Dapoxtard ِ 60 mg 3 tablets

Trade name:

Dapokstard

Dapoxtard

Composition:

Each tablet contains:

Dapoxetine 60 mg

Auxiliary components:

Lactose monohydrate, microcrystalline cellulose, carboxymethyl cellulose, aerosil, magnesium stearate, titanium dioxide, polyethylene glycol 6000, talc.

Properties:

Dapoxetine is a potent selective serotonin reuptake inhibitor (SSRI) with a half-maximal inhibition concentration (IC50) of 1.12 nM, which is metabolized in the body to the main metabolites – desmethyldapoxetine (IC50 <1.0 nM) and dideoxymethyldapoxetine (IC50 = 2.0 nM), equally or less active (dapoxetine-N-oxide (IC50 = 282 nM)).

The mechanism of action of dapoxetine in premature ejaculation is associated with inhibition of serotonin reuptake by neurons, followed by an increase in the action of a neurotransmitter on pre- and postsynaptic receptors.

The mechanism of ejaculation is regulated mainly by the sympathetic nervous system. In rats, postganglionic sympathetic nerve fibers innervate the seminal vesicles, vas deferens, prostate, urethral and bladder neck muscles, causing them to contract in a coordinated manner to achieve ejaculation. Dapoxetine affects the ejaculation reflex at the supraspinal level in the lateral paragiant cell nuclei, increasing the latency period and reducing the duration of reflex impulses of perineal ganglion motor neurons. The stimulus that triggers ejaculation is generated in the spinal reflex center, which is controlled through the brain stem by several nuclei of the brain, incl. preoptic and paraventricular.

Indications:

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

The drug Dapokstard can only be used in patients who meet the following criteria:

– Intravaginal ejaculation delay time (IVVZE) <2 min;

-Constantly or regularly occurring ejaculation after minimal sexual stimulation before, during or shortly after sexual penetration, and coming earlier than the patient’s desired moment;

– pronounced personal distress or difficulties in interpersonal relationships due to premature ejaculation;

-weak control of ejaculation;

– the onset of premature ejaculation in most attempts at sexual intercourse in the last 6 months.

The drug Dapokstard should be used only as needed before the intended sexual activity. The drug should not be used to delay ejaculation in men without a confirmed diagnosis of premature ejaculation.

Method of administration and dosage:

The recommended starting dose for all men is 30 mg; this dose is taken 1-3 hours before the expected sexual intercourse. If the effect is insufficient and the dose of 30 mg is well tolerated (there are no moderate or severe adverse reactions or prodromal symptoms that may precede fainting), the dose can be increased to the maximum recommended 60 mg taken 1-3 hours before intercourse. The frequency and severity of adverse reactions increases when the drug is taken at a dose of 60 mg.

Contraindications:

– hypersensitivity to dapoxetine and / or to any excipient in the preparation;

– severe heart disease;

– simultaneous use of MAO inhibitors and taking dapoxetine within 14 days after stopping the use of an MAO inhibitor;

– the simultaneous use of selective serotonin reuptake inhibitors (SSRIs);

– inhibitors of reuptake of serotonin and norepinephrine and tricyclic antidepressants; other medicinal products with serotonergic action – simultaneous administration with strong inhibitors of CYP3A4;

– hepatic insufficiency of moderate severity and severe degree;

– severe renal failure;

– age under 18 and over 64 years (due to the lack of data on the efficacy and safety of dapoxetine in these patient populations);

-lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome;

– history of syncope;

– a history of mania or severe depression;

-the presence of diagnosed or suspected orthostatic hypotension;

– in patients with mania / hypomania or bipolar disorder.

Precautionary measures:

The combined use of dapoxetine with alcohol can enhance its effect on the central nervous system, and can also increase neurocardiogenic adverse reactions such as fainting, thus increasing the risk of accidental injury. Therefore, patients should be advised to refrain from drinking alcohol while taking dapoxetine.

Side effects:

Mental disorders: often – anxiety, agitation, restlessness, unusual dreams, decreased libido.

From the nervous

systems: very often – dizziness, headache; often – drowsiness, impaired concentration, tremor, paresthesia.

From the side of the organ of vision: often – blurred vision; infrequently – mydriasis, eye pain, visual impairment.

From the organ of hearing and labyrinth: often – ringing in the ears; infrequently – vertigo.

From the side of the cardiovascular system: often – “hot flashes” of blood (flushing of the skin), increased blood pressure.

From the respiratory system: often – nasal congestion, yawning.

From the digestive system: very often – nausea.

Storage method:

Store at a temperature not exceeding 30 degrees.

Package:

The cardboard box contains 2 blisters of 3 tablets, paper instructions.