早發性射精 Treatment of premature ejaculation (PE) in adult males 18 to 64 years of age
#仿單變更2021
藥理
Dapoxetine and its metabolites (desmethyldapoxetine and didesmethyldapoxetine) are potent selective serotonin reuptake inhibitors; inhibition of neuronal serotonin reuptake and subsequent potentiation at pre- and postsynaptic receptors may be responsible for inhibition of the ejaculatory pathway.
藥動學
Absorption:
Rapid; time to peak: 1 to 2 hours Metabolism:
Extensively metabolized via multiple enzymes including CYP2D6, CYP3A4 (avoid grapefruit 24 hours before Priligy)<2021/7/24>, and flavin monooxygenase (FMO1) Elimination Half-life:
Initial phase: 1.5 hours; terminal phase: ~19 hours
禁忌症
1. Hypersensitivity to dapoxetine or any component of the formulation
2. Significant cardiac conditions including heart failure (class II-IV), conduction abnormalities (eg, AV block, sick sinus syndrome), significant ischemic or valvular heart disease, or history of syncope
3. History of mania or severe depression
4. Moderate to severe hepatic impairment
5. Concomitant use of strong CYP3A4 inhibitors (avoid grapefruit 24 hours before Priligy)<2021/7/24>; use with MAO inhibitors, other SSRIs, SNRIs, TCAs, thioridazine, or herbal products with serotonergic effects (concurrently, within 7 days of discontinuing dapoxetine, or within 14 days of discontinuing the MAO inhibitor, SSRI, SNRI, TCA, thioridazine, or serotonergic herbal product)
Dose:
1. Initial 30 mg 1 to 3 hours prior to sexual activity as needed; may increase to a maximum single dose of 60 mg if inadequate response, but only if initial dose is well-tolerated (eg lack of severe adverse effects or symptoms suggestive of syncope).
2. Maximum: 60 mg per 24 hours.
Administer with a glass of water, with or without food; tablet should be swallowed whole to avoid bitter taste. Avoid grapefruit juice and ethanol during therapy.