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Sarafem

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Sarafem

Sarafem

INDICATIONS

Premenstrual Dysphoric Disorder (PMDD)

SARAFEM is indicated for the treatment of premenstrual dysphoric disorder (PMDD) [see Clinical Studies].

The effectiveness of SARAFEM in long-term use (that is, for more than 6 months) has not been systematically evaluated in placebo-controlled trials. The use of SARAFEM for extended periods should be periodically re-evaluated for the individual patient [see DOSAGE AND ADMINISTRATION].

DOSAGE AND ADMINISTRATION

Treatment

The recommended dose of SARAFEM for the treatment of PMDD is 20 mg/day given continuously (every day of the menstrual cycle) or intermittently (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 dosing regimen should be based on individual patient characteristics. In a study comparing continuous dosing of fluoxetine 20 and 60 mg/day to placebo, both doses were proven to be effective, but there was no statistically significant added benefit for the 60 mg/day compared with the 20 mg/day dose. Fluoxetine doses above 60 mg/day have not been systematically studied in patients with PMDD. The maximum fluoxetine dose should not exceed 80 mg/day [see Clinical Studies].

Systematic evaluation of SARAFEM has shown that its efficacy in PMDD is maintained for periods of up to 6 months at a dose of 20 mg/day given continuously and up to 3 months at a dose of 20 mg/day given intermittently [see Clinical Studies]. Patients should be periodically re-assessed to determine the need for continued treatment.

Dosing in Specific Populations

Treatment of Pregnant Women

PMDD does not exist in pregnancy. However, if there is a need to treat pregnant women with fluoxetine, the physician should carefully consider the potential risks and potential benefits of treatment. Neonates exposed to SSRIs or SNRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding [see Use In Specific Populations].

Hepatic Impairment

A lower or less frequent dosage should be used in patients with hepatic impairment [see CLINICAL PHARMACOLOGY and Use in Specific Populations].

Concomitant Illness

Patients with concurrent disease or on multiple concomitant medications may require dosage adjustments [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].

Discontinuation of Treatment

Symptoms associated with discontinuation of fluoxetine, SNRIs, and SSRIs, have been reported [see WARNINGS AND PRECAUTIONS].

Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders

At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with SARAFEM. Conversely, at least 5 weeks should be allowed after stopping SARAFEM before starting an MAOI intended to treat psychiatric disorders [see CONTRAINDICATIONS].

Use of SARAFEM with Other MAOIs such as Linezolid or Methylene Blue

Do not start SARAFEM in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered [see CONTRAINDICATIONS].

In some cases, a patient already receiving SARAFEM therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, SARAFEM should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for five weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with SARAFEM may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue [see WARNINGS AND PRECAUTIONS].

The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with SARAFEM is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use [see WARNINGS AND PRECAUTIONS].

HOW SUPPLIED

Dosage Forms And Strengths

  • 10 mg tablet is a cream, round tablet embossed with S10 on one side.
  • 15 mg tablet is a white, round tablet embossed with S15 on one side.
  • 20 mg tablet is a yellow, round tablet embossed with S20 on one side.

SARAFEM® (fluoxetine hydrochloride tablets) is available in 10 mg1, 15 mg1 and 20 mg1 strengths.

The 10 mg tablet is a cream, round tablet embossed with S10 on one side:

N 0430-0210-14 - Four blister cards of 7 tablets each

The 15 mg tablet is a white, round tablet embossed with S15 on one side:

N 0430-0215-14 - Four blister cards of 7 tablets each

The 20 mg tablet is a yellow, round tablet embossed with S20 on one side:

N 0430-0220-14 - Four blister cards of 7 tablets each

Storage and Handling

Store at 25° C (77° F); excursions permitted to 15° - 30° C (59° - 86° F) [see USP Controlled Room Temperature]

1Equivalent to fluoxetine base.

Manufactured by: Pharmaceutics International, Inc., Hunt Valley, MD 21031 for Warner Chilcott Company, LLC Fajardo, PR 00738. Marketed by: Warner Chilcott (US), LLC Rockaway, NJ 07866. Revised 07/2013

Last reviewed on RxList: 7/22/2013
This monograph has been modified to include the generic and brand name in many instances.

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