Amoxapine (Oral route)
Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders. Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. This risk must be balanced with the clinical need. Monitor all patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Not approved for use in pediatric patients .
Uses of This Medicine:
Amoxapine is used to treat the symptoms of depression. It works on the central nervous system (CNS) to increase levels of certain chemicals in the brain. This medicine is a tricyclic antidepressant (TCA).
This medicine is available only with your doctor's prescription.
Before Using This Medicine:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of amoxapine in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of amoxapine in the elderly. However, elderly patients are more likely to have unwanted effects (e.g., movement disorders, unusual drowsiness) or age-related kidney or liver problems, which may require an adjustment in the dose for patients receiving amoxapine.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Methylene Blue
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Amtolmetin Guacil
- Arsenic Trioxide
- Chloral Hydrate
- Choline Salicylate
- Flufenamic Acid
- Iobenguane I 123
- Mefenamic Acid
- Niflumic Acid
- Nimesulide Beta Cyclodextrin
- Perflutren Lipid Microsphere
- Salicylic Acid
- Sodium Phosphate
- Sodium Phosphate, Dibasic
- Sodium Phosphate, Monobasic
- Sodium Salicylate
- Tiaprofenic Acid
- Tolfenamic Acid
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
Other medical problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Bipolar disorder (mood disorder with alternating episodes of mania and depression), or risk of or
- Heart attack, recent Should not be used in patients with these conditions.
- Glaucoma, history of or
- Heart disease or
- Schizophrenia or
- Seizures, history of or
- Urinary retention (trouble urinating), history of Use with caution. May make these conditions worse.
Proper Use of This Medicine:
Take this medicine only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
This medicine should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablets):
- For depression:
- Adults At first, 50 milligrams (mg) two or three times per day. Your doctor may increase your dose as needed. However, the dose is usually not more than 300 mg per day unless you are in a hospital. Some hospitalized patients may need higher doses. If you are taking this medicine once a day, it is best to take it at bedtime.
- Older Adults At first, 25 milligrams (mg) two or three times per day. Your doctor may increase your dose as needed. However, the dose is usually not more than 300 mg per day unless you are in a hospital. Some hospitalized patients may need higher doses. If you are taking this medicine once a day, it is best to take it at bedtime.
- Children Use and dose must be determined by your doctor.
- For depression:
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using This Medicine:
It is very important that your doctor check your progress at regular visits to allow for changes in your dose and to check for any unwanted effects.
Amoxapine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you, your child, or your caregiver notice any of these side effects, tell your doctor or your child's doctor right away.
Do not take amoxapine if you have taken a monoamine oxidase (MAO) inhibitor (isocarboxazid [Marplan®], phenelzine [Nardil®], selegiline [Eldepryl®, or tranylcypromine [Parnate®]) in the past two weeks. Do not start taking a MAO inhibitor within two weeks of stopping amoxapine. If you do, you may develop confusion, agitation, restlessness, stomach or intestinal symptoms, sudden high body temperature, extremely high blood pressure, or severe convulsions.
This medicine may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you have any of the following symptoms while taking this medicine: lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.
Check with your doctor right away if you are having convulsions (seizures); difficulty with breathing; a fast heartbeat; high fever; high or low blood pressure; increased sweating; loss of bladder control; severe muscle stiffness; unusually pale skin; or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).
Do not stop taking this medicine without first checking with your doctor . Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent a possible worsening of your condition and reduce the possibility of withdrawal symptoms such as headache, nausea, or a general feeling of discomfort or illness.
This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that cause drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies or colds; sedatives, tranquilizers, or sleeping medicines; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.
This medicine may cause some people to become drowsy or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are drowsy or not alert.
Side Effects of This Medicine:
- 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
- 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
- More common
- Dry mouth
- Less common
- 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
Along with its needed effects, a medicine 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:
Get emergency help immediately if any of the following symptoms of overdose occur:
Some side effects 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:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 9/15/2016