Fluoxetine Hydrochloride

SARAFEM®
(SAIR-a-fem)
(fluoxetine hydrochloride) Tablets

Read the Medication Guide that comes with SARAFEM before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. Talk with your healthcare provider if there is something you do not understand or you want to learn more about.

SARAFEM is in a class of drugs called selective serotonin reuptake inhibitors (SSRIs), which are often used for the treatment of depression and anxiety disorders. Although SARAFEM is not a treatment for depression, it contains fluoxetine hydrochloride, the same active ingredient in some antidepressants.

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

SARAFEM and other antidepressant medicines may cause serious side effects including:

1. Suicidal thoughts or actions :

• SARAFEM and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dos e is changed.
• Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.
• Watch for these changes and call your healthcare provider right away if you notice:
  • New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.
  • Pay particular attention to such changes when SARAFEM is started or when the dose is changed.

Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.

Call your healthcare provider right away if you have any of the following symptoms , or call 911 if an emergency, especially if they are new, worse, or worry you:

• attempts to commit suicide
• acting on dangerous impulses
• acting aggressive or violent
• thoughts about suicide or dying
• new or worse depression
• new or worse anxiety or panic attacks
• feeling agitated, restless, angry or irritable
• trouble sleeping
• an increase in activity or talking more than what is normal for you
• other unusual changes in behavior or mood

Call your healthcare provider right away if you have any of the following symptoms , or call 911 if an emergency. SARAFEM may be associated with these serious side effects :

2. Serotonin Syndrome. This condition can be life-threatening and may include:

• agitation, hallucinations, coma or other changes in mental status
• coordination problems or muscle twitching (overactive reflexes)
• racing heartbeat, high or low blood pressure
• sweating or fever
• nausea, vomiting, or diarrhea
• muscle rigidity
• dizziness
• flushing
• tremor
• seizures

3. Severe allergic reactions :

• trouble breathing
• swelling of the face, tongue, eyes or mouth
• rash, itchy welts (hives) or blisters, alone or with fever or joint pain

4. Manic episodes :

• greatly increased energy
• severe trouble sleeping
• racing thoughts
• reckless behavior
• unusually grand ideas
• excessive happiness or irritability
• talking more or faster than usual

5. Seizures or convulsions

6. Changes in appetite or weight. Children and adolescents should have height and weight monitored during treatment.

7. Abnormal bleeding: SARAFEM and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin®, Jantoven®), a nonsteroidal anti-inflammatory drug (NSAID's, like ibuprofen or naproxen), or aspirin.

8. Visual Problems

• eye pain
• changes in vision
• swelling or redness in or around the eye

Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.

9. Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this. Symptoms may include:

• headache
• weakness or feeling unsteady
• confusion, problems concentrating or thinking or memory problems

Do not s top SARAFEM without firs t talking to your healthcare provider. Stopping SARAFEM too quickly may cause serious symptoms including:

• anxiety, irritability, high or low mood, feeling restless or changes in sleep habits
• headache, sweating, nausea, dizziness
• electric shock-like sensations, shaking, confusion

What is SARAFEM?

SARAFEM is a prescription medicine used to treat premenstrual dysphoric disorder (PMDD).

It is not known if SARAFEM is safe and effective in children.

Talk with your healthcare provider if you do not think that your condition is getting better with SARAFEM treatment.

Who should not take SARAFEM?

Do not take SARAFEM if you:

• take a Monoamine Oxidase Inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.
  • Do not take an MAOI within 5 weeks of stopping SARAFEM unless directed to do so by your healthcare provider.
  • Do not start SARAFEM if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your healthcare provider.

Women who take SARAFEM close in time to an MAOI may have serious or even life-threatening side effects . Get medical help right away if you have any of these symptoms :

• high fever
• uncontrolled muscle spasms
• stiff muscles
• rapid changes in heart rate or blood pressure
• confusion
• loss of consciousness (pass out)
• take Mellaril® (thioridazine). Do not take Mellaril® within 5 weeks of s topping SARAFEM because this can cause serious heart rhythm problems or sudden death.
• take the antipsychotic medicine pimozide (Orap®) because this can cause serious heart problems .

What should I tell my healthcare provider before taking SARAFEM? Ask if you are not sure.

Before starting SARAFEM, tell your healthcare provider if you:

• Are taking certain drugs or treatments such as:
  • Triptans used to treat migraine headache
  • Medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, buspirone, SSRIs, SNRIs, MAOIs or antipsychotics
  • Tramadol and fentanyl
  • Over-the-counter supplements such as tryptophan or St. John's Wort
  • Electroconvulsive therapy (ECT)
• have liver problems
• have kidney problems
• have heart problems
• have or had seizures or convulsions
• have bipolar disorder or mania
• have low sodium levels in your blood
• have a history of a stroke
• have high blood pressure
• have or had bleeding problems
• are pregnant or plan to become pregnant. It is not known if SARAFEM will harm your unborn baby.
• are breastfeeding or plan to breastfeed. Some SARAFEM may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking SARAFEM.

Tell your healthcare provider about all the medicines that you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. SARAFEM and some medicines may interact with each other, may not work as well, or may cause serious side effects.

Your healthcare provider or pharmacist can tell you if it is safe to take SARAFEM with your other medicines. Do not start or stop any medicine while taking SARAFEM without talking to your healthcare provider first.

If you take SARAFEM, you should not take any other medicines that contain fluoxetine hydrochloride:

• Symbyax®
• Prozac®
• Prozac® Weekly™

How should I take SARAFEM?

• Take SARAFEM exactly as prescribed. Your healthcare provider may need to change the dose of SARAFEM until it is the right dose for you.
• Talk to your healthcare provider if your symptoms do not get better.
• SARAFEM may be taken with or without food.
• If you take too much SARAFEM, call your healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid while taking SARAFEM?

SARAFEM can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how SARAFEM affects you. Do not drink alcohol while using SARAFEM.

What are the possible side effects of SARAFEM?

SARAFEM may cause serious side effects, including:

• See “What is the most important information I should know about SARAFEM?”
• Problems with blood sugar control. Women who have diabetes and take SARAFEM may have problems with low blood sugar while taking SARAFEM. High blood sugar can happen when SARAFEM is stopped. Your healthcare provider may need to change the dose of your diabetes medicines when you start or stop taking SARAFEM.
• Feeling anxious or trouble sleeping

The most common side effects of SARAFEM include:

• headache
• weakness (asthenia)
• pain
• accidental injury
• infection
• flu symptoms
• nausea
• diarrhea
• trouble sleeping (insomnia)
• dizziness
• feeling anxious or nervous
• thinking differently
• sexual problems
• runny or stuffy nose (rhinitis)
• sore throat (pharyngitis)

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of SARAFEM. For more information, ask your healthcare provider or pharmacist.

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

How should I store SARAFEM?

• Store SARAFEM at room temperature between 68° F and 77° F (20° C to 25° C).

Keep SARAFEM and all medicines out of the reach of children.

General information about SARAFEM

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use SARAFEM for a condition for which it was not prescribed. Do not give SARAFEM to other people, even if they have the same condition. It may harm them.

This Medication Guide summarizes the most important information about SARAFEM. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about SARAFEM that is written for healthcare professionals.

For more information about SARAFEM call 1-800-521-8813.

What are the ingredients in SARAFEM?

Active ingredient: fluoxetine hydrochloride

Inactive ingredients: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, FD&C Yellow No. 6 aluminum lake (10 mg and 20 mg tablets) and D&C Yellow No. 10 aluminum lake (10 mg and 20 mg tablets)

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Do not take fluoxetine together with pimozide (Orap), thioridazine (Mellaril), or a monoamine oxidase inhibitor (MAOI) such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate). A dangerous drug interaction could occur, leading to serious side effects.

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.

Tell your doctor about all other antidepressants you take, especially Celexa, Cymbalta, Desyrel, Effexor, Lexapro, Luvox, Oleptro, Paxil, Pexeva, Symbyax, Viibryd, or Zoloft.

To make fluoxetine is safe for you, tell your doctor if you have any of these other conditions:

• cirrhosis of the liver;
• kidney disease;
• diabetes;
• glaucoma;
• seizures or epilepsy;
• bipolar disorder (manic depression); or
• a history of drug abuse or suicidal thoughts.

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. Tell your doctor right away if you become pregnant while taking this medication. Fluoxetine may cause heart defects or serious lung problems in a newborn if you take the medication during pregnancy. However, you may have a relapse of depression if you stop taking your antidepressant. Do not start or stop taking fluoxetine during pregnancy without your doctor's advice.

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.

Avoid taking tryptophan while you are taking fluoxetine.

Drinking alcohol can increase certain side effects of fluoxetine.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Antidepressant; selective serotonin-reuptake inhibitor (SSRI).1 2 16 28 50 51

Absorption

Bioavailability

Oral bioavailability in humans not fully elucidated,4 but at least 60–80% of an oral dose appears to be absorbed.4 7

Commercially available conventional and delayed-release capsules, tablets, and oral solution are bioequivalent.1 495 542

Onset

Antidepressant effect usually occurs within 1–4 weeks.1 2 4 16 61 69 71 72

Maximal therapeutic effect in OCD may take 5 weeks or longer.1 441

Therapeutic effect in PMDD usually occurs in 2–4 weeks.361 362 364

Food

Food does not appear to affect systemic bioavailability, although it may delay absorption by 1–2 hours.1

Special Populations

In patients receiving hemodialysis, chronic administration produced steady-state plasma fluoxetine and norfluoxetine (active metabolite) concentrations comparable with those observed in patients with normal renal function.1

Distribution

Extent

Crosses the blood-brain barrier in humans.1 54 56

Crosses the placenta in animals.1 54 56

Distributed into milk in humans.1 54 56

Plasma Protein Binding

Approximately 95%.1

Elimination

Metabolism

Extensively metabolized in the liver to norfluoxetine and a number of other unidentified metabolites.1

Elimination Route

Principally by hepatic metabolism to inactive metabolites excreted by the kidney.1

Half-life

Elimination half-life of approximately 2–3 days after a single dose and 4–6 days after chronic administration of fluoxetine.1

Elimination half-life of norfluoxetine is approximately 4–16 days after acute and chronic administration.1

Special Populations

In patients with chronic liver disease (e.g., cirrhosis), plasma clearances of fluoxetine and norfluoxetine reportedly are decreased and elimination half-lives are increased compared with those of healthy individuals.1 51

In patients with renal impairment, elimination half-lives of fluoxetine and norfluoxetine not substantially altered.3 4 50

Storage

Oral

15–30°C; protect from light.1

20–25°C; protect from light.542

20–25°C; protect from light.495

• Mechanism of action as an antidepressant or as an anti-obsessive agent is unclear but presumed to be linked to potentiation of serotonergic activity in the CNS resulting from its inhibition of CNS neuronal reuptake of serotonin (5-HT).1 2 3 4 7 8 13 18 21 28 29 31 37 76 138

• Mechanism of action in PMDD not mediated by the drug’s antidepressant or anti-obsessive effects.361 362 364

• Potent and highly selective reuptake inhibitor of serotonin.1 2 3 4 7 8 13 18 21 28 29 31 37 76 138 Increases synaptic concentrations of serotonin in the CNS but has little or no effect on other neurotransmitters.1 2 3 7 8 13 18 21 28 29 31 37 76 138 201 328 329 330

• No important anticholinergic, α1-adrenergic blocking, or antihistaminic activity at usual therapeutic dosages.1 2 3 7 8 13 18 21 31 201

• Generally less sedating than most other antidepressants (e.g., TCAs, MAO inhibitors).2 3 4 6 61 176 207

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name