Pharmacy No. 84. Delivery of medicines to your home and office.

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Dapoxetine

Are common

The drug 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 data on delayed ejaculation.

Use with narcotic drugs

Patients should be advised not to take the drug together with narcotic drugs. Concomitant use with drugs that have serotonergic activity, such as ketamine, methylenedioxymethamphetamine (MDMA), and lysergic acid diethylamide (LSD), may result in potentially serious reactions including, but not limited to, arrhythmia, hyperthermia, and serotonin syndrome. Concomitant use with sedatives such as opiates or benzodiazepines may increase drowsiness and dizziness.

Ethanol

Combining the drug with alcohol may enhance the latter's effects on the central nervous system and the neuro-cardiogenic side effects of alcohol, such as fainting, which increases the risk of accidental injury. Therefore, patients should be advised to refrain from drinking alcohol while taking the drug.

Fainting

The incidence of syncope in clinical trials of the drug 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 combined) in a study with participation of healthy volunteers.

Patients receiving the drug were more likely to have prodromal symptoms, including nausea, dizziness/lightheadedness, and sweating, compared to patients receiving placebo. At a dose of 30 mg, the incidence of nausea was 11.0%, the incidence of dizziness was 5.8%, and hyperhidrosis (sweating) was 0.8%. At a dose of 60 mg, these figures were 21.2%, 11.7% and 1.5%, respectively. The incidence of syncope and possible prodromal symptoms was dose-related, as evidenced by higher rates in patients receiving higher doses than the maximum recommended daily dose of 60 mg. The cases of syncope observed in clinical studies were regarded as having a vasovagal nature. Most of these cases occurred within the first 3 hours after the first dose, or were associated with research procedures in a clinical setting (eg, drawing a blood sample, standing up abruptly, measuring blood pressure). Possible prodromal symptoms, such as nausea, dizziness, lightheadedness, palpitations, asthenia, confusion and sweating, were also usually observed in the first 3 hours after taking the drug and often preceded syncope. Patients should be informed that syncope with or without prodromal symptoms may occur at any time during treatment with the drug. The physician should inform the patient about the importance of adequate hydration and recognition of prodromal signs and symptoms to reduce the risk of serious injury from a fall due to loss of consciousness. When possible prodromal symptoms appear, the patient should immediately lie down so that the head is lower than the body, or sit with the head lowered between the knees, and should remain in this position until the symptoms disappear. If fainting or other central nervous system effects occur, the patient should be warned to avoid potentially traumatic situations, including driving and operating dangerous machinery.

Combining the drug with alcohol may increase neurocardiogenic side effects, including syncope, which increases the risk of accidental injury; Therefore, patients should be advised to refrain from drinking alcohol during treatment with the drug.

Patients at risk of cardiovascular disease

Clinical studies of the drug did not include patients with cardiovascular diseases. Patients with organic diseases of the heart and blood vessels (for example, obstruction of blood ejection from the heart, damage to the valve apparatus, carotid artery stenosis, coronary artery atherosclerosis) have an increased risk of undesirable cardiovascular consequences of syncope of cardiac and other origin. However, there is currently insufficient data to determine whether this risk extends to vasovagal syncope in patients with cardiovascular disease.

Orthostatic hypotension

Clinical studies have described cases of orthostatic hypotension. The physician should inform the patient in advance that if possible prodromal symptoms appear, for example, a feeling of lightness in the head immediately after standing up, one should immediately lie down so that the head is lower than the body, or sit with the head lowered between the knees, and remain in this position until disappearance of symptoms. In addition, the patient should be informed about the need to avoid sudden standing up after prolonged lying or sitting. Prescribe with caution to patients taking vasodilators (for example, alpha-blockers, nitrates, PDE5 inhibitors), due to the possible reduced tolerance of such patients to the orthostatic effect of the drug.

Moderately active CYP3A4 inhibitors

When taken concomitantly with moderately active CYP3A4 inhibitors (erythromycin, clarithromycin, fluconazole, amprenavir, fosamprenavir, aprepitant, verapamil, diltiazem), the dose of the drug should be reduced to 30 mg and caution should be exercised.

Active CYP2D6 inhibitors

Caution is recommended when increasing the drug dose to 60 mg in patients receiving active CYP2D6 inhibitors and in patients with low CYP2D6 activity, as this may increase the level of systemic exposure to the drug with a corresponding increase in the frequency and severity of dose-related adverse events.

Suicide/suicidal ideation

In short-term studies, antidepressants, including SSRIs, were more likely than placebo to increase the risk of suicide and suicidal ideation in children and adolescents with generalized depression and other mental disorders. This effect was not found in adults over 24 years of age. In clinical trials of a drug for the treatment of premature ejaculation, clear data on the relationship of suicidal thoughts with treatment were not obtained.

Mania

The drug should not be taken by patients with a history of mania/hypomania or bipolar disorder; if symptoms of these diseases appear, the drug should be discontinued.

Convulsions

Due to the ability of SSRIs to lower the seizure threshold, the drug should be avoided in patients with unstable epilepsy; if seizures occur, the drug should be discontinued. Patients with controlled epilepsy require careful monitoring.

Admission in children and adolescents under 18 years of age

Not suitable for patients under 18 years of age.

Comorbid depression and mental disorders

If the patient has signs and symptoms of depression, before starting the drug, it is necessary to conduct an examination to exclude the presence of an undiagnosed depressive disorder. The drug should not be taken simultaneously with antidepressants, including SSRIs and serotonin and norepinephrine reuptake inhibitors. It is not recommended to stop treatment for depression or anxiety to start treatment with this drug. The drug is not intended for the treatment of mental disorders (for example, schizophrenia or depression), and should not be taken by men with these diseases, since this cannot exclude an increase in symptoms of depression. Any disturbing thoughts or sensations should be reported to your doctor immediately, and the drug should be discontinued if signs and symptoms of depression occur during treatment.

Bleeding

Cases of bleeding have been described with the use of SSRIs. Caution is recommended when taken concomitantly with drugs that affect platelet function (for example, atypical antipsychotics, phenothiazines, acetylsalicylic acid, NSAIDs, anticoagulants), as well as in patients with a history of bleeding or bleeding disorders.

Renal dysfunction

The drug is not recommended for use in patients with severe renal impairment; patients with moderate to mild renal impairment should exercise caution.

Withdrawal syndrome

There is evidence that abrupt withdrawal of SSRIs used long-term for the treatment of chronic depressive disorders leads to the following symptoms: decreased mood, irritability, agitation, dizziness, sensory disturbances (eg, electric shock paresthesia), anxiety, confusion, headache, lethargy, emotional instability, insomnia, hypomania.

In a clinical study conducted to evaluate the effect of drug withdrawal after 62 days of dosing at a dose of 60 mg (daily or as needed) in patients with premature ejaculation, no signs of withdrawal syndrome were detected. After switching patients to placebo after taking this drug daily, only minor withdrawal symptoms were found in the form of mild to moderate insomnia and dizziness. Similar results were obtained in another double-blind clinical study with a one-week withdrawal period after 24 weeks of use of the drug at a dose of 30 mg or 60 mg as needed.

Effect on the ability to drive a car and other mechanical means

When taking the drug, cases of dizziness, impaired attention, fainting, blurred vision, and drowsiness have been described. The patient should be warned to avoid situations where injury may occur, including driving and operating dangerous machinery.

Compatibility of Dapoxetine and alcohol

? Data from studies indicate that the combination of a reasonable amount of alcohol-containing drinks and Dapoxetine does not lead to bad consequences. Simultaneous use is possible, but subject to restrictions regarding the dosage of the drug and the volume of alcohol consumed.

If you do not follow the recommendations, the development of such adverse reactions as:

feeling of nausea;
dizziness;
pain in the head area;
bowel disorders in the form of diarrhea;
liver dysfunction;
sudden increase in blood pressure;
disorders of the heart muscle and blood vessels.

How long after drinking alcohol can you take medicine?

Considering that a small amount of alcohol (up to 200 mg) can be combined with the drug, it is allowed to use these two substances at the same time, but subject to the dosage.

If the amount of alcohol-containing drinks taken was greater, it is better to refrain from using the medicine.

There is no answer to the question of how long after you can take medicine, because everything will depend on the amount drunk, the strength of the drink, and the man’s body. It takes 1 to 2 days to completely remove alcohol from the human body.