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Fluoxetine (Oral route)

Pronunciation:

floo-OX-e-teen

Brand Names:

  • PROzac
  • PROzac Weekly
  • Rapiflux
  • Sarafem
  • Selfemra
  • Phl-FLUoxetine

Dosage Forms:

  • Capsule
  • Capsule, Delayed Release
  • Tablet
  • Syrup
  • Solution

Warnings:

Oral route(Capsule;Capsule, Delayed Release)

Antidepressants can increase the risk of suicidal thinking and behavior in children, adolescents, and young adults with major depressive disorder. Closely monitor patients of all ages for clinical worsening and emergence of suicidal thoughts and behaviors. When using Prozac and olanzapine in combination, also refer to the Boxed Warning section of the package insert for Symbyax(R) .

Oral route(Solution)

Antidepressants can increase the risk of suicidal thinking and behavior in children, adolescents, and young adults with major depressive disorder. Closely monitor patients of all ages for clinical worsening and emergence of suicidal thoughts and behaviors. Prozac(R) is approved for use in pediatric patients with MDD and obsessive compulsive disorder (OCD) .

Oral route(Tablet)

Antidepressants can increase the risk of suicidal thinking and behavior in children, adolescents, and young adults with major depressive disorder. Closely monitor patients of all ages for clinical worsening and emergence of suicidal thoughts and behaviors. Sarafem(R) is not approved for use in pediatric patients .

Classifications:

Therapeutic—

Antidepressant

Pharmacologic—

Serotonin Reuptake Inhibitor

Uses of This Medicine:

Fluoxetine is used to treat depression, obsessive-compulsive disorder (OCD), bulimia nervosa, premenstrual dysphoric disorder (PMDD), and panic disorder. It is also used together with olanzapine to treat depression that is part of bipolar disorder.

Fluoxetine is an antidepressant and belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs). This medicine works by increasing the activity of a chemical called serotonin in the brain.

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of fluoxetine in children. However, safety and efficacy have not been established to treat depression in children younger than 8 years of age, and to treat obsessive-compulsive disorder in children younger than 7 years of age.

Appropriate studies have not been performed on the relationship of age to the effects of fluoxetine in children with bulimia nervosa or panic disorder. 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 fluoxetine in the elderly. However, elderly patients are more likely to have hyponatremia (low sodium in the blood) than younger adults, which may require caution and an adjustment in the dose for patients receiving fluoxetine.

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.

  • Amifampridine
  • Bepridil
  • Cisapride
  • Clorgyline
  • Dronedarone
  • Furazolidone
  • Iproniazid
  • Isocarboxazid
  • Levomethadyl
  • Linezolid
  • Mesoridazine
  • Methylene Blue
  • Metoclopramide
  • Moclobemide
  • Nialamide
  • Pargyline
  • Phenelzine
  • Pimozide
  • Piperaquine
  • Procarbazine
  • Rasagiline
  • Saquinavir
  • Selegiline
  • Sparfloxacin
  • Terfenadine
  • Thioridazine
  • Toloxatone
  • Tranylcypromine
  • Ziprasidone

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.

  • Abciximab
  • Abiraterone Acetate
  • Acecainide
  • Aceclofenac
  • Acemetacin
  • Acenocoumarol
  • Ajmaline
  • Alfuzosin
  • Almotriptan
  • Amineptine
  • Amiodarone
  • Amisulpride
  • Amitriptyline
  • Amitriptylinoxide
  • Amoxapine
  • Amphetamine
  • Amtolmetin Guacil
  • Anagrelide
  • Ancrod
  • Anisindione
  • Antithrombin III Human
  • Apixaban
  • Apomorphine
  • Aprindine
  • Ardeparin
  • Argatroban
  • Aripiprazole
  • Arsenic Trioxide
  • Asenapine
  • Aspirin
  • Astemizole
  • Atazanavir
  • Azimilide
  • Azithromycin
  • Bedaquiline
  • Bivalirudin
  • Bretylium
  • Bromfenac
  • Brompheniramine
  • Bufexamac
  • Bupropion
  • Buserelin
  • Carbamazepine
  • Carvedilol
  • Celecoxib
  • Certoparin
  • Chloral Hydrate
  • Chloroquine
  • Chlorpheniramine
  • Chlorpromazine
  • Choline Salicylate
  • Cilostazol
  • Cinacalcet
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clomipramine
  • Clonixin
  • Clopidogrel
  • Clozapine
  • Cobicistat
  • Cocaine
  • Codeine
  • Crizotinib
  • Cyclobenzaprine
  • Dabigatran Etexilate
  • Dabrafenib
  • Dalteparin
  • Danaparoid
  • Dasatinib
  • Defibrotide
  • Delamanid
  • Dermatan Sulfate
  • Desipramine
  • Desirudin
  • Deslorelin
  • Desvenlafaxine
  • Dexfenfluramine
  • Dexibuprofen
  • Dexketoprofen
  • Dextroamphetamine
  • Dextromethorphan
  • Dibenzepin
  • Diclofenac
  • Dicumarol
  • Diflunisal
  • Dipyridamole
  • Dipyrone
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Donepezil
  • Doxepin
  • Doxorubicin
  • Doxorubicin Hydrochloride Liposome
  • Droperidol
  • Drotrecogin Alfa
  • Duloxetine
  • Ebastine
  • Eletriptan
  • Eliglustat
  • Enflurane
  • Enoxaparin
  • Eptifibatide
  • Eribulin
  • Erythromycin
  • Escitalopram
  • Etodolac
  • Etofenamate
  • Etoricoxib
  • Famotidine
  • Felbamate
  • Felbinac
  • Fenfluramine
  • Fenoprofen
  • Fentanyl
  • Fepradinol
  • Feprazone
  • Fingolimod
  • Flecainide
  • Floctafenine
  • Fluconazole
  • Flufenamic Acid
  • Fluphenazine
  • Flurbiprofen
  • Fluvoxamine
  • Fondaparinux
  • Formoterol
  • Foscarnet
  • Fosphenytoin
  • Frovatriptan
  • Galantamine
  • Gatifloxacin
  • Gemifloxacin
  • Gonadorelin
  • Goserelin
  • Granisetron
  • Halofantrine
  • Haloperidol
  • Halothane
  • Heparin
  • Histrelin
  • Hydroquinidine
  • Hydroxytryptophan
  • Ibuprofen
  • Ibuprofen Lysine
  • Ibutilide
  • Iloperidone
  • Imipramine
  • Indomethacin
  • Iobenguane I 123
  • Isoflurane
  • Isradipine
  • Itraconazole
  • Ivabradine
  • Ketoconazole
  • Ketoprofen
  • Ketorolac
  • Lapatinib
  • Lepirudin
  • Leuprolide
  • Levofloxacin
  • Levomilnacipran
  • Lidoflazine
  • Lofepramine
  • Lorcaserin
  • Lornoxicam
  • Loxoprofen
  • Lumefantrine
  • Lumiracoxib
  • Meclofenamate
  • Mefenamic Acid
  • Mefloquine
  • Melitracen
  • Meloxicam
  • Meperidine
  • Methadone
  • Metronidazole
  • Mexiletine
  • Mifepristone
  • Milnacipran
  • Mirtazapine
  • Mizolastine
  • Morniflumate
  • Moxifloxacin
  • Nabumetone
  • Nadroparin
  • Nafarelin
  • Naproxen
  • Naratriptan
  • Nefazodone
  • Nepafenac
  • Niflumic Acid
  • Nilotinib
  • Nimesulide
  • Norfloxacin
  • Nortriptyline
  • Octreotide
  • Olanzapine
  • Ondansetron
  • Opipramol
  • Oxaprozin
  • Oxyphenbutazone
  • Paliperidone
  • Palonosetron
  • Parecoxib
  • Parnaparin
  • Paroxetine
  • Pasireotide
  • Pazopanib
  • Pentamidine
  • Pentazocine
  • Pentosan Polysulfate Sodium
  • Perflutren Lipid Microsphere
  • Perphenazine
  • Phenindione
  • Phenprocoumon
  • Phenylbutazone
  • Piketoprofen
  • Pirmenol
  • Piroxicam
  • Posaconazole
  • Prajmaline
  • Pranoprofen
  • Prasugrel
  • Probucol
  • Procainamide
  • Prochlorperazine
  • Proglumetacin
  • Promethazine
  • Propafenone
  • Propranolol
  • Propyphenazone
  • Proquazone
  • Protein C, Human
  • Protriptyline Hydrochloride
  • Quetiapine
  • Quinine
  • Ranolazine
  • Reviparin
  • Rilpivirine
  • Risperidone
  • Ritonavir
  • Rivaroxaban
  • Rizatriptan
  • Rofecoxib
  • Salicylic Acid
  • Salsalate
  • Sematilide
  • Sertindole
  • Sertraline
  • Sevoflurane
  • Sibutramine
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Sodium Salicylate
  • Solifenacin
  • Sorafenib
  • Sotalol
  • Spiramycin
  • St John's Wort
  • Sulfamethoxazole
  • Sulfinpyrazone
  • Sulindac
  • Sultopride
  • Sumatriptan
  • Sunitinib
  • Tacrolimus
  • Tamoxifen
  • Tapentadol
  • Tedisamil
  • Telavancin
  • Telithromycin
  • Tenoxicam
  • Terbinafine
  • Tetrabenazine
  • Tianeptine
  • Tiaprofenic Acid
  • Ticagrelor
  • Ticlopidine
  • Timolol
  • Tinzaparin
  • Tirofiban
  • Tizanidine
  • Tolfenamic Acid
  • Tolmetin
  • Tolterodine
  • Toremifene
  • Tramadol
  • Trazodone
  • Treprostinil
  • Trifluoperazine
  • Trimethoprim
  • Trimipramine
  • Triptorelin
  • Tryptophan
  • Valdecoxib
  • Valproic Acid
  • Vandetanib
  • Vardenafil
  • Vasopressin
  • Vemurafenib
  • Venlafaxine
  • Vilazodone
  • Vinflunine
  • Voriconazole
  • Vorinostat
  • Vortioxetine
  • Warfarin
  • Zolmitriptan
  • Zotepine

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.

  • Alprazolam
  • Buspirone
  • Cyproheptadine
  • Delavirdine
  • Digoxin
  • Ginkgo
  • Lithium
  • Nebivolol
  • Phenytoin

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. Discuss with your healthcare professional the use of your medicine with 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 mania and depression), or risk of or
  • Bleeding problems or
  • Diabetes or
  • Glaucoma (angle-closure type) or
  • Hyponatremia (low sodium in the blood) or
  • Mania, history of or
  • Seizures, history of—Use with caution. May make these conditions worse.
  • Heart attack or stroke, recent or history of or
  • Heart failure or
  • Heart rhythm problems (eg, QT prolongation), or history of or
  • Hypokalemia (low potassium in the blood) or
  • Hypomagnesemia (low magnesium in the blood)—May cause side effects to become worse.
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

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. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

You may take the medicine with or without food.

For some conditions, it may take a month or longer before you begin to feel better.

If you are using the oral liquid, shake the bottle well before measuring each dose. Measure the liquid with a marked measuring spoon, oral syringe, or medicine cup. A regular household teaspoon will not measure the proper amount of medicine.

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 forms (delayed-release capsules, pulvules, or solution):
    • For bulimia nervosa:
      • Adults—60 milligrams (mg) per day as a single dose in the morning.
      • Children—Use and dose must be determined by your doctor.
    • For depression:
      • Adults—At first, 20 milligrams (mg) per day as a single dose in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 80 mg per day. After a few weeks, your doctor may change you to a weekly dose of 90 mg, taken as a single dose one day per week.
      • Children 8 years of age and older—At first, 10 to 20 mg per day as a single dose in the morning. Your doctor may adjust your dose as needed.
      • Children younger than 8 years of age—Use and dose must be determined by your doctor.
    • For obsessive-compulsive disorder:
      • Adults—At first, 20 milligrams (mg) per day as a single dose in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 80 mg per day.
      • Children 7 years of age and older—At first, 10 mg per day as a single dose in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg per day.
      • Children younger than 7 years of age—Use and dose must be determined by your doctor.
    • For panic disorder:
      • Adults—At first, 10 milligrams (mg) per day as a single dose in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg per day.
      • Children—Use and dose must be determined by your doctor.
    • For premenstrual dysphoric disorder:
      • Adults—At first, 20 milligrams (mg) per day as a single dose in the morning. Your doctor may have you take 20 mg every day of your menstrual cycle or for only 15 days of your cycle. Your doctor may adjust your dose as needed. However, the dose is usually not more than 80 mg per day.
      • 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 important that your doctor check your progress at regular visits, to allow changes in your dose and help reduce any side effects. Blood tests may be needed to check for unwanted effects.

Do not take fluoxetine with a monoamine oxidase (MAO) inhibitor (eg, isocarboxazid [Marplan®], linezolid [Zyvox®], methylene blue injection, phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]). Do not start taking fluoxetine during the 2 weeks after you stop a MAO inhibitor and wait 5 weeks after stopping fluoxetine before you start taking a MAO inhibitor. If you take them together or do not wait the proper amount of time, you may develop confusion, agitation, restlessness, stomach or intestinal symptoms, a sudden high body temperature, an extremely high blood pressure, or severe convulsions.

Do not take thioridazine (Mellaril®) with fluoxetine and wait 5 weeks after stopping fluoxetine before you start taking thioridazine. Do not use pimozide (Orap®) with fluoxetine. Using these medicines together can cause very serious heart problems.

Fluoxetine may cause a serious condition called serotonin syndrome if taken together with some medicines. Do not use fluoxetine with buspirone (Buspar®), fentanyl (Abstral®, Duragesic®), lithium (Eskalith®, Lithobid®), tryptophan, St. John's wort, or some pain or migraine medicines (eg, rizatriptan, sumatriptan, tramadol, Frova®, Imitrex®, Maxalt®, Relpax®, Ultram®, Zomig®). Check with your doctor first before taking any other medicines with fluoxetine.

Fluoxetine may cause some teenagers and young adults 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. Some people may have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. If you or your caregiver notice any of these unwanted effects, tell your doctor right away. Let the doctor know if you or anyone in your family has bipolar disorder (manic-depressive) or has tried to commit suicide.

Do not suddenly stop taking this medicine without checking first with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This will decrease the chance of having withdrawal symptoms such as agitation, breathing problems, chest pain, confusion, diarrhea, dizziness or lightheadedness, fast heartbeat, headache, increased sweating, muscle pain, nausea, restlessness, runny nose, trouble in sleeping, trembling or shaking, unusual tiredness or weakness, vision changes, or vomiting.

Tell your doctor right away if you develop a rash or hives, swelling of the face, eyes, or mouth, or trouble breathing after taking this medicine.

This medicine may increase your risk for bleeding problems. Make sure your doctor knows if you are also taking other medicines that thin the blood, such as aspirin, nonsteroidal antiinflammatory agents, also called NSAIDs (eg, diclofenac, ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, Voltaren®), or warfarin (Coumadin®, Jantoven®).

Hyponatremia (low sodium in the blood) may occur with this medicine. Check with your doctor right away if you have confusion, difficulty concentrating, headaches, memory problems, weakness, and unsteadiness.

Contact your doctor right away if you have dizziness, fainting, or a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you have ever had a heart rhythm problem, such as QT prolongation, or if you or a family member has had a heart attack, heart failure, low blood pressure, or a stroke.

The use of alcohol is not recommended in patients who are taking fluoxetine.

For diabetic patients:

  • This medicine may affect blood sugar levels. If you are diabetic and notice a change in the results of your blood or urine sugar tests, check with your doctor.

This medicine may cause some people to become drowsy or less able to think clearly, or to have poor muscle control. Make sure you know how you react to fluoxetine before you drive, use machines, or do anything else that could be dangerous if you are not alert and well able to control your movements.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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:

More common
Hives, itching, or skin rash
inability to sit still
restlessness
Less common
Chills or fever
joint or muscle pain
Rare
Anxiety
cold sweats
confusion
convulsions (seizures)
cool pale skin
diarrhea
difficulty with concentration
drowsiness
dryness of the mouth
excessive hunger
fast or irregular heartbeat
headache
increased sweating
increased thirst
lack of energy
mood or behavior changes
overactive reflexes
purple or red spots on the skin
racing heartbeat
shakiness or unsteady walk
shivering or shaking
talking, feeling, and acting with excitement and activity you cannot control
trouble with breathing
unusual or incomplete body or facial movements
unusual tiredness or weakness
Incidence not known
Abdominal or stomach pain
agitation
back or leg pains
bleeding gums
blindness
blistering, peeling, or loosening of the skin
bloating
blood in the urine or stools
bloody, black or tarry stools
blue-yellow color blindness
blurred vision
chest pain or discomfort
clay-colored stools
constipation
continuing vomiting
cough or dry cough
dark urine
decreased urine output
decreased vision
depression
difficulty with breathing
difficulty with swallowing
dizziness or lightheadedness
eye pain
fainting
fast, pounding, or irregular heartbeat or pulse
general body swelling
high fever
hives, itching, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
hostility
indigestion
irregular or slow heart rate
irritability
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
light-colored stools
loss of appetite
loss of bladder control
muscle twitching
nausea
nightmares
no blood pressure or pulse
noisy breathing
nosebleeds
pain in the ankles or knees
painful, red lumps under the skin, mostly on the legs
pains in the stomach, side, or abdomen, possibly radiating to the back
pinpoint red spots on the skin
rapid weight gain
red or irritated eyes
red skin lesions, often with a purple center
redness, tenderness, itching, burning, or peeling of the skin
severe muscle stiffness
severe sleepiness
slurred speech
sore throat
sores, ulcers, or white spots on the lips or in the mouth
stopping of heart
sudden shortness of breath or troubled breathing
sudden weakness in the arms or legs
sudden, severe chest pain
swelling of the face, ankles, or hands
swollen or painful glands
thoughts of killing oneself
tightness in the chest
tiredness
twitching, twisting, or uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
unconsciousness
unpleasant breath odor
unusual bleeding or bruising
unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
unusually pale skin
use of extreme physical or emotional force
vomiting of blood
yellow eyes or skin

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
Decreased appetite
Less common or rare
Abnormal dreams
breast enlargement or pain
change in sense of taste
changes in vision
feeling of warmth or heat
flushing or redness of the skin, especially on face and neck
frequent urination
hair loss
increased appetite
increased sensitivity of the skin to sunlight
menstrual pain
stomach cramps, gas, or pain
unusual secretion of milk, in females
weight loss
yawning
Incidence not known
Cracks in the skin
loss of heat from the body
painful or prolonged erections of the penis
scaly skin
swelling of the breasts or breast soreness in both females and males
unusual milk production

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: 11/4/2014

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