Duratia (Dapoxetine Hydrochloride) is a prescription medication specifically formulated for the treatment of premature ejaculation (PE) in adult men. As a selective serotonin reuptake inhibitor (SSRI) with a rapid onset and short half-life, it represents a targeted therapeutic approach designed for on-demand use. Its efficacy is supported by robust clinical trials, demonstrating significant improvements in intravaginal ejaculatory latency time (IELT) and patient-reported outcomes related to control over ejaculation and sexual satisfaction. This medication addresses a common male sexual health concern with a well-tolerated profile, offering a reliable option for physicians and patients seeking evidence-based intervention.

Features

• Active Pharmaceutical Ingredient: Dapoxetine Hydrochloride
• Available Dosage Strengths: 30 mg and 60 mg film-coated tablets
• Pharmacological Class: Selective Serotonin Reuptake Inhibitor (SSRI)
• Special Characteristic: Rapid absorption with a time to maximum plasma concentration (Tmax) of approximately 1-2 hours
• Short Elimination Half-Life: Approximately 1.5-2 hours, minimizing long-term systemic exposure
• Administration: Oral, with or without food
• Manufacturer Compliance: Produced in facilities adhering to current Good Manufacturing Practices (cGMP)

Benefits

• Significantly increases intravaginal ejaculatory latency time (IELT), providing tangible clinical improvement.
• Enhances perceived control over ejaculation, reducing associated anxiety and psychological distress.
• Improves sexual satisfaction for both the patient and their partner, contributing to overall relationship quality.
• On-demand dosing regimen offers flexibility and spontaneity, unlike daily SSRIs used off-label.
• Rapid onset of action allows for dosing approximately 1-3 hours prior to anticipated sexual activity.
• Well-characterized safety and efficacy profile from extensive pre-marketing clinical studies.

Common use

Duratia is indicated for the treatment of premature ejaculation (PE) in adult men aged 18 to 64 years. Premature ejaculation is defined as a persistent or recurrent pattern of ejaculation occurring during partnered sexual activity within approximately one minute following vaginal penetration and before the individual wishes it. This condition must be associated with clinically significant distress, interpersonal difficulty, and an inability to achieve control over ejaculation. It is not intended for use in men who have not been diagnosed with PE. The medication is used on an as-needed basis prior to anticipated sexual activity.

Dosage and direction

The recommended starting dose is 30 mg, taken orally approximately 1 to 3 hours prior to anticipated sexual activity. Based on efficacy and tolerability, the dose may be increased to a maximum of 60 mg. The dosing should not exceed one tablet in a 24-hour period. The tablet should be swallowed whole with a full glass of water; it should not be divided, crushed, or chewed. The medication can be taken with or without food, although a high-fat meal may delay absorption. Physicians should evaluate the need for continued therapy with Duratia periodically.

Precautions

Prior to initiating treatment, a thorough medical and psychiatric history should be obtained to rule out other causes of ejaculatory dysfunction. Use with caution in patients with a history of mood disorders. Patients should be monitored for the emergence of serotonin syndrome or neuroleptic malignant syndrome-like reactions, especially when used concomitantly with other serotonergic drugs. Orthostatic hypotension has been observed; patients should be advised to rise slowly from a sitting or lying position. Caution is advised in patients with underlying cardiovascular disease. This medication may cause dizziness or syncope; patients should not drive or operate machinery until they know how Duratia affects them.

Contraindications

Duratia is contraindicated in patients with known hypersensitivity to dapoxetine or any excipients in the formulation. It must not be used in combination with monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuing MAOI therapy due to the risk of serotonin syndrome. Concomitant use with thioridazine is contraindicated. It is also contraindicated in patients with significant hepatic impairment, as well as in those with a history of mania or severe depression. It should not be used in patients with clinically significant heart failure, conduction abnormalities, or unstable angina.

Possible side effect

Common adverse reactions (≥1%) include headache, dizziness, nausea, diarrhea, insomnia, and fatigue. Less frequently, patients may experience orthostatic hypotension, syncope, vomiting, anxiety, blurred vision, and tinnitus. As with other SSRIs, there is a potential for serotonin syndrome (symptoms include agitation, hallucinations, tachycardia, hyperthermia, muscle rigidity). Priapism is a rare but serious side effect requiring immediate medical attention. Some patients may experience withdrawal symptoms upon discontinuation, though this is less common due to the drug’s short half-life.

Drug interaction

Duratia is primarily metabolized by multiple CYP enzymes, including CYP3A4, CYP2D6, and others. Concomitant use with strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin) is contraindicated. Use with moderate CYP3A4 inhibitors or strong CYP2D6 inhibitors may require a dose reduction to 30 mg. Potentiation of effects and increased risk of adverse reactions, including serotonin syndrome, may occur with other serotonergic drugs (e.g., SSRIs, SNRIs, triptans, tramadol). Concurrent use with alcohol may increase the risk of orthostatic hypotension, dizziness, and syncope; patients should be advised to avoid alcohol. Use with other drugs that affect serotonin or that can cause hypotension or syncope should be approached with caution.

Missed dose

Duratia is not intended for daily administration but is taken on an as-needed basis approximately 1-3 hours before sexual activity. Therefore, the concept of a “missed dose” does not apply in the traditional sense. If a dose is not taken prior to sexual activity, the patient should not take it after sexual activity has begun or has concluded. The next dose can be taken as needed for a subsequent anticipated sexual event, adhering to the 24-hour dosing interval.

Overdose

In cases of overdose, which may involve doses higher than the maximum recommended 60 mg, supportive measures should be instituted. Symptoms of overdose are expected to be an exaggeration of the known adverse effect profile, including increased severity of dizziness, nausea, vomiting, tachycardia, and hypotension. There is also a heightened risk of serotonin syndrome. There is no specific antidote for dapoxetine overdose. Treatment should consist of general supportive measures, including monitoring of vital signs and ECG. Gastric lavage may be considered if presented early after ingestion.

Storage

Store Duratia tablets at room temperature, between 15°C and 30°C (59°F and 86°F). Keep the medication in its original blister pack to protect it from light and moisture. Keep out of reach of children and pets. Do not use beyond the expiration date printed on the packaging. Do not dispose of medication in wastewater or household garbage; consult a pharmacist for proper disposal methods.

Disclaimer

This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or before starting any new treatment. Never disregard professional medical advice or delay in seeking it because of something you have read here. The information provided is based on the product’s prescribing information but may not be exhaustive.

Reviews

“After struggling with PE for years, Duratia has been a game-changer. The 30mg dose provides me with the control I needed without significant side effects. The on-demand nature fits perfectly into my life.” – M.K., 42 “Prescribed Duratia 60mg by my urologist. The improvement in IELT is clinically significant and has positively impacted my relationship. I experienced some mild nausea initially, but it subsided.” – A.L., 38 “As a healthcare provider, I find Duratia to be a valuable, evidence-based tool in my arsenal for treating PE. The short half-life is a distinct advantage over daily SSRIs for this indication.” – Dr. R.S., Urologist “Effective, but the dizziness was pronounced for me after the first dose. My doctor advised taking it with a light meal, which helped considerably. It’s important to follow the dosing instructions carefully.” – J.T., 51