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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.
- The medication is generally well tolerated when used correctly.
- Erectile response to sildenafil varies among individuals.
- Avoid heavy or greasy foods before taking the pill.
- Some side effects are more common in first-time users.
- Notify your doctor if your condition worsens or persists.
- Sildenafil 100 mg may also be prescribed for other health issues.
- Do not take sildenafil if you have recent history of stroke or heart attack.
- Confirm your allergies with your healthcare provider before use.
- Always store medication in a secure location away from children.
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. 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 pfizer sildenafil 50 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.
| Condition | Details | Rationale |
|---|---|---|
| Temperature | Store below 25°C (77°F) | Preserves chemical stability |
| Humidity | Keep in a dry place | Prevents clumping and degradation |
| Light | Protect from direct sunlight | Prevents breakdown of active ingredient |
| Container | Original blister or tightly closed bottle | Maintains stability and prevents contamination |
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 alternatives
In fixed-dose studies, the incidence of some adverse reactions increased with dose. 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. Reported events include those with a plausible relation to drug use; omitted are minor events and reports too imprecise to be meaningful: Body as a Whole:face edema, photosensitivity reaction, shock, asthenia, pain, chills, accidental fall, abdominal pain, allergic reaction, chest pain, accidental injury.
Jet lag research
Sildenafil was administered to over 3700 patients (aged 19 to 87 years) during pre-marketing clinical trials worldwide.
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Viagra Generic | 25mg | 180 + 6 Pills | 154.93€ 147.55€ | |
| Kamagra Soft Tabs | 100mg | 272 + 12 Pills | 593.42€ 565.16€ | |
| Kamagra Soft Tabs | 100mg | 32 Pills | 120.11€ 114.39€ | |
| Viagra Generic | 100mg | 90 + 6 Pills | 129.02€ 122.88€ | |
| Kamagra | 100mg | 32 Pills | 121.24€ 115.47€ | |
| Kamagra Polo | 100mg | 60 + 4 Pills | 189.39€ 180.37€ | |
| Viagra Generic | 150mg | 10 Pills | 36.73€ 34.98€ | |
| Viagra Generic | 150mg | 120 + 8 Pills | 177.58€ 169.12€ | |
| Kamagra Polo | 100mg | 20 Pills | 83.56€ 79.58€ | |
| Kamagra | 100mg | 360 + 6 Pills | 839.95€ 799.95€ | |
| Viagra Generic | 150mg | 180 + 10 Pills | 236.46€ 225.20€ | |
| Viagra Generic | 25mg | 90 + 6 Pills | 105.03€ 100.03€ | |
| Kamagra Soft Tabs | 100mg | 20 Pills | 79.79€ 75.99€ |
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.
4.3 Concomitant Guanylate Cyclase (GC) Stimulators
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.
8.6 Renal Impairment
This analysis was performed retrospectively, and was not powered to detect any pre-specified difference in adverse reactions.6.2 Postmarketing ExperienceThe following adverse reactions have been identified during post approval use of sildenafil. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
| Side Effect | Frequency | Severity | Notes |
|---|---|---|---|
| Headache | Very common | Mild | Usually resolves with time |
| Flushing | Common | Mild | Due to vasodilation |
| Nasal Congestion | Common | Mild | Congestion of nasal passages |
| Dizziness | Less common | Mild | Especially when standing up quickly |
| Dyspepsia | Less common | Mild | Indigestion or stomach upset |
| Visual Disturbances | Rare | Variable | Changes in color perception or blurred vision |
These events have been chosen for inclusion either due to their seriousness, reporting frequency, lack of clear alternative causation, or a combination of these factors.Cardiovascular and cerebrovascularSerious cardiovascular, cerebrovascular, and vascular events, including myocardial infarction, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient ischemic attack, hypertension, subarachnoid and intracerebral hemorrhages, and pulmonary hemorrhage have been reported post-marketing in temporal association with the use of sildenafil. Most, but not all, of these patients had preexisting cardiovascular risk factors.
- Sildenafil’s effectiveness depends on sexual stimulation.
- It is not an aphrodisiac and requires arousal to work.
- Drinking large quantities of alcohol may impair its effectiveness.
- The drug can cause a prolonged erection if misused.
- Sildenafil may lead to sudden vision or hearing changes.
- Always discuss all medications you are taking with your doctor.
- Missing a dose should not be remedied by doubling the next dose.
- Use caution if you have a history of eye problems like retinitis pigmentosa.
- Consult your doctor before starting or stopping sildenafil treatment.
Many of these events were reported to occur during or shortly after sexual activity, and a few were reported to occur shortly after the use of sildenafil without sexual activity. Others were reported to have occurred hours to days after the use of sildenafil and sexual activity.
Information & Authors
It is not possible to determine whether these events are related directly to sildenafil, to sexual activity, to the patient’s sildenafil pink pill underlying cardiovascular disease, to a combination of these factors, or to other factors [ see Warnings and Precautions (5.1)and Patient Counseling Information (17)].Hemic and Lymphatic: vaso-occlusive crisis: In a small, prematurely terminated study of REVATIO (sildenafil) in patients with pulmonary arterial hypertension (PAH) secondary to sickle cell disease, vaso-occlusive crises requiring hospitalization were more commonly reported in patients who received sildenafil than in those randomized to placebo. The clinical relevance of this finding to men treated with sildenafil for ED is not known.Nervous: seizure, seizure recurrence, anxiety, and transient global amnesia.Respiratory: epistaxisSpecial senses:Hearing:Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including sildenafil.
Other uses for this medicine
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. This analysis was performed retrospectively, and was not powered to detect any pre-specified difference in adverse reactions.6.2 Postmarketing ExperienceThe following adverse reactions have been identified during post approval use of sildenafil.
Frequently asked questions
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These events have been chosen for inclusion either due to their seriousness, reporting frequency, lack of clear alternative causation, or a combination of these factors.Cardiovascular and cerebrovascularSerious cardiovascular, cerebrovascular, and vascular events, including myocardial infarction, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient ischemic attack, hypertension, subarachnoid and intracerebral hemorrhages, and pulmonary hemorrhage have been reported post-marketing in temporal association with the use of sildenafil. Most, but not all, of these patients had preexisting cardiovascular risk factors. Many of these events were reported to occur during or shortly after sexual activity, and a few were reported to occur shortly after the use of sildenafil without sexual activity. Others were reported to have occurred hours to days after the use of sildenafil and sexual activity. In some of the cases, medical conditions and other factors were reported that may have also played a role in the otologic adverse events. In many cases, medical follow-up information was limited.
- Sildenafil 100 mg tablets are primarily used to treat erectile dysfunction.
- The medication works by increasing blood flow to the penis.
- It is usually taken 30-60 minutes before sexual activity.
- Do not take more than one tablet per 24 hours to avoid overdose.
- Common side effects include headache, flushing, and nasal congestion.
- Sildenafil 100 mg should be used only under medical supervision.
- Avoid consuming high-fat meals close to the time of intake.
- It may interact with nitrates, leading to dangerous blood pressure drops.
- Store in a cool, dry place away from children and pets.
It is not possible to determine whether these reported events are related directly to the use of sildenafil, to the patient’s underlying risk factors for hearing loss, a combination of these factors, or to other factors [ see Warnings and Precautions (5.4)and Patient Counseling Information (17)].Ocular :diplopia, temporary vision loss/decreased vision, ocular redness or bloodshot appearance, ocular burning, ocular swelling/pressure, increased intraocular pressure, retinal edema, retinal vascular disease or bleeding, and vitreous traction/detachment.Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely post-marketing in temporal association with the use of phosphodiesterase type 5 (PDE5) inhibitors, including sildenafil.
Overdose/Missed Dose
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 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.
Before taking sildenafil,
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 pfizer sildenafil 50 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. 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. Most, but not all, of these patients had underlying anatomic or vascular risk factors for developing NAION, including but not necessarily limited to: low cup to disc ratio (“crowded disc”), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia and smoking [ see Warnings and Precautions (5.3)and Patient Counseling Information (17)].Urogenital:prolonged erection, priapism [ see Warnings and Precautions (5.2)and Patient Counseling Information (17)], and hematuria. 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. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a canada sildenafil drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
2.4 Dosage Adjustments Due to Drug Interactions
It is not possible to determine whether these events are related directly to sildenafil, to sexual activity, to the patient’s sildenafil pink pill underlying cardiovascular disease, to a combination of these factors, or to other factors [ see Warnings and Precautions (5.1)and Patient Counseling Information (17)].Hemic and Lymphatic: vaso-occlusive crisis: In a small, prematurely terminated study of REVATIO (sildenafil) in patients with pulmonary arterial hypertension (PAH) secondary to sickle cell disease, vaso-occlusive crises requiring hospitalization were more commonly reported in patients who received sildenafil than in those randomized to placebo. The clinical relevance of this finding to men treated with sildenafil for ED is not known.Nervous: seizure, seizure recurrence, anxiety, and transient global amnesia.Respiratory: epistaxisSpecial senses:Hearing:Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including sildenafil. In some of the cases, medical conditions and other factors were reported that may have also played a role in the otologic adverse events. In many cases, medical follow-up information was limited. It is not possible to determine whether these reported events are related directly to the use of sildenafil, to the patient’s underlying risk factors for hearing loss, a combination of these factors, or to other factors [ see Warnings and Precautions (5.4)and Patient Counseling Information (17)].Ocular :diplopia, temporary vision loss/decreased vision, ocular redness or bloodshot appearance, ocular burning, ocular swelling/pressure, increased intraocular pressure, retinal edema, retinal vascular disease or bleeding, and vitreous traction/detachment.Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely post-marketing in temporal association with the use of phosphodiesterase type 5 (PDE5) inhibitors, including sildenafil.
Can Viagra make sex last longer?
Most, but not all, of these patients had underlying anatomic or vascular risk factors for developing NAION, including but not necessarily limited to: low cup to disc ratio (“crowded disc”), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia and smoking [ see Warnings and Precautions (5.3)and Patient Counseling Information (17)].Urogenital:prolonged erection, priapism [ see Warnings and Precautions (5.2)and Patient Counseling Information (17)], and hematuria. 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. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a canada sildenafil drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. 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%). 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 pill is oval-shaped and often light blue in color.
- It should not be chewed or crushed; swallow whole with water.
- Do not use sildenafil if you have a condition affecting your heart.
- Keep track of your dosage to prevent accidental overuse.
- It’s effective for about 4-6 hours after taking the tablet.
- Some users may experience indigestion or stomach upset.
- Using sildenafil with certain medications can increase side effects.
- Consult your healthcare provider for personalized dosage recommendations.
- Avoid grapefruit or grapefruit juice while using sildenafil.
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.
| Condition | Risk | Recommendations |
|---|---|---|
| Use of Nitrates | Severe hypotension risk | Do not co-administer |
| Severe Liver Impairment | Altered drug metabolism | Consult healthcare provider |
| Retinitis Pigmentosa | Potential risk of vision issues | Use with caution |
| Recent Stroke or Heart Attack | Cardiac stress | Medical evaluation required |
| Hypotension (Low Blood Pressure) | Worsening symptoms | Monitor blood pressure during use |
Reported events include those with a plausible relation to drug use; omitted are minor events and reports too imprecise to be meaningful: Body as a Whole:face edema, photosensitivity reaction, shock, asthenia, pain, chills, accidental fall, abdominal pain, allergic reaction, chest pain, accidental injury.
