Sarafem is a prescription medication specifically indicated for the treatment of Premenstrual Dysphoric Disorder (PMDD), a severe and often debilitating form of premenstrual syndrome. It contains the active ingredient fluoxetine hydrochloride, a selective serotonin reuptake inhibitor (SSRI) that works by restoring the balance of serotonin in the brain, a neurotransmitter known to significantly influence mood, emotions, and behavior. By targeting the core neurochemical imbalance associated with PMDD, Sarafem provides a clinically proven, non-hormonal therapeutic option for managing the severe emotional and physical symptoms that disrupt daily functioning. This medication is designed for use in women of reproductive age who meet the specific diagnostic criteria for this condition, offering a path toward stabilized mood and improved quality of life.

Features

• Contains fluoxetine hydrochloride, a well-established SSRI.
• Available in easy-to-swallow capsules in multiple strengths (10 mg and 20 mg).
• Specifically FDA-approved for the treatment of Premenstrual Dysphoric Disorder (PMDD).
• Offers a convenient, once-daily dosing regimen, typically taken for the 14 days preceding menses or continuously.
• A non-hormonal pharmacological approach to managing severe premenstrual symptoms.

Benefits

• Significant Reduction in Emotional Symptoms: Effectively alleviates the severe mood swings, irritability, tension, and feelings of sadness or hopelessness characteristic of PMDD.
• Improved Functional Capacity: Allows for greater participation in daily social, occupational, and domestic activities by reducing symptom interference.
• Decreased Physical Discomfort: Can help manage associated physical symptoms such as bloating, breast tenderness, and joint or muscle pain.
• Non-Hormonal Treatment Option: Provides an alternative for patients who cannot or prefer not to use hormonal therapies like oral contraceptives.
• Established Safety Profile: Benefits from the extensive clinical history and well-understood safety data of its active ingredient, fluoxetine.

Common use

Sarafem is exclusively indicated for the management of Premenstrual Dysphoric Disorder (PMDD). PMDD is a serious medical condition diagnosed by a healthcare professional based on strict criteria from the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). It is characterized by severe, disabling emotional and physical symptoms—such as marked anger, irritability, anxiety, depressed mood, difficulty concentrating, lethargy, and appetite changes—that occur exclusively during the luteal phase of the menstrual cycle and resolve shortly after the onset of menses. Sarafem is not intended for the milder symptoms of premenstrual syndrome (PMS) or for general depression, unless specifically prescribed off-label by a physician.

Dosage and direction

Dosage must be individualized by a healthcare provider based on patient response and tolerability.

• The recommended initial dose for PMDD is 20 mg taken orally once daily, either continuously throughout the menstrual cycle or intermittently (starting 14 days prior to the anticipated onset of menstruation and continuing through the first full day of mensus).
• Capsules may be taken with or without food.
• If a 20 mg dose is not well tolerated after an appropriate trial period, the dose may be reduced to 10 mg daily.
• The dosage may be increased to a maximum of 60 mg per day in some cases, though this is less common for PMDD.
• It is crucial to follow the prescribed schedule exactly. Do not adjust your dose or stop taking Sarafem without consulting your doctor.

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 initial months of therapy or after dosage changes.
• Serotonin Syndrome: There is a potential risk of a rare but serious condition called 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. Inform your doctor if you take NSAIDs, aspirin, warfarin, or other drugs that affect coagulation.
• Activation of Mania/Hypomania: Use with caution in patients with a history of mania or bipolar disorder.
• Seizures: Use cautiously in patients with a history of seizures.
• Discontinuation Syndrome: Abrupt discontinuation may lead to symptoms such as dizziness, sensory disturbances, anxiety, irritability, agitation, insomnia, confusion, and lethargy. A gradual taper under medical supervision is recommended.
• Pregnancy and Nursing: Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Fluoxetine is excreted in human milk; caution is advised when administering to a nursing woman. Discuss with your obstetrician.

Contraindications

Sarafem is contraindicated in 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.
• Taking pimozide or thioridazine.
• With a known hypersensitivity to fluoxetine hydrochloride or any of the inactive ingredients in the formulation.

Possible side effect

Common side effects may include:

• Headache
• Nausea
• Insomnia or somnolence (sleepiness)
• Fatigue or asthenia (weakness)
• Diarrhea or loose stools
• Dry mouth
• Dizziness
• Anxiety and nervousness
• Decreased libido, abnormal ejaculation, impotence, or other sexual dysfunction
• Sweating
• Indigestion

This is not a complete list. Patients should report any persistent or bothersome side effects to their physician.

Drug interaction

Sarafem has a significant potential for drug interactions. Inform your doctor of all medications you are taking, including:

• MAOIs: Absolutely contraindicated (see Contraindications).
• Other Serotonergic Drugs: (e.g., triptans, tramadol, other SSRIs/SNRIs, tryptophan, lithium) due to increased risk of Serotonin Syndrome.
• Drugs Metabolized by CYP2D6: Fluoxetine is a potent inhibitor of this liver enzyme and can significantly increase plasma levels of drugs such as tricyclic antidepressants, antipsychotics (e.g., thioridazine, pimozide), certain beta-blockers, and Type 1C antiarrhythmics (e.g., flecainide, propafenone).
• Drugs Tightly Bound to Plasma Proteins: May be displaced by fluoxetine (e.g., warfarin, digitoxin).
• Tryptophan
• NSAIDs, Aspirin, Warfarin, and other Anticoagulants: Increased risk of bleeding.
• Benzodiazepines: May increase diazepam levels and prolong its half-life.
• Alcohol: Not recommended; may potentiate cognitive and motor effects.

Missed dose

If a dose is missed, take it as soon as you remember. However, if it is almost time for the next scheduled dose, skip the missed dose and take the next one at the regular time. Do not take a double dose to make up for a missed one.

Overdose

Symptoms of overdose may include nausea, vomiting, agitation, restlessness, hypomania, seizures, and somnolence. Other signs can include tachycardia, cardiac arrhythmias, and ECG changes. Fatalities have been reported with fluoxetine overdose, especially in combination with other drugs. In case of suspected overdose, immediately contact a poison control center or emergency room. Treatment is symptomatic and supportive; there is no specific antidote.

Storage

Store Sarafem capsules at room temperature, 20°C to 25°C (68°F to 77°F), in a tightly closed container. Excursions are permitted between 15°C and 30°C (59°F and 86°F). Keep this and all medications out of the reach of children and pets.

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 before starting any new treatment. Never disregard professional medical advice or delay in seeking it because of something you have read here.

Reviews

“After years of struggling with severe PMDD that made me feel like a different person for two weeks every month, my doctor prescribed Sarafem. The difference has been night and day. The intense irritability and despair are now manageable. It gave me my life back.” – J.S., 34

“It took a few cycles to find the right dosage, and the initial nausea was challenging, but sticking with it was worth it. My relationships have improved dramatically because I’m no longer ruled by my PMDD symptoms. This medication, combined with therapy, has been a cornerstone of my treatment.” – A.L., 29

“I was hesitant to try an SSRI, but the intermittent dosing schedule for my PMDD made sense. I take it for the two weeks before my period, and it significantly dulls the sharp edges of my mood swings and physical aches. It’s not a magic cure, but it’s a powerful tool that allows me to function normally.” – M.K., 41