Free Article Directory Liberia: Prozac

Generic Name: fluoxetine (Oral route)

floo-OX-e-teen hye-droe-KLOR-ide

Oral route(Capsule;Capsule, Delayed Release;Solution)

Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders. Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. This risk must be balanced with the clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. PROZAC(R) is approved for use in pediatric patients with MDD and obsessive compulsive disorder (OCD) .

Oral route(Tablet)

Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders. Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. This risk must be balanced with the clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. SARAFEM(R) is not approved for use in pediatric patients .

Commonly used brand name(s)

In the U.S.

Prozac

Prozac Weekly

Rapiflux

Sarafem

Selfemra

In Canada

Alti-Fluoxetine Hydrochloride

Fluoxetine

Available Dosage Forms:

Capsule

Capsule, Delayed Release

Tablet

Syrup

Solution

Therapeutic Class: Antidepressant

Pharmacologic Class: Fluoxetine

Uses For Prozac

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

Fluoxetine is used with olanzapine to treat depression that is a part of bipolar disorder. These medicines are also used together to treat treatment resistant depression in patients who have been treated with other antidepressants that did not work well. This medicine 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.

This medicine 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 Prozac

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.

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 younger than 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 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 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 this medicine than younger adults, and are more likely to have hyponatremia (low sodium in the blood), 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 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.

Bepridil

Clorgyline

Furazolidone

Iproniazid

Isocarboxazid

Levomethadyl

Linezolid

Mesoridazine

Methylene Blue

Metoclopramide

Moclobemide

Nialamide

Pargyline

Phenelzine

Pimozide

Procarbazine

Selegiline

Terfenadine

Thioridazine

Toloxatone

Tranylcypromine

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

Acecainide

Aceclofenac

Acemetacin

Acenocoumarol

Ajmaline

Alclofenac

Almotriptan

Amiodarone

Amisulpride

Amitriptyline

Amoxapine

Ancrod

Anisindione

Antithrombin III Human

Apazone

Aprindine

Ardeparin

Arsenic Trioxide

Aspirin

Astemizole

Azimilide

Benoxaprofen

Bivalirudin

Bretylium

Bromfenac

Bufexamac

Carprofen

Certoparin

Chloral Hydrate

Chloroquine

Chlorpromazine

Cilostazol

Citalopram

Clarithromycin

Clometacin

Clonixin

Clopidogrel

Dalteparin

Danaparoid

Defibrotide

Dermatan Sulfate

Desipramine

Desirudin

Desvenlafaxine

Dexfenfluramine

Dexketoprofen

Dextromethorphan

Dibenzepin

Diclofenac

Dicumarol

Diflunisal

Dipyridamole

Dipyrone

Disopyramide

Dofetilide

Dolasetron

Doxepin

Droperidol

Droxicam

Duloxetine

Eletriptan

Enflurane

Enoxaparin

Eptifibatide

Erythromycin

Escitalopram

Etodolac

Etofenamate

Felbinac

Fenbufen

Fenfluramine

Fenoprofen

Fentiazac

Flecainide

Floctafenine

Fluconazole

Flufenamic Acid

Fluoxetine

Flurbiprofen

Fluvoxamine

Fondaparinux

Foscarnet

Frovatriptan

Gemifloxacin

Halofantrine

Haloperidol

Halothane

Heparin

Hydroquinidine

Ibuprofen

Ibutilide

Imipramine

Indomethacin

Indoprofen

Isoflurane

Isoxicam

Isradipine

Ketoprofen

Ketorolac

Lidoflazine

Lorcainide

Lornoxicam

Magnesium Salicylate

Meclofenamate

Mefenamic Acid

Mefloquine

Meloxicam

Meperidine

Milnacipran

Mirtazapine

Nabumetone

Nadroparin

Naproxen

Naratriptan

Nepafenac

Niflumic Acid

Nimesulide

Nortriptyline

Octreotide

Oxaprozin

Oxyphenbutazone

Parnaparin

Paroxetine

Pentamidine

Pentosan Polysulfate Sodium

Phenindione

Phenprocoumon

Phenylbutazone

Pirazolac

Pirmenol

Piroxicam

Pirprofen

Prajmaline

Prasugrel

Probucol

Procainamide

Prochlorperazine

Propafenone

Propyphenazone

Proquazone

Quetiapine

Rasagiline

Reviparin

Rizatriptan

Salicylic Acid

Salsalate

Sematilide

Sertindole

Sertraline

Sibutramine

Sotalol

Spiramycin

St John's Wort

Sulfamethoxazole

Sulindac

Sultopride

Sumatriptan

Suprofen

Tamoxifen

Tapentadol

Tedisamil

Telithromycin

Tenidap

Tenoxicam

Tiaprofenic Acid

Ticlopidine

Tinzaparin

Tirofiban

Tolmetin

Tramadol

Trazodone

Trifluoperazine

Trimethoprim

Trimipramine

Tryptophan

Vasopressin

Venlafaxine

Vilazodone

Warfarin

Ziprasidone

Zolmitriptan

Zomepirac

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

Bupropion

Buspirone

Carbamazepine

Clozapine

Cyclobenzaprine

Cyproheptadine

Delavirdine

Digoxin

Fluphenazine

Fosphenytoin

Galantamine

Ginkgo

Iloperidone

Lithium

Metoprolol

Nebivolol

Paroxetine

Pentazocine

Phenytoin

Risperidone

Ritonavir

Tetrabenazine

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

This section provides information on the proper use of a number of products that contain fluoxetine. It may not be specific to Prozac. Please read with care.

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.

If this medicine 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 this medicine 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, 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.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

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 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 per 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 8 years of age and older—At first, 10 to 20 mg once a day, taken as a single dose in the morning. Your doctor may increase your dose as needed.
  - Children younger than 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 per day.
  - 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 60 mg per day.
  - Children—Use and dose must be determined by your doctor.
- For obsessive-compulsive disorder:
  - Adults—At first, usually 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 per day.
  - Children 7 years of age and older—At first, 10 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 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) 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 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 Prozac

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 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 this medicine. 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.

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

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, your child, or anyone in your family has bipolar disorder (manic-depressive) or has tried to commit suicide.

Do not stop suddenly taking this medicine 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.

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®], rizatriptan [Maxalt®], sumatriptan [Imitrex®], or zolmitriptan [Zomig®]). Check with your doctor first before taking any other medicines.

Fluoxetine may increase your risk for bleeding problems. Make sure your doctor knows if you are also using other medicines that thin the blood, such as aspirin, pain or arthritis medicines, sometimes called “NSAIDs” (e.g., ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, or Motrin®), or warfarin (Coumadin®).

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

Avoid drinking alcohol while you are taking fluoxetine.

For diabetic patients:

This medicine 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.

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.

Prozac 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

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

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Actions that are out of control

change in consciousness

change in near or distance vision

change in walking and balance

clumsiness or unsteadiness

confusion as to time, place, or person

decreased awareness or responsiveness

decreased interest in sexual intercourse

difficulty in focusing eyes

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

feeling of constant movement of self or surroundings

hallucinations

high or low blood pressure

holding false beliefs that cannot be changed by fact

inability to have or keep an erection

irregular heartbeat recurrent

loss in sexual ability, desire, drive, or performance

loss of bladder control

loss of consciousness

sensation of spinning

severe muscle stiffness

severe sleepiness

shakiness in the legs, arms, hands, or feet

sweating

talking, feeling, and acting with excitement

tiredness

trembling or shaking of the hands or feet

unresponsiveness

unusual excitement, nervousness, or restlessness

unusual or incomplete body or facial movements

unusually pale 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

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

Actions that are out of control

burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feeling

crying

depersonalization

dizziness

euphoria

feeling of distress

feeling that body or surroundings are turning

general feeling of discomfort or illness

paranoia

quick to react or overreact emotionally

rapidly changing moods

sleeplessness

sweating

unable to sleep

vaginal bleeding

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.

See also: Prozac side effects (in more detail)

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Compare Prozac with other medications

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Obsessive Compulsive Disorder
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Premature Ejaculation
Premenstrual Dysphoric Disorder
Schizoaffective Disorder
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Friday, 28 September 2012

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