 150 mg. She took Effexor XR 600 mg daily for an unknown amount of time. Actual Error. A patient received Effexor 150 mg instead of Effexor XR 150 mg. Within a week of taking Effexor 300 mg daily, she experienced increased blood pressure. Actual Error.
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