A fixed-dose combination (FDC) tablet containing Sildenafil Citrate (a phosphodiesterase type 5 inhibitor) and Dapoxetine Hydrochloride (a selective serotonin reuptake inhibitor). This combination is specifically designed for the dual management of erectile dysfunction (ED) and premature ejaculation (PE) in adult men. It addresses the significant comorbidity of these two conditions, providing a synergistic approach to male sexual health. The FDC is intended for on-demand use prior to anticipated sexual activity.
Adult: One tablet (Sildenafil 50mg + Dapoxetine 30mg) taken orally with a full glass of water, approximately 1-3 hours before anticipated sexual activity. Maximum frequency is once in 24 hours.
Note: Take with or without food. A high-fat meal may delay the onset of action of Sildenafil. Tablet should be swallowed whole, not crushed or chewed. Sexual stimulation is required for Sildenafil to be effective. Do not take more than one dose per day.
Sildenafil: Inhibits the enzyme phosphodiesterase type 5 (PDE5) in the corpus cavernosum of the penis. This inhibition increases intracellular levels of cyclic guanosine monophosphate (cGMP), which enhances the nitric oxide (NO)-mediated pathway. The result is smooth muscle relaxation and increased blood flow into the penile tissue, facilitating an erection in response to sexual stimulation. Dapoxetine: A short-acting selective serotonin reuptake inhibitor (SSRI). It blocks the presynaptic serotonin transporter, increasing serotonin activity in the synaptic cleft within the central nervous system, specifically areas involved in the ejaculatory reflex (e.g., hypothalamic nuclei). This leads to increased intravaginal ejaculatory latency time (IELT).
Pregnancy: Not indicated for use in women. Category not assigned.
Driving: Patients should be cautioned about potential dizziness, syncope, somnolence, and blurred vision. They should not drive or operate heavy machinery until they know how the medication affects them, especially after the first dose.
| Organic Nitrates (Nitroglycerin, Isosorbide) | Profound, life-threatening hypotension. | Contraindicated |
| Potent CYP3A4 Inhibitors (Ketoconazole, Itraconazole, Ritonavir, Clarithromycin) | Markedly increases plasma levels of both Sildenafil and Dapoxetine, increasing toxicity risk. | Contraindicated |
| Alpha-blockers (Doxazosin, Tamsulosin, Prazosin) | Additive vasodilatory effect leading to symptomatic hypotension, dizziness, syncope. | Major - Avoid concomitant use. If necessary, initiate alpha-blocker at lowest dose and monitor BP. |
| Other PDE5 Inhibitors (Tadalafil, Vardenafil) | Increased risk of PDE5 inhibitor-related adverse effects. | Major - Avoid combination. |
| Other SSRIs, SNRIs, TCAs, MAOIs, Antipsychotics (Thioridazine) | Increased risk of serotonin syndrome, syncope, orthostatic hypotension. | Contraindicated or Major |
| Moderate CYP3A4 Inhibitors (Erythromycin, Saquinavir, Grapefruit Juice) | May increase Sildenafil/Dapoxetine levels; use with caution and consider lower dose. | Moderate |
| CYP3A4 Inducers (Rifampicin, Carbamazepine, Phenytoin, St. John's Wort) | May decrease plasma levels of Sildenafil and Dapoxetine, reducing efficacy. | Moderate |
| Alcohol | Increased risk of orthostatic hypotension, dizziness, syncope; may worsen PE. | Major - Avoid or limit intake. |
| Antihypertensives | Potential additive hypotensive effect. | Moderate - Monitor blood pressure. |
Same composition (Sildenafil (50mg) + Dapoxetine (30mg)), different brands: