Generic Name: fluoxetine (floo-OX-e-teen)
Brand Name: Prozac
Antidepressants may increase the risk of suicidal thoughts or actions in children, teenagers, and young adults. However, depression and certain other mental problems may also increase the risk of suicide. Talk with the patient's doctor to be sure that the benefits of using Prozac solution outweigh the risks.
Family and caregivers must closely watch patients who take Prozac solution. It is important to keep in close contact with the patient's doctor. Tell the doctor right away if the patient has symptoms like worsened depression, suicidal thoughts, or changes in behavior. Discuss any questions with the patient's doctor.
Prozac solution is not approved for use in all children. If Prozac solution is prescribed for your child, talk with the doctor to be sure that Prozac solution is right for your child.
Prozac solution is used for:
Treating depression or obsessive-compulsive disorder (OCD) in adults and children. It is used to treat bulimia nervosa and panic disorder in adults. It may also be used for other conditions as determined by your doctor.
Prozac solution is a selective serotonin reuptake inhibitor (SSRI). It works by restoring the balance of serotonin, a natural substance in the brain, which helps to improve certain mood problems.
Do NOT use Prozac solution if:
- you are allergic to any ingredient in Prozac solution
- you are taking or have taken linezolid or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine, selegiline) within the last 14 days
- you are taking pimozide or thioridazine
Contact your doctor or health care provider right away if any of these apply to you.
Before using Prozac solution:
Some medical conditions may interact with Prozac solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you or a family member has a history of bipolar disorder (manic-depression), other mental or mood problems, suicidal thoughts or attempts, or alcohol or substance abuse
- if you have a history of seizures, stroke, heart problems, high blood pressure, liver problems, kidney problems, bleeding problems, increased eye pressure or glaucoma, or diabetes
- if you are dehydrated, have low blood sodium levels, or drink alcohol
- if you will be having electroconvulsive therapy (ECT)
- if you are taking a medicine that contains methylene blue
Some MEDICINES MAY INTERACT with Prozac solution. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Anorexiants (eg, phentermine), buspirone, fenfluramine derivatives (eg, dexfenfluramine), fentanyl, linezolid, lithium, MAOIs (eg, phenelzine, rasagiline, selegiline), meperidine, methylene blue, metoclopramide, nefazodone, serotonin 5-HT1 receptor agonists (eg, sumatriptan), sibutramine, SNRIs (eg, venlafaxine), another SSRI (eg, paroxetine), St. John's wort, tramadol, trazodone, or tryptophan because severe side effects, such as a reaction that may include fever, rigid muscles, blood pressure changes, mental changes, confusion, irritability, agitation, delirium, or coma, may occur
- Anticoagulants (eg, warfarin), aspirin, or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, intranasal ketorolac) because the risk of bleeding, including stomach bleeding, may be increased
- Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood sodium levels may be increased
- HIV protease inhibitors (eg, ritonavir) because they may increase the risk of Prozac solution's side effects
- Cyproheptadine because it may decrease Prozac solution's effectiveness
- Aripiprazole, benzodiazepines (eg, alprazolam), beta-blockers (eg, propranolol), bupropion, carbamazepine, clozapine, digoxin, flecainide, haloperidol, hydantoins (eg, phenytoin), iloperidone, norepinephrine reuptake inhibitors (eg, atomoxetine), phenothiazines (eg, chlorpromazine, thioridazine), pimozide, propafenone, risperidone, tetrabenazine, tricyclic antidepressants (eg, amitriptyline), or vinblastine because the risk of their side effects may be increased by Prozac solution
- Tamoxifen because its effectiveness may be decreased by Prozac solution, which may lead to an increased risk of breast cancer recurrence in women with a history of breast cancer
This may not be a complete list of all interactions that may occur. Ask your health care provider if Prozac solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Prozac solution:
Use Prozac solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Prozac solution comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Prozac solution refilled.
- Take Prozac solution by mouth with or without food.
- Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
- Taking Prozac solution at the same time each day will help you remember to take it.
- Continue to take Prozac solution even if you feel well. Do not miss any doses.
- Do not suddenly stop taking Prozac solution without checking with your doctor. Side effects may occur. They may include mental or mood changes, numbness or tingling of the skin, dizziness, confusion, headache, trouble sleeping, or unusual tiredness. You will be closely monitored when you start Prozac solution and whenever a change in dose is made.
- If you miss a dose of Prozac solution, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Prozac solution.
Important safety information:
- Prozac solution may cause drowsiness or dizziness. It may also cause you to not be able to make decisions, think clearly, or react quickly. Do not drive or perform other possibly unsafe tasks until you know how you react to Prozac solution.
- Do not drink alcohol while you are taking Prozac solution.
- Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are taking Prozac solution; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Several weeks may pass before your symptoms improve. Do NOT take more than the recommended dose, change your dose, or take Prozac solution for longer than prescribed without checking with your doctor.
- Children and teenagers who take Prozac solution may be at increased risk for suicidal thoughts or actions. Adults may also be affected. The risk may be greater in patients who have had suicidal thoughts or actions in the past. The risk may also be greater in patients who have had bipolar (manic-depressive) illness, or if their family members have had it. Watch patients who take Prozac solution closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
- Diabetes patients - Prozac solution may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Serotonin syndrome is a possibly fatal syndrome that can be caused by Prozac solution. Your risk may be greater if you take Prozac solution with certain other medicines (eg, "triptans," MAOIs). Symptoms may include agitation; confusion; hallucinations; coma; fever; fast or irregular heartbeat; tremor; excessive sweating; and nausea, vomiting, or diarrhea. Contact your doctor at once if you have any of these symptoms.
- Certain antidepressants, including Prozac solution, may increase the risk of bleeding. Sometimes, bleeding can be life-threatening. Discuss any questions or concerns with your doctor.
- Some people may be at risk for eye problems from Prozac solution. Your doctor may want you to have an eye exam to see if you are at risk for these eye problems. Call your doctor right away if you have eye pain, vision changes, or swelling or redness in or around the eye.
- Severe and sometimes fatal reactions along with a rash have rarely happened with Prozac solution. Lung, kidney, or liver problems have also happened. Call your doctor right away if you have a change in the amount of urine passed, dark urine, loss of appetite, upset stomach or stomach pain, pale stools, vomiting, yellowing of the skin or eyes, or shortness of breath.
- If your doctor tells you to stop taking Prozac solution, you will need to wait at least 5 weeks before beginning to take certain other medicines (eg, MAOIs, nefazodone, thioridazine). Ask your doctor when you should start to take your new medicines after you have stopped taking Prozac solution.
- Low blood sodium levels may occur from treatment with Prozac solution. In severe cases, this can be deadly. Call your doctor right away if you have confusion, decreased coordination, fainting, hallucinations, headache, memory problems, mental or mood changes, seizures, sluggishness, trouble concentrating, or weakness.
- Prozac solution may rarely cause a prolonged, painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens.
- Other brands of medicine that contain the same ingredient (fluoxetine) are available. These other brands may be used to treat premenstrual dysphoric disorder (PMDD) or to treat depression in patients with bipolar disorder. Do not take Prozac solution if you are taking any other medicine that contains fluoxetine. Discuss any questions or concerns with your doctor.
- Use Prozac solution with caution in the ELDERLY; they may be more sensitive to its effects, especially low blood sodium levels.
- Prozac solution should be used with extreme caution in CHILDREN younger than 7 years old; safety and effectiveness in these children have not been confirmed.
- Prozac solution may cause weight changes. CHILDREN and teenagers may need regular weight and growth checks while they take Prozac solution.
- PREGNANCY and BREAST-FEEDING: Prozac solution may cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Prozac solution while you are pregnant. Prozac solution is found in breast milk. Do not breast-feed while you are taking Prozac solution.
Possible side effects of Prozac solution:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Abnormal dreams; anxiety; diarrhea; dizziness; drowsiness; dry mouth; flu-like symptoms (eg, fever, chills, muscle aches); flushing; increased sweating; loss of appetite; nausea; nervousness; runny or stuffy nose; sore throat; stomach upset; trouble sleeping; weakness; yawning.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); black, bloody, or tarry stools; chest pain; confusion; decreased concentration; decreased coordination; decreased sexual desire or ability; exaggerated reflexes; excessive sweating; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; joint or wrist aches or pain; memory problems; new or worsening mental, mood, or behavior changes (eg, depression, anxiety, agitation, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, restlessness, or inability to sit still); persistent or severe ringing in the ears; persistent, painful erection; persistent trouble sleeping; red, swollen, blistered, or peeling skin; seizures; severe or persistent dizziness or headache; severe or persistent nausea, vomiting, diarrhea, or stomach pain; significant weight loss; suicidal thoughts or attempts; tremor; trouble urinating; unusual bruising or bleeding; unusual weakness; vomit that looks like coffee grounds.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Prozac solution:
Store Prozac solution at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Prozac solution out of the reach of children and away from pets.
- If you have any questions about Prozac solution, please talk with your doctor, pharmacist, or other health care provider.
- Prozac solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Prozac solution or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Prozac solution. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Prozac solution. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Prozac solution.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.
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