Take Priligy with caution in the following cases:
- hypersensitivity to dapoxetine hydrochloride or any drug component;
- expressed heart diseases (e. g., cardiac insufficiency of II-IV class according to NYHA, disturbances of cardiac conduction (AV-block of 2-3 degrees or SSS) in absence of permanent cardiac pacemaker, severe ischemic heart disease or valvular lesion);
- concomitant use of MAO inhibitors and within 14 days after their application cessation. Likewise, MAO inhibitors should not be taken within 7 days after drug withdrawal;
- concomitant use of thioridazine and within 14 days after its application cessation. Likewise, thioridazine should not be taken within 7 days after drug withdrawal;
- concomitant use of serotonin reuptake inhibitors (selective serotonin reuptake inhibitors – SSRIs), serotonin and norepinephrine reuptake inhibitors and tricyclic antidepressants and other drugs with serotonergic activity (e. g., L-tryptophan, triptans, tramadol, linezolid, lithium, St. John’s wort drugs (Hypericum perforatum) and within 14 days after these drugs administration cessation. Likewise, these drugs should not be taken within 7 days after Priligy withdrawal;
- concomitant use of active CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, saquinavir, telithromycin, nefazodone, nelfinavir, atazanavir, etc.;
- moderately severe and severe hepatic impairment;
- severe renal impairment;
- children and adolescents under the age of 18;
- lactose intolerance.
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If there is proved or suspected orthostatic hypotension in anamnesis, as well as mania/hypomania or bipolar disorders, patients should avoid treatment with this drug.
- mild to moderately severe renal impairment;
- concomitant use of potent CYP2D6 inhibitors and moderate CYP3A4 inhibitors in patients with genotypically low CYP2D6 isozyme activity and patients with high CYP2D6 isoenzyme activity (in combination with moderate CYP3A4 inhibitors);
- concomitant use of drugs which affect platelet aggregation and anticoagulation due to the risk of hemorrhages.
Pregnancy and Lactation
Priligy drug is not intended for use by women.
Based on the limited amount of data obtained in clinical tests, there is no reason to assume that Priligy use by man can affect partner’s pregnancy. Well-controlled studies among pregnant women have not been conducted.
It is unknown if dapoxetine and its metabolites are excreted in breast milk.
Use by Elderly Patients
A single dose of 60 mg showed no significant differences in pharmacokinetic parameters (Cmax, AUC0-∞, Tmax) in healthy elderly men (above 65 years) and younger men. Average parameters of AUC0-∞ and half-life period were higher by 12% and 46% in elderly men compared to younger men.
Effects on Ability to Operate Mechanical Means
Upon receiving this medication there were described cases of vertigo, attention disorders, fainting, blurred vision, drowsiness.
Posted by Dr. Himanshu Singh