Use with recreational drugs: Patients should be advised not to use Dapoxetine in combination with recreational drugs. Recreational drugs with serotonergic activity such as ketamine, methylenedioxymethamphetamine (MDMA) and lysergic acid diethylamide (LSD) may lead to potentially serious reactions if combined with Dapoxetine. These reactions include, but are not limited to arrhythmia, hyperthermia, and serotonin syndrome. Use of Dapoxetine with recreational drugs with sedative properties such as narcotics and benzodiazepines may further increase somnolence and dizziness.
Combining alcohol with Dapoxetine may increase alcohol-related neurocognitive effects and may also enhance neurocardiogenic adverse events such as syncope, thereby increasing the risk of accidental injury; therefore, patients should be advised to avoid alcohol while taking Dapoxetine.
Possibly prodromal symptoms such as nausea, dizziness, lightheadedness, palpitations, asthenia, confusion and diaphoresis generally occurred within the first 3 hours following dosing and often preceded the syncope. Patients need to be made aware that they could experience syncope at any time with or without prodromal symptoms during their treatment with Dapoxetine.
An orthostatic test should be performed before initiating therapy. In case of a history of documented or suspected orthostatic reaction, treatment with Dapoxetine should be avoided.
There have been reports of bleeding abnormalities with SSRIs. Caution is advised in patients taking Dapoxetine, particularly in concomitant use with medicinal products known to affect platelet function (e.g., atypical antipsychotics and phenothiazines, acetylsalicylic acid, nonsteroidal anti-inflammatory drugs [NSAIDs], anti-platelet agents) or anticoagulants (e.g., warfarin), as well as in patients with a history of bleeding or coagulation disorders.
The pharmacokinetics of Dapoxetine (60 mg) in combination with Tadalafil (20 mg) and Sildenafil (100 mg) were evaluated in a single dose crossover study. Tadalafil and Sildenafil did not affect the pharmacokinetics of Dapoxetine.
Dapoxetine should be prescribed with caution in patients who use alpha adrenergic receptor antagonists due to possible reduced orthostatic tolerance.