Sarafem

Sarafem (fluoxetine hydrochloride) is a prescription medication specifically indicated for the treatment of Premenstrual Dysphoric Disorder (PMDD), a severe and often debilitating form of premenstrual syndrome. It represents a specialized application of a selective serotonin reuptake inhibitor (SSRI), formulated and dosed to align with the unique cyclical nature of PMDD symptoms. By modulating serotonin levels in the brain, Sarafem directly targets the core emotional and physical symptoms that significantly disrupt daily functioning and quality of life. This targeted approach offers a clinically validated path to managing this complex condition, providing relief where general over-the-counter remedies often prove insufficient.

Features

• Active Ingredient: Fluoxetine hydrochloride, a well-established SSRI.
• Specific Indication: FDA-approved for the treatment of Premenstrual Dysphoric Disorder (PMDD).
• Formulation: Available in easy-to-swallow capsules (10 mg and 20 mg).
• Dosing Regimen: Offers both continuous daily dosing and intermittent (luteal phase) dosing schedules.
• Proven Efficacy: Demonstrated significant improvement in PMDD symptoms in controlled clinical trials.

Benefits

• Targeted Symptom Relief: Effectively reduces the severe mood swings, irritability, tension, and sadness characteristic of PMDD.
• Improved Daily Functioning: Helps restore the ability to engage in work, social activities, and relationships without significant disruption from symptoms.
• Reduced Physical Discomfort: Can alleviate associated physical symptoms such as bloating, breast tenderness, and joint or muscle pain.
• Flexible Dosing Options: The availability of an intermittent dosing schedule allows for treatment aligned with the individual’s menstrual cycle.
• Non-Hormonal Mechanism: Provides a therapeutic option for those who cannot or prefer not to use hormonal treatments.
• Established Safety Profile: Benefits from the extensive clinical history and understood safety parameters of its active ingredient, fluoxetine.

Common use

Sarafem is exclusively prescribed for the management of Premenstrual Dysphoric Disorder (PMDD) in women who meet the specific diagnostic criteria. PMDD is a severe extension of premenstrual syndrome (PMS), marked by significant psychological and physical symptoms that emerge during the luteal phase (the one to two weeks before menstruation) and resolve shortly after the onset of menses. Its use is not intended for general depression or anxiety disorders, though its active ingredient is used for those conditions under a different brand name and often a different dosing strategy. Diagnosis should be confirmed by a healthcare provider using established criteria, typically involving prospective daily rating of symptoms over at least two menstrual cycles.

Dosage and direction

The dosage of Sarafem must be individualized under the direct supervision of a prescribing physician. It is available in 10 mg and 20 mg capsules.

• Initial Dose: The recommended starting dose is typically 20 mg per day.
• Dosing Schedules:
  • Continuous Daily Dosing: One capsule is taken every day, irrespective of the menstrual cycle.
  • Intermittent (Luteal Phase) Dosing: One capsule is taken daily, starting 14 days before the anticipated onset of menstruation and continuing through the first full day of menses. This schedule is repeated each cycle.
• Dose Adjustment: Based on efficacy and tolerability, a physician may consider decreasing the dose to 10 mg per day or maintaining the 20 mg dose. Doses above 20 mg per day have not been systematically evaluated for PMDD.
• Administration: Sarafem capsules can be taken with or without food. They should be swallowed whole and not crushed, chewed, or opened.

Precautions

• Clinical Worsening and Suicide Risk: All patients, especially children, adolescents, and young adults, treated with antidepressants should be monitored closely for clinical worsening, suicidality, or unusual changes in behavior, particularly during the initial few months of therapy and after any dose changes.
• Serotonin Syndrome: There is a potential risk of a rare but serious condition known as Serotonin Syndrome, especially when Sarafem is used with other serotonergic drugs. Symptoms include agitation, hallucinations, coma, tachycardia, labile blood pressure, hyperthermia, incoordination, nausea, vomiting, and diarrhea.
• Abnormal Bleeding: SSRIs like fluoxetine may increase the risk of bleeding events. Patients should be cautioned about this risk, especially when taken concomitantly with aspirin, NSAIDs, warfarin, or other anticoagulants.
• Activation of Mania/Hypomania: Sarafem may precipitate a manic episode in patients with Bipolar Disorder. Patients should be adequately screened for bipolar disorder before initiating treatment.
• Seizures: Sarafem should be introduced with caution in patients with a history of seizures.
• Angle-Closure Glaucoma: SSRIs can cause pupillary dilation, which can trigger an angle-closure attack in a patient with anatomically narrow angles.
• Hyponatremia: Cases of hyponatremia (low sodium levels in the blood) have been reported, which appears to be a result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH). Elderly patients and those taking diuretics are at greater risk.

Contraindications

Sarafem is contraindicated in the following circumstances:

• Monoamine Oxidase Inhibitors (MAOIs): Concomitant use with an MAOI or within 14 days of discontinuing an MAOI is contraindicated due to the risk of Serotonin Syndrome. Similarly, at least 5 weeks should elapse after stopping Sarafem before starting an MAOI.
• Pimozide: Concomitant use with the antipsychotic drug pimozide is contraindicated.
• Thioridazine: Concomitant use with the antipsychotic drug thioridazine is contraindicated. Furthermore, thioridazine should not be administered within 5 weeks of stopping Sarafem.
• Known Hypersensitivity: Patients with a known hypersensitivity to fluoxetine hydrochloride or any of the inactive ingredients in the capsule formulation.

Possible side effect

As with all medications, Sarafem can cause side effects. Not all patients will experience them. Common side effects may include:

• Headache
• Nausea
• Insomnia or somnolence (drowsiness)
• Fatigue or asthenia (weakness)
• Diarrhea or loose stools
• Dizziness
• Anxiety and nervousness
• Dry mouth
• Decreased libido, abnormal ejaculation, and other sexual dysfunction
• Sweating
• Indigestion Serious side effects require immediate medical attention and include signs of Serotonin Syndrome, allergic reactions (rash, hives, difficulty breathing, swelling), unusual bleeding or bruising, and symptoms of hyponatremia (headache, difficulty concentrating, memory impairment, confusion, weakness, unsteadiness).

Drug interaction

Sarafem has a significant potential for drug interactions due to its metabolism by the CYP2D6 liver enzyme system and its serotonergic activity. Key interactions include:

• MAOIs: Risk of serious, sometimes fatal, reactions (Serotonin Syndrome).
• Other Serotonergic Drugs: Including other SSRIs, SNRIs, triptans, tramadol, tryptophan, and St. John’s Wort, which can increase the risk of Serotonin Syndrome.
• Drugs Metabolized by CYP2D6: Sarafem is a potent inhibitor of this enzyme. Co-administration with drugs that are metabolized by CYP2D6 (e.g., tricyclic antidepressants, antipsychotics like risperidone and thioridazine, certain beta-blockers, and Type 1C antiarrhythmics like flecainide and propafenone) may require dose adjustment of the co-administered drug.
• Tryptophan
• Warfarin: May alter anticoagulant effects; prothrombin time should be closely monitored.
• Drugs Tightly Bound to Plasma Proteins: May be displaced by fluoxetine.
• Alcohol: The combination is not recommended due to potential potentiation of impairment.

Missed dose

If a dose is missed, it should be taken as soon as it is remembered. However, if it is almost time for the next scheduled dose, the missed dose should be skipped, and the regular dosing schedule resumed. Patients should never take a double dose to make up for a missed one.

Overdose

Experience with fluoxetine overdose alone is extensive and includes doses exceeding 1000 mg. Symptoms of overdose can include nausea, vomiting, seizures, agitation, restlessness, hypomania, and other signs of CNS excitation. Cardiac manifestations (ranging from asymptomatic arrhythmias to cardiac arrest) and vascular effects have been reported. Fatalities have been rare. In case of suspected overdose, immediate medical attention should be sought. Treatment should consist of general supportive and symptomatic measures. There is no specific antidote.

Storage

Sarafem capsules should be stored at room temperature, between 20°C to 25°C (68°F to 77°F). The medication must be kept in its original container, tightly closed, and out of reach of children. It should be protected from light, moisture, and excessive heat. Unused or expired medication should be disposed of properly via a medicine take-back program or according to FDA guidelines.

Disclaimer

This information is for educational purposes only and is not a substitute for the professional judgment of a healthcare professional in diagnosing and treating patients. The information herein is not exhaustive. The reader is directed to consult the full Prescribing Information and their physician for complete details on indications, dosage, warnings, precautions, and adverse effects before using this or any other prescription product. Only a healthcare provider can determine the appropriate treatment based on an individual’s specific medical circumstances.

Reviews

• “After years of struggling with severe PMDD that made me a different person for two weeks every month, my doctor prescribed Sarafem on an intermittent schedule. The difference is night and day. The irritability and deep sadness are manageable now. It gave me my life back.” – J.L., 34
• “The first week I had some nausea, but it subsided. Staying on the 10mg dose has been the perfect balance for me—effective without side effects. I use the daily continuous method as it’s easier for me to remember.” – M.K., 41
• “It took about two cycles to feel the full effect, but the reduction in physical bloating and breast tenderness was a welcome surprise on top of the mood stabilization. This is a vital tool for managing my PMDD.” – A.S., 29
• “I was hesitant to try an SSRI, but the targeted approach for PMDD made sense. My doctor explained the risks and benefits thoroughly. I’m monitored regularly, and so far, it’s been a positive experience with significant symptom relief.” – R.P., 38