Womenra

Womenra is a prescription medication specifically developed to address the complex neurobiological factors underlying hypoactive sexual desire disorder (HSDD) in premenopausal women. As a centrally-acting serotonin receptor agonist and antagonist, it represents a targeted pharmacological approach to modulating neurotransmitter systems involved in sexual motivation and response. Unlike hormonal therapies or situational treatments, Womenra works at the neural level to help rebalance brain chemistry associated with sexual desire, offering a scientifically-validated option for women experiencing distressing deficiency in sexual interest that cannot be attributed to coexisting medical or psychiatric conditions, relationship problems, or the effects of medication or drug substance.

Features

• Contains 100mg flibanserin as the active pharmaceutical ingredient
• Formulated as immediate-release tablets for oral administration
• Manufactured under cGMP standards with consistent pharmaceutical quality
• Requires prescription and medical supervision for appropriate use
• Specifically indicated for premenopausal women with acquired, generalized HSDD

Benefits

• Increases the number of satisfying sexual events (SSEs) per month
• Reduces distress associated with low sexual desire
• Improves sexual desire scores as measured by validated patient-reported outcomes
• Provides a non-hormonal treatment option for sexual dysfunction
• Addresses the neurochemical imbalance associated with HSDD
• Offers a targeted approach that differs from traditional antidepressant medications

Common use

Womenra is specifically indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD). HSDD is characterized by persistently or recurrently deficient sexual fantasies and desire for sexual activity that causes marked distress or interpersonal difficulty, and which is not better accounted for by a medical condition, psychiatric disorder, relationship problems, or medication effects. The condition must be acquired (developing in a patient who previously had no problems with sexual desire) and generalized (not situational or partner-specific). Clinical studies have demonstrated efficacy in women who meet these diagnostic criteria, particularly those who experience associated distress about their low sexual desire.

Dosage and direction

The recommended dosage is 100mg taken orally once daily at bedtime. Administration at bedtime is crucial due to the risk of hypotension, syncope, and central nervous system depression. The tablet should be swallowed whole with water and not crushed, chewed, or broken. Patients should avoid consuming alcohol during treatment with Womenra, as concomitant use increases the risk of severe hypotension and syncope. Treatment response should be assessed after 8 weeks of continuous therapy. If no meaningful improvement is observed after this period, discontinuation should be considered. Dosage adjustment is not recommended for patients with mild hepatic impairment, but Womenra is contraindicated in patients with moderate or severe hepatic impairment.

Precautions

Womenra carries several important precautions that require careful consideration. Patients should be advised about the potential for hypotension, syncope, and central nervous system depression, particularly during the initial weeks of treatment or following dosage increases. The risk of these adverse reactions is increased with concomitant use of alcohol, strong CYP3A4 inhibitors, or other medications that can cause hypotension or CNS depression. Patients should be cautioned about engaging in potentially hazardous activities until they know how Womenra affects them. Regular monitoring of blood pressure may be advisable, especially during treatment initiation. Womenra may cause drowsiness, and patients should avoid driving or operating machinery if they experience sedation. The medication should be used with caution in patients with low blood pressure or those taking antihypertensive medications.

Contraindications

Womenra is contraindicated in several patient populations. Absolute contraindications include concomitant use with alcohol due to the increased risk of severe hypotension and syncope. The medication is contraindicated in patients taking strong CYP3A4 inhibitors such as ketoconazole, itraconazole, nefazodone, ritonavir, clarithromycin, and certain other antifungal and antibiotic medications. Womenra should not be used in patients with hepatic impairment classified as moderate or severe (Child-Pugh Class B or C). It is also contraindicated in pregnant women and during breastfeeding, as safety in these populations has not been established. Additionally, Womenra is not indicated for use in postmenopausal women or men, and is contraindicated in these populations.

Possible side effect

The most commonly reported adverse reactions include dizziness (11.9%), somnolence (11.2%), nausea (10.4%), fatigue (9.2%), insomnia (4.9%), and dry mouth (3.8%). These side effects are generally mild to moderate in severity and often diminish with continued treatment. More serious but less common adverse effects may include syncope (0.4%), hypotension (0.2%), and accidental injury (2.6%). The risk of syncope and hypotension is increased with alcohol consumption and may be more prevalent during the first two weeks of treatment. Some patients may experience anxiety, difficulty concentrating, or changes in appetite. Patients should report any persistent or severe side effects to their healthcare provider promptly.

Drug interaction

Womenra has significant drug interactions that require careful management. Concomitant use with alcohol is absolutely contraindicated due to the increased risk of severe hypotension and syncope. Strong CYP3A4 inhibitors significantly increase flibanserin exposure and are contraindicated. Moderate CYP3A4 inhibitors may also increase flibanserin concentrations and should be used with caution. Womenra may potentiate the effects of CNS depressants including benzodiazepines, opioids, antipsychotics, and antidepressants. Concomitant use with medications that can cause hypotension, including antihypertensives, alpha-blockers, and nitrates, may increase the risk of hypotension and syncope. Womenra is primarily metabolized by CYP3A4 and CYP2C19 enzymes, and medications that affect these pathways may alter its pharmacokinetics.

Missed dose

If a dose is missed at the usual bedtime administration time, the patient should skip the missed dose and take the next dose at the regular time the following evening. Patients should not take a double dose to make up for a missed dose, as this may increase the risk of adverse effects including hypotension and syncope. Consistency in bedtime administration is important for maintaining stable drug levels and minimizing side effects. Patients should establish a routine to help ensure regular dosing, such as taking the medication immediately before going to bed. If multiple doses are missed, patients should consult their healthcare provider before resuming treatment.

Overdose

In case of suspected overdose, immediate medical attention should be sought. Symptoms of overdose may include severe dizziness, profound sedation, syncope, hypotension, and CNS depression. There is no specific antidote for Womenra overdose. Treatment should be supportive and symptomatic, including monitoring of vital signs, particularly blood pressure and heart rate. Management may include maintaining airway patency, ensuring adequate oxygenation and ventilation, and administering intravenous fluids for hypotension. Activated charcoal may be considered if administered shortly after ingestion. Hemodialysis is unlikely to be effective due to Womenra’s high protein binding and extensive metabolism. Patients should be monitored for at least 24 hours due to the drug’s half-life of approximately 11 hours.

Storage

Womenra tablets should be stored at room temperature between 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C to 30°C (59°F to 86°F). The medication should be kept in its original container with the lid tightly closed to protect from moisture and light. Tablets should not be stored in bathroom cabinets or other areas subject to high humidity. Womenra should be kept out of reach of children and pets to prevent accidental ingestion. Proper storage helps maintain the stability and effectiveness of the medication throughout its shelf life. Patients should check the expiration date before use and properly dispose of any expired medication.

Disclaimer

This information is provided for educational purposes only and does not constitute medical advice. Womenra is available by prescription only and should be used under the supervision of a qualified healthcare provider. Individual results may vary, and not all patients will experience the same benefits or side effects. Patients should discuss their complete medical history, including all medications and supplements they are taking, with their healthcare provider before starting treatment. This information is not exhaustive, and patients should refer to the full prescribing information and consult with their healthcare provider for complete information about Womenra, including boxed warnings about the risk of hypotension and syncope with alcohol use.

Reviews

Clinical trial data demonstrate that Womenra shows statistically significant improvement in satisfying sexual events and sexual desire scores compared to placebo. In phase III clinical trials, women treated with Womenra experienced approximately 0.8-1.0 additional satisfying sexual events per month and showed improvement on the Female Sexual Function Index desire domain score. Patient-reported outcomes indicated reduced distress associated with low sexual desire. However, individual experiences vary, and some patients may not respond to treatment. The medication’s efficacy must be balanced against its side effect profile and the requirement to avoid alcohol consumption. Many healthcare providers report that appropriate patient selection and thorough education about risks and benefits are crucial for successful treatment outcomes.