Label: SILDENAFIL CITRATE- sildenafil tablet, film coated

8.6 Renal Impairment
Benefits You Can Expect
What side effects can this medication cause?
12.2 Pharmacodynamics
What special precautions should I follow?
In-Depth Details for Importers, Exporters, and Buyers
Pregnancy & Lactation

One randomized, double-blind, flexible-dose, placebo-controlled study included only patients with erectile dysfunction attributed to complications of diabetes mellitus (n=268). Diary data indicated that on sildenafil citrate, 48% of intercourse attempts were successful versus 12% on placebo. One randomized, double-blind, placebo-controlled, crossover, flexible-dose (up to 100 mg) study of patients with erectile dysfunction resulting from spinal cord injury (n=178) was conducted. Diary data indicated that on sildenafil citrate, 59% of attempts at sexual intercourse were successful compared to 13% on placebo. Across all trials, sildenafil citrate improved the erections of 43% of radical prostatectomy patients compared to 15% on placebo.

8.6 Renal Impairment

Recommended Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762 17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information).NitratesPhysicians should discuss with patients the contraindication of sildenafil citrate with regular and/or intermittent use of nitric oxide donors, such as organic nitrates or organic nitrites in any form [ see Contraindications (4.1)].Guanylate Cyclase (GC) StimulatorsPhysicians should discuss with patients the contraindication of sildenafil citrate with use of guanylate cyclase stimulators such as riociguat [ see Contraindications (4.3)].Concomitant Use with Drugs Which Lower Blood PressurePhysicians should advise patients of the potential for sildenafil citrate to augment the blood pressure lowering effect of alpha-blockers and anti-hypertensive medications. Concomitant administration of sildenafil citrate and an alpha-blocker may lead to symptomatic hypotension in some patients. Therefore, when sildenafil citrate is co-administered with alpha-blockers, patients should be stable on alpha-blocker therapy prior to initiating sildenafil citrate treatment and sildenafil citrate should be initiated at the lowest dose [ see Warnings and Precautions (5.5)].Cardiovascular ConsiderationsPhysicians should discuss with patients the potential cardiac risk of sexual activity in patients with preexisting cardiovascular risk factors.

Pregnancy Categories

Patients who experience symptoms (e.g., angina pectoris, dizziness, nausea) upon initiation of sexual activity should be advised to refrain from further activity and should discuss the episode with their physician [ see Warnings and Precautions (5.1)].Sudden Loss of VisionPhysicians should advise patients to stop use of all PDE5 inhibitors, including sildenafil citrate, and seek medical attention in the event of a sudden loss of vision in one or both eyes. Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including possible permanent loss of vision, that has been reported rarely post-marketing in temporal association with the use of all PDE5 inhibitors. Physicians should discuss with patients the increased risk of NAION in individuals who have already experienced NAION in one eye. Physicians should also discuss with patients the increased risk of NAION among the general population in patients with a “crowded” optic disc, although evidence is insufficient to support screening of prospective users of PDE5 inhibitor, including sildenafil citrate, for this uncommon condition [ see Warnings and Precautions (5.3)and Adverse Reactions (6.2)].Sudden Hearing LossPhysicians should advise patients to stop taking PDE5 inhibitors, including sildenafil citrate, 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 Warnings and Precautions (5.4)and Adverse Reactions (6.2)].PriapismPhysicians should warn patients that prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently since market approval of sildenafil citrate. Subgroup analyses of responses to a global improvement question in patients with psychogenic etiology in two fixed-dose studies (total n=179) and two titration studies (total n=149) showed 84% of sildenafil citrate patients reported improvement in erections compared with 26% of placebo. Diary data in two of the studies (n=178) showed rates of successful intercourse per attempt of 70% for sildenafil citrate and 29% for placebo.

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Viagra Generic	100mg	270 + 10 Pills	270.47€ 257.59€
Viagra Generic	150mg	90 + 6 Pills	147.18€ 140.17€
Kamagra	100mg	20 Pills	86.09€ 81.99€
Kamagra Polo	100mg	84 + 4 Pills	244.49€ 232.85€
Kamagra Soft Tabs	100mg	60 + 4 Pills	180.59€ 171.99€
Viagra Generic	200mg	10 Pills	40.96€ 39.01€
Viagra Generic	50mg	10 Pills	26.87€ 25.59€
Kamagra Polo	100mg	60 + 4 Pills	189.39€ 180.37€
Kamagra	100mg	180 + 6 Pills	436.79€ 415.99€
Kamagra Soft Tabs	100mg	180 + 8 Pills	425.45€ 405.19€
Kamagra Polo	100mg	20 Pills	83.56€ 79.58€
Kamagra Soft Tabs	100mg	84 + 4 Pills	233.05€ 221.95€

Efficacy Results in Subpopulations in Controlled Clinical Studies A review of population subgroups demonstrated efficacy regardless of baseline severity, etiology, race and age. HOW SUPPLIED Sildenafil 50 mg tablets USP are blue, round biconvex, film coated tablets, debossed with '87'on one side and plain on other side.NDC: 70518-1641-00PACKAGING: 30 in 1 BOTTLE PLASTICRecommended Storage: Store at 20°C to sildenafil 10mg 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].Repackaged and Distributed By:Remedy Repack, Inc.625 Kolter Dr.

Benefits You Can Expect

Suite #4 Indiana, PA 1-724-465-8762 Sildenafil 50 mg tablets USP are blue, round biconvex, film coated tablets, debossed with '87'on one side and plain on other side. Recommended Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762 17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information).NitratesPhysicians should discuss with patients the contraindication of sildenafil citrate with regular and/or intermittent use of nitric oxide donors, such as organic nitrates or organic nitrites in any form [ see Contraindications (4.1)].Guanylate Cyclase (GC) StimulatorsPhysicians should discuss with patients the contraindication of sildenafil citrate with use of guanylate cyclase stimulators such as riociguat [ see Contraindications (4.3)].Concomitant Use with Drugs Which Lower Blood PressurePhysicians should advise patients of the potential for sildenafil citrate to augment the blood pressure lowering effect of alpha-blockers and anti-hypertensive medications. Concomitant administration of sildenafil citrate and an alpha-blocker may lead to symptomatic hypotension in some patients. Therefore, when sildenafil citrate is co-administered with alpha-blockers, patients should be stable on alpha-blocker therapy prior to initiating sildenafil citrate treatment and sildenafil citrate should be initiated at the lowest dose [ see Warnings and Precautions (5.5)].Cardiovascular ConsiderationsPhysicians should discuss with patients the potential cardiac risk of sexual activity in patients with preexisting cardiovascular risk factors. Patients who experience symptoms (e.g., angina pectoris, dizziness, nausea) upon initiation of sexual activity should be advised to refrain from further activity and should discuss the episode with their physician [ see Warnings and Precautions (5.1)].Sudden Loss of VisionPhysicians should advise patients to stop use of all PDE5 inhibitors, including sildenafil citrate, and seek medical attention in the event of a sudden loss of vision in one or both eyes.

Sildenafil citrate 120 mg can cause prolonged erections if misused.
This dose may increase the risk of cardiovascular side effects.
Always consult a healthcare provider before taking high doses of sildenafil.
Combining sildenafil with nitrates can cause dangerous blood pressure drops.
Side effects may include flushing, nasal congestion, and dizziness.
Sildenafil is metabolized in the liver and excreted via feces and urine.

Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including possible permanent loss of vision, that has been reported rarely post-marketing in temporal association with the use of all PDE5 inhibitors. Physicians should discuss with patients the increased risk of NAION in individuals who have already experienced NAION in one eye.

What side effects can this medication cause?

Azole Antifungals

Physicians should also discuss with patients the increased risk of NAION among the general population in patients with a “crowded” optic disc, although evidence is insufficient to support screening of prospective users of PDE5 inhibitor, including sildenafil citrate, for this uncommon condition [ see Warnings and Precautions (5.3)and Adverse Reactions (6.2)].Sudden Hearing LossPhysicians should advise patients to stop taking PDE5 inhibitors, including sildenafil citrate, 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 Warnings and Precautions (5.4)and Adverse Reactions (6.2)].PriapismPhysicians should warn patients that prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently since market approval of sildenafil citrate.

Use Case	Description	Dosage Recommendations	Special Considerations
Erectile Dysfunction (ED)	To improve blood flow to the penis during arousal	120 mg as prescribed	Not for use with nitrates
Pulmonary Arterial Hypertension	Off-label for vasodilation in lungs	Under doctor guidance	Monitor blood pressure
Off-label Use in Sexual Dysfunction	Sometimes used in other sexual dysfunctions	As prescribed	Limited evidence for other uses
Enhancement of Exercise Capacity	Occasionally used in sports medicine	Not approved	Risk of adverse effects

12.2 Pharmacodynamics

Physicians should advise patients to stop use of all PDE5 inhibitors, including sildenafil citrate, and seek medical attention in the event of a sudden loss of vision in one or both eyes. Physicians should also discuss with patients the increased risk of NAION among the general population in patients with a “crowded” optic disc, although evidence is insufficient to support screening of prospective users of PDE5 inhibitor, including sildenafil citrate, for this uncommon condition [ see Warnings and Precautions (5.3)and Adverse Reactions (6.2)]. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [ see Warnings and Precautions (5.4)and Adverse Reactions (6.2)]. Physicians should warn patients that prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently since market approval of sildenafil citrate. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result [ see Warnings and Precautions (5.2)].

What are the serious side effects of sildenafil?

Physicians should inform patients not to take sildenafil tablets, 25 mg, 50 mg and 100 mg with other PDE5 inhibitors including sildenafil tablets, 20 mg or other pulmonary arterial hypertension (PAH) treatments containing sildenafil. The safety and efficacy of sildenafil tablets, 25 mg, 50 mg and 100 mg with other PDE5 inhibitors, including sildenafil tablets, 20 mg, have not been studied [ see Warnings and Precautions (5.7)]. Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), may be considered [ see Warnings and Precautions (5.9)]. PATIENT INFORMATION Dispense with Patient Information available at: (sil DEN a fil) Citrate Tablets USPWhat is the most important information I should know about sildenafil tablets?Sildenafil tablets can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines.Do not take sildenafil tablets if you take any other medicines called “nitrates.” Nitrates are used to treat chest pain (angina). The safety and efficacy of sildenafil tablets, 25 mg, 50 mg and 100 mg with other PDE5 inhibitors, including sildenafil tablets, 20 mg, have not been studied [ see Warnings and Precautions (5.7)].Sexually Transmitted DiseaseThe use of sildenafil citrate offers no protection against sexually transmitted diseases. Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), may be considered [ see Warnings and Precautions (5.9)].Dispense with Patient Information available at: December 2024Repackaged By / Distributed By: RemedyRepack Inc.625 Kolter Drive, Indiana, PA 15701(724) 465-8762 Advise the patient to read the FDA-approved patient labeling over the counter drugs containing sildenafil (Patient Information).

What special precautions should I follow?

Other warnings

Subgroup analyses of responses to a global improvement question in patients with psychogenic etiology in two fixed-dose studies (total n=179) and two titration studies (total n=149) showed 84% of sildenafil citrate patients reported improvement in erections compared with 26% of placebo. Diary data in two of the studies (n=178) showed rates of successful intercourse per attempt of 70% for sildenafil citrate and 29% for placebo. Efficacy Results in Subpopulations in Controlled Clinical Studies A review of population subgroups demonstrated efficacy regardless of baseline severity, etiology, race and age. HOW SUPPLIED Sildenafil 50 mg tablets USP are blue, round biconvex, film coated tablets, debossed with '87'on one side and plain on other side.NDC: 70518-1641-00PACKAGING: 30 in 1 BOTTLE PLASTICRecommended Storage: Store at 20°C to sildenafil 10mg 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].Repackaged and Distributed By:Remedy Repack, Inc.625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762 Sildenafil 50 mg tablets USP are blue, round biconvex, film coated tablets, debossed with '87'on one side and plain on other side. Physicians should discuss with patients the contraindication of sildenafil citrate with regular and/or intermittent use of nitric oxide donors, such as organic nitrates or organic nitrites in any form [ see Contraindications (4.1)]. Physicians should discuss with patients the contraindication of sildenafil citrate with use of guanylate cyclase stimulators such as riociguat [ see Contraindications (4.3)]. Concomitant Use with Drugs Which Lower Blood Pressure Physicians should advise patients of the potential for sildenafil citrate to augment the blood pressure lowering effect of sildenafil tablet manforce 50 mg alpha-blockers and anti-hypertensive medications. Therefore, when sildenafil citrate is co-administered with alpha-blockers, patients should be stable on alpha-blocker therapy prior to initiating sildenafil citrate treatment and sildenafil citrate should be initiated at the lowest dose [ see Warnings and Precautions (5.5)]. Physicians should discuss with patients the potential cardiac risk of sexual activity in patients with preexisting cardiovascular risk factors.

Patients with liver or kidney issues need dose adjustments and careful monitoring.
The recommended maximum dose for sildenafil is generally 100 mg per day.
Excessive use increases the likelihood of adverse cardiovascular events.
Use of sildenafil does not provide protection against sexually transmitted infections.
Some users report a persistent blue-tinged vision after high doses.
It’s essential to obtain sildenafil from reputable sources to avoid counterfeit products.

In-Depth Details for Importers, Exporters, and Buyers

If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result [ see Warnings and Precautions (5.2)].Avoid Use with other PDE5 InhibitorsPhysicians should inform patients not to take sildenafil tablets, 25 mg, 50 mg and 100 mg with other PDE5 inhibitors including sildenafil tablets, 20 mg or other pulmonary arterial hypertension (PAH) treatments containing sildenafil. Sildenafil is also marketed as sildenafil tablets, 20 mg for the treatment of PAH. The safety and efficacy of sildenafil tablets, 25 mg, 50 mg and 100 mg with other PDE5 inhibitors, including sildenafil tablets, 20 mg, have not been studied [ see Warnings and Precautions (5.7)].Sexually Transmitted DiseaseThe use of sildenafil citrate offers no protection against sexually transmitted diseases. Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), may be considered [ see Warnings and Precautions (5.9)].Dispense with Patient Information available at: December 2024Repackaged By / Distributed By: RemedyRepack Inc.625 Kolter Drive, Indiana, PA 15701(724) 465-8762 Advise the patient to read the FDA-approved patient labeling over the counter drugs containing sildenafil (Patient Information). Physicians should discuss with patients the contraindication of sildenafil citrate with regular and/or intermittent use of nitric oxide donors, such as organic nitrates or organic nitrites in any form [ see Contraindications (4.1)].

Factors That Influence the Right Dosage for You

Physicians should discuss with patients the contraindication of sildenafil citrate with use of guanylate cyclase stimulators such as riociguat [ see Contraindications (4.3)]. Concomitant Use with Drugs Which Lower Blood Pressure Physicians should advise patients of the potential for sildenafil citrate to augment the blood pressure lowering effect of sildenafil tablet manforce 50 mg alpha-blockers and anti-hypertensive medications. Therefore, when sildenafil citrate is co-administered with alpha-blockers, patients should be stable on alpha-blocker therapy prior to initiating sildenafil citrate treatment and sildenafil citrate should be initiated at the lowest dose [ see Warnings and Precautions (5.5)]. Physicians should discuss with patients the potential cardiac risk of sexual activity in patients with preexisting cardiovascular risk factors. Patients who experience symptoms (e.g., angina pectoris, dizziness, nausea) upon initiation of sexual activity should be advised to refrain from further activity and should discuss the episode with their physician [ see Warnings and Precautions (5.1)]. Physicians should also discuss with patients the increased risk of NAION among the general population in patients with a “crowded” optic disc, although evidence is insufficient to support screening of prospective users of PDE5 inhibitor, including sildenafil citrate, for this uncommon condition [ see Warnings and Precautions (5.3)and Adverse Reactions (6.2)]. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [ see Warnings and Precautions (5.4)and Adverse Reactions (6.2)].

Sildenafil citrate 120 mg is often used illicitly, which increases health risks.
Long-term safety data for high doses are limited; risks are not fully understood.
Use should be personalized based on medical history and current health status.
Do not crush or chew sildenafil tablets; take them whole with water.
Combining sildenafil with other vasodilators can lead to dangerous blood pressure drops.
Always seek professional guidance before initiating or adjusting sildenafil dosage.

Physicians should warn patients that prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently since market approval of sildenafil citrate. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result [ see Warnings and Precautions (5.2)]. Physicians should inform patients not to take sildenafil tablets, 25 mg, 50 mg and 100 mg with other PDE5 inhibitors including sildenafil tablets, 20 mg or other pulmonary arterial hypertension (PAH) treatments containing sildenafil.

Pregnancy & Lactation

Serious side effects

The safety and efficacy of sildenafil tablets, 25 mg, 50 mg and 100 mg with other PDE5 inhibitors, including sildenafil tablets, 20 mg, have not been studied [ see Warnings and Precautions (5.7)]. Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), may be considered [ see Warnings and Precautions (5.9)]. PATIENT INFORMATION Dispense with Patient Information available at: (sil DEN a fil) Citrate Tablets USPWhat is the most important information I should know about sildenafil tablets?Sildenafil tablets can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines.Do not take sildenafil tablets if you take any other medicines called “nitrates.” Nitrates are used to treat chest pain (angina).

Condition	Risk Factors	Precautionary Notes
Nitrate use (e.g., nitroglycerin)	Risk of severe hypotension	Do not use sildenafil if on nitrates
Cardiovascular disease	Increased risk of adverse events	Consult cardiologist before use
Severe hepatic impairment	Slower drug metabolism	Adjust dosage accordingly
Retinitis pigmentosa	Possible worsening of condition	Use with caution, consult ophthalmologist
Recent stroke or MI	Elevated risk for complications	Avoid use unless cleared by a doctor