Efficacy and safety of dapoxetine/sildenafil combination tablets in the treatment of men with premature ejaculation and concomitant erectile dysfunction-DAP-SPEED Study

Keep sildenafil tablets and all medicines out of the reach of children.

• Sildenafil is a phosphodiesterase type 5 (PDE5) inhibitor.
• Dapoxetine is a selective serotonin reuptake inhibitor (SSRI).
• Both medications can be part of a comprehensive ED or PE treatment plan.
• Overdose symptoms include persistent erections or severe dizziness.
• Avoid using these tablets if you have recent cardiovascular events.
• Alcohol consumption should be minimized when using these medications.
• Patients should monitor for any unusual or severe side effects.
• Regular medical check-ups are recommended during treatment.

General information about the safe and effective use of sildenafil tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. This Patient Information leaflet summarizes the most important information about sildenafil tablets. You can ask your healthcare provider or pharmacist for information about sildenafil tablets that is written for health professionals.

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

What are the ingredients in sildenafil tablets? This Patient Information has been approved by the U.S. Food and Drug Administration. *The other brands listed are trademarks of their respective owners and are not trademarks of Rubicon Research Limited. PACKAGE LABEL-PRINCIPAL DISPLAY PANEL Sildenafil Tablets 25 mg - NDC 72888-015-30 - 30 Tablets LabelSildenafil Tablets 25 mg - NDC 72888-015-05 - 500 Tablets LabelSildenafil Tablets 50 mg - NDC 72888-016-30 - 30 Tablets LabelSildenafil Tablets 50 mg - NDC 72888-016-01 - 100 Tablets LabelSildenafil Tablets 50 mg - NDC 72888-016-00 - 1000 Tablets LabelSildenafil Tablets 100 mg - NDC 72888-017-30 - 30 Tablets LabelSildenafil Tablets 100 mg - NDC 72888-017-01 - 100 Tablets LabelSildenafil Tablets 100 mg - NDC 72888-017-00 - 1000 Tablets Label Sildenafil Tablets 25 mg - NDC 72888-015-30 - 30 Tablets Label Sildenafil Tablets 25 mg - NDC 72888-015-05 - 500 Tablets Label Sildenafil Tablets 50 mg - NDC 72888-016-30 - 30 Tablets Label Sildenafil Tablets 50 mg - NDC 72888-016-01 - 100 Tablets Label Sildenafil Tablets 50 mg - NDC 72888-016-00 - 1000 Tablets Label Sildenafil Tablets 100 mg - NDC 72888-017-30 - 30 Tablets Label Sildenafil Tablets 100 mg - NDC 72888-017-01 - 100 Tablets Label Sildenafil Tablets 100 mg - NDC 72888-017-00 - 1000 Tablets Label INGREDIENTS AND APPEARANCE Inactive IngredientsCROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)SILICON DIOXIDE (UNII: ETJ7Z6XBU4)HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)MAGNESIUM STEARATE (UNII: 70097M6I30)CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)TITANIUM DIOXIDE (UNII: 15FIX9V2JP)TRIACETIN (UNII: XHX3C3X673)FD&C BLUE NO. 2 (UNII: L06K8R7DQK)Product CharacteristicsColorblueScoreno scoreShapeOVAL (biconvex)Size17mmFlavorImprint CodeR;100ContainsPackagingNDC:72888-017-3030 in 1 BOTTLE; Type 0: Not a Combination Product06/17/2021NDC:72888-017-01100 in 1 BOTTLE; Type 0: Not a Combination Product06/17/2021NDC:72888-017-001000 in 1 BOTTLE; Type 0: Not a Combination Product11/08/2021Marketing InformationANDAANDA20488206/17/2021Labeler - Advagen Pharma Ltd (051627256)Registrant - Rubicon Research Limited (918629544)EstablishmentRubicon Research Limited677604197manufacture(72888-015, 72888-016, 72888-017) , analysis(72888-015, 72888-016, 72888-017) , pack(72888-015, 72888-016, 72888-017) Exports To: United States Of America Australia United Kingdom Canada France United States Of America Australia United Kingdom Canada France We are one of the foremost Exporter & specialized of Pharmaceutical Tablets, Pharmaceutical Injections, Pharmaceutical Cream, Pharmaceutical Gel, Pharmaceutical Ointment, Pharmaceutical Lotion, Isotroin-20 Capsules,Isotroin-20 Capsules and much more.

Our professionals work in close coordination to assure a high-quality assortment of products to the customers. We have recruited a team dapoxetine 5mg of professionals.

5.5 Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives

In addition to this, to avoid disputes in the workplace, our professionals strive dedicatedly. Owing to our fare policies and the best quality products.Under the direction of our mentor, Mr. Vikas Jagdish Bhatia, we are creating a long list of clients. Also, owing to his knowledge, commitment, skills, and ethical business strategies, we have been able to achieve a renowned position in the market. Under the direction of our mentor, Mr.

Vikas Jagdish Bhatia, we are creating a long list of clients. Serefoglu, 058 The Efficacy and Safety of Dapoxetine / Sildenafil Combination Therapy in the Treatment of Men with Premature Ejaculation and Erectile Dysfunction – DAP-SPEED Study, The Journal of Sexual Medicine, Volume 16, Issue Supplement_1, April 2019, Page S30, Serefoglu, 058 The Efficacy and Safety of Dapoxetine / Sildenafil Combination Therapy in the Treatment of Men with Premature Ejaculation and Erectile Dysfunction – DAP-SPEED Study, The Journal of Sexual Medicine, Volume 16, Issue Supplement_1, April 2019, Page S30, Premature ejaculation (PE) and erectile dysfunction (ED) are the most prevalent sexual disorders in men. They were also instructed to complete Premature Ejaculation Diagnostic Tool (PEDT), Premature Ejaculation Profile (PEP) and International Index of Erectile Function-Erectile Function (IIEF-EF) score before and after the treatment. At the end of the study, patients were assessed with global impression of change (GIC) for the treatment satisfaction. DAPOXETINE IN SEXUAL DYSFUNCTIONS PRESENTOR DR.

Further information

Vikas Jagdish Bhatia, we are creating a long list of clients. Also, owing to his knowledge, commitment, skills, and ethical business strategies, we have been able to achieve a renowned position in the market. Under the direction of our mentor, Mr. Vikas Jagdish Bhatia, we are creating a long list of clients. Serefoglu, 058 The Efficacy and Safety of Dapoxetine / Sildenafil Combination Therapy in the Treatment of Men with Premature Ejaculation and Erectile Dysfunction – DAP-SPEED Study, The Journal of Sexual Medicine, Volume 16, Issue Supplement_1, April 2019, Page S30, Serefoglu, 058 The Efficacy and Safety of Dapoxetine / Sildenafil Combination Therapy in the Treatment of Men with Premature Ejaculation and Erectile Dysfunction – DAP-SPEED Study, The Journal of Sexual Medicine, Volume 16, Issue Supplement_1, April 2019, Page S30, Premature ejaculation (PE) and erectile dysfunction (ED) are the most prevalent sexual disorders in men.

ATC (Anatomical Therapeutic Chemical Classification)

They were also instructed to complete Premature Ejaculation Diagnostic Tool (PEDT), Premature Ejaculation Profile (PEP) and International Index of Erectile Function-Erectile Function (IIEF-EF) score before and after the treatment. At the end of the study, patients were assessed with global impression of change (GIC) for the treatment satisfaction. DAPOXETINE IN SEXUAL DYSFUNCTIONS PRESENTOR DR. ANANT KUMAR dapoxetine spain RATHI 2nd YEAR RESIDENT GUIDE DR. D.

Alcohol interaction warning

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. 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. ANANT KUMAR dapoxetine spain RATHI 2nd YEAR RESIDENT GUIDE DR. D. K. SHARMA PROF.

• Sildenafil's effects last approximately 4-6 hours.
• Dapoxetine's onset is rapid, within 1-3 hours of intake.
• Side effects of sildenafil may include nasal congestion and visual changes.
• Dapoxetine may cause dry mouth and sweating as side effects.
• Combining these drugs might increase the risk of side effects.
• Usage should be based on a healthcare provider’s assessment.
• Patients with kidney or liver issues need dosage adjustments.
• Proper storage of medications is essential to maintain efficacy.

& HEAD, DEPTT.

Can I take Priligy with other medicines?

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 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.

Prior authorization

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. 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.

Product Salbutamol 1.0 mg+Ambroxol 15.0 mg+ Guaphenesin 50 mg / 5 ml

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.

8.6 Renal Impairment

Keep sildenafil tablets and all medicines out of the reach of children. General information about the safe and effective use of sildenafil tablets. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. This Patient Information leaflet summarizes the most important information about sildenafil tablets. You can ask your healthcare provider or pharmacist for information about sildenafil tablets that is written for health professionals.

Warnings for other groups

What are the ingredients in sildenafil tablets? This Patient Information has been approved by the U.S. Food and Drug Administration. *The other brands listed are trademarks of their respective owners and are not trademarks of Rubicon Research Limited. PACKAGE LABEL-PRINCIPAL DISPLAY PANEL Sildenafil Tablets 25 mg - NDC 72888-015-30 - 30 Tablets LabelSildenafil Tablets 25 mg - NDC 72888-015-05 - 500 Tablets LabelSildenafil Tablets 50 mg - NDC 72888-016-30 - 30 Tablets LabelSildenafil Tablets 50 mg - NDC 72888-016-01 - 100 Tablets LabelSildenafil Tablets 50 mg - NDC 72888-016-00 - 1000 Tablets LabelSildenafil Tablets 100 mg - NDC 72888-017-30 - 30 Tablets LabelSildenafil Tablets 100 mg - NDC 72888-017-01 - 100 Tablets LabelSildenafil Tablets 100 mg - NDC 72888-017-00 - 1000 Tablets Label Sildenafil Tablets 25 mg - NDC 72888-015-30 - 30 Tablets Label Sildenafil Tablets 25 mg - NDC 72888-015-05 - 500 Tablets Label Sildenafil Tablets 50 mg - NDC 72888-016-30 - 30 Tablets Label Sildenafil Tablets 50 mg - NDC 72888-016-01 - 100 Tablets Label Sildenafil Tablets 50 mg - NDC 72888-016-00 - 1000 Tablets Label Sildenafil Tablets 100 mg - NDC 72888-017-30 - 30 Tablets Label Sildenafil Tablets 100 mg - NDC 72888-017-01 - 100 Tablets Label Sildenafil Tablets 100 mg - NDC 72888-017-00 - 1000 Tablets Label INGREDIENTS AND APPEARANCE Inactive IngredientsCROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)SILICON DIOXIDE (UNII: ETJ7Z6XBU4)HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)MAGNESIUM STEARATE (UNII: 70097M6I30)CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)TITANIUM DIOXIDE (UNII: 15FIX9V2JP)TRIACETIN (UNII: XHX3C3X673)FD&C BLUE NO.

Drugs you should not use with sildenafil

2 (UNII: L06K8R7DQK)Product CharacteristicsColorblueScoreno scoreShapeOVAL (biconvex)Size17mmFlavorImprint CodeR;100ContainsPackagingNDC:72888-017-3030 in 1 BOTTLE; Type 0: Not a Combination Product06/17/2021NDC:72888-017-01100 in 1 BOTTLE; Type 0: Not a Combination Product06/17/2021NDC:72888-017-001000 in 1 BOTTLE; Type 0: Not a Combination Product11/08/2021Marketing InformationANDAANDA20488206/17/2021Labeler - Advagen Pharma Ltd (051627256)Registrant - Rubicon Research Limited (918629544)EstablishmentRubicon Research Limited677604197manufacture(72888-015, 72888-016, 72888-017) , analysis(72888-015, 72888-016, 72888-017) , pack(72888-015, 72888-016, 72888-017) Exports To: United States Of America Australia United Kingdom Canada France United States Of America Australia United Kingdom Canada France We are one of the foremost Exporter & specialized of Pharmaceutical Tablets, Pharmaceutical Injections, Pharmaceutical Cream, Pharmaceutical Gel, Pharmaceutical Ointment, Pharmaceutical Lotion, Isotroin-20 Capsules,Isotroin-20 Capsules and much more. Our professionals work in close coordination to assure a high-quality assortment of products to the customers. We have recruited a team dapoxetine 5mg of professionals. In addition to this, to avoid disputes in the workplace, our professionals strive dedicatedly. Owing to our fare policies and the best quality products.Under the direction of our mentor, Mr. 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.

7.1 Nitrates

Allergy warning

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 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. 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. 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.