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What should I know about storage and disposal of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.
It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org
Amoxapine is a prescription medication used to treat depression.
Amoxapine is in a class of medications called tricyclic antidepressants (TCAs). It works by increasing the amounts of certain natural substances in the brain that are needed to maintain mental balance.
This medication comes in tablet form and is taken one or more times a day. If you take amoxapine once a day, you should take it at bedtime.
Common side effects of amoxapine include drowsiness, dry mouth, constipation, and blurred vision
Amoxapine can also cause drowsiness. Do not drive or operate heavy machinery until you know how amoxapine affects you.
Amoxapine Brand Names
Amoxapine may be found in some form under the following brand names:
What is amoxapine?
Amoxapine is a tricyclic antidepressant. Amoxapine affects chemicals in the brain that may be unbalanced in people with certain conditions.
Amoxapine is used to treat symptoms of depression, anxiety, or agitation.
Amoxapine may also be used for purposes not listed in this medication guide.
A dibenzoxazepine-derivative tricyclic antidepressant (TCA).101 a b c h i k l m
Tight containers at 15–30°C.101 a b
Commonly used brand name(s)
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antidepressant
Pharmacologic Class: Antidepressant, Tricyclic
Chemical Class: Dibenzoxazepine
What do I need to tell my doctor BEFORE I take Amoxapine?
- If you have an allergy to amoxapine or any other part of this medicine.
- If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- If you have had a recent heart attack.
- If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson's disease like selegiline or rasagiline in the last 14 days. Taking amoxapine within 14 days of those drugs can cause very bad high blood pressure.
- If you are taking any of these drugs: Linezolid or methylene blue.
This is not a list of all drugs or health problems that interact with this medicine.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take amoxapine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
If OVERDOSE is suspected
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
In prescribing the drug it should be borne in mind that the possibility of suicide is inherent in any severe depression, and persists until a significant remission occurs; the drug should be dispensed in the smallest suitable amount. Manic depressive patients may experience a shift to the manic phase. Schizophrenic patients may develop increased symptoms of psychosis; patients with paranoid symptomatology may have an exaggeration of such symptoms. This may require reduction of dosage or the addition of a major tranquilizer to the therapeutic regimen. Antidepressant drugs can cause skin rashes and/or “drug fever” in susceptible individuals. These allergic reactions may, in rare cases, be severe. They are more likely to occur during the first few days of treatment, but may also occur later. Amoxapine should be discontinued if rash and/or fever develop. Amoxapine possesses a degree of dopamine-blocking activity which may cause extrapyramidal symptoms in <1% of patients. Rarely, symptoms indicative of tardive dyskinesia have been reported.
Information for Patients
Given the likelihood that some patients exposed chronically to neuroleptics will develop tardive dyskinesia, it is advised that all patients in whom chronic use is contemplated be given, if possible, full information about this risk. The decision to inform patients and/or their guardians must obviously take into account the clinical circumstances and the competency of the patient to understand the information provided.
Patients should be warned of the possibility of drowsiness that may impair performance of potentially hazardous tasks such as driving an automobile or operating machinery.
Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with Amoxapine and should counsel them in its appropriate use. A patient Medication Guide about “Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions” is available for Amoxapine. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.
Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking Amoxapine.
Patients should be advised that taking Amoxapine can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle-closure glaucoma. Pre-existing glaucoma is almost always open-angle glaucoma because angle-closure glaucoma, when diagnosed, can be treated definitively with iridectomy. Open-angle glaucoma is not a risk factor for angle closure glaucoma. Patients may wish to be examined to determine whether they are susceptible to angle closure, and have a prophylactic procedure (e.g., iridectomy), if they are susceptible.
Clinical Worsening and Suicide Risk: Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to look for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient's prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication.
See CONTRAINDICATIONS about concurrent usage of tricyclic antidepressants and monoamine oxidase inhibitors. Paralytic ileus may occur in patients taking tricyclic antidepressants in combination with anticholinergic drugs. Amoxapine may enhance the response to alcohol and the effects of barbiturates and other CNS depressants. Serum levels of several tricyclic antidepressants have been reported to be significantly increased when cimetidine is administered concurrently. Although such an interaction has not been reported to date with Amoxapine, specific interaction studies have not been done, and the possibility should be considered.
Drugs Metabolized by P450 2D6
The biochemical activity of the drug metabolizing isozyme cytochrome P450 2D6 (debrisoquin hydroxylase) is reduced in a subset of the caucasian population (about 7 to 10% of caucasians are so called “poor metabolizers”); reliable estimates of the prevalence of reduced P450 2D6 isozyme activity among Asian, African and other populations are not yet available. Poor metabolizers have higher than expected plasma concentrations of tricyclic antidepressants (TCAs) when given usual doses. Depending on the fraction of drug metabolized by P450 2D6, the increase in plasma concentration may be small, or quite large (8 fold increase in plasma AUC of the TCA).
In addition, certain drugs inhibit the activity of this isozyme and make normal metabolizers resemble poor metabolizers. An individual who is stable on a given dose of TCA may become abruptly toxic when given one of these inhibiting drugs as concomitant therapy. The drugs that inhibit cytochrome P450 2D6 include some that are not metabolized by the enzyme (quinidine, cimetidine) and many that are substrates for P450 2D6 (many other antidepressants, phenothiazines, and the Type 1C antiarrhythmics propafenone and flecainide). While all the selective serotonin reuptake inhibitors (SSRIs), e.g., fluoxetine, sertraline, and paroxetine, inhibit P450 2D6, they may vary in the extent of inhibition. The extent to which SSRI-TCA interactions may pose clinical problems will depend on the degree of inhibition and the pharmacokinetics of the SSRI involved. Nevertheless, caution is indicated in the co-administration of TCAs with any of the SSRIs and also in switching from one class to the other. Of particular importance, sufficient time must elapse before initiating TCA treatment in a patient being withdrawn from fluoxetine, given the long half-life of the parent and active metabolite (at least 5 weeks may be necessary).
Concomitant use of tricyclic antidepressants with drugs that can inhibit cytochrome P450 2D6 may require lower doses than usually prescribed for either the tricyclic antidepressant or the other drug. Furthermore, whenever one of these other drugs is withdrawn from co-therapy, an increased dose of tricyclic antidepressant may be required. It is desirable to monitor TCA plasma levels whenever a TCA is going to be co-administered with another drug known to be an inhibitor of P450 2D6.
Concurrent administration with electroshock therapy may increase the hazards associated with such therapy.
Carcinogenesis, Impairment of Fertility
In a 21-month toxicity study at three dose levels in rats, pancreatic islet cell hyperplasia occurred with slightly increased incidence at doses 5 to 10 times the human dose. Pancreatic adenocarcinoma was detected in low incidence in the mid-dose group only, and may possibly have resulted from endocrine-mediated organ hyperfunction. The significance of these findings to man is not known.
Treatment of male rats with 5-10 times the human dose resulted in a slight decrease in the number of fertile matings. Female rats receiving oral doses within the therapeutic range displayed a reversible increase in estrous cycle length.
Pregnancy Category C
Studies performed in mice, rats, and rabbits have demonstrated no evidence of teratogenic effect due to Amoxapine. Embryotoxicity was seen in rats and rabbits given oral doses approximating the human dose. Fetotoxic effects (intrauterine death, stillbirth, decreased birth weight) were seen in animals studied at oral doses 3-10 times the human dose. Decreased postnatal survival (between days 0-4) was demonstrated in the offspring of rats at 5-10 times the human dose. There are no adequate and well-controlled studies in pregnant women. Amoxapine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Amoxapine, like many other systemic drugs, is excreted in human milk. Because effects of the drug on infants are unknown, caution should be exercised when Amoxapine is administered to nursing women.
Safety and effectiveness in the pediatric population have not been established (see BOX WARNING and WARNINGS –Clinical Worsening and Suicide Risk).
Anyone considering the use of Amoxapine in a child or adolescent must balance the potential risks with the clinical need.
Clinical studies of Amoxapine were not adequate to determine whether subjects aged 65 and over respond differently from younger subjects.
Amoxapine is known to be substantially excreted by the kidney (see CLINICAL PHARMACOLOGY). Clinical circumstances, some of which may be more common in the elderly, such as hepatic or renal impairment, should be considered.
Greater sensitivity (e.g., tardive dyskinesia, sedation) of some older individuals cannot be ruled out (see WARNINGS and ADVERSE REACTIONS). In general, dose selection for an elderly patient should be cautious, usually starting at a lower dose (see DOSAGE AND ADMINISTRATION).
(a MOKS a peen)
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Generic: 25 mg, 50 mg, 100 mg, 150 mg
Reduces the reuptake of serotonin and norepinephrine. The metabolite, 7-OH-amoxapine has significant dopamine receptor blocking activity similar to antipsychotic agents.
Rapid and well absorbed
Vd: 0.9 to 1.2 L/kg
Extensively metabolized; hepatic hydroxylation produces two active metabolites, 7-hydroxyamoxapine (7-OH-amoxapine) and 8-hydroxyamoxapine (8-OH-amoxapine); metabolites undergo conjugation to form glucuronides
Onset of Action
Antidepressant effect: Usually occurs after 1 to 2 weeks, but may require 4 to 6 weeks
Time to Peak
Serum: ~90 minutes
8 hours; 8-hydroxyamoxapine metabolite: 30 hours
Use Labeled Indications
Depression: For the relief of symptoms of depression in patients with neurotic or reactive depressive disorders as well as endogenous and psychotic depressions; for depression accompanied by anxiety or agitation.
Major psychiatric warnings:
• Suicidal thinking/behavior: [US Boxed Warning]: Antidepressants increase the risk of suicidal thinking and behavior in children, adolescents, and young adults (18 to 24 years of age) with major depressive disorder (MDD) and other psychiatric disorders; consider risk prior to prescribing. Short-term studies did not show an increased risk in patients >24 years of age and showed a decreased risk in patients ≥65 years. Closely monitor patients for clinical worsening, suicidality, or unusual changes in behavior, particularly during the initial 1 to 2 months of therapy or during periods of dosage adjustments (increases or decreases); the patient’s family or caregiver should be instructed to closely observe the patient and communicate condition with healthcare provider. A medication guide concerning the use of antidepressants should be dispensed with each prescription. Amoxapine is not FDA approved for use in pediatric patients.
• The possibility of a suicide attempt is inherent in major depression and may persist until remission occurs. Patients treated with antidepressants should be observed for clinical worsening and suicidality, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases. Worsening depression and severe abrupt suicidality that are not part of the presenting symptoms may require discontinuation or modification of drug therapy. Use caution in high-risk patients during initiation of therapy.
• Prescriptions should be written for the smallest quantity consistent with good patient care. The patient's family or caregiver should be alerted to monitor patients for the emergence of suicidality and associated behaviors such as anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia, hypomania, and mania; patients should be instructed to notify their healthcare provider if any of these symptoms or worsening depression or psychosis occur.
Concerns related to adverse effects:
• Anticholinergic effects: May cause anticholinergic effects (constipation, xerostomia, blurred vision, urinary retention); use with caution in patients with decreased gastrointestinal motility, paralytic ileus, urinary retention, BPH, xerostomia, or visual problems. The degree of anticholinergic blockade produced by this agent is high relative to other antidepressants (Bauer, 2013).
• CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks that require mental alertness (eg, operating machinery or driving). The degree of sedation is moderate relative to other antidepressants (Bauer, 2013).
• Extrapyramidal symptoms: May cause extrapyramidal symptoms (EPS), including pseudoparkinsonism, acute dystonic reactions, akathisia, and tardive dyskinesia (risk of these reactions is low). Risk of dystonia (and possibly other EPS) may be greater with increased doses, use of conventional antipsychotics, males, and younger patients (APA, 2004). Risk of tardive dyskinesia (potentially irreversible) is often associated with total cumulative dose, therapy duration, and may also be increased in elderly patients (particularly elderly women); antipsychotics may also mask signs/symptoms of tardive dyskinesia. Therapy should be discontinued in any patient if signs/symptoms of tardive dyskinesia appear.
• Fractures: Bone fractures have been associated with antidepressant treatment. Consider the possibility of a fragility fracture if an antidepressant-treated patient presents with unexplained bone pain, point tenderness, swelling, or bruising (Rabenda, 2013; Rizzoli, 2012).
• Neuroleptic malignant syndrome (NMS): Use may be associated with NMS; monitor for mental status changes, fever, muscle rigidity, and/or autonomic instability.
• Ocular effects: May cause mild pupillary dilation which in susceptible individuals can lead to an episode of narrow-angle glaucoma. Consider evaluating patients who have not had an iridectomy for narrow-angle glaucoma risk factors.
• Orthostatic hypotension: May cause orthostatic hypotension (risk is moderate relative to other antidepressants); use with caution in patients at risk of this effect or in those who would not tolerate transient hypotensive episodes (cerebrovascular disease, cardiovascular disease, hypovolemia, or concurrent medication use which may predispose to hypotension/bradycardia).
• Cardiovascular disease: Use with caution in patients with a history of cardiovascular disease (including previous MI, stroke, tachycardia, or conduction abnormalities); the risk conduction abnormalities with this agent is moderate relative to other antidepressants (APA, 2010).
• Diabetes: Use with caution in patients with diabetes mellitus; may alter glucose regulation (APA, 2010).
• Hepatic impairment: Use with caution in patients with hepatic impairment.
• Mania/hypomania: May precipitate a shift to mania or hypomania in patients with bipolar disorder. Monotherapy in patients with bipolar disorder should be avoided. Patients presenting with depressive symptoms should be screened for bipolar disorder, including details regarding family history of suicide, bipolar disorder, and depression. Amoxapine is not FDA approved for the treatment of bipolar depression.
• Renal impairment: Use with caution in patients with renal impairment.
• Seizure disorder: Use with caution in patients at risk of seizures, including those with a history of seizures, head trauma, brain damage, alcoholism, or concurrent therapy with medications which may lower seizure threshold (APA, 2010).
Concurrent drug therapy issues:
• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
• Elderly: May increase risk of adverse events, including tardive dyskinesia (particularly older women) and sedation.
• Discontinuation syndrome: Abrupt discontinuation or interruption of antidepressant therapy has been associated with a discontinuation syndrome. Symptoms arising may vary with antidepressant however commonly include nausea, vomiting, diarrhea, headaches, lightheadedness, dizziness, diminished appetite, sweating, chills, tremors, paresthesias, fatigue, somnolence, and sleep disturbances (eg, vivid dreams, insomnia). Less common symptoms include electric shock-like sensations, cardiac arrhythmias (more common with tricyclic antidepressants), myalgias, parkinsonism, arthralgias, and balance difficulties. Psychological symptoms may also emerge such as agitation, anxiety, akathisia, panic attacks, irritability, aggressiveness, worsening of mood, dysphoria, mood lability, hyperactivity, mania/hypomania, depersonalization, decreased concentration, slowed thinking, confusion, and memory or concentration difficulties. Greater risks for developing a discontinuation syndrome have been associated with antidepressants with shorter half-lives, longer durations of treatment, and abrupt discontinuation. For antidepressants of short or intermediate half-lives, symptoms may emerge within 2 to 5 days after treatment discontinuation and last 7 to 14 days (APA, 2010; Fava, 2006; Haddad, 2001; Shelton, 2001; Warner, 2006).
• Electroconvulsive therapy: May increase the risks associated with electroconvulsive therapy; consider discontinuing, when possible, prior to ECT treatment.
Pregnancy Risk Factor C Pregnancy Considerations
Adverse events were observed in some animal reproduction studies. Tricyclic antidepressants may be associated with irritability, jitteriness, and convulsions (rare) in the neonate (Yonkers, 2009).
The ACOG recommends that therapy for depression during pregnancy be individualized; treatment should incorporate the clinical expertise of the mental health clinician, obstetrician, primary healthcare provider, and pediatrician (ACOG, 2008). According to the American Psychiatric Association (APA), the risks of medication treatment should be weighed against other treatment options and untreated depression. For women who discontinue antidepressant medications during pregnancy and who may be at high risk for postpartum depression, the medications can be restarted following delivery (APA, 2010). Treatment algorithms have been developed by the ACOG and the APA for the management of depression in women prior to conception and during pregnancy (Yonkers, 2009).
Pregnant women exposed to antidepressants during pregnancy are encouraged to enroll in the National Pregnancy Registry for Antidepressants (NPRAD). Women 18 to 45 years of age or their health care providers may contact the registry by calling 844-405-6185. Enrollment should be done as early in pregnancy as possible.
For the Consumer
Applies to amoxapine: oral tablet
Along with its needed effects, amoxapine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking amoxapine:Less common
- fast, irregular, pounding, or racing heartbeat or pulse
- fear or nervousness
- mood or mental changes
- shakiness and unsteady walk
- shakiness in legs, arms, hands, or feet
- trouble sleeping
- unable to sleep
- unsteadiness, trembling, or other problems with muscle control or coordination
- Abdominal or stomach pain
- actions that are out of control
- black, tarry stools
- bleeding gums
- blood in urine or stools
- blurred vision
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chest pain or discomfort
- clay-colored stools
- confusion about identity, place, and time
- continuing ringing or buzzing or other unexplained noise in ears
- cough or hoarseness
- dark urine
- decrease in frequency of urination
- decrease in urine volume
- difficulty in breathing
- difficulty in passing urine (dribbling)
- difficulty in speaking
- disturbed concentration
- dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
- double vision
- extremely high fever or body temperature
- false beliefs that cannot be changed by facts
- fast, weak heartbeat
- fever with or without chills
- general feeling of tiredness or weakness
- hearing loss
- high fever
- high or low blood pressure
- hives or welts
- inability to move arms, legs, or facial muscles
- inability to speak
- increased need to urinate
- increased sweating
- lack of coordination
- light-colored stools
- lip smacking or puckering
- loss of appetite
- loss of bladder control
- lower back or side pain
- muscle cramps
- muscle spasm or jerking of all extremities
- muscle trembling, jerking, or stiffness
- nausea and vomiting
- pain or discomfort in arms, jaw, back, or neck
- painful or difficult urination
- pains in stomach, side, or abdomen, possibly radiating to the back
- pale, clammy skin
- passing urine more often
- pinpoint red spots on skin
- pounding in the ears
- puffing of cheeks
- rapid or worm-like movements of tongue
- redness of skin
- seeing, hearing, or feeling things that are not there
- severe muscle stiffness
- shortness of breath
- shuffling walk
- skin rash
- slow speech
- sore throat
- sores, ulcers, or white spots on lips or in mouth
- stiffness of limbs
- sudden loss of consciousness
- swollen glands
- talking, feeling, and acting with excitement
- testicular swelling
- trouble in holding or releasing urine
- twisting movements of body
- uncontrolled chewing movements
- uncontrolled movements, especially of face, neck, and back
- unpleasant breath odor
- unusual bleeding or bruising
- unusually pale skin
- upper right abdominal pain
- vomiting of blood
- yellow eyes and skin
Get emergency help immediately if any of the following symptoms of overdose occur while taking amoxapine:Symptoms of overdose
- Change in consciousness
- epileptic seizure that will not stop
- increased blood pressure
- increased thirst
- loss of consciousness
- swelling of face, fingers, or lower legs
- total body jerking
- troubled breathing
- weight gain
Some side effects of amoxapine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
- Dry mouth
- Increased appetite
- increased flow of breast milk
- breast enlargement
- change in taste bad unusual or unpleasant (after)taste
- decreased interest in sexual intercourse
- excess air or gas in stomach or intestines
- full feeling
- hair loss, thinning of hair
- inability to have or keep an erection
- increased in sexual ability, desire, drive, or performance
- increased interest in sexual intercourse
- increased sensitivity of skin to sunlight
- loss in sexual ability, desire, drive, or performance
- menstrual changes
- nasal stuffiness
- painful ejaculation
- passing gas
- rapid weight gain
- redness or other discoloration of skin
- severe sunburn
- swollen, painful, or tender lymph glands on side of face or neck
- tearing of the eyes
- unexpected or excess milk flow from breasts
Usual Adult Dose for Depression
Initial dose: 50 mg orally two or three times a day
Maintenance dose: 100 mg orally two or three times a day
Maximum dose: 600 mg orally per day
-Increases above 300 mg per day should be made only if 300 mg per day has been ineffective during at least two weeks.
-Hospitalized patients who have been refractory to antidepressant treatment and who have no history of convulsive seizures may have dosage increased cautiously up to 600 mg per day in divided doses.
-This drug may be given in a single daily dose, not to exceed 300 mg, preferably at bedtime.
-Doses above 300 mg should be given in divided doses.
-Relief of symptoms of depression in patients with neurotic or reactive depressive disorders as well as endogenous and psychotic depressions