Hypersensitivity to dapoxetine or any auxiliary component of the drug; severe heart disease (eg, cardiac insufficiency 2-4 of NYHA class, cardiac conduction abnormalities (AV block of grade 2-3 or sinus syndrome (SSS)) in the absence of a permanent pacemaker, expressed by IHD or valve apparatus damage); simultaneous administration of MAO inhibitors and admission within 14 days after discontinuation of their use. Likewise, MAO inhibitors can not be taken within 7 days after discontinuation of Dapoxetine; simultaneous administration of thioridazine and within 14 days after discontinuation of its use. Similarly, thioridazine can not be taken within 7 days after discontinuation of Dapoxetine; simultaneous administration of serotonin reuptake inhibitors (selective serotonin reuptake inhibitors-SSRIs), serotonin and noradrenaline reuptake inhibitors and tricyclic antidepressants) and other drugs that have a serotonergic effect (for example, L-tryptophan, triptans, tramadol, linezolid, lithium, preparations of St. John’s wort (Hypericum perforatum) and within 14 days after discontinuation of these drugs, Similarly, these drugs can not be taken within 7 days after discontinuation of Dapoxetine; simultaneous administration with active inhibitors of CYP3A4, for example, ketoconazole, itraconazole, ritonavir, saquinavir, telithromycin, nefazodone, nelfinavir, atazanavir, etc. Moderately severe and severe liver dysfunction, severe renal dysfunction, children and adolescents under the age of 18; lactose intolerance, with caution weak or moderately severe renal dysfunction, concomitant use with potent inhibitors of the CYP2D6 isoenzyme and moderate inhibitors of CYP3A4 in patients with genotypically low activity zofermenta CYP2D6 and patients with high activity isoenzyme CYP2D6 (in combination with moderate inhibitors isoenzyme CYP3A4); simultaneous use with drugs that affect platelet aggregation, and with anticoagulants due to the risk of bleeding.
Application in pregnancy and lactation
Dapoxetine is not intended for use in women.
Based on the limited amount of data obtained in clinical studies, there is no reason to assume that taking dapoxetine by a man can affect a partner’s pregnancy. Well-controlled studies of dapoxetine in pregnant women have not been conducted.
It is not known whether dapoxetine and its metabolites are excreted in breast milk.
Use in children
Dapoxetine should not be taken in patients younger than 18 years of age.
Use in elderly patients
A single dose of dapoxetine at a dose of 60 mg did not reveal a significant difference in pharmacokinetics in healthy elderly men (over 65 years) and men of younger age.