Fluoxetine (By mouth)

Introduction

Fluoxetine Hydrochloride (floo-OX-e-teen hye-droe-KLOR-ide)

Treats depression, obsessive compulsive disorder (OCD), eating disorders, and panic disorders. Sarafem® treats premenstrual dysphoric disorder (PMDD), which is a mood disorder and physical symptoms that occur 1 to 2 weeks before a woman's menstrual period. This medicine is a selective serotonin reuptake inhibitor (SSRI).

Brand Name(s)

Prozac, Prozac Weekly, Sarafem, Gaboxetine, Sentraflox AM-10, Sentroxatine, Fluoxetine

When This Medicine Should Not Be Used

How to Use This Medicine

Capsule, Delayed Release Capsule, Liquid, Tablet

• Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to. Some people need to take this medicine every day, and some people need to take it only once a week. Make sure you understand your own schedule.
• You may need to take this medicine for up to 4 weeks before you start feeling better. Keep using this medicine for the full treatment time. If you feel that the medicine is not working well, do not take more than your prescribed dose. Call your doctor for instructions.
• Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup.
• You may take this medicine with or without food. Take your medicine at the same time each day.
• Swallow the delayed-release capsule whole. Do not crush, break, or chew it.
• Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

If a dose is missed:

• For people who take this medicine every day (Prozac® or Sarafem®): If you miss a dose or forget to take your medicine, take it as soon as you can. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.
• For people who take this medicine once a week (Prozac® Weekly): If you miss a dose or forget to take your medicine, take it as soon as you can. Then go back to your regular schedule the next week. Do not use extra medicine to make up for a missed dose.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or planning to become pregnant. Tell your doctor if you have kidney disease, liver disease, heart disease, bleeding problems, diabetes, epilepsy or seizures, glaucoma, low sodium in the blood, a recent heart attack, or a history of mania or drug abuse. Tell your doctor if you are receiving electroconvulsive therapy (ECT).
• Do not breastfeed while you are using this medicine.
• For some children, teenagers, and young adults, this medicine can increase thoughts of suicide. Tell your doctor or your child's doctor right away if you or your child start to feel more depressed and have thoughts about hurting yourselves. Report any unusual thoughts or behaviors that trouble you or your child, especially if they are new or get worse quickly. Make sure the doctor knows if you or your child have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you or your child have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. Let the doctor know if you, your child, or anyone in your family has bipolar disorder (manic-depressive) or has tried to commit suicide.
• This medicine may cause a serious condition called serotonin syndrome and neuroleptic malignant syndrome (NMS)-like reactions when it is taken with certain medicines. Check with your doctor first before taking any other medicines.
• Do not stop using this medicine suddenly without asking your doctor. You may need to slowly decrease your dose before stopping it completely.
• If you develop a skin rash, even a mild one, stop taking this medicine and call your doctor right away.
• 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.
• This medicine may make you dizzy or drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.
• This medicine may raise or lower your blood sugar, or it may cover up symptoms of very low blood sugar (hypoglycemia).
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments. Blood tests may be needed to check for unwanted effects.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash.
• Change in how much or how often you urinate.
• Changes in behavior, or thoughts of hurting yourself or others.
• Chest pain, or fast, pounding, or uneven heartbeat.
• Confusion, body weakness, and muscle twitching.
• Dry mouth, increased thirst, muscle cramps, nausea, or vomiting.
• Feelings of intense anxiety, agitation, or irritability.
• Fever, chills, cough, sore throat, and body aches.
• Painful, prolonged erection of your penis.
• Seizures or tremors.
• Trouble sleeping or unusual dreams.
• Unusual bleeding, bruising, or weakness.
• Vomiting blood or something that looks like coffee grounds.
• Weight loss.

If you notice these less serious side effects, talk with your doctor:

• Changes in appetite with weight gain or loss.
• Diarrhea, constipation, gas, or upset stomach.
• Dizziness, drowsiness, sleepiness, or yawning more than usual.
• Ear pain or ringing in your ears.
• Headache.
• Mild skin rash.
• Nervousness, shakiness, or sweating.
• Stuffy or runny nose.
• Tiredness.
• Trouble having sex.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are using St. John's wort, alprazolam (Xanax®), diazepam (Valium®), digoxin (Lanoxin®), linezolid (Zyvox®), lithium (Eskalith®, Lithane®, Lithobid®), tramadol (Ultram®), tryptophan, vinblastine (Velban®), medicine to treat migraine headaches (such as rizatriptan, sumatriptan, zolmitriptan, Imitrex®, Maxalt®, or Zomig®), pain or arthritis medicines, sometimes called "NSAIDs" (such as aspirin, ibuprofen, naproxen, Advil®, Aleve®, Bextra®, Celebrex®, Ecotrin®, or Motrin®), or a blood thinner (such as warfarin, Coumadin®).
• Tell your doctor if you are using other medicines to treat depression (such as amitriptyline, desipramine, doxepin, imipramine, nortriptyline, Pamelor®, or Sinequan®), medicine to treat mental illness (such as clozapine, haloperidol, Clozaril®, or Haldol®), medicine for seizures (such as carbamazepine, phenytoin, Dilantin®, or Tegretol®), or medicine for heart rhythm problems (such as flecainide, propafenone, Rhythmol®, or Tambocor®).
• Tell your doctor if you are also using any other medicine that contains fluoxetine such as Symbyax®.
• Tell your doctor if you are using any medicines that make you sleepy. These include sleeping pills, cold and allergy medicine, narcotic pain relievers, and sedatives.
• Do not drink alcohol while you are using this medicine.