Dosage and Administration of Sustinex:
Oral dapoxetine is indicated for the treatment of men aged 18-64 years with premature ejaculation. The recommended starting dosage is 30 mg (administered with water) as needed 1-3 hours prior to sexual intercourse (maximum dosing frequency of once every 24 hours); the dose may be increased to 60 mg (the maximum recommended dose) based on efficacy and tolerability. Dapoxetine may be administered with or without food.
Dapoxetine is contraindicated in men with moderate to severe hepatic impairment and in those receiving concomitant therapy with potent CYP3A4 inhibitors (e.g. ketoconazole, ritonavir, telithromycin), thioridazine, MAOIs, serotonin reuptake inhibitors (e.g. SSRIs, serotonin-norepinephrine reuptake inhibitors, tricyclic antidepressants) or other medicinal/herbal products with serotonergic effects (e.g. hypericum [St John's wort].
Therapy with dapoxetine is not recommended in men with severe renal impairment; caution is advised with the administration of dapoxetine to men with mild or moderate renal impairment and in those men receiving concomitant therapy with a potent CYP2D6 inhibitor or a moderate CYP3A4 inhibitor. Concomitant dapoxetine therapy and alcohol or recreational drugs should also be avoided.
Patients treated with moderate or potent inhibitors of CYP3A4: Concomitant use of potent CYP3A4 inhibitors is contraindicated. The dose is restricted to 30 mg in patients concomitantly treated with moderate CYP3A4 inhibitors and caution is advised.
Hypersensitivity to the active substance or to any of the excipients. Significant pathological cardiac conditions such as:
Concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing treatment with an MAOI. Similarly, an MAOI should not be administered within 7 days after dapoxetine has been discontinued.
Concomitant treatment with thioridazine, or within 14 days of discontinuing treatment with thioridazine. Similarly, 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 [e.g., L-tryptophan, triptans, tramadol, linezolid, lithium, St. John's Wort (Hypericum perforatum)] or within 14 days of discontinuing treatment with these medicinal/herbal products. Similarly, these medicinal/herbal products should not be administered within 7 days after dapoxetine has been discontinued.
Concomitant treatment of potent CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, saquinavir, telithromycin, nefazadone, nelfinavir, atazanavir, etc.
Moderate and severe hepatic impairment.
- Heart failure (NYHA class II-IV)
- Conduction abnormalities (second- or third-degree AV block or sick sinus syndrome) not treated with a permanent pacemaker
- Significant ischemic heart disease
- Significant valvular disease