Sarafem: Effective Relief for Premenstrual Dysphoric Disorder
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Sarafem is a prescription medication specifically indicated for the treatment of Premenstrual Dysphoric Disorder (PMDD), a severe form of premenstrual syndrome that significantly impacts daily functioning and quality of life. It contains fluoxetine hydrochloride, a selective serotonin reuptake inhibitor (SSRI) that works by restoring the balance of serotonin in the brain, a neurotransmitter known to regulate mood. Clinical studies have demonstrated its efficacy in reducing the emotional and physical symptoms associated with PMDD, offering a targeted therapeutic option for patients who have not found sufficient relief through lifestyle modifications or other interventions. By addressing the underlying neurochemical imbalances, Sarafem provides a clinically validated approach to managing this debilitating condition.
Features
- Active ingredient: Fluoxetine hydrochloride
- Available in 10 mg and 20 mg oral capsules
- Delayed-release formulation for consistent serum levels
- FDA-approved specifically for PMDD
- Manufactured under strict pharmaceutical quality controls
- Brand-name equivalent of Prozac® for this indication
Benefits
- Significantly reduces mood swings, irritability, and tension associated with PMDD
- Decreases physical symptoms including bloating, breast tenderness, and appetite changes
- Improves overall quality of life and social functioning during the luteal phase
- Provides predictable symptom relief when taken as directed
- Non-habit forming with established long-term safety profile
- Allows for better management of daily responsibilities and relationships
Common use
Sarafem is primarily prescribed for the treatment of Premenstrual Dysphoric Disorder (PMDD) in women who meet diagnostic criteria for this condition. PMDD represents a severe form of premenstrual syndrome characterized by marked mood disturbances, anxiety, irritability, and physical symptoms that occur consistently during the luteal phase of the menstrual cycle and resolve shortly after menstruation begins. The medication is typically administered intermittently (during symptomatic phases) or continuously, depending on the prescribing physician’s assessment and patient response. Sarafem may also be used off-label for other conditions where SSRIs have demonstrated efficacy, though such use should only occur under direct medical supervision.
Dosage and direction
The recommended initial dosage of Sarafem for PMDD is 20 mg daily, administered either continuously throughout the menstrual cycle or intermittently (starting 14 days before the anticipated onset of menses and continuing through the first full day of menses). Dosage may be adjusted based on individual response and tolerability, with some patients responding adequately to 10 mg daily. The maximum recommended dosage is 80 mg daily, though most PMDD patients require lower doses. Capsules should be swallowed whole with water and may be taken with or without food, though consistent administration with food may help minimize potential gastrointestinal side effects. Dose adjustments should only be made under medical supervision, and treatment duration should be periodically reevaluated based on therapeutic response.
Precautions
Patients should be monitored for the emergence of anxiety, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and mania. Sarafem should be prescribed with caution to patients with a history of mania or hypomania. Use with caution in patients with hepatic impairment, abnormal bleeding tendencies, or those taking anticoagulants. SSRIs may increase the risk of bleeding events. Caution is advised when treating elderly patients or those with comorbid medical conditions. Sarafem may impair judgment, thinking, or motor skills; patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that Sarafem does not affect them adversely. Discontinuation symptoms may occur with abrupt cessation.
Contraindications
Sarafem is contraindicated in patients known to be hypersensitive to fluoxetine hydrochloride or any of the inactive ingredients in the formulation. Concomitant use with monoamine oxidase inhibitors (MAOIs) is contraindicated due to the risk of serotonin syndrome. Sarafem should not be initiated within 14 days of discontinuing an MAOI, and MAOIs should not be started within 5 weeks of discontinuing Sarafem. Contraindicated with pimozide and thioridazine due to the potential for QT prolongation. Not recommended for use during pregnancy unless clearly needed and after careful consideration of risks versus benefits.
Possible side effects
Common side effects (≥5%) include: headache, asthenia, nausea, diarrhea, insomnia, anxiety, nervousness, drowsiness, tremor, sweating, decreased libido, and dry mouth. Less frequent adverse reactions may include: rash, pruritus, vasodilation, abnormal vision, yawning, sinusitis, pharyngitis, and taste perversion. Serious side effects requiring immediate medical attention include: serotonin syndrome symptoms (agitation, hallucinations, coma, tachycardia, instability, nausea/vomiting, diarrhea), abnormal bleeding, seizures, angle-closure glaucoma, hyponatremia, and manic episodes. Any unexpected or severe symptoms should be reported to a healthcare provider promptly.
Drug interaction
Sarafem may interact with: MAOIs (risk of serotonin syndrome), other serotonergic drugs (triptans, tramadol, tryptophan), drugs metabolized by CYP2D6 (increased levels of TCAs, antipsychotics, antiarrhythmics), warfarin (increased anticoagulant effect), NSAIDs/aspirin (increased bleeding risk), and drugs that affect platelet function. May decrease the efficacy of tamoxifen through CYP2D6 inhibition. Use with caution with other CNS-active drugs. May interact with alcohol, though clinical significance is variable. Healthcare providers should conduct complete medication reviews before initiation and during treatment.
Missed dose
If a dose is missed, it should be taken as soon as remembered unless it is almost time for the next scheduled dose. In that case, the missed dose should be skipped, and the regular dosing schedule resumed. Patients should not take double or extra doses to make up for a missed dose. For intermittent dosing regimens specific to PMDD treatment, patients should contact their healthcare provider for guidance if doses are missed during the treatment phase, as this may affect therapeutic efficacy for that menstrual cycle.
Overdose
Symptoms of overdose may include: nausea, vomiting, agitation, restlessness, hypomania, seizures, and other signs of serotonin syndrome. Laboratory findings may include elevated serum transaminases and electrolyte abnormalities. Fatalities have been reported with massive overdoses, particularly in combination with other drugs. There is no specific antidote for Sarafem overdose. Management should include supportive care and symptomatic treatment. Gastric lavage with activated charcoal may be considered if presented early. Forced diuresis, dialysis, hemoperfusion, and exchange transfusion are unlikely to be beneficial due to high protein binding and large volume of distribution.
Storage
Store at room temperature (20°-25°C or 68°-77°F) with excursions permitted between 15°-30°C (59°-86°F). Keep container tightly closed and protect from light and moisture. Keep out of reach of children and pets. Do not use after the expiration date printed on the packaging. Properly dispose of any unused medication through medication take-back programs or according to FDA-recommended disposal guidelines. Do not flush medications down the toilet or pour down a drain unless specifically instructed to do so.
Disclaimer
This information is provided for educational purposes only and does not constitute medical advice. Sarafem is a prescription medication that should only be used under the supervision of a qualified healthcare professional. Individual results may vary, and not all patients will experience the same benefits or side effects. Patients should consult with their healthcare provider for complete information about their specific medical condition and treatment options. The prescribing physician should be the ultimate source of information regarding medication use, dosing, and potential risks.
Reviews
Clinical trials have demonstrated that Sarafem significantly improves PMDD symptoms compared to placebo, with particular efficacy in reducing irritability, tension, and mood swings. Many patients report improved quality of life and better functional capacity during treatment. Some users note initial side effects that often diminish with continued use. Healthcare providers generally consider Sarafem a valuable option within the PMDD treatment algorithm, particularly for patients who have not responded adequately to first-line interventions. Long-term follow-up studies support its sustained efficacy and generally favorable safety profile when used as directed under medical supervision.