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Oral sildenafil in the treatment of erectile dysfunction. Sildenafil Study Group
Standard operating procedure for performing physical quality assessment of oral and topical liquids.
About this article
Although plasma levels of this drug at 24 hours post-dose are much lower than at peak concentration, it is unknown whether nitrates can be safely co-administered at this time point. Concomitant use of organic nitrates in any form, either regularly or intermittently, because of the greater risk of hypotension Concomitant use of riociguat, a guanylate cyclase stimulator; PDE5 inhibitors, including this drug, may potentiate the hypotensive effects of riociguat. Known hypersensitivity to either the active component or to any of the ingredients of the tablet, injection, or oral suspension; hypersensitivity reactions have been reported, including anaphylactic reaction, anaphylactic shock, and anaphylactoid reaction Safety and efficacy have not been established in patients with ED younger than 18 years. Safety and efficacy have not been established in patients with PAH younger than 1 year. Due to high plasma protein binding and poor elimination in urine, removal via hemodialysis is unlikely.
Embase Keywords
Tablets: Administer orally with or without food. Reconstitute product before oral administration, and shake well before use. An oral syringe is sildenafil generic recommended for dose measurement (and delivery). Use within 60 days after reconstitution; discard any remainder after expiration. The liquid suspension is premixed and may contain flavoring.
Pulmonary Arterial Hypertension
Shake well before oral administration and use a calibrated measuring device for accurate dosing. IV: Administer as an IV bolus injection; the supplied product is ready for use. Tablets/IV solution: Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F). Oral suspension (liquid): Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F). Oral suspension (powder): Store below 30C (86F) in the original package in order to protect from moisture. Bethesda, MD: American Society of Health-System Pharmacists; 2016:1918-1932.7. To comment on this article, contact rdavidson@uspharmacist.com. N Engl J Med 1998;339:59 Oral Sildenafil in the Treatment of Erectile Dysfunction Original Article, N Engl J Med 1998:338;1397 - 1404 . On page 1397, the first sentence of the abstract should have read, “Sildenafil is a potent inhibitor of cyclic guanosine monophosphate hydrolysis in the corpus cavernosum,” not “a potent inhibitor of cyclic guanosine monophosphate in the corpus cavernosum,” as printed.
- Sildenafil should not be used with certain medications like alpha-blockers.
- Avoid alcohol consumption when taking sildenafil to reduce side effects.
- Discuss all medications with your doctor to prevent interactions.
Also, on page 1399, the second sentence under the heading “Results” should have read, “The men in the dose-escalation study had had erectile dysfunction for longer periods,” not “The men in the dose–response study,” as printed. Any commercial reuse of NEJM Group content requires permission. A novel standard‐free detection of adulteration method for sildenafil derivatives in dietary supplements, Biomedical Chromatography, 38, 8, (2024). Duplex ultrasonography and its role in the assessment of male sexual dysfunction, Male Sexual Dysfunction, (91-101), (2016).
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Viagra Generic | 100mg | 120 + 6 Pills | 149.50€ 142.38€ | |
| Viagra Generic | 150mg | 270 + 10 Pills | 326.61€ 311.06€ | |
| Viagra Generic | 100mg | 180 + 8 Pills | 199.37€ 189.88€ | |
| Viagra Generic | 150mg | 90 + 6 Pills | 147.18€ 140.17€ | |
| Kamagra Polo | 100mg | 12 Pills | 60.21€ 57.34€ | |
| Viagra Generic | 25mg | 180 + 6 Pills | 154.93€ 147.55€ | |
| Viagra Generic | 50mg | 20 Pills | 40.52€ 38.59€ | |
| Kamagra Polo | 100mg | 120 + 6 Pills | 327.15€ 311.57€ | |
| Kamagra Soft Tabs | 100mg | 12 Pills | 57.55€ 54.81€ | |
| Viagra Generic | 100mg | 60 + 4 Pills | 96.36€ 91.77€ | |
| Viagra Generic | 200mg | 30 + 2 Pills | 83.07€ 79.11€ | |
| Kamagra Soft Tabs | 100mg | 120 + 6 Pills | 311.78€ 296.93€ | |
| Kamagra Soft Tabs | 100mg | 20 Pills | 79.79€ 75.99€ | |
| Viagra Generic | 50mg | 90 + 6 Pills | 107.37€ 102.26€ | |
| Viagra Generic | 100mg | 90 + 6 Pills | 129.02€ 122.88€ |
Vasodilatory and hypoglycaemic effects of two pyrano-isoflavone extractives from Eriosema kraussianum N. E. Br.
Information & Authors
After reconstitution, store below 30C (86F) or in refrigerator at 2C to 8C (36F to 46F); do not freeze. Oral suspension (powder): Reconstitute with water (total 90 mL) in separate additions; shake vigorously after each addition. Do not mix with other medications or flavoring; insert adaptor into bottle neck. Consult the manufacturer product information for detailed instructions. Cardiovascular: Cardiac status/risk factors (prior to initiation); blood pressure (periodically during treatment in patients with PAH on concomitant anti-hypertensive agents) Drug Interactions: For concomitant use of medications that may be contraindicated or for dose adjustment (at baseline and during treatment) Ocular: NAION risk factors (prior to initiation) Read the US FDA-approved patient labeling (Patient Information and/or Instructions for Use).
Specific interventions included in the review
Tell your healthcare provider about all of the medicines you (or your child take). Regular and/or intermittent use of nitric oxide donors (e.g., organic nitrates or nitrites) in any form Other PDE5 inhibitors or products containing sildenafil Seek immediate medical attention in the event of: Sudden loss of vision in one or both eyes Sudden decrease or loss of hearing; may be accompanied by tinnitus and dizziness An erection that persists longer than 4 hours. It is not recommended to take this drug more than once a day. This medication can cause your blood pressure to unsafely drop suddenly if it is taken with certain other medicines. Stop sexual activity and seek medical attention if you experience symptoms such as chest pain, dizziness, or nausea during sex, or if you have any side effect that bothers you or does not go away.
How is sildenafil supplied (dosage forms)?
Use protective measures to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV). BACKGROUND: In a previous study, 6‐minute walk distance (6MWD) improvement with sildenafil was not dose dependent at the 3 doses tested (20, 40, and 80 mg 3 times daily [TID]). This study assessed whether lower doses were less effective than the approved 20‐mg TID dosage. Switching patients with erectile dysfunction from sildenafil citrate to tadalafil: Results of a European multicenter, open-label study of patient preference, Clinical Therapeutics, 25, 11, (2724-2737), (2003).
- Sildenafil is used to treat erectile dysfunction and pulmonary hypertension.
- It belongs to the class of phosphodiesterase inhibitors.
- Oral sildenafil should be taken about 30-60 minutes before activity.
Changing Practice Patterns in Erectile Dysfunction: A Diagnostic Algorithm for the New Millennium, Advances in Renal Replacement Therapy, 6, 4, (314-326), (1999). Applies to the following strengths: 10 mg/mL; 10 mg/12.5 mL; 20 mg; 25 mg; 50 mg; 100 mg; 75 mg TABLETS (Viagra) Initial dose: 50 mg orally once a day, as needed, about 1 hour prior to sexual activity Maintenance dose: May increase to 100 mg or decrease to 25 mg once a day, based on efficacy and tolerability. Maximum dose: 100 mg orally once a day Comments: This drug may be taken anywhere from 30 minutes to 4 hours before sexual activity. TABLETS (Revatio)/ORAL SUSPENSION (Revatio, Liqrev): Initial dose: 20 mg orally 3 times a day Maintenance dose: May titrate up to 80 mg orally 3 times a day, if required, based on symptoms and tolerability. Maximum dose: 80 mg orally 3 times a day IV: 10 mg IV bolus 3 times a day Comments: No adjustment for body weight is required for IV dosing. The 10 mg IV bolus dose is predicted to provide an equivalent pharmacological effect to that of 20 mg orally. Doses up to a maximum of 80 mg orally 3 times a day are supported by delayed clinical worsening with long-term use in clinical studies despite sildenafil citrate 100 mg a lack of observed dose-response improvement in exercise ability in short-term clinical studies. In adults 65 years or older, use caution with dose selection due to a higher incidence of compromised renal, cardiac, and/or hepatic function, and of concomitant disease or drug therapy. Use: For the treatment of PAH (WHO Group I) to improve exercise ability and delay clinical worsening TABLETS (Viagra) Initial dose: 25 mg orally once a day, as needed, about 1 hour prior to sexual activity Maintenance dose: May titrate up to 100 mg orally once a day, based on effectiveness and toleration.
Further information
Maximum dose: 100 mg orally once a day Comments: This drug may be administered anywhere from 30 minutes to 4 hours before sexual activity. A reduced starting dose is recommended in older adults due to higher systemic exposure as compared to younger adults. TABLETS (Revatio)/ORAL SUSPENSION (Revatio) 1 to less than 18 years: Weight 20 kg or less: 10 mg orally 3 times a day Weight greater than 20 kg to 45 kg: 20 mg orally 3 times a day Weight greater than 45 kg: 20 mg orally 3 times a day; dose may be titrated up to a maximum of 40 mg orally 3 times a day, if required, based on symptoms and tolerability Use: For the treatment of pulmonary arterial hypertension (WHO Group I) to improve exercise ability and, in pediatric patients too young to perform standard exercise testing, pulmonary hemodynamics thought to underlie improvements in exercise ERECTILE DYSFUNCTION: Mild to Moderate Renal Dysfunction (CrCl 30 to 80 mL/min): No adjustment recommended Severe Renal Dysfunction (CrCl less than 30 mL/min): Consider a starting dose of 25 mg orally once a day, about 1 hour prior to sexual activity Mild, Moderate, or Severe Renal Dysfunction (CrCl 80 to less than 30 mL/min): No adjustment recommended ERECTILE DYSFUNCTION: Mild, Moderate, or Severe Liver Dysfunction (Child-Pugh A, B, or C): Consider a starting dose of 25 mg orally once a day, about 1 hour prior to sexual activity. Mild or Moderate Liver Dysfunction (Child-Pugh A or B): No adjustment recommended Severe Liver Dysfunction (Child-Pugh C): Data not available in this population. Initiate treatment with 25 mg orally once a day, as needed, about 1 hour prior to sexual activity Patients should be stable on alpha blocker therapy prior initiating treatment with this drug. Administration with CYP450 3A4 Inhibitors (e.g., ketoconazole, itraconazole, saquinavir) or Erythromycin: Consider a starting dose of 25 orally once a day, as needed, about 1 hour prior to sexual activity. Recommended dose: 25 mg orally, as needed, about 1 hour prior to sexual activity Maximum dose: 25 mg orally within a 48 hour period Known hypersensitivity to either the active component or to any of the ingredients; hypersensitivity reactions have been reported, including rash and urticaria In patients who are using a guanylate cyclase (GC) stimulators, such as riociguat; phosphodiesterase type 5 inhibitors (PDE5), including this drug, may potentiate the hypotensive effects of GC stimulators. In patients who are using nitric oxide donors such as organic nitrates or organic nitrites in any form either regularly and/or intermittently; this drug has been shown to potentiate the hypotensive effects of nitrates based on its mechanism of action After patients have taken this drug for ED, it is unknown when nitrates, if necessary, can be safely administered.
| Medication Type | Potential Interaction | Effect | Notes |
|---|---|---|---|
| Nitrates | Severe hypotension | Dangerous drop in blood pressure | Absolute contraindication |
| Alpha-blockers | Enhanced hypotensive effect | Blood pressure may drop too low | Use with caution, monitor BP |
| CYP3A4 inhibitors | Increased sildenafil levels | Increased risk of side effects | Dose adjustment may be needed |
| Rifampin | Reduced sildenafil effectiveness | Lower plasma levels | May require dose increase |
Although plasma levels of this drug at 24 hours post-dose are much lower than at peak concentration, it is unknown whether nitrates can be safely co-administered at this time point. Concomitant use of organic nitrates in any form, either regularly or intermittently, because of the greater risk of hypotension Concomitant use of riociguat, a guanylate cyclase stimulator; PDE5 inhibitors, including this drug, may potentiate the hypotensive effects of riociguat.
| Side Effect | Incidence (%) | Severity | Recommendations |
|---|---|---|---|
| Headache | 16-30 | Mild to moderate | Usually resolves spontaneously |
| Flushing | 10-15 | Mild | Can be reduced with lower doses |
| Dyspepsia | 10-20 | Mild | Take with food to reduce symptoms |
| Nasal Congestion | 10-20 | Mild | Usually transient |
| Visual Disturbances | 2-4 | Mild to moderate | Rare, discontinue if persistent |
Known hypersensitivity to either the active component or to any of the ingredients of the tablet, injection, or oral suspension; hypersensitivity reactions have been reported, including anaphylactic reaction, anaphylactic shock, and anaphylactoid reaction Safety and efficacy have not been established in patients with ED younger than 18 years.
Chemical synthesis
Maximum dose: 100 mg orally once a day Comments: This drug may be taken anywhere from 30 minutes to 4 hours before sexual activity. TABLETS (Revatio)/ORAL SUSPENSION (Revatio, Liqrev): Initial dose: 20 mg orally 3 times a day Maintenance dose: May titrate up to 80 mg orally 3 times a day, if required, based on symptoms and tolerability. Maximum dose: 80 mg orally 3 times a day IV: 10 mg IV bolus 3 times a day Comments: No adjustment for body weight is required for IV dosing. The 10 mg IV bolus dose is predicted to provide an equivalent pharmacological effect to that of 20 mg orally. Doses up to a maximum of 80 mg orally 3 times a day are supported by delayed clinical worsening with long-term use in clinical studies despite sildenafil citrate 100 mg a lack of observed dose-response improvement in exercise ability in short-term clinical studies.
Sildenafil Tablets for ED
In adults 65 years or older, use caution with dose selection due to a higher incidence of compromised renal, cardiac, and/or hepatic function, and of concomitant disease or drug therapy. Use: For the treatment of PAH (WHO Group I) to improve exercise ability and delay clinical worsening TABLETS (Viagra) Initial dose: 25 mg orally once a day, as needed, about 1 hour prior to sexual activity Maintenance dose: May titrate up to 100 mg orally once a day, based on effectiveness and toleration. Maximum dose: 100 mg orally once a day Comments: This drug may be administered anywhere from 30 minutes to 4 hours before sexual activity. A reduced starting dose is recommended in older adults due to higher systemic exposure as compared to younger adults. TABLETS (Revatio)/ORAL SUSPENSION (Revatio) 1 to less than 18 years: Weight 20 kg or less: 10 mg orally 3 times a day Weight greater than 20 kg to 45 kg: 20 mg orally 3 times a day Weight greater than 45 kg: 20 mg orally 3 times a day; dose may be titrated up to a maximum of 40 mg orally 3 times a day, if required, based on symptoms and tolerability Use: For the treatment of pulmonary arterial hypertension (WHO Group I) to improve exercise ability and, in pediatric patients too young to perform standard exercise testing, pulmonary hemodynamics thought to underlie improvements in exercise ERECTILE DYSFUNCTION: Mild to Moderate Renal Dysfunction (CrCl 30 to 80 mL/min): No adjustment recommended Severe Renal Dysfunction (CrCl less than 30 mL/min): Consider a starting dose of 25 mg orally once a day, about 1 hour prior to sexual activity Mild, Moderate, or Severe Renal Dysfunction (CrCl 80 to less than 30 mL/min): No adjustment recommended ERECTILE DYSFUNCTION: Mild, Moderate, or Severe Liver Dysfunction (Child-Pugh A, B, or C): Consider a starting dose of 25 mg orally once a day, about 1 hour prior to sexual activity.
Other Medical Problems
Mild or Moderate Liver Dysfunction (Child-Pugh A or B): No adjustment recommended Severe Liver Dysfunction (Child-Pugh C): Data not available in this population. Initiate treatment with 25 mg orally once a day, as needed, about 1 hour prior to sexual activity Patients should be stable on alpha blocker therapy prior initiating treatment with this drug. Administration with CYP450 3A4 Inhibitors (e.g., ketoconazole, itraconazole, saquinavir) or Erythromycin: Consider a starting dose of 25 orally once a day, as needed, about 1 hour prior to sexual activity. Recommended dose: 25 mg orally, as needed, about 1 hour prior to sexual activity Maximum dose: 25 mg orally within a 48 hour period Known hypersensitivity to either the active component or to any of the ingredients; hypersensitivity reactions have been reported, including rash and urticaria In patients who are using a guanylate cyclase (GC) stimulators, such as riociguat; phosphodiesterase type 5 inhibitors (PDE5), including this drug, may potentiate the hypotensive effects of GC stimulators. In patients who are using nitric oxide donors such as organic nitrates or organic nitrites in any form either regularly and/or intermittently; this drug has been shown to potentiate the hypotensive effects of nitrates based on its mechanism of action After patients have taken this drug for ED, it is unknown when nitrates, if necessary, can be safely administered. Safety and efficacy have not been established in patients with PAH younger than 1 year. Due to high plasma protein binding and poor elimination in urine, removal via hemodialysis is unlikely. Tablets: Administer orally with or without food. Reconstitute product before oral administration, and shake well before use.
- Always consult a healthcare provider before starting sildenafil.
- Do not exceed the prescribed dose to avoid side effects.
- Sildenafil can interact with nitrates, causing dangerous blood pressure drops.
An oral syringe is sildenafil generic recommended for dose measurement (and delivery). Use within 60 days after reconstitution; discard any remainder after expiration. The liquid suspension is premixed and may contain flavoring. Shake well before oral administration and use a calibrated measuring device for accurate dosing. IV: Administer as an IV bolus injection; the supplied product is ready for use. Tablets/IV solution: Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F). Oral suspension (liquid): Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).
| Dose (mg) | Typical Usage Frequency | Time to Onset (minutes) | Duration of Effect (hours) | Notes |
|---|---|---|---|---|
| 50 | Once or twice daily | 30-60 | 4-6 | Starting dose for most patients |
| 100 | Once daily | 30-60 | 4-6 | Common for moderate ED |
| 25 | As needed | 30-60 | 4-6 | For mild ED |
| 10 | As needed | 30-60 | 4-6 | Lower dose option |
Oral suspension (powder): Store below 30C (86F) in the original package in order to protect from moisture. After reconstitution, store below 30C (86F) or in refrigerator at 2C to 8C (36F to 46F); do not freeze. Oral suspension (powder): Reconstitute with water (total 90 mL) in separate additions; shake vigorously after each addition. Do not mix with other medications or flavoring; insert adaptor into bottle neck. Consult the manufacturer product information for detailed instructions. Cardiovascular: Cardiac status/risk factors (prior to initiation); blood pressure (periodically during treatment in patients with PAH on concomitant anti-hypertensive agents) Drug Interactions: For concomitant use of medications that may be contraindicated or for dose adjustment (at baseline and during treatment) Ocular: NAION risk factors (prior to initiation) Read the US FDA-approved patient labeling (Patient Information and/or Instructions for Use). Tell your healthcare provider about all of the medicines you (or your child take). Regular and/or intermittent use of nitric oxide donors (e.g., organic nitrates or nitrites) in any form Other PDE5 inhibitors or products containing sildenafil Seek immediate medical attention in the event of: Sudden loss of vision in one or both eyes Sudden decrease or loss of hearing; may be accompanied by tinnitus and dizziness An erection that persists longer than 4 hours.
Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet].
Standard operating procedure for performing physical quality assessment of oral and topical liquids. Bethesda, MD: American Society of Health-System Pharmacists; 2016:1918-1932.7. To comment on this article, contact rdavidson@uspharmacist.com. N Engl J Med 1998;339:59 Oral Sildenafil in the Treatment of Erectile Dysfunction Original Article, N Engl J Med 1998:338;1397 - 1404 . On page 1397, the first sentence of the abstract should have read, “Sildenafil is a potent inhibitor of cyclic guanosine monophosphate hydrolysis in the corpus cavernosum,” not “a potent inhibitor of cyclic guanosine monophosphate in the corpus cavernosum,” as printed.
Vybrique Oral Film
Also, on page 1399, the second sentence under the heading “Results” should have read, “The men in the dose-escalation study had had erectile dysfunction for longer periods,” not “The men in the dose–response study,” as printed. Any commercial reuse of NEJM Group content requires permission. A novel standard‐free detection of adulteration method for sildenafil derivatives in dietary supplements, Biomedical Chromatography, 38, 8, (2024). Duplex ultrasonography and its role in the assessment of male sexual dysfunction, Male Sexual Dysfunction, (91-101), (2016). Vasodilatory and hypoglycaemic effects of two pyrano-isoflavone extractives from Eriosema kraussianum N.
Clinics in Geriatric Medicine
E. Br. Switching patients with erectile dysfunction from sildenafil citrate to tadalafil: Results of a European multicenter, open-label study of patient preference, Clinical Therapeutics, 25, 11, (2724-2737), (2003). Changing Practice Patterns in Erectile Dysfunction: A Diagnostic Algorithm for the New Millennium, Advances in Renal Replacement Therapy, 6, 4, (314-326), (1999). Applies to the following strengths: 10 mg/mL; 10 mg/12.5 mL; 20 mg; 25 mg; 50 mg; 100 mg; 75 mg TABLETS (Viagra) Initial dose: 50 mg orally once a day, as needed, about 1 hour prior to sexual activity Maintenance dose: May increase to 100 mg or decrease to 25 mg once a day, based on efficacy and tolerability. It is not recommended to take this drug more than once a day. This medication can cause your blood pressure to unsafely drop suddenly if it is taken with certain other medicines. Stop sexual activity and seek medical attention if you experience symptoms such as chest pain, dizziness, or nausea during sex, or if you have any side effect that bothers you or does not go away. Use protective measures to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV). BACKGROUND: In a previous study, 6‐minute walk distance (6MWD) improvement with sildenafil was not dose dependent at the 3 doses tested (20, 40, and 80 mg 3 times daily [TID]).
- Sildenafil is available by prescription only in most countries.
- The medication comes in various dosages, typically 25mg, 50mg, and 100mg.
- Adjust dosage as directed by your healthcare provider.
This study assessed whether lower doses were less effective than the approved 20‐mg TID dosage.