Optimal Dosing Guidelines for 20 mg Vardenafil

Consult your doctor if you have any questions about this medication. Drug interactions may change how your medications work or increase your risk for serious side effects.

• Clinical studies demonstrate improved ability to achieve and maintain erection.
• The drug's molecular structure differs slightly from sildenafil and tadalafil.
• Patients should avoid taking it with other vasodilators.
• May cause a small, temporary decrease in blood pressure.
• Sexual activity may pose cardiac risk for those with pre-existing heart disease.
• The tablet should be swallowed whole with a glass of water.

This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug are: Vardenafil can cause a serious drop in your blood pressure when used with nitrates, which can lead to dizziness, fainting, and rarely heart attack or stroke. Do not use vardenafil with any of the following: certain drugs used to treat chest pain/angina (nitrates such as nitroglycerin, isosorbide) recreational drugs called "poppers" containing amyl or butyl nitrite If you are also taking an alpha blocker medication (such as doxazosin, tamsulosin) to treat an enlarged prostate/BPH or high blood pressure, your blood pressure may get too low which can lead to dizziness or fainting.

Your doctor may start treatment with a lower dose of vardenafil to minimize your risk of low blood pressure. Other medications can affect the removal of vardenafil from your body, which may affect how vardenafil works. Examples include azole antifungals (such as itraconazole, ketoconazole), macrolide antibiotics (such as clarithromycin, erythromycin), ritonavir, among others. Do not take this medication with any other product that contains vardenafil or other similar medications used to treat erectile dysfunction-ED or pulmonary hypertension (such as sildenafil, tadalafil). If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222.

Medical uses

Consult your doctor if you have any questions about this medication. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

2.2 Patients

Some products that may interact with this drug are: Vardenafil can cause a serious drop in your blood pressure when used with nitrates, which can lead to dizziness, fainting, and rarely heart attack or stroke. Do not use vardenafil with any of the following: certain drugs used to treat chest pain/angina (nitrates such as nitroglycerin, isosorbide) recreational drugs called "poppers" containing amyl or butyl nitrite If you are also taking an alpha blocker medication (such as doxazosin, tamsulosin) to treat an enlarged prostate/BPH or high blood pressure, your blood pressure may get too low which can lead to dizziness or fainting. Your doctor may start treatment with a lower dose of vardenafil to minimize your risk of low blood pressure. Other medications can affect the removal of vardenafil from your body, which may affect how vardenafil works. Examples include azole antifungals (such as itraconazole, ketoconazole), macrolide antibiotics (such as clarithromycin, erythromycin), ritonavir, among others.

What should I know about vardenafil before taking it?

Do not take this medication with any other product that contains vardenafil or other similar medications used to treat erectile dysfunction-ED or pulmonary hypertension (such as sildenafil, tadalafil). If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: back/muscle pain, abnormal vision. Do not share this medication with others. Store at room temperature away from light and moisture. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company. HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional.

Always ask your health care professional for complete information about this product and your specific health needs. Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First Databank, Inc., 2019. This copyrighted material has been downloaded from a licensed data provider.

Coverage and cost comparison of Levitra vs. Cialis

Patients were randomized to 10 weeks of treatment with flexible-dose vardenafil or placebo. The starting dose was 10mg; thereafter, the dose could be titrated to 5 or 20mg, on the basis of response and tolerability at weeks 2 and 6. Patients were instructed to take study medication, without regard to food, 8hours before attempting intercourse. One tablet was to be taken as needed with no more than one dose per day. Patients were advised to attempt sexual intercourse at least once between each study visit (weeks 2, 6 and 10).

Full Text Sources

Patients recorded in diaries the date and time that (1) study medication was taken and (2) sexual activity was attempted, and answered questions about erections and attempts at sexual activity. Study medication compliance was monitored by noting discrepancies between diary entries and the number of unused tablets returned at each study visit. Eligible patients were men with ED for >6 months according to the National Institutes of Health Consensus Statement (the inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance); in a heterosexual relationship; and aged ≥18 years. Patients had a score of ≥5 and <26 on the International Index of Erectile Function-Erectile Function (IIEF-EF) domain at randomization. Exclusion criteria included presence of penile anatomic abnormalities that could significantly impair erectile function; primary hypoactive sexual desire; spinal cord injury; history of surgical prostatectomy (excluding transurethral resection of the prostate); retinitis pigmentosa; history of positive test for hepatitis B surface antigen or hepatitis C; history of moderate/severe hepatic impairment; clinically significant chronic haematological disease that could lead to priapism; bleeding disorder; unstable angina pectoris; history of myocardial infarction, stroke or life-threatening arrhythmia within previous 6 months; uncontrolled atrial fibrillation/flutter at screening; resting hypo- (<90mmHg) or hypertension (>170mmHg); New York Heart Association class III or IV heart failure; symptomatic postural hypotension within 6 months of screening; use of nitrates or nitric oxide donors, antiandrogens, androgens, α-blockers and anticoagulants (other than antiplatelet agents); use of vardenafil within 30 days of screening or any treatment for ED within 7 days of screening or during the study; use of potent inhibitors of cytochrome P-450 3A4; presence of abnormal laboratory values (low serum total testosterone level; elevated serum creatinine or aminotransferases); poorly controlled diabetes (HbA1c >12%); history of unresponsiveness to other PDE5 inhibitor treatments or known hypersensitivity to vardenafil.

2.3 Treatment outcomes and their analysis

The primary measurement of efficacy was patient diary responses to Sexual Encounter Profile Question 3 (SEP3). Secondary efficacy measurements were SEP2, IIEF-EF domain score (sum of scores from questions 1–5 and 15), Global Assessment Question (GAQ), Global Confidence Question (GCQ) and Erection Quality Scale (EQS) [22] total score. Patients were instructed to take medication 8hours before attempting intercourse; attempts that fell into an assigned-time window of 6–10hours postdose were included in the 8-hour efficacy analyses. This ±2-hour window was built into the statistical analyses to ensure that sufficient data were available for meaningful analysis. Information from previous patient diary studies indicated that patients often deviated from specific instructions, and the ±2-hour window thus represents a realistic expectation of patients’ behaviour. The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment. bUniversity of California, San Francisco, California, USA dAsociación Mexicana Para la Salud Sexual, Tlalpan, Mexico eSouth Florida Medical Research, Aventura, Florida, USA fGlaxoSmithKline, Research Triangle Park, North Carolina, USA hCan-Med Clinical Research Inc., Victoria, British Columbia, Canada 92nd Department of Urology and Center for Sexual and Reproductive Health, Aristotle University of Thessaloniki, Greece Accepted May 18, 2006; Published online June 6, 2006 DOI: 10.1016/j.eururo.2006.05.036 External LinkAlso available on ScienceDirect External Link It has been estimated that >150 million men worldwide experience erectile dysfunction (ED) and that its prevalence is likely to rise with the ageing population [1,2].

• The medication should be taken as part of a comprehensive treatment plan.
• Using vardenafil unexpectedly or recreationally is unsafe and not recommended.
• Discuss any concerns or prior medication reactions with your healthcare provider.
• Proper storage and disposal of unused medication prevent misuse and accidents.

ED has a detrimental impact on quality of life, self-esteem and personal relationships [3–6]. Oral phosphodiesterase type 5 (PDE5) inhibitors increase levels of cyclic guanosine monophosphate, thereby increasing cavernosal tumescence and rigidity, and are considered first-line treatments for ED [7–9]. Vardenafil has demonstrated efficacy and tolerability in a broad population of men with ED and in those with traditionally difficult-to-treat ED in both fixed and flexibly dosed studies [10–16]; a recent review confirms that the trial results are consistent with clinical experience [17].

In the multinational Men’s Attitudes to Life Events and Sexuality (MALES) study, 69% of men could not predict sexual activity >30min in advance [18]. Similar findings (71%) were reported by partners of men with ED in the Female Experience of Men’s Attitudes to Life Events and Sexuality (FEMALES) study [19]. However, analysis of pooled clinical trial data found vardenafil 5 mg that even when instructed to take vardenafil 1hour before intercourse, some patients attempted sex several hours later [20].

• Vardenafil may interact with medications for blood pressure or prostate issues.
• Patients with heart problems should discuss risks with their doctor before use.
• The medication is not intended for use by women.
• Avoid taking vardenafil with fatty meals to improve absorption time.

For many couples, even after manifestation of ED, timing of sexual activities remains flexible and unplanned rather than a scheduled event. Any PDE5 inhibitor that could provide a wide time frame for achieving successful sexual intercourse, within 1hour and lasting many hours after taking the medication, would be likely to meet more couples’ expectations and needs, thereby increasing acceptance and treatment continuation. The duration of such a time frame would need to extend for a period that has practical meaning and to reflect the fact that 90% of couples engage in sexual activity over the period of one night. Vardenafil has previously demonstrated a rapid onset of action, within 10minutes postdose in some men [21].

Antidepressants And Menopause

A pooled retrospective analysis provided evidence of efficacy up to 8–12hours postdose [20]. Our study investigated prospectively whether vardenafil had an extended duration of action, at least for 8hours after dosing.

Why is this medication prescribed?

Symptoms of overdose may include: back/muscle pain, abnormal vision. Do not share this medication with others. Store at room temperature away from light and moisture. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so.

Am. J. Med.

Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company. HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional.

3.2 Dosing

Always ask your health care professional for complete information about this product and your specific health needs. Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First Databank, Inc., 2019. This copyrighted material has been downloaded from a licensed data provider. The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment. This international, multicentre, randomized, double-blind, placebo-controlled, parallel-group study was conducted at 31 centres in the United States, Germany, Canada, Australia, Austria, Brazil, Greece, South Korea, Mexico, Sweden, Singapore and Turkey. During a 4-week, treatment-free, run-in period, patients had to have experienced unsuccessful sexual intercourse on ≥50% of attempts to qualify for study entry. Patients were randomized to 10 weeks of treatment with flexible-dose vardenafil or placebo. The starting dose was 10mg; thereafter, the dose could be titrated to 5 or 20mg, on the basis of response and tolerability at weeks 2 and 6. Patients were instructed to take study medication, without regard to food, 8hours before attempting intercourse. One tablet was to be taken as needed with no more than one dose per day. Patients were advised to attempt sexual intercourse at least once between each study visit (weeks 2, 6 and 10). Patients recorded in diaries the date and time that (1) study medication was taken and (2) sexual activity was attempted, and answered questions about erections and attempts at sexual activity. Study medication compliance was monitored by noting discrepancies between diary entries and the number of unused tablets returned at each study visit. Eligible patients were men with ED for >6 months according to the National Institutes of Health Consensus Statement (the inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance); in a heterosexual relationship; and aged ≥18 years. Patients had a score of ≥5 and <26 on the International Index of Erectile Function-Erectile Function (IIEF-EF) domain at randomization. Exclusion criteria included presence of penile anatomic abnormalities that could significantly impair erectile function; primary hypoactive sexual desire; spinal cord injury; history of surgical prostatectomy (excluding transurethral resection of the prostate); retinitis pigmentosa; history of positive test for hepatitis B surface antigen or hepatitis C; history of moderate/severe hepatic impairment; clinically significant chronic haematological disease that could lead to priapism; bleeding disorder; unstable angina pectoris; history of myocardial infarction, stroke or life-threatening arrhythmia within previous 6 months; uncontrolled atrial fibrillation/flutter at screening; resting hypo- (<90mmHg) or hypertension (>170mmHg); New York Heart Association class III or IV heart failure; symptomatic postural hypotension within 6 months of screening; use of nitrates or nitric oxide donors, antiandrogens, androgens, α-blockers and anticoagulants (other than antiplatelet agents); use of vardenafil within 30 days of screening or any treatment for ED within 7 days of screening or during the study; use of potent inhibitors of cytochrome P-450 3A4; presence of abnormal laboratory values (low serum total testosterone level; elevated serum creatinine or aminotransferases); poorly controlled diabetes (HbA1c >12%); history of unresponsiveness to other PDE5 inhibitor treatments or known hypersensitivity to vardenafil.

The primary measurement of efficacy was patient diary responses to Sexual Encounter Profile Question 3 (SEP3). Secondary efficacy measurements were SEP2, IIEF-EF domain score (sum of scores from questions 1–5 and 15), Global Assessment Question (GAQ), Global Confidence Question (GCQ) and Erection Quality Scale (EQS) [22] total score.

3 Results

Patients were instructed to take medication 8hours before attempting intercourse; attempts that fell into an assigned-time window of 6–10hours postdose were included in the 8-hour efficacy analyses.

Brand names

This ±2-hour window was built into the statistical analyses to ensure that sufficient data were available for meaningful analysis.

Pregnancy & Lactation

bUniversity of California, San Francisco, California, USA dAsociación Mexicana Para la Salud Sexual, Tlalpan, Mexico eSouth Florida Medical Research, Aventura, Florida, USA fGlaxoSmithKline, Research Triangle Park, North Carolina, USA hCan-Med Clinical Research Inc., Victoria, British Columbia, Canada 92nd Department of Urology and Center for Sexual and Reproductive Health, Aristotle University of Thessaloniki, Greece Accepted May 18, 2006; Published online June 6, 2006 DOI: 10.1016/j.eururo.2006.05.036 External LinkAlso available on ScienceDirect External Link It has been estimated that >150 million men worldwide experience erectile dysfunction (ED) and that its prevalence is likely to rise with the ageing population [1,2]. ED has a detrimental impact on quality of life, self-esteem and personal relationships [3–6]. Oral phosphodiesterase type 5 (PDE5) inhibitors increase levels of cyclic guanosine monophosphate, thereby increasing cavernosal tumescence and rigidity, and are considered first-line treatments for ED [7–9]. Vardenafil has demonstrated efficacy and tolerability in a broad population of men with ED and in those with traditionally difficult-to-treat ED in both fixed and flexibly dosed studies [10–16]; a recent review confirms that the trial results are consistent with clinical experience [17]. In the multinational Men’s Attitudes to Life Events and Sexuality (MALES) study, 69% of men could not predict sexual activity >30min in advance [18].

Adverse Reactions

Similar findings (71%) were reported by partners of men with ED in the Female Experience of Men’s Attitudes to Life Events and Sexuality (FEMALES) study [19]. However, analysis of pooled clinical trial data found vardenafil 5 mg that even when instructed to take vardenafil 1hour before intercourse, some patients attempted sex several hours later [20]. For many couples, even after manifestation of ED, timing of sexual activities remains flexible and unplanned rather than a scheduled event. Any PDE5 inhibitor that could provide a wide time frame for achieving successful sexual intercourse, within 1hour and lasting many hours after taking the medication, would be likely to meet more couples’ expectations and needs, thereby increasing acceptance and treatment continuation. The duration of such a time frame would need to extend for a period that has practical meaning and to reflect the fact that 90% of couples engage in sexual activity over the period of one night.

What is vardenafil used for?

Vardenafil has previously demonstrated a rapid onset of action, within 10minutes postdose in some men [21]. A pooled retrospective analysis provided evidence of efficacy up to 8–12hours postdose [20]. Our study investigated prospectively whether vardenafil had an extended duration of action, at least for 8hours after dosing. This international, multicentre, randomized, double-blind, placebo-controlled, parallel-group study was conducted at 31 centres in the United States, Germany, Canada, Australia, Austria, Brazil, Greece, South Korea, Mexico, Sweden, Singapore and Turkey. During a 4-week, treatment-free, run-in period, patients had to have experienced unsuccessful sexual intercourse on ≥50% of attempts to qualify for study entry. Information from previous patient diary studies indicated that patients often deviated from specific instructions, and the ±2-hour window thus represents a realistic expectation of patients’ behaviour.