Daprotab
Generic Name
Dapoxetine
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
daprotab 6 mg tablet | ৳ 120.00 | ৳ 1,200.00 |
Description
Overview of the medicine
Dapoxetine is a selective serotonin reuptake inhibitor (SSRI) specifically developed for the treatment of premature ejaculation (PE) in adult males aged 18-64 years.
Uses & Indications
Dosage
Adults
The recommended starting dose is 30 mg (5 tablets of 6 mg) taken approximately 1 to 3 hours before anticipated sexual activity. If the effect of 30 mg is insufficient and side effects are acceptable, the dose may be increased to a maximum of 60 mg (10 tablets of 6 mg) once every 24 hours.
Elderly
Efficacy and safety have not been established in patients 65 years and over. Use with caution, and individual patient assessment is recommended.
Renal_impairment
No dose adjustment is required in patients with mild or moderate renal impairment. Use with caution in patients with severe renal impairment, and it is not recommended for severe cases.
How to Take
Oral administration. Tablets should be swallowed whole with a full glass of water, with or without food. To avoid dizziness or fainting, patients should avoid rapid standing after taking the tablet.
Mechanism of Action
Dapoxetine inhibits the serotonin transporter, thereby increasing serotonin levels in the synaptic cleft, which prolongs the ejaculatory latency time.
Pharmacokinetics
Onset
Efficacy can be observed approximately 1-3 hours post-dose.
Excretion
Primarily excreted in the urine as metabolites.
Half life
The terminal half-life of dapoxetine is approximately 1.5-2 hours, while its active metabolite has a longer half-life.
Absorption
Rapidly absorbed, reaching peak plasma concentrations (Cmax) within 1-2 hours after oral administration.
Metabolism
Extensively metabolized in the liver, primarily by CYP2D6 and CYP3A4, to various inactive and active metabolites.
Side Effects
Contraindications
- Known hypersensitivity to dapoxetine or any excipients.
- Significant pathological cardiac conditions (e.g., heart failure, conduction abnormalities).
- History of syncope or mania/severe depression.
- Moderate to severe hepatic impairment.
- Concomitant use with Monoamine Oxidase Inhibitors (MAOIs), thioridazine, SSRIs, SNRIs, TCAs, or strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir).
Drug Interactions
MAOIs
Concomitant use with MAOIs is contraindicated due to the risk of serious reactions, including serotonin syndrome.
Alcohol
Increases the risk of alcohol-related neurocognitive adverse effects such as dizziness, somnolence, and impaired judgment.
Thioridazine
Concomitant use is contraindicated due to increased QTc prolongation.
CYP3A4 Inhibitors (strong)
Concomitant use with strong CYP3A4 inhibitors is contraindicated due to increased dapoxetine exposure and potential for adverse reactions.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include drowsiness, gastrointestinal disturbances (e.g., nausea, vomiting), tachycardia, tremor, and dizziness. Management involves supportive care and symptomatic treatment.
Pregnancy & Lactation
Dapoxetine is not indicated for use in females. It is not intended for use by women.
Side Effects
Contraindications
- Known hypersensitivity to dapoxetine or any excipients.
- Significant pathological cardiac conditions (e.g., heart failure, conduction abnormalities).
- History of syncope or mania/severe depression.
- Moderate to severe hepatic impairment.
- Concomitant use with Monoamine Oxidase Inhibitors (MAOIs), thioridazine, SSRIs, SNRIs, TCAs, or strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir).
Drug Interactions
MAOIs
Concomitant use with MAOIs is contraindicated due to the risk of serious reactions, including serotonin syndrome.
Alcohol
Increases the risk of alcohol-related neurocognitive adverse effects such as dizziness, somnolence, and impaired judgment.
Thioridazine
Concomitant use is contraindicated due to increased QTc prolongation.
CYP3A4 Inhibitors (strong)
Concomitant use with strong CYP3A4 inhibitors is contraindicated due to increased dapoxetine exposure and potential for adverse reactions.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include drowsiness, gastrointestinal disturbances (e.g., nausea, vomiting), tachycardia, tremor, and dizziness. Management involves supportive care and symptomatic treatment.
Pregnancy & Lactation
Dapoxetine is not indicated for use in females. It is not intended for use by women.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from manufacturing date, check specific packaging.
Availability
Pharmacies
Approval Status
Approved
Patent Status
Off-patent in many regions
Clinical Trials
Dapoxetine has been extensively studied in multiple randomized, double-blind, placebo-controlled clinical trials, demonstrating its efficacy and safety for the treatment of premature ejaculation.
Lab Monitoring
- No specific routine laboratory monitoring is required for dapoxetine.
Doctor Notes
- Counsel patients thoroughly on the on-demand nature of dapoxetine use and the importance of adhering to the 1-3 hour pre-activity timing.
- Emphasize the contraindication with alcohol and other serotonergic agents due to potential for serious adverse events.
- Assess for history of cardiac events, syncope, or psychiatric disorders before prescribing.
- Educate patients on symptoms of orthostatic hypotension and how to manage them.
Patient Guidelines
- Take 1 to 3 hours before sexual activity.
- Do not take more than one dose within a 24-hour period.
- Swallow tablets whole with a full glass of water.
- Avoid alcohol while taking this medicine.
- Be aware of potential dizziness or fainting and avoid situations where injury could occur if fainting happens.
Missed Dose Advice
Dapoxetine is an on-demand medication taken before sexual activity. It is not intended for regular daily use, so the concept of a 'missed dose' does not apply.
Driving Precautions
Dapoxetine may cause dizziness, lightheadedness, syncope, or somnolence. Patients should be advised to avoid driving or operating hazardous machinery if they experience these effects.
Lifestyle Advice
- Maintain open communication with your partner.
- Consider counseling or behavioral therapy as adjuncts to medication for PE management.
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