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.
NEFAZODONE - ORAL
COMMON BRAND NAME(S): Serzone
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 immediately 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.
Nefazodone has rarely caused very serious (possibly fatal) liver disease. Tell your doctor immediately if you develop symptoms of liver disease, including severe stomach/abdominal pain, unusual tiredness, persistent loss of appetite, dark urine, yellowing eyes/skin, persistent nausea/vomiting.
Before using this medication, tell your doctor if you have liver disease or abnormal liver function tests.
Your doctor should perform liver function tests periodically while you are taking this medication. If your doctor directs you to stop taking this medication because of liver problems or abnormal liver function tests, you should not take this drug again. Consult your doctor or pharmacist for more details.
USES: This medication is used to treat depression. Because of the risk of liver disease, this medication is usually used after trying other drugs. Nefazodone works by helping to restore the balance of certain natural chemicals (neurotransmitters such as serotonin, norepinephrine) in the brain.
HOW TO USE: Read the Medication Guide and Patient Information Leaflet provided by your pharmacist before you start using nefazodone and each time you get a refill. If you have any questions, consult your doctor or pharmacist.
Take this medication by mouth with or without food, usually twice daily or as directed by your doctor.
Dosage is based on your medical condition and response to treatment. To reduce your risk of side effects, your doctor may start you at a low dose and gradually increase your dose.
Take this medication exactly as prescribed. Do not increase your dose or take this medication more often than prescribed. Your condition will not improve any faster, and the risk of serious side effects may be increased.
Use this medication regularly in order to get the most benefit from it. To help you remember, take it at the same times each day.
It is important to continue taking this medication as prescribed even if you feel well. Do not stop taking this medication without consulting your doctor.
It may take several weeks before this drug takes effect. Tell your doctor if your condition persists or worsens.
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To reduce dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.
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.
Get medical help right away if you have any very serious side effects, including: black stools, vomit that looks like coffee grounds, eye pain/swelling/redness, vision changes (such as seeing rainbows around lights at night, blurred vision).
For males, in the very unlikely event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and seek immediate medical attention, or permanent problems could occur.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: 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.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Serzone (nefazodone) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: See also Warning section.
Before taking nefazodone, tell your doctor or pharmacist if you are allergic to it; or to trazodone; 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: liver disease, personal or family history of psychiatric disorder (e.g., bipolar/manic-depressive disorder), personal or family history of suicide attempts, heart/blood vessel disease (e.g., history of stroke/heart attack), loss of too much body water (dehydration), seizures, intestinal ulcers/bleeding (peptic ulcer disease), personal or family history of glaucoma (angle-closure type).
Before having surgery, tell your doctor or dentist that you are using this medication.
This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages since they can make you dizzy or drowsy and also cause liver disease.
Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially dizziness/drowsiness or bleeding.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
Since untreated mental/mood problems (such as depression) 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.
It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.
Some products that may interact with this drug include: carbamazepine, eplerenone, ergot alkaloids (such as dihydroergotamine, ergonovine, ergotamine, methylergonovine), ivabradine, lurasidone, pimozide, triazolam, alpha blockers (e.g., terazosin), digoxin, fluoxetine, medications for high blood pressure, other antidepressants (e.g., trazodone, SSRIs such as fluoxetine), other drugs that can cause bleeding/bruising (e.g., anticoagulants such as heparin or warfarin, antiplatelet drugs including NSAIDs such as ibuprofen).
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 and 1 week after treatment with this medication. Ask your doctor when to start or stop taking this medication.
Avoid taking eletriptan within 72 hours of taking this medication.
This medication can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include buspirone, cyclosporine, dasatinib, domperidone, fentanyl, regorafenib, sunitinib, tacrolimus, "statin" cholesterol drugs (such as simvastatin, lovastatin, atorvastatin), certain benzodiazepines (such as alprazolam, diazepam) among others.
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., phenytoin), medicine for sleep (e.g., zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, haloperidol).
Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about using those products safely.
Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (NSAIDs such as aspirin, ibuprofen, naproxen) that may increase your risk for bleeding if taken together with this drug. Low-dose aspirin should be continued if prescribed by your doctor for specific medical reasons such as heart attack or stroke prevention (usually at dosages of 81-325 milligrams per day). Consult your doctor or pharmacist for more details.
Also report the use of drugs which might increase seizure risk when combined with nefazodone such as isoniazid (INH), phenothiazines (e.g., thioridazine), theophylline, or tricyclic antidepressants (e.g., amitriptyline), among others. Consult your doctor or pharmacist for details.
OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: nausea, vomiting, extreme drowsiness.
NOTES: Do not share this medication with others.
Psychiatric/medical checkups (and laboratory tests such as liver function tests) must be done periodically to monitor your progress and 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 between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines 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 for more details about how to safely discard your product.
Information last revised March 2015. Copyright(c) 2015 First Databank, Inc.