Bioequivalence and Bioavailability of an Orodispersible Tablet of Sildenafil Citrate in Healthy Chinese Male Subjects
Phosphodiesterase-5 (PDE-5) inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat.Known hypersensitivity to sildenafil or any component of the tablet.
5.4 Hearing Loss
It is not possible to determine whether these reported events are related directly to the use of sildenafil citrate, to the patient’s underlying risk factors for hearing loss, a combination of these factors, or to other factors.Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking PDE-5 inhibitors, including sildenafil citrate.5.6 Combination with other PDE-5 InhibitorsSildenafil is also marketed as VIAGRA ®. The safety and efficacy of combinations of sildenafil citrate with VIAGRA or other PDE-5 inhibitors have not been studied. Inform patients taking sildenafil citrate not to take VIAGRA or other PDE-5 inhibitors.5.7 PriapismUse sildenafil citrate with caution in patients with anatomical deformation of the penis (e.g., angulation, cavernosal fibrosis, or Peyronie’s disease) or in patients who have conditions, which may predispose them to priapism (e.g., sickle cell anemia, multiple myeloma, or leukemia). If priapism (painful erection greater than 6 hours in duration) is not treated immediately, penile tissue damage and permanent loss of potency could result.5.8 Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell DiseaseIn a small, prematurely terminated study of patients with pulmonary hypertension (PH) secondary to sickle cell disease, vaso-occlusive crises requiring hospitalization were more commonly reported by patients who received sildenafil citrate than by those randomized to placebo. The effectiveness and safety of sildenafil citrate in the treatment of PH secondary to sickle cell disease has not been established.
Factors That Influence the Right Dosage for You
Sildenafil citrate has vasodilatory properties, resulting in mild and transient decreases in blood pressure. Monitor blood pressure when co-administering blood pressure lowering drugs with sildenafil citrate. Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD). Should signs of pulmonary edema occur when sildenafil citrate is administered, consider the possibility of associated PVOD. The incidence of epistaxis was 13% in patients taking sildenafil citrate with PAH secondary to CTD.
Adjusting Your Sildenafil Dosage Over Time
The incidence of epistaxis was also higher in sildenafil citrate-treated sildenafil otc patients with a concomitant oral vitamin K antagonist (9% versus 2% in those not treated with concomitant vitamin K antagonist). The safety of sildenafil citrate is unknown in patients with bleeding disorders or active peptic ulceration. When used to treat erectile dysfunction, non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported post-marketing in temporal association with the use of PDE-5 inhibitors, including sildenafil. Most patients had underlying anatomic or vascular risk factors for developing NAION, including low cup to disc ratio (“crowded disc”). Advise patients to seek immediate medical attention in the event of a sudden loss of vision in one or both eyes while taking sildenafil citrate. Hypersensitivity, including anaphylactic reaction, anaphylactic shock and anaphylactoid reaction, has been reported in association with the use of sildenafil. Sildenafil tablets are contraindicated in patients with: Concomitant use of organic nitrates in any form, either regularly or intermittently, because of the greater risk of hypotension [see Warnings and Precautions (5.1)] . Phosphodiesterase-5 (PDE-5) inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat.
| Country | Legal Status | Prescription Required | Notes |
|---|---|---|---|
| USA | Prescription required | Yes | Approved for ED, PH |
| UK | Prescription required | Yes | Prescription necessary |
| India | Over-the-counter in some states | Varies | Varies by region |
| Canada | Prescription required | Yes | Approved for ED and PH |
Known hypersensitivity to sildenafil or any component of the tablet. 5 WARNINGS AND PRECAUTIONS 5.1 HypotensionSildenafil citrate has vasodilatory properties, resulting in mild and transient decreases in blood pressure.
- Sildenafil tablets 125 mg are linked to rare priapism cases.
- Discontinue use and seek medical help if this occurs.
- Staying upright for a few hours after taking helps.
- Always check the expiration date on your medication.
- Sildenafil is designed for adult men only.
- Use caution if you have low blood pressure.
- The medication should be taken with water.
- Report any unusual side effects to your doctor immediately.
Before prescribing sildenafil citrate, carefully consider whether patients with certain underlying conditions could be adversely affected by such vasodilatory effects (e.g., patients on antihypertensive therapy or with resting hypotension [blood pressure less than 90/50], fluid depletion, severe left ventricular outflow obstruction, or autonomic dysfunction).
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Viagra Generic | 100mg | 120 + 6 Pills | 149.50€ 142.38€ | |
| Viagra Generic | 100mg | 30 + 4 Pills | 60.91€ 58.01€ | |
| Kamagra Oral Jelly | 100mg | 90 + 8 Sachets | 303.56€ 289.10€ | |
| Kamagra Polo | 100mg | 272 + 12 Pills | 622.94€ 593.28€ | |
| Viagra Generic | 50mg | 10 Pills | 26.87€ 25.59€ | |
| Viagra Generic | 25mg | 20 Pills | 37.74€ 35.94€ | |
| Viagra Generic | 200mg | 90 + 6 Pills | 170.79€ 162.66€ | |
| Viagra Generic | 200mg | 10 Pills | 40.96€ 39.01€ | |
| Viagra Generic | 25mg | 360 + 10 Pills | 213.68€ 203.50€ | |
| Kamagra Polo | 100mg | 20 Pills | 83.56€ 79.58€ | |
| Kamagra Oral Jelly | 100mg | 30 + 5 Sachets | 136.20€ 129.71€ | |
| Kamagra | 100mg | 360 + 6 Pills | 839.95€ 799.95€ | |
| Viagra Generic | 150mg | 120 + 8 Pills | 177.58€ 169.12€ | |
| Viagra Generic | 200mg | 120 + 8 Pills | 204.80€ 195.05€ |
Monitor blood pressure when co-administering blood pressure lowering drugs with sildenafil citrate.5.2 Worsening Pulmonary Vascular Occlusive DiseasePulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD). Since there are no clinical data on administration of sildenafil citrate to patients with veno-occlusive disease, administration of sildenafil citrate to such patients is not recommended.
6.1 Clinical Trials Experience
There are no controlled clinical data on the safety or efficacy of sildenafil citrate in patients with retinitis pigmentosa, a minority of whom have genetic disorders of retinal phosphodiesterases. Therefore, use of sildenafil citrate in patients with retinitis pigmentosa is not recommended. Cases of sudden decrease or loss of hearing, which may be accompanied by tinnitus and dizziness, have been reported in temporal association with the use of PDE-5 inhibitors, including sildenafil citrate. It is not possible to determine whether these reported events are related directly to the use of sildenafil citrate, to the patient’s underlying risk factors for hearing loss, a combination of these factors, or to other factors. Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking PDE-5 inhibitors, including sildenafil citrate.
Other Interactions
Inform patients taking sildenafil citrate not to take VIAGRA or other PDE-5 inhibitors. If priapism (painful erection greater than 6 hours in duration) is not treated immediately, penile tissue damage and permanent loss of potency could result. In a small, prematurely terminated study of patients with pulmonary hypertension (PH) secondary to sickle cell disease, vaso-occlusive crises requiring hospitalization were more commonly reported by patients who received sildenafil citrate than by those randomized to placebo. 6 ADVERSE REACTIONS The following serious adverse events are discussed elsewhere in the labeling:Hypotension [see Warnings and Precautions (5.1)]Vision Loss [see Warnings and Precautions (5.4)]Hearing Loss [see Warnings and Precautions (5.5)]Priapism [see Warnings and Precautions (5.7)]Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell Disease [see Warnings and Precautions (5.8)]6.1 Clinical Trials ExperienceBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.In a 12-week, placebo-controlled clinical study and an open-label extension study (SUPER-1) in 277 sildenafil citrate-treated adults with PAH (WHO Group I) [see Clinical Studies (14)] the adverse reactions that were reported by at least 10% of sildenafil citrate -treated patients in any dosing group, and were more frequent in sildenafil citrate -treated patients than in placebo-treated patients are shown in Table 1. Adverse reactions were generally transient and mild to moderate in nature.
8.1 Pregnancy
The overall frequency of discontinuation in sildenafil citrate -treated patients was 3% (20 mg and 40 mg three times a day). The overall frequency of discontinuation for placebo was 3%.Table 1: Most Common Adverse Reactions in Patients Treated with Sildenafil Citrate 20 mg and Placebo three times per day in SUPER-1 (More Frequent in Sildenafil Citrate -Treated Patients than Placebo-Treated Patients)In a placebo-controlled fixed dose titration study (PACES-1) of sildenafil citrate (starting with recommended dose of 20 mg and increased to 40 mg and then 80 mg all three times a day) as an adjunct to intravenous epoprostenol in patients with PAH, no new safety issues were identified except for edema, which occurred in 25% of subjects in the combined sildenafil citrate + epoprostenol group compared with 13% of subjects in the epoprostenol group [see Clinical Studies (14)] .Pediatric use information is approved for Viatris Specialty LLC’s, REVATIO (sildenafil) tablets. Should signs of pulmonary edema occur when sildenafil citrate is administered, consider the possibility of associated PVOD.5.3 EpistaxisThe incidence of epistaxis was 13% in patients taking sildenafil citrate with PAH secondary to CTD. This effect was not seen in idiopathic PAH (sildenafil citrate 3%, placebo 2%) patients. The incidence of epistaxis was also higher in sildenafil citrate-treated patients with a concomitant oral vitamin K antagonist (9% versus 2% in those not treated with concomitant vitamin K antagonist).The safety of sildenafil citrate is unknown in patients with bleeding disorders or active peptic ulceration.5.4 Visual LossWhen used to treat erectile dysfunction, non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported post-marketing in temporal association with the use of PDE-5 inhibitors, including sildenafil. Most patients had underlying anatomic or vascular risk factors for developing NAION, including low cup to disc ratio (“crowded disc”).Advise patients to seek immediate medical attention in the event of a sudden loss of vision in one or both eyes while taking sildenafil citrate.There are no controlled clinical data on the safety or efficacy of sildenafil citrate in patients with retinitis pigmentosa, a minority of whom have genetic disorders of retinal phosphodiesterases. Therefore, use of sildenafil citrate in patients with retinitis pigmentosa is not recommended.5.5 Hearing LossCases of sudden decrease or loss of hearing, sildenafil 100 mg cost which may be accompanied by tinnitus and dizziness, have been reported in temporal association with the use of PDE-5 inhibitors, including sildenafil citrate. In some of the cases, medical conditions and other factors were reported that may have played a role. It is not possible to determine whether these reported events are related directly to the use of sildenafil citrate, to the patient’s underlying risk factors for hearing loss, a combination of these factors, or to other factors.Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking PDE-5 inhibitors, including sildenafil citrate.5.6 Combination with other PDE-5 InhibitorsSildenafil is also marketed as VIAGRA ®. The safety and efficacy of combinations of sildenafil citrate with VIAGRA or other PDE-5 inhibitors have not been studied. Inform patients taking sildenafil citrate not to take VIAGRA or other PDE-5 inhibitors.5.7 PriapismUse sildenafil citrate with caution in patients with anatomical deformation of the penis (e.g., angulation, cavernosal fibrosis, or Peyronie’s disease) or in patients who have conditions, which may predispose them to priapism (e.g., sickle cell anemia, multiple myeloma, or leukemia). If priapism (painful erection greater than 6 hours in duration) is not treated immediately, penile tissue damage and permanent loss of potency could result.5.8 Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell DiseaseIn a small, prematurely terminated study of patients with pulmonary hypertension (PH) secondary to sickle cell disease, vaso-occlusive crises requiring hospitalization were more commonly reported by patients who received sildenafil citrate than by those randomized to placebo. The effectiveness and safety of sildenafil citrate in the treatment of PH secondary to sickle cell disease has not been established. Sildenafil citrate has vasodilatory properties, resulting in mild and transient decreases in blood pressure. Monitor blood pressure when co-administering blood pressure lowering drugs with sildenafil citrate. Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD). Should signs of pulmonary edema occur when sildenafil citrate is administered, consider the possibility of associated PVOD.
- Sildenafil tablets 125 mg are manufactured by various brands.
- Always verify the authenticity of medication sources.
- Use only FDA-approved or certified pharmacies.
- Cost can vary based on brand and location.
- Generic versions are typically more affordable.
- Beware of counterfeit sildenafil products.
- Read customer reviews before purchasing online.
- Consult your doctor about the best brand for you.
The incidence of epistaxis was 13% in patients taking sildenafil citrate with PAH secondary to CTD. The incidence of epistaxis was also higher in sildenafil citrate-treated sildenafil otc patients with a concomitant oral vitamin K antagonist (9% versus 2% in those not treated with concomitant vitamin K antagonist). The safety of sildenafil citrate is unknown in patients with bleeding disorders or active peptic ulceration. When used to treat erectile dysfunction, non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported post-marketing in temporal association with the use of PDE-5 inhibitors, including sildenafil. Most patients had underlying anatomic or vascular risk factors for developing NAION, including low cup to disc ratio (“crowded disc”). Advise patients to seek immediate medical attention in the event of a sudden loss of vision in one or both eyes while taking sildenafil citrate. There are no controlled clinical data on the safety or efficacy of sildenafil citrate in patients with retinitis pigmentosa, a minority of whom have genetic disorders of retinal phosphodiesterases. Therefore, use of sildenafil citrate in patients with retinitis pigmentosa is not recommended. Cases of sudden decrease or loss of hearing, which may be accompanied by tinnitus and dizziness, have been reported in temporal association with the use of PDE-5 inhibitors, including sildenafil citrate. It is not possible to determine whether these reported events are related directly to the use of sildenafil citrate, to the patient’s underlying risk factors for hearing loss, a combination of these factors, or to other factors.
Frequently asked questions
Phosphodiesterase-5 (PDE-5) inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat.Known hypersensitivity to sildenafil or any component of the tablet. Hypersensitivity, including anaphylactic reaction, anaphylactic shock and anaphylactoid reaction, has been reported in association with the use of sildenafil. Sildenafil tablets are contraindicated in patients with: Concomitant use of organic nitrates in any form, either regularly or intermittently, because of the greater risk of hypotension [see Warnings and Precautions (5.1)] . Phosphodiesterase-5 (PDE-5) inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat. Known hypersensitivity to sildenafil or any component of the tablet.
Risk Summary
5 WARNINGS AND PRECAUTIONS 5.1 HypotensionSildenafil citrate has vasodilatory properties, resulting in mild and transient decreases in blood pressure. Before prescribing sildenafil citrate, carefully consider whether patients with certain underlying conditions could be adversely affected by such vasodilatory effects (e.g., patients on antihypertensive therapy or with resting hypotension [blood pressure less than 90/50], fluid depletion, severe left ventricular outflow obstruction, or autonomic dysfunction). Monitor blood pressure when co-administering blood pressure lowering drugs with sildenafil citrate.5.2 Worsening Pulmonary Vascular Occlusive DiseasePulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD). Since there are no clinical data on administration of sildenafil citrate to patients with veno-occlusive disease, administration of sildenafil citrate to such patients is not recommended. Should signs of pulmonary edema occur when sildenafil citrate is administered, consider the possibility of associated PVOD.5.3 EpistaxisThe incidence of epistaxis was 13% in patients taking sildenafil citrate with PAH secondary to CTD.
5.3 Epistaxis
This effect was not seen in idiopathic PAH (sildenafil citrate 3%, placebo 2%) patients. The incidence of epistaxis was also higher in sildenafil citrate-treated patients with a concomitant oral vitamin K antagonist (9% versus 2% in those not treated with concomitant vitamin K antagonist).The safety of sildenafil citrate is unknown in patients with bleeding disorders or active peptic ulceration.5.4 Visual LossWhen used to treat erectile dysfunction, non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported post-marketing in temporal association with the use of PDE-5 inhibitors, including sildenafil. Most patients had underlying anatomic or vascular risk factors for developing NAION, including low cup to disc ratio (“crowded disc”).Advise patients to seek immediate medical attention in the event of a sudden loss of vision in one or both eyes while taking sildenafil citrate.There are no controlled clinical data on the safety or efficacy of sildenafil citrate in patients with retinitis pigmentosa, a minority of whom have genetic disorders of retinal phosphodiesterases. Therefore, use of sildenafil citrate in patients with retinitis pigmentosa is not recommended.5.5 Hearing LossCases of sudden decrease or loss of hearing, sildenafil 100 mg cost which may be accompanied by tinnitus and dizziness, have been reported in temporal association with the use of PDE-5 inhibitors, including sildenafil citrate. In some of the cases, medical conditions and other factors were reported that may have played a role. Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking PDE-5 inhibitors, including sildenafil citrate.
- For best results, take sildenafil on an empty stomach.
- Eating fatty foods may delay its onset.
- The medication should be taken approximately 30 minutes before activity.
- Do not double dose to compensate for missed doses.
- Keep regular medical appointments during treatment.
- Report any worsening of symptoms to your doctor.
- Never use sildenafil if experiencing chest pain without medical guidance.
- Always follow the prescribed health regimen.
Inform patients taking sildenafil citrate not to take VIAGRA or other PDE-5 inhibitors. If priapism (painful erection greater than 6 hours in duration) is not treated immediately, penile tissue damage and permanent loss of potency could result. In a small, prematurely terminated study of patients with pulmonary hypertension (PH) secondary to sickle cell disease, vaso-occlusive crises requiring hospitalization were more commonly reported by patients who received sildenafil citrate than by those randomized to placebo. 6 ADVERSE REACTIONS The following serious adverse events are discussed elsewhere in the labeling:Hypotension [see Warnings and Precautions (5.1)]Vision Loss [see Warnings and Precautions (5.4)]Hearing Loss [see Warnings and Precautions (5.5)]Priapism [see Warnings and Precautions (5.7)]Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell Disease [see Warnings and Precautions (5.8)]6.1 Clinical Trials ExperienceBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.In a 12-week, placebo-controlled clinical study and an open-label extension study (SUPER-1) in 277 sildenafil citrate-treated adults with PAH (WHO Group I) [see Clinical Studies (14)] the adverse reactions that were reported by at least 10% of sildenafil citrate -treated patients in any dosing group, and were more frequent in sildenafil citrate -treated patients than in placebo-treated patients are shown in Table 1.
Publication types
Adverse reactions were generally transient and mild to moderate in nature. The overall frequency of discontinuation in sildenafil citrate -treated patients was 3% (20 mg and 40 mg three times a day). The overall frequency of discontinuation for placebo was 3%.Table 1: Most Common Adverse Reactions in Patients Treated with Sildenafil Citrate 20 mg and Placebo three times per day in SUPER-1 (More Frequent in Sildenafil Citrate -Treated Patients than Placebo-Treated Patients)In a placebo-controlled fixed dose titration study (PACES-1) of sildenafil citrate (starting with recommended dose of 20 mg and increased to 40 mg and then 80 mg all three times a day) as an adjunct to intravenous epoprostenol in patients with PAH, no new safety issues were identified except for edema, which occurred in 25% of subjects in the combined sildenafil citrate + epoprostenol group compared with 13% of subjects in the epoprostenol group [see Clinical Studies (14)] .Pediatric use information is approved for Viatris Specialty LLC’s, REVATIO (sildenafil) tablets.