"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 "...
(asenapine) Sublingual Tablets
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. SAPHRIS® (asenapine) is not approved for the treatment of patients with dementia-related psychosis [see WARNINGS AND PRECAUTIONS].
SAPHRIS contains asenapine maleate which is a psychotropic agent that is available for sublingual administration. Asenapine belongs to the class dibenzo-oxepino pyrroles. The chemical designation is (3aRS,12bRS)-5-Chloro-2-methyl2,3,3a,12b-tetrahydro-1Hdibenzo[2,3:6,7]oxepino[4,5-c]pyrrole (2Z)-2-butenedioate (1:1). Its molecular formula is C17H16ClNO•C4H4O4 and its molecular weight is 401.84 (free base: 285.8). The chemical structure is:
Asenapine maleate is a white to off-white powder.
SAPHRIS, black cherry flavor, is supplied for sublingual administration in tablets containing 2.5 mg, 5 mg or 10 mg asenapine; inactive ingredients include gelatin, mannitol, sucralose, and black cherry flavor.
What are the possible side effects of asenapine (Saphris)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using asenapine and call your doctor at once if you have any of these serious side effects:
- very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, feeling like you might pass out;
- twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;
- tremor (uncontrolled shaking);
- trouble swallowing;
- sudden numbness or weakness,...
What are the precautions when taking asenapine sublingual tablets (Saphris)?
See also Warning section.
Before taking asenapine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems, heart problems (such as past heart attack, angina, abnormal heart rhythm), stroke, diabetes (including family history), obesity, low blood pressure, seizures, low white blood cell count, loss of too much body water (dehydration), breast cancer, drug/alcohol/substance abuse, Alzheimer's disease, dementia, trouble swallowing.
Asenapine may cause a condition that affects the...
Last reviewed on RxList: 3/26/2015
This monograph has been modified to include the generic and brand name in many instances.
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