Fluoxetine Hydrochloride

Generic Name: fluoxetine (floo OX e teen)
Brand Names: Prozac, Prozac Weekly, Rapiflux, Sarafem, Selfemra

What is fluoxetine?

Fluoxetine is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs). Fluoxetine affects chemicals in the brain that may become unbalanced and cause depression, panic, anxiety, or obsessive-compulsive symptoms.

Fluoxetine is used to treat major depressive disorder, bulimia nervosa (an eating disorder) obsessive-compulsive disorder, panic disorder, and premenstrual dysphoric disorder (PMDD).

Fluoxetine is sometimes used together with another medication called olanzapine (Zyprexa) to treat depression caused by bipolar disorder (manic depression). This combination is also used to treat depression after at least 2 other medications have been tried without successful treatment of symptoms.

Fluoxetine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about fluoxetine?

Do not take fluoxetine together with pimozide (Orap), thioridazine (Mellaril), or a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate).

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. SSRI antidepressants may cause serious or life-threatening lung problems in newborn babies whose mothers take the medication during pregnancy. However, you may have a relapse of depression if you stop taking your antidepressant during pregnancy. If you are planning a pregnancy, or if you become pregnant while taking fluoxetine, do not stop taking the medication without first talking to your doctor.

What should I discuss with my healthcare provider before taking fluoxetine?

Do not use fluoxetine if you are using any of the following drugs:

• pimozide (Orap);

• thioridazine (Mellaril); or

• an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), rasagiline (Azilect), or selegiline (Eldepryl, Emsam).

Serious and sometimes fatal reactions can occur when these medicines are taken with fluoxetine. You must wait at least 14 days after stopping an MAO inhibitor before you can take fluoxetine. You must wait 5 weeks after stopping fluoxetine before you can take thioridazine (Mellaril) or an MAOI.

Before taking fluoxetine, tell your doctor if you are allergic to any drugs, or if you have:

• cirrhosis of the liver;

• kidney disease;

• diabetes;

• seizures or epilepsy;

• bipolar disorder (manic depression); or

• a history of drug abuse or suicidal thoughts.

If you have any of these conditions, you may not be able to use fluoxetine, or you may need a dosage adjustment or special tests.

You may have thoughts about suicide while taking an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

FDA pregnancy category C. SSRI antidepressants may cause serious or life-threatening lung problems in newborn babies whose mothers take the medication during pregnancy. However, you may have a relapse of depression if you stop taking your antidepressant during pregnancy. If you are planning a pregnancy, or if you become pregnant while taking fluoxetine, do not stop taking the medication without first talking to your doctor. Fluoxetine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give fluoxetine to anyone younger than 18 years old without a doctor's advice. Fluoxetine is the only antidepressant that is FDA-approved for use in children with depression.

How should I take fluoxetine?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results from the medication.

Do not break, chew, or open an extended-release capsule. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time.

Measure the liquid form of fluoxetine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

It may take 4 weeks or longer before you start feeling better. Do not stop using fluoxetine without first talking to your doctor. You may have unpleasant side effects if you stop taking this medication suddenly.

To treat premenstrual dysphoric disorder, the usual dose of fluoxetine is once daily while you are having your period, or 14 days before you expect your period to start. Follow your doctor's instructions.

Store fluoxetine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next regularly scheduled dose, skip the missed dose and take the next one as directed. Do not take extra medicine to make up the missed dose.

If you miss a dose of Prozac Weekly, take the missed dose as soon as you remember and take the next dose 7 days later. However, if it is almost time for the next regularly scheduled weekly dose, skip the missed dose and take the next one as directed.Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have taken too much of this medication. Overdose may cause nausea, vomiting, fever, sleepiness, rapid or uneven heartbeat, confusion, fainting, seizures, or coma.

What should I avoid while taking fluoxetine?

Avoid drinking alcohol, which can increase some of the side effects of fluoxetine. Fluoxetine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures or anxiety). They can add to sleepiness caused by fluoxetine.

Fluoxetine side effects

Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:

• severe blistering, peeling, and red skin rash;

• very stiff (rigid) muscles, high fever, sweating, fast or uneven heartbeats, tremors, overactive reflexes;

• nausea, vomiting, diarrhea, loss of appetite, feeling unsteady, loss of coordination; or

• headache, trouble concentrating, memory problems, weakness, confusion, hallucinations, fainting, seizure, shallow breathing or breathing that stops.

Less serious side effects may include:

• cold symptoms such as stuffy nose, sneezing, sore throat;

• drowsiness, dizziness, feeling nervous;

• mild nausea, upset stomach, constipation;

• increased appetite, weight changes;

• sleep problems (insomnia);

• decreased sex drive, impotence, or difficulty having an orgasm; or

• dry mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Fluoxetine Dosing Information

Usual Adult Dose for Premenstrual Dysphoric Disorder:

Initial dose: 20 mg orally once daily.
Maintenance dose: 20 mg/day continuously or, alternatively, 20 mg/day during the luteal phase of the menstrual system (the 14 days prior to the anticipated start of menses). The 20 mg/day dosage has been shown to be effective for up to six months of treatment. A 60 mg/day dosage has also been studied, but has not been shown to be significantly more effective than 20 mg/day.
Maximum dose: 80 mg/day.

Usual Adult Dose for Depression:

Immediate-release capsules or tablets:
Initial dose: 20 mg orally once a day in the morning.
Maintenance dose: 20 to 80 mg/day in 1 to 2 divided doses.

Extended-release capsules: Patients taking 20 mg daily may be converted to 90 mg orally once a week. The first weekly dose should be given 7 days after the last daily dose.

Usual Adult Dose for Obsessive Compulsive Disorder:

Initial dose: 20 mg orally once a day in the morning.
Maintenance dose: 20 to 60 mg/day in 1 to 2 divided doses.
Maximum dose: 80 mg/day.

Usual Adult Dose for Panic Disorder:

Initial dose: 20 mg orally once a day in the morning.
Maintenance dose: 20 to 60 mg/day in 1 to 2 divided doses.
Maximum dose: 80 mg/day.

Usual Adult Dose for Bulimia:

Initial dose: 60 mg orally once a day in the morning. Some patients have started with lower doses. Doses greater than 60 mg/day have not been systematically studied.

Usual Pediatric Dose for Depression:

Major depression:

7 years or younger:
Safety and efficacy have not been established.

8 years to less than 18 years:
Initial dose: 10 to 20 mg orally once daily. After 1 week at 10 mg/day, the dose should be increased to 20 mg/day.

Lower weight children:
Due to higher plasma levels in lower weight children, the starting and target dose in this group should generally be 10 mg/day. A dose increase to 20 mg/day may be considered after several weeks if clinical improvement is insufficient.

Usual Pediatric Dose for Obsessive Compulsive Disorder:

6 years or younger:
Safety and efficacy have not been established.

7 years to less than 18 years:
Initial dose: 10 mg orally once daily.

Adolescents and higher weight children:
After 2 weeks at 10 mg/day, the dose should be increased to 20 mg/day. Additional dose increases may be considered after several more weeks if clinical improvement is insufficient. A dose range of 20 to 60 mg/day is recommended.

Lower weight children:
Additional dose increases may be considered after several weeks if clinical improvement is insufficient. A dose range of 20 to 30 mg/day is recommended. There is minimal experience with doses greater than 20 mg/day and none with doses greater than 60 mg/day.

What other drugs will affect fluoxetine?

Talk to your doctor before taking any medicine for pain, arthritis, fever, or swelling. This includes aspirin and NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn), diclofenac (Voltaren), indomethacin, piroxicam (Feldene), nabumetone (Relafen), etodolac (Lodine), and others. Taking any of these drugs with fluoxetine may cause you to bruise or bleed easily.

Before taking fluoxetine, tell your doctor if you are using any of the following medicines:

• alprazolam (Xanax);

• clozapine (Clozaril, Fazaclo);

• digitoxin (Crystodigin);

• flecainide (Tambocor);

• haloperidol (Haldol);

• seizure medication such as phenytoin (Dilantin) or carbamazepine (Tegretol);

• tryptophan (also called L-tryptophan);

• vinblastine (Velban);

• a blood thinner such as warfarin (Coumadin);

• almotriptan (Axert), frovatriptan (Frova), sumatriptan (Imitrex), naratriptan (Amerge), rizatriptan (Maxalt), or zolmitriptan (Zomig); or

• any other antidepressants such as amitriptyline (Elavil), escitalopram (Lexapro), imipramine (Tofranil), sertraline (Zoloft), and others.

This list is not complete and there may be other drugs that can interact with fluoxetine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about fluoxetine.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Where can I buy fluoxetine hydrochloride?

You can buy fluoxetine hydrochloride by any brand name such as Prozac at any reputable online pharmacy.