Oral sildenafil in erectile dysfunction

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.

Original Paper URL

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.

Sildenafil, a novel effective oral therapy for male erectile dysfunction

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. 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. 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. 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. Tablets: Administer orally with or without food. Reconstitute product before oral administration, and shake well before use.

• Common side effects include headache, flushing, and nasal congestion.
• Serious side effects are rare but can include vision changes and priapism.
• Report any severe reactions to your doctor immediately.

An oral syringe is 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 sildenafil oral strips 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.

Before taking this medicine

Raynaud's phenomenon

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.

• Sildenafil is not a cure for erectile dysfunction but helps improve function.
• Use sildenafil only as prescribed to ensure safety and efficacy.
• It is not intended for recreational use and can be harmful.

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.

What happens if I miss a dose?

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 pfizer sildenafil 100 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. METHODS: Treatment‐naive patients with pulmonary arterial hypertension were randomized to 12 weeks of double‐blind sildenafil 1, 5, or 20 mg TID; 12 weeks of open‐label sildenafil 20 mg TID followed.

What should I do if I miss a dose of sildenafil?

Changes from baseline in 6‐minute walk distance (6MWD) for sildenafil 1 or 5 mg versus 20 mg TID were compared using a Williams test. Hemodynamics, functional class, and biomarkers were assessed. RESULTS: The study was prematurely terminated for non‐safety reasons, with 129 of 219 planned patients treated. At week 12, 6MWD change from baseline was significantly greater for sildenafil 20 versus 1 mg (P = 0.011) but not versus 5 mg. At week 24, 6MWD increases from baseline were larger in those initially randomized to 20 versus 5 or 1 mg (74 vs 50 and 47 m, respectively). 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 pfizer sildenafil 100 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.

Mechanism of action

At week 12, changes in hemodynamic parameters were generally small and variable between treatment groups; odds ratios for improvement in functional class were not statistically significantly different. Improvements in B‐type natriuretic peptide levels were significantly greater with sildenafil 20 versus 1 but not 5 mg. CONCLUSIONS: Sildenafil 20 mg TID appeared to be more effective than 1 mg TID for improving 6MWD; sildenafil 5 mg TID appeared to have similar clinical and hemodynamic effects as 20 mg TID. TRIAL REGISTRATION: ClinicalTrials.gov NCT00430716 (Registration date: January 31, 2007). Cochrane Central Register of Controlled Trials (CENTRAL) Cochrane Central Register of Controlled Trials (CENTRAL) Vizza, University of Rome La Sapienza, Department of Cardiovascular and Respiratory Disease, Viale del Policlinico 155, Rome 00161, Italy.

Diabetes-related impotence in the elderly

Vizza, University of Rome La Sapienza, Department of Cardiovascular and Respiratory Disease, Viale del Policlinico 155, Rome 00161, Italy. Adult; Aged; Aged, 80 and over; Female; Humans; Male; Middle Aged; Young Adult; adult; aged; anemia/si [Side Effect]; article; backache/si [Side Effect]; clinical outcome; controlled study; dizziness/si [Side Effect]; dose response; double blind procedure; drug dose comparison; drug efficacy; drug safety; drug tolerability; dyspnea/si [Side Effect]; epistaxis/si [Side Effect]; fatigue/si [Side Effect]; female; headache/si [Side Effect]; human; low drug dose; major clinical study; male; open study; *pulmonary hypertension/dt [Drug Therapy]; pulmonary hypertension/dt [Drug Therapy]; randomized controlled trial; rhinopharyngitis/si [Side Effect]; six minute walk test; *sildenafil/ae [Adverse Drug Reaction]; *sildenafil/ct [Clinical Trial]; *sildenafil/do [Drug Dose]; *sildenafil/dt [Drug Therapy]; *sildenafil/po [Oral Drug Administration]; *sildenafil/pd [Pharmacology]; clinical trial; controlled clinical trial; drug therapy; *echocardiography; *exercise test; gene expression; hemodynamic parameters; hemodynamics; odds ratio; *pulmonary hypertension; registration; visually impaired person; brain natriuretic peptide; endogenous compound; *sildenafil aDepartment of Surgery, Division of Thoracic and Cardiovascular Surgery bDepartment of Anesthesiology, University of Florida College of Medicine cDepartment of Anesthesiology, Malcolm B. Randall Veterans Affairs Medical Center, Gainesville, Florida USA DOI: 10.1016/j.athoracsur.2004.06.086 External LinkAlso available on ScienceDirect External Link Copyright: © 2005 The Society of Thoracic Surgeons. Pulmonary hypertension can present a formidable challenge in the management of patients undergoing cardiac surgery. Strategies to reduce pulmonary vascular tone aim to enrich vascular smooth muscle cyclic adenosine monophosphate levels through beta agonists (isoproterenol) or with phosphodiesterase type III inhibitors (milrinone). METHODS: Treatment‐naive patients with pulmonary arterial hypertension were randomized to 12 weeks of double‐blind sildenafil 1, 5, or 20 mg TID; 12 weeks of open‐label sildenafil 20 mg TID followed. Changes from baseline in 6‐minute walk distance (6MWD) for sildenafil 1 or 5 mg versus 20 mg TID were compared using a Williams test.

Warnings & Precautions

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. An oral syringe is recommended for dose measurement (and delivery). Use within 60 days after reconstitution; discard any remainder after expiration.

Dosage Forms & Strengths

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 sildenafil oral strips 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). Hemodynamics, functional class, and biomarkers were assessed.

• Sildenafil may cause dizziness; avoid driving until effects are known.
• Seek immediate medical help if an erection lasts more than 4 hours.
• Do not mix sildenafil with other ED medications unless directed.

RESULTS: The study was prematurely terminated for non‐safety reasons, with 129 of 219 planned patients treated. At week 12, 6MWD change from baseline was significantly greater for sildenafil 20 versus 1 mg (P = 0.011) but not versus 5 mg.

Database entry date

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.

Medical Subject Headings (MeSH) Keywords

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. 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. At week 24, 6MWD increases from baseline were larger in those initially randomized to 20 versus 5 or 1 mg (74 vs 50 and 47 m, respectively). At week 12, changes in hemodynamic parameters were generally small and variable between treatment groups; odds ratios for improvement in functional class were not statistically significantly different.

• Take sildenafil on an empty stomach for faster absorption.
• High-fat meals may delay the effectiveness of the medication.
• Do not crush or chew sildenafil tablets; swallow whole.

Improvements in B‐type natriuretic peptide levels were significantly greater with sildenafil 20 versus 1 but not 5 mg. CONCLUSIONS: Sildenafil 20 mg TID appeared to be more effective than 1 mg TID for improving 6MWD; sildenafil 5 mg TID appeared to have similar clinical and hemodynamic effects as 20 mg TID. TRIAL REGISTRATION: ClinicalTrials.gov NCT00430716 (Registration date: January 31, 2007). Cochrane Central Register of Controlled Trials (CENTRAL) Cochrane Central Register of Controlled Trials (CENTRAL) Vizza, University of Rome La Sapienza, Department of Cardiovascular and Respiratory Disease, Viale del Policlinico 155, Rome 00161, Italy. Vizza, University of Rome La Sapienza, Department of Cardiovascular and Respiratory Disease, Viale del Policlinico 155, Rome 00161, Italy. Adult; Aged; Aged, 80 and over; Female; Humans; Male; Middle Aged; Young Adult; adult; aged; anemia/si [Side Effect]; article; backache/si [Side Effect]; clinical outcome; controlled study; dizziness/si [Side Effect]; dose response; double blind procedure; drug dose comparison; drug efficacy; drug safety; drug tolerability; dyspnea/si [Side Effect]; epistaxis/si [Side Effect]; fatigue/si [Side Effect]; female; headache/si [Side Effect]; human; low drug dose; major clinical study; male; open study; *pulmonary hypertension/dt [Drug Therapy]; pulmonary hypertension/dt [Drug Therapy]; randomized controlled trial; rhinopharyngitis/si [Side Effect]; six minute walk test; *sildenafil/ae [Adverse Drug Reaction]; *sildenafil/ct [Clinical Trial]; *sildenafil/do [Drug Dose]; *sildenafil/dt [Drug Therapy]; *sildenafil/po [Oral Drug Administration]; *sildenafil/pd [Pharmacology]; clinical trial; controlled clinical trial; drug therapy; *echocardiography; *exercise test; gene expression; hemodynamic parameters; hemodynamics; odds ratio; *pulmonary hypertension; registration; visually impaired person; brain natriuretic peptide; endogenous compound; *sildenafil aDepartment of Surgery, Division of Thoracic and Cardiovascular Surgery bDepartment of Anesthesiology, University of Florida College of Medicine cDepartment of Anesthesiology, Malcolm B. Randall Veterans Affairs Medical Center, Gainesville, Florida USA DOI: 10.1016/j.athoracsur.2004.06.086 External LinkAlso available on ScienceDirect External Link Copyright: © 2005 The Society of Thoracic Surgeons. Pulmonary hypertension can present a formidable challenge in the management of patients undergoing cardiac surgery. Strategies to reduce pulmonary vascular tone aim to enrich vascular smooth muscle cyclic adenosine monophosphate levels through beta agonists (isoproterenol) or with phosphodiesterase type III inhibitors (milrinone).