Dejac
Generic Name
Dapoxetine
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| dejac 30 mg tablet | ৳ 30.00 | ৳ 120.00 |
Description
Overview of the medicine
Dejac 30 mg tablet contains Dapoxetine, a short-acting selective serotonin reuptake inhibitor (SSRI) used for the on-demand treatment of premature ejaculation (PE) in adult men aged 18 to 64 years.
Uses & Indications
Dosage
Adults
The recommended starting dose is 30 mg, taken orally approximately 1 to 3 hours before anticipated sexual activity. It can be taken with or without food. The dose should not be taken more than once every 24 hours. If the 30 mg dose is insufficient and side effects are tolerable, the dose may be increased to a maximum of 60 mg, taken 1 to 3 hours before sexual activity.
Elderly
Efficacy and safety have not been established in patients 65 years and older. Therefore, dapoxetine is not recommended for use in this population.
Renal_impairment
Caution is advised in patients with severe renal impairment. No dose adjustment is required for patients with mild to moderate renal impairment, but careful dose titration should be considered.
How to Take
Dejac 30 mg tablet should be swallowed whole with at least one full glass of water, with or without food. To avoid dizziness or syncope, patients should not lie down immediately after taking the tablet.
Mechanism of Action
Dapoxetine selectively inhibits the reuptake of serotonin by neurons, leading to increased serotonin levels in the synaptic cleft. This increased serotonin activity delays the ejaculatory reflex, thereby prolonging the ejaculatory latency time.
Pharmacokinetics
Onset
Efficacy can be observed within 1 to 3 hours after administration.
Excretion
Excreted primarily in the urine, mainly as metabolites.
Half life
The terminal half-life of dapoxetine is approximately 1.5-2.5 hours, while its active metabolites may have longer half-lives.
Absorption
Rapidly absorbed after oral administration, with peak plasma concentrations (Cmax) reached within approximately 1-2 hours.
Metabolism
Extensively metabolized in the liver primarily by CYP2D6, CYP3A4, and flavin monooxygenase 1 (FMO1).
Side Effects
Contraindications
- Known hypersensitivity to dapoxetine or any excipients.
- Significant pathological cardiac conditions (e.g., heart failure, conduction abnormalities, ischemic heart disease).
- Concomitant treatment with monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuing an MAOI.
- Concomitant treatment with thioridazine or within 14 days of discontinuing thioridazine.
- Concomitant treatment with other SSRIs, SNRIs, or tricyclic antidepressants.
- Concomitant use of potent CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, atazanavir).
- Moderate to severe hepatic impairment.
Drug Interactions
Thioridazine
Increased QTc prolongation risk. Should not be used concomitantly or within 14 days of thioridazine cessation.
MAOIs and other serotonergic agents
Increased risk of serotonin syndrome. Should not be used concomitantly or within 14 days of MAOI cessation.
Alpha-adrenergic receptor antagonists
Increased risk of orthostatic hypotension.
PDE5 inhibitors (e.g., sildenafil, tadalafil)
May increase the risk of orthostatic hypotension when co-administered.
Potent CYP3A4 inhibitors (e.g., ketoconazole, ritonavir)
Significantly increases dapoxetine exposure, leading to increased risk of dose-related adverse effects including syncope.
Moderate CYP3A4 inhibitors (e.g., erythromycin, diltiazem)
May increase dapoxetine exposure, use with caution.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Limited information on overdose. Symptoms may include serotonin-related effects such as somnolence, gastrointestinal disturbances (nausea, vomiting), tachycardia, and dizziness. Management should be symptomatic and supportive, with close monitoring of vital signs and cardiac function.
Pregnancy & Lactation
Dapoxetine is not indicated for use in women and should not be used during pregnancy or lactation.
Side Effects
Contraindications
- Known hypersensitivity to dapoxetine or any excipients.
- Significant pathological cardiac conditions (e.g., heart failure, conduction abnormalities, ischemic heart disease).
- Concomitant treatment with monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuing an MAOI.
- Concomitant treatment with thioridazine or within 14 days of discontinuing thioridazine.
- Concomitant treatment with other SSRIs, SNRIs, or tricyclic antidepressants.
- Concomitant use of potent CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, atazanavir).
- Moderate to severe hepatic impairment.
Drug Interactions
Thioridazine
Increased QTc prolongation risk. Should not be used concomitantly or within 14 days of thioridazine cessation.
MAOIs and other serotonergic agents
Increased risk of serotonin syndrome. Should not be used concomitantly or within 14 days of MAOI cessation.
Alpha-adrenergic receptor antagonists
Increased risk of orthostatic hypotension.
PDE5 inhibitors (e.g., sildenafil, tadalafil)
May increase the risk of orthostatic hypotension when co-administered.
Potent CYP3A4 inhibitors (e.g., ketoconazole, ritonavir)
Significantly increases dapoxetine exposure, leading to increased risk of dose-related adverse effects including syncope.
Moderate CYP3A4 inhibitors (e.g., erythromycin, diltiazem)
May increase dapoxetine exposure, use with caution.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Limited information on overdose. Symptoms may include serotonin-related effects such as somnolence, gastrointestinal disturbances (nausea, vomiting), tachycardia, and dizziness. Management should be symptomatic and supportive, with close monitoring of vital signs and cardiac function.
Pregnancy & Lactation
Dapoxetine is not indicated for use in women and should not be used during pregnancy or lactation.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Usually 2 to 3 years from the date of manufacture. Check the packaging for the exact expiry date.
Availability
Available in pharmacies and drug stores
Approval Status
Approved by national drug regulatory authorities
Patent Status
Off-patent in many regions allowing generics
Clinical Trials
Dapoxetine has undergone extensive clinical trials demonstrating its efficacy and safety for the on-demand treatment of premature ejaculation across various populations.
Lab Monitoring
- No specific routine laboratory monitoring is typically required for dapoxetine. However, patients should be assessed for underlying cardiac conditions before starting treatment.
Doctor Notes
- Emphasize on-demand use only, maximum one dose per 24 hours.
- Counsel patients regarding potential for syncope and orthostatic hypotension, particularly with initial doses or alcohol co-ingestion. Advise taking with water and avoiding immediate recumbency.
- Assess for underlying cardiac conditions or moderate to severe hepatic impairment before prescription.
- Review all concomitant medications, especially other serotonergic agents and strong CYP3A4 inhibitors, due to significant interaction risks.
Patient Guidelines
- Take the tablet 1 to 3 hours before sexual activity.
- Swallow the tablet whole with a full glass of water.
- Do not take more than one dose within any 24-hour period.
- Avoid or limit alcohol consumption while taking this medicine.
- Do not lie down immediately after taking the tablet to reduce the risk of dizziness or fainting.
- Inform your doctor about all other medications you are taking.
Missed Dose Advice
Dejac is an on-demand medication taken before anticipated sexual activity. If you have not taken it before activity, do not take it afterwards. Do not take an extra dose to make up for a missed one. Do not take more than one dose in 24 hours.
Driving Precautions
Dapoxetine may cause dizziness, somnolence, blurred vision, and syncope. Patients should be advised to exercise caution when driving or operating hazardous machinery, especially after the initial dose or dose escalation.
Lifestyle Advice
- This medication is part of a comprehensive approach to managing premature ejaculation. Consider discussing counseling or behavioral therapy options with your doctor for long-term strategies.
- Maintain a healthy lifestyle, including regular exercise and a balanced diet.
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