The labels indicate that the diluted concentration (expressed as imipenem content) is 2.5 mg/m L instead of the actual concentration of 5 mg/m L (when prepared according to the instructions in the package insert).
Health care providers should consult the package insert or the Canadian product monograph for the correct reconstitution and dilution instructions.
Patients receiving imipenem/cilastatin therapy at home should consult their health care provider to confirm that they are receiving the correct dose of their medication. An FDA review has found that the combined use of opioid medicines with benzodiazepines or other drugs that depress the CNS resulted in serious adverse reactions, including slowed or difficult breathing and deaths.
The FDA will also continue to evaluate the evidence regarding combined use of benzodiazepines or other CNS depressants with medication-assisted therapy drugs used to treat opioid addiction and dependence, and whether labeling changes will be needed for other CNS depressants.
Health care providers should limit prescribing opioid pain medicines with benzodiazepines or other CNS depressants only to patients for whom alternative treatment options are inadequate.
If these medicines are prescribed together, the dosages and duration of each drug should be limited to the minimum needed to achieve the desired clinical effect.
As new information of a critical nature is identified (such as Black Box Warnings) about medications in our database, we publish what we call a Special Alert.
These Special Alerts are intended to notify clinicians of important news and warnings.
This information remains on our Special Alerts list for a period of 12 months from its original release date.
The Special Alerts listed below are available immediately to subscribers through Lexicomp Online and through our Mobile App software for smartphones and tablets.
Due to the results of a recent study commissioned by Health Canada to evaluate the risk management measures currently in place for isotretinoin, the agency is reinforcing the importance of pregnancy prevention in women taking isotretinoin (Accutane, Clarus, and Epuris).
The study identified continued reports of pregnancy among patients using isotretinoin, despite the comprehensive risk management measures in place.