"Feb. 22, 2011 -- The FDA has issued a safety announcement notifying health care professionals that it has updated the pregnancy section of drug labels for the entire class of antipsychotic medications.
Antipsychotic drugs are used to "...
Physicians are advised to discuss the following issues with patients for whom they prescribe INVEGA® .
Patients should be advised that there is risk of orthostatic hypotension, particularly at the time of initiating treatment, re-initiating treatment, or increasing the dose [see WARNINGS AND PRECAUTIONS].
Interference With Cognitive And Motor Performance
As INVEGA® has the potential to impair judgment, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that INVEGA® therapy does not affect them adversely [see WARNINGS AND PRECAUTIONS].
Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during treatment with INVEGA® [see Use In Specific Populations].
Caution should be exercised when INVEGA® is administered to a nursing woman. The known benefits of breastfeeding should be weighed against the unknown risks of infant exposure to paliperidone. [See Use in Specific Populations].
Patients should be advised to inform their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs, as there is a potential for interactions [see DRUG INTERACTIONS].
Patients should be advised to avoid alcohol while taking INVEGA® [see DRUG INTERACTIONS].
Heat Exposure And Dehydration
Patients should be advised regarding appropriate care in avoiding overheating and dehydration [see WARNINGS AND PRECAUTIONS].
Patients should be informed that INVEGA® should be swallowed whole with the aid of liquids. Tablets should not be chewed, divided, or crushed. The medication is contained within a nonabsorbable shell designed to release the drug at a controlled rate. The tablet shell, along with insoluble core components, is eliminated from the body; patients should not be concerned if they occasionally notice something that looks like a tablet in their stool [see DOSAGE AND ADMINISTRATION].
Last reviewed on RxList: 5/19/2014
This monograph has been modified to include the generic and brand name in many instances.
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