"The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended restricting the use of codeine for cough and cold in children because there is a risk for serious adverse effects, including respiratory"...
Patients should be advised not to increase the dose or dosing frequency of Vituz Oral Solution because serious adverse events such as respiratory depression may occur with overdosage [see WARNINGS AND PRECAUTIONS; OVERDOSAGE].
Patients should be advised to measure Vituz 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 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 Vituz 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 Vituz Oral Solution may produce marked drowsiness [see WARNINGS AND PRECAUTIONS].
Patients should be cautioned that Vituz Oral Solution contains hydrocodone bitartrate and can produce drug dependence [see WARNINGS AND PRECAUTIONS].
Last reviewed on RxList: 3/1/2013
This monograph has been modified to include the generic and brand name in many instances.
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