Priligy drug 30mg Menarini treats premature ejaculation (1 blister x 3 tablets)

Men's ejaculation is mainly regulated by sympathetic nervous system. The ejaculation comes from a reflective center in the spinal cord, regulated by brain cells, starting from some nucleus in brain cells (inside the hypothalamus and hypothalamus). In mice, dapoxetin inhibits ejaculation through the effect of the spinal cord with the presence of a giant cell nucleus in the side, is the brain with the structure needed to cause this effect. The nerve fibers at the back lymphadenopathy stimulate the testes, vasectomy, prostate, penis muscles and bladder neck causing ejaculation.

dapoxetin regulates ejaculation reflexes in mice, increases the ability to delay ejaculation in the vagina and reduce the time of vaginal ejaculation.

pharmacokinetic

absorption

dapoxetin is quickly absorbed at maximum dose in plasma (CMAX) reaching approximately 1-2 hours after taking the drug. Birth completely is 42% (about 15 - 76%). After taking a dose of 30mg and 60mg when hungry, the peak concentration of dapoxetin is achieved, respectively 297mg/ml after 1.01 hours and 498ng/ml after 1.27 hours.

When eating a lot of fat will reduce CMAX (about 10%) and increase the curve area below the AUC concentration (about 12%) of dapoxetin and slow down a little time to reach the peak concentration of dapoxetin. However, when consuming a more fat will not affect the absorption process. These changes have no clinical significance. Priligy can drink when hungry or when full.

Distribution

There are more than 99% dapoxetin is connected to people's plasma proteins in in vitro studies. The active metabolites are desmethyldapoxetin connected up to 98.5% to protein.

dapoxetin is quickly distributed with an average constant volume of 162L. After intravenous intravenous injection, the initial average disposal time, the semi -intermediate duration and the last waste time are 0.10 hours, 2.19 hours and 19.3 hours.

Biological Change

In vitro studies suggest that dapoxetin is cleaned by an enzyme system in the liver and kidneys, mainly CYP2D6, CYP3A4 and Flavin Monooxygenase (FMO).

After taking the medicine, in a clinical study designed to learn about the metabolism of dapoxetin, dapoxetin is converted mainly into many types of metabolic substances, mainly through the biological pathway: N-Oxidation, N-Demethylation, Naphthyl Hydroxylation, Glucuronidation and Sulfation.

There is also evidence that the drug first undergo a system of money metabolism after taken.

Dapoxetin is not metabolized and dapoxetin-n-oxide are two main substances circulated in plasma. The auxiliary metabolites include desmethyldapoxetin, which meets the equivalent of dapoxetin, and the discomethyldapoxetin, accounting for about 50% of the effect of dapoxetin. It should be noted that the amount of dapoxetin is valid and not cohesive with plasma proteins, only desmethyldapoxetin can contribute to the effect of dapoxetin in in vivo.

Elimination

Dapoxetin metabolites are mainly eliminated through urine in the non -metabolic form of unknown metabolism in urine.

dapoxetin is quickly eliminated, based on evidence that the remaining concentration is very low after 24 hours (less than 5% of the top concentration). There is a small amount of dapoxetin accumulated after daily dose. The final half -life is approximately 19 hours after taking the medicine.

The half -life of desmethyldapoxetin is equivalent to dapoxetin.

Precautions when using

General warning

Only use Priligy 30mg for patients with premature ejaculation (PE).

The safety of the drug has not been proven and there is no data on the effectiveness of the drug for late ejaculation cases.

Use simultaneously with other pleasure drugs.

Do not use Priligy 30mg combination with other excitement drugs. Excited drugs that have sympathetic effects such as ketamine, methylenediooxymethampinphetamine (MDMA) and Lysergic acid diethylamid (LSD) can cause serious adverse reactions when used simultaneously with Priligy 30mg. These reactions include, but not as limited as tachycardia, increased body temperature and sympathetic syndrome. Using Priligy 30mg simultaneously with excited drugs that have a sedative effect like addictive drugs and benzodiazepin groups that cause chicken sleep and dizziness.

alcohol

Simultaneous use of Priligy 30mg with alcohol can increase the effects of alcohol related to cognitive ability and can also increase adverse effects such as fainting, so it can cause injury, so patients should not drink alcohol while using Priligy 30mg.

Alcohol during use of Priligy 30mg may increase adverse reactions on the nervous and cardiovascular system as a fainting phenomenon that can increase the risk of accidents. Therefore, patients should not expel alcohol while using Priligy 30mg.

Patients with cardiovascular disease risk factors

Subjects with purple purple diseases have been excluded from stage 3 studies. There is currently no full data to determine whether the situation of increasing the risk of these adverse effects occurs in cases where there are potential diseases.

Lower acupuncture points when standing

Hypotension when standing has been reported in clinical trials. The physician should give patients if the signs of millions appear such as mild headache when standing up, immediately should lie down or sit down between the knees until the signs pass. Do not stand up suddenly but should get up slowly after lying or sitting for a long time. Be careful when using Priligy 30mg and for patients to use vasodilators (alpha adrenergic, nitrate, inhibitors) because it can reduce endurance when standing

with CYP3A4 drugs at an average level

Be cautious and do not take the dose exceeding 30mg when used simultaneously with CYP3A4 inhibitors at an average level such as erythromycin, clarithromycin, fluconazole, amprenavir, fosamprenavir ,prepitant, verapamil and diltiazem.

With strong CYP2D6 inhibitors

Be careful when increasing the dose to 60mg when used simultaneously with strong inhibitors CYP2D6 or when increasing the dose to 60mg in patients with difficulty metabolic CYP2D6 because this can increase the severity of the adverse reactions of the drug

suicide/suicide thought

Antidepressants include Seretonin Restrain Serial Selection (SSRI: Selective Servonin Reuptake Inhitor), which will increase the risk that the patient tends to commit suicide and suicide in some short -term studies on basic depression disorders and mental disorders in children and young people. These short -term studies do not show that there is an increase in the risk of suicide due to antidepressants compared to placebo in adults over 24 years old.

Do not use Priligy 30mg for patients with a history of emotional disorders such as excitement/depression or bipolar disorder and should stop the drug immediately if any symptoms of these disorders appear.

epilepsy

Due to the selective inhibitors of SSRI's reconfacelonation, SSRI is capable of reducing seizures, so stop using Priligy 30mg when the patient appears convulsions and does not indicate Priligy 30mg for patients with an unstable history of epilepsy. For control patients under control should be closely monitored.

Take drugs in children and teenagers under 18

Do not use Priligy 30mg for subjects under 18 years old.

Mental depression

Patients with depression manifestations need to be carefully tested before treating Priligy 30mg to eliminate undefected depression disorders.

Do not use Priligy 30mg simultaneously with antidepressants, including SSRIs and SNRIS. It is not necessary to stop using drugs that are treating depression symptoms or anxiety and confusion to use Priligy 30mg in premature ejaculation patients.

Do not use Priligy 30mg for cases of mental disorders such as schizophrenia or mental disorders with depression because it is not possible to rule out the possibility of depression signs will become worse. This may be the result of potential mental disorders or may be due to the effect of the drug.

It is necessary to encourage patients to notify the doctor whenever there is thought or feeling of anxiety, sadness or any symptoms of depression that appears during the treatment process, then stop using Priligy 30mg.

Bleeding

There have been some reports on abnormal bleeding phenomenon when treating SSRIs. Be careful when using Priligy 30mg, especially when using simultaneously with drugs that affect the function of platelets (for example, non -typical mental disorders and phenothiazines, acetylsalicylic acids, nonsteroidal anti -inflammatory drugs (NSAIDs), anti -platelets anti -coagules (Warfarin), as well as for patients with bleeding patients or patients with bleeding cost patients or patients with bleeding history Bloody.

Renal function

Do not use Priligy 30mg for patients with severe renal function and should be cautious for patients with medium and mild renal function.

Reaction when stopping treatment suddenly

There has been a report that when suddenly stopped using SSRIs in the treatment of symptoms of chronic depression disorders, it will cause symptoms such as: discomfort, irritability, chest drum, nervous, dizziness, sensory disorders (for example, cow -shocking, anxiety, concerns, headaches, sleep, unstable mood, insomnia, insomnia.

Eye disorders

Like other SSRIs, the use of Priligy 30mg causes eye effects such as pupils and eye pain. Precautions when using Priligy 30mg in patients with increased pressure in the eye or at risk of closed angle glaucoma.

The ability to drive and operate machinery

Symptoms of dizziness, loss of concentration, fainting, blurred vision, chicken sleep situation has been reported in some cases of dapoxetin use in clinical studies. Therefore, it is necessary to recommend that patients stay away from situations that may occur in an accident, including driving or operating machinery.

Pregnancy

There is no evidence of the ability to give birth, or cause fetal toxicity in mice and rabbits when using the corresponding dose of 100mg/kg of weight (in mice) and 75mg/kg (in rabbits).

There is also no evidence that the use of dapoxetin has influenced partners during pregnancy because data from clinical studies is limited. There are no controlled studies of dapoxetin in pregnant women.

Breastfeeding period

It is not known whether dapoxetin and its metabolites are exposed to breast milk.

Medicinal interaction

The ability to interact with Monoamin Oxidase inhibitors

There have been a serious report on adverse reactions that can be fatal, including hyperthermia, spasticity, muscle vibration, abnormal changing functions and mental state, including severe chest drums that can lead to delusion and coma in patients using SSRI simultaneously with an oxidase monoamine inhibitor (MAOI). These reactions are also recorded in patients who begin to use monoamine inhibitors of oxidase right after the SSRI usage. In some cases, there are manifestations of malignant insomnia syndrome.

When using the poison of Thioridazin often extends the QT range on the electrocardiogram, can cause serious ventricular arrhythmia. Medications like Priligy have the effect of inhibiting isenzyme CYP2D6 often inhibit the metabolism of Thioridazin and thus increasing the concentration of Thioridazin, which can increase the risk of extending the QT range. Priligy should not be used simultaneously with thioridazin or within 14 days after stopping the use of Thioridazin. Similarly, thioridazin should not be used within 7 days after stopping using Priligy (see the contraindication section).

Medicines/herbs have the sympathetic effect

Like other SSRIs, simultaneously used with sympathetic effects/herbal effects (including Maois, L-Tryptophan, Triptans, Tramadol, Linezolid, SSRI, SNRIS, Lithium and St. John’s World (Hypericum Perforatum) can increase sympathetic effects. The drug/ herb has a sympathetic effect or within 14 days after stopping the use of those drugs.

with medications on the central nervous system

The coordination effect of dapoxetin hydrochlorid with other drugs

CYP3A4 inhibitors

Strong inhibition CYP3A4

Use ketoconazole (200mg, twice a day in 7 days) will increase the concentration of nails in serum CMAX and the curve area below the AUC concentration of dapoxentin (dose of 60mg/day) respectively 35% and 99%. Considering the contribution of dapoxetin without cohesion and desmethyldapoxetin, peak concentration of active components (daPoxetin does not connect and do not connect and do not connect and do not connect and do not connect and do not connect and do not connect and do not connect and do not connect and do not connect and do not connect and do not connect and do not connect and do not connect and do not connect and not Desmethyldapoxetin) may increase to 25% and the curve area below the concentration of the active ingredient can double if used simultaneously with strong CYP3A4 inhibitors. CYP2D6 inhibitors

CYP3A4 inhibitors at an average level

Combined treatment of Priligy 30mg with CYP3A4 inhibitors such as erythromycin, Clarithromycin, Fluconazol, Amprenavir, Fosamprenavir, Aprepitant, Verapamil and Diltiazem will significantly increase the absorption with Dapoxetin and Desmethyldapoxetin specially in poor patients with poorly adolescent patients. Therefore, be careful when using a combination of Priligy 30mg with the above -mentioned drugs and should only take a maximum dose of 30mg.

CYP2D6 inhibitors

Maximum cmax concentration and the area below the AUC concentration of dapoxetin (when using a single dose of 60mg) will increase to 50% and 882% respectively, in the presence of fluoxetin (use of 60mg doses/day for 7 days).

When considering the concentration of dapoxetin is not cohesive and desmethyldapoxetin, the maximum cmax concentration of the drug has an activity that can increase approximately 50% and the curve area below the AUC concentration of the activity can be doubled if used simultaneously with CYP2D6 inhibitors.

The rise of both the maximum concentration in the serum and the curve area below the AUC concentration of the activity is similar to those who are poorly metabolized to CYP2D6 and may increase the risk of serious adverse effects dependent on the dose. Therefore, it is necessary to be cautious if the dose increases to 60mg of dapoxetin for people with a history of poor metabolism CYP2D6.

Dyet pharmacokinetics of dapoxetin (60mg) when used simultaneously with Tadalafil (20mg) and Sildenafil (100mg) were evaluated in a single -dose diagonal study.

Tadalafil does not affect the pharmacokinetics of dapoxetin.

Sildenafil slightly changes the pharmacokinetics of dapoxetin (increasing the curve area below the curve below AUC concentration and 4% of the maximum cmax concentration), this does not significantly change the clinical effects.

However, be careful when prescribing Priligy 30mg for patients who use PDE5 inhibitors because it can lower blood pressure when standing.

The effect of dapoxetin hvdrochlorid on drugs used simultaneously

tamsulosin

Simultaneously use a single or many consecutive doses of 30mg or 60mg Priligy 30mg in patients using Tamsulosin daily does not change the pharmacokinetics of Tamsulosin. The combination of Priligy 30mg with Tamsulosin does not change the hemodynamic parameters when standing and there is no difference when using tamsulosin alone or combined with Priligy 30mg at a dose of 30mg or 60mg. However, be careful when using Priligy 30mg for patients who use Alpha Andreneric receptor inhibitors because it can reduce blood pressure when standing.

with metabolic drugs through CYP2D6

Use many doses of Priligy 30mg (60mg/day for 6 days) along with a single dose of 50mg Desipramin will increase the maximum concentration of CMAX average and the curve area below the AUC concentration of Despiramin is 11% and 19%, compared to the single desipramine. Similarly, dapoxetin can increase the plasma concentration of metabolic drugs through CYP2D6 system. Clinical influences seem to be very small.

Metabolic drugs thanks to CYP3A

Using many doses of Priligy 30mg (60mg/day for 6 days) will reduce the curve area below the concentration of Midazolam (single -dose 8mg) by approximately 20% (between -60 to +18%). Clinical effectiveness has not changed markedly in most patients. The increase in the activity of CYP3A4 can be clinically affected in some sporadic cases simultaneously used with mainly metabolic drugs.

Metabolic drugs through CYP2C9

Long -term use Priligy 30mg (60mg/day for 6 days) does not affect the pharmacokinetics or pharmacokinetics of Glyburid when using a single dose of 5mg. Dapoxetin does not seem to affect the pharmacological effects of metabolic drugs through CYP2C9.

PDE5 inhibitors

Dyet pharmacokinetics of dapoxetin (60mg) when used simultaneously with Tadalafil (20mg) and Sildenafil (100mg) were assessed in a single -dose study of unchanged.

warfarin

There is no effect of evaluating effects when using warfarin with Priligy 30mg, so be careful when using Priligy 30mg for patients using long warfarin (see caution and note when using: bleeding). In a pharmacokinetics study, dapoxetin (dose of 60mg/day for 6 days) does not affect the pharmacokinetics or pharmacokinetics of warfarin when using a single dose of 25mg.

ethanol

Use single -dose ethanols 0.5g/kg body weight (equivalent to about 2 cups) while using Priligy 30mg (single dose 60mg) does not affect the pharmacokinetics of dapoxetin or ethanol pharmacokinetics. However, simultaneous use of priligy with ethanol will increase the symptoms of chicken sleep and significantly reduce alertness.

The pharmacological assessment of cognitive decline (assessment of vigilance and alternative signs) does not show a significant difference between the placebo group compared to the group using a mere priligy 30mg or ethanol. However, it shows significant statistical significance between the group with a combination of Priligy 30mg and ethanol and a single ethanol group.

Simultaneous use of Priligy 30mg with ethanol increases the risk or aggravates the adverse effects such as dizziness, headache, slow reaction or change of judgment.

The combination of Priligy 30mg and alcohol can increase the adverse effects on the nervous and cardiovascular system as shocking, thus increasing the risk of causing injury due to accidents, which should recommend that patients do not drink alcohol during use.