Description

XENO Dapoxetine US – 50 Tablets x 30 mg

Product Overview

XENO Dapoxetine US is a pharmaceutical-grade selective serotonin reuptake inhibitor (SSRI) formulated specifically for the management of premature ejaculation (PE) in adult men. Each pack contains 50 film-coated tablets, each providing 30 mg of dapoxetine hydrochloride, a short-acting compound designed for on-demand use prior to anticipated sexual activity. Manufactured by Xeno Lab and sourced from US domestic supply, this product offers a reliable option for individuals seeking pharmacological support for PE.

Dapoxetine is distinguished from other SSRIs by its rapid absorption and elimination profile, making it suitable for intermittent, event-based dosing rather than daily administration. The mechanism of action is presumed to be linked to the inhibition of neuronal reuptake of serotonin, with subsequent potentiation of the neurotransmitter’s action at pre- and post-synaptic receptors. This serotonergic modulation is believed to delay the ejaculatory reflex and improve ejaculatory control.

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Key Features

• Active Substance: Dapoxetine (30 mg per tablet)

• Quantity: 50 tablets per pack

• Origin: US domestic supply

• Manufacturer: Xeno Lab

• Administration: Oral, on-demand use

• Onset of Action: Approximately 1-3 hours after ingestion

• Recommended Dosing: One tablet taken 1-3 hours before anticipated sexual activity; maximum one tablet per 24 hours

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Indication and Clinical Evidence

Dapoxetine is indicated for the treatment of premature ejaculation in adult men aged 18 to 64 years who meet diagnostic criteria including persistent or recurrent ejaculation with minimal sexual stimulation, marked personal distress or interpersonal difficulty, and poor control over ejaculation.

Clinical trials have demonstrated that dapoxetine significantly increases intravaginal ejaculation latency time (IELT) and improves sexual satisfaction when taken prior to intercourse. A randomized clinical trial comparing on-demand dapoxetine 30 mg with other pharmacological interventions reported a 197% median gain in IELT. Furthermore, dapoxetine has shown positive effects on patient satisfaction in both primary and secondary forms of premature ejaculation. A systematic review and meta-analysis concluded that while dapoxetine is recognized for its beneficial effects, its clinical efficacy is significantly enhanced when combined with non-pharmacological interventions.

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Dosage and Administration

The recommended starting dose is one 30 mg tablet, taken with a full glass of water 1 to 3 hours before anticipated sexual activity. Dapoxetine should be administered only as on-demand treatment and should not be taken more than once within a 24-hour period. If the effect of 30 mg is insufficient and side effects are tolerable, the dose may be increased to a maximum of 60 mg, though this should be determined under appropriate medical guidance.

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Safety Information and Contraindications

Dapoxetine should not be used in men who have not been diagnosed with premature ejaculation. The following contraindications and precautions apply:

• Known hypersensitivity to dapoxetine or any excipients

• Concomitant use with other SSRIs, MAOIs, or serotonergic medicinal or herbal products

• Concomitant use with thioridazine or within 14 days of discontinuing thioridazine

• Concomitant use with antidepressants, including SSRIs and SNRIs

• History of syncope (fainting) or tendency to faint

• Significant heart conditions

• Bleeding or clotting disorders

• Epilepsy or seizure disorders

• Bipolar disorder, depression, or mania

• Glaucoma or increased intraocular pressure

• Hepatic or renal impairment

• Galactose intolerance or lactose intolerance

Drug Interactions

Dapoxetine may interact with numerous medications. Patients should inform their healthcare professional if they are taking any other medication, supplements, traditional medicines, or herbal remedies. Alcohol consumption should be avoided while taking dapoxetine, as it may increase the sedative effects and the risk of fainting. Grapefruit juice should also be avoided.

Adverse Effects

The most frequently reported adverse events in clinical studies include nausea, dizziness, headache, diarrhea, insomnia, dry mouth, and fatigue. Nausea and dizziness are the most common dose-related side effects. Patients should be cautioned about activities requiring alertness, such as driving or operating hazardous machinery, as dizziness, drowsiness, blurred vision, and somnolence have been reported.

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Regulatory Status

Dapoxetine is not approved by the U.S. Food and Drug Administration (FDA). The FDA has not established the safety and efficacy of dapoxetine for any indication. However, dapoxetine is approved in numerous other countries including Australia, Austria, Bangladesh, Belgium, Bosnia, Brazil, Bulgaria, Chile, China, and Colombia. Healthcare professionals and patients are encouraged to report any adverse events or side effects to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

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Top 10 Frequently Asked Questions

1. What is dapoxetine used for?

Dapoxetine is a selective serotonin reuptake inhibitor (SSRI) used for the treatment of premature ejaculation (PE) in adult men aged 18 to 64 years. It is designed to increase the time to ejaculation and improve control over ejaculation.

2. How should I take XENO Dapoxetine 30 mg?

Take one 30 mg tablet with a full glass of water 1 to 3 hours before anticipated sexual activity. Do not take more than one tablet within a 24-hour period.

3. How quickly does dapoxetine work?

Dapoxetine is rapidly absorbed, with maximum plasma concentrations occurring approximately 1 to 2 hours after oral administration. The drug has a rapid elimination profile, with concentrations decreasing to less than 5% of peak levels by 24 hours.

4. What are the common side effects of dapoxetine?

The most common side effects include nausea (reported in 11.0% of patients at 30 mg), dizziness (5.8%), headache (5.6%), diarrhea (3.5%), insomnia (2.1%), and fatigue (2.0%). Other reported effects include dry mouth, somnolence, tremor, blurred vision, and sinus congestion.

5. Can I drink alcohol while taking dapoxetine?

No. Alcohol should be avoided while taking dapoxetine as it may increase the sedative effects of alcohol and increase the risk of fainting.

6. Is dapoxetine FDA approved?

No. Dapoxetine is not approved by the U.S. Food and Drug Administration (FDA). It is, however, approved in many other countries worldwide.

7. Who should not take dapoxetine?

Dapoxetine is contraindicated in men with a history of fainting, heart conditions, bleeding disorders, epilepsy, bipolar disorder or depression, glaucoma, liver or kidney problems, and those taking other SSRIs, MAOIs, or serotonergic medications.

8. Can I take dapoxetine with other medications?

Dapoxetine may interact with many medications. It should not be taken with other SSRIs, MAOIs, antidepressants, or serotonergic products. Always inform your healthcare professional about all medications, supplements, and herbal products you are taking.

9. How effective is dapoxetine for premature ejaculation?

Clinical trials have confirmed dapoxetine’s efficacy in significantly increasing intravaginal ejaculation latency time (IELT) and improving sexual satisfaction. One randomized trial reported a 197% median gain in IELT with on-demand 30 mg dapoxetine.

10. What should I do if I miss a dose?

Dapoxetine is taken on an as-needed basis, not daily. If you miss taking the tablet before sexual activity, you may take it as long as you have at least 1 to 3 hours before sexual activity. Do not take more than one tablet in 24 hours.

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Reputable Sources for Further Information

• NCATS Inxight Drugs – Dapoxetine – Comprehensive drug data from the National Center for Advancing Translational Sciences

• Drugs.com – Priligy (Dapoxetine) FDA Status – FDA approval status and drug information

• PubMed Central – Clinical Trial on Dapoxetine Efficacy – Peer-reviewed randomized clinical trial comparing dapoxetine with other treatments

• Patient.info – Dapoxetine Tablets – Detailed patient information on dapoxetine usage and safety

• FDA Public Notification – Dapoxetine Warning – FDA advisory regarding dapoxetine-containing products