Daposense

Таблетки By prescription

Agent for the treatment of premature ejaculation

Daposense

Important

If there is a history of established or suspected orthostatic hypotension, as well as a history of mania/hypomania or bipolar disorder, treatment with the drug should be avoided.

Indications

The drug is intended for the treatment of premature ejaculation in men aged 18 to 64 years.

Contraindications

  • Hypersensitivity to dapoxetine hydrochloride or to any of the auxiliary components of the drug
  • Severe heart diseases (for example, NYHA class II – IV heart failure, cardiac conduction disorders (grade 2-3 atrioventricular conduction block or sinus weakness syndrome) in the absence of a permanent pacemaker, severe coronary artery disease or damage to the valvular apparatus)
  • Simultaneous administration of monoamine oxidase inhibitors (MAO-I) and administration within 14 days after discontinuation of their use. Similarly, MAO-I should not be taken for 7 days after discontinuation of Dapoxetine
  • Simultaneous administration of thioridazine and within 14 days after discontinuation of its use. Similarly, thioridazine should not be taken for 7 days after discontinuation of Dapoxetine
  • Simultaneous administration of serotonin reuptake inhibitors (selective serotonin reuptake inhibitors – SSRIs), serotonin and norepinephrine reuptake inhibitors and tricyclic antidepressants) and other drugs with serotonergic effects (L-tryptophan, triptans, tramadol, linezolid, lithium, St. John's wort (Hypericum perforatum) and within 14 days after discontinuation of administration these drugs. Similarly, these drugs should not be taken for 7 days after discontinuation of the drug Dapoxetine
  • Concomitant administration with active CYP3A4 inhibitors, for example, ketoconazole, itraconazole, ritonavir, saquinavir, telithromycin, nefazodone, nelfinavir, atazanavir, etc.
  • Moderate and severe liver dysfunction
  • Severe renal dysfunction
  • Children under 18 years of age
  • Lactose intolerance, lactase deficiency, glucose-galactose malabsorption

With caution

  • Mild or moderate renal impairment
  • Concomitant use with potent inhibitors of the CYP2D6 isoenzyme and moderate CYP3A4 inhibitors in patients with genotypically low activity of the CYP2D6 isoenzyme and patients with high activity of the CYP2D6 isoenzyme (in combination with moderate inhibitors of the CYP3A4 isoenzyme)
  • Concomitant use with drugs that affect platelet aggregation and with anticoagulants due to the risk of bleeding


Use during pregnancy and lactation

The drug is not intended for use in women.

Pregnancy
Based on the limited amount of data obtained in clinical trials, there is no reason to assume that taking dapoxetine by a man can affect his partner's pregnancy. There have been no well-controlled studies on the use of dapoxetine in pregnant women.

Breastfeeding period
It is unknown whether dapoxetine and its metabolites are excreted in breast milk.

Usage

Inside, regardless of the meal. The tablet should be taken without crushing or chewing, washed down with a sufficient amount of water.

Adult men aged 18 to 64 years: the recommended starting dose for all men is 30 mg; this dose is taken 1-3 hours before the intended sexual intercourse. If the effect is insufficient and the dose of 30 mg is well tolerated, it can be increased to 60 mg. The maximum recommended dose frequency is 1 time per day.

The doctor prescribing the drug Dapoxetine for the treatment of premature ejaculation should assess the risk and benefit of using the drug after 4 weeks of treatment or after taking 6 doses and should determine the risk-benefit ratio in order to decide whether further treatment with the drug is appropriate.

Patients with impaired renal function: No dose adjustment is required for patients with mild or moderate renal impairment, but caution is recommended. The drug is not recommended for patients with severe renal impairment.

Patients with impaired liver function: no dose adjustment is required for patients with mild hepatic impairment. The drug is contraindicated in patients with moderate to severe hepatic impairment (Child-Pugh classes B and C).

Patients with low CYP2D6 activity, concomitant administration with active CYP2D6 inhibitors: caution should be exercised when increasing the dose of Dapoxetine to 60 mg in patients with low CYP2D6 activity or in patients taking active CYP2D6 inhibitors simultaneously with the drug.

Patients receiving active or moderately active CYP3A4 inhibitors: concomitant administration of active CYP3A4 inhibitors is contraindicated. When taking Dapoxetine concomitantly with moderately active CYP3A4 inhibitors, the dose of the drug should be reduced to 30 mg.

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