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New Sarafem is the first and only FDA-approved prescription treatment for both the mood and physical symptoms of PMDD (premenstrual dysphoric disorder). Safe enough to take daily, Sarafem works on the imbalance of serotonin in the body. Many doctors believe that this imbalance can cause the symptoms of PMDD. And for many women, Sarafem can bring relief of their mood swings, irritability, bloating…by their next monthly period.

Is Sarafem Right for You?

Talk to your doctor about your symptoms, their timing and intensity to determine if you suffer from PMDD and if Sarafem can help.

What should you know about Sarafem?

If you develop a rash while taking Sarafem, call your doctor right away because a rash can be a sign of a serious illness. If you take MAO inhibitors, you should not take Sarafem. You must also wait at least two weeks after you have stopped taking an MAO inhibitor before you start taking Sarafem. And don't take MAO inhibitors for at least five weeks after stopping Sarafem. Thioridazine should not be administered with Sarafem or within a minimum of five weeks after Sarafem has been discontinued. Some women may experience side effects such as tiredness, upset stomach, nervousness, dizziness and difficulty concentrating. Side effects are usually mild and tend to go away within a few weeks. Sarafem contains the same active ingredient as Prozac® (fluoxetine hydrochloride). Be sure to tell your doctor if you are pregnant, nursing or planning on becoming pregnant.

SARAFEM (fluoxetine hydrochloride) By: Paula T. Trzepacz, MD Medical Director, U.S. Neuroscience.

Eli Lilly and Company proudly introduces Sarafem - the first and only prescription medication approved by the FDA to treat the mood and physical symptoms of premenstrual dysphoric disorder (PMDD).

PMDD is an important and distinct disorder. For up to 5% of all menstruating women, the monthly cycle triggers severe premenstrual mood and physical symptoms known as PMDD. Mood symptoms, such as irritability, tension, and mood swings, and physical symptoms, including breast tenderness and bloating, are all part of a cluster of symptoms that can be severe enough to interfere with day-to-day activities and relationships. Typically, sufferers are affected for 1 to 2 weeks each month. Being affected by the symptoms of PMDD for an average of one week per month means that some women may suffer for up to 25% of their reproductive years.

A new treatment offers hope for millions of women. Sarafem, the first and only prescription medication approved by the FDA to treat both the mood and physical symptoms of PMDD, helps women overscome the effects of this important disorder. Sarafem prescribed at 20 mg/day significantly improved the overall mood and physical symptoms and social functioning was significant by the first cycle on treatment.

What you should know about Sarafem before dispensing.

Although Sarafem is new, the history behind this medication isn't. Its well established safety and tolerability profile is derived from its active ingredient - fluoxetine hydrochloride. This same active ingredient, found in Prozac, has been prescribed for more than 38 million patients worldwide over the past 13 years. The additional trade name, Sarafem, was designed to help women and their healthcare providers differentiate PMDD from depression and other mental disorder, ultimately helping women with PMDD receive appropriate diagnosis, treatment, and follow-up.

Sarafem is a treatment designed with the woman in mind, offering helpful patient educational materials, dosing flexibility with a choice of 10-mg and 20-mg Pulvules, and familiar 28-day package similar to birth control. Each 28-day package contains four 7-day blister cards. To help patients get the benefits of Sarafem whin it is prescribed, it should be dispensed in the 28-capsule tradepack. Physicians are being informed to write prescriptions for Sarafem as "Sasrafem 20 mg, one pack of 28, one capsule daily." Eli Lilly and Company has priced Sarafem and Prozac equally to the wholesalers on a per capsule basis.

Counseling Tips (in addition to Important Safety Information below):

· Patients should be counseled on PMDD and not depression. · Patents can start taking Sarafem immediately. · The usual dose is 20 mg a day, but Sarafem should be taken exactly as directed by the physician. · If a dose is missed, it should be taken as soon as the patient remembers. However, if it is time for the next dose, skip the missed dose and take only the regularly scheduled dose. The patient should not take more than the daily prescribed amount of Sarafem. · Patients should continue to take Sarafem even if they feel better. · Patients should talk with their doctors before they stop taking Sarafem.
· Sarafem can be taken with or without food. · Patients should be encouraged to get their refills before they run out of Sarafem. · If patients develop a rash or any other medical condition that concerns while while taking Sarafem, they should call their doctors immediately. A rash can be a sign of a serious medical condition. · Patients should be counseled that if they have any questions or concerns, want to report any problems with the use of Sarafem, or want more information about Sarafem, they should contact their doctor, pharmacist, or other healthcare professional.

Important Safety Information on Sarafem.

The most commonly observed adverse events for 20-mg Sarafem vs placebo in a US controlled clinical trial for PMDD included: rhinitis (23 vs 17%), headache (13 vs 9%), nausea (13 vs 7%), asthenia (12 vs 3%), pharyngitis (10 vs 6%), dizziness (7 vs 4%), nervousness (7 vs 4%),and difficulty concentrating (6 vs .5%). An additional adverse event referenced in this letter is pain (9 vs 7%).

Sarafem is contraindicated until at least 2 weeks have passed since discontinuing an MAQ inhibitor, and an MAO inhibitor is contraindicated for at least 5 weeks after discontinuation of Sarafem. Thioridazine should not be administered with Sarafem or within a minimum of 5 weeks after Sarafem has been discontinued. Discontinue immediately if rash or other possibly allergic phenomena appear for which an alternative etiology cannot be identified. Safety and effectiveness not established in pediatric patients.

If you have any questions about the use of Sarafem as a treatment for PMDD, please call 1-800-LILLY-RX (1-800-545-5979) or visit our website at www.sarafem.com.