Product Overview
Product name
Wan Aiqu Dapoxetine Hydrochloride Tablets 30mg*3 tablets*3 plates
Product specifications
30mg*3 tablets*3 plates
Expiration date
36 months
Main raw materials
Main ingredients: Dapoxetine hydrochloride Chemical name: (+)-(S)-N,N-dimethyl-(α)-[2-(1-naphthyloxy)ethyl]-benzylamine hydrochloride Molecular formula: C21H23NO·HCl Molecular weight: 341.88
Manufacturer
Xiamen Lizhuo Pharmaceutical Co., Ltd.
Precautions
General Precautions This product is only for use in male patients with premature ejaculation. The safety of this product in men without premature ejaculation is unknown, and there is no data on its effect of delaying ejaculation in this population.
Patients are advised not to take this product at the same time as "recreational drugs" because the effects are unknown and serious adverse events may occur.
Taking Psychotropic Drugs
It is recommended that patients do not take stimulant psychotropic drugs while taking this product. Psychotropic drugs with serotonergic activity, such as ketamine, MDMA, 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 sedative psychotropic drugs, such as narcotics and benzodiazepines, while taking this product may aggravate 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 taking alcohol while taking this product.
Syncope
Use of this product may cause syncope or dizziness.
The incidence of syncope (characterized by loss of consciousness) in the clinical development program of this product varies with the study population. In the placebo-controlled Phase III clinical trial, the rate of subjects experiencing syncope was 0.06% (30 mg) to 0.23% (60 mg), 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 zeafacine group than in the placebo group. In Phase 3 clinical trials, the incidence of nausea in patients receiving 30 mg of zeafacine was 11%, dizziness was 5.8%, and sweating was 0.8%. In Phase 3 clinical trials, the incidence of nausea in patients receiving 60 mg of zeafacine was 21.2%, dizziness was 11.7%, and sweating was 1.5%. In addition, the higher incidence in the group receiving a dose higher than the maximum recommended daily dose of 60 mg indicates 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 believed to be vasovagal in etiology, with the majority of cases occurring within 3 hours of dosing, after the first dose, or in conjunction with study-related procedures performed in the clinic (e.g., 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 drug. Prescribers should inform patients of the importance of maintaining adequate hydration and how to recognize prodromal signs and symptoms to reduce the likelihood of serious injury from a fall due to loss of consciousness. If patients experience possible prodromal symptoms, they should immediately lie down with their head lower than the rest of their body or sit with their head between their knees until symptoms subside, and they should be warned to avoid situations that could result in injury if syncope or other central nervous system (CNS) effects occur, including driving or operating hazardous machinery.
Taking alcohol at the same time as this product can 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 Phase III clinical trials. Patients with underlying organic cardiovascular disease (such as documented 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 develop into the risk of vasovagal syncope in patients with underlying diseases.
Orthostatic hypotension
Orthostatic hypotension has been reported in clinical trials. Prescribers should inform patients in advance that if possible prodromal symptoms occur (e.g., dizziness or lightheadedness shortly after standing up), they should immediately lie down with their head lower than the rest of their body, or sit down with 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 this product to patients who are taking drugs with vasodilatory effects (e.g., alpha-adrenergic receptor antagonists, nitrates, phosphodiesterase type 5 (PDE5 inhibitors)) because of the potential for decreased orthostatic tolerance.
Moderate cytochrome P450 3A4 inhibitors
The dose of this product is limited to 30 mg when taking moderate cytochrome P450 3A4 inhibitors, such as erythromycin, clarithromycin, fluconazole, amprenavir, fosamprenavir, aprepitant, verapamil and diltiazem, 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 cytochrome P450 2D6 poor metabolizers, as this may result in increased exposure, which may ultimately lead to a higher incidence and severity of dose-dependent adverse reactions.
Suicide/Suicidal thinking
Short-term studies in children and adolescents with major depression and other psychiatric disorders have found that antidepressants (including SSRIs) can increase the risk of suicidal thinking and behavior compared with placebo. Short-term studies have not shown that antidepressants increase the risk of suicidal behavior in adults over 24 years of age compared with placebo. In clinical trials of SSRIs for the treatment of premature ejaculation, no suicidal behavior with clear emergency treatment occurred.
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
Since SSRIs may lower the threshold for seizures, 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 Old
This product should not be used in people under 18 years old.
Comorbid Depression and Psychiatric Disorders
Men with signs and symptoms of depression should be evaluated before taking this product to rule out undiagnosed depressive illness. 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 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, they should stop taking this product.
Bleeding
Bleeding abnormalities have been reported during treatment with selective serotonin reuptake inhibitors. Patients should be cautious when taking this product, especially those taking drugs known to affect platelet function (such as atypical antipsychotics and phenothiazines, acetylsalicylic acid, nonsteroidal anti-inflammatory drugs [NSAIDs], antiplatelet drugs) or anticoagulants (such as warfarin), and those with a history of bleeding or coagulation disorders.
Renal Impairment
This product is 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 therapy for chronic depression has been reported to result in the following symptoms: anxious mood, irritability, agitation, dizziness, paresthesias (i.e., sensory disturbances, such as electroshock perception), anxiety, confusion, headache, lethargy, mood lability, insomnia, and hypomania.
However, a double-blind clinical trial evaluating the discontinuation effects of 60 mg of tamoxifen once daily or as needed for 62 days in subjects with premature ejaculation did not find a 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 tamoxifen treatment. Consistent results were obtained in a second double-blind clinical trial consisting of 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 SSRIs, use of this product has been associated with some eye 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 reach of children
