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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.
- The term 'sildenafil white' often refers to unbranded, generic pills.
- It may be available online through various pharmacies and vendors.
- Users should verify the legitimacy of sildenafil sources to avoid fake products.
- This medication is not suitable for individuals with certain heart conditions.
- Sildenafil white is sometimes used recreationally for its euphoric effects.
- It may interact with certain antibiotics and antifungals, altering effectiveness.
- Patients should inform their doctor of all medications before use.
- The medication is not an aphrodisiac; it only facilitates erectile response.
- Overuse or misuse of sildenafil white can lead to serious health risks.
- The recommended maximum frequency is once per day unless advised otherwise.
- Consultation with a healthcare professional is essential prior to use.
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 to 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. A causal relationship between sildenafil and over the counter drugs containing sildenafil these events has not been established. In humans, sildenafil has no effect on bleeding time when taken alone or with aspirin. However, in vitro studies 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. Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), may be considered.
7.1 Nitrates
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Sildenafil has systemic vasodilatory properties that resulted in transient decreases in supine blood pressure in healthy volunteers (mean maximum decrease of 8.4/5.5 mmHg), [see Clinical Pharmacology (12.2)]. While this normally would be expected to be of little consequence in most patients, prior to prescribing sildenafil, physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects, especially in combination with sexual activity. Use with caution in patients with the following underlying conditions which can be particularly sensitive to the actions of vasodilators including sildenafil – those with left ventricular outflow obstruction (e.g., aortic stenosis, idiopathic hypertrophic subaortic stenosis) and those with severely impaired autonomic control of blood pressure. There are no controlled clinical data on the safety or efficacy of sildenafil in the following groups; if prescribed, this should be done with caution. 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. 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)].
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| Kamagra Polo | 100mg | 32 Pills | 125.88€ 119.89€ | |
| Viagra Generic | 25mg | 270 + 8 Pills | 184.26€ 175.49€ | |
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| Kamagra Polo | 100mg | 272 + 12 Pills | 622.94€ 593.28€ | |
| Viagra Generic | 150mg | 10 Pills | 36.73€ 34.98€ | |
| Viagra Generic | 100mg | 180 + 8 Pills | 199.37€ 189.88€ | |
| Kamagra Polo | 100mg | 20 Pills | 83.56€ 79.58€ | |
| Viagra Generic | 200mg | 30 + 2 Pills | 83.07€ 79.11€ |
Physicians should consider whether their patients with underlying NAION risk factors could be adversely affected by use of PDE5 inhibitors. 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. There are no controlled clinical data on the safety or efficacy of sildenafil in patients with retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases); if prescribed, this should be done with caution.
12.3 Pharmacokinetics
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.
Sildenafil may reduce neuroinflammation through mTOR pathway activation
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 to 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.
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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 over the counter drugs containing sildenafil these events has not been established. In humans, sildenafil has no effect on bleeding time when taken alone or with aspirin. However, in vitro studies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside (a nitric oxide donor). 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 sildenafil tablets 125 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.
- Sildenafil white is often sold as small, round, white tablets.
- It is available in various formulations, including sublingual and capsules.
- The drug increases cGMP levels, leading to smooth muscle relaxation.
- Generic sildenafil is usually cheaper than brand-name Viagra.
- Erectile dysfunction can be caused by physical or mental health issues.
- Misusing sildenafil white can result in priapism, a painful erection lasting hours.
- Some formulations come with flavoring to improve taste.
- Patient education about correct use is key to safety and effectiveness.
- Sildenafil white does not protect against sexually transmitted infections.
- It is important to avoid taking more than the recommended dose.
- Long-term safety data is still being studied, but generally considered safe when used properly.
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)].
7.3 Amlodipine
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.
Does sildenafil interact with other medicines (drug interactions)?
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 to 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. At doses above the recommended dose range, adverse reactions were similar to those detailed in Table 1 below but generally were reported more frequently.When sildenafil was taken as recommended (on an as-needed basis) in flexible-dose, placebo-controlled clinical trials of two to twenty-six weeks duration, patients took sildenafil at least once weekly, and the following adverse reactions were reported:The following events occurred in <2% of patients in controlled clinical trials; a causal relationship to sildenafil is uncertain.
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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.
12.1 Mechanism of Action
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. Sildenafil has systemic vasodilatory properties that resulted in transient decreases in supine blood pressure in healthy volunteers (mean maximum decrease of 8.4/5.5 mmHg), [see Clinical Pharmacology (12.2)]. While this normally would be expected to be of little consequence in most patients, prior to prescribing sildenafil, physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects, especially in combination with sexual activity. Use with caution in patients with the following underlying conditions which can be particularly sensitive to the actions of vasodilators including sildenafil – those with left ventricular outflow obstruction (e.g., aortic stenosis, idiopathic hypertrophic subaortic stenosis) and those with severely impaired autonomic control of blood pressure.
Why it’s used
There are no controlled clinical data on the safety or efficacy of sildenafil in the following groups; if prescribed, this should be done with caution. 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. 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 should consider whether their patients with underlying NAION risk factors could be adversely affected by use of PDE5 inhibitors.
What should I do if I accidentally use too much sildenafil?
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. There are no controlled clinical data on the safety or efficacy of sildenafil in patients with retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases); if prescribed, this should be done with caution. 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 sildenafil tablets 125 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. 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.
| Country/Region | Regulatory Body | Status of Sildenafil White | Notes |
|---|---|---|---|
| United States | FDA | Approved for ED and pulmonary hypertension | Prescription-only |
| European Union | EMA | Approved, similar indications | Prescription required |
| Canada | Health Canada | Approved with similar uses | Prescription needed |
| Australia | TGA | Approved for ED and pulmonary use | Prescription-only |
| India | CDSCO | Approved, widely available | Over-the-counter in some states |
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 to 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.
| Property | Description | Typical Dosage | Appearance | Packaging Type |
|---|---|---|---|---|
| Name | Sildenafil White | 50 mg, 100 mg | White, Round Pills | Blister Pack |
| Chemical Formula | C22H30N6O4S | N/A | N/A | N/A |
| Manufacturer | Example Pharma Co. | N/A | N/A | N/A |
| Storage Conditions | Store in a cool, dry place | N/A | N/A | N/A |
The type of adverse reactions in flexible-dose studies, which reflect the recommended dosage regimen, was similar to that for fixed-dose studies.
- Sildenafil white was first approved by the FDA in 1998.
- It is marketed under various brand and generic names worldwide.
- The drug belongs to a class called phosphodiesterase inhibitors.
- It is effective for many men with both physical and psychological ED.
- Sildenafil white may also help treat pulmonary arterial hypertension.
- Some users report experiencing visual disturbances after taking it.
- The medication’s effects last approximately 4 to 6 hours.
- It is advisable to avoid alcohol when taking sildenafil white.
- Consumers should check for potential drug allergies before use.
- The pill's color and shape can vary depending on the manufacturer.
- Always consult a healthcare provider for appropriate use and dosing.
At doses above the recommended dose range, adverse reactions were similar to those detailed in Table 1 below but generally were reported more frequently.When sildenafil was taken as recommended (on an as-needed basis) in flexible-dose, placebo-controlled clinical trials of two to twenty-six weeks duration, patients took sildenafil at least once weekly, and the following adverse reactions were reported:The following events occurred in <2% of patients in controlled clinical trials; a causal relationship to sildenafil is uncertain.
