Dasutra

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Dasutra

Method of action: Urologicals

Treatment option:

Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Dasutra

What is Dasutra? (Overview and Quick Facts)

Property Description
Active ingredient Dapoxetine Hydrochloride
Form Oral Tablet
Pharmacological class Selective Serotonin Reuptake Inhibitor (SSRI)
General Purpose To modulate timing of a specific reflex
Origin Synthetic Compound

What Type of Medication is Dasutra (Dapoxetine)?

Dasutra is a prescription-only medication administered via the oral route, categorized pharmacologically as a Selective Serotonin Reuptake Inhibitor (SSRI). Its core chemical entity is Dapoxetine Hydrochloride, a compound specifically engineered to modulate central nervous system functions related to timing and reflexes. Dapoxetine was the first pharmaceutical agent specifically created and approved for the treatment of the target male sexual health condition.

Dapoxetine is classified as a short-acting SSRI because it demonstrates a rapid onset and quick elimination from the body. This characteristic provides a significant differentiating factor from other conventional SSRIs, supporting its intended use as an on-demand treatment specifically targeted at adult men.

Composition, Origin, and Unique Form

The chemical identity of the medication is defined by its core active substance, Dapoxetine, which is a synthetic compound. The foundational Dasutra preparation is consistently a single-ingredient product, delivering only Dapoxetine alongside standard solid pharmaceutical excipients necessary for the formation and integrity of the oral tablet.

As a chemically synthesized agent, Dapoxetine ensures a pure and consistent chemical entity. The compound functions as an inhibitor of the neuronal reuptake of serotonin.

General Purpose and Core Physiological Benefit

The general purpose of the medication is to modulate the central nervous system's control over a rapid, involuntary bodily response. This is achieved by temporarily increasing the influence of the neurotransmitter serotonin in specific nerve pathways, facilitating an inhibitory effect on the neural circuit governing the reflex. The resulting benefit is the facilitation of ejaculatory delay, supporting the overall therapeutic objective of achieving a more controlled response. This approach is typically used in the context of lifelong or acquired ejaculation challenges.

What side effects are possible with Dasutra?

Possible Side Effects and Safety Information

The safety characteristics of Dasutra (Dapoxetine) are classified by regulatory authorities using System-Organ Classes (SOC) and specific frequency categories, detailing the potential adverse reactions documented in official prescribing information.

Frequency-Classified Adverse Reactions

Adverse reactions are classified based on their estimated frequency in clinical use:

Classification Representative Reactions
Very Common (ge 1/10) Nausea, Headache
Common (ge 1/100 to <1/10) Dizziness, Somnolence (Drowsiness), Insomnia, Dry mouth, Diarrhoea, Fatigue, Anxiety, Decreased libido
Uncommon (ge 1/1,000 to <1/100) Syncope (Fainting), Tachycardia, Flushing, Blurred vision

High-Level Safety Patterns and Constraints

The regulatory safety profile notes that effects such as Syncope (fainting), which is a documented serious adverse reaction, and Dizziness are more commonly observed during the initiation of treatment or following dose escalation. Postural Orthostatic Tachycardia Syndrome (POTs) is also listed as a serious adverse reaction.

Safety constraints prohibit the use of Dasutra in individuals with Severe Hepatic Impairment and those with certain pre-existing cardiovascular conditions, including unpaced heart failure (NYHA Class II-IV) or specific conduction abnormalities. Caution is advised when the medication is used by Older Adults (65 years and over) and patients with mild or moderate Renal Impairment as defined in official labeling. Use is also restricted in patients with a history of mania/hypomania or severe depression.

Overdose and Emergency Response

Overdose and when to seek help

Regulatory documents define the overdose profile for Dasutra based on specific high-exposure manifestations and required emergency procedures. Individuals must contact a doctor or pharmacist immediately if they have taken more than the recommended dose, as the risk of adverse effects is increased.


Documented Manifestations and Serious Outcomes

Official prescribing information documents that overdose or high exposure may present with clinical signs such as nausea, vomiting, and dose-dependent syncope (loss of consciousness). Serious outcomes include the risk of cardiovascular events, such as bradycardia (slow heart rate) and sinus arrest, which have been observed during episodes of syncope. If symptoms like dizziness or light-headedness occur, the individual should immediately lie down or sit down with their head between their knees to mitigate the risk of injury.


Official Management and Limitations

Management of Dasutra overdose requires the adoption of standard supportive measures and symptomatic treatment. No specific antidote is known. The drug’s high protein binding and large volume of distribution are pharmacokinetic factors that make common elimination procedures, such as dialysis or forced diuresis, unlikely to be of benefit. Monitoring of cardiac function is required in high-exposure cases. Use of the drug is contraindicated in moderate to severe hepatic impairment, which relates to an increased risk of high exposure.

Therapeutic Uses of Dasutra

What Dasutra Treats: Main Uses and Benefits

Dasutra (Dapoxetine) is primarily relevant for the symptomatic management of Premature Ejaculation (PE) in adult men, a condition defined by the persistent and recurrent pattern of rapid ejaculation occurring with minimal stimulation. Clinical criteria for use include poor control over ejaculation and the presence of marked personal distress or interpersonal difficulty.

This medication is applied across conditions where additional symptomatic support is needed, being relevant for patients who have been diagnosed with both lifelong and acquired forms of the condition. It is commonly used across conditions characterized by recurrent or episodic manifestations.

Enhancing Control and Easing Symptom Burden

The primary therapeutic purpose is to address the symptom cluster of deficiency in ejaculatory timing control, supporting a significant prolongation of the time to ejaculation and assisting in achieving greater voluntary control over the response. The medicine plays a role in managing associated secondary symptoms, including psychological distress and interpersonal difficulties. By improving functional performance, it contributes to improved comfort during symptomatic periods.

“This approach is considered relevant for easing the overall symptom load and supporting patients during episodes of heightened discomfort.”

Quick Fact: Relief for Ejaculatory Timing The medication is commonly used to help manage the lack of ejaculatory control and the associated psychological distress and relational strain in adult men.

Regulatory References

  1. National Institute for Health and Care Excellence (NICE)

Eligibility and Restrictions for Use

Dasutra is officially approved for use only in adult men aged 18 to 64 years who have a clinical diagnosis of the condition the medicine is intended to treat. It is not intended for use in women or by any person under the age of 18.


Contraindications (Who must not use Dasutra)

Official regulatory documents state that this medicine is contraindicated (must not be used) in patients with the following conditions or circumstances:

  • A known allergy or hypersensitivity to the active ingredient, dapoxetine, or any component of the tablet.
  • Significant underlying heart conditions, including heart failure, permanent or non-permanent pacemaker use, or certain heart rhythm disorders.
  • Moderate to severe hepatic impairment (liver problems).
  • Concurrent use with Monoamine Oxidase Inhibitors (MAOIs), thioridazine, or powerful CYP3A4 inhibitors (such as ketoconazole or ritonavir).

Use Restrictions and Precautions

Use is not recommended or requires special caution in certain groups, including elderly patients (65 years or older), men with a history of fainting (syncope), or those with a history of mania or severe depression. Patients with renal impairment (kidney problems) should also use the medicine with caution.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official interaction profile for Dasutra (Dapoxetine) is primarily structured around avoiding combinations that significantly alter drug clearance or produce hazardous additive effects, as documented by regulatory authorities.

Co-administration is formally contraindicated with several medicinal products due to the documented risk of Serotonin Syndrome, including Monoamine Oxidase Inhibitors (MAOIs), Thioridazine, and other agents with serotonergic effects. To mitigate this risk, a 14-day washout period must pass after discontinuing these agents before Dasutra can be started, and a 7-day washout is required after stopping Dasutra before initiating the other agents.

A major pharmacokinetic restriction involves the metabolic pathway. Co-administration with Potent CYP3A4 Inhibitors (e.g., Ketoconazole, Ritonavir) is contraindicated as this severely impairs Dasutra's clearance, significantly increasing its plasma concentration. A dose restriction is mandated when co-administering with moderate CYP3A4 inhibitors.

Pharmacodynamic interactions include an increased risk of hypotension and syncope when combined with products that lower blood pressure, and an increased risk of bleeding abnormalities when co-administered with NSAIDs or anticoagulants. The labeling advises strictly avoiding alcohol due to documented potentiation of neurocognitive and cardiovascular adverse events. Furthermore, the medicine is contraindicated for use in patients with moderate or severe hepatic impairment due to expected impaired clearance.

Mechanism of Action

Dual Mechanism: Modulating Vascular Flow and Neural Reflexes

Dasutra acts through a dual mechanism, combining actions on the peripheral vascular system and the central nervous system. One component acts by inhibiting an enzyme crucial for blood vessel relaxation, while the other modulates the reuptake of a key neurotransmitter involved in reflex timing.


Targeting Enzyme PDE5 for Increased Blood Flow

The sildenafil component acts as a selective inhibitor of the Phosphodiesterase type 5 (PDE5) enzyme. This mechanism increases levels of the signaling molecule cGMP, leading to the relaxation of vascular smooth muscle in targeted tissue. This facilitates enhanced blood flow capacity when the body receives a natural neural signal, shaping the resulting hemodynamic effect.


Modulating Serotonin Reuptake for Reflex Control

The dapoxetine component acts by inhibiting the neuronal reuptake of the neurotransmitter serotonin (5-HT) via the SERT protein. This temporary increase in 5-HT in the synaptic cleft dampens the excitability of central neural circuits governing a key reflex. The physiological consequence is a prolongation of the neural threshold required to complete the reflex arc, contributing to a predictable adjustment within this pathway.

Dosage and Administration Information

The use of Dasutra (Dapoxetine) is defined by a highly specific, on-demand protocol, mandating the oral administration of the film-coated tablet. This medication is not intended for continuous daily use, and its core principle is based on strict, time-specific dosing. The tablets must be swallowed whole to avoid a bitter taste and should be taken with at least one full glass of water, although intake is permissible with or without food.

The administration schedule requires the user to take the dose approximately one to three hours prior to anticipated sexual activity. The frequency is limited to a maximum of once every 24 hours.

The adult regimen begins with a starting dose of 30 mg. The maximum recommended dose is 60 mg. Dose escalation to the higher strength is only considered if the 30 mg dose is ineffective and was well-tolerated without significant adverse events.

Regarding the duration of therapy, standard clinical practice emphasizes periodic clinical oversight. The initial necessity for continuation should be formally appraised after the first four weeks or following a minimum of six doses. Furthermore, the overall benefit/risk balance requires re-evaluation at least every six months. Dasutra is indicated only for adult men aged 18 to 64; its use is not recommended for older adults (65 years and over), and it is not indicated for individuals under 18 years of age.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Dasutra

Evidence for use in Premature Ejaculation (PE)

Research exploring Dasutra (Dapoxetine) was studied for its use in adult men diagnosed with Premature Ejaculation (PE), covering both lifelong and acquired forms of the condition. The core evidence was evaluated in multiple large, short-term randomized controlled trials (RCTs) over defined time intervals, typically comparing the study drug to a placebo.

The main focus of these studies was to explore what measurements of physical and perceived symptoms were recorded over time. Researchers primarily measured the Intravaginal Ejaculatory Latency Time (IELT), which is the time from penetration to ejaculation, and patient-reported outcomes (PROs) on aspects like perceived control and personal distress.

Studies monitored IELT measurements and recorded the differences between participants receiving the study medication and those receiving the placebo. In addition, researchers monitored changes measured during the study period in PROs, contributing to the overall record of how patients reported their experience within the research context.


Research on Long-Term Use and Durability

The majority of the initial, high-certainty data for Dasutra is derived from short-term studies, generally covering periods up to 6 months. To gain insight into what happens over more extended periods, researchers was evaluated in long-term extension studies.

However, the data gathered from these long-term settings remains limited. Because of the limited duration of follow-up, long-term outcomes are not fully established, and there is limited information concerning the durability of the observed patterns of change in patients' self-reported experiences.


Understanding Research Gaps and Limitations

While a significant amount of research contributes to the broader evidence landscape for Dasutra, areas where scientific certainty remains low or evidence is limited still exist. The primary limitation relates to limited follow-up durations; most definitive research does not offer comprehensive data on use beyond 6 months.

Furthermore, comparative evidence is lacking. The core trials often compared the medication to a placebo. While studies explored other pharmacological treatments, comparative evidence is lacking between on-demand Dasutra and the on-demand use of those other options. This means the evidence describes symptom patterns within the trial setting but does not fully determine how it compares against all possible alternatives in a head-to-head fashion.

How should Dasutra be stored and disposed of?

How to Store and Dispose of Dasutra?

Dasutra must be stored according to official regulatory specifications to maintain its stability and effectiveness.

Storage Requirements

Classification Official Requirement
Temperature Store below 30 C or at controlled room temperature.
Protection Keep in the original, tightly closed container; protect from moisture and excessive heat.
Handling Do not freeze the medicine.
Access Keep the medicine out of the sight and reach of children and pets.

Disposal Instructions

To dispose of unused or expired Dasutra, follow local medicine take-back programs if available. If a take-back program is unavailable, mix the medicine with an undesirable substance, such as coffee grounds or cat litter, and place it in a sealed bag or container before discarding in the household trash. Do not flush Dasutra down the toilet or pour it down a drain unless specifically instructed to do so by an authorized regulatory body.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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