(WellsYI-O) Sublingual Rapid Dissolve Mini-Tab
75 mg / 100 IU
Product Overview
Flibanserin / Oxytocin Description1-9
Flibanserin has been utilized for the treatment of hypoactive sexual desire disorder in premenopausal women. The objective of this medication is to enhance sexual desire and increase the number of satisfying sexual experiences. Commonly administered at bedtime, Flibanserin has a half-life of 11 hours. Following oral administration, flibanserin reaches peak concentration within 45 minutes, has an oral bioavailability of approximately 33%, and achieves steady-state levels within 3 days.
Oxytocin is produced in the hypothalamus and stored in the posterior portion of the pituitary gland. It is also manufactured synthetically with activity identical to that of naturally occurring oxytocin. Oxytocin promotes smooth muscle contraction in the uterus during labor and stimulates the alveolar ducts to release milk after it has been produced in the breast. Due to its effects on the uterus, it has been used to induce labor, assist with placental delivery, and manage postpartum bleeding. Oxytocin has additionally been associated with social bonding, mood regulation, and sexual function.
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.
Oxytocin3-9
Oxytocin causes G-protein coupled receptors to increase intracellular calcium which leads to uterine contraction. The stimulation of uterine contractions causes more oxytocin to be released. As more oxytocin is released it positively influences even more release of oxytocin. This release of oxytocin is called positive feedback which is much different than how many hormones work in the endocrine system. Oxytocin administered exogenously causes the same response as endogenously produced oxytocin. Not only does oxytocin stimulate uterine contractions, but it also causes contractions of myoepithelial cells in the alveolar ducts found in female breast tissue. These contractions force milk from these ducts into even larger sinuses, which subsequently enables milk expulsion. When a baby attempts to latch onto the mother’s breast it causes oxytocin secretion into the blood in the same manner as vaginal delivery; instead of uterine contractions, milk is ejected from the breast. Like the actions of oxytocin in the uterus to stimulate contractions during delivery, milk-ejection from breast tissue occurs due to positive feedback. In the brain, it is proposed that oxytocin stimulates social and sexual function by its activity in many areas of the brain including its activity on and with neurotransmitters including dopamine. Both oxytocin and dopamine have been found to increase in the brain during sexual activity.
Common2
Flibanserin
Oxytocin3-9
Common
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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