Dapoxetine is used to treat premature ejaculation in men.
Therapeutic of Dapoxetine
The nosological classification (ICD-10)
F52.4 Premature ejaculation
Dapoxetine, marketed as Priligy and Westoxetin, among and other brands, is the first compound developed specially for the treatment of premature ejaculation (PE) in men 18â€“64 years old.
Contraindications of Dapoxetine
Hypersensitivity to dapoxetine hydrochloride. Severe heart disease (eg heart failure II-IV NYHA class, disturbances of cardiac conduction (AV conduction block 2-3rd degree or sinus node weakness syndrome) in the absence of a permanent pacemaker, severe coronary heart disease or valvular disease). Simultaneous reception of MAO inhibitors and receive within 14 days after the termination of their use; similarly MAO inhibitors should not be taken within 7 days after you stop taking dapoxetine. Simultaneous treatment with thioridazine, and within 14 days after the termination of its use; similarly thioridazine should not be taken within 7 days after you stop taking dapoxetine. Simultaneous treatment with SSRIs reuptake inhibitor of serotonin and norepinephrine, and tricyclic antidepressants and other drugs which have serotonergic activity (eg L-tryptophan, triptans, tramadol, linezolid, lithium, drugs St. John’s wort (Hypericum perforatum) and within 14 days after discontinuation of these drugs ; similarly, these drugs should not be taken within 7 days after you stop taking dapoxetine Simultaneous treatment with inhibitors of CYP3A4 active, such as ketoconazole, itraconazole, ritonavir, saquinavir, telithromycin, nefazodone, nelfinavir, atazanavir, etc. Moderate and severe hepatic dysfunction. . Severe renal impairment. Children and adolescents under the age of 18 years.
Restrictions apply of Dapoxetine
Mild or moderate renal dysfunction; simultaneous application of potent inhibitors of CYP2D6 isozyme CYP3A4 inhibitors and moderate patients with genotype CYP2D6 isozyme low activity and patients with high activity isoenzyme CYP2D6 (in combination with moderate inhibitors isoenzyme CYP3A4); simultaneous application of drugs which affect platelet aggregation and anticoagulation due to the risk of bleeding.
Pregnancy and breast-feeding
Side effects of Dapoxetine
The following side effects reported in clinical studies were observed frequently and were dose-dependent nausea (11 and 22.2% when taking 30 mg and 60 mg dapoxetine respectively), dizziness (5.8 and 10.9%), headache (5, 6 and 8.8%), diarrhea (3.5 and 6.9%), insomnia (2.1 and 3.9%), fatigue (4.1 and 2%). The most common phenomena, demanding the withdrawal of treatment were nausea (2.2% of patients) and dizziness (1.2%).
The frequency of side effects is defined as very common (â‰Ą1 / 10); frequently (â‰Ą1 / 100- <1/10); uncommon (â‰Ą1 / 1000- <1/100); rare (â‰Ą1 / 10000- <1/1000).
often — anxiety, agitation, restlessness, abnormal dreams, decreased libido; rarely — depression, depressed mood, a state of euphoria, mood changes, nervousness, apathy, lethargy, confusion, disorientation, abnormal thinking, somatosensory amplification, insomnia, initial insomnia, intrasomnicheskoe disorder, nightmares, bruxism, loss of libido, anorgasmia.
On the part of the central nervous system: very often — dizziness, headache; often — drowsiness, impaired concentration, tremor, paresthesia; infrequently — syncope, including vasovagal, postural dizziness, akathisia, dysgeusia, hypersomnia, lethargy, sedation state, depression of consciousness; rare — dizziness during exercise, a sudden falling asleep.
From the side of view: often — blurred vision; infrequently — mydriasis, in the field of eye pain, blurred vision.
On the part of the ear and labyrinth organs: often — ringing in the ears; rare — vertigo.
From the CCC: often — flushing; infrequently — the cessation of activity of the sinus node, sinus bradycardia, tachycardia, decreased blood pressure, systolic hypertension; seldom — flushing heat.
With the respiratory system: often — stuffy nose, yawning.
On the part of the digestive tract: often — nausea; often — diarrhea, vomiting, constipation, abdominal pain, dyspepsia, flatulence, stomach discomfort, bloating, dry mouth.
Skin and subcutaneous tissue disorders: often — rash; rarely — itching, cold sweat.
Reproductive system: often — erectile dysfunction; infrequent — lack of ejaculation, orgasm disturbance, including anorgasmia in men, male genital paresthesia.
General condition: often — fatigue, irritability; rarely — fatigue, feeling hot, feeling of anxiety, a feeling of malaise, a feeling of intoxication.
Changes in laboratory parameters: often — increased blood pressure; rare — increase in heart rate, increase in DBP increase in orthostatic blood pressure.
Description of the individual side effects of Dapoxetine
Fainting with loss of consciousness, with bradycardia or sinus arrest observed in patients with Holter monitoring, and have been reported in clinical studies. These adverse events are regarded as being associated with dapoxetine. Most of the cases occurred within the first 3 hours after taking dapoxetine, after the first dose, or associated with medical procedures (blood sampling, changes in body position, blood pressure measurement). Prodromal symptoms often preceded the syncope. The incidence of syncope and prodromal symptoms depend on the dose that has been demonstrated in patients treated with higher doses of dapoxetine.