Clinical Uses of Combined Dapoxetine Sildenafil

For our accomplishment story, we are grateful to our Mr. Amitrajan Sharma , whose continual backing and direction have been useful to us for attaining exponential development in the current market Menarini, Singapore; Berlin Chemie, Bosnia & Herzegowina; Berlin-Chemie, Croatia (Hrvatska); Berlin-Chemie, Lithuania; Berlin-Chemie, Latvia; Berlin-Chemie, Romania; Berlin-Chemie/ Menarini, Poland; Janssen, Lebanon; Menarini, Slovakia; UFSA, Turkey; Zuellig, Philippines PriligyA Menarini Australia, Australia; A. Menarini, Hong Kong; A. Menarini, Ireland; A. Menarini, South Korea; A. Menarini, Portugal; A. Menarini, Thailand; A. Menarini Farmaceutica Internazionale, United Kingdom; A. Menarini New Zealand, New Zealand; A.

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Most cases are due to performance anxiety Etiology:- Combination of Psychogenic and Organic factor is presumed, with role of endocrinopathy, Peyronie disease & Prostatitis PE is a psychosomatic disturbance & due to over Biological anxious personality Young Genes age Cultural Etiology of PrematureEjaculation Low 5HT Hyposensitivity of neurotransmission 5HT2C Ejaculatory threshold genetically "set" at a lower point Ejaculate quickly and with minimal stimulation Epidemiology:- PE isthe most prevalent male sexual dysfunction (4-39% of men in general community) Distribution of IELT values in a random cohort of 491 men demonstrated median IELT of 5.4 min. (range 1-45 min) Median IELT decreased with age Median IELT varied between countries (Waldinger, Quinn 2005) In a study of 1326 men with PE:- lifelong PE was present in 74.4% men acquired PE was found in 25.6% men (McMohan 2002) Men with PE appear younger than those without. (Fasolo, Mirone 2005) No association found with HTN, Cardiac disease, Peripheral or central neuropathy MANAGEMENT OF PE Detailed medical & sexual history should be taken Physical examination Appropriate investigation Identify obvious biological causes as genital & urinary tract infection Treatment encompasses:- Behavioral aspect Pharmacological aspect Psychological aspect TREATMENT OF PREMATURE EJACUALTION Incorporate into sexual practice Behavioural techniques - stop/start, squeeze Oral medication - SSRI, clomipramine, PDE5i Intra-cavernosal injections Anaesthetic cream Pelvic floor exercises Surgery to dorsal nerve (Brazil) Treatment PE cont’d Sensate focus: Tailor to clients, work on intimacy Sexual script change: Extend foreplay, modify rigid sex patterns, “partner first” Treatment aim: Restore IELT, address relationship issues, restore confidence Pharmacological management SSRIs has been used as off the label drugs for the treatment of PE for past 15 to 20 years utilizing its side effect delayed ejaculation as therapeutic effect Paroxetin, Fluoxetin, Sertraline, Cetalopram, Fluvoxamine and Clomipramine has revolutionized the approach to treat PE Yet daily dosing, long half life, accumulation of drug, gradual receptor desensitization and other side effects of long acting SSRIs were the drawbacks However lack of approved drug & total reliance on off Ejaculo-Selective Serotonin TransportInhibitor (ESSTIs) Drugs under investigation are Dapoxetine UK-390 UK-957 Tramadol Dapoxetine, an SSRI is first oral pharmacological agent indicated for treatment of men aged 18- 64 years with PE Has been approved in various European countries, South America & Asia Pacific It is novel potent SSRI structurally similar to Fluoxetin Pharmacokinetics Oral formulation Rapidly absorbed Absolute bioavailability 42% Tmax of 1.4-2 hrs Cmax of 1.01-1.27 hrs Initial half life 1.3-1.5 hrs Terminal half life 15-19 hrs Steady state plasma conc.

Chemical Formula

Menarini Singapore, Vietnam; Berlin-Chemie, Czech Republic; Berlin-Chemie, Germany; Berlin-Chemie, Estonia; Berlin-Chemie, Norway; Berlin-Chemie, Sweden; Janssen-Cilag, Italy; Laboratorios Menarini, Spain; Menarini, Belgium; Menarini, Finland; Menarini, France; Menarini, Georgia; Menarini, Greece; Menarini, Mexico; Menarini, Malaysia; Menarini, Netherlands; Menarini International, Malta; A.Menarini China Holding Co., Ltd., China Priligy 30mgBerlin-Chemie, Austria; Berlin-Chemie, Hungary; Menarini, Switzerland; Menarini, Luxembourg Further information on drug naming conventions: International Nonproprietary Names.

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Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. 0% found this document useful (0 votes) This research article presents the development and validation of a rapid and sensitive RP-HPLC method for the simultaneous estimation of Sildenafil Citrate and Dapoxetine Hydrochloride in ph… 0% found this document useful (0 votes) This research article presents the development and validation of a rapid and sensitive RP-HPLC method for the simultaneous estimation of Sildenafil Citrate and Dapoxetine Hydrochloride in pharmaceutical dosage forms. The study highlights the importance of these drugs in treating premature ejaculation and erectile dysfunction, detailing the methodology for sample preparation and chromatographic conditions.

How do I take Priligy, and how often?

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. 0% found this document useful (0 votes) This research article presents the development and validation of a rapid and sensitive RP-HPLC method for the simultaneous estimation of Sildenafil Citrate and Dapoxetine Hydrochloride in ph… 0% found this document useful (0 votes) This research article presents the development and validation of a rapid and sensitive RP-HPLC method for the simultaneous estimation of Sildenafil Citrate and Dapoxetine Hydrochloride in pharmaceutical dosage forms. The study highlights the importance of these drugs in treating premature ejaculation and erectile dysfunction, detailing the methodology for sample preparation and chromatographic conditions. The results indicate that the method is effective for the analysis of these compounds, ensuring accuracy and reliability in pharmaceutical applications. 0% found this document useful (0 votes) This research article presents the development and validation of a rapid and sensitive RP-HPLC method for the simultaneous estimation of Sildenafil Citrate and Dapoxetine Hydrochloride in ph… DAPOXETINE IN SEXUAL DYSFUNCTIONS PRESENTOR DR.

ATC (Anatomical Therapeutic Chemical Classification)

ANANT KUMAR RATHI 2nd YEAR RESIDENT GUIDE DR. D. K. SHARMA PROF. & HEAD, DEPTT. The results indicate that the method is effective for the analysis of these compounds, ensuring accuracy and reliability in pharmaceutical applications. 0% found this document useful (0 votes) This research article presents the development and validation of a rapid and sensitive RP-HPLC method for the simultaneous estimation of Sildenafil Citrate and Dapoxetine Hydrochloride in ph… DAPOXETINE IN SEXUAL DYSFUNCTIONS PRESENTOR DR. ANANT KUMAR RATHI 2nd YEAR RESIDENT GUIDE DR. D. K. SHARMA PROF. & HEAD, DEPTT. NORMAL PHYSIOLOGY (GanongPhysiology) ERECTION EJACULATION AUTONOMIC PARASYMPATHETIC SYMPATHETIC NERVOUS SYSTEM SYSTEM SYSTEM AFFERENT PUDENDAL NERVE & PUDENDAL NERVE SACRAL PLEXUS RELAY SACRAL SEGMENTS LUMBAR SEGMENTS OF SPINAL CORD OF SPINAL CORD EFFERENT PELVIC SPLANCHNIC HYPOGASTRIC & NERVE (NERVI PELVIC SYMPATHETIC ERIGENTIS) PLEXUS NEUROTRANSMITOR NITRIC OXIDE (NO) CARBON MONOXIDE (CO) Phases of SexualResponse Cycle & Associated Sexual Dysfunctions PHASES CHARACTERSTICS DYSFUNCTION 1.

• There is no evidence that this combination affects fertility or sperm quality.
• Dapoxetine, as an SSRI, has been associated with slight changes in semen parameters.
• These changes are not thought to be clinically significant for fertility.
• Sildenafil has no known negative impact on sperm count or motility.
• Men trying to conceive should discuss any medications with their doctor.
• The drugs are not known to cause birth defects if a partner is exposed to semen.
• However, this is not a well-studied area, and caution is always advised.
• The primary focus of treatment is on the male partner's sexual function.
• The female partner's satisfaction is an important secondary outcome measure.
• Open communication between partners about the treatment is encouraged.
• Sexual dysfunction is a couples' issue, and treatment should involve both partners when possible.

Desire Reflects person’s motivations, drives & Hypoactive sexual desire personality; characterized by sexual disorder; sexual aversion fantasies & desire to have sex disorder (male or female) 2. Subjective sense of sexual pleasure & Female sexual arousal Excitement accompanying physiological responses disorder (sexual flush, erection by vasocongestion, Male erectile disorder; tightening & lifting of scrotal sac, increase dyspareunia size of testes ) 3. Orgasm Peaking of sexual pleasure, release of Orgasmic disorder (male & sexual tension & rhythmic contraction of female); premature perineal muscles and pelvic reproductive ejaculation organs 4.

Condition	Dapoxetin	Sildenafil
Cardiovascular disease	Use cautiously	Contraindicated with nitrates
Use with MAO inhibitors	Avoid	Avoid
Liver impairment	Dose adjustment required	Use with caution
Eye Disorders (e.g., retinitis pigmentosa)	No specific caution	Caution due to rare visual disturbances
Medication interactions	Serotonergic drugs may increase risk of serotonin syndrome	Other vasodilators or antihypertensives

A sense of general relaxation, wellbeing & Post coital dysphoria; post Resolution muscle relaxation coital headache PHYSIOLOGY OF EJACULATION Normal ante grade ejaculation:- 3 basic mechanism (Lipshultz 1981) (1) Emission:- Result of a sympathetic spinal cord reflex Initiated by genital/cerebral erotic stimuli Involves sequential contraction of accessory sexual organs (2) Ejection:- Involve bladder neck closure Rhythmic contraction of bulbocavernosus, bulbospongiosus and other dapoxetine over counter pelvic floor muscles Relaxation of external urethral sphincter (Yeates 1987) (3) Orgasm:- Result of cerebral processing of pudendal nerve sensory stimuli resulting from increased pressure in posterior urethra, contraction of urethral bulb & accessory sexual Neurology of ejaculation Seminal emission & ejection are integrated by medial preoptic area(MPOA) and nucleus paragigantocellularis (nPGI) Descending serotonergic pathway from nPGI to lumbosacral motor nuclei tonically inhibit ejaculation (Yells 1992) Disinhibition of nPGI by MPOA facilitates ejaculation Lumbar spinothalamic neurons send projection to autonomic nuclei & motor neurons involved in emission and ejection, while they receive sensory projection from pelvis Neurobiology of ejaculation(Ahlenius 1981) Ejaculatory reflex is controlled by central serotonergic & dopaminegric neurons with secondary involvement of cholinergic, adrenergic, nitregic, oxytocinergic neurons Speed of ejaculation appears to be determined by 5HT2C & 5HT1A receptors Stimulation of postsynaptic 5HT2C receptor by its agonist delays ejaculation Stimulation of somatodendritic 5HT1A receptors decreases ejaculation latency The Male SexualResponse Sexual Ejaculation Interest/ Orgasm Accompanied by Stimulation Orgasm Penile Penile Penetration tumescence Detumesence Plateau Resolution High arousal/ Erection Excitement Time Premature Ejaculation (PE)[ICD-10 F52.4] WHO 2nd International consultation on sexual health:- “Persistent or recurrent ejaculation with minimal stimulation before, on, or shortly after penetration, and before the person wishes it, over which the sufferer has little or no voluntary control, which causes the sufferer and/or his partner bother or distress” (Leu et al 2004) International Society for Sexual Medicine(ISSM) :- “ Male sexual dysfunction characterized by ejaculation which always or nearly always occurs before or within approximately 1 minute of vaginal penetration; the inability to delay ejaculation on all or nearly all vaginal penetration; and negative personal consequences such as distress, bother, frustration and/or the avoidance of sexual intimacy” Recent normative data suggest that men with an :- Intravaginal Ejaculatory Latency Time (IELT) less than 1 min have “definite PE” IELT between 1 and 1.5 min have “probable PE” (Waldiner, Zwinderman 2005) DSM IV TRDiagnostic criteria for PE A. Persistent or recurrent ejaculation with minimal stimulation before, on, or shortly after penetration, and before the person wishes it. The clinician must take into account factors that affect duration of excitement phase, such as age, novelty of sexual partner or situation, and recent frequency of sexual activity.B. The disturbance causes marked distress or interpersonal difficulty.

Sildenafil Citrate + Dapoxetine HCl DC Grade

NORMAL PHYSIOLOGY (GanongPhysiology) ERECTION EJACULATION AUTONOMIC PARASYMPATHETIC SYMPATHETIC NERVOUS SYSTEM SYSTEM SYSTEM AFFERENT PUDENDAL NERVE & PUDENDAL NERVE SACRAL PLEXUS RELAY SACRAL SEGMENTS LUMBAR SEGMENTS OF SPINAL CORD OF SPINAL CORD EFFERENT PELVIC SPLANCHNIC HYPOGASTRIC & NERVE (NERVI PELVIC SYMPATHETIC ERIGENTIS) PLEXUS NEUROTRANSMITOR NITRIC OXIDE (NO) CARBON MONOXIDE (CO) Phases of SexualResponse Cycle & Associated Sexual Dysfunctions PHASES CHARACTERSTICS DYSFUNCTION 1. Desire Reflects person’s motivations, drives & Hypoactive sexual desire personality; characterized by sexual disorder; sexual aversion fantasies & desire to have sex disorder (male or female) 2. Subjective sense of sexual pleasure & Female sexual arousal Excitement accompanying physiological responses disorder (sexual flush, erection by vasocongestion, Male erectile disorder; tightening & lifting of scrotal sac, increase dyspareunia size of testes ) 3. Orgasm Peaking of sexual pleasure, release of Orgasmic disorder (male & sexual tension & rhythmic contraction of female); premature perineal muscles and pelvic reproductive ejaculation organs 4. A sense of general relaxation, wellbeing & Post coital dysphoria; post Resolution muscle relaxation coital headache PHYSIOLOGY OF EJACULATION Normal ante grade ejaculation:- 3 basic mechanism (Lipshultz 1981) (1) Emission:- Result of a sympathetic spinal cord reflex Initiated by genital/cerebral erotic stimuli Involves sequential contraction of accessory sexual organs (2) Ejection:- Involve bladder neck closure Rhythmic contraction of bulbocavernosus, bulbospongiosus and other dapoxetine over counter pelvic floor muscles Relaxation of external urethral sphincter (Yeates 1987) (3) Orgasm:- Result of cerebral processing of pudendal nerve sensory stimuli resulting from increased pressure in posterior urethra, contraction of urethral bulb & accessory sexual Neurology of ejaculation Seminal emission & ejection are integrated by medial preoptic area(MPOA) and nucleus paragigantocellularis (nPGI) Descending serotonergic pathway from nPGI to lumbosacral motor nuclei tonically inhibit ejaculation (Yells 1992) Disinhibition of nPGI by MPOA facilitates ejaculation Lumbar spinothalamic neurons send projection to autonomic nuclei & motor neurons involved in emission and ejection, while they receive sensory projection from pelvis Neurobiology of ejaculation(Ahlenius 1981) Ejaculatory reflex is controlled by central serotonergic & dopaminegric neurons with secondary involvement of cholinergic, adrenergic, nitregic, oxytocinergic neurons Speed of ejaculation appears to be determined by 5HT2C & 5HT1A receptors Stimulation of postsynaptic 5HT2C receptor by its agonist delays ejaculation Stimulation of somatodendritic 5HT1A receptors decreases ejaculation latency The Male SexualResponse Sexual Ejaculation Interest/ Orgasm Accompanied by Stimulation Orgasm Penile Penile Penetration tumescence Detumesence Plateau Resolution High arousal/ Erection Excitement Time Premature Ejaculation (PE)[ICD-10 F52.4] WHO 2nd International consultation on sexual health:- “Persistent or recurrent ejaculation with minimal stimulation before, on, or shortly after penetration, and before the person wishes it, over which the sufferer has little or no voluntary control, which causes the sufferer and/or his partner bother or distress” (Leu et al 2004) International Society for Sexual Medicine(ISSM) :- “ Male sexual dysfunction characterized by ejaculation which always or nearly always occurs before or within approximately 1 minute of vaginal penetration; the inability to delay ejaculation on all or nearly all vaginal penetration; and negative personal consequences such as distress, bother, frustration and/or the avoidance of sexual intimacy” Recent normative data suggest that men with an :- Intravaginal Ejaculatory Latency Time (IELT) less than 1 min have “definite PE” IELT between 1 and 1.5 min have “probable PE” (Waldiner, Zwinderman 2005) DSM IV TRDiagnostic criteria for PE A.

Global Distribution Network

Persistent or recurrent ejaculation with minimal stimulation before, on, or shortly after penetration, and before the person wishes it. The clinician must take into account factors that affect duration of excitement phase, such as age, novelty of sexual partner or situation, and recent frequency of sexual activity.B. The disturbance causes marked distress or interpersonal difficulty. C. The premature ejaculation is not due to exclusively to the direct effect of the substance (e.g., withdrawal from opioids) PE sub classification:- (Schapiro1943) Lifelong(Primary) PE :- Commences with onset of sexual activity Acquired(secondary) PE :- Develops following a period of normal ejaculatory response. C. The premature ejaculation is not due to exclusively to the direct effect of the substance (e.g., withdrawal from opioids) PE sub classification:- (Schapiro1943) Lifelong(Primary) PE :- Commences with onset of sexual activity Acquired(secondary) PE :- Develops following a period of normal ejaculatory response.

Possible Side Effects

For our accomplishment story, we are grateful to our Mr. Amitrajan Sharma , whose continual backing and direction have been useful to us for attaining exponential development in the current market Menarini, Singapore; Berlin Chemie, Bosnia & Herzegowina; Berlin-Chemie, Croatia (Hrvatska); Berlin-Chemie, Lithuania; Berlin-Chemie, Latvia; Berlin-Chemie, Romania; Berlin-Chemie/ Menarini, Poland; Janssen, Lebanon; Menarini, Slovakia; UFSA, Turkey; Zuellig, Philippines PriligyA Menarini Australia, Australia; A. Menarini, Hong Kong; A. Menarini, Ireland; A. Menarini, South Korea; A.

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Menarini, Portugal; A. Menarini, Thailand; A. Menarini Farmaceutica Internazionale, United Kingdom; A. Menarini New Zealand, New Zealand; A. Menarini Singapore, Vietnam; Berlin-Chemie, Czech Republic; Berlin-Chemie, Germany; Berlin-Chemie, Estonia; Berlin-Chemie, Norway; Berlin-Chemie, Sweden; Janssen-Cilag, Italy; Laboratorios Menarini, Spain; Menarini, Belgium; Menarini, Finland; Menarini, France; Menarini, Georgia; Menarini, Greece; Menarini, Mexico; Menarini, Malaysia; Menarini, Netherlands; Menarini International, Malta; A.Menarini China Holding Co., Ltd., China Priligy 30mgBerlin-Chemie, Austria; Berlin-Chemie, Hungary; Menarini, Switzerland; Menarini, Luxembourg Further information on drug naming conventions: International Nonproprietary Names. Most cases are due to performance anxiety Etiology:- Combination of Psychogenic and Organic factor is presumed, with role of endocrinopathy, Peyronie disease & Prostatitis PE is a psychosomatic disturbance & due to over Biological anxious personality Young Genes age Cultural Etiology of PrematureEjaculation Low 5HT Hyposensitivity of neurotransmission 5HT2C Ejaculatory threshold genetically "set" at a lower point Ejaculate quickly and with minimal stimulation Epidemiology:- PE isthe most prevalent male sexual dysfunction (4-39% of men in general community) Distribution of IELT values in a random cohort of 491 men demonstrated median IELT of 5.4 min. (range 1-45 min) Median IELT decreased with age Median IELT varied between countries (Waldinger, Quinn 2005) In a study of 1326 men with PE:- lifelong PE was present in 74.4% men acquired PE was found in 25.6% men (McMohan 2002) Men with PE appear younger than those without.

• Documented case reports of adverse events exist in medical literature.
• These often involve inappropriate use, overdose, or interaction with other drugs.
• The medical community remains cautious about widely recommending this combo.
• It is considered a second or third-line option after other treatments have failed.
• Lifestyle modifications are always recommended as a first-line intervention.
• Psychological therapies like CBT are effective for both PE and ED.
• The placebo effect can play a significant role in the treatment of sexual dysfunction.
• Clinical trials are always conducted with a placebo control group to account for this.
• The subjective nature of the endpoints makes designing robust trials challenging.
• Future research may provide clearer guidelines on the safe use of this combination.
• For now, it remains a valuable but carefully considered tool for specialists.

(Fasolo, Mirone 2005) No association found with HTN, Cardiac disease, Peripheral or central neuropathy MANAGEMENT OF PE Detailed medical & sexual history should be taken Physical examination Appropriate investigation Identify obvious biological causes as genital & urinary tract infection Treatment encompasses:- Behavioral aspect Pharmacological aspect Psychological aspect TREATMENT OF PREMATURE EJACUALTION Incorporate into sexual practice Behavioural techniques - stop/start, squeeze Oral medication - SSRI, clomipramine, PDE5i Intra-cavernosal injections Anaesthetic cream Pelvic floor exercises Surgery to dorsal nerve (Brazil) Treatment PE cont’d Sensate focus: Tailor to clients, work on intimacy Sexual script change: Extend foreplay, modify rigid sex patterns, “partner first” Treatment aim: Restore IELT, address relationship issues, restore confidence Pharmacological management SSRIs has been used as off the label drugs for the treatment of PE for past 15 to 20 years utilizing its side effect delayed ejaculation as therapeutic effect Paroxetin, Fluoxetin, Sertraline, Cetalopram, Fluvoxamine and Clomipramine has revolutionized the approach to treat PE Yet daily dosing, long half life, accumulation of drug, gradual receptor desensitization and other side effects of long acting SSRIs were the drawbacks However lack of approved drug & total reliance on off Ejaculo-Selective Serotonin TransportInhibitor (ESSTIs) Drugs under investigation are Dapoxetine UK-390 UK-957 Tramadol Dapoxetine, an SSRI is first oral pharmacological agent indicated for treatment of men aged 18- 64 years with PE Has been approved in various European countries, South America & Asia Pacific It is novel potent SSRI structurally similar to Fluoxetin Pharmacokinetics Oral formulation Rapidly absorbed Absolute bioavailability 42% Tmax of 1.4-2 hrs Cmax of 1.01-1.27 hrs Initial half life 1.3-1.5 hrs Terminal half life 15-19 hrs Steady state plasma conc.