First Product Approved for Premenstrual Dysphoric Disorder (PMDD)
Brand Name
Premenstrual Dysphoric Disorder (PMDD), a more severe form ofpremenstrual syndrome (PMS), affects approximately 3-5% ofmenstruating women in the U.S. Symptoms include a range of Generic Name
fluoxetine hydrochloride
emotional changes and physical complaints that occur one to twoweeks before and remit within a few days after the start of FDA Approved
July 6, 2000
menstruation. Symptoms must significantly interfere witheveryday activities or relationships and be confirmed for two Manufacturer
Eli Lilly
consecutive menstrual cycles.
Sarafem (fluoxetine) is the first and only prescription drug Dosage Form/
- 10 mg capsules
approved by the FDA for the treatment of PMDD. Fluoxetine is - 20 mg capsules
also marketed by Lilly under the brand name of Prozac. Sarafem Available in 7 day blister packs
and Prozac are one in the same - the difference is in the color of thecapsules and approved indications. Lilly claims marketing Available
Late August 2000
fluoxetine under another brand name will promote education for theunder-recognized disorder of PMDD and will help differentiate Comparative Cost
Agent/Dose AWP/Day
between the diagnosis of depression and PMDD.
Sarafem 10 mg $2.65
Clinical Study Results
Sarafem 20 mg $2.72
The reason behind fluoxetine’s effectiveness for PMDD is not Prozac 10 mg $2.65
completely understood. Normal cyclical changes in femalehormones affect brain neurotransmitters, including serotonin, and Prozac 20 mg $2.72
may produce the mood and physical symptoms of PMDD. Sincefluoxetine is specific for serotonin, it may help to normalize Recommended
20 mg once daily.
serotonin levels and ease symptoms in those suffering with PMDD.
Other selective serotonin reuptake inhibitor (SSRI) antidepressants,including Zoloft (sertraline) and Paxil (paroxetine), have been Indication†
Treatment of Premenstrual
studied and prescribed off-label for PMS and PMDD.
Dysphoric Disorder (PMDD).
Multiple studies have shown that Sarafem produces statisticallysignificant improvements in mood and physical impairmentassociated with PMDD when compared with placebo. Womentreated with Sarafem also demonstrated improvement in social Contraindications/
The safety and efficacy of
functioning compared to women receiving placebo.
Sarafem has not been studied
Side Effects/Drug Interactions
for longer than 6 months.
The most common side effects reported are “runny nose” (23%), Fluoxetine trademarked as
headache (13%), nausea (13%), and “funny feeling” (12%).
Prozac has been studied for
Sarafem should not be taken at the same time as a monoamine greater than 6 months for the
oxidase inhibitor (MAOI). A minimum of 14 days should pass treatment of other conditions.
after an MAOI is stopped and Sarafem is begun. A minimum of 5 weeks should pass after Sarafem is stopped before starting an Note: This document provides a brief overview of the subject. Please MAOI. Sarafem can interact with other drugs metabolized by the refer to the manufacturer's full prescribing information for a completediscussion of the product.
liver such as Tegretol (carbamazepine), Valium (diazepam),Imitrex (sumatriptan), and lithium. Sarafem can also interact with Generic Available
other drugs, such as Coumadin (warfarin).
Other Agents in the Category
The manufacturers of Zoloft (Pfizer) and Paxil (SmithKlineBeecham) are currently conducting clinical trials in support of PMS 58-16-00-40-00-01-10
and PMDD indications. Generic fluoxetine is expected to become - Antidepressants
available in the third quarter of 2001.
Therapeutic Class
Drug Coverage
Sarafem is covered for all Caremark clients.
Contents Subject To Change Without Notice For Internal Caremark Employee and Customer Use Only Mark E. Greg, Pharm.D., R.Ph.
(847) 559-3872



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