Sarafem

Generic name: Fluoxetine hydrochloride

What is Sarafem?

Sarafem is indicated for the treatment of premenstrual dysphoric disorder (PMDD).

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

Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults when the medicine is first started. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar disorder (also called manic-depressive illness) or suicidal thoughts or actions.

Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is first started or when the dose is changed.

Call the doctor right away to report new or sudden changes in mood, behavior, thoughts, or feelings. Signs to watch for include new or worsening depression, new or worsening anxiety, agitation, insomnia, hostility, panic attacks, restlessness, extreme hyperactivity, and suicidal thinking or behavior.

Keep all follow-up visits as scheduled, and call the doctor between visits as needed, especially if you have concerns about symptoms.

Who should not take Sarafem?

You should not take Sarafem if you have a known hypersensitivity to any of its ingredients.

Do not take Sarafem if you are taking a monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI less than 14 days ago.

If you are taking pimozide you should not take Sarafem.

If you are taking thioridazine, you should not take Sarafem or wait a minimum of 5 weeks after Sarafem has been discontinued.

What should I tell my doctor before I take the first dose of Sarafem?

Tell your doctor about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Sarafem. Talk to your doctor about your complete medical history, especially past or current liver or kidney disease. Tell your doctor if you are pregnant, planning to become pregnant, or are breastfeeding.

What is the usual dosage?

The information below is based on the dosage guidelines your doctor uses. Depending on your condition and medical history, your doctor may prescribe a different regimen. Do not change the dosage or stop taking your medication without your doctor's approval.

Adults: The recommended starting dose of Sarafem for the treatment of PMDD is 20 milligrams (mg) a day given continuously (every day of the menstrual cycle) or intermittently for up to 3 months at a dose of 20 mg a day (defined as starting a daily dose 14 days prior to the anticipated onset of menstruation through the first full day of menses and repeating with each new cycle).

The maximum dose of Sarafem should not exceed 80 mg a day.

How should I take Sarafem?

Take Sarafem as directed by your physician.

What should I avoid while taking Sarafem?

Avoid taking Sarafem with other medications that affect serotonin; see below for more on drug interactions.

What are possible food and drug interactions associated with Sarafem?

If Sarafem is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Sarafem with the following: anticonvulsants, antipsychotics, benzodiazepines, digoxin, electroconvulsive therapy, lithium, MAOIs, nonsteroidal anti-inflammatory drugs (NSAIDs), pimozide, selective norepinephrine reuptake inhibitors, selective serotonin reuptake inhibitors (eg, Prozac, Zoloft), thioridazine, triptans (eg, Imitrex, Maxalt, Frova), tryptophan, and warfarin.

What are the possible side effects of Sarafem?

Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking this drug.

Side effects may include: headache, body pain, nausea, diarrhea, insomnia, dizziness, nervousness, abnormalities in thinking, decreased libido, runny nose, sore throat

Can I receive Sarafem if I am pregnant or breastfeeding?

Sarafem should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Sarafem is excreted in breast milk, hence nursing while on Sarafem is not recommended.

What should I do if I miss a dose of Sarafem?

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose, and resume your normal dosage schedule.

How should I store Sarafem?

Store at room temperature away from heat, light, and moisture.