"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 "...
- For sublingual use only
- Do not remove tablet until ready to administer.
- Use dry hands when handling tablet.
Step 1. Firmly press and hold thumb button, then pull out tablet pack.
Do not push tablet through tablet pack.
Do not cut or tear tablet pack.
Step 2. Peel back colored tab.
Step 3. Gently remove tablet.
Do not split, cut or crush tablet.
Step 4. Place the whole tablet under tongue and allow it to dissolve completely.
Do not chew or swallow tablet.
Do not eat or drink for 10 minutes.
Step 5. Slide tablet pack into case until it clicks.
Increased Mortality In Elderly Patients With Dementia-Related Psychosis
Patients and caregivers should be advised that elderly patients with dementia-related psychoses treated with atypical antipsychotic drugs are at increased risk of death compared with placebo. SAPHRIS is not approved for elderly patients with dementia-related psychosis [see WARNINGS AND PRECAUTIONS].
Patients should be informed of the signs and symptoms of a serious allergic reaction (e.g., difficulty breathing, itching, swelling of the face, tongue or throat, feeling lightheaded etc.). Patients should be instructed to seek immediate emergency assistance if they develop any of these signs and symptoms [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS].
Application Site Reactions
Inform patients that application site reactions including oral ulcers, blisters, peeling/sloughing and inflammation have been reported. Instruct patients to monitor for these reactions [see ADVERSE REACTIONS].
Neuroleptic Malignant Syndrome
Patients and caregivers should be counseled that a potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with administration of antipsychotic drugs. Signs and symptoms of NMS include hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia) [see WARNINGS AND PRECAUTIONS].
Metabolic Changes (Hyperglycemia And Diabetes Mellitus, Dyslipidemia, And Weight Gain)
Educate patients and caregivers about the risk of metabolic changes and the need for specific monitoring. The risks include hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Patients should be aware of the symptoms of hyperglycemia (high blood sugar) and diabetes mellitus. Patients who are diagnosed with diabetes, those with risk factors for diabetes, or those that develop these symptoms during treatment should have their blood glucose monitored at the beginning of and periodically during treatment. Patients should have their weight monitored regularly [see WARNINGS AND PRECAUTIONS].
Patients should be advised of the risk of orthostatic hypotension (symptoms include feeling dizzy or lightheaded upon standing) especially early in treatment, and also at times of re-initiating treatment or increases in dose [see WARNINGS AND PRECAUTIONS].
Patients with a pre-existing low WBC or a history of drug induced leukopenia/neutropenia should be advised that they should have their CBC monitored while taking SAPHRIS [see WARNINGS AND PRECAUTIONS].
Interference With Cognitive And Motor Performance
Patients should be cautioned about performing activities requiring mental alertness, such as operating hazardous machinery or operating a motor vehicle, until they are reasonably certain that SAPHRIS therapy does not affect them adversely [see WARNINGS AND PRECAUTIONS].
Heat Exposure And Dehydration
Patients should be advised regarding appropriate care in avoiding overheating and dehydration [see WARNINGS AND PRECAUTIONS].
Concomitant Medication And Alcohol
Patients should be advised to inform their physicians if they are taking, or plan to take, any prescription or over-thecounter medications since there is a potential for interactions. Patients should be advised to avoid alcohol while taking SAPHRIS [see DRUG INTERACTIONS].
Pregnancy And Nursing
Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy with SAPHRIS. Patients should be advised not to breast feed if they are taking SAPHRIS [see Use in Specific Populations].
Last reviewed on RxList: 12/5/2014
This monograph has been modified to include the generic and brand name in many instances.
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