The medication should be stored at room temperature between 15-30°C (59-86°F).
Keep the tablets in their original container, tightly closed.
Protect from light and moisture; avoid storing in bathrooms or near sinks.
Do not use the medication if the packaging is torn or shows signs of tampering.
Check the expiration date printed on the bottle or blister pack before use.
Properly discard any medication that is outdated or no longer needed.
Do not flush medications down the toilet or pour them into a drain.
Consult a pharmacist or local waste disposal company for proper disposal methods.
Many communities have drug take-back programs for safe disposal.
Keeping old medication increases the risk of accidental ingestion or misuse.
Safe storage and disposal protect children, pets, and the environment.

Thereafter, sildenafil tablets 100 mg or matching placebo was administered simultaneously with doxazosin 4 mg (14 subjects) or doxazosin 8 mg (6 subjects) in standard crossover fashion.

Population Group	Considerations	Recommendations
Elderly	Altered pharmacokinetics	Start with lower dose
Patients with Renal Impairment	Slower clearance, risk of accumulation	Dose reduction or careful use
Patients with Liver Disease	Reduced metabolism, higher plasma levels	Dose adjustment or caution
Women	Not FDA-approved for female ED	Usually not prescribed

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 tablets 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 tablets 50 mg). For the 20 subjects who received sildenafil tablets 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 tablets or matching placebo are shown in Figure 4. Figure 4: Mean Standing Systolic Blood Pressure Change from Baseline Blood pressure was measured after administration of sildenafil tablets at the same times as those specified for the previous doxazosin studies. All three were taking sildenafil tablets 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 tablets 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 tablets and placebo.

What special dietary instructions should I follow?

Factors That Influence the Right Dosage for You

While there were no severe adverse events potentially related to blood pressure reported in this study, one subject reported moderate vasodilatation after both sildenafil tablets 50 mg and 100 mg. Effect of Sildenafil Tablets on Blood Pressure When Co-administered with Anti-hypertensives: When sildenafil tablets 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 Tablets on Blood Pressure When Co-administered with Alcohol: Sildenafil tablets (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%.

20mg sildenafil is a low dose used for erectile dysfunction.
It typically begins working within 30-60 minutes.
Sildenafil should be taken on an empty stomach for best results.
Common side effects include headache, flushing, and dizziness.
Consult a doctor before using 20mg sildenafil to ensure safety.

The maximum recommended dose of 100 mg sildenafil was not evaluated in this study [see Drug Interactions(7.5)]. Effects of Sildenafil Tablets 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 tablets on cardiac output.

Product	Dosage	Quantity + Bonus	Price
Viagra Generic	25mg	60 + 4 Pills	71.99€ 68.56€
Kamagra	100mg	60 + 4 Pills	201.34€ 191.75€
Viagra Generic	100mg	180 + 8 Pills	199.37€ 189.88€
Viagra Generic	25mg	270 + 8 Pills	184.26€ 175.49€
Viagra Generic	50mg	20 Pills	40.52€ 38.59€
Viagra Generic	200mg	30 + 2 Pills	83.07€ 79.11€
Kamagra	100mg	360 + 6 Pills	839.95€ 799.95€
Kamagra Soft Tabs	100mg	20 Pills	79.79€ 75.99€
Viagra Generic	100mg	60 + 4 Pills	96.36€ 91.77€
Kamagra Soft Tabs	100mg	272 + 12 Pills	593.42€ 565.16€
Viagra Generic	25mg	10 Pills	25.19€ 23.99€
Kamagra Polo	100mg	20 Pills	83.56€ 79.58€
Kamagra Soft Tabs	100mg	120 + 6 Pills	311.78€ 296.93€
Viagra Generic	50mg	60 + 4 Pills	83.93€ 79.93€
Viagra Generic	100mg	30 + 4 Pills	60.91€ 58.01€
Viagra Generic	200mg	360 + 10 Pills	481.98€ 459.03€
Kamagra	100mg	12 Pills	55.64€ 52.99€

Hemodynamic Data in Patients with Stable Ischemic Heart Disease after Intravenous Administration of 40 mg of Sildenafil 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 tablets 100 mg 1 hour prior to exercise testing. These results demonstrated that the effect of sildenafil tablets on the primary endpoint was statistically non-inferior to placebo. Effects of Sildenafil Tablets 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 sildenafil tablets on visual acuity, intraocular pressure, or pupillometry.

Before Using

Effect of Sildenafil Tablets on Blood Pressure When Co-administered with Alcohol: Sildenafil tablets (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 Sildenafil Tablets 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 tablets on cardiac output. Hemodynamic Data in Patients with Stable Ischemic Heart Disease after Intravenous Administration of 40 mg of Sildenafil 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 tablets 100 mg 1 hour prior to exercise testing.

Is 20 mg of sildenafil effective for ED?

These results demonstrated that the effect of sildenafil tablets on the primary endpoint was statistically non-inferior to placebo. Effects of Sildenafil Tablets 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 sildenafil tablets on visual acuity, intraocular pressure, or pupillometry. Effects of Sildenafil Tablets on Sperm:There was no effect on sperm motility or morphology after single 100 mg oral doses of sildenafil tablets in healthy volunteers. Sildenafil tablets are rapidly absorbed after oral administration, blue sildenafil with a mean absolute bioavailability of 41% (range 25 to 63%). Effects of Sildenafil Tablets on Sperm:There was no effect on sperm motility or morphology after single 100 mg oral doses of sildenafil tablets in healthy volunteers.

Storage Requirement	Temperature Range	Light Exposure	Humidity Control	Notes
Room Temperature	20–25°C (68–77°F)	Keep away from direct sunlight	Keep in a dry place	Keep out of reach of children
Avoid Humidity	≤60% RH	Store in original container	Avoid bathroom storage	Protect from moisture
Temperature Fluctuations	Avoid extreme temperatures	-	-	Prevent degradation

Sildenafil tablets are rapidly absorbed after oral administration, blue sildenafil with a mean absolute bioavailability of 41% (range 25 to 63%). Absorption and Distribution: Sildenafil tablets are rapidly absorbed. When sildenafil tablets are 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%. Metabolism and Excretion:Sildenafil is cleared predominantly by the CYP3A4 (major route) and CYP2C9 (minor route) hepatic microsomal isoenzymes. Pharmacokinetics in Special Populations Geriatrics:Healthy elderly volunteers (65 years or over) had a reduced clearance of sildenafil, resulting in approximately 84% and 107% higher plasma AUC values of sildenafil and its active N-desmethyl metabolite, respectively, compared to those seen in healthy younger volunteers (18 to 45 years).

Sildenafil enhances natural erectile response, requiring sexual stimulation.
It is not effective as a contraceptive or protection against STDs.
Alcohol consumption can impair its effectiveness and increase side effects.
Be cautious if you have low blood pressure or heart issues.
Combining sildenafil with other ED medications can be dangerous.

Due to age-differences in plasma protein binding, the corresponding increase in the AUC of free (unbound) sildenafil and its active N-desmethyl metabolite were 45% and 57%, respectively [ see Dosage and Administration (2.5),and Use in Specific Populations (8.5)] Renal Impairment:In volunteers with mild (CLcr=50 to 80 mL/min) and moderate (CLcr=30 to 49 mL/min) renal impairment, the pharmacokinetics of a single oral dose of sildenafil tablets (50 mg) were not altered. In volunteers with severe (CLcr <30 mL/min) renal impairment, sildenafil clearance was reduced, resulting in approximately doubling of AUC and C maxcompared to age-matched volunteers with no renal impairment [see Dosage and Administration (2.5),and Use in Specific Populations (8.6)]. In addition, N-desmethyl metabolite AUC and C maxvalues significantly increased by 200% and 79%, respectively in subjects with severe renal impairment compared to subjects with normal renal function. Hepatic Impairment:In volunteers with hepatic impairment (Child-Pugh Class A and B), sildenafil clearance was reduced, resulting in increases in AUC (85%) and C max(47%) compared to age-matched volunteers with no hepatic impairment. The pharmacokinetics of sildenafil in patients with severely impaired hepatic function (Child-Pugh Class C) have not been studied [see Dosage and Administration (2.5),and Use in Specific Populations (8.7)]. Drug Interaction Studies Effects of Other Drugs on Sildenafil Tablets Sildenafil metabolism is principally mediated by CYP3A4 (major route) and CYP2C9 (minor route). In vivo studies: Cimetidine (800 mg), a nonspecific CYP inhibitor, caused a 56% increase in plasma sildenafil concentrations when co-administered with sildenafil tablets (50 mg) to healthy volunteers. When a single 100 mg dose of sildenafil tablets were administered with erythromycin, a moderate CYP3A4 inhibitor, at steady state (500 mg bid for 5 days), there was a 160% increase in sildenafil C maxand a 182% increase in sildenafil AUC. In addition, in a study performed in healthy male volunteers, co-administration of the HIV protease inhibitor saquinavir, also a CYP3A4 inhibitor, at steady state (1200 mg tid) with sildenafil tablets (100 mg single dose) resulted in a 140% increase in sildenafil Cmax and a 210% increase in sildenafil AUC.

Dosing & Uses

Subjects who had successfully completed the previous doxazosin interaction study (using sildenafil tablets 50 mg), including no significant hemodynamic adverse events, were allowed to skip dose period 1. Thereafter, sildenafil tablets 100 mg or matching placebo was administered simultaneously with doxazosin 4 mg (14 subjects) or doxazosin 8 mg (6 subjects) in standard crossover fashion. 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 tablets 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 tablets 50 mg). For the 20 subjects who received sildenafil tablets 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 tablets or matching placebo are shown in Figure 4.

5.3 Effects on the Eye

Figure 4: Mean Standing Systolic Blood Pressure Change from Baseline Blood pressure was measured after administration of sildenafil tablets at the same times as those specified for the previous doxazosin studies. All three were taking sildenafil tablets 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 tablets 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 tablets 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 tablets 50 mg and 100 mg. Effect of Sildenafil Tablets on Blood Pressure When Co-administered with Anti-hypertensives: When sildenafil tablets 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. Population pharmacokinetic data from patients in clinical trials also indicated a reduction in sildenafil clearance when it was co- administered with CYP3A4 inhibitors (such as ketoconazole, erythromycin, or cimetidine) [see Dosage and Administration (2.4)and Drug Interactions ( 7.4)]. In another study in healthy male volunteers, co-administration with the HIV protease inhibitor ritonavir, which is a highly potent P450 inhibitor, at steady state (500 mg bid) with sildenafil tablets (100 mg single dose) resulted in a 300% (4-fold) increase in sildenafil C maxand a 1000% (11-fold) increase in sildenafil plasma AUC. Sildenafil tablets had no canada sildenafil effect on ritonavir pharmacokinetics [see Dosage and Administration (2.4)and Drug Interactions (7.4)].

A large body of post-marketing surveillance data exists for sildenafil.
Spontaneous reporting systems have helped identify rare adverse events.
These include NAION, sudden hearing loss, and serious cardiovascular events.
The overall benefit-risk profile remains positive for its approved indications.
Studies continue to monitor long-term safety in chronic users.
Data is collected on use in special populations, like the elderly.
Real-world evidence often confirms the findings from controlled trials.
Pharmacovigilance is ongoing to detect any new or changing safety signals.
This data is used to update product labeling and inform healthcare providers.
Patients are encouraged to report any suspected side effects to their doctor or FDA/MedWatch.
This surveillance is a critical component of ensuring drug safety.

In a study of healthy male volunteers, co-administration of sildenafil at steady state (80 mg t.i.d.) with endothelin receptor antagonist bosentan (a moderate inducer of CYP3A4, CYP2C9 and possibly of CYP2C19) at steady state (125 mg b.i.d.) resulted in a 63% decrease of sildenafil AUC and a 55% decrease in sildenafil C max. Single doses of antacid (magnesium hydroxide/aluminum hydroxide) did not affect the bioavailability of sildenafil tablets.

Patient Group	Recommended Dose	Frequency of Use	Notes
First-time users	20 mg	Once per day	Take 30-60 min before activity
Experienced users	May increase to 50 mg	As needed	Under medical supervision
Elderly patients	20 mg or lower	As needed	Start with lowest dose
Patients on other medications	Consult doctor	Varies	Adjust dose accordingly

Effects of Sildenafil Tablets on Other Drugs In vitro studies: Sildenafil is a weak inhibitor of the CYP isoforms 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 (IC50 >150 μM).

1. Indications and Usage for Sildenafil Tablets

In vivo studies: No significant interactions were shown with tolbutamide (250 mg) or warfarin (40 mg), both of which are metabolized by CYP2C9. Sildenafil tablets (50 mg) did not potentiate the increase in bleeding time caused by aspirin (150 mg). Sildenafil at steady state, at a dose not approved for the treatment of erectile dysfunction (80 mg t.i.d.) resulted in a 50% increase in AUC and a 42% increase in C maxof bosentan (125 mg b.i.d.). Carcinogenesis Sildenafil was not carcinogenic when administered to rats for 24 months at a dose resulting in total systemic drug exposure (AUCs) for unbound sildenafil and its major metabolite of 20-and 38-times, for male and female rats, respectively, the exposures observed in human males given the Maximum Recommended Human Dose (MRHD) of 100 mg. Sildenafil was not carcinogenic when administered to mice for 18 to 21 months at dosages up to the Maximum Tolerated Dose (MTD) of 10 mg/kg/day, approximately 0.4 times the MRHD on a mg/m2 basis in a 50 kg subject.

Dosage Forms & Strengths

Impairment of Fertility There was no impairment of fertility in rats given sildenafil up to 60 mg/kg/day for 36 days to females and 102 days to males, a dose producing an AUC value of more than 25 times the human male AUC. Given sildenafil peak plasma concentrations of approximately 1 μM after recommended doses, it is unlikely that sildenafil tablets will alter the clearance of substrates of these isoenzymes. In vivo studies: No significant interactions were shown with tolbutamide (250 mg) or warfarin (40 mg), both of which are metabolized by CYP2C9.

How to take liquid

When and How to Take Sildenafil for Best Results

Sildenafil tablets (50 mg) did not potentiate the increase in bleeding time caused by aspirin (150 mg). Sildenafil at steady state, at a dose not approved for the treatment of erectile dysfunction (80 mg t.i.d.) resulted in a 50% increase in AUC and a 42% increase in C maxof bosentan (125 mg b.i.d.). Carcinogenesis Sildenafil was not carcinogenic when administered to rats for 24 months at a dose resulting in total systemic drug exposure (AUCs) for unbound sildenafil and its major metabolite of 20-and 38-times, for male and female rats, respectively, the exposures observed in human males given the Maximum Recommended Human Dose (MRHD) of 100 mg.

17. Patient Counseling Information

Absorption and Distribution: Sildenafil tablets are rapidly absorbed. When sildenafil tablets are 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%. Metabolism and Excretion:Sildenafil is cleared predominantly by the CYP3A4 (major route) and CYP2C9 (minor route) hepatic microsomal isoenzymes. Pharmacokinetics in Special Populations Geriatrics:Healthy elderly volunteers (65 years or over) had a reduced clearance of sildenafil, resulting in approximately 84% and 107% higher plasma AUC values of sildenafil and its active N-desmethyl metabolite, respectively, compared to those seen in healthy younger volunteers (18 to 45 years). Due to age-differences in plasma protein binding, the corresponding increase in the AUC of free (unbound) sildenafil and its active N-desmethyl metabolite were 45% and 57%, respectively [ see Dosage and Administration (2.5),and Use in Specific Populations (8.5)] Renal Impairment:In volunteers with mild (CLcr=50 to 80 mL/min) and moderate (CLcr=30 to 49 mL/min) renal impairment, the pharmacokinetics of a single oral dose of sildenafil tablets (50 mg) were not altered.

Drug Interactions

In volunteers with severe (CLcr <30 mL/min) renal impairment, sildenafil clearance was reduced, resulting in approximately doubling of AUC and C maxcompared to age-matched volunteers with no renal impairment [see Dosage and Administration (2.5),and Use in Specific Populations (8.6)]. In addition, N-desmethyl metabolite AUC and C maxvalues significantly increased by 200% and 79%, respectively in subjects with severe renal impairment compared to subjects with normal renal function. Hepatic Impairment:In volunteers with hepatic impairment (Child-Pugh Class A and B), sildenafil clearance was reduced, resulting in increases in AUC (85%) and C max(47%) compared to age-matched volunteers with no hepatic impairment. The pharmacokinetics of sildenafil in patients with severely impaired hepatic function (Child-Pugh Class C) have not been studied [see Dosage and Administration (2.5),and Use in Specific Populations (8.7)]. Drug Interaction Studies Effects of Other Drugs on Sildenafil Tablets Sildenafil metabolism is principally mediated by CYP3A4 (major route) and CYP2C9 (minor route). Sildenafil was not carcinogenic when administered to mice for 18 to 21 months at dosages up to the Maximum Tolerated Dose (MTD) of 10 mg/kg/day, approximately 0.4 times the MRHD on a mg/m2 basis in a 50 kg subject.

In case of emergency/overdose

In vivo studies: Cimetidine (800 mg), a nonspecific CYP inhibitor, caused a 56% increase in plasma sildenafil concentrations when co-administered with sildenafil tablets (50 mg) to healthy volunteers. When a single 100 mg dose of sildenafil tablets were administered with erythromycin, a moderate CYP3A4 inhibitor, at steady state (500 mg bid for 5 days), there was a 160% increase in sildenafil C maxand a 182% increase in sildenafil AUC. In addition, in a study performed in healthy male volunteers, co-administration of the HIV protease inhibitor saquinavir, also a CYP3A4 inhibitor, at steady state (1200 mg tid) with sildenafil tablets (100 mg single dose) resulted in a 140% increase in sildenafil Cmax and a 210% increase in sildenafil AUC. Population pharmacokinetic data from patients in clinical trials also indicated a reduction in sildenafil clearance when it was co- administered with CYP3A4 inhibitors (such as ketoconazole, erythromycin, or cimetidine) [see Dosage and Administration (2.4)and Drug Interactions ( 7.4)]. In another study in healthy male volunteers, co-administration with the HIV protease inhibitor ritonavir, which is a highly potent P450 inhibitor, at steady state (500 mg bid) with sildenafil tablets (100 mg single dose) resulted in a 300% (4-fold) increase in sildenafil C maxand a 1000% (11-fold) increase in sildenafil plasma AUC.

2.5 Dosage Adjustments in Special Populations

Sildenafil tablets had no canada sildenafil effect on ritonavir pharmacokinetics [see Dosage and Administration (2.4)and Drug Interactions (7.4)]. In a study of healthy male volunteers, co-administration of sildenafil at steady state (80 mg t.i.d.) with endothelin receptor antagonist bosentan (a moderate inducer of CYP3A4, CYP2C9 and possibly of CYP2C19) at steady state (125 mg b.i.d.) resulted in a 63% decrease of sildenafil AUC and a 55% decrease in sildenafil C max. Single doses of antacid (magnesium hydroxide/aluminum hydroxide) did not affect the bioavailability of sildenafil tablets. Effects of Sildenafil Tablets on Other Drugs In vitro studies: Sildenafil is a weak inhibitor of the CYP isoforms 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 (IC50 >150 μM). Given sildenafil peak plasma concentrations of approximately 1 μM after recommended doses, it is unlikely that sildenafil tablets will alter the clearance of substrates of these isoenzymes. Impairment of Fertility There was no impairment of fertility in rats given sildenafil up to 60 mg/kg/day for 36 days to females and 102 days to males, a dose producing an AUC value of more than 25 times the human male AUC.