Efficacy and safety of dapoxetine/sildenafil combination tablets in the treatment of men with premature ejaculation and concomitant erectile dysfunction-DAP-SPEED Study
Sildenafil tablets was shown to potentiate the hypotensive effect of nitrates ( 4.1, 7.1, 12.2) Known hypersensitivity to sildenafil or any component of tablet ( 4.2) Administration with guanylate cyclase (GC) stimulators, such as riociguat ( 4.3) Patients should not use sildenafil tablets if sexual activity is inadvisable due to cardiovascular status ( 5.1) Patients should seek emergency treatment if an erection lasts >4 hours. Use sildenafil tablets with caution in patients predisposed to priapism ( 5.2) Patients should stop sildenafil tablets and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non arteritic anterior ischemic optic neuropathy (NAION). Patients should stop sildenafil tablets and seek prompt medical attention in the event of sudden decrease or loss of hearing ( 5.4) Caution is advised when sildenafil tablets is co-administered with alpha-blockers or anti- hypertensives.
- Sildenafil is not recommended for use by women.
- Dapoxetine is approved specifically for men with PE.
- Both drugs help improve sexual confidence and performance.
- Proper hydration can help mitigate side effects.
- Patients with retinal disorders should consult a healthcare professional.
- Use of these medications does not protect against sexually transmitted infections.
- Combining medications without medical guidance can be dangerous.
- Inform your doctor if you experience any adverse reactions.
Concomitant use may lead to hypotension ( 5.5) Decreased blood pressure, syncope, and prolonged erection may occur at higher sildenafil exposures. Decrease in sildenafil tablets dosage is recommended ( 2.4, 5.6) Most common adverse reactions (≥ 2%) include headache, flushing, dyspepsia, abnormal vision,nasal congestion, back pain, myalgia, nausea, dizziness and rash ( 6.1) To report SUSPECTED ADVERSE REACTIONS, contact Advagen Pharma Ltd, at 866-488-0312 or FDA at 1-800-FDA-1088 or Sildenafil can potentiate the hypotensive effects of nitrates, alpha blockers, and anti- hypertensives ( 4.1, 5.5, 7.1, 7.2, 7.3, 12.2) With concomitant use of alpha blockers, initiate sildenafil at 25 mg dose ( 2.3) CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin): Increase sildenafil exposure ( 2.4, 7.4, 12.3) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
- Sildenafil can be combined with lifestyle changes for better results.
- Dapoxetine helps subjects gain better control during sexual activity.
- Use caution in hot weather as both drugs can cause dehydration.
- Patients should avoid grapefruit or high-fat foods around intake time.
- Sildenafil has been studied extensively for safety and efficacy.
- Dapoxetine's rapid onset makes it convenient for planned activity.
- These medications are not substitutes for safe sexual practices.
- Always follow the prescribed dosage and timing instructions.
Table of Contents FULL PRESCRIBING INFORMATION: CONTENTS*1 INDICATIONS AND USAGE2 DOSAGE AND ADMINISTRATION2.1 Dosage Information2.2 Use with Food2.3 Dosage Adjustments in Specific Situations2.4 Dosage Adjustments Due to Drug Interactions2.5 Dosage Adjustments in Special Populations3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS4.1 Nitrates4.2 Hypersensitivity Reactions4.3 Concomitant Guanylate Cyclase (GC) Stimulators5 WARNINGS AND PRECAUTIONS5.1 Cardiovascular5.2 Prolonged Erection and Priapism5.3 Effects on the Eye5.4 Hearing Loss5.5 Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives5.6 Adverse Reactions with the Concomitant Use of Ritonavir5.7 Combination with other PDE5 Inhibitors or Other Erectile Dysfunction Therapies5.8 Effects on Bleeding5.9 Counseling Patients about Sexually Transmitted Diseases6 ADVERSE REACTIONS6.1 Clinical Trials Experience6.2 Postmarketing Experience7 DRUG INTERACTIONS7.1 Nitrates7.2 Alpha-blockers7.3 Amlodipine7.4 Ritonavir and other CYP3A4 inhibitors7.5 Alcohol8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy8.2 Lactation8.4 Pediatric Use8.5 Geriatric Use8.6 Renal Impairment8.7 Hepatic Impairment10 OVERDOSAGE11 DESCRIPTION12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action12.2 Pharmacodynamics12.3 Pharmacokinetics13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility14 CLINICAL STUDIES16 HOW SUPPLIED/STORAGE AND HANDLING17 PATIENT COUNSELING INFORMATION*Sections or subsections omitted from the full prescribing information are not listed.
8.2 Lactation
Sections or subsections omitted from the full prescribing information are not listed. 2 DOSAGE AND ADMINISTRATION 2.1 Dosage InformationFor most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity.
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Priligy Generic Dapoxetine | 60mg | 30 + 6 Pills | 106.65€ 101.57€ | |
| Priligy Generic Dapoxetine | 60mg | 90 + 10 Pills | 265.64€ 252.99€ | |
| Levitra Original | 20mg | 12 Pills | 81.99€ 78.09€ | |
| Viagra Professional | 100mg | 120 + 4 Pills | 262.83€ 250.31€ | |
| Viagra Soft Tabs | 100mg | 180 + 10 Pills | 314.95€ 299.95€ | |
| Kamagra Soft Tabs | 100mg | 32 Pills | 120.11€ 114.39€ | |
| Priligy Generic Dapoxetine | 60mg | 60 + 8 Pills | 183.06€ 174.34€ | |
| Priligy Generic Dapoxetine | 60mg | 120 + 10 Pills | 341.26€ 325.01€ | |
| Priligy Generic Dapoxetine | 60mg | 10 Pills | 47.63€ 45.36€ | |
| Priligy Generic Dapoxetine | 60mg | 180 + 10 Pills | 494.76€ 471.20€ | |
| Priligy Generic Dapoxetine | 60mg | 20 + 4 Pills | 77.31€ 73.63€ | |
| Cialis Generic | 5mg | 30 + 4 Pills | 53.56€ 51.01€ | |
| Levitra Generic | 20mg | 270 + 10 Pills | 376.33€ 358.41€ | |
| Levitra Professional | 20mg | 30 Pills | 119.12€ 113.45€ |
However, sildenafil tablets may be taken anywhere from 30 minutes to 4 hours before sexual activity.The maximum recommended dosing frequency is once per day.Based on effectiveness and toleration, the dose may be increased to a maximum recommended dose of 100 mg or decreased to 25 mg.2.3 Dosage Adjustments in Specific SituationsSildenafil tablets was shown to potentiate the hypotensive effects of nitrates and its administration in patients who use nitric oxide donors such as organic nitrates or organic nitrites in any form is therefore contraindicated [ see Contraindications (4.1), Drug Interactions (7.1), and Clinical Pharmacology (12.2)] .When sildenafil tablets is co-administered with an alpha-blocker, patients should be stable on alpha-blocker therapy prior to initiating sildenafil tablets treatment and sildenafil tablets should be initiated at 25 mg [ see Warnings and Precautions (5.5), Drug Interactions (7.2), and Clinical Pharmacology (12.2)].2.4 Dosage Adjustments Due to Drug InteractionsThe recommended dose for ritonavir-treated patients is 25 mg prior to sexual activity and the recommended maximum dose is 25 mg within a 48 hour period because concomitant administration increased the blood levels of sildenafil by 11-fold [ see Warnings and Precautions (5.6), Drug Interactions (7.4), and Clinical Pharmacology (12.3)].CYP3A4 InhibitorsConsider a starting dose of 25 mg in patients treated with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, or saquinavir) or erythromycin. Clinical data have shown that co- administration with saquinavir or erythromycin increased plasma levels of sildenafil by about 3 fold [ see Drug Interactions (7.4)and Clinical Pharmacology (12.3)].2.5 Dosage Adjustments in Special PopulationsConsider a starting dose of 25 mg in patients > 65 years, patients with hepatic impairment (e.g., cirrhosis), and patients with severe dapoxetine tadalafil tablets renal impairment (creatinine clearance <30 mL/minute) because administration of sildenafil tablets in these patients resulted in higher plasma levels of sildenafil [ see Use in Specific Populations( 8.5, 8.6, 8.7) and Clinical Pharmacology( 12.3) ]. For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. However, sildenafil tablets may be taken anywhere from 30 minutes to 4 hours before sexual activity.
Age and Dose Restrictions
When sildenafil tablets is co-administered with an alpha-blocker, patients should be stable on alpha-blocker therapy prior to initiating sildenafil tablets treatment and sildenafil tablets should be initiated at 25 mg tadalafil dapoxetine [ see Warnings and Precautions (5.5), Drug Interactions (7.2), and Clinical Pharmacology (12.2)]. The recommended dose for ritonavir-treated patients is 25 mg prior to sexual activity and the recommended maximum dose is 25 mg within a 48 hour period because concomitant administration increased the blood levels of sildenafil by 11-fold [ see Warnings and Precautions (5.6), Drug Interactions (7.4), and Clinical Pharmacology (12.3)]. Consider a starting dose of 25 mg in patients treated with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, or saquinavir) or erythromycin. Clinical data have shown that co- administration with saquinavir or erythromycin increased plasma levels of sildenafil by about 3 fold [ see Drug Interactions (7.4)and Clinical Pharmacology (12.3)]. Consider a starting dose of 25 mg in patients > 65 years, patients with hepatic impairment (e.g., cirrhosis), and patients with severe renal impairment (creatinine clearance <30 mL/minute) because administration of sildenafil tablets in these patients resulted in higher plasma levels of sildenafil [ see Use in Specific Populations( 8.5, 8.6, 8.7) and Clinical Pharmacology( 12.3) ].
Interactions that increase your risk for side effects
4 CONTRAINDICATIONS 4.1 NitratesConsistent with its known effects on the nitric oxide/cGMP pathway [ see Clinical Pharmacology (12.1, 12.2) ], sildenafil tablets was shown to potentiate the hypotensive effects of nitrates, and its administration to patients who are using nitric oxide donors such as organic nitrates or organic nitrites in any form either regularly and/or intermittently is therefore contraindicated.After patients have taken sildenafil tablets, it is unknown when nitrates, if necessary, can be safely administered. Although plasma levels of sildenafil at 24 hours post dose are much lower than at peak concentration, it is unknown whether nitrates can be safely co-administered at this time point [ see Dosage and Administration (2.3), Drug Interactions (7.1), and Clinical Pharmacology (12.2)].4.2 Hypersensitivity ReactionsSildenafil tablets are contraindicated in patients with a known hypersensitivity to sildenafil, as contained in sildenafil tablets and REVATIO (sildenafil citrate), or any component of the tablet. Hypersensitivity reactions have been reported, including rash and urticaria [ see dapoxetine 30mg tablet Adverse Reactions (6.1)]. Consistent with its known effects on the nitric oxide/cGMP pathway [ see Clinical Pharmacology (12.1, 12.2) ], sildenafil tablets was shown to potentiate the hypotensive effects of nitrates, and its administration to patients who are using nitric oxide donors such as organic nitrates or organic nitrites in any form either regularly and/or intermittently is therefore contraindicated. After patients have taken sildenafil tablets, it is unknown when nitrates, if necessary, can be safely administered.
Serious side effects
Although plasma levels of sildenafil at 24 hours post dose are much lower than at peak concentration, it is unknown whether nitrates can be safely co-administered at this time point [ see Dosage and Administration (2.3), Drug Interactions (7.1), and Clinical Pharmacology (12.2)]. Sildenafil tablets are contraindicated in patients with a known hypersensitivity to sildenafil, as contained in sildenafil tablets and REVATIO (sildenafil citrate), or any component of the tablet. The maximum recommended dosing frequency is once per day. Based on effectiveness and toleration, the dose may be increased to a maximum recommended dose of 100 mg or decreased to 25 mg.
Usage Information
Sildenafil tablets was shown to potentiate the hypotensive effect of nitrates ( 4.1, 7.1, 12.2) Known hypersensitivity to sildenafil or any component of tablet ( 4.2) Administration with guanylate cyclase (GC) stimulators, such as riociguat ( 4.3) Patients should not use sildenafil tablets if sexual activity is inadvisable due to cardiovascular status ( 5.1) Patients should seek emergency treatment if an erection lasts >4 hours. Use sildenafil tablets with caution in patients predisposed to priapism ( 5.2) Patients should stop sildenafil tablets and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non arteritic anterior ischemic optic neuropathy (NAION). Patients should stop sildenafil tablets and seek prompt medical attention in the event of sudden decrease or loss of hearing ( 5.4) Caution is advised when sildenafil tablets is co-administered with alpha-blockers or anti- hypertensives. Concomitant use may lead to hypotension ( 5.5) Decreased blood pressure, syncope, and prolonged erection may occur at higher sildenafil exposures. Decrease in sildenafil tablets dosage is recommended ( 2.4, 5.6) Most common adverse reactions (≥ 2%) include headache, flushing, dyspepsia, abnormal vision,nasal congestion, back pain, myalgia, nausea, dizziness and rash ( 6.1) To report SUSPECTED ADVERSE REACTIONS, contact Advagen Pharma Ltd, at 866-488-0312 or FDA at 1-800-FDA-1088 or Sildenafil can potentiate the hypotensive effects of nitrates, alpha blockers, and anti- hypertensives ( 4.1, 5.5, 7.1, 7.2, 7.3, 12.2) With concomitant use of alpha blockers, initiate sildenafil at 25 mg dose ( 2.3) CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin): Increase sildenafil exposure ( 2.4, 7.4, 12.3) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Product Sodium Picosulfate Tablets 10 mg
Table of Contents FULL PRESCRIBING INFORMATION: CONTENTS*1 INDICATIONS AND USAGE2 DOSAGE AND ADMINISTRATION2.1 Dosage Information2.2 Use with Food2.3 Dosage Adjustments in Specific Situations2.4 Dosage Adjustments Due to Drug Interactions2.5 Dosage Adjustments in Special Populations3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS4.1 Nitrates4.2 Hypersensitivity Reactions4.3 Concomitant Guanylate Cyclase (GC) Stimulators5 WARNINGS AND PRECAUTIONS5.1 Cardiovascular5.2 Prolonged Erection and Priapism5.3 Effects on the Eye5.4 Hearing Loss5.5 Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives5.6 Adverse Reactions with the Concomitant Use of Ritonavir5.7 Combination with other PDE5 Inhibitors or Other Erectile Dysfunction Therapies5.8 Effects on Bleeding5.9 Counseling Patients about Sexually Transmitted Diseases6 ADVERSE REACTIONS6.1 Clinical Trials Experience6.2 Postmarketing Experience7 DRUG INTERACTIONS7.1 Nitrates7.2 Alpha-blockers7.3 Amlodipine7.4 Ritonavir and other CYP3A4 inhibitors7.5 Alcohol8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy8.2 Lactation8.4 Pediatric Use8.5 Geriatric Use8.6 Renal Impairment8.7 Hepatic Impairment10 OVERDOSAGE11 DESCRIPTION12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action12.2 Pharmacodynamics12.3 Pharmacokinetics13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility14 CLINICAL STUDIES16 HOW SUPPLIED/STORAGE AND HANDLING17 PATIENT COUNSELING INFORMATION*Sections or subsections omitted from the full prescribing information are not listed. Sections or subsections omitted from the full prescribing information are not listed. 2 DOSAGE AND ADMINISTRATION 2.1 Dosage InformationFor most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. However, sildenafil tablets may be taken anywhere from 30 minutes to 4 hours before sexual activity.The maximum recommended dosing frequency is once per day.Based on effectiveness and toleration, the dose may be increased to a maximum recommended dose of 100 mg or decreased to 25 mg.2.3 Dosage Adjustments in Specific SituationsSildenafil tablets was shown to potentiate the hypotensive effects of nitrates and its administration in patients who use nitric oxide donors such as organic nitrates or organic nitrites in any form is therefore contraindicated [ see Contraindications (4.1), Drug Interactions (7.1), and Clinical Pharmacology (12.2)] .When sildenafil tablets is co-administered with an alpha-blocker, patients should be stable on alpha-blocker therapy prior to initiating sildenafil tablets treatment and sildenafil tablets should be initiated at 25 mg [ see Warnings and Precautions (5.5), Drug Interactions (7.2), and Clinical Pharmacology (12.2)].2.4 Dosage Adjustments Due to Drug InteractionsThe recommended dose for ritonavir-treated patients is 25 mg prior to sexual activity and the recommended maximum dose is 25 mg within a 48 hour period because concomitant administration increased the blood levels of sildenafil by 11-fold [ see Warnings and Precautions (5.6), Drug Interactions (7.4), and Clinical Pharmacology (12.3)].CYP3A4 InhibitorsConsider a starting dose of 25 mg in patients treated with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, or saquinavir) or erythromycin. Clinical data have shown that co- administration with saquinavir or erythromycin increased plasma levels of sildenafil by about 3 fold [ see Drug Interactions (7.4)and Clinical Pharmacology (12.3)].2.5 Dosage Adjustments in Special PopulationsConsider a starting dose of 25 mg in patients > 65 years, patients with hepatic impairment (e.g., cirrhosis), and patients with severe dapoxetine tadalafil tablets renal impairment (creatinine clearance <30 mL/minute) because administration of sildenafil tablets in these patients resulted in higher plasma levels of sildenafil [ see Use in Specific Populations( 8.5, 8.6, 8.7) and Clinical Pharmacology( 12.3) ].
Dapoxetine sildenafil
For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. However, sildenafil tablets may be taken anywhere from 30 minutes to 4 hours before sexual activity. The maximum recommended dosing frequency is once per day. Based on effectiveness and toleration, the dose may be increased to a maximum recommended dose of 100 mg or decreased to 25 mg. Sildenafil tablets was shown to potentiate the hypotensive effects of nitrates and its administration in patients who use nitric oxide donors such as organic nitrates or organic nitrites in any form is therefore contraindicated [ see Contraindications (4.1), Drug Interactions (7.1), and Clinical Pharmacology (12.2)] . Sildenafil tablets was shown to potentiate the hypotensive effects of nitrates and its administration in patients who use nitric oxide donors such as organic nitrates or organic nitrites in any form is therefore contraindicated [ see Contraindications (4.1), Drug Interactions (7.1), and Clinical Pharmacology (12.2)] . When sildenafil tablets is co-administered with an alpha-blocker, patients should be stable on alpha-blocker therapy prior to initiating sildenafil tablets treatment and sildenafil tablets should be initiated at 25 mg tadalafil dapoxetine [ see Warnings and Precautions (5.5), Drug Interactions (7.2), and Clinical Pharmacology (12.2)].
5.9 Counseling Patients about Sexually Transmitted Diseases
Drugs you should not use with sildenafil
The recommended dose for ritonavir-treated patients is 25 mg prior to sexual activity and the recommended maximum dose is 25 mg within a 48 hour period because concomitant administration increased the blood levels of sildenafil by 11-fold [ see Warnings and Precautions (5.6), Drug Interactions (7.4), and Clinical Pharmacology (12.3)]. Consider a starting dose of 25 mg in patients treated with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, or saquinavir) or erythromycin.
| Condition | Recommended Dosage | Onset Time | Duration of Effect | Additional Notes |
|---|---|---|---|---|
| Erectile Dysfunction | 100 mg sildenafil | 30-60 min | 4-6 hours | Take 30 min before activity |
| Premature Ejaculation | 60 mg dapoxetine | 1-3 hours | 1-2 hours | May be taken daily or on demand |
| Combined Use for Both Conditions | As prescribed | Varies | Varies | Under medical supervision |
Clinical data have shown that co- administration with saquinavir or erythromycin increased plasma levels of sildenafil by about 3 fold [ see Drug Interactions (7.4)and Clinical Pharmacology (12.3)]. Consider a starting dose of 25 mg in patients > 65 years, patients with hepatic impairment (e.g., cirrhosis), and patients with severe renal impairment (creatinine clearance <30 mL/minute) because administration of sildenafil tablets in these patients resulted in higher plasma levels of sildenafil [ see Use in Specific Populations( 8.5, 8.6, 8.7) and Clinical Pharmacology( 12.3) ]. 4 CONTRAINDICATIONS 4.1 NitratesConsistent with its known effects on the nitric oxide/cGMP pathway [ see Clinical Pharmacology (12.1, 12.2) ], sildenafil tablets was shown to potentiate the hypotensive effects of nitrates, and its administration to patients who are using nitric oxide donors such as organic nitrates or organic nitrites in any form either regularly and/or intermittently is therefore contraindicated.After patients have taken sildenafil tablets, it is unknown when nitrates, if necessary, can be safely administered. Although plasma levels of sildenafil at 24 hours post dose are much lower than at peak concentration, it is unknown whether nitrates can be safely co-administered at this time point [ see Dosage and Administration (2.3), Drug Interactions (7.1), and Clinical Pharmacology (12.2)].4.2 Hypersensitivity ReactionsSildenafil tablets are contraindicated in patients with a known hypersensitivity to sildenafil, as contained in sildenafil tablets and REVATIO (sildenafil citrate), or any component of the tablet. Hypersensitivity reactions have been reported, including rash and urticaria [ see dapoxetine 30mg tablet Adverse Reactions (6.1)].
| Point | Explanation | Additional Tips |
|---|---|---|
| Take as directed | Follow prescribed dose and timing | Do not exceed recommended dose |
| Avoid alcohol | Can impair effectiveness and increase side effects | Limit or abstain before use |
| Report adverse effects | Seek medical attention if serious reactions occur | Especially priapism or severe dizziness |
| Ensure medical consultation | Before starting, especially if on other meds | For personalized advice |
Consistent with its known effects on the nitric oxide/cGMP pathway [ see Clinical Pharmacology (12.1, 12.2) ], sildenafil tablets was shown to potentiate the hypotensive effects of nitrates, and its administration to patients who are using nitric oxide donors such as organic nitrates or organic nitrites in any form either regularly and/or intermittently is therefore contraindicated.
How long does dapoxetine make me last?
Clinical monitoring
Product Sertraline Tablets BP 100 mg
After patients have taken sildenafil tablets, it is unknown when nitrates, if necessary, can be safely administered. Although plasma levels of sildenafil at 24 hours post dose are much lower than at peak concentration, it is unknown whether nitrates can be safely co-administered at this time point [ see Dosage and Administration (2.3), Drug Interactions (7.1), and Clinical Pharmacology (12.2)]. Sildenafil tablets are contraindicated in patients with a known hypersensitivity to sildenafil, as contained in sildenafil tablets and REVATIO (sildenafil citrate), or any component of the tablet.
- Sildenafil is contraindicated in patients taking alpha-blockers.
- Dapoxetine may cause mood changes or suicidal thoughts in rare cases.
- Combining these drugs can increase the risk of side effects.
- Use these medications only as prescribed by your healthcare provider.
- Patients should seek immediate medical attention for prolonged erections.
- Alcohol might exacerbate side effects like dizziness or hypotension.
- Combining sildenafil and dapoxetine requires medical supervision.
- Both meds are part of a broader approach to sexual health management.