(WellsYI-M Cap) Capsules
75 mg / 1 mg
Product Overview
Flibanserin / Melatonin Capsules Description1-5
Flibanserin has been utilized in the treatment of hypoactive sexual desire disorder in premenopausal women. The purpose of this medication is to enhance sexual desire and increase the number of satisfying sexual experiences. Typically taken at bedtime, Flibanserin has an approximate half-life of 11 hours. Following oral administration, it reaches peak concentration within 45 minutes, has an oral bioavailability of about 33%, and achieves steady-state levels within 3 days.
Melatonin is a neurohormone that has been used to help regulate the circadian rhythm. It has been utilized for jet lag and sleep disorders, including irregular sleep-wake disorders, shift-work disorders, and non-24-hour sleep disorders in adults. Because Flibanserin may lead to insomnia in certain patients, it is combined with melatonin to support sleep.
Flibanserin1,2
An imbalance in the neurotransmitters dopamine (DA), norepinephrine (NA) and serotonin (5-HT) may affect the ability for women to have positive sexual desire (libido) and have satisfying sexual events. In the prefrontal cortex, serotonin may be at increased amounts while norepinephrine and dopamine may be at decreased levels. Flibanserin has activity on serotonin receptors (5-HT1A and 5-HT2A). This activity leads to elevated NE and DA levels and reduced serotonin levels within the prefrontal cortex intracellularly. The drug may also have activity on 5-HT2B, 5-HT2C, and DA D4 receptors. The drug has not been found to be addictive or lead to misuse.
Melatonin3-5
Melatonin production is generated from the conversion of tryptophan. Tryptophan is converted to serotonin and then subsequently to melatonin. The neurohormone is synthesized and secreted in the pineal gland. The suprachiasmatic nucleus in the hypothalamus maintains the circadian rhythms in the body including rest and activity from photic input. Synthesis and secretion of melatonin is activated by darkness and decreased via light. During jet lag or circadian rhythm disorders endogenous melatonin is not secreted. Administering exogenous melatonin helps to reset behavioral sleep patterns. It may also facilitate sleep.
Common2
Flibanserin
Melatonin3
Adverse effects that have been reported with pharmacologic therapies in this category may include dizziness, somnolence, fatigue, nausea, dry mouth, and hypotension. Syncope has been reported in rare cases. Most adverse effects are mild to moderate and may improve with continued use or dose adjustment under medical supervision.
Contraindications2
Precautions2
Other Contraindications & Precautions
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Flibanserin WELLSYI patient information
WellsYI Contraindications WellsYI, a compounded preparation, should not be used in patients with known hypersensitivity to any component of the formulation. Use is contraindicated in patients with hepatic impairment due to increased risk of adverse effects. Concomitant use with strong or moderate CYP3A4 inhibitors may significantly increase systemic exposure and risk of adverse reactions. Alcohol use may increase the risk of hypotension and syncope and should be avoided.
Warnings & Precautions Use caution in patients with a history of hypotension, cardiovascular conditions, or those taking medications that may lower blood pressure or cause CNS depression. Patients should be counseled on the potential for dizziness, somnolence, and impaired alertness, particularly when initiating therapy or adjusting dose.
WPPL operates as a 503A compounding pharmacy and prepares individualized prescription medications pursuant to provider direction. Compounded preparations are not reviewed, tested, or approved by the FDA.
This listing also includes commercially manufactured products for convenience; these items are not compounded by our pharmacy and are sold as provided by their manufacturers. Actual products in stock at time of dispensing may vary due to supply chain variability. Any statements regarding non-compounded products are manufacturer-supplied, have not been evaluated by the FDA, and are not intended to diagnose, treat, cure, or prevent any disease. WPPL does not verify or endorse any therapeutic claims made by manufacturers. Please refer to original labeling for complete product information.
Clinical Use: This compounded preparation has not been evaluated or approved by the FDA for safety or effectiveness. Therapy should be prescribed only after appropriate patient evaluation and individualized risk-benefit assessment by a licensed healthcare provider.
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