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These brands contain the same active ingredient (Dapoxetine Hydrochloride). Strength and form may differ — confirm substitution with your doctor or pharmacist before switching.
Indications & Uses
Prolong is indicated for the treatment of premature ejaculation (PE) in men 18 to 64 years of age, who have one or all of the following: Persistent or recurrent ejaculation with minimal sexual stimulation before, on, or shortly after penetration and before the patient wishes. Marked personal distress or interpersonal difficulty as a consequence of PE. Poor control over ejaculation.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
For Premature Ejaculation:Adult men (18 to 64 years of age): The recommended starting dose for all patients is 30 mg, taken as needed approximately 1 to 3 hours prior to sexual activity. The maximum recommended dosing frequency is once every 24 hours. If the effect of 30 mg is insufficient and the side effects are acceptable, the dose may be increased to the maximum recommended dose of 60 mg. Dapoxetine may be taken with or without food.Children and adolescents: Dapoxetine should not be used in individuals below 18 years of age. Elderly (age 65 years and over): Safety and efficacy of Dapoxetine have not been established in patients age 65 years and over as limited data are available in this population.Patients with renal impairment: Caution is advised in patients with mild or moderate renal impairment. Dapoxetine is not recommended for use in patients with severe renal impairment.Patients with hepatic impairment: Dapoxetine is contraindicated in patients with moderate and severe hepatic impairment
Side Effects
The most common effects when taking Prolong are nausea, dizziness, dry mouth, headache, diarrhea, and insomnia. Discontinuation due to adverse effects is dose related. The rate of discontinuation is 0.3%, 1.7%, and 5.3% of 1067 studied subjects with placebo, Prolong 30 mg, and Prolong 60 mg respectively. Unlike others SSRIs used to treat depression, which have been associated with high incidences of sexual dysfunction, Prolong is associated with low rates of sexual dysfunction. Taken as needed, Prolong has very mild adverse effects on loss of libido (<1%) and ED (<4%).
Cautions & Contraindications
Warnings & Precautions
Use with recreational drugs: Patients should be advised not to use Prolong 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 Prolong. These reactions include, but are not limited to arrhythmia, hyperthermia, and serotonin syndrome. Use of Prolong with recreational drugs with sedative properties such as narcotics and benzodiazepines may further increase somnolence and dizziness.Ethanol: Combining alcohol with Prolong 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 Prolong.Syncope: 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 Prolong.Orthostatic hypotension: An orthostatic test should be performed before initiating therapy. In case of a history of documented or suspected orthostatic reaction, treatment with Prolong should be avoided.Haemorrhage: There have been reports of bleeding abnormalities with SSRIs. Caution is advised in patients taking Prolong, particularly in concomitant use with medicinal products known to affect platelet function (e.g., atypical antipsychotics and phenothiazines, acetylsalicylic acid, nonsteroidal anti-inflammatory drugs [NSAIDs], anti-platelet agents) or anticoagulants (e.g., warfarin), as well as in patients with a history of bleeding or coagulation disorders.PDE5 inhibitors: The pharmacokinetics of Prolong (60 mg) in combination with Tadalafil (20 mg) and Sildenafil (100 mg) were evaluated in a single dose crossover study. Tadalafil and Sildenafil did not affect the pharmacokinetics of Prolong.Tamsulosin: Prolong should be prescribed with caution in patients who use alpha adrenergic receptor antagonists due to possible reduced orthostatic tolerance.
Contraindications
Patients with known hypersensitivity to Dapoxetine Hydrochloride. Patients with significant pathological cardiac conditions (such as heart failure (NYHA class ll-IV), conduction abnormalities (second- or third-degree AV block or sick sinus syndrome) not treated with a permanent pacemaker, significant ischemic heart disease or significant valvular disease. Concomitant treatment with monoamine oxidase inhibitors (MAOIs), thioridazine, or within 14 days of discontinuing treatment with MAOIs, thioridazine. Similarly, MAOIs, thioridazine should not be administered within 7 days after Dapoxetine has been discontinued. Concomitant treatment with serotonin reuptake inhibitors [selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs)] or other medicinal/herbal products with serotonergic effects or within 14 days of discontinuing treatment with these medicinal/herbal products.