It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [ see Adverse Reactions (6.1, 6.2)].5.5 Hypotension when Co-administered with Alpha-blockers or Anti-hypertensivesAlpha-blockersCaution is advised when PDE5 inhibitors are co-administered with alpha-blockers. PDE5 inhibitors, including sildenafil, and alpha-adrenergic blocking agents are both vasodilators with blood pressure lowering effects. When vasodilators are used in combination, an additive effect on blood pressure may occur. In some patients, concomitant use of these two drug classes can lower blood pressure significantly [ see Drug Interactions (7.2)and Clinical Pharmacology (12.2)] leading to symptomatic hypotension (e.g., dizziness, lightheadedness, fainting).Consideration should be given to the following:Patients who demonstrate hemodynamic instability on alpha-blocker therapy alone are at increased risk of symptomatic hypotension with concomitant use of PDE5 inhibitors. Patients should be stable on alpha-blocker therapy prior to initiating a PDE5 inhibitor.In those patients who are stable on alpha-blocker therapy, PDE5 inhibitors should be initiated at the lowest dose [ see Dosage and Administration (2.3)].In those patients already taking an optimized dose of a PDE5 inhibitor, alpha-blocker therapy should be initiated at the lowest dose. Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure when taking a PDE5 inhibitor.Safety of combined use of PDE5 inhibitors and alpha-blockers may be affected by other variables, including intravascular volume depletion and other anti-hypertensive drugs.Anti-hypertensivesSildenafil has systemic vasodilatory properties and may further lower blood pressure in patients taking anti-hypertensive medications.In a separate drug interaction study, when amlodipine, 5 mg or 10 mg, and sildenafil, 100 mg were orally administered concomitantly to hypertensive patients mean additional blood pressure reduction of 8 mmHg systolic and 7 mmHg diastolic were noted [ see Drug Interactions (7.3) and Clinical Pharmacology (12.2)].5.6 Adverse Reactions with the Concomitant Use of RitonavirThe concomitant administration of the protease inhibitor ritonavir substantially increases serum concentrations of sildenafil (11-fold increase in AUC). If sildenafil is prescribed to patients taking ritonavir, caution should be used. Data from subjects exposed to high systemic levels of sildenafil are limited. Decreased blood pressure, syncope, and prolonged erection were reported in some healthy volunteers exposed to high doses of sildenafil (200-800 mg). To decrease the chance of adverse reactions in patients taking ritonavir, a decrease in sildenafil dosage is recommended [ see Dosage and Administration (2.4), Drug Interactions (7.4), and Clinical Pharmacology (12.3)].5.7 Combination with other PDE5 Inhibitors or Other Erectile Dysfunction TherapiesThe safety and efficacy of combinations of sildenafil with other PDE5 Inhibitors, including REVATIO or other pulmonary arterial hypertension (PAH) treatments containing sildenafil, or other treatments for erectile dysfunction have not been studied. Such combinations may further lower blood pressure. Therefore, the use of such combinations is not recommended.5.8 Effects on BleedingThere have been postmarketing reports of bleeding events in patients who have taken sildenafil .
Further information
In those patients who are stable on alpha-blocker therapy, PDE5 inhibitors should be initiated at the lowest dose [ see Dosage and Administration (2.3)]. In those patients already taking an optimized dose of a PDE5 inhibitor, alpha-blocker therapy should be initiated at the lowest dose. Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure when taking a PDE5 inhibitor. Safety of combined use of PDE5 inhibitors and alpha-blockers may be affected by other variables, including intravascular volume depletion and other anti-hypertensive drugs. To decrease the chance of adverse reactions in patients taking ritonavir, a decrease in sildenafil dosage is recommended [ see Dosage and Administration (2.4), Drug Interactions (7.4), and Clinical Pharmacology (12.3)].
Recreational use
The safety and efficacy of combinations of sildenafil with other PDE5 Inhibitors, including REVATIO or other pulmonary arterial hypertension (PAH) treatments containing sildenafil, or other treatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended. There have been postmarketing reports of bleeding events in patients who have taken sildenafil . In addition, the combination of heparin and sildenafil had an additive effect on bleeding time in the anesthetized rabbit, but this interaction has not been studied in humans. The use of sildenafil offers no protection against sexually transmitted diseases.
Drugs you should not use with sildenafil
6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling:Cardiovascular [ see Warnings and Precautions (5.1)]Prolonged Erection and Priapism [ see Warnings and Precautions (5.2)]Effects on the Eye [ see Warnings and Precautions (5.3)]Hearing Loss [ see Warnings and Precautions (5.4)]Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives [ see Warnings and Precautions (5.5)]Adverse Reactions with the Concomitant Use of Ritonavir [ see Warnings and Precautions (5.6)]Combination with other PDE5 Inhibitors or Other Erectile Dysfunction Therapies [ see Warnings and Precautions (5.7)]Effects on Bleeding [ see Warnings and Precautions (5.8)]Counseling Patients About Sexually Transmitted Diseases [ see Warnings and Precautions (5.9)]The most common adverse reactions reported in clinical trials (≥ 2%) are headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness, and rash.6.1 Clinical Trials ExperienceBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.Sildenafil was administered to over 3700 patients (aged 19-87 years) during pre-marketing clinical trials worldwide. Over 550 patients were treated for longer than one year.In placebo-controlled clinical studies, the discontinuation rate due to adverse reactions for sildenafil (2.5%) was not significantly different from placebo (2.3%).In fixed-dose studies, the incidence of some adverse reactions increased with dose. The type of adverse reactions in flexible-dose studies, which reflect the recommended dosage regimen, was similar to that for fixed- dose studies. A causal relationship between sildenafil and these events has not been established. In humans, sildenafil has no effect on bleeding time when taken alone or with aspirin.
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Kamagra | 100mg | 120 + 6 Pills | 330.74€ 314.99€ | |
| Kamagra Soft Tabs | 100mg | 12 Pills | 57.55€ 54.81€ | |
| Viagra Generic | 150mg | 180 + 10 Pills | 236.46€ 225.20€ | |
| Kamagra Soft Tabs | 100mg | 84 + 4 Pills | 233.05€ 221.95€ | |
| Viagra Generic | 50mg | 90 + 6 Pills | 107.37€ 102.26€ | |
| Viagra Generic | 50mg | 30 + 4 Pills | 54.26€ 51.68€ | |
| Viagra Generic | 100mg | 60 + 4 Pills | 96.36€ 91.77€ | |
| Viagra Generic | 100mg | 270 + 10 Pills | 270.47€ 257.59€ | |
| Kamagra | 100mg | 20 Pills | 86.09€ 81.99€ | |
| Viagra Generic | 150mg | 270 + 10 Pills | 326.61€ 311.06€ | |
| Kamagra Polo | 100mg | 60 + 4 Pills | 189.39€ 180.37€ | |
| Viagra Generic | 100mg | 30 + 4 Pills | 60.91€ 58.01€ | |
| Viagra Generic | 25mg | 20 Pills | 37.74€ 35.94€ | |
| Kamagra Polo | 100mg | 120 + 6 Pills | 327.15€ 311.57€ | |
| Viagra Generic | 150mg | 30 + 2 Pills | 72.32€ 68.88€ | |
| Kamagra Soft Tabs | 100mg | 120 + 6 Pills | 311.78€ 296.93€ |
However, in vitrostudies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside (a nitric oxide donor). In addition, the combination of heparin and sildenafil had an additive effect on bleeding time in the anesthetized rabbit, but this interaction has not been studied in humans.The safety of sildenafil is unknown in patients with bleeding disorders and patients with active peptic ulceration.5.9 Counseling Patients About Sexually Transmitted DiseasesThe use of sildenafil offers no protection against sexually transmitted diseases.
12.1 Mechanism of Action
Pregnancy Categories
Sildenafil may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), may be considered.
- Sildenafil citrate 100 mg may interact with other medications, affecting how they work.
- A healthcare professional should review your medications to avoid adverse interactions.
- Avoid combining sildenafil with certain antibiotics, antifungals, or blood pressure medications.
There is a potential for cardiac risk of sexual activity in patients with preexisting cardiovascular disease. The evaluation of erectile dysfunction should include a determination of potential underlying causes and the identification of appropriate treatment following a complete medical assessment. Patients who have suffered a myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months; Patients with resting hypotension (BP <90/50 mmHg) or hypertension (BP >170/110 mmHg); Patients with cardiac failure or coronary artery disease causing unstable angina.
Monographie du produit
It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [ see Adverse Reactions (6.1, 6.2)].5.5 Hypotension when Co-administered with Alpha-blockers or Anti-hypertensivesAlpha-blockersCaution is advised when PDE5 inhibitors are co-administered with alpha-blockers. PDE5 inhibitors, including sildenafil, and alpha-adrenergic blocking agents are both vasodilators with blood pressure lowering effects. When vasodilators are used in combination, an additive effect on blood pressure may occur. In some patients, concomitant use of these two drug classes can lower blood pressure significantly [ see Drug Interactions (7.2)and Clinical Pharmacology (12.2)] leading to symptomatic hypotension (e.g., dizziness, lightheadedness, fainting).Consideration should be given to the following:Patients who demonstrate hemodynamic instability on alpha-blocker therapy alone are at increased risk of symptomatic hypotension with concomitant use of PDE5 inhibitors. Patients should be stable on alpha-blocker therapy prior to initiating a PDE5 inhibitor.In those patients who are stable on alpha-blocker therapy, PDE5 inhibitors should be initiated at the lowest dose [ see Dosage and Administration (2.3)].In those patients already taking an optimized dose of a PDE5 inhibitor, alpha-blocker therapy should be initiated at the lowest dose.
Warnings for people with certain health conditions
Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure when taking a PDE5 inhibitor.Safety of combined use of PDE5 inhibitors and alpha-blockers may be affected by other variables, including intravascular volume depletion and other anti-hypertensive drugs.Anti-hypertensivesSildenafil has systemic vasodilatory properties and may further lower blood pressure in patients taking anti-hypertensive medications.In a separate drug interaction study, when amlodipine, 5 mg or 10 mg, and sildenafil, 100 mg were orally administered concomitantly to hypertensive patients mean additional blood pressure reduction of 8 mmHg systolic and 7 mmHg diastolic were noted [ see Drug Interactions (7.3) and Clinical Pharmacology (12.2)].5.6 Adverse Reactions with the Concomitant Use of RitonavirThe concomitant administration of the protease inhibitor ritonavir substantially increases serum concentrations of sildenafil (11-fold increase in AUC). If sildenafil is prescribed to patients taking ritonavir, caution should be used. Data from subjects exposed to high systemic levels of sildenafil are limited. Decreased blood pressure, syncope, and prolonged erection were reported in some healthy volunteers exposed to high doses of sildenafil (200-800 mg). To decrease the chance of adverse reactions in patients taking ritonavir, a decrease in sildenafil dosage is recommended [ see Dosage and Administration (2.4), Drug Interactions (7.4), and Clinical Pharmacology (12.3)].5.7 Combination with other PDE5 Inhibitors or Other Erectile Dysfunction TherapiesThe safety and efficacy of combinations of sildenafil with other PDE5 Inhibitors, including REVATIO or other pulmonary arterial hypertension (PAH) treatments containing sildenafil, or other treatments for erectile dysfunction have not been studied.
Enhanced understanding of the relationship between erection and satisfaction in ED treatment: application of a longitudinal mediation model
Such combinations may further lower blood pressure. Therefore, the use of such combinations is not recommended.5.8 Effects on BleedingThere have been postmarketing reports of bleeding events in patients who have taken sildenafil . A causal relationship between sildenafil and these events has not been established. In humans, sildenafil has no effect on bleeding time when taken alone or with aspirin. However, in vitrostudies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside (a nitric oxide donor). Prolonged erection greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently since market approval of sildenafil tablets. If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result.
| Property | Description | Typical Dose | Onset Time | Duration of Action |
|---|---|---|---|---|
| Mechanism of Action | PDE5 inhibitor that enhances blood flow to the penis | 100 mg | 30-60 min | 4-6 hours |
| Bioavailability | Percentage of drug reaching systemic circulation | ~40% | N/A | N/A |
| Half-life | Time for plasma concentration to reduce by half | 4 hours | N/A | N/A |
| Metabolism | Liver enzymes involved (primarily CYP3A4) | CYP3A4 | N/A | N/A |
Physicians should advise patients to stop use of all phosphodiesterase type 5 (PDE5) inhibitors, including sildenafil , and seek medical attention in the event of a sudden loss of vision in one or both eyes. Neither the rare post-marketing reports, nor the association of PDE5 inhibitor use and NAION in the observational studies, substantiate a causal relationship between PDE5 inhibitor use and NAION [ see Adverse Reactions (6.2) ]. Physicians pfizer sildenafil 100 should consider whether their patients with underlying NAION risk factors could be adversely affected by use of PDE5 inhibitors.
| Patient Type | Recommended Dose | Notes |
|---|---|---|
| Adult Men | 50-100 mg approximately 1 hour before activity | Max dose per event; not to exceed 100 mg |
| Elderly Patients | Start at lower end, 25-50 mg | Increased sensitivity and risk of side effects |
| Patients with Kidney or Liver Disease | Dose adjustment may be necessary | Consult healthcare provider |
Individuals with “crowded” optic disc are also considered at greater risk for NAION compared to the general population, however, evidence is insufficient to support screening of prospective users of PDE5 inhibitors, including sildenafil, for this uncommon condition. Physicians should advise patients to stop taking PDE5 inhibitors, including sildenafil , and seek prompt medical attention in the event of sudden decrease or loss of hearing. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [ see Adverse Reactions (6.1, 6.2)]. Patients who demonstrate hemodynamic instability on alpha-blocker therapy alone are at increased risk of symptomatic hypotension with concomitant use of PDE5 inhibitors. Patients should be stable on alpha-blocker therapy prior to initiating a PDE5 inhibitor.
- People with heart problems should consult a doctor before using sildenafil 100 mg.
- Sildenafil is contraindicated in patients with severe liver or kidney impairment.
- Allergic reactions, though rare, may include rash, itching, or swelling.
In those patients who are stable on alpha-blocker therapy, PDE5 inhibitors should be initiated at the lowest dose [ see Dosage and Administration (2.3)]. In those patients already taking an optimized dose of a PDE5 inhibitor, alpha-blocker therapy should be initiated at the lowest dose. Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure when taking a PDE5 inhibitor. Safety of combined use of PDE5 inhibitors and alpha-blockers may be affected by other variables, including intravascular volume depletion and other anti-hypertensive drugs. To decrease the chance of adverse reactions in patients taking ritonavir, a decrease in sildenafil dosage is recommended [ see Dosage and Administration (2.4), Drug Interactions (7.4), and Clinical Pharmacology (12.3)].
- The onset of action for sildenafil citrate 100 mg is typically within 30 minutes.
- Effects can last for up to 4-6 hours, providing a window for sexual activity.
- Individual response to the drug varies based on health and dosage.
The safety and efficacy of combinations of sildenafil with other PDE5 Inhibitors, including REVATIO or other pulmonary arterial hypertension (PAH) treatments containing sildenafil, or other treatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended. There have been postmarketing reports of bleeding events in patients who have taken sildenafil .
| Research Area | Focus | Potential Impact |
|---|---|---|
| New Formulations | Long-acting or transdermal options | Improved convenience and adherence |
| Combination Therapy | Sildenafil with other agents | Enhanced efficacy or reduced doses |
| Genetic Factors in Response | Personalized dosing based on genetics | Minimize side effects, maximize effectiveness |
| New Indications | Expanding uses beyond current approved purposes | Broader therapeutic applications |
In addition, the combination of heparin and sildenafil had an additive effect on bleeding time in the anesthetized rabbit, but this interaction has not been studied in humans. The use of sildenafil offers no protection against sexually transmitted diseases. 6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling:Cardiovascular [ see Warnings and Precautions (5.1)]Prolonged Erection and Priapism [ see Warnings and Precautions (5.2)]Effects on the Eye [ see Warnings and Precautions (5.3)]Hearing Loss [ see Warnings and Precautions (5.4)]Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives [ see Warnings and Precautions (5.5)]Adverse Reactions with the Concomitant Use of Ritonavir [ see Warnings and Precautions (5.6)]Combination with other PDE5 Inhibitors or Other Erectile Dysfunction Therapies [ see Warnings and Precautions (5.7)]Effects on Bleeding [ see Warnings and Precautions (5.8)]Counseling Patients About Sexually Transmitted Diseases [ see Warnings and Precautions (5.9)]The most common adverse reactions reported in clinical trials (≥ 2%) are headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness, and rash.6.1 Clinical Trials ExperienceBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.Sildenafil was administered to over 3700 patients (aged 19-87 years) during pre-marketing clinical trials worldwide. Over 550 patients were treated for longer than one year.In placebo-controlled clinical studies, the discontinuation rate due to adverse reactions for sildenafil (2.5%) was not significantly different from placebo (2.3%).In fixed-dose studies, the incidence of some adverse reactions increased with dose.
8.4 Pediatric Use
The type of adverse reactions in flexible-dose studies, which reflect the recommended dosage regimen, was similar to that for fixed- dose studies.
Non-medical use
In addition, the combination of heparin and sildenafil had an additive effect on bleeding time in the anesthetized rabbit, but this interaction has not been studied in humans.The safety of sildenafil is unknown in patients with bleeding disorders and patients with active peptic ulceration.5.9 Counseling Patients About Sexually Transmitted DiseasesThe use of sildenafil offers no protection against sexually transmitted diseases. Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), may be considered. There is a potential for cardiac risk of sexual activity in patients with preexisting cardiovascular disease. The evaluation of erectile dysfunction should include a determination of potential underlying causes and the identification of appropriate treatment following a complete medical assessment. Patients who have suffered a myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months; Patients with resting hypotension (BP <90/50 mmHg) or hypertension (BP >170/110 mmHg); Patients with cardiac failure or coronary artery disease causing unstable angina.
Professional resources
Prolonged erection greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently since market approval of sildenafil tablets. If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result. Physicians should advise patients to stop use of all phosphodiesterase type 5 (PDE5) inhibitors, including sildenafil , and seek medical attention in the event of a sudden loss of vision in one or both eyes. Neither the rare post-marketing reports, nor the association of PDE5 inhibitor use and NAION in the observational studies, substantiate a causal relationship between PDE5 inhibitor use and NAION [ see Adverse Reactions (6.2) ]. Physicians pfizer sildenafil 100 should consider whether their patients with underlying NAION risk factors could be adversely affected by use of PDE5 inhibitors.
What’s the difference between sildenafil and Viagra?
Individuals with “crowded” optic disc are also considered at greater risk for NAION compared to the general population, however, evidence is insufficient to support screening of prospective users of PDE5 inhibitors, including sildenafil, for this uncommon condition. Physicians should advise patients to stop taking PDE5 inhibitors, including sildenafil , and seek prompt medical attention in the event of sudden decrease or loss of hearing. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [ see Adverse Reactions (6.1, 6.2)]. Patients who demonstrate hemodynamic instability on alpha-blocker therapy alone are at increased risk of symptomatic hypotension with concomitant use of PDE5 inhibitors. Patients should be stable on alpha-blocker therapy prior to initiating a PDE5 inhibitor.