Product Overview
[Drug name]
Generic name: Dapoxetine hydrochloride tablets
Trade name: Jieshile Dapoxetine hydrochloride tablets 30mg*6 tablets
Pinyin full code: ehiLeYnSuaaBoXiingiaOPian
[Main ingredients]
The main ingredient of this product is dapoxetine hydrochloride.
[Properties]
Dapoxetine hydrochloride tablets are gray film-coated tablets, which appear white or off-white after removing the coating.
[Indications/Main functions]
This product is suitable for the treatment of male premature ejaculation (PE) patients aged 18 to 64 years who meet all of the following conditions: intravaginal ejaculation latency time (IELT) is less than 2 minutes; and the vaginal base is inserted into the vagina before and during the process. Persistent or repeated ejaculation during or shortly after penetration, and before sexual satisfaction with minimal sexual stimulation; and significant personal distress or interpersonal difficulties caused by premature ejaculation (PE); and poor ejaculation control; and a history of premature ejaculation in most sexual attempts in the past 6 months.
〖Specification model]
30mg*6 tablets
[Usage and dosage]
Oral. The tablet should be swallowed whole. It is recommended that patients 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.
[Adverse Reactions]
Syncope (characterized by loss of consciousness) has been reported in clinical trials and is considered to be drug-related. Most cases occurred within 3 hours of dosing, after the first dose, or during study-related procedures performed in the clinic (such as blood draws, upright maneuvers, and blood pressure measurements), and prodromal symptoms often occurred before syncope. Orthostatic hypotension has been reported in clinical trials. The most common (25%) adverse drug reactions in clinical trials included headache, dizziness, nausea, diarrhea, insomnia, and fatigue. The most common events leading to discontinuation included nausea and dizziness.
[Contraindications]
This product is contraindicated in patients with known hypersensitivity to dapoxetine hydrochloride or any of the excipients. Dapoxetine hydrochloride tablets are contraindicated in patients with significant cardiac pathology (e.g. heart failure (NYHA -IV class), 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 with monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuation of MAOI treatment. Similarly, MAOIs should not be used within 7 days of discontinuation of this product (see Drug Interactions section). This product should not be used with thioridazine or within 14 days of discontinuation of thioridazine treatment. Similarly, thioridazine should not be taken within 7 days of discontinuation of this product (see Drug Interactions section).
This product should not be used with selective serotonin reuptake inhibitors [selective serotonin reuptake inhibitors (SSRI), 5-hydroxytryptamine-norepinephrine reuptake inhibitors (SNRI), tricyclic antidepressants (TCA)) or other drugs/herbal medicines with serotonin effects [such as L-tryptophan, triptans, tramadol, linezolid, lithium, Hypericum perforatum extract (Hypericum wilfordii), and should not be taken within 14 days after stopping these drugs/herbal medicines. Similarly, these drugs/herbal medicines should not be taken within 7 days after stopping this product (see the drug interactions section). This product is contraindicated in patients who are taking strong cytochrome P4534 drugs such as ketoconazole, itraconazole, ritonavir, tadalafil, sofranolol, atazanavir, etc. Dazhixiding hydrochloride tablets are contraindicated for patients with moderate and severe injuries.
[Precautions]
1. General precautions This product is only used for male patients with premature ejaculation. The safety of this product in men who do not suffer from premature ejaculation is not yet clear. At the same time, there is no data on the effect of this product on delayed ejaculation in this population. It is recommended that patients should not take this product at the same time as "entertainment drugs" because the effect is unknown and serious adverse events may occur.2. Taking psychotropic drugs: Patients are advised not to take psychotropic drugs with stimulant effects while taking this product. Psychotropic drugs with 5-hydroxytryptamine activity, such as oxytocin, methylphenidate and lysergic acid diethylamide, may cause serious adverse reactions if taken with this product. These adverse reactions include but are not limited to arrhythmia, hyperthermia, and 5-hydroxytryptamine syndrome. Taking sedative psychotropic drugs, such as narcotics and dihydrobenzoic acid, while taking this product may aggravate drowsiness and dizziness.3. Alcohol: The concurrent use of this product with alcohol may aggravate alcohol-related neurorecognition 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.4. Syncope This product may cause syncope or dizziness. Possible prodromal symptoms such as nausea, dizziness, lightheadedness, palpitations, weakness, confusion and sweating generally occur within 3 hours after administration, and often appear before syncope. If the patient has possible prodromal symptoms, he should lie down immediately so that the head is lower than other parts of the body, or sit down and put the head between the knees until the symptoms disappear. At the same time, the patient should be warned to avoid situations that may cause injury once syncope or other central nervous system (CNS) effects occur, including driving or operating dangerous machinery. Taking alcohol while taking 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 while taking this product.5. Patients with cardiovascular risk factors Subjects with underlying cardiovascular disease were not included in the active 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 of 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.6. Orthostatic hypotension Orthostatic hypotension has been reported in clinical trials. Prescribing physicians should inform patients 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 down and place their head between their knees until the symptoms disappear. Prescribing physicians should also inform patients that they should not stand up quickly after lying or sitting for a long time. In addition, caution should be exercised when prescribing this product for patients who are taking drugs with vasodilatory effects (such as α-adrenergic receptor antagonists, nitrates, and phosphodiesterase type 5 (PDE5 inhibitors)) because it may reduce orthostatic tolerance.7. Moderate cytochrome P450 3A4 inhibitors When taking moderate cytochrome P450 3A4 inhibitors at the same time, such as erythromycin, clarithromycin, fluconazole, amprenavir, fosamprenavir, azuretidine, verapamil and diltiazem, the dosage of this product is limited to 30 mg, and it is recommended to be used with caution.8. Strong cytochrome P450 2D6 inhibitors Patients taking strong cytochrome P450 2D6 inhibitors or known cytochrome P450 2D6 poor metabolizers should be cautious when increasing the dose to 60 mg, as this may result in increased exposure and ultimately a higher incidence and severity of dose-dependent adverse reactions.9. Suicide/suicidal thinking Short-term studies in children and adolescents with severe depression and other mental illnesses 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 confirmed that antidepressants can increase the risk of suicidal behavior in adults over 24 years old compared with placebo. In clinical trials of this product for the treatment of premature ejaculation, no suicidal behavior with clear emergency treatment has occurred.10. Mania This product should not be used in patients with a history of mania/hypomania or bipolar disorder. At the same time, any patient who develops symptoms of the above diseases should discontinue use of this product.11. Epilepsy: Since selective serotonin reuptake inhibitors may lower the threshold for epilepsy, any patient who develops an addictive seizure should stop using this product. At the same time, patients with "unstable dementia" should avoid using this product. Patients whose epilepsy has been controlled should be closely monitored.12. Use in children and adolescents under 18 years of age: This product should not be used in people under 18 years of age. 13. Concomitant depression and mental illness; Men with depressive symptoms and signs should be evaluated before taking this product to rule out undiagnosed depressive diseases. 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 to treat 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 is impossible to rule out the aggravation of depression-related symptoms. This may be the result of underlying mental illness, or it may be the result of drug treatment. If signs and symptoms of depression worsen, this product should be stopped.14. Bleeding There have been reports of abnormal bleeding during treatment with selective serotonin reuptake inhibitors. Patients should be cautious when taking this product, especially those who are taking drugs known to affect platelet function (such as atypical antipsychotics and phenezines, acetylsalicylic acid, nonsteroidal anti-inflammatory drugs [INSAIDs], antiplatelet drugs) or anticoagulants (such as warfarin), as well as patients with a history of bleeding or coagulation disorders. 15. 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. 16. Discontinuation effects It has been reported that sudden cessation of long-term selective serotonin reuptake inhibitor treatment for chronic depression can lead to the following symptoms: anxious mood, irritability, excitement, dizziness, paresthesia (i.e., sensory confusion, such as electric shock perception), anxiety, confusion, headache, drowsiness, emotional instability, insomnia and hypomania. 17. Eye diseases Like other selective serotonin reuptake inhibitors, the use of this product is associated with some eye reactions, such as pupil dilation and eye pain. Patients with increased intraocular pressure or risk of angle-closure glaucoma should use dapoxetine hydrochloride tablets with caution.
18. Keep out of reach of children.
