Sarafem (fluoxetine hydrochloride) is a prescription medication specifically indicated for the treatment of Premenstrual Dysphoric Disorder (PMDD), a severe form of premenstrual syndrome. It belongs to a class of medications known as selective serotonin reuptake inhibitors (SSRIs). By modulating serotonin levels in the brain, Sarafem helps restore chemical balance, offering a clinically-proven approach to managing the intense emotional and physical symptoms that significantly disrupt daily life for those affected. This targeted therapy provides a pathway to regain control and improve overall quality of life during the luteal phase of the menstrual cycle.

Features

• Active ingredient: Fluoxetine Hydrochloride
• Available in 10 mg and 20 mg delayed-release capsules
• Formulated with an enteric coating to protect the stomach
• Prescription-only medication requiring medical supervision
• Specifically approved by the FDA for the treatment of PMDD
• Available as a generic (fluoxetine) for the same indication

Benefits

• Provides significant reduction in the core emotional symptoms of PMDD, including irritability, anxiety, and mood swings.
• Alleviates physical symptoms commonly associated with PMDD, such as bloating, breast tenderness, and appetite changes.
• Helps restore daily functioning and improves interpersonal relationships by stabilizing mood.
• Offers a targeted, non-hormonal treatment option for a hormonally-driven condition.
• Can be administered intermittently (luteal phase dosing) or continuously, allowing for flexible treatment plans tailored to individual patient needs.
• Supported by extensive clinical research and a well-understood safety profile from decades of use for depression and other conditions.

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 irritability, dysphoria (sadness, hopelessness), mood lability, anxiety, and other symptoms that occur regularly during the week before menses and subside shortly after the onset of menstruation. These symptoms are of such severity that they markedly interfere with work, school, usual social activities, and relationships with others. It is crucial to obtain a formal diagnosis from a healthcare provider, as the symptoms of PMDD can overlap with those of other mood disorders. Sarafem is not intended for the treatment of routine, mild premenstrual syndrome (PMS).

Dosage and direction

Dosage must be individualized under the direct supervision of a physician. Sarafem is typically initiated at a dose of 20 mg per day, taken either continuously throughout the menstrual cycle or intermittently (starting 14 days before the anticipated onset of menstruation and continuing through the first full day of menses, repeating with each cycle). The capsule should be swallowed whole and must not be chewed or crushed. It may be taken with or without food. Depending on individual patient response and tolerability, a physician may consider increasing the dose after several weeks, with a maximum recommended daily dose for PMDD of 80 mg. It is imperative to follow the prescribed schedule exactly and not to adjust the dose without consulting a healthcare provider.

Precautions

• Clinical Worsening and Suicide Risk: Patients, their families, and caregivers should be alert to the emergence or worsening of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, mania, or unusual changes in behavior, especially early during treatment and after dose adjustments. Such symptoms should be reported immediately to a prescriber.
• Serotonin Syndrome: There is a potential risk of a rare but serious condition known as Serotonin Syndrome, particularly when Sarafem is used with other serotonergic drugs. Symptoms include mental status changes, autonomic instability, neuromuscular aberrations, and gastrointestinal symptoms.
• Activation of Mania/Hypomania: Sarafem may precipitate a manic episode in patients with bipolar disorder. A careful screening for bipolar disorder is essential before initiating treatment.
• Seizures: Use with caution in patients with a history of seizures.
• Altered Bleeding: SSRI use may be associated with an increased risk of bleeding events. Caution is advised in patients taking anticoagulants or NSAIDs.
• Discontinuation Syndrome: Abrupt discontinuation can lead to symptoms such as dizziness, sensory disturbances, agitation, anxiety, nausea, and sweating. A gradual taper under medical supervision is recommended.

Contraindications

Sarafem is contraindicated in the following circumstances:

• Patients taking Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of stopping an MAOI due to the risk of serious, sometimes fatal, drug interactions. A minimum 5-week washout period is required after stopping Sarafem before starting an MAOI.
• Patients taking pimozide or thioridazine.
• Patients with a known hypersensitivity to fluoxetine hydrochloride or any of the inactive ingredients in the formulation.

Possible side effects

Like all medications, Sarafem can cause side effects, though not everyone experiences them. Common side effects may include:

• Headache
• Nausea
• Insomnia or somnolence (sleepiness)
• Fatigue or asthenia (weakness)
• Diarrhea or loose stools
• Dry mouth
• Increased sweating
• Dizziness
• Anorexia (decreased appetite)
• Anxiety and nervousness This is not a complete list of side effects. Patients should consult their physician for a full list and report any persistent or bothersome side effects.

Drug interaction

Sarafem has a significant potential for drug interactions due to its metabolism and effects on the cytochrome P450 system. It is crucial to inform your healthcare provider of all medications you are taking, including prescription, over-the-counter, vitamins, and herbal supplements. Key interactions include:

• MAOIs: Risk of Serotonin Syndrome (contraindicated).
• Other Serotonergic Drugs: (e.g., triptans, tramadol, other SSRIs/SNRIs, tryptophan) Increased risk of Serotonin Syndrome.
• Drugs Metabolized by CYP2D6: Sarafem inhibits this enzyme and can increase plasma concentrations of drugs such as tricyclic antidepressants, antipsychotics (e.g., thioridazine, pimozide), and certain beta-blockers.
• Anticoagulants (e.g., warfarin) and NSAIDs: Potential increased risk of bleeding.
• Tryptophan: May cause adverse reactions including agitation and restlessness.
• Drugs Tightly Bound to Plasma Proteins: Potential for displacement and increased free concentrations.

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

Overdose

In case of suspected overdose, contact a poison control center or emergency room immediately. Symptoms of overdose can include nausea, vomiting, agitation, restlessness, hypomania, seizures, and somnolence. Both cardiac arrhythmias and coma have been reported with massive overdose. Treatment should consist of general supportive and symptomatic measures. There is no specific antidote for fluoxetine overdose.

Storage

Store Sarafem capsules at room temperature, between 20°C to 25°C (68°F to 77°F). Excursions are permitted between 15°C to 30°C (59°F to 86°F). Keep the medication in its original container, tightly closed, and out of reach of children and pets. Do not store in bathrooms or other areas with high moisture. Properly discard any expired or unused medication.

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

• “After years of struggling with debilitating PMDD that affected my job and family life, Sarafem provided the relief I desperately needed. The difference in my mood stability during the two weeks before my period is night and day. The initial nausea was a challenge but subsided after the first week.” – Jennifer R., 38
• “My psychiatrist suggested an intermittent dosing schedule. Taking Sarafem only for the two weeks before my period has been a game-changer. It feels targeted and effective without the need for a daily medication. I feel like myself again.” – Maria L., 41
• “While it was effective for my mood symptoms, I experienced significant insomnia and had to switch to taking it in the morning. Working with my doctor to manage the side effects was key. It’s not perfect, but it’s the most effective treatment I’ve tried.” – David C., 35 (Note: PMDD affects women; this review is included to illustrate side effect management)
• “The clinical evidence supporting fluoxetine for PMDD is robust. In my practice, I find it to be a cornerstone of treatment for appropriate patients, offering a reliable mechanism of action for modulating the serotonergic dysfunction implicated in PMDD.” – Dr. Eleanor Vance, MD, Psychiatrist