What is fluoxetine?

floo-OX-e-teen

Commonly used brand name(s)

In the U.S.

PROzac
PROzac Weekly
Rapiflux
Sarafem
Selfemra

In Canada

Phl-FLUoxetine

Available Dosage Forms:

Capsule
Capsule, Delayed Release
Tablet
Syrup
Solution

Therapeutic Class: Antidepressant

Pharmacologic Class: Serotonin Reuptake Inhibitor

Uses For fluoxetine

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). fluoxetine works by increasing the activity of a chemical called serotonin in the brain.

fluoxetine is available only with your doctor's prescription.

Before Using fluoxetine

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 fluoxetine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to fluoxetine 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.

Pediatric

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.

Geriatric

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 Category Explanation All Trimesters C Animal 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.

Interactions with 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 fluoxetine, 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 fluoxetine 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 fluoxetine 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
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
Darunavir
Dasatinib
Defibrotide
Degarelix
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
Hydroxychloroquine
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
Panobinostat
Parecoxib
Parnaparin
Paroxetine
Pasireotide
Pazopanib
Pentamidine
Pentazocine
Pentosan Polysulfate Sodium
Perflutren Lipid Microsphere
Perphenazine
Phenindione
Phenprocoumon
Phenylbutazone
Piketoprofen
Pirmenol
Piroxicam
Posaconazole
Prajmaline
Prasugrel
Probucol
Procainamide
Prochlorperazine
Proglumetacin
Promethazine
Propafenone
Propionic Acid
Propranolol
Propyphenazone
Proquazone
Protein C
Protriptyline
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 fluoxetine 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

Interactions with Food/Tobacco/Alcohol

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.

Proper Use of fluoxetine

Take fluoxetine 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.

fluoxetine 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 fluoxetine 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 fluoxetine. 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 fluoxetine, 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 fluoxetine

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 fluoxetine 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 fluoxetine.

fluoxetine 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 fluoxetine. 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:

fluoxetine 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.

fluoxetine 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.

fluoxetine Side Effects

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, 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.

How to use fluoxetine?

Usual Adult Dose for Bulimia

Immediate-release oral formulations:
Recommended dose: 60 mg orally once a day

Comments:
-Some patients may need to be started at a lower dose and titrated up over several days to the recommended dose
-Daily doses greater than 60 mg have not been systematically studied for the treatment of Bulimia

Use: Acute and maintenance treatment of binge-eating and vomiting behaviors in moderate to severe Bulimia Nervosa.

Usual Adult Dose for Depression

Immediate-release oral formulations:
Initial dose: 20 mg orally once a day, increased after several weeks if insufficient clinical improvement is observed
Maintenance dose: 20 to 60 mg orally per day
Maximum dose: 80 mg orally per day

Delayed release oral capsules:
Initial dose: 90 mg orally once a week, commenced 7 days after the last daily dose of immediate-release fluoxetine 20 mg formulations.

Comments:
-Doses above 20 mg per day may be given in divided doses, in the morning and at noon
-The full effect may be delayed until after at least 4 weeks of treatment
-If a satisfactory response with the once weekly oral fluoxetine is not maintained, a change back to daily fluoxetine dosing using the immediate-release oral formulations should be considered.
-Acute episodes of Major Depressive Disorder require several months or longer of sustained pharmacologic therapy
-Whether the dose needed to induce remission is the same as the dose needed to maintain and/or sustain euthymia is unknown

Use: Acute and maintenance treatment of Major Depressive Disorder (MDD)

Usual Adult Dose for Obsessive Compulsive Disorder

Immediate-release oral formulations:
Initial dose: 20 mg orally once a day, increased after several weeks if insufficient clinical improvement is observed.
Maintenance dose: 20 to 60 mg orally per day
Maximum dose: 80 mg orally per day

Comments:
-Doses above 20 mg per day may be given in divided doses, in the morning and at noon
-The full effect may be delayed until after at least 5 weeks of treatment

Use: Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD)

Usual Adult Dose for Panic Disorder

Immediate-release oral formulations:
Initial dose: 10 mg orally once a day, increased after one week to 20 mg orally once a day
Maintenance dose: 20 to 60 mg orally per day
Maximum dose: 60 mg orally per day

Comments:
-Doses above 20 mg per day may be given in divided doses, in the morning and at noon
-A dose increase may be considered after several weeks if no clinical improvement is observed.
-Doses greater than 60 mg per day have not been systematically studied for the treatment of Panic Disorder

Use: Acute treatment of Panic Disorder

Usual Adult Dose for Premenstrual Dysphoric Disorder

Immediate-release oral formulations:
Initial dose:
Continuous regimen: 20 mg orally once a day on every day of the menstrual cycle
Cyclic regimen: 20 mg orally once a day starting 14 days prior to the anticipated start of menstruation through to the first full day of menses, and repeated with each new cycle

Maintenance dose: 20 to 60 mg per day for either the continuous or intermittent regimens
Maximum dose: 80 mg orally per day

Duration: The 20 mg daily dosage has been shown to be effective for up to 6 months of treatment

Comments:
-A daily dose of 60 mg has not been shown to be significantly more effective than 20 mg daily
-Daily doses above 60 mg have not been systematically studied in patients with this condition

Usual Pediatric Dose for Depression

Immediate-release oral formulations:
8 to 18 years:
Initial dose: 10 to 20 mg orally once a day; the 10 mg daily dose may be increased after one week to 20 mg orally once a day

Lower weight children:
Initial dose: 10 mg orally once a day, increased to 20 mg orally once a day after several weeks if insufficient clinical improvement is observed

Maintenance dose: 10 to 20 mg orally once a day

Comments:
-The full effect may be delayed until after at least 4 weeks of treatment
-The potential risks versus clinical need should be assessed prior to using this drug in children and adolescents

Use: Acute and maintenance treatment of Major Depressive Disorder (MDD)

Usual Pediatric Dose for Obsessive Compulsive Disorder

7 to 18 years:
Immediate-release oral formulations:
Adolescents and higher weight children:
Initial dose: 10 mg orally once a day, increased to 20 mg orally once a day after 2 weeks
Maintenance dose: 20 to 60 mg orally per day
Maximum dose: 60 mg orally per day

Lower weight children:
Initial dose: 10 mg orally once a day, increased after several weeks if insufficient clinical improvement is observed
Maintenance dose: 20 to 30 mg orally once a day
Maximum dose: 60 mg orally per day

Comments:
-Additional dose increases may be considered after several more weeks if clinical improvement is insufficient
-Doses above 20 mg per day may be given in divided doses, in the morning and at noon
-In lower weight children, there is minimal experience with doses greater than 20 mg per day, and none with doses greater than 60 mg per day
-The full effect may be delayed until after at least 5 weeks of treatment
-The potential risks versus clinical need should be assessed prior to using this drug in children and adolescents

Use: Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

Immediate-release oral formulations:
Adults:
Cirrhosis: Lower or less frequent dosing may be appropriate in these patients

Children: Dose adjustment may be required; however, no specific guidelines have been suggested. Caution is recommended.

Delayed-release oral capsules: Data not available

Dose Adjustments

A lower or less frequent dose should be considered in elderly patients.

Patients with concurrent disease or those on multiple concomitant medicines may require dose adjustment.

Switching from
MAOI therapy to fluoxetine therapy: At least 14 days should elapse
Fluoxetine therapy to MAOI therapy: At least 5 weeks should elapse
Fluoxetine therapy to TCA therapy: The dose of the TCA may need to be reduced and plasma levels temporarily monitored

Treatment withdrawal:
-A gradual dose reduction is recommended instead of abrupt cessation where possible
-If intolerable symptoms occur, it is recommended to consider resuming the previously prescribed dose and to decrease the dose at a more gradual rate.

Precautions

US BOXED WARNING:
-Antidepressants increase the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older.
-In patients of all ages who are started on antidepressant therapy, monitor closely for worsening and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber.
-Fluoxetine is not approved for use in children less than 7 years of age.

Safety and efficacy have not been established in pediatric patients younger than 8 years of age in Major Depressive Disorder and younger than 7 years of age in Obsessive Compulsive Disorder.

Consult WARNINGS section for additional precautions.

Dialysis

No adjustment recommended

Other Comments

Administration advice:
-A once a day dose should be taken in the morning; doses greater than 20 mg per day may be divided into morning and noon doses.
-Because fluoxetine may cause insomnia, night-time dosing should be limited to those patients experiencing sedation.

General:
-Fluoxetine oral capsules (Pulvules (R)), tablets, oral solution, and delayed release oral capsules (given weekly) are bioequivalent
-Changes in dose will not be fully reflected in plasma for several weeks due to the long elimination half-lives of fluoxetine and its major active metabolite.
-The need for ongoing treatment should be regularly reviewed
-Patients should be maintained on the lowest effective dose
-Avoid use as monotherapy in treatment-resistant depression i.e., patients who do not respond to two antidepressants of adequate dose and duration in the current episode

Monitoring:
-Cardiovascular: ECG monitoring (in patients with risk factors for QT-interval prolongation)
-Hepatic: Liver function
-Metabolic: Hyponatremia
-Nervous system: Serotonin syndrome
-Psychiatric: Emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

Patient advice:
-Tell your healthcare provider about all of the medicines that you take, including prescription and non-prescription medicines.
-This medicine may increase the risk of suicidal thoughts and behavior. Be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Report any behavior of concern to your healthcare provider as soon as possible.
-This medicine may cause impaired judgment, thinking, or motor skills; do not drive a car or operate dangerous machinery until you know how this drug affects you.
-Concomitant ingestion of alcohol is not advised.

What are the side effects of fluoxetine?

Fluoxetine, as with most antidepressants, can cause nausea, headaches, anxiety, insomnia, drowsiness, and loss of appetite. Fluoxetine has been implicated in serious skin rashes and vasculitis (inflammation of small blood vessels). Increased blood pressure can occur, and blood pressure should be monitored. Seizures have been reported as has sexual dysfunction. Some patients may experience withdrawal reactions upon stopping fluoxetine. Symptoms of withdrawal include anxiety, nausea, nervousness, and insomnia. The dose of fluoxetine should be gradually reduced when therapy is discontinued. Fluoxetine and other antidepressants have been associated with angle closure attacks in people with narrow angle glaucoma.

What are the precautions of fluoxetine?

Capsules: 10, 20 and 40 mg. Capsules (delayed release): 90 mg. Tablets: 10, 20 and 60 mg. Oral suspension: 20 mg/5ml

What is fluoxetine?

Commonly used brand name(s)

Uses For fluoxetine

Before Using fluoxetine

Allergies

Pediatric

Geriatric

Pregnancy

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Proper Use of fluoxetine

Dosing

Missed Dose

Storage

Precautions While Using fluoxetine

fluoxetine Side Effects

How to use fluoxetine?

Usual Adult Dose for Bulimia

Usual Adult Dose for Depression

Usual Adult Dose for Obsessive Compulsive Disorder

Usual Adult Dose for Panic Disorder

Usual Adult Dose for Premenstrual Dysphoric Disorder

Usual Pediatric Dose for Depression

Usual Pediatric Dose for Obsessive Compulsive Disorder

Renal Dose Adjustments

Liver Dose Adjustments

Dose Adjustments

Precautions

Dialysis

Other Comments

What are the side effects of fluoxetine?

What are the precautions of fluoxetine?