Sildenafil at recommended doses has no effect in the absence of sexual stimulation.Binding CharacteristicsStudies in vitro have shown that sildenafil is selective for PDE5. This lower selectivity is thought to be the basis for abnormalities related to color vision [see Clinical Pharmacology (12.2)].In addition to human corpus cavernosum smooth muscle, PDE5 is also found in other tissues including platelets, vascular and visceral smooth muscle, and skeletal muscle, brain, heart, liver, kidney, lung, pancreas, prostate, bladder, testis, and seminal vesicle.
8.7 Hepatic Impairment
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The inhibition of PDE5 in some of these tissues by sildenafil may be the basis for the enhanced platelet antiaggregatory activity of NO observed in vitro, an inhibition of platelet thrombus formation in vivo and peripheral arterial-venous dilatation in vivo.12.2 PharmacodynamicsEffects of VIAGRA on Erectile Response: In eight double-blind, placebo-controlled crossover studies of patients with either organic or psychogenic erectile dysfunction, sexual stimulation resulted in improved erections, as assessed by an objective measurement of hardness and duration of erections (RigiScan®), after VIAGRA administration compared with placebo. The time course of effect was examined in one study, showing an effect for up to 4 hours but the response was diminished compared to 2 hours.Effects of VIAGRA on Blood Pressure: Single oral doses of sildenafil (100 mg) administered to healthy volunteers produced decreases in sitting blood pressure (mean maximum decrease in systolic/diastolic blood pressure of 8.3/5.3 mmHg). Larger effects were recorded among patients receiving concomitant nitrates [see Contraindications (4.1)].Figure 1: Mean Change from Baseline in Sitting Systolic Blood Pressure, Healthy Volunteers.Effects of VIAGRA on Blood viagra medicine Pressure When Nitroglycerin is Subsequently Administered: Based on the pharmacokinetic profile of a single 100 mg oral dose given to healthy normal volunteers, the plasma levels of sildenafil at 24 hours post dose are approximately 2 ng/mL (compared to peak plasma levels of approximately 440 ng/mL).
- Viagra daily is often used by men with chronic erectile issues.
- It is not a cure but can enhance everyday sexual activity.
- Proper hydration can support the effectiveness of Viagra.
- Report any ongoing side effects to your healthcare provider.
- Store Viagra in a cool, dry place away from children.
- Combining Viagra with other ED medications is not recommended.
- The medication should be used as part of a broader health plan.
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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 Contraindications (4.1)].Effects of VIAGRA on Blood Pressure When Co-administered with Alpha-Blockers: Three double-blind, placebo-controlled, randomized, two-way crossover studies were conducted to assess the interaction of VIAGRA with doxazosin, an alpha-adrenergic blocking agent.Study 1: VIAGRA with DoxazosinIn the first study, a single oral dose of VIAGRA 100 mg or matching placebo was administered in a 2-period crossover design to 4 generally healthy males with benign prostatic hyperplasia (BPH). The mean subject age was 66.5 years.For the 17 subjects who received VIAGRA 25 mg and matching placebo, the placebo-subtracted mean maximum decreases from baseline (95% CI) in systolic blood pressure were as follows:The mean profiles of the change from baseline in standing systolic blood pressure in subjects treated with doxazosin in combination with 25 mg VIAGRA or matching placebo are shown in Figure 2.Figure 2: Mean Standing Systolic Blood Pressure Change from BaselineBlood pressure was measured immediately pre-dose and at 15, 30, 45 minutes, and 1, 1.5, 2, 2.5, 3, 4, 6 and 8 hours after VIAGRA or matching placebo. No severe adverse events potentially related to blood pressure effects were reported in this group.Of the four subjects who received VIAGRA 100 mg in the first part of this study, a severe adverse event related to blood pressure effect was reported in one patient (postural hypotension that began 35 minutes after dosing with VIAGRA with symptoms lasting for 8 hours), and mild adverse events potentially related to blood pressure effects were reported in two others (dizziness, headache and fatigue at 1 hour after dosing; and dizziness, lightheadedness and nausea at 4 hours after dosing). Both of these subjects were protocol violators, one due to a low baseline standing SBP, and the other due to baseline orthostatic hypotension.Study 2: VIAGRA with DoxazosinIn the second study, a single oral dose of VIAGRA 50 mg or matching placebo was administered in a 2-period crossover design to 20 generally healthy males with BPH.
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The mean subject age in this study was 63.9 years.Twenty subjects received VIAGRA 50 mg, but only 19 subjects received matching placebo.
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This patient had been taking minoxidil, a potent vasodilator, during the study.For the 19 subjects who received both VIAGRA and matching placebo, the placebo-subtracted mean maximum decreases from baseline (95% CI) in systolic blood pressure were as follows:The mean profiles of the change from baseline in standing systolic blood pressure in subjects treated with doxazosin in combination with 50 mg VIAGRA or matching placebo are shown in Figure 3.Figure 3: Mean Standing Systolic Blood Pressure Change from BaselineBlood pressure was measured after administration of VIAGRA at the same times as those specified for the first doxazosin study.
Proper Use
Sildenafil at recommended doses has no effect in the absence of sexual stimulation.Binding CharacteristicsStudies in vitro have shown that sildenafil is selective for PDE5. This lower selectivity is thought to be the basis for abnormalities related to color vision [see Clinical Pharmacology (12.2)].In addition to human corpus cavernosum smooth muscle, PDE5 is also found in other tissues including platelets, vascular and visceral smooth muscle, and skeletal muscle, brain, heart, liver, kidney, lung, pancreas, prostate, bladder, testis, and seminal vesicle. The inhibition of PDE5 in some of these tissues by sildenafil may be the basis for the enhanced platelet antiaggregatory activity of NO observed in vitro, an inhibition of platelet thrombus formation in vivo and peripheral arterial-venous dilatation in vivo.12.2 PharmacodynamicsEffects of VIAGRA on Erectile Response: In eight double-blind, placebo-controlled crossover studies of patients with either organic or psychogenic erectile dysfunction, sexual stimulation resulted in improved erections, as assessed by an objective measurement of hardness and duration of erections (RigiScan®), after VIAGRA administration compared with placebo. The time course of effect was examined in one study, showing an effect for up to 4 hours but the response was diminished compared to 2 hours.Effects of VIAGRA on Blood Pressure: Single oral doses of sildenafil (100 mg) administered to healthy volunteers produced decreases in sitting blood pressure (mean maximum decrease in systolic/diastolic blood pressure of 8.3/5.3 mmHg). Larger effects were recorded among patients receiving concomitant nitrates [see Contraindications (4.1)].Figure 1: Mean Change from Baseline in Sitting Systolic Blood Pressure, Healthy Volunteers.Effects of VIAGRA on Blood viagra medicine Pressure When Nitroglycerin is Subsequently Administered: Based on the pharmacokinetic profile of a single 100 mg oral dose given to healthy normal volunteers, the plasma levels of sildenafil at 24 hours post dose are approximately 2 ng/mL (compared to peak plasma levels of approximately 440 ng/mL).
More common
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 Contraindications (4.1)].Effects of VIAGRA on Blood Pressure When Co-administered with Alpha-Blockers: Three double-blind, placebo-controlled, randomized, two-way crossover studies were conducted to assess the interaction of VIAGRA with doxazosin, an alpha-adrenergic blocking agent.Study 1: VIAGRA with DoxazosinIn the first study, a single oral dose of VIAGRA 100 mg or matching placebo was administered in a 2-period crossover design to 4 generally healthy males with benign prostatic hyperplasia (BPH). The mean subject age was 66.5 years.For the 17 subjects who received VIAGRA 25 mg and matching placebo, the placebo-subtracted mean maximum decreases from baseline (95% CI) in systolic blood pressure were as follows:The mean profiles of the change from baseline in standing systolic blood pressure in subjects treated with doxazosin in combination with 25 mg VIAGRA or matching placebo are shown in Figure 2.Figure 2: Mean Standing Systolic Blood Pressure Change from BaselineBlood pressure was measured immediately pre-dose and at 15, 30, 45 minutes, and 1, 1.5, 2, 2.5, 3, 4, 6 and 8 hours after VIAGRA or matching placebo. No severe adverse events potentially related to blood pressure effects were reported in this group.Of the four subjects who received VIAGRA 100 mg in the first part of this study, a severe adverse event related to blood pressure effect was reported in one patient (postural hypotension that began 35 minutes after dosing with VIAGRA with symptoms lasting for 8 hours), and mild adverse events potentially related to blood pressure effects were reported in two others (dizziness, headache and fatigue at 1 hour after dosing; and dizziness, lightheadedness and nausea at 4 hours after dosing). Both of these subjects were protocol violators, one due to a low baseline standing SBP, and the other due to baseline orthostatic hypotension.Study 2: VIAGRA with DoxazosinIn the second study, a single oral dose of VIAGRA 50 mg or matching placebo was administered in a 2-period crossover design to 20 generally healthy males with BPH. The mean subject age in this study was 63.9 years.Twenty subjects received VIAGRA 50 mg, but only 19 subjects received matching placebo.
Know the potential side effects of Viagra
This patient had been taking minoxidil, a potent vasodilator, during the study.For the 19 subjects who received both VIAGRA and matching placebo, the placebo-subtracted mean maximum decreases from baseline (95% CI) in systolic blood pressure were as follows:The mean profiles of the change from baseline in standing systolic blood pressure in subjects treated with doxazosin in combination with 50 mg VIAGRA or matching placebo are shown in Figure 3.Figure 3: Mean Standing Systolic Blood Pressure Change from BaselineBlood pressure was measured after administration of VIAGRA at the same times as those specified for the first doxazosin study. There were no severe adverse events potentially related to blood pressure and no episodes of syncope reported in this study.Study 3: VIAGRA with DoxazosinIn the third study, a single oral dose of VIAGRA 100 mg or matching placebo was administered in a 3-period crossover design to 20 generally healthy males with BPH. The mean subject age in this study was 66.4 years.Twenty-five subjects were screened. Two were discontinued after study period 1: one failed to meet pre-dose screening qualifications and the other experienced symptomatic hypotension as a moderately severe adverse event 30 minutes after dosing with open-label VIAGRA 50 mg. Of the twenty subjects who were ultimately assigned to treatment, a total of 13 subjects successfully completed dose period 1, and seven had successfully completed the viagra black previous doxazosin study (using VIAGRA 50 mg).For the 20 subjects who received VIAGRA 100 mg and matching placebo, the placebo-subtracted mean maximum decreases from baseline (95% CI) in systolic blood pressure were as follows:The mean profiles of the change from baseline in standing systolic blood pressure in subjects treated with doxazosin in combination with 100 mg VIAGRA or matching placebo are shown in Figure 4.Figure 4: Mean Standing Systolic Blood Pressure Change from BaselineBlood pressure was measured after administration of VIAGRA at the same times as those specified for the previous doxazosin studies. There were no severe adverse events potentially related to blood pressure and no episodes of syncope reported in this study.Study 3: VIAGRA with DoxazosinIn the third study, a single oral dose of VIAGRA 100 mg or matching placebo was administered in a 3-period crossover design to 20 generally healthy males with BPH.
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Long-term use
The mean subject age in this study was 66.4 years.Twenty-five subjects were screened.
| Brand/Generic | Average Cost per Month ($) | Availability |
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| Viagra (Brand) | 600–900 | Widely available |
| Sildenafil (Generic) | 50–150 | Readily accessible |
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Two were discontinued after study period 1: one failed to meet pre-dose screening qualifications and the other experienced symptomatic hypotension as a moderately severe adverse event 30 minutes after dosing with open-label VIAGRA 50 mg.
- Daily Viagra may contribute to improved self-esteem in men with ED.
- Consistent medication can lead to better natural erectile responses over time.
- It is not suitable for use with certain health conditions; screening is important.
- The medication typically starts working within 30-60 minutes.
- Some users report better sleep quality due to improved confidence.
- Avoid altering the prescribed dose without consulting a healthcare professional.
- Regular physical activity can enhance Viagra's benefits.
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Of the twenty subjects who were ultimately assigned to treatment, a total of 13 subjects successfully completed dose period 1, and seven had successfully completed the viagra black previous doxazosin study (using VIAGRA 50 mg).For the 20 subjects who received VIAGRA 100 mg and matching placebo, the placebo-subtracted mean maximum decreases from baseline (95% CI) in systolic blood pressure were as follows:The mean profiles of the change from baseline in standing systolic blood pressure in subjects treated with doxazosin in combination with 100 mg VIAGRA or matching placebo are shown in Figure 4.Figure 4: Mean Standing Systolic Blood Pressure Change from BaselineBlood pressure was measured after administration of VIAGRA at the same times as those specified for the previous doxazosin studies. There were no episodes of syncope reported in this study.Effect of VIAGRA on Blood Pressure When Co-administered with Anti-hypertensives: When VIAGRA 100 mg oral was co-administered with amlodipine, 5 mg or 10 mg oral, to hypertensive patients, the mean additional reduction on supine blood pressure was 8 mmHg systolic and 7 mmHg diastolic.Effect of VIAGRA on Blood Pressure When Co-administered with Alcohol: VIAGRA (50 mg) did not potentiate the hypotensive effect of alcohol (0.5 g/kg) in healthy volunteers with mean maximum blood alcohol levels of 0.08%. The maximum recommended dose of 100 mg sildenafil was not evaluated in this study [see Drug Interactions (7.5)].Effects of VIAGRA on Cardiac Parameters: Single oral doses of sildenafil up to 100 mg produced no clinically relevant changes in the ECGs of normal male volunteers.Studies have produced relevant data on the effects of VIAGRA on cardiac output.
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
There were no episodes of syncope reported in this study.Effect of VIAGRA on Blood Pressure When Co-administered with Anti-hypertensives: When VIAGRA 100 mg oral was co-administered with amlodipine, 5 mg or 10 mg oral, to hypertensive patients, the mean additional reduction on supine blood pressure was 8 mmHg systolic and 7 mmHg diastolic.Effect of VIAGRA on Blood Pressure When Co-administered with Alcohol: VIAGRA (50 mg) did not potentiate the hypotensive effect of alcohol (0.5 g/kg) in healthy volunteers with mean maximum blood alcohol levels of 0.08%. The maximum recommended dose of 100 mg sildenafil was not evaluated in this study [see Drug Interactions (7.5)].Effects of VIAGRA on Cardiac Parameters: Single oral doses of sildenafil up to 100 mg produced no clinically relevant changes in the ECGs of normal male volunteers.Studies have produced relevant data on the effects of VIAGRA on cardiac output. A total dose of 40 mg sildenafil was administered by four intravenous infusions.The results from this pilot study liquid viagra are shown in Table 3; the mean resting systolic and diastolic blood pressures decreased by 7% and 10% compared to baseline in these patients. Even though this total dosage produced plasma sildenafil concentrations which were approximately 2 to 5 times higher than the mean maximum plasma concentrations following a single oral dose of 100 mg in healthy male volunteers, the hemodynamic response to exercise was preserved in these patients.In a double-blind study, 144 patients with erectile dysfunction and chronic stable angina limited by exercise, not receiving chronic oral nitrates, were randomized to a single dose of placebo or VIAGRA 100 mg 1 hour prior to exercise testing. These results demonstrated that the effect of VIAGRA on the primary endpoint was statistically non-inferior to placebo.Effects of VIAGRA on Vision: At single oral doses of 100 mg and 200 mg, transient dose-related impairment of color discrimination was detected using the Farnsworth-Munsell 100-hue test, with peak effects near the time of peak plasma levels.
Typical dosages
An evaluation of visual function at doses up to twice the maximum recommended dose revealed no effects of VIAGRA on visual acuity, intraocular pressure, or pupillometry.12.3 PharmacokineticsVIAGRA is rapidly absorbed after oral administration, with a mean absolute bioavailability of 41% (range 25–63%). Both sildenafil and the metabolite have terminal half lives of about 4 hours.Mean sildenafil plasma concentrations measured after the administration of a single oral dose of 100 mg to healthy male volunteers is depicted below:Figure 5: Mean Sildenafil Plasma Concentrations in Healthy Male Volunteers.Absorption and Distribution: VIAGRA is rapidly absorbed. Protein binding is independent of total drug concentrations.Based upon measurements of sildenafil in semen of healthy volunteers 90 minutes after dosing, less than 0.001% of the administered dose may appear in the semen of patients.Metabolism and Excretion: Sildenafil is cleared predominantly by the CYP3A4 (major route) and CYP2C9 (minor route) hepatic microsomal isoenzymes. Plasma concentrations of this metabolite are approximately 40% of those seen for sildenafil, so that the metabolite accounts for about 20% of sildenafil's pharmacologic effects.After either oral or intravenous administration, sildenafil is excreted as metabolites predominantly in the feces (approximately 80% of administered oral dose) and to a lesser extent in the urine (approximately 13% of the administered oral dose).
How should I store sildenafil?
A total dose of 40 mg sildenafil was administered by four intravenous infusions.The results from this pilot study liquid viagra are shown in Table 3; the mean resting systolic and diastolic blood pressures decreased by 7% and 10% compared to baseline in these patients. Even though this total dosage produced plasma sildenafil concentrations which were approximately 2 to 5 times higher than the mean maximum plasma concentrations following a single oral dose of 100 mg in healthy male volunteers, the hemodynamic response to exercise was preserved in these patients.In a double-blind study, 144 patients with erectile dysfunction and chronic stable angina limited by exercise, not receiving chronic oral nitrates, were randomized to a single dose of placebo or VIAGRA 100 mg 1 hour prior to exercise testing.
- Viagra daily has a different dosing schedule compared to as-needed use.
- Typically, a lower dose is prescribed for daily use.
- Consistent use may help regulate erectile function.
- Some users notice increased spontaneity in intimacy.
- Regular check-ups are essential while using daily Viagra.
- Be aware of potential interactions with other medications.
- Avoid grapefruit or grapefruit juice, as it may interfere.
- Erectile response can vary based on overall health.
These results demonstrated that the effect of VIAGRA on the primary endpoint was statistically non-inferior to placebo.Effects of VIAGRA on Vision: At single oral doses of 100 mg and 200 mg, transient dose-related impairment of color discrimination was detected using the Farnsworth-Munsell 100-hue test, with peak effects near the time of peak plasma levels. An evaluation of visual function at doses up to twice the maximum recommended dose revealed no effects of VIAGRA on visual acuity, intraocular pressure, or pupillometry.12.3 PharmacokineticsVIAGRA is rapidly absorbed after oral administration, with a mean absolute bioavailability of 41% (range 25–63%).
| Benefit | Description | Evidence Level |
|---|---|---|
| Improved Erectile Function | Regular use may enhance bedroom performance | Moderate |
| Increased Confidence | More spontaneous intimacy supported | Anecdotal |
| Reduced Performance Anxiety | Consistent medication reduces stress | Moderate |
| Possible Heart Benefits | Some studies suggest vascular benefits | Limited |
Both sildenafil and the metabolite have terminal half lives of about 4 hours.Mean sildenafil plasma concentrations measured after the administration of a single oral dose of 100 mg to healthy male volunteers is depicted below:Figure 5: Mean Sildenafil Plasma Concentrations in Healthy Male Volunteers.Absorption and Distribution: VIAGRA is rapidly absorbed.
| Population Group | Effectiveness Percentage | Notes |
|---|---|---|
| Men aged 40–60 | 70–80% | Common age group effectiveness |
| Men over 60 | 60–70% | Slightly lower effectiveness |
| Men with diabetes | 50–65% | Variable depending on severity |
| Men without comorbidities | 80–90% | Highest success rate |
Protein binding is independent of total drug concentrations.Based upon measurements of sildenafil in semen of healthy volunteers 90 minutes after dosing, less than 0.001% of the administered dose may appear in the semen of patients.Metabolism and Excretion: Sildenafil is cleared predominantly by the CYP3A4 (major route) and CYP2C9 (minor route) hepatic microsomal isoenzymes. Plasma concentrations of this metabolite are approximately 40% of those seen for sildenafil, so that the metabolite accounts for about 20% of sildenafil's pharmacologic effects.After either oral or intravenous administration, sildenafil is excreted as metabolites predominantly in the feces (approximately 80% of administered oral dose) and to a lesser extent in the urine (approximately 13% of the administered oral dose).