Sarafem (Fluoxetine Hydrochloride) Patient Information: How Should I Take the Drug at RxList

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May 27, 2012

Sarafem

Antidepressants: Get the Facts »

What does the new study say about the ineffectiveness of antidepressants?

In findings published in the February issue of the journal PloS Medicine, researchers conclude that when taken as a whole, the data show that only a small group of the most severely depressed patients benefit from taking one of the antidepressants.

For less severely depressed patients, the antidepressants were found to work no better than placebos, leading the researchers to conclude that most patients who take antidepressants probably shouldn't be on them.

Does this study contradict numerous positive studies on antidepressants?

Yes, it does. In a statement, American Psychiatric Association President-elect Nada Stotland, MD, maintains that studies like this one, which compare a single drug to placebo, do not accurately reflect the way doctors prescribe antidepressants today.

Stotland says many people who are depressed do n...

Read the Antidepressants: Get the Facts article »

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Sarafem Patient Information including How Should I Take

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

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.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely fluoxetine:

cirrhosis of the liver;
kidney disease;
diabetes;
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. 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.

How should I take fluoxetine (Sarafem)?

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.

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