Daprotab
Generic Name
Dapoxetine
Manufacturer
Example Pharmaceuticals
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| daprotab 4 mg tablet | ৳ 80.00 | ৳ 800.00 |
Description
Overview of the medicine
Dapoxetine is a short-acting selective serotonin reuptake inhibitor (SSRI) used for the on-demand treatment of premature ejaculation (PE) in adult men.
Uses & Indications
Dosage
Adults
The usual recommended starting dose is 30 mg, taken orally approximately 1 to 3 hours before anticipated sexual activity. The dose may be increased to a maximum of 60 mg if the 30 mg dose is insufficient and side effects are tolerable. Do not exceed one dose per 24 hours. (Note: 4 mg is an unusually low dose for Dapoxetine and not standard for treating PE).
Elderly
No specific dose adjustment is recommended for elderly patients based on pharmacokinetics; however, caution is advised due to potential increased sensitivity.
Renal_impairment
No dose adjustment needed for mild or moderate renal impairment. Not recommended for severe renal impairment.
How to Take
Take orally with a full glass of water, with or without food. Avoid alcohol.
Mechanism of Action
Dapoxetine inhibits the serotonin transporter, thereby increasing serotonin levels in the synaptic cleft and enhancing post-synaptic receptor stimulation. This helps to delay the ejaculatory reflex.
Pharmacokinetics
Onset
Within 1 to 3 hours.
Excretion
Mainly excreted in urine as metabolites.
Half life
The initial half-life is approximately 1.5-2 hours, with a terminal half-life of 18-19 hours due to active metabolites.
Absorption
Rapidly absorbed. Peak plasma concentrations (Cmax) are achieved approximately 1-2 hours after oral administration.
Metabolism
Primarily metabolized in the liver by CYP2D6 and CYP3A4.
Side Effects
Contraindications
- Significant pathological cardiac conditions (e.g., heart failure, conduction abnormalities, ischemic heart disease)
- Concomitant use with Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of stopping MAOIs
- Concomitant use with potent CYP3A4 inhibitors (e.g., ketoconazole, ritonavir)
- Moderate to severe hepatic impairment
- History of syncope
- Known hypersensitivity to Dapoxetine or any excipients
Drug Interactions
MAOIs
Risk of serious adverse reactions, including serotonin syndrome, if used concomitantly or within 14 days.
Alcohol
Increases severity of alcohol-related neurocognitive effects and may enhance cardiovascular adverse effects.
Thioridazine
Increased risk of QT prolongation and ventricular arrhythmias; concomitant use is contraindicated.
SSRIs/SNRIs and other serotonergic drugs
Increased risk of serotonin syndrome.
PDE5 Inhibitors (e.g., sildenafil, tadalafil)
May increase risk of orthostatic hypotension, especially in combination with alcohol.
Alpha-adrenergic receptor antagonists (e.g., tamsulosin)
Increased risk of orthostatic hypotension.
CYP2D6 Inhibitors (e.g., fluoxetine, paroxetine, quinidine)
Increased dapoxetine exposure; use with caution.
Moderate CYP3A4 Inhibitors (e.g., erythromycin, diltiazem, verapamil)
Increased dapoxetine exposure; use with caution and consider lower starting dose.
Potent CYP3A4 Inhibitors (e.g., ketoconazole, ritonavir, telithromycin)
Significantly increases dapoxetine plasma levels, increasing risk of adverse effects. Concomitant use is contraindicated.
Storage
Store below 30°C in a dry place, away from moisture and direct sunlight. Keep out of reach of children.
Overdose
Symptoms of overdose include somnolence, gastrointestinal disturbances, tachycardia, tremor, and dizziness. Management is symptomatic and supportive; no specific antidote is known.
Pregnancy & Lactation
Dapoxetine is not indicated for use in women. Therefore, information on use during pregnancy and lactation is not relevant.
Side Effects
Contraindications
- Significant pathological cardiac conditions (e.g., heart failure, conduction abnormalities, ischemic heart disease)
- Concomitant use with Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of stopping MAOIs
- Concomitant use with potent CYP3A4 inhibitors (e.g., ketoconazole, ritonavir)
- Moderate to severe hepatic impairment
- History of syncope
- Known hypersensitivity to Dapoxetine or any excipients
Drug Interactions
MAOIs
Risk of serious adverse reactions, including serotonin syndrome, if used concomitantly or within 14 days.
Alcohol
Increases severity of alcohol-related neurocognitive effects and may enhance cardiovascular adverse effects.
Thioridazine
Increased risk of QT prolongation and ventricular arrhythmias; concomitant use is contraindicated.
SSRIs/SNRIs and other serotonergic drugs
Increased risk of serotonin syndrome.
PDE5 Inhibitors (e.g., sildenafil, tadalafil)
May increase risk of orthostatic hypotension, especially in combination with alcohol.
Alpha-adrenergic receptor antagonists (e.g., tamsulosin)
Increased risk of orthostatic hypotension.
CYP2D6 Inhibitors (e.g., fluoxetine, paroxetine, quinidine)
Increased dapoxetine exposure; use with caution.
Moderate CYP3A4 Inhibitors (e.g., erythromycin, diltiazem, verapamil)
Increased dapoxetine exposure; use with caution and consider lower starting dose.
Potent CYP3A4 Inhibitors (e.g., ketoconazole, ritonavir, telithromycin)
Significantly increases dapoxetine plasma levels, increasing risk of adverse effects. Concomitant use is contraindicated.
Storage
Store below 30°C in a dry place, away from moisture and direct sunlight. Keep out of reach of children.
Overdose
Symptoms of overdose include somnolence, gastrointestinal disturbances, tachycardia, tremor, and dizziness. Management is symptomatic and supportive; no specific antidote is known.
Pregnancy & Lactation
Dapoxetine is not indicated for use in women. Therefore, information on use during pregnancy and lactation is not relevant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 to 36 months from manufacturing date.
Availability
Pharmacies, Hospitals
Approval Status
Approved in many countries for PE
Patent Status
Patent expired in many regions, generics available
Clinical Trials
Dapoxetine has been evaluated in multiple Phase III clinical trials demonstrating its efficacy and safety for the treatment of premature ejaculation across various populations.
Lab Monitoring
- No routine laboratory monitoring is typically required for Dapoxetine. However, liver function tests may be considered in patients with pre-existing hepatic impairment.
Doctor Notes
- Prior to prescribing, a thorough medical history and physical examination should be conducted, particularly to assess for cardiovascular conditions and history of syncope.
- Educate patients on the on-demand nature of the medication and the importance of not exceeding one dose per 24 hours.
- Counsel patients about potential side effects, including dizziness and orthostatic hypotension, and advise on measures to mitigate these risks (e.g., slow postural changes, avoid alcohol).
- Assess for concurrent use of other serotonergic agents or potent CYP inhibitors/inducers.
Patient Guidelines
- Take 1-3 hours before anticipated sexual activity.
- Do not take more than one tablet within a 24-hour period.
- Avoid alcohol while taking this medicine.
- Be aware of potential dizziness or fainting, especially when standing up quickly. Sit or lie down if you feel dizzy.
- Inform your doctor about all other medicines you are taking.
Missed Dose Advice
Dapoxetine is taken on-demand, so there is no regular dosing schedule. If a dose is forgotten before sexual activity, it can be taken when remembered, but not more than once within 24 hours.
Driving Precautions
This medicine may cause dizziness, somnolence, difficulty concentrating, or blurred vision. Patients should be advised to exercise caution when driving or operating machinery until they are certain the medicine does not adversely affect them.
Lifestyle Advice
- Maintain a healthy and balanced lifestyle.
- Stay hydrated.
- Avoid sudden changes in posture to prevent dizziness and lightheadedness.
- Regular exercise may help improve overall sexual health.
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