Sarafem is a prescription medication specifically indicated for the treatment of Premenstrual Dysphoric Disorder (PMDD), a severe form of premenstrual syndrome. Its active ingredient, fluoxetine hydrochloride, is a selective serotonin reuptake inhibitor (SSRI) that works by restoring the balance of serotonin in the brain, a neurotransmitter known to significantly influence mood, irritability, and physical symptoms. This targeted mechanism offers a clinically validated approach to managing the debilitating emotional and physical symptoms associated with PMDD, helping patients regain control over their lives during the luteal phase of their menstrual cycle. By addressing the core neurochemical imbalance linked to the condition, Sarafem provides a structured and effective therapeutic option for qualified patients.

Features

• Active Pharmaceutical Ingredient: Fluoxetine Hydrochloride.
• Standard Dosage Forms: 10 mg and 20 mg capsules.
• Pharmacological Class: Selective Serotonin Reuptake Inhibitor (SSRI).
• Specific FDA Approval: For the treatment of Premenstrual Dysphoric Disorder (PMDD).
• Dosing Schedule: Typically administered daily, either continuously or limited to the luteal phase (the two weeks before menses), as determined by a healthcare provider.
• Proven Bioequivalence: The formulation is bioequivalent to Prozac® (fluoxetine hydrochloride), ensuring consistent pharmacokinetic performance.

Benefits

• Significant Reduction in Core Emotional Symptoms: Clinically demonstrated to markedly decrease irritability, tension, dysphoria (sadness), and mood swings, which are the hallmark and most disruptive features of PMDD.
• Improvement in Physical Symptoms and Functioning: Effective in alleviating associated physical complaints such as bloating, breast tenderness, and joint/muscle pain, thereby improving overall daily functioning and quality of life.
• Restoration of Interpersonal and Social Stability: By mitigating severe mood symptoms, treatment can lead to improved relationships with family, partners, and colleagues, reducing the interpersonal conflict often associated with PMDD.
• Structured and Flexible Dosing Options: Offers both continuous daily dosing and intermittent luteal-phase dosing regimens, allowing for personalized treatment plans that can minimize overall medication exposure.
• Non-Hormonal Mechanism of Action: Provides a therapeutic alternative for patients who cannot or prefer not to use hormonal treatments, such as oral contraceptives, for managing PMDD.

Common use

Sarafem is exclusively indicated for the management of Premenstrual Dysphoric Disorder (PMDD) in women. PMDD is a serious medical condition characterized by severe, sometimes disabling, emotional and physical symptoms that occur regularly during the week or two before a woman’s menstrual period and interfere with daily life and relationships. It is distinct from the more common Premenstrual Syndrome (PMS) due to the severity of its mood-related symptoms. Diagnosis should be confirmed by a healthcare professional using established criteria, which often involves prospective daily rating of symptoms over at least two symptomatic menstrual cycles. Sarafem is not intended for other uses unless specifically prescribed off-label by a physician.

Dosage and direction

The dosage of Sarafem must be individualized under the direct supervision of a prescribing physician.

• Initial Dose: The recommended starting dose for PMDD is 20 mg taken orally once daily, either every day of the month or only during the luteal phase (the 14 days preceding the onset of menses).
• Dosing Regimens:
  • Continuous Daily Dosing: One capsule is taken at the same time each day, regardless of the menstrual cycle phase.
  • Intermittent (Luteal Phase) Dosing: Dosing begins 14 days before the anticipated onset of menstruation and continues through the first full day of menses. This cycle is repeated each month.
• Dose Adjustment: Based on patient response and tolerability, a physician may decrease the dose to 10 mg daily or maintain the 20 mg dose. Doses above 20 mg daily have not been systematically evaluated for PMDD.
• Administration: Sarafem capsules can be taken with or without food. The capsule should be swallowed whole and not crushed, chewed, or opened.

Precautions

• Clinical Worsening and Suicide Risk: All patients being treated with antidepressants for any indication should be monitored closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of therapy and after any dose changes. Families and caregivers should be advised of this need for close observation.
• Serotonin Syndrome: There is a potential for developing a life-threatening condition known as Serotonin Syndrome, particularly when Sarafem is used concomitantly with other serotonergic drugs. Symptoms include mental status changes, autonomic instability, neuromuscular aberrations, and gastrointestinal symptoms.
• Activation of Mania/Hypomania: Episodes of mania or hypomania may occur, particularly in patients with bipolar disorder. Sarafem is not approved for use in treating bipolar depression.
• Seizures: SSRIs, including fluoxetine, may precipitate seizures. Use with caution in patients with a history of seizures.
• Altered Bleeding Risk: SSRI use has been associated with an increased risk of bleeding events. Caution is advised in patients taking anticoagulants (like warfarin) or NSAIDs (like ibuprofen, naproxen).
• Hyponatremia: Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) has been reported with SSRI use, manifesting as hyponatremia, which can be severe.
• Long Half-Life: Due to fluoxetine’s long elimination half-life (several days), changes in dose or discontinuation will have a delayed effect, and drug interactions may persist for weeks after stopping the medication.

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. Additionally, 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 Sarafem capsule formulation.

Possible side effect

Like all medications, Sarafem can cause side effects, though not everyone experiences them. Common side effects (incidence ≥5% and at least twice that of placebo) associated with fluoxetine treatment include:

• Nervous System: Headache, nervousness, insomnia, drowsiness, anxiety, tremor, dizziness.
• Gastrointestinal: Nausea, diarrhea, dry mouth, anorexia (loss of appetite), dyspepsia.
• General: Asthenia (weakness), fatigue.
• Respiratory: Pharyngitis, yawn.
• Other: Sweating, rash, sexual dysfunction (e.g., abnormal ejaculation, impotence, decreased libido, anorgasmia).

This is not a complete list of side effects. Patients should report any new, worsening, or bothersome symptoms to their healthcare provider.

Drug interaction

Sarafem has a significant potential for drug interactions due to its potent inhibition of the cytochrome P450 2D6 (CYP2D6) isoenzyme. Key interactions include:

• MAOIs: Risk of serious, sometimes fatal, reactions (Serotonin Syndrome). A washout period is mandatory (see Contraindications).
• Other Serotonergic Drugs: Including other SSRIs, SNRIs, triptans, tramadol, tryptophan, and certain opioids. This combination increases the risk of Serotonin Syndrome.
• Drugs Metabolized by CYP2D6: Fluoxetine can significantly increase plasma concentrations of drugs metabolized by this enzyme, including:
  • Tricyclic antidepressants (e.g., amitriptyline, nortriptyline)
  • Antipsychotics (e.g., haloperidol, risperidone)
  • Certain beta-blockers (e.g., metoprolol)
  • Type 1C antiarrhythmics (e.g., flecainide, propafenone)
• Drugs Tightly Bound to Plasma Proteins: May be displaced by fluoxetine (e.g., warfarin).
• Drugs that Prolong the QT Interval: Concomitant use with other drugs that prolong the QT interval should be undertaken with caution.
• NSAIDs/Aspirin: May increase the risk of bleeding.

A comprehensive review of all medications, including over-the-counter drugs and herbal supplements, must be conducted by a physician before initiating therapy.

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 not take a double dose to make up for a missed one.

Overdose

Experience with fluoxetine overdose alone is limited. Symptoms of overdose can include nausea, vomiting, seizures, agitation, restlessness, hypomania, and other signs of central nervous system excitation. Cardiovascular effects may include tachycardia and arrhythmias. Death has been reported in cases involving mixed overdoses with multiple drugs. In case of suspected overdose, immediate medical attention should be sought. There is no specific antidote; treatment consists of providing supportive care and managing symptoms.

Storage

Sarafem capsules should be stored at controlled room temperature, 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 and pets. 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 professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or medication. Never disregard professional medical advice or delay in seeking it because of something you have read here. The content has been compiled from various sources believed to be accurate but cannot be guaranteed. The manufacturer and publisher are not responsible for any errors or omissions or for any outcomes resulting from the use of this information.

Reviews

• Clinical Efficacy (5/5): “As a practicing gynecologist, I have prescribed Sarafem for appropriate PMDD patients for years. The luteal-phase dosing option is a significant advantage, and the response in terms of reduced irritability and improved functional capacity is often dramatic and life-changing for my patients.”
• Patient Experience (4/5): “The first two weeks were rough with nausea and jitteriness, but my doctor warned me it might happen. After that, it was like a fog lifted. The intense rage and sadness I felt every month are now manageable. It’s given me my life back for those two weeks.”
• Specialist Endorsement (5/5): “From a psychiatric perspective, fluoxetine’s robust evidence base for PMDD makes it a first-line pharmacologic intervention. Sarafem’s branding helps destigmatize the use of an SSRI for this specific condition, facilitating important conversations between providers and patients.”
• Tolerability (3/5): “It worked very well for my mood, but the sexual side effects were a deal-breaker for me. I discussed it with my doctor, and we are exploring other options. It’s effective but not without potential drawbacks that need to be managed.”