Goa, India to package in Florida Size: 12.25 x 11.25 Folds to 1.25 x 1.25 (MDD) and other psychiatric disorders. Short-term studies did duration of treatment and the total cumulative dose of Suicidality and Antidepressant Drugs not show an increase in the risk of suicidality with neuroleptic drugs administered to the patient increase. However, Medication Guide Antidepressants increased the risk compared to placebo of antidepressants compared to placebo in adults beyond age 24; the syndrome can develop, although much less commonly, after Antidepressant Medicines, suicidal thinking and behavior (suicidality) in children, there was a reduction with antidepressants compared to placebo relatively brief treatment periods at low doses. adolescents, and young adults in short-term studies of in adults aged 65 and older. There is no known treatment for established cases of tardive Depression and other Serious major depressive disorder (MDD) and other psychiatric The pooled analyses of placebo-controlled trials in children and dyskinesia, although the syndrome may remit, partially or Mental Illnesses, and Suicidal disorders. Anyone considering the use of amoxapine or any adolescents with MDD, obsessive compulsive disorder (OCD), or completely, if neuro leptic treatment is withdrawn. Neuroleptic Thoughts or Actions other antidepressant in a child, adolescent, or young adult other psychiatric disorders included a total of 24 short-term treatment itself, however, may suppress (or partially suppress) must balance this risk with the clinical need. Short-term trials of 9 antidepressant drugs in over 4400 patients. The the signs and symptoms of the syndrome and thereby may Read the Medication Guide that studies did not show an increase in the risk of suicidality pooled analyses of placebo-controlled trials in adults with MDD possibly mask the underlying disease process. The effect that with antidepressants compared to placebo in adults beyond or other psychiatric disorders included a total of 295 short-term symptomatic suppression has upon the long-term course of the comes with you or your family age 24; there was a reduction in risk with antidepressants trials (median duration of 2 months) of 11 antidepressant drugs syndrome is unknown. member’s antidepressant medicine. compared to placebo in adults aged 65 and older. in over 77,000 patients. There was considerable variation in risk Given these considerations, neuroleptics should be prescribed in This Medication Guide is only Depression and certain other psychiatric disorders are of suicidality among drugs, but a tendency toward an increase in a manner that is most likely to minimize the occurrence of themselves associated with increases in the risk of suicide. the younger patients for almost all drugs studied. There were tardive dyskinesia. Chronic neuroleptic treatment should about the risk of suicidal thoughts Patients of all ages who are started on antidepressant differences in absolute risk of suicidality across the different generally be reserved for patients who suffer from a chronic and actions with antidepressant therapy should be monitored appropriately and observed indications, with the highest incidence in MDD. The risk illness that, 1) is known to respond to neuroleptic drugs, and, 2) medicines. Talk to your, or your closely for clinical worsening, suicidality, or unusual differences (drug vs placebo), however, were relatively stable for whom alternative, equally effective, but potentially less changes in behavior. Families and caregivers should be within age strata and across indications. These risk differences harmful treatments are not available or appropriate. In patients family member’s, healthcare advised of the need for close observation and (drug-placebo difference in the number of cases of suicidality who do require chronic treatment, the smallest dose and the provider about: communication with the prescriber. Amoxapine is not per 1000 patients treated) are provided in Table 1. shortest duration of treatment producing a satisfactory clinical approved for use in pediatric patients. (See Warnings: Table 1 response should be sought. The need for continued treatment • all risks and benefits of treatment Clinical Worsening and Suicide Risk, Precautions: should be reassessed periodically. Information for Patients, and Precautions: Pediatric Use) Age Range Drug-Placebo Difference in with antidepressant medicines Number of Cases of Suicidality If signs and symptoms of tardive dyskinesia appear in a patient per 1000 Patients Treated on neuroleptics, drug discontinuation should be considered. • all treatment choices for DESCRIPTION Increases Compared to Placebo However, some patients may require treatment despite the depression or other serious presence of the syndrome. Amoxapine is an antidepressant of the dibenz oxazepine class, <18 14 additional cases mental illness chemically distinct from the dibenzazepines, dibenzocyclohep - 18 to 24 5 additional cases (For further information about the description of tardive tenes, and dibenzoxepines. dyskinesia and its clinical detection, please refer to the sections Decreases Compared to Placebo What is the most important It is designated chemically as 2-Chloro-11- on Information for Patients and ADVERSE REACTIONS.) 25 to 64 1 fewer case information I should know about (1-piperazinyl)dibenz[ b,f ][1,4]oxazepine. The structu r al formula Neuroleptic Malignant Syndrome (NMS) >65 6 fewer cases is represented below: A potentially fatal symptom complex sometimes referred to as antidepressant medicines, No suicides occurred in any of the pediatric trials. There were Neuroleptic Malignant Syndrome (NMS) has been reported in depression and other serious suicides in the adult trials, but the number was not sufficient to association with antipsychotic drugs and with amox apine. mental illnesses, and suicidal NNH reach any conclusion about drug effect on suicide. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, It is unknown whether the suicidality risk extends to longer-term altered mental status and evidence of autonomic instability thoughts or actions? N CI use, i.e., beyond several months. However, there is substantial (irregular pulse or blood pressure, tachycardia, diaphoresis, and evidence from placebo-controlled maintenance trials in adults cardiac dysrhythmias). 1. Antidepressant medicines may with depression that the use of antidepressants can delay the The diagnostic evaluation of patients with this syndrome is increase suicidal thoughts or recurrence of depression. complicated. In arriving at a diagnosis, it is important to identify O actions in some children, All patients being treated with antidepressants for any cases where the clinical presentation includes both serious teenagers, and young adults C17 H16 CIN 3O M.W. 313.78 indication should be monitored appropriately and observed medical illness (e.g., pneumonia, systemic infection, etc.) and Amoxapine is supplied for oral administration as 25 mg, 50 mg, closely for clinical worsening, suicidality, and unusual untreated or inadequately treated extrapyramidal signs and within the first few months of 100 mg and 150 mg tablets. changes in behavior, especially during the initial few months symptoms (EPS). Other important considerations in the treatment. Amoxapine Tablets USP, 25 mg, 50 mg, 100 mg and 150 mg of a course of drug therapy, or at times of dose changes, either differential diagnosis include central anticholinergic toxicity, heat contain: dibasic calcium phosphate, magnesium stearate, starch increases or decreases. stroke, drug fever and primary central nervous system (CNS) 2. Depression and other serious pathology. (corn), and stearic acid. The following symptoms, anxiety, agitation, panic attacks, mental illnesses are the most Amoxapine The management of NMS should include 1) im mediate Amoxapine Tablets USP, 50 mg and 150 mg also contain: FD&C insomnia, irritability, hostility, aggressiveness, impulsivity, important causes of suicidal Tablets USP Yellow No. 6. akathisia (psychomotor restlessness), hypomania, and mania, discontinuation of antipsychotic drugs and other drugs not have been reported in adult and pediatric patients being treated essential to concurrent therapy, 2) intensive symptomatic Amoxapine Tablets USP, 100 mg also contain: FD&C Blue No. 2. thoughts and actions. Some Revised: June 2014 with antidepressants for major depressive disorder as well as for treatment and medical monitoring, and 3) treatment of any people may have a particularly Rx only CLINICAL PHARMACOLOGY other indications, both psychiatric and nonpsychiatric. Although concomitant serious medical problems for which specific 190829-1 Amoxapine is an antidepressant with a mild sed ative component a causal link between the emergence of such symptoms and treatments are available. There is no general agreement about high risk of having suicidal to its action. The mechanism of its clinical action in man is not either the worsening of depression and/or the emergence of specific pharmacological treatment regimens for uncomplicated thoughts or actions. These well understood. In animals, amoxapine reduced the uptake of suicidal impulses has not been established, there is concern that NMS. norepinephrine and serotonin and blocked the response of such symptoms may represent precursors to emerging If a patient requires antipsychotic drug treatment after recovery include people who have (or dopamine receptors to dopamine. Amoxapine is not a suicidality. from NMS, the potential reintroduction