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Rezira

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Rezira

PATIENT INFORMATION

[See FDA-Approved Patient Labeling]

Overdosage

Patients should be advised not to increase the dose or dosing frequency of REZIRA Oral Solution because serious adverse events such as respiratory depression may occur with overdosage [see WARNINGS AND PRECAUTIONS; OVERDOSAGE].

Dosing

Patients should be advised to measure REZIRA Oral Solution with an accurate milliliter measuring device. Patients should be informed that a household teaspoon is not an accurate measuring device and could lead to overdosage, especially when half a teaspoon is measured. Patients should be advised to ask their pharmacist to recommend an appropriate measuring device and for instructions for measuring the correct dose [see DOSING AND ADMINISTRATION, WARNINGS AND PRECAUTIONS].

Concomitant Use of Alcohol and Other Central Nervous System Depressants

Patients should be advised to avoid the use of alcohol and other central nervous system depressants while taking REZIRA Oral Solution because additional reduction in mental alertness may occur [see WARNINGS AND PRECAUTIONS].

Activities Requiring Mental Alertness

Patients should be advised to avoid engaging in hazardous tasks that require mental alertness and motor coordination such as operating machinery or driving a motor vehicle as REZIRA Oral Solution may produce marked drowsiness [see WARNINGS AND PRECAUTIONS].

Drug Dependence

Patients should be cautioned that REZIRA Oral Solution contains hydrocodone bitartrate and can produce drug dependence [see WARNINGS AND PRECAUTIONS].

MAOIs

Patients should be informed that due to its pseudoephedrine component, they should not use REZIRA Oral Solution with an MAOI or within 14 days of stopping the use of an MAOI [see WARNINGS AND PRECAUTIONS].

Last reviewed on RxList: 8/2/2011
This monograph has been modified to include the generic and brand name in many instances.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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