Sarafem (Fluoxetine Hydrochloride)
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Fluoxetine Hydrochloride Information
(floo ox' e teen)A small number of children, teenagers, and young adults (up to 24 years of age) who took antidepressants ('mood elevators') such as fluoxetine during clinical studies became suicidal (thinking about harming or killing oneself or planning or trying to do so). Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal than children, teenagers, and young adults who do not take antidepressants to treat these conditions. However, experts are not sure about how great this risk is and how much it should be considered in deciding whether a child or teenager should take an antidepressant. You should know that your mental health may change in unexpected ways when you take fluoxetine or other antidepressants even if you are an adult over 24 years of age. You may become suicidal, especially at the beginning of your treatment and any time that your dose is increased or decreased. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and frenzied abnormal excitement. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own. Your healthcare provider will want to see you often while you are taking fluoxetine, especially at the beginning of your treatment. Be sure to keep all appointments for office visits with your doctor. No matter your age, before you take an antidepressant, you, your parent, or your caregiver should talk to your doctor about the risks and benefits of treating your condition with an antidepressant or with other treatments. You should also talk about the risks and benefits of not treating your condition. You should know that having depression or another mental illness greatly increases the risk that you will become suicidal. This risk is higher if you or anyone in your family has or has ever had bipolar disorder (mood that changes from depressed to abnormally excited) or mania (frenzied, abnormally excited mood) or has thought about or attempted suicide. Talk to your doctor about your condition, symptoms, and personal and family medical history. You and your doctor will decide what type of treatment is right for you.
Before taking fluoxetine,
- tell your doctor and pharmacist if you are allergic to fluoxetine, any other medications, or any of the ingredients in fluoxetine preparations. Ask your pharmacist for a list of the ingredients.
- tell your doctor if you are taking pimozide (Orap), thioridazine, or a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate), or if you have stopped taking a monoamine oxidase inhibitor within the past 2 weeks. Your doctor will probably tell you that you should not take fluoxetine. If you stop taking fluoxetine, you should wait at least 5 weeks before you begin to take thioridazine or a monoamine oxidase inhibitor.
- tell your doctor and pharmacist what other prescription and nonprescription medications and vitamins you are taking or plan to take. Be sure to mention any of the following: alprazolam (Xanax); amiodarone (Pacerone, Nexterone); certain antibiotics such as erythromycin (E.E.S, Eryc, Ery-tab), gatifloxacin, moxifloxacin (Avelox), and sparfloxacin (no longer available in U.S., Zagam); amphetamines such as amphetamine (in Adderall), dextroamphetamine (Dexedrine, Dextrostat, in Adderall), and methamphetamine (Desoxyn); anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven); antidepressants (mood elevators) such as amitriptyline (Elavil), amoxapine, clomipramine (Anafranil), desipramine (Norpramin), doxepin, imipramine (Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil); aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); buspirone; clopidogrel (Plavix); diazepam (Valium); digoxin (Lanoxin); diuretics ('water pills'); dolasetron (Anzemet); fentanyl (Duragesic, Lazanda, Subsys, others); flecainide (Tambocor); insulin or oral medications for diabetes; lithium (Lithobid); medications for anxiety and Parkinson's disease; medications for mental illness such as chlorpromazine, clozapine (Clozaril, Versacloz), droperidol (Inapsine), haloperidol (Haldol), iloperidone (Fanapt), and ziprasidone (Geodon); methadone (Methadose); medications for migraine headaches such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex), and zolmitriptan (Zomig); pentamidine (Pentam); quinidine (in Nuedexta); procainamide; medications for seizures such as carbamazepine (Epitol, Tegretol, Teril) and phenytoin (Dilantin, Phenytek); sedatives; sleeping pills; other selective serotonin-reuptake inhibitors such as citalopram (Celexa), fluoxetine (Prozac, Sarafem, Selfemra), or fluvoxamine (Luvox); serotonin–norepinephrine reuptake inhibitors (SNRI) medications desvenlafaxine (Khedezla, Pristiq), duloxetine (Cymbalta), levomilnacipran (Fetzima), and venlafaxine; sotalol (Betapace, Sorine); tramadol (Ultram); tranquilizers; and vinblastine (Velban). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor what nutritional supplements and herbal products you are taking, especially products that contain St. John's wort or tryptophan.
- tell your doctor if you or anyone in your family has or has ever had a prolonged QT interval (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death). Also tell your doctor if you have a low level of potassium or magnesium in your blood or are being treated with electroshock therapy (procedure in which small electric shocks are administered to the brain to treat certain mental illnesses). Tell your doctor if you have recently had a heart attack and if you have or have ever had heart failure, diabetes, seizures, or liver or heart disease.
- tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, or if you plan to become pregnant or are breastfeeding. If you become pregnant while taking fluoxetine, call your doctor. Fluoxetine may cause problems in newborns following delivery if it is taken during the last months of pregnancy.
- talk to your doctor about the risks and benefits of taking fluoxetine on a daily basis if you are 65 years of age or older. Older adults should not usually take fluoxetine on a daily basis because it is not as safe as other medications that can be used to treat the same conditions.
- you should know that fluoxetine may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
- remember that alcohol can add to the drowsiness caused by this medication.
- you should know that fluoxetine may cause angle-closure glaucoma (a condition where the fluid is suddenly blocked and unable to flow out of the eye causing a quick, severe increase in eye pressure which may lead to a loss of vision). Talk to your doctor about having an eye examination before you start taking this medication. If you have nausea, eye pain, changes in vision, such as seeing colored rings around lights, and swelling or redness in or around the eye, call your doctor or get emergency medical treatment right away.
- difficulty falling asleep or staying asleep
- dry mouth
- uncontrollable shaking of a part of the body
- loss of appetite
- weight loss
- changes in sex drive or ability
- excessive sweating
- headache, confusion, weakness, difficulty concentrating, or memory problems
- hives or blisters
- joint pain
- swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
- difficulty breathing or swallowing
- agitation, fever, sweating, confusion, fast or irregular heartbeat, shivering, severe muscle stiffness or twitching, hallucinations, loss of coordination, nausea, vomiting, or diarrhea
- fast, slow, or irregular heartbeat
- shortness of breath
- dizziness or fainting
- abnormal bleeding or bruising