sign in sign up
<<
Home , Amoxapine

Goa, 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 Drugs not show an increase in the risk of suicidality with neuroleptic drugs administered to the patient increase. However, Medication Guide 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 , 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amoxapine or any adolescents with MDD, obsessive compulsive disorder (OCD), or completely, if neuro leptic treatment is withdrawn.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 . 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 , 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 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, , 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 toxicity, heat contain: dibasic calcium phosphate, magnesium stearate, starch increases or decreases. , 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), , 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. and 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 receptors to dopamine. Amoxapine is not a suicidality. from NMS, the potential reintroduction of drug therapy should have a family history of) bipolar monoamine oxidase inhibitor. Consideration should be given to changing the therapeutic be carefully considered. The patient should be carefully illness (also called manic- Amoxapine is absorbed rapidly and reaches peak blood levels regimen, including possibly discontinuing the medication, in monitored since recurrences of NMS have been reported. depressive illness) or suicidal approximately 90 minutes after ingestion. It is almost completely patients whose depression is persistently worse, or who are Amoxapine should be used with caution in patients with a history metabolized. The main route of is the . In vitro experiencing emergent suicidality or symptoms that might be of , angle-closure glaucoma, or increased thoughts or actions. tests show that amoxapine binding to human serum is precursors to worsening depression or suicidality, especially if intra ocular pressure. Patients with cardiovascular disorders approximately 90%. these symptoms are severe, abrupt in onset, or were not part of should be watched closely. antidepressant drugs, 3. How can I watch for and try to In man, amoxapine serum concentration declines with a half-life the patient's presenting symptoms. particularly when given in high doses, can induce sinus prevent suicidal thoughts and of eight hours. However, the major metabolite, 8-hydroxy- Families and caregivers of patients being treated with tachycardia, changes in conduction time, and arrhythmias. actions in myself or a family amoxapine, has a biologic half-life of 30 hours. Metabolites are antidepressants for major depressive disorder or other and stroke have been reported with drugs excreted in the urine in conjugated form as glucuronides. indications, both psychiatric and nonpsychiatric, should be of this class. member? Clinical studies have demonstrated that amoxa pine has a more alerted about the need to monitor patients for the emergence Extreme caution should be used in treating patients with a • Pay close attention to any rapid onset of action than either or . The of agitation, irritability, unusual changes in behavior, and the history of convulsive disorder or those with overt or latent initial clinical effect may occur within four to seven days and other symptoms described above, as well as the emergence of disorders. changes, especially sudden occurs within two weeks in over 80% of responders. suicidality, and to report such symptoms immediately to PRECAUTIONS changes, in mood, behaviors, health care providers. Such monitoring should include daily INDICATIONS AND USAGE observation by families and caregivers. Prescriptions for General thoughts, or feelings. This is very Amoxapine is indicated for the relief of symptoms of depression amoxapine should be written for the smallest quantity of tablets In prescribing the drug it should be borne in mind that the important when an in patients with neurotic or reactive depressive disorders as well consistent with good patient management, in order to reduce the possibility of suicide is inherent in any severe depression, and as endog enous and psychotic depressions. It is indicated for risk of overdose. persists until a significant remission occurs; the drug should be antidepressant medicine is depression accompanied by anxiety or agitation. Screening Patients for Bipolar Disorder: A major depressive dispensed in the smallest suitable amount. Manic depressive started or when the dose is CONTRAINDICATIONS episode may be the initial presentation of bipolar disorder. It is patients may experience a shift to the manic phase. changed. Schizophrenic patients may develop increased symptoms of Amoxapine is contraindicated in patients who have shown prior generally believed (though not established in controlled trials) that treating such an episode with an antidepressant alone may psychosis; patients with paranoid symptomatology may have an • Call the healthcare provider right hypersensitivity to dibenz oxazepine compounds. It should not be exaggeration of such symptoms. This may require reduction of given concomitantly with monoamine oxidase inhibitors. increase the likelihood of precipitation of a mixed/manic episode away to report new or sudden in patients at risk for bipolar disorder. Whether any of the dosage or the addition of a major tranquilizer to the therapeutic Hyperpyretic crises, severe convulsions, and deaths have regimen. Antidepressant drugs can cause skin rashes and/or occurred in patients receiving tricyclic antidepressants and symptoms described above represent such a conversion is changes in mood, behavior, unknown. However, prior to initiating treatment with an “drug fever” in susceptible individuals. These allergic reactions monoamine oxidase inhibitors simultaneously. When it is may, in rare cases, be severe. They are more likely to occur thoughts, or feelings. desired to replace a monoamine oxidase inhibitor with antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar during the first few days of treatment, but may also occur later. • Keep all follow-up visits with the amoxapine, a minimum of 14 days should be allowed to elapse Amoxapine should be discontinued if rash and/or fever develop. after the former is discontinued. Amoxapine should then be disorder; such screening should include a detailed psychiatric healthcare provider as scheduled. history, including a family history of suicide, bipolar disorder, Amox apine possesses a degree of dopamine-blocking activity initiated cautiously with gradual increase in dosage until which may cause in <1% of patients. optimum response is achieved. The drug is not recommended and depression. It should be noted that amoxapine is not Call the healthcare provider approved for use in treating bipolar depression. Rarely, symptoms indicative of tardive dyskinesia have been for use during the acute recovery phase following myocardial reported. between visits as needed, infarction. Angle-Closure Glaucoma: Information for Patients especially if you have concerns WARNINGS The pupillary dilation that occurs following use of many Given the likelihood that some patients exposed chronically to about symptoms . Clinical Worsening and Suicide Risk antidepressant drugs including amoxapine, may trigger an angle closure attack in a patient with anatomically narrow angles who neuroleptics will develop tardive dyskinesia, it is advised that all Patients with major depressive disorder (MDD), both adult and Call a healthcare provider right does not have a patent iridectomy. patients in whom chronic use is contemplated be given, if pediatric, may experience worsening of their depression and/or possible, full information about this risk. The decision to inform away if you or your family the emergence of suicidal ideation and behavior (suicidality) or Tardive Dyskinesia patients and/or their guardians must obviously take into account unusual changes in behavior, whether or not they are taking Tardive dyskinesia, a syndrome consisting of potentially the clinical circumstances and the competency of the patient to member has any of the following antidepressant medications, and this risk may persist until irreversible, involuntary, dyskinetic movements may develop in understand the information provided. symptoms, especially if they are significant remission occurs. Suicide is a known risk of patients treated with neuroleptic (i.e., antipsychotic) drugs. Patients should be warned of the possibility of drowsiness that new, worse, or worry you: depression and certain other psychiatric disorders, and these (Amoxapine is not an antipsychotic, but it has substantive may impair performance of potentially hazardous tasks such as disorders themselves are the strongest predictors of suicide. neuroleptic activity.) Although the prevalence of the syndrome driving an automobile or operating machinery. • thoughts about suicide or dying There has been a long-standing concern, however, that appears to be highest among the elderly, especially elderly antidepressants may have a role in inducing worsening of women, it is impossible to rely upon prevalence estimates to Prescribers or other health professionals should inform patients, • attempts to commit suicide depression and the emergence of suicidality in certain patients predict, at the inception of neuroleptic treatment, which patients their families, and their caregivers about the benefits and risks during the early phases of treatment. Pooled analyses of short- are likely to develop the syndrome. Whether neuro leptic drug associated with treatment with amoxapine and should counsel • new or worse depression term placebo-controlled trials of antidepressant drugs (SSRIs products differ in their potential to cause tardive dyskinesia is them in its appropriate use. A patient Medication Guide about and others) showed that these drugs increase the risk of suicidal unknown. “Antidepressant Medicines, Depression and other Serious • new or worse anxiety thinking and behavior (suicidality) in children, adolescents, and Mental Illness, and Suicidal Thoughts or Actions” is available for Both the risk of developing the syndrome and the likelihood that amoxapine . The prescriber or health professional should instruct • young adults (ages 18-24) with major depressive disorder it will become irreversible are believed to increase as the feeling very agitated or restless

Reference ID: 3540907 • panic attacks patients, their families, and their caregivers to read the studied at oral doses 3-10 times the human dose. Decreased amoxapine overdosage in some cases. Fatal overdoses with Medication Guide and should assist them in understanding its postnatal survival (between days 0-4) was demonstrated in the amoxapine have occurred. • trouble sleeping (insomnia) contents. Patients should be given the opportunity to discuss the offspring of rats at 5-10 times the human dose. There are no Renal failure may develop two to five days after toxic overdosage contents of the Medication Guide and to obtain answers to any adequate and well-controlled studies in pregnant women. in patients who may appear otherwise recovered. Acute tubular • new or worse irritability questions they may have. The complete text of the Medication Amoxapine should be used during pregnancy only if the potential necrosis with and myoglobinuria is the most Guide is reprinted at the end of this document. benefit justifies the potential risk to the fetus. common renal complication in such cases. This reaction • acting aggressive, being angry or Patients should be advised of the following issues and asked to Nursing Mothers probably occurs in less than 5% of overdose cases, and typically violent alert their prescriber if these occur while taking amoxapine . Amoxapine, like many other systemic drugs, is excreted in in those who have experienced multiple . • acting on dangerous impulses Patients should be advised that taking amoxapine can cause mild human milk. Because effects of the drug on infants are unknown, Treatment pupillary dilation, which in susceptible individuals, can lead to an caution should be exercised when amoxa pine is administered to Treatment of amoxapine overdosage should be symptomatic and • an extreme increase in activity episode of angle-closure glaucoma. Pre-existing glaucoma is nursing women. supportive, but with special attention to prevention or control of almost always open-angle glaucoma because angle-closure Pediatric Use seizures. If the patient is conscious, induced emesis followed by and talking (mania) glaucoma, when diagnosed, can be treated definitively with Safety and effectiveness in the pediatric population have not gastric lavage with appropriate precautions to prevent iridectomy. Open-angle glaucoma is not a risk factor for angle pulmonary aspiration should be accomplished as soon as • other unusual changes in closure glaucoma. Patients may wish to be examined to been established (see BOX WARNING and WARNING S–Clinical Worsening and Suicide Risk ). possible. Following lavage, activated charcoal may be behavior or mood determine whether they are susceptible to angle closure, and administered to reduce absorption, and repeated admin istrations have a prophylactic procedure (e.g., iridectomy), if they are Anyone considering the use of amoxapine in a child or adoles - may facilitate drug elimination. An adequate airway should be • Visual problems: eye pain, susceptible. cent must balance the potential risks with the clinical need. established in comatose patients and assisted ventilation changes in vision, swelling or Clinical Worsening and Suicide Risk: Patients, their families, Geriatric Use instituted if necessary. Seizures may respond to standard and their caregivers should be encouraged to be alert to the Clinical studies of amoxapine were not adequate to determine therapy such as intravenous and/or redness in or around the eye emergence of anxiety, agitation, panic attacks, insomnia, whether subjects aged 65 and over respond differently from phenytoin. The value of physostigmine appears less certain. What else do I need to know about irritability, hostility, aggressiveness, impulsivity, akathisia younger subjects. , should it develop, requires vigorous (psychomotor restlessness), hypomania, mania, other unusual Amoxapine is known to be substantially excreted by the kidney treatment such as that described by Delgado-Escueta et al antidepressant medicines? changes in behavior, worsening of depression, and suicidal (see CLINICAL PHARMACOLOGY ). Clinical circumstances, some (N Engl J Med 1982; 306:1337-1340). ideation, especially early during antidepressant treatment and 190829-1 • Never stop an antidepressant of which may be more common in the elderly, such as hepatic or Convulsions, when they occur, typically begin within 12 hours when the dose is adjusted up or down. Families and caregivers renal impairment, should be considered. after ingestion. Because seizures may occur precipitously in of patients should be advised to look for the emergence of such medicine without first talking to Greater sensitivity (e.g., tardive dyskinesia, sedation) of some some overdosage patients who appear otherwise relatively symptoms on a day-to-day basis, since changes may be abrupt. asymptomatic, the treating physician may wish to consider a healthcare provider. Stopping Such symptoms should be reported to the patient's prescriber or older individuals cannot be ruled out (see WARNINGS and ADVERSE REACTIONS ). In general, dose selection for an elderly prophylactic administration of anticonvulsant medication during an antidepressant medicine health professional, especially if they are severe, abrupt in onset, this period. suddenly can cause other or were not part of the patient's presenting symptoms. patient should be cautious, usually starting at a lower dose (see Symptoms such as these may be associated with an increased DOSAGE AND ADMINISTRATION ). Treatment of renal impairment, should it occur, is the same as symptoms. risk for suicidal thinking and behavior and indicate a need for ADVERSE REACTIONS that for nondrug-induced renal dysfunction. Serious cardiovascular effects are rare following amoxa pine • Visual problems: Only some very close monitoring and possibly changes in the medication. Adverse reactions reported in controlled studies in the United Drug Interactions States are categorized with respect to incidence below. Following overdosage, and the ECG typically remains within normal limits except for sinus tachycardia. Hence, prolongation of the QRS people are at risk for these See CONTRAINDICATIONS about concurrent usage of tricyclic this is a listing of reactions known to occur with other antidepressant drugs of this class. interval beyond 100 milliseconds within the first 24 hours is not problems. You may want to antidepressants and monoamine oxidase inhibitors. Paralytic a useful guide to the severity of overdosage with this drug. undergo an eye examination to may occur in patients taking tricyclic antidepressants in Incidence Greater Than 1% combination with anticholinergic drugs. Amoxapine may Fatalities and neurologic sequelae have resulted from prolonged see if you are at risk and receive The most frequent types of adverse reactions occurring with status epilepticus in amoxapine overdosage patients. While the enhance the response to and the effects of bar biturates amoxa pine in controlled clinical trials were and and other CNS depressants. Serum levels of several tricyclic lethal dose appears higher than that of other tricyclic preventative treatment if you are. anticholinergic: these included drowsiness (14%), dry mouth antidepressants (80% of lethal amoxapine overdosages have antidepressants have been reported to be significantly increased (14%), constipation (12%), and blurred vision (7%). • Antidepressants are medicines when is administered concurrently. Although such an involved ingestion of 3 grams or more), many factors other than Less frequently reported reactions are: amount ingested are important in assessing probability of used to treat depression and interaction has not been reported to date with amoxapine, specific interaction studies have not been done, and the CNS and Neuromuscular: anxiety, insomnia, restlessness, survival. These include age and physical condition of the patient, other illnesses. It is important to possibility should be considered. nervousness, palpitations, tremors, confusion, excitement, concomitant ingestion of other drugs, and especially the interval between drug ingestion and initiation of emergency treatment. discuss all the risks of treating Drugs Metabolized by P450 2D6 nightmares, , alterations in EEG patterns. DOSAGE AND ADMINISTRATION depression and also the risks of The biochemical activity of the drug metabolizing isozyme Allergic: , skin rash. 2D6 (debrisoquin hydroxylase) is reduced in a Endocrine: elevation of levels. Effective dosage of amoxapine may vary from one patient to not treating it. Patients and their another. Usual effective dosage is 200 to 300 mg daily. Three subset of the caucasian population (about 7 to 10% of Gastrointestina l: nausea. families or other caregivers caucasians are so called “poor metabolizers”); reliable estimates weeks constitutes an adequate period of trial providing dosage Othe r: dizziness, headache, fatigue, weakness, excessive of the prevalence of reduced P450 2D6 isozyme activity among has reached 300 mg daily (or lower level of tolerance) for at least should discuss all treatment appetite, increased perspiration. Asian, African and other populations are not yet available. Poor two weeks. If no response is seen at 300 mg, dosage may be choices with the healthcare metabolizers have higher than expected plasma concentrations Incidence Less Than 1% increased, depending upon tolerance, up to 400 mg daily. Hospitalized patients who have been refractory to antidepressant of tricyclic antidepressants (TCAs) when given usual doses. Anticholinergic: disturbances of accommodation, , provider, not just the use of therapy and who have no history of convulsive seizures may Depending on the fraction of drug metabolized by P450 2D6, the delayed micturition, urinary retention, nasal stuffiness. antidepressants. have dosage raised cautiously up to 600 mg daily in divided increase in plasma concentration may be small, or quite large (8 Cardiovascula r: , , , tachycardia. • fold increase in plasma AUC of the TCA). doses. Antidepressant medicines have Allergic: drug fever, urticaria, photosensitization, pruritus, Amoxapine may be given in a single daily dose, not to exceed Talk to the In addition, certain drugs inhibit the activity of this isozyme and , . other side effects. make normal metabolizers resemble poor metabolizers. An 300 mg, preferably at bedtime. If the total daily dosage exceeds healthcare provider about the individual who is stable on a given dose of TCA may become CNS and Neuromuscula r: tingling, of the 300 mg, it should be given in divided doses. abruptly toxic when given one of these inhibiting drugs as extremities, , disorientation, seizures, hypomania, Initial Dosage for Adults side effects of the medicine numbness, incoordination, disturbed concentration, concomitant therapy. The drugs that inhibit cytochrome Usual starting dosage is 50 mg two or three times daily. hyper thermia, extrapyramidal symptoms, including, tardive prescribed for you or your family P450 2D6 include some that are not metabolized by the enzyme Depending upon tolerance, dosage may be increased to 100 mg dyskinesia. Neuroleptic malignant syndrome has been reported. member. (, cimetidine) and many that are substrates for two or three times daily by the end of the first week. (Initial (See WARNINGS .) P450 2D6 (many other anti depressants, , and the dosage of 300 mg daily may be given, but notable sedation may • Antidepressant medicines can Type 1C antiarrhythmics and flecainide). While all Hematologic: , . occur in some patients during the first few days of therapy at this interact with other medicines. the selective serotonin reuptake inhibitors (SSRIs), Gastrointestina l: epigastric distress, vomiting, flatulence, level.) Increases above 300 mg daily should be made only if e.g., , , and , inhibit P450 2D6, they abdominal pain, peculiar taste, diarrhea. 300 mg daily has been ineffective during a trial period of at least Know all of the medicines that you may vary in the extent of inhibition. The extent to which Endocrine: increased or decreased libido, impotence, menstrual two weeks. When effective dosage is established, the drug may SSRI-TCA interactions may pose clinical problems will depend or your family member takes. irregularity, breast enlargement and in the female, be given in a single dose (not to exceed 300 mg) at bedtime. on the degree of inhibition and the of the SSRI syndrome of inappropriate antidiuretic hormone secretion. Elderly Patients Keep a list of all medicines to involved. Nevertheless, caution is indicated in the show the healthcare provider. Do co-administration of TCAs with any of the SSRIs and also in Othe r: lacrimation, weight gain or loss, altered function, In general, lower dosages are recommended for these patients. not start new medicines without switching from one class to the other. Of particular importance, painful ejaculation. Recommended starting dosage of amoxapine is 25 mg two or sufficient time must elapse before initiating TCA treatment in a Drug Relationship Unknown three times daily. If no intolerance is observed, dosage may be first checking with your healthcare patient being withdrawn from fluoxetine, given the long half-life increased by the end of the first week to 50 mg two or three The following reactions have been reported rarely, and occurred times daily. Although 100 to 150 mg daily may be adequate for provider. of the parent and (at least 5 weeks may be under uncontrolled circumstances where a drug relationship was necessary). many elderly patients, some may require higher dosage. Careful • difficult to assess. These observations are listed to serve as increases up to 300 mg daily are indicated in such cases. Not all antidepressant Concomitant use of tricyclic antidepressants with drugs that can alerting information to physicians. Once an effective dosage is established, amoxapine may conve - medicines prescribed for inhibit cytochrome P450 2D6 may require lower doses than Anticholinergic: paralytic ileus. usually prescribed for either the or the niently be given in a single bedtime dose, not to exceed 300 mg. children are FDA approved for other drug. Furthermore, whenever one of these other drugs is Cardiovascula r: atrial arrhythmias (including ), Maintenance myocardial infarction, stroke, heart block. use in children. Talk to your withdrawn from co-therapy, an increased dose of tricyclic Recommended maintenance dosage of amoxapine is the lowest child’s healthcare provider for anti depressant may be required. It is desirable to monitor TCA CNS and Neuromuscula r: hallucinations. dose that will maintain remission. If symptoms reappear, dosage plasma levels whenever a TCA is going to be co-administered Hematologic: , , , petechiae. should be increased to the earlier level until they are controlled. more information. with another drug known to be an inhibitor of P450 2D6. Gastrointestinal: parotid swelling. For maintenance therapy at dosages of 300 mg or less, a single Therapeutic Interactions Call your doctor for medical advice Endocrine: change in blood glucose levels. dose at bedtime is recommended. Concurrent administration with electroshock therapy may about side effects. You may report side Othe r: , hepatitis, , urinary frequency, HOW SUPPLIED increase the hazards associated with such therapy. testicular swelling, , alopecia. Amoxapine Tablets USP, 25 mg are 8/32", scored, round, white effects to FDA at 1-800-FDA-1088. Carcinogenesis, Impairment of Fertility Additional Adverse Reactions tablets imprinted DAN 25 and 5713 supplied in bottles of 100. In a 21-month toxicity study at three dose levels in rats, This Medication Guide has been The following reactions have been reported with other Amoxapine Tablets USP, 50 mg are 10/32", scored, round, orange pancreatic islet cell hyperplasia occurred with slightly increased antidepressant drugs. tablets imprinted DAN 50 and 5714 supplied in bottles of 100. approved by the U.S. Food and incidence at doses 5-10 times the human dose. Pancreatic Drug Administration for all adenocarcinoma was detected in low incidence in the mid-dose Anticholinergi c: sublingual adenitis, dilation of the urinary tract. Amoxapine Tablets USP, 100 mg are 11/32", scored, round, blue tablets imprinted DAN 100 and 5715 supplied in bottles of 100. antidepressants. group only, and may possibly have resulted from endocrine- CNS and Neuromuscula r:delusions. Amoxapine Tablets USP, 150 mg are 12/32", scored, round, orange mediated organ hyperfunction. The significance of these Gastrointestinal: stomatitis, black tongue. findings to man is not known. tablets imprinted DAN 150 and 5716 supplied in bottles of 30. Manufactured by: Endocrine: gynecomastia. Treatment of male rats with 5-10 times the human dose resulted Dispense in a tight container with child-resistant closure. Watson Pharma Private Ltd. OVERDOSAGE Verna, Salcette Goa 403 722 INDIA in a slight decrease in the number of fertile matings. Female rats Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room receiving oral doses within the therapeutic range displayed a Signs and Symptoms Temperature]. reversible increase in estrous cycle length. Distributed by: Toxic manifestations of amoxapine overdosage differ Manufactured by: significantly from those of other tricyclic antidepressants. Watson Pharma, Inc. Pregnancy Watson Pharma Private Ltd. Pregnancy Category C Serious cardiovascular effects are seldom if ever observed. Verna, Salcette Goa 403 722 INDIA Parsippany, NJ 07054 USA However, CNS effects - particularly grand mal convulsions - 190829-1 Studies performed in mice, rats, and rabbits have demonstrated occur frequently, and treatment should be directed primarily Distributed by: no evidence of teratogenic effect due to amoxapine. toward prevention or control of seizures. Status epilepticus may Watson Pharma, Inc. Embryotoxicity was seen in rats and rabbits given oral doses develop and constitutes a neurologic emergency. Coma and Parsippany, NJ 07054 USA Revised: June 2014 190829-1 approximating the human dose. Fetotoxic effects (intrauterine acidosis are other serious complications of substantial Revised: June 2014 190829-1 death, stillbirth, decreased birth weight) were seen in animals

Reference ID: 3540907