Two were discontinued after study period 1: one failed to meet pre-dose screening qualifications and the other

10. Overdosage

The decrease in supine blood pressure was generally observed from 15 min to 4 h post-dose. Figure2: Mean Change from Baseline inSupineSystolic Blood Pressure,Elderly Effects ofSildenafil on Blood Pressure When Nitroglycerin is Subsequently Administered:Based on the pharmacokinetic profile of a single 100 mg sildenafil 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). In the following patients: age >65 years, hepatic impairment (e.g., cirrhosis), severe renal impairment (e.g., creatinine clearance <30 mL/min), and concomitant use of erythromycin or strong CYP3A4 inhibitors, plasma levels of sildenafil at 24 hours post dose have been found to be 3 to 8 times higher than those seen in healthy volunteers. 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 ofSildenafil 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 sildenafil with doxazosin, an alpha-adrenergic blocking agent.

12.2 Pharmacodynamics

In the first study, a single oral dose of sildenafil 100 mg or matching placebo was administered in a 2-period crossover design to 4 generally healthy males with benign prostatic hyperplasia (BPH). Following at least 14 consecutive daily doses of doxazosin, sildenafil 100 mg or matching placebo was administered simultaneously with doxazosin. Following a review of the data from these first 4 subjects (details provided below), the sildenafil dose was reduced to 25 mg. Thereafter, 17 subjects were treated with sildenafil 25 mg or matching placebo in combination with doxazosin 4 mg (15 subjects) or doxazosin 8 mg (2 subjects). The mean subject age canadian sildenafil citrate was 66.5 years. experienced symptomatic hypotension as a moderately severe adverse event 30 minutes after dosing with open-label sildenafil 50 mg.

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Of the twenty subjects who were ultimately assigned to treatment, a total of 13 subjects successfully

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If a subject did not successfully complete this first dosing period, he was discontinued from the study. Subjects who had successfully completed the previous doxazosin interaction study (using sildenafil 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 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. completed dose period 1, and seven had successfully completed the previous doxazosin study (using sildenafil 50 mg). For the 20 subjects who received sildenafil 100 mg and matching placebo, the placebo-subtracted mean

Step	Description	Equipment Needed	Quality Control Measures
Ingredient Mixing	Blend active and excipients uniformly	Mixers, blenders	Homogeneity testing
Casting	Pouring mixture into strip molds	Molding machines	Thickness and uniformity checks
Drying	Removing moisture to solidify strips	Drying ovens	Moisture content analysis
Cutting & Packaging	Cutting into individual strips and sealing	Cutting machines, sealers	Weight, appearance, and sterility tests

maximum decreases from baseline (95% CI) in systolic blood pressure were as follows: The mean

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profiles of the change from baseline in standing systolic blood pressure in subjects treated with

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doxazosin in combination with 100 mg sildenafil citrate or matching placebo are shown in Figure 5.

8. Future perspective

In these two subjects, hypotension was reported as a moderately severe adverse event, beginning at approximately 1 hour after administration of sildenafil 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 50 mg and one subject with a decrease from baseline in standing systolic BP >30 mmHg following both sildenafil 50 mg and placebo. There were no severe adverse events potentially related to blood pressure and no episodes of syncope reported in this study. In the third study, a single oral dose of sildenafil 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 50 mg simultaneously, after at least 14 consecutive days of doxazosin. Figure5: Mean Standing Systolic Blood Pressure Change from Baseline Blood pressure was measured after

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administration of sildenafil at the same times as those specified for the previous doxazosin studies.

Dosage Accuracy

Effects ofSildenafil 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 sildenafil administration compared with placebo. Most studies assessed the efficacy of sildenafil approximately 60 minutes post dose. The erectile response, as assessed by RigiScan®, generally increased with increasing sildenafil dose and plasma concentration. 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 ofSILDENAFIL ORAL FILM on Blood Pressure: Single oral doses (50 mg, 75 mg, 100 mg) of VYBRIQYE administered to 12 healthy young volunteers produced decreases in supine blood pressure.

7.4 Ritonavir and other CYP3A4 inhibitors

The placebo-subtracted mean maximum decreases in systolic/diastolic blood pressure were 6.1/2.8 mmHg after a single 100 mg dose. Subjects were under fasting conditions and lay in the supine position for the first 4 hours post-dose and were not initially titrated. The decrease in supine blood pressure was most notable approximately 1-2 hours after dosing. Figure1: Mean Change from Baseline inSupineSystolic Blood Pressure, Healthy Volunteers Single oral doses of 50 mg, 75 mg, 100 mg of SILDENAFIL ORAL FILM administered to 12 elderly volunteers produced decreases in supine blood pressure. The placebo-subtracted maximum mean decreases in systolic/diastolic blood pressure were 13.7/8.5 mmHg after a single 100 mg dose. There were three subjects who had a standing SBP of <85 mmHg.

Region	Regulatory Authority	Approval Status	Notes
USA	FDA	Approved	For prescription use
European Union	EMA	Approved	As per medical guidelines
India	CDSCO	Approved	Readily available over the counter
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All three were taking sildenafil 100 mg, and all three reported mild adverse

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For the 17 subjects who received sildenafil 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 sildenafil or matching placebo are shown in Figure 3. Figure3:Mean Standing Systolic Blood Pressure Change from Baseline Blood 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 sildenafil or matching placebo. Outliers were defined as subjects with a standing systolic blood pressure of <85 mmHg or a decrease from baseline in standing systolic blood pressure of >30 mmHg at one or more timepoints. There were no subjects treated with sildenafil 25 mg who had a standing SBP <85mmHg. There were three subjects with a decrease from baseline in standing systolic BP >30mmHg following sildenafil 25 mg, one subject with a decrease from baseline in standing systolic BP > 30 mmHg following placebo and two subjects with a decrease from baseline in standing systolic BP >30 mmHg following both sildenafil and placebo.

Key Takeaways

No severe adverse events potentially related to blood pressure effects were reported in this group. Of the four subjects who received sildenafil 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 sildenafil 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). There were no reports of syncope among these patients. For these four subjects, the placebo-subtracted mean maximum decreases from baseline in supine and standing systolic blood pressures were 14.8 mmHg and 21.5 mmHg, respectively. Two of these subjects had a standing SBP <85mmHg. events at the time of reductions in standing SBP, including vasodilation and lightheadedness.

14. Clinical Studies

Both these subjects were protocol violators, one due to a low baseline standing SBP, and the other due to baseline orthostatic hypotension. In the second study, a single oral dose of sildenafil 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 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 50 mg, but only 19 subjects received matching placebo.

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One patient discontinued the study prematurely due to an adverse event of hypotension following dosing with sildenafil 50 mg. This patient had been taking minoxidil, a potent vasodilator, during sildenafil pink pill the study. For the 19 subjects who received both sildenafil 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 or matching placebo are shown in Figure 4. Figure4: Mean Standing Systolic Blood Pressure Change from Baseline Blood pressure was measured after administration of sildenafil at the same times as those specified for the first doxazosin study. There were two subjects who had a standing SBP of <85 mmHg.