Product Overview
[Generic Name]: Dapoxetine Hydrochloride Tablets
[Trade Name]: Guanai
[English Name]: Dapoxetine Hydrochloride Tablet
[Chinese Pinyin]: Yansuan Daboxiting Pian
[Ingredients]: Main ingredient: Dapoxetine hydrochloride. Chemical name: ( )-(S)-N,N-dimethyl-(α)-[2-(1-naphthyloxy)ethyl]-benzylamine hydrochloride Chemical structure: Molecular formula: C21H23N0.HCL Molecular weight: 341.88
[Properties]: This product is a film-coated tablet, which is white or off-white after removing the coating.
[Indications]: This product is indicated for the treatment of male patients with premature ejaculation (PE) aged 18 to 64 years who meet all of the following conditions: - Continuous or repeated ejaculation due to minimal sexual stimulation before, during or shortly after vaginal insertion and before sexual satisfaction; and - Significant personal distress or interpersonal impairment caused by premature ejaculation (PE); and - Poor ejaculation control.
Dosage and Administration: Oral. The tablet should be swallowed whole. Patients are advised to take the drug with at least a full glass of water. Patients should try to avoid injuries caused by prodromal symptoms such as syncope or dizziness. Adult males (18 to 64 years old) The recommended first dose for all patients is 30 mg, which needs to be taken about 1 to 3 hours before sexual intercourse. If the effect after taking 30 mg is not satisfactory and the side effects are still within the acceptable range, the dose can be increased to the maximum recommended dose of 60 mg. The recommended maximum dose frequency is once every 24 hours. This product can be taken before or after meals (see the pharmacokinetics section). If the doctor chooses this product to treat premature ejaculation, the risks and patient-reported benefits should be evaluated in the first 4 weeks of treatment with this drug, or the patient's risk-benefit balance should be evaluated after 6 treatment doses and decide whether to continue using this product for treatment. Elderly (65 years and older) The safety and efficacy of this product in patients aged 65 and older have not been evaluated. The main reason is that the data on the use of this product in this population is extremely limited (see the pharmacokinetics section). Children and adolescents This product is not for use in people 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 used. This product is not recommended for patients with severe renal impairment (see pharmacokinetics). Patients with hepatic impairment No dose adjustment is required for patients with mild hepatic impairment; this product is contraindicated for patients with moderate and severe hepatic impairment (Child-pugh class C) (see pharmacokinetics).
[Adverse Reactions]: Clinical trial data The safety of this product was evaluated in 6081 patients with premature ejaculation who participated in 5 double-blind, placebo-controlled clinical trials. Among these evaluated subjects, 4222 received this product, of which 1615 received 30 mg of this product as needed and 2607 received 60 mg of this product, either as needed or once a day. Syncope (characterized by loss of consciousness) has been reported in clinical trials, and this event is considered to be drug-related. Most cases occurred within 3 hours after administration, after the first dose or accompanied by research-related operations performed in the clinic (such as blood draws, upright movements, and blood pressure measurements), and prodromal symptoms often occurred before syncope. Orthostatic hypotension has been reported in clinical trials The most common (≥5%) adverse drug reactions in clinical trials include headache, dizziness, nausea, diarrhea, insomnia, and fatigue. The most common events leading to discontinuation include nausea (2.2% of subjects in the group treated with this product) and dizziness (1.2% of subjects in the group treated with this product).
[Contraindications]: This product is contraindicated for patients with known hypersensitivity to dapoxetine hydrochloride or any excipients. This product is contraindicated for patients with significant cardiac pathological conditions [such as heart failure (NYHA II-IV), conduction abnormalities (grade 2 or 3 atrioventricular block or sick sinus syndrome) not treated with a permanent pacemaker, significant myocardial ischemia and valvular disease]. This product should not be used in combination with monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping monoamine oxidase inhibitor treatment. Similarly, monoamine oxidase inhibitors should not be used within 7 days of stopping this product (see the Drug Interactions section). This product should not be used in combination with thioridazine or within 14 days of stopping thioridazine treatment. Similarly, thioridazine should not be taken within 7 days of stopping this product (see the Drug Interactions section). This product is contraindicated in patients who are taking strong cytochrome P450 3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, saquinavir, telithromycin, nefazodone, nafinavir, and atazanavir. This product is contraindicated in patients with moderate and severe liver damage.
【Precautions】: General Precautions This product is only for male patients with premature ejaculation. The safety of this product in men without premature ejaculation is not clear, and there is no data on the effect of this product in delaying ejaculation in this population. Patients are advised not to take this product with "recreational drugs" because the effects are unknown and serious adverse events may occur. Taking psychotropic drugs (Increational Drug) Patients are advised not to take psychotropic drugs with incest effects while taking this product. Psychotropic drugs with serotonergic activity, such as ketamine, methylenedioxymethamphetamine and lysergic acid diethylamide, may cause serious adverse reactions if taken with this product. These adverse reactions include but are not limited to arrhythmias, hyperthermia, and serotonin syndrome. Taking this product with sedative psychotropic drugs, such as narcotics and benzodiazepines, may increase drowsiness and dizziness. Alcohol: Concomitant use of this product with alcohol may aggravate alcohol-related neurocognitive effects and may also aggravate neurocardiovascular adverse reactions (such as syncope), thereby increasing the risk of accidental injury; therefore, patients are advised to avoid alcohol while taking this product.Syncope This product may cause syncope or dizziness. In the clinical development of this product, the incidence of syncope (characterized by loss of consciousness) varies with the study population. In the placebo-controlled Phase II clinical trial, the rate of subjects experiencing syncope was 0.06% (30mg) to 0.23% (60mg), and in the Phase I clinical trial of healthy non-premature ejaculation subjects, the rate of subjects experiencing syncope was 0.64% (including all doses). The incidence of possible prodromal symptoms such as nausea, dizziness and sweating was higher in the group receiving this product than in the placebo group.In Phase 3 clinical trials, the incidence of nausea was 11% in patients receiving 30 mg of tamoxifen, dizziness was 5.8%, and sweating was 0.8%. In Phase 3 clinical trials, the incidence of nausea was 21.2%, dizziness was 11.7%, and sweating was 1.5% in patients receiving 60 mg of tamoxifen. In addition, the higher incidence in the group receiving a dose higher than the maximum recommended daily dose of 60 mg suggests that the incidence of syncope and possible prodromal symptoms may be dose-dependent. Cases of syncope (characterized by loss of consciousness) observed in clinical trials were all considered to be vasovagal in etiology, and most cases occurred within 3 hours of dosing, after the first dose, or in conjunction with study-related procedures performed in the clinic (such as blood draws, upright maneuvers, and blood pressure measurements).Possible prodromal symptoms such as nausea, dizziness, lightheadedness, palpitations, weakness, confusion and sweating generally occur within 3 hours of dosing and often precede syncope. Patients must be aware that they may experience syncope (with or without prodromal symptoms) at any time during treatment with this product. Prescribers should inform patients of the importance of maintaining adequate hydration and how to recognize prodromal symptoms and signs to reduce the possibility of serious injury caused by falls due to loss of consciousness. If patients experience possible prodromal symptoms, they should immediately lie down with their head lower than the rest of the body, or sit down and place their head between their knees until the symptoms disappear. At the same time, patients should be warned to avoid situations that may cause injury if syncope or other central nervous system (CNS) effects occur, including driving or operating dangerous machinery.Taking alcohol at the same time as this product will increase adverse events of the neurocardiovascular system (such as syncope), thereby increasing the risk of accidental injury. Therefore, patients are advised not to take alcohol at the same time as this product. Patients with cardiovascular risk factors Subjects with underlying cardiovascular disease did not participate in the Phase III clinical trial. Patients with underlying organic cardiovascular disease (such as clear outflow tract obstruction, valvular heart disease, carotid artery stenosis and coronary heart disease) have an increased risk of adverse cardiovascular reactions caused by syncope (cardiogenic syncope and syncope from other causes). There is not enough data to prove whether this increased risk can be translated into the risk of vasovagal syncope in patients with underlying cardiovascular disease.Other forms of sexual dysfunction Before treatment, the physician should carefully examine the patient for other forms of sexual dysfunction, including erectile dysfunction. Men with erectile dysfunction (ED) who are taking PDE5 inhibitors should not use this product (see [Drug Interactions]). Orthostatic hypotension Before starting treatment, the prescriber should conduct a careful physical examination of the patient, including a history of orthostatic events. Before starting treatment, an orthostatic response test (supine and standing blood pressure and pulse) should be performed. If a history of orthostatic reactions is confirmed or suspected, this product should be avoided. Orthostatic hypotension has been reported in clinical trials. The prescriber should inform the patient in advance that if possible prodromal symptoms occur (such as dizziness shortly after standing up), they should immediately lie down with their head lower than the rest of the body, or sit and place their head between their knees until the symptoms disappear.Prescribers should also inform patients that they should not stand up quickly after lying down or sitting for a long time. In addition, caution should be exercised when prescribing levofloxacin to patients taking medications with vasodilatory properties (e.g., alpha-adrenergic receptor antagonists, nitrates, phosphodiesterase type 5 (PDE5 inhibitors)) due to the potential for decreased orthostatic tolerance. Moderate cytochrome P450 3A4 inhibitors Concomitant use of strong cytochrome P450 3A4 inhibitors, such as erythromycin, clarithromycin, fluconazole, amprenavir, fosamprenavir, aprepitant, verapamil, and diltiazem, should limit levofloxacin to 30 mg and caution is recommended. Strong cytochrome P450 2D6 inhibitors Caution should be used when increasing the dose to 60 mg in patients taking strong cytochrome P450 2D6 inhibitors or known poor metabolizers of cytochrome P450 2D6, as this may result in increased exposure and ultimately a higher incidence and severity of dose-dependent adverse reactions.Suicide/Suicidal Thinking Antidepressants (including SSRIs) have been shown to increase the risk of suicidal thinking and behavior compared with placebo in short-term studies in children and adolescents with major depressive disorder and other psychiatric disorders. Short-term studies have not demonstrated an increased risk of suicidal behavior in adults over 24 years of age compared with placebo. No suicidal behavior with clear emergency treatment was reported in clinical trials of SSRIs for the treatment of premature ejaculation. Mania SSRIs should not be used in patients with a history of mania/hypomania or bipolar disorder and should be discontinued in any patient who develops symptoms of these disorders. Epilepsy Because SSRIs may lower schizophrenia readings, SSRIs should be discontinued in any patient who develops a seizure and should be avoided in patients with unstable epilepsy. Patients whose epilepsy is controlled should be closely monitored.Use in children and adolescents under 18 years of age This product should not be used in people under 18 years of age. Concomitant depression and psychiatric disorders Males with signs and symptoms of depression should be evaluated before taking this product to rule out undiagnosed depressive disorders. Concomitant use of antidepressants, including selective serotonin reuptake inhibitors and selective norepinephrine reuptake inhibitors, is prohibited. It is not recommended to interrupt treatment for depression and anxiety to take this product for the treatment of premature ejaculation. This product is not suitable for mental disorders and should not be used in male patients with mental illness (such as schizophrenia), or patients with mental illness and depression, because it cannot be ruled out that the symptoms related to depression are aggravated. This may be the result of the underlying mental illness, or it may be the result of drug treatment.Physicians should encourage patients to report any distressing thoughts or feelings at any time, and if signs and symptoms of depression worsen, the drug should be discontinued. Bleeding Bleeding abnormalities have been reported during treatment with SSRIs. Patients should be cautious when taking SSRIs, especially those taking medications known to affect platelet function (e.g., atypical antipsychotics and phenothiazines, acetylsalicylic acid, nonsteroidal anti-inflammatory drugs [NSAIDs], antiplatelet drugs) or anticoagulants (e.g., warfarin), and those with a history of bleeding or coagulation disorders. Renal Impairment SSRIs are not recommended for patients with severe renal impairment and should be used with caution in patients with mild or moderate renal impairment. Discontinuation Effects Abrupt discontinuation of long-term SSRI treatment for chronic depression has been reported to result in the following symptoms: anxious mood, irritability, agitation, dizziness, paresthesias (i.e., sensory confusions, such as electric shock perception), anxiety, confusion, headache, lethargy, mood swings, insomnia, and hypomania.However, a double-blind clinical trial evaluating the discontinuation effects of 60 mg once daily or as needed for 62 days in subjects with premature ejaculation found no discontinuation syndrome, with the only evidence of withdrawal symptoms being a slightly increased incidence of mild or moderate insomnia and dizziness in patients who switched to placebo after once daily sirolimus. Consistent results were obtained in a second double-blind clinical trial that included a 24-week treatment period of 30 and 60 mg, as needed, followed by a 1-week discontinuation evaluation period. Eye Disorders As with other selective serotonin reuptake inhibitors, the use of sirolimus is associated with some ocular reactions, such as pupil dilation and eye pain. This product should be used with caution in patients with increased intraocular pressure or at risk for angle-closure glaucoma. Keep out of the reach of children.
Children's Precautions】: This product should not be used in people under 18 years of age.
【Precautions during pregnancy and lactation】: This product is not suitable for women. Pregnancy No evidence of teratogenicity, embryotoxicity or fetotoxicity was found when rats or rabbits received up to 100mg/kg (rats) or 75mgkg (rabbits) of this product. Based on the limited observational data currently from the clinical trial database, there is no evidence that taking dapoxetine will affect maternal pregnancy. There are currently no adequate and well-controlled studies on pregnant women. Lactation It is not clear whether dapoxetine or its metabolites can be secreted in human milk.
【Precautions for the elderly】: The safety and efficacy of this product in patients aged 65 years and above have not been evaluated, mainly because the data on the use of this product in this population are extremely limited. Analysis of a single-dose clinical pharmacology study using 60mg of dapoxetine hydrochloride showed that there were no significant differences in pharmacokinetic parameters (Cmax, AUCinf, Tmax) between healthy elderly men and healthy young men.
[Drug Interactions]: Possibility of interactions with monoamine oxidase inhibitors Severe (sometimes fatal) reactions have been reported in patients taking a selective serotonin reuptake inhibitor plus a monoamine oxidase inhibitor (MAOI) at the same time. These reactions include hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations in vital signs and changes in mental status, including extreme excitement and development of delirium and coma. These reactions have also been reported in patients who recently discontinued a selective serotonin reuptake inhibitor and started using a monoamine oxidase inhibitor. Some cases showed characteristics similar to neuromuscular blocking malignant syndrome. Experiments in animal models using selective serotonin reuptake inhibitors and monoamine oxidase inhibitors in combination have shown that these drugs may have synergistic effects in increasing blood pressure and inducing behavioral excitement. Therefore, this product cannot be used in combination with monoamine oxidase inhibitors. It cannot be used within 14 days of discontinuing monoamine oxidase inhibitors. Similarly, monoamine oxidase inhibitors cannot be used within 7 days of discontinuing this product. (See Contraindications) Potential for interaction with thioridazine Thioridazine alone can prolong the QTc interval, which is associated with serious ventricular arrhythmias. Some medicinal products that inhibit the cytochrome P450 2D6 isoenzyme, such as this product, can inhibit the metabolism of thioridazine, resulting in increased thioridazine concentrations, which can increase the prolongation of the QTc interval.This product should not be used with thioridazine or within 14 days of stopping thioridazine. Likewise, thioridazine should not be used within 7 days of stopping this product. (See Contraindications) Drugs/Herbal Drugs with Serotonergic Effects As with other selective serotonin reuptake inhibitors, the combination of this product with drugs/herbal drugs with serotonergic effects (including monoamine oxidase inhibitors, L-tryptophan, triptans, tramadol, linezolid, selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, lithium, and Hypericum perforatum (Hypericum wilfordii)) may lead to the development of serotonergic effects. This product should not be used with other selective serotonin reuptake inhibitors, monoamine oxidase inhibitors, or other drugs/herbal drugs with serotonin-related effects. This product should not be used within 14 days of stopping these drugs/herbal drugs. Likewise, these drugs/herbal drugs should not be taken within 7 days of stopping this product. (See Contraindications) Central Nervous System Active Medications The concomitant use of this product with CNS active medications has not been systematically evaluated in patients with premature ejaculation; therefore, if concomitant use of this product with such medications is necessary, treat the patient with caution.Effects of co-administered drugs on dapoxetine In vitro studies in human liver, kidney, and intestinal microsomes have shown that dapoxetine is primarily metabolized by cytochrome P450 2D6, cytochrome P450 3A4, and flavin-containing monooxygenase 1 (FMO1), so inhibitors of these enzymes may reduce the clearance of dapoxetine. Ketoconazole (200 mg, twice daily for 7 days), a potent cytochrome P450 3A4 inhibitor, can increase the CMAX and AUCINF of dapoxetine (single dose of 60 mg) by 35% and 99%, respectively. Considering the effects of free dapoxetine and desmethyl dapoxetine, if a strong CYP3A4 inhibitor is taken, the maximum plasma concentration of the active portion (the sum of free dapoxetine and desmethyl dapoxetine) may increase by approximately 25%, and the AUC may double. Such an increase may be significant in some patients, mainly including those who lack the functional cytochrome CYP2D6 enzyme, i.e., cytochrome CYP2D6 poor metabolizers, or those who take a strong cytochrome P2D6 inhibitor in combination.herefore, this product is contraindicated in patients taking ketoconazole, itraconazole, ritonavir, saquinavir, telithromycin, nefazodone, nafinavir, atazanavir, etc. Moderate cytochrome P450 3A4 inhibitors Concomitant use of moderate cytochrome P450 3A4 inhibitors, such as erythromycin, clarithromycin, fluconazole, amprenavir, fusamprenavir, aprepitant, verapamil and diltiazem, may also increase the exposure of dapoxetine and desmethyl dapoxetine, especially in patients with cytochrome CYP2D6 poor metabolizers. Therefore, the maximum dose of this product is limited to 30 mg when used in combination with any of the above drugs, and caution is recommended. Strong cytochrome P450 2D6 inhibitors When fluoxetine (60 mg/day for 7 days) is used in combination with dapoxetine (60 mg single dose), the latter's Cmax and AUCinf increase by 50% and 88%, respectively.Considering the effects of free dapoxetine and desmethyl dapoxetine, the maximum plasma concentration of the active moiety (the sum of free dapoxetine and desmethyl dapoxetine) may be increased by approximately 50% and the AUC may be doubled if a strong cytochrome P450 2D6 inhibitor is taken. This increase in the maximum plasma concentration and AUC of the active moiety is similar to that expected in poor cytochrome P450 2D6 metabolizers and may increase the incidence and severity of adverse events in a dose-dependent manner.Therefore, in patients taking potent cytochrome P450 2D6 inhibitors and known cytochrome P450 2D6 poor metabolizers, increasing the dose to 60 mg should be considered carefully. Phosphodiesterase Type 5 Inhibitors A single-dose crossover study evaluated the pharmacokinetics of dapoxetine (60 mg) when co-administered with tadalafil (20 mg) and sildenafil (100 mg). Tadalafil did not affect the pharmacokinetics of dapoxetine. Sildenafil slightly altered the pharmacokinetics of dapoxetine (AUCinf increased by 22% and Cmax increased by 4%), but this effect was not clinically significant.However, due to the potential for decreased orthostatic tolerance, dapoxetine should be used with caution in patients taking phosphodiesterase type 5 inhibitors. Effects of dapoxetine hydrochloride on concomitant medications Tamsulosin Coadministration (single or multiple doses) of 30 mg or 60 mg of dapoxetine hydrochloride in patients receiving tamsulosin daily did not alter the pharmacokinetics of tamsulosin. Addition of dapoxetine to tamsulosin did not result in changes in orthostatic tolerance, and the orthostatic effect of 30 or 60 mg of tamsulosin combined with 30 mg or 60 mg of dapoxetine hydrochloride was not different from that of tamsulosin alone; however, due to the potential for decreased orthostatic tolerance, dapoxetine should be used with caution in patients receiving alpha-adrenergic receptor antagonists. Drugs metabolized by cytochrome P450 2D6 A single 50 mg dose of desipramine followed by multiple doses of dapoxetine hydrochloride (60 mg/day for 6 days) increased the mean Cmax and AUCinf of desipramine by approximately 11% and 19%, respectively, compared to desipramine alone. Dapoxetine also increases plasma concentrations of drugs metabolized by cytochrome P450 2D6 to a similar degree. However, these increases are less clinically significant.Drugs Metabolized by Cytochrome P450 3A Repeated dosing of dapoxetine (60 mg/day for 6 days) decreased the AUCinf of midazolam (8 mg single dose) by approximately 20% (-60 to 18%). The clinical relevance of this effect of midazolam is minimal in most patients. The enhancement of cytochrome P450 3A activity may be clinically relevant in patients who are taking concomitant drugs that are dependent on cytochrome P450 3A metabolism and have a narrow therapeutic window. Drugs Metabolized by Cytochrome P450 2C19 Repeated dosing of dapoxetine (60 mg/day for 6 days) did not affect the pharmacokinetics of omeprazole (40 mg single dose). Dapoxetine is unlikely to affect the pharmacokinetics of other cytochrome P450 2C19 substrates. Drugs Metabolized by Cytochrome P450 2C9 Repeated dosing of dapoxetine (60 mg/day for 6 days) did not affect the pharmacokinetics and pharmacodynamics of glyburide (5 mg single dose). Dapoxetine is unlikely to affect the pharmacokinetics of other cytochrome P450 2C9 substrates. Phosphodiesterase Type 5 Inhibitors In a single-dose crossover study, dapoxetine (60 mg) did not affect the pharmacokinetics of tadalafil (20 mg) or sildenafil (100 mg). Warfarin There are no data to evaluate the effect of dapoxetine on chronic warfarin use; therefore, dapoxetine should be used with caution in patients taking chronic warfarin (see PRECAUTIONS).In a pharmacokinetic study, dapoxetine (60 mg/day for 6 days) did not affect the pharmacokinetics and pharmacodynamics (PT or INR) of warfarin (single dose of 25 mg). Alcohol The concomitant consumption of 0.5 g/kg of alcohol did not affect the pharmacokinetics of dapoxetine (single dose of 60 mg) and alcohol; however, the combination of dapoxetine and alcohol increased the incidence of somnolence and significantly decreased self-rated alertness. Pharmacodynamic measures of cognitive impairment (digit alertness speed, digit symbol substitution test) also showed no significant difference between alcohol or dapoxetine alone and placebo, but the combination of dapoxetine and alcohol was statistically significant compared with alcohol alone. The combination of alcohol and dapoxetine may increase the incidence or severity of the following adverse reactions: dizziness, somnolence, slowed reaction time or altered judgment. The combination of alcohol and dapoxetine may also increase the risk of neurocardiovascular adverse reactions, such as syncope, thereby increasing the risk of accidental injury; therefore, patients should be advised to avoid alcohol while taking dapoxetine.
[Pharmacological action]: Pharmacological action Dapoxetine is a potent selective serotonin reuptake inhibitor (SSRI) with an ICso of 1.12nM. Its main metabolites are equivalent to the original drug (such as demethyl dapoxetine (ICso< 1.0nM) and dimethyl dapoxetine (ICso=2.0nM)) or weakly effective (such as methoxychlor dapoxetine, ICso=282nM). Human ejaculation is mainly mediated by the sympathetic nervous system. The reflex pathway of ejaculation originates from the spinal reflex center, which is mediated by the brainstem, and the reflex center is initially affected by many brain nuclei (medial preoptic nucleus and inferior paraventricular nucleus). The mechanism of action of dapoxetine in the treatment of premature ejaculation may be related to its inhibition of the reabsorption of serotonin by neurons, thereby enhancing the effect of neurotransmitters on pre- and postsynaptic receptors. In rats, dapoxetine inhibits the ejaculation drive reflex by acting on the supraspinal level, among which the lateral paragigantic nucleus (LPGi) is an essential brain structure. The postganglionic sympathetic nerve fibers that control the seminal vesicle, vas deferens, prostate, urethral bulbar muscles and bladder neck can make the above organs contract in coordination to achieve ejaculation. Dapoxetine can regulate the ejaculation reflex of rats. Toxicological studies Genetic toxicity: The results of dapoxetine Ames test, mouse lymphoma tk test, Chinese hamster ovary cell in vitro chromosome aberration test and mouse in vitro micronucleus test were negative. Reproductive toxicity: Dapoxetine had no significant effect on the fertility, reproductive function or reproductive organ morphology of male and female rats, and no embryonic or fetal toxicity was observed in rats or rabbits. Carcinogenicity: Rats were gavaged with dapoxetine 225mg/kg/day for 2 consecutive years (the exposure was about twice the maximum dose of 60mg for males in clinical practice), and no carcinogenicity was observed. Administration of dapoxetine to Tg.rasH2 mice at the maximum possible dose of 100 mg/kg for 6 consecutive months (steady-state exposure is lower than the exposure of a single dose of 60 mg in humans) or dapoxetine at 200 mg/kg for 4 consecutive months did not result in tumor development.
【Storage】: Store at room temperature.
【Specifications】: 30 mg x 7 tablets x 1 plate
【Validity period】: 24 months
【Implementation standard】: National Drug Administration standard YBH15722021
【Approval number】: National Medicine Standard H20213945
【Company name】: Jiangsu Lianhuan Pharmaceutical Co., Ltd.
【Company abbreviation】: Lianhuan Pharmaceutical
