Primaxetin pills 30mg 6 pcs
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Active ingredients
Release form
Composition
1 tablet, film coated, contains:
- active substance: dapoxetine hydrochloride 33.6 mg in terms of 30 mg dapoxetine;
- Excipients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, anhydrous colloidal silicon dioxide, magnesium stearate;
- shell auxiliaries: [Hypromellose (hydroxypropylmethylcellulose), macrogol 6000 (polyethylene glycol 6000), titanium dioxide, ferric oxide black, ferric oxide yellow].
Pharmacological effect
The mechanism of action of dapoxetine during premature ejaculation is associated with inhibition of serotonin reuptake by neurons, followed by an increase in the action of the neurotransmitter on pre- and postsynaptic receptors.
The mechanism of ejaculation is regulated mainly by the sympathetic nervous system. Postganglionic sympathetic nerve fibers innervate the seminal vesicles, vas deferens, prostate gland, muscles of the urethra and bladder neck, causing their coordinated contraction to achieve ejaculation. Dapoxetine affects the ejaculation reflex, increasing the latent period and reducing the duration of the reflex impulses of the motor neurons of the perineal ganglia.
Pharmacodynamics It is assumed that the mechanism of action of dapoxetine during premature ejaculation is associated with inhibition of serotonin reuptake by neurons with subsequent enhancement of the neurotransmitter effect on pre- and postsynaptic receptors. 2 The mechanism of ejaculation is regulated mainly by the sympathetic nervous system. Postganglionic sympathetic nerve fibers innervate the seminal vesicles, vas deferens, prostate gland, muscles of the urethra and bladder neck, causing their coordinated contraction to achieve ejaculation. Dapoxetine affects the ejaculation reflex, increasing the latent period and reducing the duration of the reflex impulses of the motor neurons of the perineal ganglia. The stimulus that triggers ejaculation is generated in the spinal reflex center, which is controlled by several brain nuclei through the brain stem, including the preoptic and paraventricular.
Pharmacokinetics
Dapoxetine is rapidly absorbed, and the maximum plasma concentration (C max) is reached within 1–2 hours after taking the drug. Absolute bioavailability is 42% (range 15-76%). After a single oral dose of dapoxetine on an empty stomach in doses of 30 mg and 60 mg, the maximum concentration of the substance in the blood plasma is 297 ng / ml (after 1.01 hours) and 498 ng / ml (after 1.27 hours), respectively. Eating fatty foods moderately reduces Cmax of dapoxetine (by 10%) and increases AUC (area under the concentration-time curve) and time to reach maximum plasma concentration by 12%. However, the degree of absorption of dapoxetine does not change. These changes are not clinically significant. The drug Primaksetin® can be taken regardless of the meal. Distribution Over 99% of dapoxetine binds to plasma proteins in vitro. The active metabolite - desmetildadoxetin - binds to plasma proteins by 98.5%. Dapoxetine is rapidly distributed throughout the body with an average equilibrium distribution volume of 162 liters. When administered intravenously in humans, the average half-life in the initial, intermediate and terminal phase of elimination is 0.10, 2.19 and 19.3 hours, respectively. Metabolism In vitro studies suggest that dapoxetine is metabolized by many liver and kidney enzymes, especially CYP2D6, CYP3A4, and flavin-containing monooxygenase (FMO1) of the kidneys. In a clinical study, during which the metabolism of 14C-dapoxetine was studied, dapoxetine after oral administration was extensively metabolized mainly by N-oxidation, N-demethylation, naphtho-group hydroxylation, sulfo-group addition. After oral administration, signs of presystemic metabolism were found in the liver. 3 The main components circulating in the blood plasma were intact dapoxetine and dapoxetine N-oxide. In vitro studies have found that dapoxetine-N-oxide is inactive. In addition, desmethyldioxetine and didesmethyldipoxetine were detected in an amount of less than 3% of the total number of circulating metabolites of dapoxetine. In an in vitro study, it was found that desmethyldapoxetine is comparable in activity to dapoxetine, and didemetmethyldipoxetine is approximately 2 times less active than dapoxetine. Exposure (AUC and C max) of unbound desmethyldipoxetine was 50% and 23% of unbound dapoxetine, respectively. Withdrawal Metabolites of dapoxetine are derived mainly from the urine in the form of conjugates. Unchanged active substance is not detected in the urine.Dapoxetine is rapidly excreted, as evidenced by the low concentration of the substance in the blood plasma (less than 5% of the maximum) 24 hours after the dose. With daily intake, the accumulation of a substance in the body is minimal. When taken orally, the final half-life is approximately 19 hours. Special groups of patients Race A single dose of dapoxetine at a dose of 60 mg did not reveal a statistically significant difference in rates among Europeans, people of the Negroid race, Latin Americans and people of the Asian race. Comparison of the pharmacokinetics of dapoxetine among Europeans and Japanese showed higher Cmax and AUC values, the latter (by 10-20%) due to lower body weight. A higher level of systemic exposure is unlikely to cause a significant difference in clinical effect. Elderly patients (65 years and older) A single dose of 60 mg dapoxetine did not reveal a significant difference in pharmacokinetics (Cmax, AUC, Tmax) in healthy older men and younger men. The mean AUC values of dapoxetine and the terminal half-life were higher, respectively, by 12% and 46% in older men compared with younger men. Impaired renal function A single dose of 60 mg dapoxetine did not reveal a relationship between creatinine clearance and Cmax or AUC of dapoxetine in patients with weak (creatinine clearance 50–80 ml / min), moderately expressed (creatinine clearance from 30 to <50 ml / min) and severe (creatinine clearance <30 ml / min) impaired renal function. AUC of dapoxetine in 4 patients with severe impaired renal function was approximately 2 times higher than in patients with normal renal function. Data on the use of the drug in patients with severe impaired renal function is limited. In patients requiring hemodialysis, the pharmacokinetics of dapoxetine have not been studied. Hepatic dysfunction In patients with mild hepatic impairment, the pharmacokinetics of dapoxetine and desmethyldapoxetine did not change. In patients with impaired moderate liver function (Child-Pugh class B), Cmax and AUC of unbound dapoxetine were increased by 55% and 120%, respectively. Cmax of the unbound active fraction of dapoxetine was unchanged, and AUC - 2 times increased. In patients with severe hepatic impairment, C max of unbound dapoxetine was unchanged, and the AUC of unbound dapoxetine was increased more than 3 times.AUC of the active fraction was also increased several times. CYP2D6 Polymorphism The concentration of dapoxetine in the blood plasma after a single dose of the drug Primaxetin® in a dose of 60 mg in patients with low CYP2D6 activity was higher than in patients with high CYP2D6 activity (Cmax approximately 31%, AUC approximately 36%). Similarly, Cmax of desmethyldioxetine in patients with low CYP2D6 activity was increased by 98%, and AUC - by 161%. The average terminal half-life of dapoxetine was increased by 2.4 hours in patients with low activity of the CYP2D6 isoenzyme compared to patients with high activity of the CYP2D6 isoenzyme. Cmax of the active fraction of dapoxetine increased by - 46%, a AUC by - 90%. This increase may be accompanied by an increased frequency and severity of dose-related adverse events. The safety of the use of Primaxetin® in patients with low CYP2D6 activity may raise doubts while taking other medications that can inhibit the metabolism of dapoxetine, in particular, active and moderately active CYP3A4 inhibitors. Patients with ultra-high CYP2D6 activity are expected to lower plasma levels of dapoxetine and desmethydapoxetine.
Indications
The drug Primaksetin® is intended for the treatment of premature ejaculation in men aged 18 to 64 years.
Contraindications
Hypersensitivity to dapoxetine hydrochloride or any other component of the drug. 5 - Severe heart disease (for example, NYHA grade II-IV heart failure, cardiac conduction disturbances (2-3 degree atrioventricular conduction blockage or sinus weakness syndrome) in the absence of a permanent pacemaker, severe coronary heart disease or valvular lesion). - 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 within 7 days after discontinuation of the drug Primaxetin®. - Simultaneous administration of thioridazine and within 14 days after discontinuation of its use. Similarly, thioridazine should not be taken within 7 days after discontinuation of taking Primaxetin®. - concurrently taking serotonin reuptake inhibitors (selective serotonin reuptake inhibitors - SSRIs), serotonin and noradrenaline reuptake inhibitors and tricyclic antidepressants and other drugs that have serotonergic effects (for example, L-tryptophan, triptans, tramadol, tramadol). (Hypericum perforatum) and within 14 days after discontinuation of these drugs.Similarly, these drugs should not be taken within 7 days after stopping taking Primaxetin®. - Simultaneous administration with active inhibitors of CYP3A4, for example, ketoconazole, itraconazole, ritonavir, saquinavir, telithromycin, nefazodone, nelfinavir, atazanavir, etc. - Moderately severe and severe liver dysfunction. - Severe renal dysfunction. - Children and teenagers younger than 18 years. - Lactase deficiency, lactose intolerance, glucose-galactose malabsorption. In the case of a history of established or suspected orthostatic hypotension, as well as a history of mania / hypomania or bipolar disorder, treatment with Primaxetin® should be avoided. With caution - mild or moderate renal dysfunction; - simultaneous use with powerful inhibitors of CYP2D6 isoenzyme and moderate CYP3A4 inhibitors in patients with genotypically low CYP2D6 isoenzyme activity and patients with high CYP2D6 isoenzyme activity (in combination with moderate inhibitors of CYP3A4 isoenzyme); - simultaneous use with drugs that affect platelet aggregation and anticoagulants due to the risk of bleeding. 6 Use during pregnancy and during breastfeeding.
Use during pregnancy and lactation
The drug Primaksetin® is not intended for use in women.
Based on the limited amount of data obtained in clinical studies, there is no reason to assume that dapoxetine intake by a man may affect the partner's pregnancy. Well-controlled studies of the use of dapoxetine in pregnant women have not been conducted. Breastfeeding period It is not known whether dapoxetine and its metabolites are excreted in breast milk.
For oral administration. The tablet should be swallowed whole with a minimum of one full glass of water. The drug Primaksetin® can be taken regardless of the meal. Adults men 18 to 64 years old. The recommended starting dose for all men is 30 mg; This dose is taken 1-3 hours before the intended sexual intercourse. With insufficient effect and good tolerability of a dose of 30 mg, it can be increased to 60 mg. The maximum recommended dose frequency is 1 time per 24 hours.The physician prescribing the drug Primaksetin® for the treatment of premature ejaculation should evaluate the risk and benefit of using the drug after the first 4 weeks of treatment or after taking 6 doses and should determine the risk-benefit ratio to decide whether to continue to treat Primaxetin®. Patients with impaired renal function For patients with mild or moderately impaired renal function, dose adjustment is not required, but caution is advised. Primaksetin® is not recommended for patients with severely impaired renal function. Patients with impaired liver function For patients with mild hepatic impairment, dose adjustment is not required. The drug Primaksetin® is contraindicated in patients with moderately severe and severe liver dysfunction (classes B and C according to the Child-Pugh classification). Patients with low CYP2D6 activity, concomitant use with active CYP2D6 inhibitors. Care should be taken when increasing the dose of the drug Primaxetin® to 60 mg in patients with low CYP2D6 activity or in patients simultaneously with the drug Primaxetin® who are taking active CYP2D6 inhibitors. 7 Patients receiving active or moderately active active CYP3A4 inhibitors Simultaneous administration of active inhibitors of CYP3A4 is contraindicated. At the same time taking the drug Primaksetin® with moderately active inhibitors of CYP3A4, the dose should be reduced to 30 mg.
Side effects
The following side effects were observed in clinical studies, which were observed frequently and were dose-dependent: nausea (11.0% 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 (2.0% and 4.1 %). Nausea (in 2.2% of patients) and dizziness (1.2%) were the most frequent events that required discontinuation of treatment. Unwanted adverse reactions observed during clinical studies are listed below: Mental disorders Often: anxiety, agitation, anxiety, unusual dreams, decreased libido. Uncommon: depression, depressed mood, a state of euphoria, mood swings, nervousness, apathy, lethargy, confusion, disorientation, abnormal thinking, somatosensory amplification, sleep disorder, initial insomnia, intrasomnicheskoe disorder, nightmares, bruxism, loss of libido, anorgasmia. Violations of the central nervous system Very often: dizziness, headache.Often: drowsiness, impaired concentration, tremor, paresthesia. Infrequently: fainting, including vasovagal syncope, postural dizziness, akathisia, taste perversion, hypersomnia, lethargy, sedation, depression of consciousness. Seldom: dizziness at an exercise stress, sudden falling asleep. Violations of the organ of vision Often: blurred vision. Infrequently: mydriasis, pain in the eye area, blurred vision. Disturbances from an organ of hearing and labyrinth disturbances Often: a ring in ears. Infrequently: vertigo. Violations of the cardiovascular system Often: "tides" of blood. Infrequently: cessation of sinus node activity, sinus bradycardia, tachycardia, lowering blood pressure, systolic hypertension. 8 Rarely: "tides" of heat. Respiratory system disorders Often: nasal congestion, yawning. Disorders of the gastrointestinal tract Often: diarrhea, vomiting, constipation, pain in the abdomen, dyspepsia, flatulence, discomfort in the stomach, bloating, dry mouth. Violations of the skin and subcutaneous tissues Often: hyperhidrosis. Infrequently: itch, cold sweat. Reproductive system disorders Often: erectile dysfunction. Infrequently: lack of ejaculation, impaired orgasm, including anorgasmia in men, paresthesia of male genitals. General condition Often: weakness, irritability. Infrequently: asthenia, heat sensation, anxiety, malaise, intoxication. Changes in laboratory parameters Often: increase in blood pressure. Infrequently: increase in heart rate, increase in diastolic arterial pressure, increase in orthostatic arterial pressure. Description of individual side effects Fainting with loss of consciousness, with bradycardia, or sinus node arrest were observed in patients with Holter monitoring and were reported in clinical studies. These adverse events are regarded as associated with the use of the drug. Most cases were observed during the first 3 hours after taking the drug, after taking the first dose, or are associated with medical procedures (blood sampling, changes in body position, blood pressure measurement). Prodromal symptoms often preceded syncope.The incidence of syncope and prodromal symptoms depended on the dose, which was demonstrated in patients who received higher doses of the drug. Effects during drug withdrawal With the sudden cancellation of long-term selective serotonin reuptake inhibitors for the treatment of chronic depressive disorders, the following symptoms were observed: dysphoric state, irritability, agitation, dizziness, sensory disturbances (eg, paresthesia), anxiety, confusion 9 of consciousness, headache, lethargy , emotional lability, insomnia and hypomania. The results of the safety study showed a higher frequency of withdrawal symptoms in the form of insomnia and mild and moderate dizziness after discontinuation of the drug after 62 days of use.
Overdose
Symptoms In clinical studies of cases of overdose is not described. The administration of the drug Primaxetin® in a dose of up to 240 mg (2 doses of 120 mg each with an interval of 3 hours) did not cause unforeseen undesirable effects. In general, symptoms of an SSRI overdose include serotonergic reactions, including drowsiness, gastrointestinal disturbances (nausea, vomiting), tachycardia, tremor, agitation and dizziness. Treatment In case of overdose, standard maintenance therapy should be carried out, if necessary. Due to the significant binding of the drug to plasma proteins and the large distribution of dapoxetine hydrochloride, forced diuresis, dialysis, hemoperfusion, and blood transfusion are unlikely to be effective. The specific antidote is unknown.
Interaction with other drugs
Interactions with monoamine oxidase inhibitors In patients who received simultaneous SSRIs and monoamine oxidase inhibitor (MAO-I), serious, sometimes fatal reactions, including hyperthermia, rigidity, myoclonus, instability of the vegetative system with possible rapid fluctuation of vital signs, as well as mental changes conditions, including intense agitation, progressing to delirium and coma. These reactions were also observed in patients who recently stopped taking SSRIs and started treatment with MAO-I. In some cases, the symptoms resembled a neuroleptic malignant syndrome.Data on the combined use of SSRIs and MAO-I in animals suggest that these drugs can synergistically increase blood pressure and cause behavioral arousal. Therefore, the drug Primaksetin® should not be taken simultaneously with MAO-I and for 14 days after stopping their administration. Similarly, MAO-I should not be taken within 7 days after discontinuation of the drug Primaxetin®. 10 Interaction with thioridazine Thioridazine prolongs the QTc interval, which is accompanied by ventricular arrhythmia. Preparations like Primaxetin®, which inhibit the CYP2D6 enzyme, appear to inhibit the metabolism of thioridazine. It is expected that the increase in thioridazine caused by this will enhance the prolongation of the QTc interval. The drug Primaksetin® can not be taken simultaneously with thioridazine and for 14 days after discontinuation. Similarly, thioridazine should not be taken within 7 days after discontinuation of taking Primaxetin®. Preparations with a serotonergic effect As in the case of SSRIs, taking Primaxetin® simultaneously with serotonergic drugs (including MAO-I, L-tryptophan, triptans, tramadol, linezolid, SIOZS, serotonin and notarenrenaline capturing inhibitors, asymptomatics, formidine, linezolid, SIOZS, serotonin uptake and noradrenaline, as well as patterns and preparations, serotonergic, serotonergic, and ) may increase the frequency of serotonergic side effects. The drug Primaxetin® should not be taken simultaneously with other SSRIs, MAO-I and other serotonergic drugs and for 14 days after discontinuation of these drugs. Similarly, these drugs should not be taken within 7 days after discontinuation of the drug Primaxetin®. Drugs acting on the CHC The administration of the drug Primaxetin® simultaneously with drugs acting on the central nervous system has not been studied in patients with premature ejaculation. the need to take these drugs at the same time.The effect of other drugs on dapoxetine hydrochloride Studies in vitro using microsomes of the liver, kidneys and intestines of humans have shown that dapoxetine is metabolized predominantly by CYP2D6, CYP3A4, and flavin-containing monooxygenase 1 (FMO1). Therefore, inhibitors of these enzymes can reduce the clearance of dapoxetine.CYP3A4 inhibitors Active CYP3A4 inhibitors Reception of ketoconazole at a dose of 200 mg 2 times a day for 7 days increased Cmax and AUC of dapoxetine (60 mg once) by 35% and 99%, respectively. Considering the fraction of unbound dapoxetine and desmethyldapoxetine, the Cmax of the active fraction (the amount of unbound dapoxetine and desmethyldipoxetine) in the presence of active CYP3A4 inhibitors can increase by about 25%, and AUC can double. This increase in Cmax and AUC of the active fraction can be significantly more pronounced in 11 subpopulations of patients who do not have the functionally active CYP2D6 enzyme, as well as while taking active inhibitors of CYP2D6. The drug Primaksetin® should not be taken simultaneously with active CYP3A4 inhibitors, for example, ketoconazole, intraconazole, ritonavir, saquinavir, telithromycin, nefazodone, nelfinavir and atazanavir. Moderately active CYP3A4 inhibitors Simultaneous administration of moderately active CYP3A4 inhibitors, for example, erythromycin, clarithromycin, fluconazole, amprenavir, fosamprenavir, aprepitant, verapamil, or diltiazem, can significantly increase the level of systemic exposure to dapoxetine and despatin, and the number of people who have a poor number of people for people who have a poor number of people for people who have a poor number of people for people who have a poor number of people for people who have a poor number of people for people who have a poor number of people for people who have a poor number of people for people who have a poor number of people for people have a lot of people, people, people, people, etc., are a lot of people, people, people, people, have a poor number of people who have a lot of people, people, people, people, people, etc., have a poor number of people who have a lot of people who have a lot of people who are working with you have already taken it. The maximum dose of the drug Primaksetin®, taken simultaneously with these drugs, should be limited to 30 mg and taken with caution. Active CYP2D6 inhibitors. Taking fluoxetine at a dose of 60 mg / day for 7 days increased Cmax and AUC of dapoxetine (60 mg once) by 50% and 88%, respectively. Taking into account the proportion of unbound dapoxetine and desmethyldapoxetine, the Cmax of the active fraction (the amount of unbound dapoxetine and desmethyldipoxetine) in the presence of active CYP2D6 inhibitors can increase by about 50%, and AUC can double. This increase in Cmax and AUC of the active fraction is close to that expected in patients with low CYP2D6 activity and may lead to an increase in the frequency and severity of dose-related adverse reactions. Therefore, it is recommended to exercise caution when increasing the dose of the drug Primaxetin® to 60 mg in patients receiving active CYP2D6 inhibitors, and in patients with low CYP2D6 activity. Interaction with drugs metabolized by CYP1A and CYP2B6 isoenzymes Based on comparative data from Cmax of dapoxetine when taking a 60 mg dose of the drug and dapoxetine concentration at 50% inhibition (IC50) of the CYP1A2 isoenzyme in vitro, the effect of dapoxetine on the concentration of concurrent drugs is not expected metabolized by this isoenzyme.The effect of dapoxetine on the CYP2B6 isoenzyme has not been studied. PDE5 inhibitors The pharmacokinetics of dapoxetine taken at a dose of 60 mg simultaneously with tadalafil (20 mg) or sildenafil (100 mg) was studied. Tadalafil did not affect the pharmacokinetics of dapoxetine. Sildenafil slightly increased AUC and C max of dapoxetine (22% and 4% respectively), which is considered clinically insignificant. Drug 12 Primaxetin® should be used with caution in patients receiving PDE5 inhibitors, because of the possibly reduced tolerance of these patients to orthostatic hypotension. The effect of dapoxetine hydrochloride on concomitantly administered drugs Tamsulosin The single and repeated intake of the drug Primaxetin® in doses of 30 mg and 60 mg in patients receiving tamsulosin daily did not change the pharmacokinetics of the latter. It also did not change the frequency of orthostatic hypotension, which was the same when taking only tamsulosin and in combination with tamsulosin and Primaxetin® 30 mg or 60 mg. Primaksetin® should be used with caution in patients taking alpha-blockers, because of the possibly reduced tolerance of these patients to orthostatic hypotension. CYP2D6 Metabolized Drugs Repeated intake of the drug Primaxetin® (60 mg / day for 6 days) increased Cmax and AUC of desipramine (50 mg once) by 11% and 19%, respectively, compared to taking only desipramine. Dapoxetine can similarly increase the concentration in plasma and other drugs metabolized by CYP2D6. The clinical significance of this is likely to be small. CYP3A metabolized drugs Repeated intake of the drug Primaxetin® (60 mg / day for 6 days) reduced the AUC of midazolam (8 mg once) by about 20% (range from -60% to + 18%). The clinical significance of this phenomenon in most patients is likely to be small. However, an increase in CYP3A activity may be of clinical significance in some patients who are simultaneously taking drugs that are metabolized mainly by CYP3A and have a narrow therapeutic window. CYP2C19 metabolized drugs Repeated intake of the drug Primaxetin® (60 mg / day for 6 days) did not affect the pharmacokinetics of omeprazole (40 mg once). Dapoxetine is unlikely to affect the pharmacokinetics of other CYP2C19 substrates.CYP2C9 metabolized drugs Repeated intake of Primaxetin® (60 mg / day for 6 days) did not affect the pharmacokinetics and pharmacodynamics of glyburide (5 mg once). Dapoxetine is unlikely to affect the pharmacokinetics of other CYP2C9 substrates. PDE5 inhibitors According to the results of a study, dapoxetine (60 mg) did not affect the pharmacokinetics of tadalafil (20 mg) and sildenafil (100 mg). 13 Warfarin There is no data on the effects of long-term use of warfarin concurrently with Primaxetin ®. It is recommended to exercise caution when prescribing the drug Primaxetin® to patients who take warfarin for a long time. In the pharmacokinetic study, repeated administration of dapoxetine (60 mg / day for 6 days) did not affect the pharmacokinetics and pharmacodynamics (PV and INR) of warfarin (25 mg once). Ethanol A single dose of ethanol (0.5 g / kg, or about 2 doses) did not affect the pharmacokinetics of dapoxetine (60 mg once) and vice versa. The simultaneous use of the drug Primaxetin® and ethanol increased drowsiness and significantly reduced wakefulness when evaluated by the patient. Taking only ethanol and only Primaxetin® did not significantly alter cognitive functions (reaction rate in the digit recognition test and the digit character substitution test) compared with placebo, however, the combination of ethanol with Primaxetin® statistically significantly changed these indicators compared to ethanol alone . The simultaneous use of ethanol and the drug Primaxetin® increases the frequency and severity of unwanted reactions such as dizziness, drowsiness, slow reflexes, and changes in judgment. The combination of alcohol with Primaxetin® can also increase neuro-cardiogenic side effects, in particular, the incidence of syncope, which increases the risk of accidental injury. Therefore, patients should be advised to refrain from taking alcohol during the period of treatment with Primaxetin®.
special instructions
General The drug Primaksetin® is intended only for men with premature ejaculation. The safety of the drug in men without premature ejaculation has not been established, there is no evidence of delayed ejaculation. Reception together with narcotic drugs Patients should be advised not to take the drug Primaxetin® together with narcotic drugs.Simultaneous use of the drug Primaxetin® with drugs with serotonergic activity, for example, ketamine, methylenedioxymethamphetamine (MDMA) and lysergic acid diethylamide (LSD), can lead to potentially serious reactions, including, but not limited to, arrhythmia, hyperthermia, and serotonism, in the presence of hyperthermia and serotinism, and in the presence of hypertension and serotomy, and in the case of serotonin and serotonism. Taking Primaksetin® together with sedatives, such as opiates or benzodiazepines, may increase drowsiness and dizziness. 14 Ethanol The combination of Primaxatin® with alcohol may enhance the effect of the latter on the central nervous system and the neuro-cardiogenic side effects of alcohol, for example, syncope, which increases the risk of accidental injury. Therefore, patients should be advised to refrain from taking alcohol in the period of taking the drug Primaxetin®. Fainting The frequency of fainting in clinical studies of the drug Primaxetin® depended on the patient category and ranged from 0.06% (for a dose of 30 mg) to 0.23% (for a dose of 60 mg) to 0.64% (for both doses together) in a study involving healthy volunteers. Patients who received Primaxetin® compared with patients who received a placebo, were more likely to have prodromal symptoms, including nausea, dizziness / lightness in the head, and sweating. At the dose of the drug Primaxetin® 30 mg, the frequency of nausea was 11.0%, the frequency of dizziness - 5.8%, hyperhidrosis - 0.8%. At the dose of the drug Primaxetin® 60 mg, these figures were 21.2%, 11.7% and 1.5%, respectively. The frequency of syncope and possible prodromal symptoms was dose-dependent, as evidenced by higher rates in patients who received higher doses than the maximum recommended daily dose of 60 mg. The cases of syncope observed in clinical studies were regarded as having a vaso-vagal nature. Most of these cases occurred during the first 3 hours after taking the first dose, or were associated with conducting research procedures in a clinical setting (for example, taking a blood sample, rising sharply, measuring blood pressure). Possible prodromal symptoms, such as nausea, dizziness, a feeling of lightness in the head, palpitations, asthenia, confusion and sweating, were usually also observed in the first 3 hours after taking the drug and often preceded fainting. Patients should be informed that during the period of treatment with Primaxetin® at any time, fainting may develop with or without prodromal symptoms.The physician must inform the patient of the importance of suf