Understanding the Dapoxetine and Sildenafil Combination

Study drug was administered 2 hrs prior to planned intercourse Primary efficacy measure was IELT measured by partner operated switch Result of dapoxetinephase 2 study (Hellstrom et al 2004) Age range (yrs)- 18-60 Inclusion IELT- less than 2 mins estimated Treatment period- 4 weeks/treatment Dapoxetine Dose 20 mg 40 mg Placebo (n=145) (n=141) (n=142) Mean baseline IELT 1.34 1.34 1.34 Mean treatment IELT 2.72 3.31 2.22 IELT fold increase 2 2.5 1.7 Discontinuation due to adverse 0 2 0 effect Result of dapoxetinephase 2 study (Hellstrom et al 2005) Age range (yrs)- 18-65 Inclusion IELT- less than 2 mins by stopwatch Treatment period- 2 weeks/treatment Dapoxetine Dose 60 mg 100 mg Placebo (n=144) (n=155) (n=145) Mean baseline IELT 1.01 1.01 1.01 Mean treatment IELT 2.86 3.24 2.07 IELT fold increase 2.9 3.2 2.0 Discontinuation due to 0 9 1 adverse effect Analysis Magnitude of effect of 20 mg dapoxetine on IELT was small Adverse events were dose dependant Most common AE were nausea, diarrhea headache, dizziness Overall 60 mg dose was better tolerated Most common reason of study withdrawal at dose 100 mg was nausea Based on these results 30, 60 mg dose were chosen for phase 3 study Phase 3 studies:- To present safety & efficacy data five randomized, double blinded, placebo controlled studies conducted in over 25 countries All studies enrolled heterosexual men & their partners who were more than 18 yrs age, in monogamous relationship and met DSMIV TR criteria for PE Study Description Treatmen Randomiz Inclusion criteria t duration ed subjects U.S.

Is Priligy available through the NHS?

Dapoxetine sildenafil

Generic Names

Multicentre, D/B, 12 weeks 1294 IELT less than 2 mins during randomized, placebo 2 wks baseline period, met Study controlled DSM IV TR criteria U.S.

Multicentre, D/B, 12 weeks 1320 Same as above randomized, placebo Study controlled Internation Multicentre, D/B, 24 weeks 1162 IELT less than 2 mins during randomized, placebo 4 week baseline period, met al Study controlled DSM IV TR criteria Asia Multicentre, D/B, 12 weeks 1067 Same as above randomized, placebo Pacific controlled Study Phase 3 studiespooled data analysis This is the largest efficacy and safety database for any agent intended to treat PE Overall 6081 men with mean age of 40.6 yrs (18-82) from 32 countries were enrolled & 4232 (69.6%) completed the study (9-24 weeks) Baseline average IELT was 0.9 min (DSM IV TR, less than 2 mins) 58% subjects met criteria for lifelong PE Primary outcome measure was stopwatch IELT Secondary outcome measure was Premature Ejaculation Profile (PEP) a validated tool that includes perceived control over ejaculation, satisfaction with intercourse, ejaculation related personal distress & interpersonal difficulty and subject response to Clinical Global Impression of Change (CGIC) Dapoxetine dose 30 mg 60 mg Placebo (n=1613) (n=1611) (n=1608) Mean baseline IELT 0.9 0.9 0.9 Mean treatment IELT 3.1 3.6 1.9 IELT fold increase 2.5 3.0 1.6 Good/very good control over ejaculation % baseline 0.3 0.6 0.5 % study end 26.2 30.2 11.2 Good/very good satisfaction % baseline 15.5 14.7 15.5 % study end 37.3 42.8 24.4 Quite a bit/extreme personal distress % baseline 73.5 71.3 69.7 % study end 28.2 22.2 41.9 Quite a bit/extreme interpersonal distress Changes in IELT(mins) over time 4 3.5 3 2.5 Placebo 1 Series 2 Series 2 Dapoxetine 30 mg 1.5 Series 3 Dapoxetine 60 mg 1 0.5 0 Baseline Week 4 Week 8 Week 12 Week 24 Percentage of subjectsreporting that their PE was better/much better at 12 weeks (CGIC) 45 Placebo 40 Dapoxetine 30 35 mg 30 Dapoxetine 60 25 mg 20 15 10 5 0 Category 1 Effect of dapoxetineon female partner Dapoxetine dose 30 mg 60 mg Placebo Good/very good control over 26.7 % 34.3 % 11.9 % ejaculation Good/very good satisfaction 37.5 % 44.7 % 24.0 % Man’s PE was better 27.5 % 35.7 % 9.0 % Ejaculation related personal Significant Significant - distress decrease decrease Interpersonal difficulties Significant Significant - decrease decrease Dapoxetine analysis Effect on mood:- Scores for Beck Depression Inventory (BDI-II) & Montgomery Asberg Depression Rating Scale (MADRS) decreased slightly or stayed same over time.

(Decrease in depression symptoms/no worsening of symptoms) Effect on anxiety:- Mean Hamilton Anxiety Scale (HAM- A) scores decreased slightly. (Decrease in anxiety/no worsening of anxiety ) Effect on akathisia:- Barnes Akathisia Rating Scale (BARS) scores did not changed. (No change in akathisia) Effect on suicidality:- BDI-II or MADRS score of 0 on suicidality item. Safety Adverse event occurred in 56.1% subjects v/s 35.1% in placebo.

• Dapoxetin is generally well-tolerated with minimal interactions.
• Sildenafil interacts with nitrates, causing dangerous blood pressure drops.
• Inform your doctor of all medications you are taking.

[Most AE were of mild to moderate category(3%) or serious (less than 1%)] Nausea, diarrhea, headache, dizziness, insomnia, somnolence, fatigue, nasopharyngitis were most common S/Es (More than half AE were reported within 4 weeks) Erectile dysfunction is most common sexual S/E (placebo,1.6%; dapoxetin 30mg prn, 2.3%; dapoxetin 60mg prn, 2.6%; dapoxetin 60mg qd.1.2% ) Syncope occurred in 0.05%, 0.06%, 0.23% of subjects with placebo, dapoxetine 30mg, dapoxetine 60mg Safety AE led to discontinuation of 1.0%, 3.5%, 8.8%, 10.0% of subjects with placebo, dapoxetine 30mg prn, dapoxetine 60mg prn, dapoxetine 60mg qd Discontinuation Emergent Signs & Symptoms (DESS):- It comprises of 43 possible withdrawal signs & symptoms Incidence of discontinuation syndrome was 3, 1.1, 1.3% for those continuing to take dapoxetine 30, 60 mg prn & placebo respectively (Lack of chronic serotonergic stimulation & receptor desensitization) Doses & administration Starting dose is 30mg taken as needed, about 1-3 hrs before intercourse If effect of 30mg is insufficient and AE are acceptable, the dose can be increased for maximum of 60mg Maximum dosing frequency is once in every 24 hrs USE IN SPECIALPOPULATION Contraindicated in Men with moderate to severe hepatic impairment, severe renal impairment concomitant therapy with potent CYP3A4 inhibitors (ketoconazole, erythromycin), thioridazine, other SSRI/SNRI/TCA Use cautiously in Mild hepatic, mild to moderate renal impairment concomitant therapy with potent CYP2D6 inhibitor or moderate CYP3A4 inhibitors Alcohol or recreational drugs should be avoided with TO SUMMARISE First & only SSRI specifically developed for treatment of PE Rapid oral absorption, Rapid elimination Minimal accumulation Metabolized in liver by CYP3A4 & CYP2D6 Metabolites excreted in urine Ejaculo-Selective Serotonin Transport Inhibitor (ESSTIs) Convenience of on demand dosing Starting dose is 30 mg 1-3 hrs prior to intercourse Efficacy appears with 1st dose Can be increased up to 60 mg Not to use more than once in 24 hrs TO SUMMARISE Significant improvements in IELT, ejaculatory control, sexual satisfaction Reduction in personal and interpersonal distress Improved relationships & quality of life Severe the illness, better the improvement Common AE are nausea, headache, dizziness, somnolence, insomnia No change in blood pressure, heart rate, ECG No discontinuation syndrome Rare serious side effects TO SUMMARISE Avoid with hepatic, severe renal impairment, concomitant potent CYP3A4 & CYP2D6 inhibitors & alcohol Lack of chronic serotonergic stimulation & receptor desensitization minimize risk of withdrawal syndrome At present it has largest efficacy and safety database for use in men with PE PROS & CONS Potentialadvantages On demand medicine Significant improvement in IELT & PEP Less frequent side effects No withdrawal symptoms Potential disadvantages Lack of studies Not U.S.

Cơ chế hoạt động

Octavius Pharma has developed DC granules of Sildenafil Citrate + Dapoxetine HCl for making Sildenafil Citrate + Dapoxetine HCl plain tablets. Product has been developed to produce uniform particles that help give a better flow-ability in a way that facilitates tablet compression maintain content uniformity and designed to release drug within 15 minutes. Finished tablet qualitative composition and dissolution profile is in line with the Innovator “Priligy” throughout shelf life, Granules complies as per IH specification. Sildenafil Citrate + Dapoxetine HCl: Sildenafil+Dapoxetine is used in the treatment of premature ejaculation. It is a combination of two medicines, Sildenafil is a phosphodiesterase type 5 (PDE 5) inhibitor which works by increasing blood flow to the penis during sexual stimulation and enables its erection following sexual stimulation.

Xuất tinh sớm

Dapoxetine is a selective serotonin reuptake inhibitor (SSRI) which increases the level of serotonin in nerves to increase the time taken to ejaculate and improve control over ejaculation. For inquiries and collaboration opportunities, reach out to us today! Your gateway to innovative healthcare solutions awaits! Cenforce d 100 60 mg vary per patient is said to multiple reasons that you must consult your health.

ATC (Anatomical Therapeutic Chemical Classification)

FDA, UK approved Several drug to drug interactions Can not be used in hepatic and renal dysfunction Future trend Development of drug that act as antagonist on 5HT 1A receptor & inhibit the serotonergic transmission at synapse A simple, specific and accurate reverse phase high performance liquid chromatographic method was developed for the simultaneous determination Sildenafil and Dapoxetine in pharmaceutical dosage form.

Tên thương mại

Study drug was administered 2 hrs prior to planned intercourse Primary efficacy measure was IELT measured by partner operated switch Result of dapoxetinephase 2 study (Hellstrom et al 2004) Age range (yrs)- 18-60 Inclusion IELT- less than 2 mins estimated Treatment period- 4 weeks/treatment Dapoxetine Dose 20 mg 40 mg Placebo (n=145) (n=141) (n=142) Mean baseline IELT 1.34 1.34 1.34 Mean treatment IELT 2.72 3.31 2.22 IELT fold increase 2 2.5 1.7 Discontinuation due to adverse 0 2 0 effect Result of dapoxetinephase 2 study (Hellstrom et al 2005) Age range (yrs)- 18-65 Inclusion IELT- less than 2 mins by stopwatch Treatment period- 2 weeks/treatment Dapoxetine Dose 60 mg 100 mg Placebo (n=144) (n=155) (n=145) Mean baseline IELT 1.01 1.01 1.01 Mean treatment IELT 2.86 3.24 2.07 IELT fold increase 2.9 3.2 2.0 Discontinuation due to 0 9 1 adverse effect Analysis Magnitude of effect of 20 mg dapoxetine on IELT was small Adverse events were dose dependant Most common AE were nausea, diarrhea headache, dizziness Overall 60 mg dose was better tolerated Most common reason of study withdrawal at dose 100 mg was nausea Based on these results 30, 60 mg dose were chosen for phase 3 study Phase 3 studies:- To present safety & efficacy data five randomized, double blinded, placebo controlled studies conducted in over 25 countries All studies enrolled heterosexual men & their partners who were more than 18 yrs age, in monogamous relationship and met DSMIV TR criteria for PE Study Description Treatmen Randomiz Inclusion criteria t duration ed subjects U.S. Multicentre, D/B, 12 weeks 1294 IELT less than 2 mins during randomized, placebo 2 wks baseline period, met Study controlled DSM IV TR criteria U.S. Multicentre, D/B, 12 weeks 1320 Same as above randomized, placebo Study controlled Internation Multicentre, D/B, 24 weeks 1162 IELT less than 2 mins during randomized, placebo 4 week baseline period, met al Study controlled DSM IV TR criteria Asia Multicentre, D/B, 12 weeks 1067 Same as above randomized, placebo Pacific controlled Study Phase 3 studiespooled data analysis This is the largest efficacy and safety database for any agent intended to treat PE Overall 6081 men with mean age of 40.6 yrs (18-82) from 32 countries were enrolled & 4232 (69.6%) completed the study (9-24 weeks) Baseline average IELT was 0.9 min (DSM IV TR, less than 2 mins) 58% subjects met criteria for lifelong PE Primary outcome measure was stopwatch IELT Secondary outcome measure was Premature Ejaculation Profile (PEP) a validated tool that includes perceived control over ejaculation, satisfaction with intercourse, ejaculation related personal distress & interpersonal difficulty and subject response to Clinical Global Impression of Change (CGIC) Dapoxetine dose 30 mg 60 mg Placebo (n=1613) (n=1611) (n=1608) Mean baseline IELT 0.9 0.9 0.9 Mean treatment IELT 3.1 3.6 1.9 IELT fold increase 2.5 3.0 1.6 Good/very good control over ejaculation % baseline 0.3 0.6 0.5 % study end 26.2 30.2 11.2 Good/very good satisfaction % baseline 15.5 14.7 15.5 % study end 37.3 42.8 24.4 Quite a bit/extreme personal distress % baseline 73.5 71.3 69.7 % study end 28.2 22.2 41.9 Quite a bit/extreme interpersonal distress Changes in IELT(mins) over time 4 3.5 3 2.5 Placebo 1 Series 2 Series 2 Dapoxetine 30 mg 1.5 Series 3 Dapoxetine 60 mg 1 0.5 0 Baseline Week 4 Week 8 Week 12 Week 24 Percentage of subjectsreporting that their PE was better/much better at 12 weeks (CGIC) 45 Placebo 40 Dapoxetine 30 35 mg 30 Dapoxetine 60 25 mg 20 15 10 5 0 Category 1 Effect of dapoxetineon female partner Dapoxetine dose 30 mg 60 mg Placebo Good/very good control over 26.7 % 34.3 % 11.9 % ejaculation Good/very good satisfaction 37.5 % 44.7 % 24.0 % Man’s PE was better 27.5 % 35.7 % 9.0 % Ejaculation related personal Significant Significant - distress decrease decrease Interpersonal difficulties Significant Significant - decrease decrease Dapoxetine analysis Effect on mood:- Scores for Beck Depression Inventory (BDI-II) & Montgomery Asberg Depression Rating Scale (MADRS) decreased slightly or stayed same over time. (Decrease in depression symptoms/no worsening of symptoms) Effect on anxiety:- Mean Hamilton Anxiety Scale (HAM- A) scores decreased slightly. (Decrease in anxiety/no worsening of anxiety ) Effect on akathisia:- Barnes Akathisia Rating Scale (BARS) scores did not changed.

Chemical Formula

(No change in akathisia) Effect on suicidality:- BDI-II or MADRS score of 0 on suicidality item. Safety Adverse event occurred in 56.1% subjects v/s 35.1% in placebo. [Most AE were of mild to moderate category(3%) or serious (less than 1%)] Nausea, diarrhea, headache, dizziness, insomnia, somnolence, fatigue, nasopharyngitis were most common S/Es (More than half AE were reported within 4 weeks) Erectile dysfunction is most common sexual S/E (placebo,1.6%; dapoxetin 30mg prn, 2.3%; dapoxetin 60mg prn, 2.6%; dapoxetin 60mg qd.1.2% ) Syncope occurred in 0.05%, 0.06%, 0.23% of subjects with placebo, dapoxetine 30mg, dapoxetine 60mg Safety AE led to discontinuation of 1.0%, 3.5%, 8.8%, 10.0% of subjects with placebo, dapoxetine 30mg prn, dapoxetine 60mg prn, dapoxetine 60mg qd Discontinuation Emergent Signs & Symptoms (DESS):- It comprises of 43 possible withdrawal signs & symptoms Incidence of discontinuation syndrome was 3, 1.1, 1.3% for those continuing to take dapoxetine 30, 60 mg prn & placebo respectively (Lack of chronic serotonergic stimulation & receptor desensitization) Doses & administration Starting dose is 30mg taken as needed, about 1-3 hrs before intercourse If effect of 30mg is insufficient and AE are acceptable, the dose can be increased for maximum of 60mg Maximum dosing frequency is once in every 24 hrs USE IN SPECIALPOPULATION Contraindicated in Men with moderate to severe hepatic impairment, severe renal impairment concomitant therapy with potent CYP3A4 inhibitors (ketoconazole, erythromycin), thioridazine, other SSRI/SNRI/TCA Use cautiously in Mild hepatic, mild to moderate renal impairment concomitant therapy with potent CYP2D6 inhibitor or moderate CYP3A4 inhibitors Alcohol or recreational drugs should be avoided with TO SUMMARISE First & only SSRI specifically developed for treatment of PE Rapid oral absorption, Rapid elimination Minimal accumulation Metabolized in liver by CYP3A4 & CYP2D6 Metabolites excreted in urine Ejaculo-Selective Serotonin Transport Inhibitor (ESSTIs) Convenience of on demand dosing Starting dose is 30 mg 1-3 hrs prior to intercourse Efficacy appears with 1st dose Can be increased up to 60 mg Not to use more than once in 24 hrs TO SUMMARISE Significant improvements in IELT, ejaculatory control, sexual satisfaction Reduction in personal and interpersonal distress Improved relationships & quality of life Severe the illness, better the improvement Common AE are nausea, headache, dizziness, somnolence, insomnia No change in blood pressure, heart rate, ECG No discontinuation syndrome Rare serious side effects TO SUMMARISE Avoid with hepatic, severe renal impairment, concomitant potent CYP3A4 & CYP2D6 inhibitors & alcohol Lack of chronic serotonergic stimulation & receptor desensitization minimize risk of withdrawal syndrome At present it has largest efficacy and safety database for use in men with PE PROS & CONS Potentialadvantages On demand medicine Significant improvement in IELT & PEP Less frequent side effects No withdrawal symptoms Potential disadvantages Lack of studies Not U.S. FDA, UK approved Several drug to drug interactions Can not be used in hepatic and renal dysfunction Future trend Development of drug that act as antagonist on 5HT 1A receptor & inhibit the serotonergic transmission at synapse A simple, specific and accurate reverse phase high performance liquid chromatographic method was developed for the simultaneous determination Sildenafil and Dapoxetine in pharmaceutical dosage form. The column used was Kromasil C18(150mm x 4.6 mm, 5mm) in isocratic mode, with mobile phase containing phosphate buffer(accurately weighed 1.36gm of Potassium dihydrogen Ortho phosphate in a 1000ml of Volumetric flask add about 900ml of milli-Q water added and degas to sonicate, add 0.5ml of Triethylamine, finally made up the volume with water and pH adjusted to 3.5 with dil.

Brand Names

The flow rate was 1.0ml/ min and effluents dapoxetine 60mg tablet price were monitored at 293nm. The retention times of Sildenafil and Dapoxetine were found to be 2.813mins and 4.447mins, respectively. The recoveries of Sildenafil and Dapoxetine were found to be 98.52 to 100.54% and 98.61 to 100.43%, respectively. The proposed method was validated and successfully applied to the estimation of Sildenafil and Dapoxetine in combined tablet dosage forms. Skip to content Sildenafil Citrate + Dapoxetine HCl DC Grade Enquire Now Want to develop a new product? The column used was Kromasil C18(150mm x 4.6 mm, 5mm) in isocratic mode, with mobile phase containing phosphate buffer(accurately weighed 1.36gm of Potassium dihydrogen Ortho phosphate in a 1000ml of Volumetric flask add about 900ml of milli-Q water added and degas to sonicate, add 0.5ml of Triethylamine, finally made up the volume with water and pH adjusted to 3.5 with dil. The flow rate was 1.0ml/ min and effluents dapoxetine 60mg tablet price were monitored at 293nm. The retention times of Sildenafil and Dapoxetine were found to be 2.813mins and 4.447mins, respectively.

The recoveries of Sildenafil and Dapoxetine were found to be 98.52 to 100.54% and 98.61 to 100.43%, respectively. The proposed method was validated and successfully applied to the estimation of Sildenafil and Dapoxetine in combined tablet dosage forms.

Chống chỉ định

Skip to content Sildenafil Citrate + Dapoxetine HCl DC Grade Enquire Now Want to develop a new product? Octavius Pharma has developed DC granules of Sildenafil Citrate + Dapoxetine HCl for making Sildenafil Citrate + Dapoxetine HCl plain tablets.

Product has been developed to produce uniform particles that help give a better flow-ability in a way that facilitates tablet compression maintain content uniformity and designed to release drug within 15 minutes. Finished tablet qualitative composition and dissolution profile is in line with the Innovator “Priligy” throughout shelf life, Granules complies as per IH specification. Sildenafil Citrate + Dapoxetine HCl: Sildenafil+Dapoxetine is used in the treatment of premature ejaculation. It is a combination of two medicines, Sildenafil is a phosphodiesterase type 5 (PDE 5) inhibitor which works by increasing blood flow to the penis during sexual stimulation and enables its erection following sexual stimulation. Dapoxetine is a selective serotonin reuptake inhibitor (SSRI) which increases the level of serotonin in nerves to increase the time taken to ejaculate and improve control over ejaculation. For inquiries and collaboration opportunities, reach out to us today! Your gateway to innovative healthcare solutions awaits!

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Cenforce d 100 60 mg vary per patient is said to multiple reasons that you must consult your health.

• Environmental factors like stress or relationship issues can override drug effects.
• The drugs facilitate the physical response but do not create desire.
• A low libido (sex drive) may need to be addressed separately.
• Testosterone replacement therapy might be considered if levels are low.
• The combination does not protect against sexually transmitted infections (STIs).
• Safe sex practices remain important regardless of medical treatment.
• There is no interaction between these drugs and condoms or lubricants.
• The treatment is for heterosexual and homosexual men alike.
• The principles of diagnosis and treatment apply regardless of sexual orientation.
• Cultural and religious beliefs may influence a patient's decision to pursue treatment.
• A doctor must provide culturally sensitive care and respect patient choices.