IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
AMOXAPINE - ORAL
COMMON BRAND NAME(S): Asendin
WARNING: Antidepressant medications are used to treat a variety of conditions, including depression and other mental/mood disorders. These medications can help prevent suicidal thoughts/attempts and provide other important benefits. However, studies have shown that a small number of people (especially people younger than 25) who take antidepressants for any condition may experience worsening depression, other mental/mood symptoms, or suicidal thoughts/attempts. Therefore, it is very important to talk with the doctor about the risks and benefits of antidepressant medication (especially for people younger than 25), even if treatment is not for a mental/mood condition.
Tell the doctor right away if you notice worsening depression/other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, trouble sleeping, irritability, hostile/angry feelings, impulsive actions, severe restlessness, very rapid speech). Be especially watchful for these symptoms when a new antidepressant is started or when the dose is changed.
USES: This medication is used to treat depression. Treating depression can improve your mood and sense of well-being and allow you to enjoy everyday life more.
Amoxapine is a tricyclic antidepressant. It works by restoring the balance of natural chemicals (neurotransmitters) in the brain. Because amoxapine has some effects that are similar to those of major tranquilizers, it may work better in patients who have agitation or anxiety along with depression.
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
Amoxapine may also be used to treat anxiety disorders (e.g., panic disorder) and bipolar disorder. Your doctor may also use this medication to treat other conditions.
HOW TO USE: Read the Medication Guide if one is available from your pharmacist. Consult your doctor or pharmacist if you have any questions.
Take this medication by mouth with or without food, one or more time(s) daily. To lessen side effects, amoxapine may be started at a low dose and slowly increased as your body gets used to it. Follow your doctor's instructions carefully. After you have reached the best dose for you, the total dose (when the daily dose is 300 milligrams or less) can be taken once daily, usually at bedtime to prevent daytime drowsiness, or as directed by your doctor. Your dosage is based on your medical condition, age, and your response to therapy.
Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time(s) each day. This medication does not work right away. It may take up to two weeks before you experience the full benefits.
It is important to continue taking this medication even if you feel well. Do not suddenly stop taking this medication without consulting your doctor. Some conditions may become worse when the drug is abruptly stopped. Your dose may need to be gradually decreased.
Inform your doctor if your condition does not improve or if it worsens.
SIDE EFFECTS: See also the Warning section.
Drowsiness, dizziness, difficulty urinating, dry mouth, constipation, headache, weakness, blurred vision, or changes in appetite/weight may occur as your body gets used to the medication. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.
To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water or use a saliva substitute. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.
To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while using this drug, consult your pharmacist for help in selecting a laxative (e.g., stimulant-type with stool softener).
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if any of these unlikely but serious side effects occur: dizziness/fainting, feelings of restlessness, mental/mood changes (e.g., confusion, depression, hallucinations, nervousness), numbness/tingling of the hands/feet, ringing in the ears, shakiness (tremors), stomach/abdominal pain, severe vomiting/constipation.
Get medical help right away if you have any very serious side effects, including: chest pain, jaw/left arm pain, slow/fast/irregular heartbeat, pain/redness/swelling of arms/legs, seizures, severe headache, weakness on one side of the body, eye pain/swelling/redness, vision changes (such as seeing rainbows around lights at night), slurred speech.
In rare instances, this medication may increase your level of a certain natural chemical made by the body (prolactin). For females, this increase in prolactin may result in unwanted breast milk, missing/stopped periods, or difficulty becoming pregnant. For males, it may result in decreased sexual ability, inability to produce sperm, or enlarged breasts. If you develop any of these symptoms, tell your doctor right away.
This drug may rarely cause a condition known as tardive dyskinesia. In some cases, this condition may be permanent. Tell your doctor right away if you develop any unusual/uncontrolled movements (especially of the face, mouth, tongue, arms or legs).
Amoxapine may rarely cause a serious condition called neuroleptic malignant syndrome. Seek immediate medical attention if you develop the following: fever, muscle stiffness, increased sweating, fast/irregular heartbeat, severe confusion.
This medication may rarely cause serious blood problems (e.g., agranulocytosis, thrombocytopenia) or liver problems. Seek immediate medical attention if you notice any of the following rare but very serious side effects: easy bleeding/bruising, signs of infection (e.g., fever, persistent sore throat), severe stomach/abdominal pain, dark urine, yellowing of the eyes/skin.
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: See also the Warning section.
Before taking amoxapine, tell your doctor or pharmacist if you are allergic to it; or to other tricyclic antidepressants (e.g., amitriptyline); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood problems (e.g., agranulocytosis, thrombocytopenia), breathing problems (e.g., asthma, COPD), personal or family history of glaucoma (angle-closure type), intestinal problems (e.g., chronic constipation, ileus), heart problems (e.g., recent heart attack, arrhythmias, coronary artery disease, heart failure), kidney problems, liver problems, other mental/mood conditions (e.g., bipolar disorder, psychosis), family history of mental/mood conditions (e.g., bipolar disorder) or suicide, history of neuroleptic malignant syndrome, movement disorders (e.g., Parkinson's disease, tardive dyskinesia), overactive thyroid (hyperthyroidism), problems urinating (urinary retention, enlarged prostate), seizures, conditions that may increase your risk of seizures (e.g., electroshock therapy, stroke, alcohol withdrawal).
This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.
To minimize the dizziness and lightheadedness, get up slowly when rising from a seated or lying position.
Before having surgery, tell your doctor or dentist that you are taking this medication.
This drug may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths and sunlamps. Use a sunscreen and wear protective clothing when outdoors.
Older adults may be more sensitive to the side effects of this drug, especially drowsiness, dizziness, confusion, constipation, trouble urinating, and involuntary movements (tardive dyskinesia). Drowsiness, dizziness, and confusion can increase the risk of falling.
This medication should be used only when clearly needed during pregnancy. Infants born to mothers who have taken similar medications during pregnancy may have problems such as very deep sleep, trouble urinating, shaking (tremors), and seizures. Discuss the risks and benefits with your doctor.
Since untreated mental/mood problems (such as depression, panic disorders, bipolar disorder) can be a serious condition, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately discuss with your doctor the benefits and risks of using this medication during pregnancy.
This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Some products that may interact with this drug include: anticholinergics (e.g., atropine, belladonna alkaloids), certain drugs for high blood pressure (e.g., clonidine, guanethidine, reserpine), drugs for motion sickness (e.g., meclizine), psychiatric drugs (e.g., antipsychotics, antidepressants), thyroid supplements.
Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop taking this medication.
Also report the use of drugs which might increase seizure risk (decrease seizure threshold) when combined with this medication such as isoniazid (INH), phenothiazines (e.g., thioridazine), theophylline, tricyclic antidepressants (e.g., amitriptyline) or tramadol, among others. Consult your doctor or pharmacist for details.
Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicines for sleep or anxiety (e.g., alprazolam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, trazodone).
Check the labels on all your medicines (e.g., cough-and-cold products, diet aids, motion sickness) because they may contain drowsiness-causing ingredients, drying agents (anticholinergics) or stimulants/nasal decongestants. Ask your pharmacist about the safe use of those products.
This medication may interfere with certain medical/laboratory tests (including brain scan for Parkinson's disease), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
OVERDOSE: If overdose is suspected, contact a poison control center or emergency room right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Overdose of this medication may be fatal and symptoms include: seizures, delirium, and loss of consciousness .
NOTES: Do not share this medication with others.
Laboratory and/or medical tests may be performed periodically to monitor your progress or check for side effects. Keep all medical appointments so your doctor can monitor your progress closely or check for side effects. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised October 2015. Copyright(c) 2015 First Databank, Inc.