Product Overview
[Drug name]
Generic name: Dapoxetine hydrochloride tablets
Trade name: AiLeJiu Dapoxetine hydrochloride tablets 30mg*9 tablets
Pinyin full code: AiLeJiu YanSuanDaBoXiTingPian 30mg*9Pian
[Main ingredients]
Main ingredients: Dapoxetine hydrochloride. Chemical name: (+)-(S)-N,N-dimethyl-α-[2-(1-naphthyloxy)ethyl]-benzylamine hydrochloride Molecular formula: C21H23N0.HCL Molecular weight: 341.88
[Properties]
This product is a yellow film-coated tablet, which appears white or off-white after removing the coating.
[Indications/Main Functions]
This product is suitable for treating male patients aged 18 to 64 with premature ejaculation (PE) 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 communication difficulties caused by premature ejaculation (PE); and poor ejaculation control ability.
[Specifications]
30 mg * 9
【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. 1. The recommended first dose for all patients in adult males (18 to 64 years old) 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 risk-benefit balance of the patient should be evaluated after 6 treatment doses and a decision should be made whether to continue the treatment with this product. Elderly (65 years and above) The safety and efficacy of this product in patients aged 65 years and above has not been evaluated, mainly because 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 Patients with mild or moderate renal impairment do not need to make dose adjustments when taking this product, but should be taken with caution. This product is not recommended for patients with severe renal impairment (see the pharmacokinetics section). Patients with liver impairment Patients with mild liver impairment do not need to make dose adjustments when taking this product; this product is contraindicated for patients with moderate and severe liver impairment (Child-pugh C grade) (see the pharmacokinetics section).
[Adverse Reactions]
See the instructions for details.
[Contraindications]
This product is contraindicated for patients with known hypersensitivity to dapoxetine hydrochloride or any of the excipients. This product is contraindicated for patients with significant cardiac pathology [such as heart failure (NYHA II-IV), conduction abnormalities not treated with a permanent pacemaker (grade 2 or 3 atrioventricular block or sick sinus syndrome), significant myocardial ischemia and valvular disease]. This product should not be used with monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping treatment with MAOIs. Similarly, MAOIs should not be used within 7 days of stopping Priligy (see Drug Interactions). This product should not be used with thioridazine or within 14 days of stopping treatment with thioridazine. Similarly, thioridazine should not be taken within 7 days of stopping Priligy (see Drug Interactions). This product is contraindicated for patients taking strong cytochrome P4503A4 inhibitors such as ketoconazole, itraconazole, ritonavir, saquinavir, telithromycin, nefazodone, nafinavir, and atazanavir. This product is contraindicated for patients with moderate and severe liver damage.
[Precautions]
See the instructions for details.
