Mechanism of Action

Dapoxetine is a short-acting selective serotonin reuptake inhibitor (SSRI). It works by increasing the levels of serotonin in specific areas of the brain, which helps to prolong the time it takes to ejaculate and can improve control over ejaculation.

Pharmacokinetics and Metabolism

Dapoxetine is rapidly absorbed after oral administration. Peak plasma concentrations are usually achieved within 1-2 hours. The drug is extensively metabolized, primarily by the liver, and excreted in the urine as inactive metabolites. The half-life of dapoxetine is approximately 1.5 hours after dosing.

Indications for Use

Dapoxetine is indicated for the treatment of premature ejaculation in men between 18 and 64 years old. Typically prescribed when the condition is persistent and causes significant distress or interpersonal difficulty.

Recommended Dosage

The standard initial dose of dapoxetine is 30 mg, taken 1-3 hours before sexual activity. Based on individual response and tolerability, the dose may be increased to 60 mg. It should not be taken more than once every 24 hours.

Contraindications and Interactions

Dapoxetine is contraindicated in patients with significant heart disease, such as heart failure or conduction disorders. It should not be used in conjunction with monoamine oxidase inhibitors (MAOIs), thioridazine, or potent CYP3A4 inhibitors like ketoconazole or ritonavir.

Side Effects and Adverse Reactions

Common side effects include nausea, dizziness, dry mouth, headache, and diarrhea. Serious, but rare, adverse reactions can include syncope, seizures, and serotonin syndrome. Most side effects tend to resolve spontaneously over time.

Drug Storage and Handling

Dapoxetine should be stored at room temperature, away from moisture and direct heat. Ensure the medication is kept out of reach of children and pets. The tablets should be kept in their original blister packaging until use.

Patient Counseling Points

Patients should be informed about the correct dosing schedule and advised to take the medication with a full glass of water. They should be cautioned about the potential for dizziness and advised not to engage in potentially hazardous activities, such as driving, immediately after taking a dose.

Pregnancy and Lactation

Dapoxetine is not indicated for use in women. Therefore, its safety in pregnancy and lactation has not been established nor studied extensively.

Clinical Efficacy

Clinical trials show that dapoxetine is effective in delaying ejaculation and improving ejaculation-related control. Patients reported higher satisfaction with sexual intercourse and reduced distress related to premature ejaculation.

Drug Identification Information

Dapoxetine tablets are typically available in two dosages: 30 mg and 60 mg. The tablets are film-coated and marked with identifying imprints, which may vary depending on the manufacturer.

Special Populations

Patients with renal impairment do not require dose adjustment but should be monitored for any adverse effects. The medication is not recommended for use in individuals over 65 years due to limited clinical experience in this age group.

Effect on QT Interval

Dapoxetine has not been shown to produce clinically significant QT interval prolongation in thorough QT studies, making it a safer option regarding cardiac electrophysiology compared to other SSRIs.

Pharmacodynamic Properties

It has a rapid onset of action and a short half-life. Dapoxetine has a minimal impact on resting heart rate and blood pressure, making it a suitable option for individuals who might have concerns about cardiovascular side effects associated with SSRIs.

Administration with Alcohol

Combining dapoxetine with alcohol can increase the risk of neuropsychiatric side effects, such as dizziness and syncope. Patients are advised to moderate their alcohol intake while using this medication.

Behavioral Interventions

Alongside pharmacological treatment, behavioral strategies such as the stop-start technique and pelvic floor exercises can help enhance the efficacy of dapoxetine in managing premature ejaculation.

Clinical Trial Data

Multiple randomized, placebo-controlled trials have demonstrated the superiority of dapoxetine over placebo at both 30 mg and 60 mg doses in prolonging intravaginal ejaculatory latency time (IELT) and improving patient satisfaction and distress levels.

Monitoring Treatment Response

It is advisable to reassess the patient’s response to the initial 30 mg dosage before considering an increase to 60 mg. Regular follow-up appointments can help assess efficacy, tolerability, and side effects over time.

Off-Label Uses

The primary focus is on the treatment of premature ejaculation; however, dapoxetine has also been explored for its potential use in depression and anxiety, though this is not well-established and lacks sufficient clinical evidence to support regular use for these purposes.

Patient Experience

Overall, many patients report a significant improvement in their relationships and a reduction in anxiety related to premature ejaculation. The majority find the medication to be effective and experience a high level of satisfaction with its use.