Poxet-60 Dapoxetine 60mg

[Drug Name]

Generic Name: Dapoxetine Hydrochloride Tablets

Brand Name: PRILIGY

English Name: Dapoxetine Hydrochloride Tablets

Pinyin: Yansuan Daboxiting Pian

[Composition] Main ingredient: Dapoxetine hydrochloride.

[Description] This product is a blue film-coated tablet; the core appears white or off-white after the coating is removed.

[Indications] This product is indicated for the treatment of premature ejaculation (PE) in men aged 18 to 64 years who meet all of the following criteria:

Persistent or recurrent ejaculation with minimal sexual stimulation before, during, or shortly after vaginal penetration and before the patient wishes; and marked personal distress or interpersonal difficulty as a consequence of PE; and poor control over ejaculation.

[Strength] 60 mg × 100 tablets/box

[Dosage and Administration] Oral administration. Tablets should be swallowed whole. It is recommended that patients take the medication with at least one full glass of water. Patients should take precautions to avoid injury resulting from fainting or dizziness (prodromal symptoms).

Adult men (18 to 64 years of age)

The recommended starting dose for all patients is 30 mg, taken approximately 1 to 3 hours prior to sexual activity. If the effect of the 30 mg dose is insufficient and side effects remain within an acceptable range, the dose may be increased to the maximum recommended dose of 60 mg. The maximum recommended dosing frequency is once every 24 hours.

This product may be taken with or without food (see Pharmacokinetics section).

If a physician chooses to treat PE with this product, the risks and patient-reported benefits should be evaluated after the first 4 weeks of treatment, or the risk-benefit balance should be assessed after 6 doses to determine whether to continue treatment.

Elderly (65 years of age and older)

The safety and efficacy of this product in patients aged 65 years and older have not been evaluated, primarily due to extremely limited data regarding its use in this population (see Pharmacokinetics section).

Children and adolescents

This product is not intended for use in individuals under 18 years of age. Patients with renal impairment

No dose adjustment is required for patients with mild or moderate renal impairment, but caution should be exercised. Use in patients with severe renal impairment is not recommended (see Pharmacokinetics section).

Patients with hepatic impairment

No dose adjustment is required for patients with mild hepatic impairment; use is contraindicated in patients with moderate or severe hepatic impairment (Child-Pugh Class C) (see Pharmacokinetics section).

[Adverse Reactions] Clinical trial data

The safety of this product was evaluated in 6,081 subjects with premature ejaculation participating in five double-blind, placebo-controlled clinical trials. Of these, 4,222 subjects received treatment with this product: 1,615 received 30 mg on an as-needed basis, and 2,607 received 60 mg either on an as-needed basis or once daily. Syncope (characterized by loss of consciousness) has been reported in clinical trials and was considered drug-related. Most cases occurred within 3 hours of dosing, after the first dose, or in association with study-related procedures performed in the clinic (e.g., blood draws, postural changes, and blood pressure measurements). Prodromal symptoms often preceded the syncope. Orthostatic hypotension has been reported in clinical trials. The most common (≥5%) adverse drug reactions in clinical trials included headache, dizziness, nausea, diarrhea, insomnia, and fatigue. The most common events leading to discontinuation were nausea (2.2% of subjects treated with this product) and dizziness (1.2% of subjects treated with this product). Table 1 lists adverse drug reactions with an incidence of ≥1% in subjects treated with this product in these trials. Table 1: Adverse drug reactions with an incidence of ≥1% in subjects treated with this product across five double-blind, placebo-controlled clinical trials (see package insert for details).

[Contraindications] This product is contraindicated in patients with known hypersensitivity to dapoxetine hydrochloride or any of the excipients.

This product is contraindicated in patients with significant cardiac conditions [e.g., heart failure (NYHA Class II-IV), conduction abnormalities without a permanent pacemaker (second- or third-degree AV block or sick sinus syndrome), significant myocardial ischemia, and valvular disease].

This product must not be used concomitantly with monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuing MAOI therapy. Similarly, MAOIs must not be used within 7 days of discontinuing this product (see Drug Interactions section).

This product must not be used concomitantly with thioridazine or within 14 days of discontinuing thioridazine therapy. Similarly, thioridazine must not be taken within 7 days of discontinuing this product (see Drug Interactions section).

This product is contraindicated in patients concomitantly taking potent cytochrome P450 3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, saquinavir, telithromycin, nefazodone, nelfinavir, and atazanavir.

This product is contraindicated in patients with moderate to severe hepatic impairment.

[Precautions] General Precautions: This product is intended for use only in male patients with premature ejaculation. The safety of this product in men without premature ejaculation has not been established, nor are there data regarding its effect on delaying ejaculation in this population. Patients are advised not to take this product concomitantly with "recreational drugs" due to unknown effects and the potential for serious adverse events. Patients are advised not to take psychoactive drugs with stimulant effects (e.g., ketamine, MDMA, and LSD) while taking this product. Concomitant use of this product with controlled substances possessing serotonergic activity (such as diethylamine derivatives) may result in serious adverse reactions. These reactions include, but are not limited to, cardiac arrhythmias, hyperthermia, and serotonin syndrome. Concomitant use of this product with sedative controlled substances—such as narcotics and benzodiazepines—may exacerbate drowsiness and dizziness. Concomitant use with alcohol may intensify alcohol-related neurocognitive effects and increase the risk of adverse neuropsychiatric and cardiovascular reactions (such as syncope), thereby raising the risk of accidental injury; therefore, patients are advised to avoid alcohol consumption while taking this product. Syncope: Use of this product may cause syncope or dizziness. In the clinical development program, the incidence of syncope (characterized by loss of consciousness) varied across study populations; the rate of syncope ranged from 0.06% (30 mg dose) to 0.23% (60 mg dose) in placebo-controlled Phase III clinical trials, and was 0.64% in Phase I clinical trials involving healthy subjects without premature ejaculation (including... ...dose-related). The reported incidence of potential prodromal symptoms—such as nausea, dizziness, and sweating—was higher in the group receiving this drug compared to the placebo group. In Phase 3 clinical trials, the incidence rates for patients receiving a 30 mg dose were 11% for nausea, 5.8% for dizziness, and 0.8% for sweating. For patients receiving a 60 mg dose, the incidence rates were 21.2% for nausea, 11.7% for dizziness, and 1.5% for sweating. Furthermore, the higher incidence rates observed in groups receiving doses exceeding the recommended maximum daily dose of 60 mg suggest that the occurrence of syncope and potential prodromal symptoms may be dose-dependent. Cases of syncope (characterized by loss of consciousness) observed in clinical trials were attributed to vasovagal reactions; the majority occurred within three hours of dosing, following the initial dose, or in association with study-related procedures performed in the clinic (such as blood draws, postural changes, or blood pressure measurements). Potential prodromal symptoms—such as nausea, vertigo, lightheadedness, palpitations, weakness, confusion, and sweating—generally occurred after dosing... ...within 3 hours, often preceding syncope. Patients must be aware that syncope (with or without prodromal symptoms) may occur at any time during treatment with this drug. Prescribers should advise patients on the importance of maintaining adequate hydration and recognizing prodromal signs and symptoms to minimize the risk of serious injury from falls resulting from loss of consciousness. If prodromal symptoms occur, patients should immediately lie down with their head positioned lower than the rest of the body, or sit down with their head between their knees until the symptoms resolve. Patients should also be warned to avoid situations where injury could occur in the event of syncope or other central nervous system (CNS) effects, such as driving or operating dangerous machinery. Concomitant use of alcohol with this drug increases the risk of adverse neuro-cardiovascular events (e.g., syncope) and, consequently, the risk of accidental injury; therefore, patients are advised not to consume alcohol while taking this drug. Patients with cardiovascular risk factors or underlying cardiovascular disease were not included in Phase III clinical trials. Patients with underlying structural cardiovascular disease (e.g., documented outflow tract obstruction, valvular heart disease, carotid stenosis, or coronary artery disease) are at increased risk of adverse cardiovascular reactions involving syncope (whether of cardiac or other origin). There are insufficient data to determine whether this increased risk extends to the risk of vasovagal syncope in patients with underlying conditions. Orthostatic hypotension has been reported in clinical trials. Prescribers should advise patients that if prodromal symptoms occur (e.g., dizziness or lightheadedness shortly after standing), they should immediately lie down with their head positioned lower than the rest of the body, or sit down with their head between their knees until the symptoms resolve. Prescribers should also advise patients against rising quickly after prolonged periods of lying or sitting. Furthermore, caution should be exercised when prescribing this drug to patients taking vasodilators (e.g., alpha-adrenergic receptor antagonists, nitrates, or PDE5 inhibitors), as orthostatic tolerance may be reduced. Moderate cytochrome P... When co-administered with moderate cytochrome P450 3A4 (CYP3A4) inhibitors—such as erythromycin, clarithromycin, fluconazole, amprenavir, fosamprenavir, aprepitant, verapamil, and diltiazem—the dose of this product is limited to 30 mg, and caution is advised. Caution should be exercised when increasing the dose to 60 mg during co-administration with strong cytochrome P450 2D6 (CYP2D6) inhibitors or in patients known to be CYP2D6 poor metabolizers, as this may lead to increased drug exposure, potentially resulting in a higher incidence and severity of dose-dependent adverse reactions. Suicide/Suicidal Ideation: Short-term studies involving children and adolescents with major depressive disorder and other psychiatric conditions have found that antidepressants (including selective serotonin reuptake inhibitors) increase the risk of suicidal ideation and behavior compared to placebo. Short-term studies have not demonstrated an increased risk of suicidal behavior with antidepressants compared to placebo in adults over the age of 24. In clinical trials of this product for the treatment of premature ejaculation, no clear... ...emergency management of suicidal behavior. Agitation: This product must not be used in patients with a history of mania/hypomania or bipolar disorder; furthermore, the drug should be discontinued in any patient who develops symptoms of these conditions. Seizures: Since selective serotonin reuptake inhibitors (SSRIs) may lower the seizure threshold, the drug should be discontinued in any patient who experiences a seizure; additionally, use should be avoided in patients with unstable epilepsy. Patients with controlled epilepsy require close monitoring. Use in children and adolescents under 18 years of age: This product should not be used in individuals under 18. Comorbid depression and psychiatric disorders: Men presenting with symptoms and signs of depression should be evaluated prior to taking this product to rule out undiagnosed depressive disorders. Concomitant use with antidepressants—including SSRIs and selective norepinephrine reuptake inhibitors (SNRIs)—is contraindicated. Interrupting treatment for depression or anxiety to use this product for the treatment of premature ejaculation is not recommended. This product is not indicated for psychiatric disorders and must not be used in men with psychiatric conditions (e.g., schizophrenia) or those with psychiatric disorders comorbid with depression... An exacerbation of depression-related symptoms cannot be ruled out. This may result from the underlying psychiatric condition or from the pharmacological treatment. Physicians should encourage patients to report any distressing thoughts or feelings at any time; if signs and symptoms of depression worsen, use of this product should be discontinued. Bleeding: Abnormal bleeding has been reported during treatment with selective serotonin reuptake inhibitors (SSRIs). Caution should be exercised in patients taking this product, particularly those concomitantly using drugs known to affect platelet function (e.g., atypical antipsychotics, phenothiazines, acetylsalicylic acid, non-steroidal anti-inflammatory drugs [NSAIDs], antiplatelet agents) or anticoagulants (e.g., warfarin), as well as patients with a history of bleeding or coagulation disorders. Renal impairment: Use of this product is not recommended in patients with severe renal impairment; caution should be exercised in patients with mild or moderate renal impairment. Discontinuation effects: Abrupt cessation of long-term SSRI treatment for chronic depression has been reported to cause the following symptoms: anxious mood, irritability, agitation, dizziness, and paresthesia (i.e., abnormal sensations). ...such as electric shock-like sensations), anxiety, confusion, headache, lethargy, emotional instability, insomnia, and hypomania. However, a double-blind clinical trial involving subjects with premature ejaculation—designed to evaluate the discontinuation effects of the drug administered at 60 mg once daily or on an as-needed basis for 62 days—did not identify a discontinuation syndrome; the only evidence of withdrawal symptoms was a slight increase in the incidence of mild to moderate insomnia and dizziness among patients switching from once-daily treatment to placebo. Consistent results were obtained in a second double-blind clinical trial, which included a 24-week treatment period (30 mg and 60 mg, as-needed) followed by a one-week discontinuation evaluation period. Eye disorders: As with other selective serotonin reuptake inhibitors (SSRIs), the use of this drug has been associated with certain ocular reactions, such as mydriasis (pupil dilation) and eye pain. Caution should be exercised when using this drug in patients with elevated intraocular pressure or those at risk of angle-closure glaucoma. Keep out of reach of children.

[Use in Pregnant and Lactating Women]

This drug is not intended for use by women.

Pregnancy

Rats or rabbits received doses up to 100... No evidence of teratogenicity, embryotoxicity, or fetal toxicity was observed with this product at doses of mg/kg (rats) or 75 mg/kg (rabbits). Based on limited observational data from clinical trial databases, there is no evidence that dapoxetine administration affects pregnancy outcomes. Adequate and well-controlled studies in pregnant women have not been conducted.

Lactation

It is unknown whether dapoxetine or its metabolites are excreted in human milk.

[Pediatric Use] This product should not be used in individuals under 18 years of age.

[Geriatric Use] 1. The safety and efficacy of this product in patients aged 65 years and older have not been evaluated, primarily due to extremely limited data regarding its use in this population. 2. Analysis of a clinical pharmacology study involving a single 60 mg dose of dapoxetine hydrochloride indicates no significant differences in pharmacokinetic parameters (Cmax, AUCinf, Tmax) between healthy elderly men and healthy young men.

[Drug Interactions] Please refer to the package insert.

[Overdose] No cases of overdose were reported during clinical trials. In clinical pharmacology studies where the drug was administered at a maximum daily dose of 240 mg (two 120 mg doses separated by a 3-hour interval), no unexpected adverse events occurred. In general, symptoms of overdose with selective serotonin reuptake inhibitors (SSRIs) include serotonin-mediated adverse reactions such as somnolence, gastrointestinal disturbances (e.g., nausea and vomiting), tachycardia, tremor, agitation, and dizziness. In the event of overdose, standard supportive measures should be adopted as necessary. Due to the high protein binding and large volume of distribution of dapoxetine hydrochloride, forced diuresis, dialysis, hemoperfusion, and exchange transfusion are unlikely to be effective. There is currently no specific antidote for this drug.

[Pharmacology and Toxicology] Please refer to the package insert.

[Pharmacokinetics] 1. Absorption: Following oral administration, dapoxetine is rapidly absorbed, reaching maximum plasma concentration (Cmax) in approximately 1–2 hours. Absolute bioavailability is 42% (range: 15–76%). After single oral doses of 30 mg and 60 mg of dapoxetine in the fasted state, peak plasma concentrations (297 ng/mL and 498 ng/mL, respectively) were reached at 1.01 and 1.27 hours, respectively. Consumption of a high-fat meal modestly reduces dapoxetine Cmax (by 10%) and modestly increases AUC (by 12%); it also slightly delays the time to reach peak concentration; however, a high-fat meal does not affect the extent of absorption. None of these changes are clinically significant. Priligy may be taken with or without food. 2. Distribution: In vitro, more than 99% of dapoxetine binds to human serum proteins. The protein binding rate of the active metabolite, desmethyldapoxetine, is 98.5%. Dapoxetine is rapidly distributed, with a mean steady-state volume of distribution of 162 L. Following intravenous administration in humans, the estimated mean initial, intermediate, and terminal half-lives of dapoxetine are 0.10, 2.19, and 19.3 hours, respectively. 3. Metabolism: In vitro studies indicate that dapoxetine is cleared by multiple enzyme systems in the liver and kidney, primarily cytochrome P450 2D6, cytochrome P450 3A4, and flavin-containing monooxygenase 1 (FMO1). In a clinical study examining the metabolism of ¹⁴C-dapoxetine, the drug underwent extensive metabolism following oral administration, primarily via the following biotransformation pathways: N-oxidation, N-demethylation, naphthyl hydroxylation, glucuronidation, and sulfation. Evidence suggests the occurrence of first-pass metabolism prior to systemic absorption. Intact dapoxetine and dapoxetine-N-oxide are the major circulating forms in plasma. Other metabolites include desmethyldapoxetine, which possesses potency equivalent to that of dapoxetine, and didesmethyldapoxetine, which has approximately 50% of the potency of dapoxetine. Considering potency and unbound plasma concentrations, only desmethyldapoxetine contributes to the overall pharmacological activity of dapoxetine in vivo. 4. Excretion: Dapoxetine metabolites are primarily excreted in the urine as conjugates. Unchanged active drug was not detected in the urine. Dapoxetine is rapidly cleared; plasma concentrations 24 hours post-dose are low (less than 5% of peak concentration). There is minimal drug accumulation with daily dosing. The terminal half-life following oral administration is approximately 19 hours. The half-life of desmethyldapoxetine is similar to that of dapoxetine. (See package insert for details.)

[Storage] Store at room temperature.

[Packaging] 100 tablets/box.

[Shelf Life] 36 months.

Important Information for Purchasing Sexual Health Products:

Note: Oral medications for men to aid erection require sexual stimulation to be effective; they do not induce erections automatically. When using medications such as sildenafil, vardenafil, tadalafil, avanafil, or Priligy (dapoxetine), many people are concerned about whether the expected results will be achieved.

Based on clinical data and real-world usage feedback, there are slight variations in the proportion of users for whom these drugs prove ineffective:

Sildenafil: Approximately 15%–20% of users do not achieve the expected results;

Vardenafil: The rate of ineffectiveness is similar to that of sildenafil, at approximately 15%–22%;

Tadalafil: Due to its longer half-life and slightly broader suitability, the rate of ineffectiveness is marginally lower, at approximately 12%–18%;

Avanafil: Known for rapid onset and metabolism, the rate of ineffectiveness is approximately 14%–19%;

Priligy (dapoxetine): Targeted at premature ejaculation, its efficacy is significantly influenced by individual neurological sensitivity and psychological state; the rate of ineffectiveness is relatively higher, at approximately 20%–25%.

It is important to clarify that suboptimal results in some users are not due to product quality issues, but rather the interplay between the drug's mechanism of action and individual physiological or pathological conditions. Even with original brand-name products, a significant proportion of users may not experience the desired effect; for instance, approximately 20% of men who use Pfizer’s Viagra (sildenafil) do not see results—this is not a quality defect. It is common for the same box of medication to be effective for one person but not another, or for a different product to work for the other person while failing to work for you. Our store guarantees that all sexual health products are 100% authentic, but we cannot guarantee that every user will achieve the expected results. Please consider this carefully before placing an order. The specific reasons vary depending on the medication:

Sildenafil / Vardenafil / Avanafil: These drugs work by promoting vasodilation. Their efficacy is influenced by individual metabolic capacity (liver and kidney function affecting the rate of drug breakdown), underlying medical conditions (such as diabetes or hypertension, which damage blood vessels and reduce drug efficiency), and the circumstances of use (alcohol consumption can inhibit the drug's effect, while high-fat meals may delay the absorption of sildenafil and vardenafil). Additionally, in cases of severe arterial disease, the drugs struggle to facilitate blood flow, naturally limiting their effectiveness.

Tadalafil: Although its mechanism of action is similar to the three drugs mentioned above, it remains in the body for a longer period. However, its efficacy is still influenced by factors such as individual drug sensitivity and the presence of severe prostate disease or spinal cord injuries; some individuals may experience suboptimal results due to weaker receptor binding affinity.

Priligy (Dapoxetine): This drug improves ejaculation control by inhibiting neurotransmitter reuptake. Its effectiveness is closely linked to individual nerve conduction efficiency, psychological state (anxiety and tension can counteract the drug's effects), and the appropriateness of the dosage relative to body weight and the severity of the condition. If there is abnormal nerve sensitivity or long-standing psychogenic premature ejaculation, the drug's regulatory effect may be limited.

If the results of using any of the aforementioned medications or dual-effect tablets fall short of expectations, do not arbitrarily increase the dosage, switch medications, or continue taking them blindly over the long term; instead, consult a urologist or andrologist promptly. A doctor will assess your physical condition through a detailed consultation and, based on test results, adjust your treatment plan (e.g., optimizing the dosage or changing the type of medication) or incorporate psychological interventions and behavioral training to develop a solution better suited to your needs. Specifications

Product Name: Dapoxetine Hydrochloride Tablets (Priligy) 60mg x 100 tablets (Poxet-60)

Common Name: Priligy

Active Ingredient: Dapoxetine hydrochloride

Dosage Form: Tablet

Specification: 100 tablets/box

Manufacturer: Sunrise Pharmaceuticals

Indications: Priligy is indicated for the treatment of premature ejaculation (PE) in men aged 18 to 64 who meet all of the following criteria: 1. Persistent or recurrent ejaculation with minimal sexual stimulation before, during, or shortly after vaginal penetration and before the patient wishes; 2. Marked personal distress or interpersonal difficulty as a consequence of PE; 3. Poor control over ejaculation.

Dosage and Administration: Oral administration. 1. Adult men (18 to 64 years old): The recommended starting dose for all patients is 30 mg, taken approximately 1 to 3 hours prior to sexual activity. If the effect of the 30 mg dose is insufficient and side effects are within an acceptable range, the dosage may be increased to the maximum recommended dose of 60 mg. The maximum recommended dosing frequency is once every 24 hours. This product may be taken with or without food (see Pharmacokinetics section). If a physician prescribes this product for PE, the risks and patient-reported benefits should be evaluated after the first 4 weeks of treatment, or after 6 doses, to assess the risk-benefit balance and determine whether to continue treatment. Elderly (65 years and older): The safety and efficacy of this product in patients aged 65 and older have not been evaluated, primarily due to extremely limited data regarding its use in this population (see Pharmacokinetics section). Children and adolescents: This product is not intended for use in individuals under 18 years of age. Patients with renal impairment: No dose adjustment is required for patients with mild or moderate renal impairment, but caution should be exercised. Use of this product is not recommended in patients with severe renal impairment (see Pharmacokinetics section). Patients with hepatic impairment: No dose adjustment is required for patients with mild hepatic impairment; use of this product is contraindicated in patients with moderate to severe hepatic impairment (Child-Pugh Class C) (see Pharmacokinetics section).