I need to order Sildenafil Citrate 50 mg tablets as I am running low. My dispensed date was 02/07/2026. I have 4 left.

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: Sildenafil citrate with DoxazosinIn the second study, a single oral dose of sildenafil citrate 50 mg or matching placebo was administered in a 2-period crossover design to 20 generally healthy males with BPH.

• Sildenafil 50mg is a phosphodiesterase inhibitor for ED treatment.
• The medication is not a cure but helps achieve an erection on demand.
• Avoid combining sildenafil with recreational drugs or alcohol.
• It is important to follow the timing recommended by your doctor.
• The medication may cause a temporary decrease in blood pressure.
• Use with caution in individuals with kidney or liver impairment.
• Always read the patient information leaflet that accompanies the medicine.
• Regular medical check-ups are advised when using sildenafil long-term.

Following at least 14 consecutive days of doxazosin, sildenafil citrate 50 mg or matching placebo was administered simultaneously with doxazosin 4 mg (17 subjects) or with doxazosin 8 mg (3 subjects). The mean subject age in this study was 63.9 years.Twenty subjects received sildenafil citrate 50 mg, but only 19 subjects received matching placebo. One patient discontinued the study prematurely due to an adverse event of hypotension following dosing with sildenafil citrate 50 mg. This patient had been taking minoxidil, a potent vasodilator, during the study.For the 19 subjects who received both sildenafil citrate 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 sildenafil citrate or matching placebo are shown in Figure 3.Figure 3: Mean Standing Systolic Blood Pressure Change from BaselineBlood pressure was measured after administration of sildenafil citrate at the same times as those specified for the first doxazosin study. There were two subjects who had a standing SBP of < 85 mmHg.

In these two subjects, hypotension was reported as a moderately severe adverse event, beginning at approximately 1 hour after administration of sildenafil citrate 50 mg and resolving after approximately 7.5 hours. There was one subject with a decrease from baseline in standing systolic BP >30mmHg following sildenafil citrate 50 mg and one subject with a decrease from baseline in standing systolic BP > 30 mmHg following both sildenafil citrate 50 mg and placebo. There were no severe adverse events potentially related to blood pressure and no episodes of syncope reported in this study.Study 3: Sildenafil citrate with DoxazosinIn the third study, a single oral dose of sildenafil citrate 100 mg or matching placebo was administered in a 3-period crossover design to 20 generally healthy males with BPH. In dose period 1, subjects were administered open-label doxazosin and a single dose of sildenafil citrate 50 mg simultaneously, after at least 14 consecutive days of doxazosin. If a subject did not successfully complete this first dosing period, he sildenafil pills was discontinued from the study. Subjects who had successfully completed the previous doxazosin interaction study (using sildenafil citrate 50 mg), including no significant hemodynamic adverse events, were allowed to skip dose period 1.

How to take Sildenafil 50mg Tablets

When sildenafil citrate is taken with a high fat meal, the rate of absorption is reduced, with a mean delay in T maxof 60 minutes and a mean reduction in C maxof 29%. The mean steady state volume of distribution (Vss) for sildenafil is 105 L, indicating distribution into the tissues. Sildenafil and its major circulating N-desmethyl metabolite are both approximately 96% bound to plasma proteins. Treatment with doxazosin continued for at least 7 days after dose period 1. Thereafter, sildenafil citrate 100 mg or matching placebo was administered simultaneously with doxazosin 4 mg (14 subjects) or doxazosin 8 mg (6 subjects) in standard crossover fashion. 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 sildenafil citrate 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 previous doxazosin study (using sildenafil citrate 50 mg).For the 20 subjects who received sildenafil citrate 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 sildenafil citrate or matching placebo are shown in Figure 4.Figure 4: Mean Standing Systolic Blood Pressure Change from BaselineBlood pressure was measured after administration of sildenafil citrate at the same times as those specified for the previous doxazosin studies.

8.1 Pregnancy

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: Sildenafil citrate with DoxazosinIn the second study, a single oral dose of sildenafil citrate 50 mg or matching placebo was administered in a 2-period crossover design to 20 generally healthy males with BPH. Following at least 14 consecutive days of doxazosin, sildenafil citrate 50 mg or matching placebo was administered simultaneously with doxazosin 4 mg (17 subjects) or with doxazosin 8 mg (3 subjects). The mean subject age in this study was 63.9 years.Twenty subjects received sildenafil citrate 50 mg, but only 19 subjects received matching placebo. One patient discontinued the study prematurely due to an adverse event of hypotension following dosing with sildenafil citrate 50 mg. This patient had been taking minoxidil, a potent vasodilator, during the study.For the 19 subjects who received both sildenafil citrate 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 sildenafil citrate or matching placebo are shown in Figure 3.Figure 3: Mean Standing Systolic Blood Pressure Change from BaselineBlood pressure was measured after administration of sildenafil citrate at the same times as those specified for the first doxazosin study.

Adjusting Your Sildenafil Dosage Over Time

There were two subjects who had a standing SBP of < 85 mmHg. In these two subjects, hypotension was reported as a moderately severe adverse event, beginning at approximately 1 hour after administration of sildenafil citrate 50 mg and resolving after approximately 7.5 hours. There was one subject with a decrease from baseline in standing systolic BP >30mmHg following sildenafil citrate 50 mg and one subject with a decrease from baseline in standing systolic BP > 30 mmHg following both sildenafil citrate 50 mg and placebo. There were no severe adverse events potentially related to blood pressure and no episodes of syncope reported in this study.Study 3: Sildenafil citrate with DoxazosinIn the third study, a single oral dose of sildenafil citrate 100 mg or matching placebo was administered in a 3-period crossover design to 20 generally healthy males with BPH. In dose period 1, subjects were administered open-label doxazosin and a single dose of sildenafil citrate 50 mg simultaneously, after at least 14 consecutive days of doxazosin.

Common Side Effects:

If a subject did not successfully complete this first dosing period, he sildenafil pills was discontinued from the study. Subjects who had successfully completed the previous doxazosin interaction study (using sildenafil citrate 50 mg), including no significant hemodynamic adverse events, were allowed to skip dose period 1. Treatment with doxazosin continued for at least 7 days after dose period 1. Thereafter, sildenafil citrate 100 mg or matching placebo was administered simultaneously with doxazosin 4 mg (14 subjects) or doxazosin 8 mg (6 subjects) in standard crossover fashion. The mean subject age in this study was 66.4 years.Twenty-five subjects were screened. There were three subjects who had a standing SBP of < 85 mmHg. All three were taking sildenafil citrate 100 mg, and all three reported mild adverse events at the time of reductions in standing SBP, including vasodilation and lightheadedness. There were four subjects with a decrease from baseline in standing systolic BP > 30 mmHg following sildenafil citrate 100 mg, one subject with a decrease from baseline in standing systolic BP > 30 mmHg following placebo and one subject with a decrease from baseline in standing systolic BP > 30 mmHg following both sildenafil citrate and placebo. While there were no severe adverse events potentially related to blood pressure reported in this study, one subject reported moderate vasodilatation after both sildenafil citrate 50 mg and 100 mg. There were no episodes of syncope reported in this study.Effect of Sildenafil citrate on Blood Pressure When Co-administered with Anti-hypertensives:When sildenafil citrate 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 Sildenafil citrate on Blood Pressure When Co-administered with Alcohol:Sildenafil citrate (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 50mg dosage is common but adjustable based on individual response.
• Overdose symptoms include severe dizziness, fainting, or prolonged erection.
• Sildenafil can cause visual disturbances, such as blurred vision.
• Use caution when driving or operating machinery after taking.
• Always check the expiration date on the medication packaging.
• Consult a healthcare professional for any underlying health concerns.
• Avoid using grapefruit or grapefruit juice with sildenafil.
• Notify your doctor if you experience chest pain during use.

The maximum observed decrease in systolic blood pressure was -18.5 mmHg when sildenafil was co-administered with alcohol versus -17.4 mmHg when alcohol was administered alone. The maximum observed decrease in diastolic blood pressure was -17.2 mmHg when sildenafil was co-administered with alcohol versus -11.1 mmHg when alcohol was administered alone. There were no reports of postural dizziness or orthostatic hypotension. The maximum recommended dose of 100 mg sildenafil was not evaluated in this study [ see Drug Interactions (7.5)].Effects of Sildenafil citrate 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 sildenafil citrate on cardiac output. In one small, open-label, uncontrolled, pilot study, eight patients sildenafil tables with stable ischemic heart disease underwent Swan-Ganz catheterization. A total dose of 40 mg sildenafil was administered by four intravenous infusions.The results from this pilot study are shown in Table 3; the mean resting systolic and diastolic blood pressures decreased by 7% and 10% compared to baseline in these patients. Mean resting values for right atrial pressure, pulmonary artery pressure, pulmonary artery occluded pressure and cardiac output decreased by 28%, 28%, 20% and 7% respectively. 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 sildenafil citrate 100 mg 1 hour prior to exercise testing. The primary endpoint was time to limiting angina in the evaluable cohort. The mean times (adjusted for baseline) to onset of limiting angina were 423.6 and 403.7 seconds for sildenafil (N=70) and placebo, respectively.

• Sildenafil citrate 50mg tablets are available by prescription only.
• The medication helps men achieve and maintain an erection.
• Do not take sildenafil if you are allergic to it.
• Alcohol may increase the risk of side effects when combined.
• Notify your doctor if you experience vision changes or hearing loss.
• Avoid heavy meals or alcohol before taking the medication.
• Usage may be inappropriate for men with certain health conditions.
• Keep out of reach of children and pets.

These results demonstrated that the effect of sildenafil citrate on the primary endpoint was statistically non-inferior to placebo.Effects of Sildenafil citrate 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. This finding is consistent with the inhibition of PDE6, which is involved in phototransduction in the retina. Subjects in the study reported this finding as difficulties in discriminating blue/green. An evaluation of visual function at doses up to twice the maximum recommended dose revealed no effects of sildenafil citrate on visual acuity, intraocular pressure, or pupillometry.Effects of Sildenafil citrate on Sperm:There was no effect on sperm motility or morphology after single 100 mg oral doses of sildenafil citrate in healthy volunteers.12.3 PharmacokineticsSildenafil citrate is rapidly absorbed after oral administration, with a mean absolute bioavailability of 41% (range 25 to 63%).

2.4 Dosage Adjustments Due to Drug Interactions

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 sildenafil citrate 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 previous doxazosin study (using sildenafil citrate 50 mg).For the 20 subjects who received sildenafil citrate 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 sildenafil citrate or matching placebo are shown in Figure 4.Figure 4: Mean Standing Systolic Blood Pressure Change from BaselineBlood pressure was measured after administration of sildenafil citrate at the same times as those specified for the previous doxazosin studies. There were three subjects who had a standing SBP of < 85 mmHg. All three were taking sildenafil citrate 100 mg, and all three reported mild adverse events at the time of reductions in standing SBP, including vasodilation and lightheadedness. There were four subjects with a decrease from baseline in standing systolic BP > 30 mmHg following sildenafil citrate 100 mg, one subject with a decrease from baseline in standing systolic BP > 30 mmHg following placebo and one subject with a decrease from baseline in standing systolic BP > 30 mmHg following both sildenafil citrate and placebo.

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While there were no severe adverse events potentially related to blood pressure reported in this study, one subject reported moderate vasodilatation after both sildenafil citrate 50 mg and 100 mg. There were no episodes of syncope reported in this study.Effect of Sildenafil citrate on Blood Pressure When Co-administered with Anti-hypertensives:When sildenafil citrate 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 Sildenafil citrate on Blood Pressure When Co-administered with Alcohol:Sildenafil citrate (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 observed decrease in systolic blood pressure was -18.5 mmHg when sildenafil was co-administered with alcohol versus -17.4 mmHg when alcohol was administered alone. The maximum observed decrease in diastolic blood pressure was -17.2 mmHg when sildenafil was co-administered with alcohol versus -11.1 mmHg when alcohol was administered alone. There were no reports of postural dizziness or orthostatic hypotension.

Custom Packaging & Labeling:

The maximum recommended dose of 100 mg sildenafil was not evaluated in this study [ see Drug Interactions (7.5)].Effects of Sildenafil citrate 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 sildenafil citrate on cardiac output. In one small, open-label, uncontrolled, pilot study, eight patients sildenafil tables with stable ischemic heart disease underwent Swan-Ganz catheterization. A total dose of 40 mg sildenafil was administered by four intravenous infusions.The results from this pilot study are shown in Table 3; the mean resting systolic and diastolic blood pressures decreased by 7% and 10% compared to baseline in these patients. Mean resting values for right atrial pressure, pulmonary artery pressure, pulmonary artery occluded pressure and cardiac output decreased by 28%, 28%, 20% and 7% respectively. 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 sildenafil citrate 100 mg 1 hour prior to exercise testing. The pharmacokinetics of sildenafil citrate tablet sildenafil are dose-proportional over the recommended dose range.

What special dietary instructions should I follow?

The primary endpoint was time to limiting angina in the evaluable cohort. The mean times (adjusted for baseline) to onset of limiting angina were 423.6 and 403.7 seconds for sildenafil (N=70) and placebo, respectively. These results demonstrated that the effect of sildenafil citrate on the primary endpoint was statistically non-inferior to placebo.Effects of Sildenafil citrate 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. This finding is consistent with the inhibition of PDE6, which is involved in phototransduction in the retina. Subjects in the study reported this finding as difficulties in discriminating blue/green.

CYP3A4 Inhibitors

An evaluation of visual function at doses up to twice the maximum recommended dose revealed no effects of sildenafil citrate on visual acuity, intraocular pressure, or pupillometry.Effects of Sildenafil citrate on Sperm:There was no effect on sperm motility or morphology after single 100 mg oral doses of sildenafil citrate in healthy volunteers.12.3 PharmacokineticsSildenafil citrate is rapidly absorbed after oral administration, with a mean absolute bioavailability of 41% (range 25 to 63%). The pharmacokinetics of sildenafil citrate tablet sildenafil are dose-proportional over the recommended dose range. It is eliminated predominantly by hepatic metabolism (mainly CYP3A4) and is converted to an active metabolite with properties similar to the parent, sildenafil. 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:Sildenafil citrate is rapidly absorbed. Maximum observed plasma concentrations are reached within 30 to 120 minutes (median 60 minutes) of oral dosing in the fasted state. It is eliminated predominantly by hepatic metabolism (mainly CYP3A4) and is converted to an active metabolite with properties similar to the parent, sildenafil. 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:Sildenafil citrate is rapidly absorbed. Maximum observed plasma concentrations are reached within 30 to 120 minutes (median 60 minutes) of oral dosing in the fasted state. When sildenafil citrate is taken with a high fat meal, the rate of absorption is reduced, with a mean delay in T maxof 60 minutes and a mean reduction in C maxof 29%. The mean steady state volume of distribution (Vss) for sildenafil is 105 L, indicating distribution into the tissues. Sildenafil and its major circulating N-desmethyl metabolite are both approximately 96% bound to plasma proteins.