Dapoxetine
Dapoxetine — it is a drug recommended for premature ejaculation in adult men. Tablets are prescribed only to patients who have been diagnosed with PE. Dapoxetine — is a potent selective serotonin reuptake inhibitor. There are two dosages: 30 mg and 60 mg.
Composition
Active ingredient: dapoxetine;
1 coated tablet contains dapoxetine hydrochloride 33 .6 or 67.2 mg, which corresponds to dapoxetine 30 or 60 mg, respectively;
lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate.
Sheath:
- 30 mg film-coated tablets: Powder Gray 4 (lactose, hypromellose, titanium dioxide (E 171), triacetin, iron oxide black (E172), iron oxide yellow (E172));
- film-coated tablets, 60 mg: Powder Gray 3 (lactose, hypromellose, titanium dioxide (E 171), triacetin, iron oxide black (E172), iron oxide yellow (E 172)).
Indications for use
Treatment of premature ejaculation (PE) in adult men aged 18 to 64.
Dapoxetine recommended only for patients who meet the following criteria:
- intravaginal ejaculation latency time (IELT) of less than two minutes;
- persistent or recurrent ejaculation after minimal sexual stimulation before, during time or shortly after sexual penetration, which occurs earlier than the moment desired by the patient;
- severe stress or difficulties that arose in interpersonal relationships as a result of PE;
- poor control over the onset of ejaculation;
- Premature ejaculation onset in most intercourse attempts in the last 6 months.
Dapoxetine should be taken if necessary only as a treatment — before the intended sexual intercourse. Dapoxetine should not be used to delay ejaculation in men who have not been diagnosed with PE.
Usage
The recommended starting dose for patients aged 18 to 64 years is 30 mg to be taken 1 to 3 hours before anticipated sexual intercourse. Treatment with Dapoxetine do not start at 60 mg.
Dapoxetine not intended for continuous daily use. Dapoxetine should only be taken in case of intended sexual intercourse. The drug should not be taken more than 24 hours later.
If the individual response to the drug at a dose of 30 mg is insufficient and the patient has not had moderate or severe adverse reactions, as well as prodromal symptoms suggesting the possibility of syncope, the dose can be increased to the maximum recommended dose of 60 mg, should be taken if necessary approximately 1-3 hours before sexual intercourse. The frequency and severity of adverse reactions when taking the drug at a dose of 60 mg increases.
If the patient has experienced orthostatic reactions after taking the drug at the initial dose, it is not recommended to increase the dose to 60 mg. The maximum recommended dose should not be exceeded.
A careful assessment of the benefit over the possible risk is required when taking Dapoxetine after the first four weeks of treatment (or at least after 6 doses of treatment) to determine whether continued treatment with Dapoxetine is appropriate.
Evidence regarding the efficacy and safety of Dapoxetine; for more than 24 weeks are limited. Clinical need for continued treatment and risk-benefit ratio of treatment with Dapoxetine should be reviewed at least every six months.
Elderly patients (over 65)
Efficacy and safety of Dapoxetine has not been established for patients over the age of 65.
Impaired kidney function
When taking the drug in patients with mild or moderate renal impairment, the caution. Patients with severe renal impairment Dapoxetine it is not recommended to take.
Impaired liver function
The drug is contraindicated in patients with moderate or severe liver dysfunction.
Slow CYP2D6 metabolizers or patients treated with CYP2D6 inhibitors
Caution should be exercised in increasing the dose to 60 mg in patients with an established CYP2D6 slow metabolizer genotype or in patients who are concomitantly receiving potent CYP2D6 inhibitors.
Patients taking moderate-strength CYP3A4 inhibitors or strong CYP3A4 inhibitors
Concomitant use of strong CYP3A4 inhibitors is contraindicated. Patients who are simultaneously taking moderate-strength CYP3A4 inhibitors should be careful not to exceed a dose of 30 mg.
Usage
The drug is intended for oral use. To avoid a bitter taste, tablets should be swallowed by breaking. Tablets should be taken with plenty of water. Dapoxetine may be taken with or without food.
Children
Using Dapoxetine contraindicated in children due to lack of clinical experience.
Contraindications
- Hypersensitivity to the active substance or to any excipient of the drug.
- Heart failure (NYHA class II-IV).
- Conduction disorders such as AV block or sick sinus syndrome.
- Severe ischemic heart disease.
- Severe coronary artery disease.
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- Severe valvular deficiency.
- History of syncope.
- History of mania or severe depression.
- Concomitant use of MAO inhibitors (inhibitors MAO) or if less than 14 days have passed since stopping their intake. Application of Dapoxetine should be discontinued at least 7 days before the start of therapy with MAO inhibitors.
- Simultaneous administration of thioridazine or within 14 days after the end of administration. Application of Dapoxetine should be discontinued at least 7 days before starting thioridazine therapy.
- Concomitant use of serotonin reuptake inhibitors (selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs) )) or other serotonergic drugs/herbal products [such as L-tryptophan, triptans, tramadol, linezolid, lithium, St. These medicinal/herbal products should not be taken within 7 days of stopping Dapoxetine.
- Concomitant use of strong CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, saquinavir, telithromycin, nefazodone, nelfinavir, atazanavir and the like.
- Impaired liver function of moderate or severe.
Product form
PVC blister- PE-PVDC/aluminum in a child-resistant fold-out pouch containing 3 or 6 film-coated tablets.
Storage conditions
Special conditions storage is not required. Keep out of the reach of children.