Sildenafil 20mg Tablets
Theresults suggestan approximate 2-fold increase in the risk of NAION, with a risk estimate of 2.15 (95% CI 1.06, 4.34). Other risk factors for NAION,such as the presence of ''crowded'' optic disc, may have contributed to the occurrence of NAION in these studies. Neither the rare post-marketing reports, nor the association of PDE5 inhibitor use and NAION in theobservationalstudies, substantiate a causal relationship between PDE5 inhibitor use and NAION [see Adverse Reactions(6.2)].
Other uses for this medicine
Theresults suggestan approximate 2-fold increase in the risk of NAION, with a risk estimate of 2.15 (95% CI 1.06, 4.34). Other risk factors for NAION,such as the presence of ''crowded'' optic disc, may have contributed to the occurrence of NAION in these studies. Neither the rare post-marketing reports, nor the association of PDE5 inhibitor use and NAION in theobservationalstudies, substantiate a causal relationship between PDE5 inhibitor use and NAION [see Adverse Reactions(6.2)]. Therefore, PDE5 inhibitors, including sildenafil tablets, should be used with caution in these patients and only when the anticipated benefits outweigh the risks. Individuals with ''crowded'' optic disc are also considered at greater risk for NAION compared to the general population, however, evidence is insufficient to support screening of prospective users of PDE5 inhibitors, including sildenafil tablets, for this uncommon condition.
Use In Specific Populations
There are no controlled clinical data on the safety or efficacy of sildenafil tablets in patients with retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases); if prescribed, this should be done with caution. Physicians should advise patients to stop taking PDE5 inhibitors, including sildenafil tablets, and seek prompt medical attention in the event of sudden decrease or loss of hearing. These events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to the intake of PDE5 inhibitors, including sildenafil tablets. Alpha-blockers Caution is advised when PDE5 inhibitors are co-administered with alpha-blockers. PDE5 inhibitors, including sildenafil tablets, and alpha-adrenergic blocking agents are both vasodilators with blood pressure lowering effects.
Revatio Injection
In some patients, concomitant use of these two drug classes can lower blood pressure significantly [see Drug Interactions (7.2)and Clinical Pharmacology (12.2)]leading to symptomatic hypotension (e.g., dizziness, lightheadedness, fainting). Consideration should be given to the following: •Patients who demonstrate hemodynamic instability on alpha-blocker therapy alone are at increased risk of symptomatic hypotension with concomitant use of PDE5 inhibitors. •In those patients already taking an optimized dose of a PDE5 inhibitor, alpha-blocker therapy should be initiated at the lowest dose. •Safety of combined use of PDE5 inhibitors and alpha-blockers may be affected by other variables, including intravascular volume depletion and other anti-hypertensive drugs. Anti-hypertensives Sildenafil tablets have systemic vasodilatory properties and may further lower blood pressure in patients taking anti-hypertensive medications. Therefore, PDE5 inhibitors, including sildenafil tablets, should be used with caution in these patients and only when the anticipated benefits outweigh the risks. Individuals with ''crowded'' optic disc are also considered at greater risk for NAION compared to the general population, however, evidence is insufficient to support screening of prospective users of PDE5 inhibitors, including sildenafil tablets, for this uncommon condition. There are no controlled clinical data on the safety or efficacy of sildenafil tablets in patients with retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases); if prescribed, this should be done with caution. Physicians should advise patients to stop taking PDE5 inhibitors, including sildenafil tablets, and seek prompt medical attention in the event of sudden decrease or loss of hearing. These events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to the intake of PDE5 inhibitors, including sildenafil tablets.
- Sildenafil 20 mg is a prescription medication used for erectile dysfunction.
- It helps increase blood flow to the penis during sexual activity.
- Typically prescribed for men with ED to improve sexual performance.
Alpha-blockers Caution is advised when PDE5 inhibitors are co-administered with alpha-blockers. PDE5 inhibitors, including sildenafil tablets, and alpha-adrenergic blocking agents are both vasodilators with blood pressure lowering effects. In some patients, concomitant use of these two drug classes can lower blood pressure significantly [see Drug Interactions (7.2)and Clinical Pharmacology (12.2)]leading to symptomatic hypotension (e.g., dizziness, lightheadedness, fainting). Consideration should be given to the following: •Patients who demonstrate hemodynamic instability on alpha-blocker therapy alone are at increased risk of symptomatic hypotension with concomitant use of PDE5 inhibitors. •In those patients already taking an optimized dose of a PDE5 inhibitor, alpha-blocker therapy should be initiated at the lowest dose. •Safety of combined use of PDE5 inhibitors and alpha-blockers may be affected by other variables, including intravascular volume depletion and other anti-hypertensive drugs.
- Sildenafil 20 mg is not intended for use by women or children.
- Keep medication out of reach of children to prevent accidental ingestion.
- Store in a cool, dry place away from direct sunlight.
Anti-hypertensives Sildenafil tablets have systemic vasodilatory properties and may further lower blood pressure in patients taking anti-hypertensive medications. In a separate drug interaction study, when amlodipine, 5 mg or 10 mg, and sildenafil tablets, 100 mg were orally administered concomitantly to hypertensive patients mean additional blood pressure reduction of 8 mmHg systolic and 7 mmHg diastolic were noted [see Drug Interactions (7.3)and Clinical Pharmacology (12.2)]. If sildenafil tablets are prescribed to patients taking ritonavir, caution should be used.
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Decreased blood pressure, syncope, and prolonged erection were reported in some healthy volunteers exposed to high doses of sildenafil (200 to 800 mg). To decrease the chance of adverse reactions in patients taking ritonavir, a decrease in sildenafil dosage is recommended [see Dosage and Administration (2.4),Drug Interactions (7.4),and Clinical Pharmacology (12.3)].
5.7 Combination with other PDE-5 inhibitors
Table 1: Adverse Reactions Reported by ≥2% of Patients with Sildenafil Tablets and More Frequently than Placebo in Fixed-Dose Phase II/III Studies †Abnormal Vision: Mild to moderate in severity and transient, predominantly color tinge to vision, but also increased sensitivity to light, or blurred vision. When sildenafil tablets were taken as recommended (on an as-needed basis) in flexible-dose, placebo-controlled clinical trials of two to twenty-six weeks duration, patients took sildenafil tablets at least once weekly, and the following adverse reactions were reported: Table 2. Adverse Reactions Reported by ≥2% of Patients Treated with Sildenafil Tablets and More Frequent than Placebo in Flexible-Dose Phase II/III Studies † Abnormal Vision: Mild and transient, predominantly color tinge to vision, but also increased sensitivity to light or blurred vision. In these studies, only one patient discontinued due to abnormal vision. The following events occurred in <2% of patients in controlled clinical trials; a causal relationship to sildenafil tablets is uncertain.
Most Asked Questions
Reported events include those with a plausible relation to drug use; omitted are minor events and reports too imprecise to be meaningful: Body as a Whole:face edema, photosensitivity reaction, shock, asthenia, pain, chills, accidental fall, abdominal pain, allergic reaction, chest pain, accidental injury. Metabolic and Nutritional:thirst, edema, gout, unstable diabetes, hyperglycemia, peripheral edema, hyperuricemia, hypoglycemic reaction, hypernatremia. Respiratory:asthma, dyspnea, laryngitis, pharyngitis, sinusitis, bronchitis, sputum increased, cough increased. Skin and Appendages:urticaria, herpes simplex, pruritus, sweating, skin ulcer, contact dermatitis, exfoliative dermatitis. Analysis of the safety database from controlled clinical trials showed no apparent difference in adverse reactions in patients taking sildenafil tablets with and without anti-hypertensive medication.
The Bottom Line
The following adverse reactions have been identified during post approval use of sildenafil tablets. Cardiovascular and cerebrovascular Serious cardiovascular, cerebrovascular, and vascular events, including myocardial infarction, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient ischemic attack, hypertension, subarachnoid and intracerebral hemorrhages, and pulmonary hemorrhage have been reported post-marketing in temporal association with the use of sildenafil tablets. Many of these events were reported to occur during or shortly after sexual activity, and a few were reported to occur shortly after the use of sildenafil tablets without sexual activity. Others were reported to have occurred hours to days after the use of sildenafil tablets and sexual activity. It is not possible to determine whether these events are related directly to sildenafil tablets, to sexual activity, to the patient’s underlying cardiovascular disease, to a combination of these factors, or to other factors [see Warnings and Precautions (5.1)and Patient Counseling Information (17)]. The safety and efficacy of combinations of sildenafil tablets with other PDE5 Inhibitors, including REVATIO or other pulmonary arterial hypertension (PAH) treatments containing sildenafil, or other treatments for erectile dysfunction have not been studied. There have been postmarketing reports of bleeding events in patients who have taken sildenafil tablets. A causal relationship between sildenafil tablets and these events has not been established. In humans, sildenafil tablets have no effect on bleeding time when taken alone or with aspirin.
6.2 Postmarketing Experience
However, in vitrostudies with human platelets indicate that sildenafil potentiates tablet sildenafil 50 mg the antiaggregatory effect of sodium nitroprusside (a nitric oxide donor). In addition, the combination of heparin and sildenafil tablets had an additive effect on bleeding time in the anesthetized rabbit, but this interaction has not been studied in humans. The safety of sildenafil tablets is unknown in patients with bleeding disorders and patients with active peptic ulceration.
- Sildenafil 20 mg tablets should be taken about 30 to 60 minutes before sexual activity.
- It’s important not to take more than one dose in 24 hours.
- Do not crush or chew the medication; swallow it whole with water.
The use of sildenafil tablets offers no protection against sexually transmitted diseases. The following are discussed in more detail in other sections of the labeling: •Cardiovascular [see Warnings and Precautions(5.1)] •Prolonged Erection and Priapism [see Warnings and Precautions (5.2)] •Effects on the Eye [see Warnings and Precautions(5.3)] •Hearing Loss [ see Warnings and Precautions (5.4)] •Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives [see Warnings and Precautions(5.5)] •Adverse Reactions with the Concomitant Use of Ritonavir [see Warnings and Precautions(5.6)] •Combination with other PDE5 Inhibitors or Other Erectile Dysfunction Therapies [see Warnings and Precautions (5.7)] •Effects on Bleeding [see Warnings and Precautions(5.8)] •Counseling Patients About Sexually Transmitted Diseases [see Warnings and Precautions (5.9)] The most common adverse reactions reported in clinical trials (≥ 2%) are headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness, and rash. Sildenafil tablets were administered to over 3700 patients (aged 19 to 87 years) during pre-marketing clinical trials worldwide. In placebo-controlled clinical studies, the discontinuation rate due to adverse reactions for sildenafil tablets (2.5%) was not significantly different from placebo (2.3%). Table 1: Adverse Reactions Reported by ≥2% of Patients with Sildenafil Tablets and More Frequently than Placebo in Fixed-Dose Phase II/III Studies †Abnormal Vision: Mild to moderate in severity and transient, predominantly color tinge to vision, but also increased sensitivity to light, or blurred vision. When sildenafil tablets were taken as recommended (on an as-needed basis) in flexible-dose, placebo-controlled clinical trials of two to twenty-six weeks duration, patients took sildenafil tablets at least once weekly, and the following adverse reactions were reported: Table 2. Adverse Reactions Reported by ≥2% of Patients Treated with Sildenafil Tablets and More Frequent than Placebo in Flexible-Dose Phase II/III Studies † Abnormal Vision: Mild and transient, predominantly color tinge to vision, but also increased sensitivity to light or blurred vision. In these studies, only one patient discontinued due to abnormal vision. The following events occurred in <2% of patients in controlled clinical trials; a causal relationship to sildenafil tablets is uncertain. Reported events include those with a plausible relation to drug use; omitted are minor events and reports too imprecise to be meaningful: Body as a Whole:face edema, photosensitivity reaction, shock, asthenia, pain, chills, accidental fall, abdominal pain, allergic reaction, chest pain, accidental injury. Metabolic and Nutritional:thirst, edema, gout, unstable diabetes, hyperglycemia, peripheral edema, hyperuricemia, hypoglycemic reaction, hypernatremia.
What to avoid
In a separate drug interaction study, when amlodipine, 5 mg or 10 mg, and sildenafil tablets, 100 mg were orally administered concomitantly to hypertensive patients mean additional blood pressure reduction of 8 mmHg systolic and 7 mmHg diastolic were noted [see Drug Interactions (7.3)and Clinical Pharmacology (12.2)]. If sildenafil tablets are prescribed to patients taking ritonavir, caution should be used. Decreased blood pressure, syncope, and prolonged erection were reported in some healthy volunteers exposed to high doses of sildenafil (200 to 800 mg). To decrease the chance of adverse reactions in patients taking ritonavir, a decrease in sildenafil dosage is recommended [see Dosage and Administration (2.4),Drug Interactions (7.4),and Clinical Pharmacology (12.3)]. The safety and efficacy of combinations of sildenafil tablets with other PDE5 Inhibitors, including REVATIO or other pulmonary arterial hypertension (PAH) treatments containing sildenafil, or other treatments for erectile dysfunction have not been studied.
Special Populations
There have been postmarketing reports of bleeding events in patients who have taken sildenafil tablets. A causal relationship between sildenafil tablets and these events has not been established. In humans, sildenafil tablets have no effect on bleeding time when taken alone or with aspirin. However, in vitrostudies with human platelets indicate that sildenafil potentiates tablet sildenafil 50 mg the antiaggregatory effect of sodium nitroprusside (a nitric oxide donor). In addition, the combination of heparin and sildenafil tablets had an additive effect on bleeding time in the anesthetized rabbit, but this interaction has not been studied in humans.
Indications and Usage for Sildenafil Tablets
The safety of sildenafil tablets is unknown in patients with bleeding disorders and patients with active peptic ulceration. The use of sildenafil tablets offers no protection against sexually transmitted diseases. The following are discussed in more detail in other sections of the labeling: •Cardiovascular [see Warnings and Precautions(5.1)] •Prolonged Erection and Priapism [see Warnings and Precautions (5.2)] •Effects on the Eye [see Warnings and Precautions(5.3)] •Hearing Loss [ see Warnings and Precautions (5.4)] •Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives [see Warnings and Precautions(5.5)] •Adverse Reactions with the Concomitant Use of Ritonavir [see Warnings and Precautions(5.6)] •Combination with other PDE5 Inhibitors or Other Erectile Dysfunction Therapies [see Warnings and Precautions (5.7)] •Effects on Bleeding [see Warnings and Precautions(5.8)] •Counseling Patients About Sexually Transmitted Diseases [see Warnings and Precautions (5.9)] The most common adverse reactions reported in clinical trials (≥ 2%) are headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness, and rash. Sildenafil tablets were administered to over 3700 patients (aged 19 to 87 years) during pre-marketing clinical trials worldwide. In placebo-controlled clinical studies, the discontinuation rate due to adverse reactions for sildenafil tablets (2.5%) was not significantly different from placebo (2.3%). Respiratory:asthma, dyspnea, laryngitis, pharyngitis, sinusitis, bronchitis, sputum increased, cough increased. Skin and Appendages:urticaria, herpes simplex, pruritus, sweating, skin ulcer, contact dermatitis, exfoliative dermatitis. Analysis of the safety database from controlled clinical trials showed no apparent difference in adverse reactions in patients taking sildenafil tablets with and without anti-hypertensive medication. The following adverse reactions have been identified during post approval use of sildenafil tablets. Cardiovascular and cerebrovascular Serious cardiovascular, cerebrovascular, and vascular events, including myocardial infarction, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient ischemic attack, hypertension, subarachnoid and intracerebral hemorrhages, and pulmonary hemorrhage have been reported post-marketing in temporal association with the use of sildenafil tablets. Many of these events were reported to occur during or shortly after sexual activity, and a few were reported to occur shortly after the use of sildenafil tablets without sexual activity. Others were reported to have occurred hours to days after the use of sildenafil tablets and sexual activity. It is not possible to determine whether these events are related directly to sildenafil tablets, to sexual activity, to the patient’s underlying cardiovascular disease, to a combination of these factors, or to other factors [see Warnings and Precautions (5.1)and Patient Counseling Information (17)]. Hemic and Lymphatic:vaso-occlusive crisis: In a small, prematurely terminated study of REVATIO (sildenafil) in patients with pulmonary arterial hypertension (PAH) secondary to sickle cell disease, vaso-occlusive crises requiring hospitalization were more commonly reported in patients who received sildenafil than in those randomized to placebo. The clinical relevance of this finding to men treated with sildenafil tablets for ED is not known. Nervous:seizure, seizure recurrence, anxiety, and transient global amnesia. Respiratory:epistaxis Special senses: Hearing:Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including sildenafil tablets.
How to Take Sildenafil Correctly for Erectile Dysfunction
Hemic and Lymphatic:vaso-occlusive crisis: In a small, prematurely terminated study of REVATIO (sildenafil) in patients with pulmonary arterial hypertension (PAH) secondary to sickle cell disease, vaso-occlusive crises requiring hospitalization were more commonly reported in patients who received sildenafil than in those randomized to placebo. The clinical relevance of this finding to men treated with sildenafil tablets for ED is not known. Nervous:seizure, seizure recurrence, anxiety, and transient global amnesia. Respiratory:epistaxis Special senses: Hearing:Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including sildenafil tablets. It is not possible to determine whether these reported events are related directly to the use of sildenafil tablets, to the patient’s underlying risk factors for hearing loss, a combination of these factors, or to other factors [see Warnings and Precautions (5.4)and Patient Counseling Information (17)].
Azole Antifungals
Ocular:diplopia, temporary vision loss/decreased vision, ocular redness or bloodshot appearance, ocular burning, ocular swelling/pressure, increased intraocular pressure, retinal edema, retinal vascular disease or bleeding, and vitreous traction/detachment. It is not possible to determine whether these reported events are related directly to the use of sildenafil tablets, to the patient’s underlying risk factors for hearing loss, a combination of these factors, or to other factors [see Warnings and Precautions (5.4)and Patient Counseling Information (17)]. Ocular:diplopia, temporary vision loss/decreased vision, ocular redness or bloodshot appearance, ocular burning, ocular swelling/pressure, increased intraocular pressure, retinal edema, retinal vascular disease or bleeding, and vitreous traction/detachment.