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Amoxapine (Oral route)

Pronunciation:

a-MOX-a-peen

Brand Names:

  • Asendin

Dosage Forms:

  • Tablet

Warnings:

Oral route(Tablet)

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 .

Classifications:

Therapeutic—

Antidepressant

Pharmacologic—

Antidepressant, Tricyclic

Chemical—

Dibenzoxazepine

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:

Allergies—

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.

Children—

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.

Older adults—

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.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersCAnimal 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.

Breast-feeding—

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.

Other medicines—

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.

  • Bromopride
  • Clorgyline
  • Grepafloxacin
  • Isocarboxazid
  • Levomethadyl
  • Linezolid
  • Methylene Blue
  • Metoclopramide
  • Moclobemide
  • Phenelzine
  • Ranolazine
  • Safinamide
  • Selegiline
  • Tranylcypromine

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.

  • Acecainide
  • Aceclofenac
  • Acemetacin
  • Albuterol
  • Alfentanil
  • Alfuzosin
  • Almotriptan
  • Amitriptyline
  • Amphetamine
  • Amtolmetin Guacil
  • Apomorphine
  • Aprindine
  • Arsenic Trioxide
  • Asenapine
  • Aspirin
  • Astemizole
  • Azimilide
  • Azithromycin
  • Benzphetamine
  • Bretylium
  • Bromfenac
  • Bromocriptine
  • Brompheniramine
  • Bufexamac
  • Buprenorphine
  • Bupropion
  • Buspirone
  • Butorphanol
  • Celecoxib
  • Chloral Hydrate
  • Chloroquine
  • Chlorpheniramine
  • Chlorpromazine
  • Choline Salicylate
  • Ciprofloxacin
  • Citalopram
  • Clomipramine
  • Clonidine
  • Clonixin
  • Cocaine
  • Codeine
  • Cyclobenzaprine
  • Darunavir
  • Dasatinib
  • Desipramine
  • Desmopressin
  • Desvenlafaxine
  • Dexibuprofen
  • Dexketoprofen
  • Dextroamphetamine
  • Dextromethorphan
  • Diclofenac
  • Diflunisal
  • Dihydrocodeine
  • Dipyrone
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Donepezil
  • Doxepin
  • Droperidol
  • Droxicam
  • Eletriptan
  • Enflurane
  • Epinephrine
  • Erythromycin
  • Escitalopram
  • Etilefrine
  • Etodolac
  • Etofenamate
  • Etoricoxib
  • Felbinac
  • Fenoprofen
  • Fentanyl
  • Fepradinol
  • Feprazone
  • Fingolimod
  • Flecainide
  • Floctafenine
  • Fluconazole
  • Flufenamic Acid
  • Fluoxetine
  • Flurbiprofen
  • Fluvoxamine
  • Foscarnet
  • Frovatriptan
  • Gatifloxacin
  • Gemifloxacin
  • Granisetron
  • Halofantrine
  • Halothane
  • Hydrocodone
  • Hydromorphone
  • Hydroxytryptophan
  • Ibuprofen
  • Ibutilide
  • Iloperidone
  • Imipramine
  • Indomethacin
  • Iobenguane I 123
  • Iproniazid
  • Isoflurane
  • Isradipine
  • Ketoprofen
  • Ketorolac
  • Lapatinib
  • Levalbuterol
  • Levomilnacipran
  • Levorphanol
  • Levothyroxine
  • Lidoflazine
  • Lisdexamfetamine
  • Lithium
  • Lopinavir
  • Lorcainide
  • Lorcaserin
  • Lornoxicam
  • Loxoprofen
  • Lumefantrine
  • Lumiracoxib
  • Meclofenamate
  • Mefenamic Acid
  • Mefloquine
  • Meloxicam
  • Meperidine
  • Methadone
  • Methamphetamine
  • Methoxamine
  • Midodrine
  • Milnacipran
  • Mirtazapine
  • Moricizine
  • Morniflumate
  • Morphine
  • Morphine Sulfate Liposome
  • Nabumetone
  • Nalbuphine
  • Naproxen
  • Naratriptan
  • Nefazodone
  • Nefopam
  • Nepafenac
  • Niflumic Acid
  • Nilotinib
  • Nimesulide
  • Nimesulide Beta Cyclodextrin
  • Norepinephrine
  • Norfloxacin
  • Nortriptyline
  • Octreotide
  • Ofloxacin
  • Ondansetron
  • Oxaprozin
  • Oxilofrine
  • Oxycodone
  • Oxymetazoline
  • Oxymorphone
  • Oxyphenbutazone
  • Paliperidone
  • Palonosetron
  • Parecoxib
  • Pargyline
  • Pazopanib
  • Pentamidine
  • Pentazocine
  • Phenylbutazone
  • Phenylephrine
  • Piketoprofen
  • Piroxicam
  • Pranoprofen
  • Procainamide
  • Procarbazine
  • Prochlorperazine
  • Proglumetacin
  • Promethazine
  • Propafenone
  • Propyphenazone
  • Proquazone
  • Protriptyline
  • Quinidine
  • Quinine
  • Rasagiline
  • Remifentanil
  • Rofecoxib
  • Salicylic Acid
  • Salsalate
  • Sematilide
  • Sertraline
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Sodium Salicylate
  • Solifenacin
  • Sorafenib
  • Sotalol
  • Spiramycin
  • Sufentanil
  • Sulfamethoxazole
  • Sulindac
  • Sumatriptan
  • Sunitinib
  • Tapentadol
  • Tedisamil
  • Telavancin
  • Telithromycin
  • Tenoxicam
  • Tetrabenazine
  • Tiaprofenic Acid
  • Tiotropium
  • Tolfenamic Acid
  • Tolmetin
  • Toremifene
  • Tramadol
  • Trazodone
  • Trifluoperazine
  • Trimethoprim
  • Trimipramine
  • Tryptophan
  • Valdecoxib
  • Vardenafil
  • Vasopressin
  • Venlafaxine
  • Vilanterol
  • Vilazodone
  • Voriconazole
  • Vortioxetine
  • Ziprasidone
  • Zolmitriptan

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.

  • Acenocoumarol
  • Arbutamine
  • Atomoxetine
  • Cannabis
  • Carbamazepine
  • Dicumarol
  • Paroxetine
  • Phenprocoumon
  • S-Adenosylmethionine

Other interactions—

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.

  • Ethanol

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.

Dosing—

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.

Missed dose—

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.

Storage—

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:

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:

Less common
Excitement
fast, irregular, pounding, or racing heartbeat or pulse
fear or nervousness
mood or mental changes
nightmares
restlessness
shakiness and unsteady walk
shakiness in legs, arms, hands, or feet
sleeplessness
swelling
trouble sleeping
unable to sleep
unsteadiness, trembling, or other problems with muscle control or coordination
Rare
Abdominal or stomach pain
actions that are out of control
black, tarry stools
bleeding gums
bloating
blood in urine or stools
blurred vision
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
chest pain or discomfort
chills
clay-colored stools
confusion
confusion about identity, place, and time
constipation
continuing ringing or buzzing or other unexplained noise in ears
convulsions
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
drooling
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
headache
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
indigestion
irritability
itching
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
nervousness
numbness
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
sweating
swollen glands
talking, feeling, and acting with excitement
testicular swelling
thirst
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:

Symptoms of overdose
Change in consciousness
drowsiness
epileptic seizure that will not stop
fatigue
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 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
Less common
Increased appetite
increased flow of breast milk
Rare
Agitation
breast enlargement
change in taste bad unusual or unpleasant (after)taste
decreased interest in sexual intercourse
depression
excess air or gas in stomach or intestines
full feeling
hair loss, thinning of hair
heartburn
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
seizures
severe sunburn
stupor
swollen, painful, or tender lymph glands on side of face or neck
tearing of the eyes
unexpected or excess milk flow from breasts

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: 7/4/2017
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