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FLUTONIN 20

Uses For fluoxetine

Fluoxetine is used to treat mental depression. It is also used to treat obsessive-compulsive disorder, bulimia nervosa, premenstrual dysphoric disorder (PMDD), and panic disorder.

Fluoxetine is used with olanzapine to treat depression that is a part of bipolar disorder. It is also used to treat treatment resistant depression in patients who have been treated with other antidepressants that did not work well. fluoxetine may also be used for other conditions as determined by your doctor.

Fluoxetine belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs). These medicines are thought to work by increasing the activity of a chemical called serotonin in the brain.

fluoxetine is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, fluoxetine is used in certain patients with the following medical conditions:

Premature ejaculation.

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 with depression. However, safety and efficacy have not been established in children below 8 years of age.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of fluoxetine in children with obsessive-compulsive disorder. However, safety and efficacy have not been established in children below 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 and panic disorder. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of olanzapine and fluoxetine combination in the pediatric population. 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 may be more sensitive to the effects of fluoxetine than younger adults and are more likely to have liver problems, 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

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.

Bepridil
Clorgyline
Dihydroergotamine
Ergoloid Mesylates
Ergonovine
Ergotamine
Furazolidone
Iproniazid
Isocarboxazid
Levomethadyl
Linezolid
Mesoridazine
Methylergonovine
Methysergide
Metoclopramide
Moclobemide
Nialamide
Pargyline
Phenelzine
Pimozide
Procarbazine
Selegiline
Terfenadine
Thioridazine
Toloxatone
Tranylcypromine

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
Acecainide
Acenocoumarol
Ajmaline
Almotriptan
Amiodarone
Amisulpride
Amitriptyline
Amoxapine
Ancrod
Anisindione
Antithrombin III Human
Aprindine
Ardeparin
Arsenic Trioxide
Aspirin
Astemizole
Azimilide
Bivalirudin
Bretylium
Certoparin
Chloral Hydrate
Chloroquine
Chlorpromazine
Cilostazol
Clarithromycin
Clopidogrel
Dalteparin
Danaparoid
Defibrotide
Dermatan Sulfate
Desipramine
Desirudin
Desvenlafaxine
Dexfenfluramine
Dextromethorphan
Dibenzepin
Dicumarol
Dipyridamole
Disopyramide
Dofetilide
Dolasetron
Doxepin
Droperidol
Duloxetine
Eletriptan
Enflurane
Enoxaparin
Eptifibatide
Erythromycin
Fenfluramine
Flecainide
Fluconazole
Fondaparinux
Foscarnet
Frovatriptan
Gemifloxacin
Halofantrine
Haloperidol
Halothane
Heparin
Hydroquinidine
Ibutilide
Imipramine
Isoflurane
Isradipine
Lidoflazine
Lorcainide
Mefloquine
Meperidine
Milnacipran
Mirtazapine
Nadroparin
Naratriptan
Nortriptyline
Octreotide
Parnaparin
Pentamidine
Pentosan Polysulfate Sodium
Phenindione
Phenprocoumon
Pirmenol
Prajmaline
Prasugrel
Probucol
Procainamide
Prochlorperazine
Propafenone
Quetiapine
Rasagiline
Reviparin
Rizatriptan
Sematilide
Sertindole
Sibutramine
Sotalol
Spiramycin
St John's Wort
Sulfamethoxazole
Sultopride
Sumatriptan
Tapentadol
Tedisamil
Telithromycin
Ticlopidine
Tinzaparin
Tirofiban
Tramadol
Trazodone
Trifluoperazine
Trimethoprim
Trimipramine
Tryptophan
Vasopressin
Venlafaxine
Warfarin
Ziprasidone
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.

Aceclofenac
Acemetacin
Alclofenac
Alprazolam
Benoxaprofen
Bromfenac
Bufexamac
Bupropion
Buspirone
Carbamazepine
Carprofen
Celecoxib
Clonixin
Clozapine
Cyclobenzaprine
Cyproheptadine
Delavirdine
Dexketoprofen
Diclofenac
Diflunisal
Digoxin
Dipyrone
Droxicam
Etodolac
Etofenamate
Etoricoxib
Felbinac
Fenbufen
Fenoprofen
Fentiazac
Floctafenine
Flufenamic Acid
Fluphenazine
Flurbiprofen
Fosphenytoin
Galantamine
Ginkgo
Ibuprofen
Iloperidone
Indomethacin
Indoprofen
Isoxicam
Ketoprofen
Ketorolac
Lithium
Lornoxicam
Meclofenamate
Mefenamic Acid
Meloxicam
Metoprolol
Morniflumate
Nabumetone
Naproxen
Nebivolol
Niflumic Acid
Nimesulide
Oxaprozin
Parecoxib
Paroxetine
Pentazocine
Phenylbutazone
Phenytoin
Pirazolac
Piroxicam
Pirprofen
Propyphenazone
Proquazone
Risperidone
Ritonavir
Rofecoxib
Sulindac
Suprofen
Tenidap
Tenoxicam
Tetrabenazine
Tiaprofenic Acid
Tolmetin
Valdecoxib
Zomepirac

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. Read and follow these instructions carefully. Talk with your doctor if you have any questions.

If fluoxetine upsets your stomach, it may be taken with food.

If you are taking fluoxetine for depression, it may take 4 weeks or longer before you begin to feel better. Also, you may need to keep taking fluoxetine for 6 months or longer to stop the depression from returning. If you are taking fluoxetine for obsessive-compulsive disorder, it may take 5 weeks or longer before you begin to get better. Your doctor should check your progress at regular visits during this time.

If you are taking fluoxetine for bulimia nervosa, you may begin to get better after 1 week. However, it may take 4 weeks or longer before you get better.

If you are using the oral liquid form of fluoxetine, shake the bottle well before measuring each dose. Use a small measuring cup or a measuring spoon to measure each dose. The teaspoons and tablespoons that are used for serving and eating food do not measure exact amounts.

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 depression:
  - Adults—At first, 20 milligrams (mg) once a day, taken as a single dose in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 80 mg a day. Once your depression is under control, your doctor may wish to change you to a weekly dose. In this case, you will usually take a 90-mg capsule as a single dose one day per week.
  - Children above 8 years of age—At first, 10 to 20 mg a day, taken as a single dose in the morning. Your doctor may increase your dose as needed.
  - Children below 8 years of age—Use and dose must be determined by your doctor.
- For depression that occurs with bipolar disorder or treatment resistant depression:
  - Adults—At first, one capsule of 20 mg fluoxetine and 5 mg oral olanzapine once a day in the evening. Your doctor may increase your dose as needed. However, the dose is usually not more than 18 mg of oral olanzapine and 75 mg of fluoxetine.
  - Children—Use and dose must be determined by your doctor.
- For bulimia nervosa:
  - Adults—60 milligrams (mg) once a day, taken as a single dose in the morning. Your doctor may start with a lower dose and increase it gradually. The dose is usually not more than 80 mg a day.
  - Children—Use and dose must be determined by your doctor.
- For obsessive-compulsive disorder:
  - Adults—At first, usually 20 milligrams (mg) a day, taken as a single dose in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 80 mg a day.
  - Children above 7 years of age—At first, 10 mg a day, taken as a single dose in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 60 mg a day.
  - Children below 7 years of age—Use and dose must be determined by your doctor.
- For panic disorder:
  - Adults—At first, 10 milligrams (mg) once a day, taken as a single dose in the morning or evening for one week. Your doctor may increase 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, usually 20 milligrams (mg) once a day, taken as a single dose in the morning. Your doctor may have you take 20 mg every day of your menstrual cycle or for only 14 days out of your cycle. Your doctor will determine the use and dose that is right for you. Your doctor may increase your dose as needed. However, the dose is usually not more than 80 mg a 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.

If you develop a skin rash or hives, stop taking fluoxetine and check with your doctor as soon as possible.

Fluoxetine may cause some people 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. If you, your child, or your caregiver notice any of these unwanted effects, tell your doctor or your child's doctor right away.

Do not stop suddenly taking fluoxetine without checking first with your doctor. If you have been instructed to stop taking fluoxetine, ask your doctor how to slowly decrease the dose. This is to decrease the chance of having symptoms such as agitation, breathing problems, chest pain, confusion, diarrhea, dizziness or lightheadedness, a fast heartbeat, headache, increased sweating, muscle pain, nausea, restlessness, runny nose, trouble with sleeping, trembling or shaking, unusual tiredness or weakness, vision changes, or vomiting.

Do not take fluoxetine within 2 weeks of taking an monoamine oxidase (MAO) inhibitor (e.g., isocarboxazid [Marplan®], phenelzine [Nardil®], selegiline [Eldepryl®], or tranylcypromine [Parnate®]). Do not take an MAO inhibitor for at least 5 weeks after taking fluoxetine. If you do, you may develop extremely high blood pressure or seizures.

Do not take thioridazine (Mellaril®) while you are taking fluoxetine or less than 5 weeks after you have stopped taking fluoxetine. You should not use pimozide (Orap®) while you are taking fluoxetine. Using these medicines together can cause very serious heart problems.

You should not take other medicines that also contain fluoxetine. This includes Symbyax®, Sarafem®, or Prozac Weekly®. Using these medicines together may increase your chance for more serious side effects.

Make sure your doctor knows about all the other medicines you are using. Fluoxetine may cause serious conditions such as serotonin syndrome and neuroleptic malignant syndrome (NMS)-like reactions when taken with certain medicines such as linezolid [Zyvox®], lithium, tryptophan, St. John's Wort, or some pain medicines (e.g., tramadol [Ultram®], sumatriptan [Imitrex®], zolmitriptan [Zomig®], or rizatriptan [Maxalt®]). Check with your doctor first before taking any other medicines.

Make sure your doctor knows if you are also using aspirin, NSAIDS (e.g., ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, or Motrin®), or a blood thinner (e.g., warfarin [Coumadin®]). Fluoxetine may increase your risk of having bleeding problems especially when taken together with these medicines.

Avoid drinking alcohol while you are taking fluoxetine.

Do not breastfeed while you are using fluoxetine.

For diabetic patients:

fluoxetine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, 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

Inability to sit still
restlessness
skin rash, hives, or itching

Less common

Chills or fever
joint or muscle pain

Rare

Anxiety or nervousness
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
high or low blood pressure
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
shortness of breath
skin rash
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
wheezing
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: