Generic Name: fluoxetine (Oral route)
Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults. Monitor patients of all ages for clinical worsening and emergence of suicidal thoughts and behaviors. Prozac(R) is not approved for use in children less than 7 years of age. 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 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 with placebo in adults older than 24 years, and there was a reduction in risk with antidepressants compared with placebo in adults aged 65 or 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 with placebo in adults older than 24 years, and there was a reduction in risk with antidepressants compared with placebo in adults aged 65 or 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 Weekly
Available Dosage Forms:
- Capsule, Delayed Release
Therapeutic Class: Antidepressant
Pharmacologic Class: Serotonin Reuptake Inhibitor
Uses For Sarafem
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 Sarafem
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:
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.
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 or panic disorder. Safety and efficacy have not been established.
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.
|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.|
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.
- Methylene Blue
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.
- Abiraterone Acetate
- Amtolmetin Guacil
- Anagrelide Hydrochloride
- Antithrombin III Human
- Arsenic Trioxide
- Chloral Hydrate
- Choline Salicylate
- Dabigatran Etexilate Mesylate
- Dermatan Sulfate
- Drotrecogin Alfa
- Flufenamic Acid
- Ibuprofen Lysine
- Iobenguane I 123
- Mefenamic Acid
- Niflumic Acid
- Pentosan Polysulfate Sodium
- Protein C, Human
- Protriptyline Hydrochloride
- Salicylic Acid
- Sodium Phosphate
- Sodium Phosphate, Dibasic
- Sodium Phosphate, Monobasic
- Sodium Salicylate
- St John's Wort
- Tiaprofenic Acid
- Tolfenamic Acid
- Treprostinil Sodium
- Valproic Acid
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.
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.
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, narrow-angle 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 fluoxetine
This section provides information on the proper use of a number of products that contain fluoxetine. It may not be specific to Sarafem. 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.
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.
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.
- For bulimia nervosa:
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.
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 Sarafem
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®], 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®), linezolid (Zyvox®), lithium (Eskalith®, Lithobid®), methylene blue injection, 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.
Sarafem 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
- skin rash
- Chills or fever
- joint or muscle pain
- cold sweats
- convulsions (seizures)
- cool pale skin
- difficulty with concentration
- dryness of the mouth
- excessive hunger
- fast or irregular heartbeat
- 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
- Abdominal or stomach pain
- back or leg pains
- bleeding gums
- blistering, peeling, or loosening of the skin
- blood in the urine or stools
- bloody, black, or tarry stools
- blue-yellow color blindness
- blurred vision
- chest pain or discomfort
- clay-colored stools
- continuing vomiting
- cough or dry cough
- dark urine
- decreased urine output
- decreased vision
- difficulty with breathing
- difficulty with swallowing
- dizziness or lightheadedness
- eye pain
- 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
- irregular or slow heart rate
- 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
- no blood pressure or pulse
- noisy breathing
- 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
- twitching, twisting, or uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
- 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
- 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
- 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.
See also: Sarafem side effects (in more detail)
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More Sarafem resources
- Sarafem MedFacts Consumer Leaflet (Wolters Kluwer)
- Sarafem Prescribing Information (FDA)
- Fluoxetine Prescribing Information (FDA)
- Fluoxetine Hydrochloride Monograph (AHFS DI)
- Prozac Consumer Overview
- Prozac Weekly Prescribing Information (FDA)
- Prozac Weekly delayed-release capsules MedFacts Consumer Leaflet (Wolters Kluwer)
- Selfemra Prescribing Information (FDA)
- fluoxetine MedFacts Consumer Leaflet (Wolters Kluwer)