"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 "...
- Patient Information:
Details with Side Effects
Physicians are advised to discuss the following issues with patients for whom they prescribe INVEGA® (paliperidone) .
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® (paliperidone) 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® (paliperidone) 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® (paliperidone) 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® (paliperidone) 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: 5/19/2011
This monograph has been modified to include the generic and brand name in many instances.
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