Dapoxetine Hydrochloride Tablets

Priligy is a gray film-coated tablet, which appears white or off-white after removing the coating.

Priligy is indicated for the treatment of male premature ejaculation (PE) aged 18 to 64 who meet all of the following conditions: 1. Continuous or repeated ejaculation due to minimal sexual stimulation before, during, or shortly after vaginal insertion, and before sexual satisfaction is achieved; 2. Significant personal distress or interpersonal communication difficulties caused by premature ejaculation (PE); 3. Poor ability to control ejaculation.

Oral. The tablet should be swallowed whole. Patients are advised to take the medication with at least a full glass of water. Patients should try to avoid injuries caused by prodromal symptoms such as syncope or dizziness. Adult males (18 to 64 years) The recommended initial dose for all patients is 30 mg, which should be taken approximately 1 to 3 hours before sexual intercourse. If the effect after taking 30 mg is not satisfactory and the side effects are within the acceptable range, the dose can be increased to the maximum recommended dose of 60 mg. The maximum recommended dose frequency is once every 24 hours. Priligy can be taken before or after meals (see Pharmacokinetics). If the physician selects Priligy for the treatment of premature ejaculation, the risks and patient-reported benefits should be evaluated after the first 4 weeks of treatment with this drug, or after 6 treatment doses to evaluate the patient's risk-benefit balance and decide whether to continue treatment with Priligy. Elderly (65 years and older) The safety and efficacy of Priligy in patients 65 years and older have not been evaluated, mainly because the data on the use of this product in this population are very limited (see Pharmacokinetics). Children and Adolescents Priligy is not for use in people under 18 years of age. Patients with Renal Impairment No dose adjustment is required for Priligy in patients with mild or moderate renal impairment, but it should be used with caution. Priligy is not recommended for patients with severe renal impairment (see Pharmacokinetics). Patients with Hepatic Impairment No dose adjustment is required for Priligy in patients with mild hepatic impairment; Priligy is contraindicated in patients with moderate and severe hepatic impairment (Child-Pugh C) (see Pharmacokinetics).

Syncope (characterized by loss of consciousness) has been reported in clinical trials and is considered drug-related. Most cases occurred within 3 hours of dosing, after the first dose, or during study-related procedures performed in the clinic (e.g., blood draws, orthostatic maneuvers, and blood pressure measurements). Syncope is often preceded by prodromal symptoms. Orthostatic hypotension has been reported in clinical trials. The most common (≥5%) adverse drug reactions in clinical trials included headache, dizziness, nausea, diarrhea, insomnia, and fatigue. The most common events leading to discontinuation included nausea and dizziness.

Priligy is contraindicated in patients with known hypersensitivity to dapoxetine hydrochloride or any of the excipients. Priligy is contraindicated in patients with significant cardiac pathology (e.g., heart failure (NYHA class II-IV), conduction abnormalities (grade 2 or 3 atrioventricular block or sick sinus syndrome) not treated with a permanent pacemaker, significant myocardial ischemia, and valvular disease). Priligy should not be used with monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuation of MAOI therapy. Likewise, MAOIs should not be used within 7 days of discontinuation of Priligy (see Drug Interactions section). Priligy should not be used with thioridazine or within 14 days of discontinuation of thioridazine therapy. Likewise, thioridazine should not be taken within 7 days of discontinuation of Priligy (see Drug Interactions section). Priligy should not be used with selective serotonin reuptake inhibitors [selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs)] or other drugs/herbal medicines with serotonergic effects [e.g., L-tryptophan, triptans, tramadol, linezolid, lithium, Hypericum perforatum extract (Hypericum wilfordii)] or within 14 days of stopping these drugs/herbal medicines. Similarly, these drugs/herbal medicines should not be taken within 7 days of stopping Priligy (see Drug Interactions section). Priligy is contraindicated in patients taking strong cytochrome P450 3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, saquinavir, telithromycin, nefazodone, nafinavir, and atazanavir. Priligy is contraindicated in patients with moderate and severe hepatic impairment.

60 mg