Priligy precautions for use

 

Patients should be cautioned to avoid situations where injury could result, including driving or operating hazardous machinery, should syncope or its prodromal symptoms such as dizziness or lightheadedness occur. Possibly prodromal symptoms such as nausea, dizziness/lightheadedness, and diaphoresis were reported more frequently among patients treated with Dapoxetine compared to placebo.

In the clinical trials, cases of syncope characterized as loss of consciousness, with bradycardia or sinus arrest observed in patients wearing Holter monitors,were considered vasovagal in etiology and the majority occurred during the first 3 hours after dosing, after the first dose, or associated with study-related procedures in the clinic setting (such as blood draw and orthostatic maneuvers and blood pressure measurements). Possibly prodromal symptoms, such as nausea, dizziness, lightheadedness, palpitations, asthenia, confusion and diaphoresis generally occurred within the first 3 hours following dosing, and often preceded the syncope. Patients need to be made aware that they could experience syncope at any time with or without prodromal symptoms during their treatment with Priligy. Prescribers should counsel patients about the importance of maintaining adequate hydration and about how to recognize prodromal signs and symptoms to decrease the likelihood of serious injury associated with falls due to loss of consciousness. If the patient experiences possibly prodromal symptoms, the patient should immediately lie down so his head is lower than the rest of his body or sit down with his head between his knees until the symptoms pass, and be cautioned to avoid situations where injury could result, including driving or operating hazardous machinery, should syncope or other CNS effects occur.

 

Subjects with underlying cardiovascular disease were excluded from Phase 3 clinical trials. The risk of adverse cardiovascular outcomes from syncope (cardiac syncope and syncope from other causes) is increased in patients with underlying structural cardiovascular disease (e.g., documented outflow obstruction, valvular heart disease, carotid stenosis and coronary artery disease). There are insufficient data to determine whether this increased risk extends to vasovagal syncope in patients with underlying cardiovascular disease.

 

Patients should be advised not to use Priligy in combination with recreational drugs.

Recreational drugs with serotonergic activity such as ketamine, methylenedioxymethamphetamine (MDMA) and lysergic acid diethylamide (LSD) may lead to potentially serious reactions if combined with Dapoxetine. These reactions include, but are not limited to, arrhythmia, hyperthermia, and serotonin syndrome. Use of Priligy with recreational drugs with sedative properties such as narcotics and benzodiazepines may further increase somnolence and dizziness.

 

Patients should be advised not to use Priligy in combination with alcohol.

Combining alcohol with dapoxetine may increase alcohol-related neurocognitive effects and may also enhance neurocardiogenic adverse events such as syncope, thereby increasing the risk of accidental injury; therefore, patients should be advised to avoid alcohol while taking Dapoxetine.

 

For those who decided to buy priligy – this medicine should not be used in individuals below 18 years of age.

 

Men with underlying signs and symptoms of depression should be evaluated prior to treatment with Priligy to rule out undiagnosed depressive disorders. Concomitant treatment of Dapoxetine with antidepressants, including SSRIs and SNRIs, is contraindicated. Discontinuation of treatment for ongoing depression or anxiety in order to initiate Priligy for the treatment of PE is not recommended. Dapoxetine is not indicated for psychiatric disorders and should not be used in men with these disorders, such as schizophrenia, or in those suffering with co-morbid depression, as worsening of symptoms associated with depression cannot be excluded. This could be the result of underlying psychiatric disorder or might be a result of medicinal product therapy. Physicians should encourage patients to report any distressing thoughts or feelings at any time and if signs and symptoms of depression develop during treatment, Priligy should be discontinued.

 

Abrupt discontinuation of chronically administered SSRIs used to treat chronic depressive disorders has been reported to result in the following symptoms: dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g., paresthesias such as electric shock sensations), anxiety, confusion, headache, lethargy, emotional lability, insomnia and hypomania.

A double-blind clinical trial in subjects with PE designed to assess the withdrawal effects of 62 days of daily or as needed dosing with 60 mg Dapoxetine showed mild withdrawal symptoms with a slightly higher incidence of insomnia and dizziness in subjects switched to placebo after daily dosing.

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