Duratia (dapoxetine hydrochloride) is a short-acting selective serotonin reuptake inhibitor (SSRI) specifically developed for the on-demand treatment of premature ejaculation (PE) in adult men. As the first and only oral medication approved for this indication, Duratia represents a significant advancement in sexual medicine, offering a targeted pharmacological approach to a condition affecting approximately 20-30% of the male population globally. Its rapid absorption and elimination profile make it uniquely suited for episodic use, distinguishing it from conventional SSRIs used off-label for PE. Clinical trials demonstrate that Duratia effectively increases intravaginal ejaculatory latency time (IELT) while maintaining a favorable safety profile when administered according to prescribed guidelines.

Features

• Contains dapoxetine hydrochloride 30mg or 60mg as active pharmaceutical ingredient
• Rapid onset of action with peak plasma concentrations achieved within 1-2 hours
• Short elimination half-life of approximately 15 hours
• Film-coated tablet formulation for ease of administration
• Manufactured under cGMP standards ensuring consistent quality and potency
• Available in blister packs with clear dosage identification

Benefits

• Significantly prolongs time to ejaculation, with clinical studies showing 2.5 to 3-fold increases in IELT
• Improves perceived control over ejaculation and sexual satisfaction for both partners
• Reduces personal distress and interpersonal difficulty associated with premature ejaculation
• On-demand administration allows for spontaneous sexual activity without daily medication commitment
• Demonstrated improvement in all domains of the Premature Ejaculation Profile (PEP)
• Flexible dosing options allow for individualized treatment optimization

Common use

Duratia is specifically indicated for the treatment of premature ejaculation in men aged 18-64 years. It is prescribed for patients who meet the diagnostic criteria for lifelong or acquired PE, characterized by persistent or recurrent ejaculation with minimal sexual stimulation before, on, or shortly after penetration and before the person wishes it. The medication is typically used by men in stable sexual relationships where premature ejaculation causes marked distress or interpersonal difficulty. Clinical evidence supports its efficacy across diverse ethnic populations and age groups within the indicated range.

Dosage and direction

The recommended starting dose is 30mg taken orally approximately 1-3 hours before anticipated sexual activity. Based on efficacy and tolerability, the dose may be increased to 60mg. Duratia should not be taken more than once every 24 hours. Tablets should be swallowed whole with at least a full glass of water, with or without food. Patients should be advised that sexual stimulation is still required to achieve the therapeutic effect—the medication does not automatically induce erection or orgasm. Dose adjustment may be necessary for patients with renal or hepatic impairment, as determined by a healthcare provider.

Precautions

Patients should be screened for history of manic episodes or bipolar disorder before initiation. Caution is advised in elderly patients (65 years and older) due to limited clinical experience. Those with underlying cardiovascular conditions should undergo appropriate evaluation before treatment. Patients should be warned about the potential for orthostatic hypotension and advised to avoid sudden posture changes. Alcohol consumption should be limited or avoided due to increased risk of adverse events including dizziness, hypotension, and syncope. Regular follow-up with prescribing physician is recommended to assess treatment response and tolerability.

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), thioridazine, or other SSRIs due to risk of serotonin syndrome. Concomitant use with potent CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, or clarithromycin is prohibited. Patients with significant hepatic impairment (Child-Pugh class C) should not use Duratia. Those with history of syncope, unstable angina, significant cardiovascular disease, or uncontrolled hypertension are not candidates for therapy.

Possible side effects

Common adverse reactions (≥1%) include nausea (11.0%), dizziness (5.8%), headache (5.6%), diarrhea (3.9%), insomnia (3.1%), and fatigue (2.1%). Less frequently reported effects include vomiting, abdominal pain, flushing, increased blood pressure, tachycardia, anxiety, tremors, and blurred vision. Syncope or pre-syncope has been reported in approximately 0.06% of patients in clinical trials. Most adverse events are mild to moderate in severity and tend to decrease in frequency with continued use. Patients should report any persistent or concerning symptoms to their healthcare provider.

Drug interaction

Duratia is primarily metabolized by CYP3A4, CYP2D6, and flavin-containing monooxygenase systems. Concomitant use with strong CYP3A4 inhibitors increases dapoxetine exposure approximately 3-fold and is contraindicated. Moderate CYP3A4 inhibitors (erythromycin, fluconazole, aprepitant) may increase exposure and require dose adjustment. Concurrent administration with serotonergic drugs (tramadol, tryptophan, St. John’s Wort) may increase serotonin syndrome risk. Duratia may potentiate effects of alcohol and other CNS depressants. Caution is advised with drugs that affect blood pressure or heart rate. Physicians should review all medications, including over-the-counter products and herbal supplements, before prescribing.

Missed dose

As Duratia is taken on an as-needed basis rather than regularly scheduled dosing, the concept of a “missed dose” does not apply in the conventional sense. If a patient forgets to take Duratia before sexual activity, they should not take it after sexual activity has begun or immediately afterward. The next dose may be taken 1-3 hours before anticipated sexual activity on a subsequent occasion. Patients should not double the dose to make up for a missed administration.

Overdose

Symptoms of overdose may include serotonin syndrome manifestations (agitation, confusion, diaphoresis, tachycardia, hypertension, hyperthermia), syncope, dizziness, nausea, vomiting, and seizures. There is no specific antidote for dapoxetine overdose. Treatment should consist of general supportive measures including monitoring of vital signs and cardiac function. Gastric lavage may be considered if presented early after ingestion. Activated charcoal may be administered if the patient presents within one hour of ingestion. Management of serotonin syndrome may require benzodiazepines, cyproheptadine, and active cooling measures.

Storage

Store at room temperature (15-30°C or 59-86°F) in the original packaging to protect from moisture and light. Keep the blister strips sealed until immediately before use. Do not transfer tablets to other containers. Keep out of reach of children and pets. Do not use beyond the expiration date printed on the packaging. Properly dispose of any unused or expired medication through medication take-back programs or according to local regulations.

Disclaimer

This information is provided for educational purposes only and does not constitute medical advice. Duratia is a prescription medication that should be used only under the supervision of a qualified healthcare professional. Individual results may vary. Patients should consult with their physician for proper diagnosis and treatment recommendations. The manufacturer is not responsible for misuse or incorrect administration of the product.

Reviews

Clinical studies involving over 6,000 patients demonstrate that Duratia significantly improves IELT and patient-reported outcomes. In randomized controlled trials, 30mg and 60mg doses increased geometric mean IELT from 0.9 minutes at baseline to 2.78 and 3.32 minutes, respectively. Patient Global Impression of Change (PGI-C) scores showed 85% of patients reported improvement compared to 25% with placebo. Real-world evidence from post-marketing surveillance supports maintained efficacy and tolerability with appropriate patient selection and dosing. The majority of adverse events were mild to moderate and self-limiting, with discontinuation rates of 3-5% in clinical trials.