Product Overview
Product name
Aierjiu Dapoxetine Hydrochloride Tablets 30mg*3 tablets*2 plates
Product specifications
30mg*3 tablets*2 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 on 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
Patients are advised not to take stimulant psychiatric drugs with 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 sedative psychiatric drugs, such as narcotics and benzodiazepines, with this product may increase drowsiness and dizziness.
Alcohol
The concomitant use of alcohol with this product may aggravate alcohol-related neurocognitive effects and 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
The 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 subjects without premature ejaculation, 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 advise 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 while taking this product can increase the risk of adverse neurocardiovascular events (such as syncope), thereby increasing the risk of accidental injury. Therefore, patients are advised not to take alcohol while taking this product.
Patients with cardiovascular risk factors
Subjects with underlying cardiovascular disease were not included in Phase III clinical trials. Patients with underlying organic cardiovascular disease (e.g., documented outflow tract obstruction, valvular heart disease, carotid artery stenosis, and coronary heart disease) have an increased risk of adverse cardiovascular reactions due to syncope (cardiac syncope and syncope of other causes). There is insufficient data to demonstrate 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 selective serotonin reuptake inhibitors) 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 this product for the treatment of premature ejaculation, no suicidal behavior with clear emergency treatment occurred.
Mania
This product should not be used in patients with a history of mania/hypomania or bipolar disorder, and any patient who develops symptoms of these diseases should stop using this product.
Epilepsy
Since SSRIs may lower the seizure threshold, 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
SSRIs should not be used in people under 18 years of age.
Concomitant 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 contraindicated. 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 psychiatric disorders and should not be used in male patients with psychiatric disorders (such as schizophrenia) or patients with psychiatric disorders and depression because it cannot be ruled out that the symptoms related to depression may be aggravated. This may be the result of the underlying psychiatric disorder 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 concomitant medications known to affect platelet function (e.g., atypical antipsychotics and phenothiazines, acetylsalicylic acid, nonsteroidal anti-inflammatory drugs [NSAIDs], antiplatelet agents) or anticoagulants (e.g., 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
Sudden discontinuation of long-term selective serotonin reuptake inhibitor therapy for chronic depression has been reported to result in the following symptoms: anxious mood, irritability, excitement, 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 sera. 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 sera has been 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 reach of children.
