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Dapoxetine is a selective serotonin reuptake inhibitor, for the treatment of premature ejaculation. In a phase II proof-of-concept study conducted by PPD, dapoxetine demonstrated a statistically significant increase in ejaculatory latency when compared to placebo. Alza submitted an NDA to the FDA for dapoxetine for the treatment of premature ejaculation in December 2004. In October 2005, the company received an FDA Non-Approvable letter from the FDA, at which time they planned to work with regulators to address outstanding questions
Mechanism of Action of Dapoxetine
The drug’s mechanism of action is thought to be related to the inhibition of neuronal reuptake of serotonin and subsequent potentiation of serotonin activity. The central ejaculatory neural circuit comprises spinal and cerebral areas that form a highly interconnected network. The sympathetic, parasympathetic, and somatic spinal centers, under the influence of sensory genital and cerebral stimuli, integrated and processed at the spinal cord level, act in synergy to command physiologic events occurring during ejaculation. Experimental evidence indicates that serotonin (5-HT), throughout brain descending pathways, exerts an inhibitory role on ejaculation. To date, three 5-HT receptor subtypes (5-HT(1A), 5-HT(1B), and 5-HT(2C)) have been postulated to mediate 5-HT’s modulating activity on ejaculation.
Indications of Dapoxetine
An intravaginal ejaculatory latency time (IELT) of less than two minutes
- Poor sexual desire
- Poor control over intercourse
- Erectile Dysfunction
- Sexual Dysfunction
- Persistent or recurrent ejaculation with minimal sexual stimulation before, on, or shortly after penetration and before the patient wishes; and
- Marked personal distress or interpersonal difficulty as a consequence of PE; and
- Poor control over ejaculation
- A history of premature ejaculation in the majority of intercourse attempts over the prior 6 months.
- Very short sexual intercourse
- Sexual erectile dysfunction
- Inability to sustain a satisfactory erection to complete intercourse
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Treatment of premature ejaculation (PE) in men 18 to 64 years of age
Contra-Indications of Dapoxetine
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Allergy
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Heart rhythm disorders
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Loss of consciousness
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Kidney Disease
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Thioridazine
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Strong CYP3A4 inhibitors
Dosage of Dapoxetine
Strengths: 30 mg, 60 mg
Erectile Dysfunction
- Dosage 30 mg one to three hours before planned sexual activity. Dapoxetine should only be taken once a day. In the case of inefficacy without side effects, the dosage may be increased to 60 mg.
Side Effects of Dapoxetine
The most common
- Dry mouth
- Pain in the stomach area
- Constipation
- Sleepiness or unusual drowsiness
- Clumsiness or unsteadiness
- Dizziness
- Drowsiness
- dry mouth
- False sense of well-being
- increased watering of mouth
- lightheadedness
- constipation;
- vision changes;
- breast swelling (in men or women); or
- decreased sex drive, impotence, or difficulty having an orgasm.
- blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
- restless muscle movements in your eyes, tongue, jaw, or neck;
Common
- Drowsiness and lightheadedness the day after taking the medicine.
- Confusion.
- Numbed emotions.
- Visual disturbances such as blurred vision or double vision.
- Shaky movements and unsteady walk (ataxia).
- Loss of memory (amnesia).
- Muscle weakness.
- Dizziness.
- A headache.
- Skin rashes.
- Disturbances of the gut such as diarrhea, constipation, nausea, vomiting or abdominal pain.
- Changes in sex drive.
- Low blood pressure (hypotension).
- Blood disorders.
- Unexpected aggression, restlessness or irritability (tell your doctor if you experience this).
- Nightmares or hallucinations (tell your doctor if you experience this).
Rare
- agitation
- anxiety
- behavioral changes, including aggressiveness, angry outbursts, bizarre behavior, or decreased inhibitions
- confusion
- increased trouble sleeping
- memory problems
- muscle spasms
- shortness of breath
- signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
- sleepwalking
Drug Interactions of Dapoxetine
Dapoxetine may interact with following drugs, supplements, & may change the efficacy of drugs
- angiotensin-converting enzyme inhibitors (ACEIs; e.g., captopril, enalapril, ramipril)
- angiotensin receptor blockers (ARBs; e.g., candesartan, irbesartan, losartan)
- aripiprazole
- “azole” antifungals (e.g., itraconazole, ketoconazole, voriconazole)
- barbiturates (e.g., butalbital, pentobarbital, phenobarbital)
- beta-adrenergic blockers (e.g., atenolol, propranolol, sotalol)
- calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
- carbamazepine
- dexamethasone
- diuretics (water pills; e.g., furosemide, hydrochlorothiazide, )
- fusidic acid
- macrolide antibiotics (e.g., clarithromycin, erythromycin)
- methyldopa
- metronidazole
- phenytoin
- sertraline
- “statins” (e.g., lovastatin, simvastatin, atorvastatin)
Pregnancy & Lactation of Dapoxetine
Not Prescribe for women
References
