Label: VARDENAFIL tablet, orally disintegrating
· In those patients already taking an optimized dose of PDE5 inhibitor, alpha-blocker therapy should be initiated at the lowest dose. Stepwise increases in alpha-blocker dose may be associated with further lowering of blood pressure in patients taking a PDE5 inhibitor.
5.10 Combination with Other Erectile Dysfunction Therapies
Vardenafil Hydrochloride Orally Disintegrating Tablets: Safety of vardenafil hydrochloride orally disintegrating tablets were evaluated in two identical multi-national, randomized, double-blind, placebo-controlled trials. Table 1 below details the most frequently reported adverse reactions. Table 1: Adverse drug reactions reported by ≥2% of the patients treated with vardenafil hydrochloride orally disintegrating tablets and more frequent on drug than placebo in controlled trials Adverse drug reactions reported in the vardenafil hydrochloride orally disintegrating tablets placebo controlled trials were comparable to the adverse drug reactions reported in earlier vardenafil film-coated tablets placebo controlled trials.
Pulmonary Arterial Hypertension (Orphan)
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. In a study of the effect of vardenafil on QT interval in 59 healthy males [see Clinical Pharmacology (12.2)], therapeutic (10 mg film-coated tablets) and supratherapeutic (80 mg) doses of vardenafil and the active control moxifloxacin (400 mg) produced similar increases in QTc interval. These observations should be considered in clinical decisions when prescribing vardenafil to patients with known history of QT prolongation or patients who are taking medications known to prolong the QT interval. Patients taking Class 1A (for example, quinidine, procainamide) or Class III (for example, amiodarone, sotalol) antiarrhythmic medications or those with congenital QT prolongation, should avoid using vardenafil hydrochloride orally disintegrating tablets. Do not use vardenafil hydrochloride orally disintegrating tablets in patients with moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment [see Dosage and Administration (2.3) Clinical Pharmacology (12.3)] and Use in Specific Populations (8.6)]. Do not use vardenafil hydrochloride orally disintegrating tablets in patients on renal dialysis, as vardenafil has not been evaluated in this population [see Dosage and Administration (2.3) and Use in Specific Populations (8.7)]. The safety and efficacy of vardenafil hydrochloride orally disintegrating tablets used in combination with other treatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended.
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In humans, vardenafil film-coated tablet alone in doses up to 20 mg does not prolong the bleeding time.
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What else should I know about vardenafil?
Therefore vardenafil hydrochloride orally disintegrating tablets should be administered to sex tablet 100mg these patients after careful benefit-risk assessment. Vardenafil hydrochloride orally disintegrating tablets contain aspartame, a source of phenylalanine which may be harmful for people with phenylketonuria.
What happens if I miss a dose?
Table 1 below details the most frequently reported adverse reactions.Table 1: Adverse drug reactions reported by ≥2% of the patients treated with vardenafil hydrochloride orally disintegrating tablets and more frequent on drug than placebo in controlled trialsAdverse drug reactions reported in the vardenafil hydrochloride orally disintegrating tablets placebo controlled trials were comparable to the adverse drug reactions reported in earlier vardenafil film-coated tablets placebo controlled trials.All Vardenafil Studies: Vardenafil film-coated tablets and vardenafil hydrochloride orally disintegrating tablets have been administered to over 17,000 men (mean age 54.5, range 18 to 89 years; 70% White, 5% Black, 13% Asian, 4% Hispanic and 8% Other) during controlled and uncontrolled clinical trials worldwide. The number of patients treated for 6 months or longer was 3357, and 1350 patients were treated for at least 1 year.In the placebo-controlled clinical trials for vardenafil film-coated tablets and vardenafil hydrochloride orally disintegrating tablets, the discontinuation rate due to adverse events was 1.9% for vardenafil compared to 0.8% for placebo.Placebo-controlled trials suggested a dose effect in the incidence of some adverse reactions (for example, dizziness, headache, flushing, dyspepsia, nausea, nasal congestion) over the 5 mg, 10 mg, and 20 mg doses of vardenafil film-coated tablets.The following section identifies additional, less frequent adverse reactions (<2%) reported during the clinical development of vardenafil film-coated tablets and vardenafil hydrochloride orally disintegrating tablets. Excluded from this list are those adverse reactions that are infrequent and minor, those events that may be commonly observed in the absence of drug therapy, and those events that are not reasonably associated with the drug:Body as a whole: allergic edema and angioedema, feeling unwell, allergic reactions, chest painAuditory: tinnitus, vertigoCardiovascular: palpitation, tachycardia, angina pectoris, myocardial infarction, ventricular tachyarrhythmias, hypotensionDigestive: nausea, gastrointestinal and abdominal pain, dry mouth, diarrhea, gastroesophageal reflux disease, gastritis, vomiting, increase in transaminasesMusculoskeletal: increase in creatine phosphokinase (CPK), increased muscle tone and cramping, myalgiaNervous: paresthesia and dysesthesia, somnolence, sleep disorder, syncope, amnesia, seizureRespiratory: dyspnea, sinus congestionSkin and appendages: erythema, rashOphthalmologic: visual disturbance, ocular hyperemia, visual color distortions, eye pain and eye discomfort, photophobia, increase in intraocular pressure, conjunctivitisUrogenital: increase in erection, priapism6.2 Postmarketing ExperienceThe following adverse reactions have been identified during post approval use of vardenafil in the film-coated tablet formulation. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to drug exposure.Ophthalmologic: Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely postmarketing in temporal association with the use of PDE5 inhibitors, including vardenafil. Most, but not all, of these patients had underlying anatomic or vascular risk factors for development of NAION, including but not necessarily limited to: low cup to disc ratio (“crowded disc”), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia and smoking ceridaviescampaigner co uk [see Warnings and Precautions (5.4) and Patient Counseling Information (17)].Visual disturbances including vision loss (temporary or permanent), such as visual field defect, retinal vein occlusion, and reduced visual acuity, have also been reported rarely in postmarketing experience.
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It is not possible to determine whether these events are related directly to the use of vardenafil.Neurologic: Seizure, seizure recurrence and transient global amnesia have been reported postmarketing in temporal association with vardenafil.Otologic: Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including vardenafil. In some cases, medical conditions and other factors were reported that may have also played a role in the otologic adverse events. In many cases, medical follow-up information was limited. It is not possible to determine whether these reported events are related directly to the use of vardenafil, to the patient’s underlying risk factors for hearing loss, a combination of these factors, or to other factors [see Patient Counseling Information (17)]. The following serious adverse reactions with the use of vardenafil hydrochloride orally disintegrating tablets are discussed elsewhere in the labeling: · Cardiovascular effects [see Contraindications (4.1) and Warnings and Precautions (5.1)] · Priapism [see Warnings and Precautions (5.3)] · QT Prolongation [see Warnings and Precautions (5.7)] · Effects on eye [see Warnings and Precautions (5.4)] · Sudden hearing loss [see Warnings and Precautions (5.5)] Because 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. Phenylketonurics: Each vardenafil hydrochloride orally disintegrating tablet contains 1.403 mg phenylalanine per tablet.
Liver Dose Adjustments
· In those patients already taking an optimized dose of PDE5 inhibitor, alpha-blocker therapy should be initiated at the lowest dose. Stepwise increases in alpha-blocker dose may be associated with further lowering of blood pressure in patients taking a PDE5 inhibitor. 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. In a study of the effect of vardenafil on QT interval in 59 healthy males [see Clinical Pharmacology (12.2)], therapeutic (10 mg film-coated tablets) and supratherapeutic (80 mg) doses of vardenafil and the active control moxifloxacin (400 mg) produced similar increases in QTc interval. These observations should be considered in clinical decisions when prescribing vardenafil to patients with known history of QT prolongation or patients who are taking medications known to prolong the QT interval.
Pregnancy and breastfeeding
Patients taking Class 1A (for example, quinidine, procainamide) or Class III (for example, amiodarone, sotalol) antiarrhythmic medications or those with congenital QT prolongation, should avoid using vardenafil hydrochloride orally disintegrating tablets. Do not use vardenafil hydrochloride orally disintegrating tablets in patients with moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment [see Dosage and Administration (2.3) Clinical Pharmacology (12.3)] and Use in Specific Populations (8.6)]. Do not use vardenafil hydrochloride orally disintegrating tablets in patients on renal dialysis, as vardenafil has not been evaluated in this population [see Dosage and Administration (2.3) and Use in Specific Populations (8.7)]. The safety and efficacy of vardenafil hydrochloride orally disintegrating tablets used in combination with other treatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended. Use of vardenafil hydrochloride orally disintegrating tablets offers no protection against sexually transmitted diseases. 6 ADVERSE REACTIONS The following serious adverse reactions with the use of vardenafil hydrochloride orally disintegrating tablets are discussed elsewhere in the labeling:· Cardiovascular effects [see Contraindications (4.1) and Warnings and Precautions (5.1)]· Priapism [see Warnings and Precautions (5.3)]· QT Prolongation [see Warnings and Precautions (5.7)]· Effects on eye [see Warnings and Precautions (5.4)]· Sudden hearing loss [see Warnings and Precautions (5.5)]6.1 Clinical Studies 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.Vardenafil Hydrochloride Orally Disintegrating Tablets: Safety of vardenafil hydrochloride orally disintegrating tablets were evaluated in two identical multi-national, randomized, double-blind, placebo-controlled trials. In both pivotal studies, enrollment was stratified so that approximately 50% of patients were ≥65 years old. Approximately 8% (n=29) were ≥75 years old. An integrated analysis of both studies included a total of 355 subjects that received vardenafil hydrochloride orally disintegrating tablets compared to 340 subjects that received placebo (mean age was 61.7, range 21 to 88; 68% White, 5% Black, 6% Asian, 11% Hispanic and 11% Other).
- Vardenafil 10 mg may be used by men over 18 years.
- The medication is not approved for use in women or children.
- May be contraindicated in patients with certain eye conditions.
- Use caution if you have a history of stroke.
- The drug’s chemical action involves improving blood flow.
- It is important to distinguish ED causes before treatment.
- Use only medications prescribed by a healthcare professional.
- Avoid combining with other erectile dysfunction medications.
- Keep medication out of sunlight and moisture.
- Seek emergency medical help for severe side effects.
The discontinuation rates due to adverse reactions were 1.4% for vardenafil hydrochloride orally disintegrating tablets compared to 0.6% for placebo.
- The onset of vardenafil 10 mg is typically 30-60 minutes.
- It can last up to 4-5 hours in some users.
- Vardenafil is contraindicated with certain heart medications.
- Use caution if you have a history of hypotension.
- The tablet may cause mild gastrointestinal upset.
- Do not consume large amounts of alcohol when taking vardenafil.
- Inform your doctor if you experience sudden hearing loss.
- Use only as directed by your healthcare provider.
- Discontinue if you experience persistent erection issues.
- The medication does not increase sexual desire.
Table 1 below details the most frequently reported adverse reactions.Table 1: Adverse drug reactions reported by ≥2% of the patients treated with vardenafil hydrochloride orally disintegrating tablets and more frequent on drug than placebo in controlled trialsAdverse drug reactions reported in the vardenafil hydrochloride orally disintegrating tablets placebo controlled trials were comparable to the adverse drug reactions reported in earlier vardenafil film-coated tablets placebo controlled trials.All Vardenafil Studies: Vardenafil film-coated tablets and vardenafil hydrochloride orally disintegrating tablets have been administered to over 17,000 men (mean age 54.5, range 18 to 89 years; 70% White, 5% Black, 13% Asian, 4% Hispanic and 8% Other) during controlled and uncontrolled clinical trials worldwide.
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The number of patients treated for 6 months or longer was 3357, and 1350 patients were treated for at least 1 year.In the placebo-controlled clinical trials for vardenafil film-coated tablets and vardenafil hydrochloride orally disintegrating tablets, the discontinuation rate due to adverse events was 1.9% for vardenafil compared to 0.8% for placebo.Placebo-controlled trials suggested a dose effect in the incidence of some adverse reactions (for example, dizziness, headache, flushing, dyspepsia, nausea, nasal congestion) over the 5 mg, 10 mg, and 20 mg doses of vardenafil film-coated tablets.The following section identifies additional, less frequent adverse reactions (<2%) reported during the clinical development of vardenafil film-coated tablets and vardenafil hydrochloride orally disintegrating tablets. Excluded from this list are those adverse reactions that are infrequent and minor, those events that may be commonly observed in the absence of drug therapy, and those events that are not reasonably associated with the drug:Body as a whole: allergic edema and angioedema, feeling unwell, allergic reactions, chest painAuditory: tinnitus, vertigoCardiovascular: palpitation, tachycardia, angina pectoris, myocardial infarction, ventricular tachyarrhythmias, hypotensionDigestive: nausea, gastrointestinal and abdominal pain, dry mouth, diarrhea, gastroesophageal reflux disease, gastritis, vomiting, increase in transaminasesMusculoskeletal: increase in creatine phosphokinase (CPK), increased muscle tone and cramping, myalgiaNervous: paresthesia and dysesthesia, somnolence, sleep disorder, syncope, amnesia, seizureRespiratory: dyspnea, sinus congestionSkin and appendages: erythema, rashOphthalmologic: visual disturbance, ocular hyperemia, visual color distortions, eye pain and eye discomfort, photophobia, increase in intraocular pressure, conjunctivitisUrogenital: increase in erection, priapism6.2 Postmarketing ExperienceThe following adverse reactions have been identified during post approval use of vardenafil in the film-coated tablet formulation.
What should I avoid while using vardenafil?
Prevention & Wellness
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to drug exposure.Ophthalmologic: Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely postmarketing in temporal association with the use of PDE5 inhibitors, including vardenafil. Most, but not all, of these patients had underlying anatomic or vascular risk factors for development of NAION, including but not necessarily limited to: low cup to disc ratio (“crowded disc”), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia and smoking ceridaviescampaigner co uk [see Warnings and Precautions (5.4) and Patient Counseling Information (17)].Visual disturbances including vision loss (temporary or permanent), such as visual field defect, retinal vein occlusion, and reduced visual acuity, have also been reported rarely in postmarketing experience. It is not possible to determine whether these events are related directly to the use of vardenafil.Neurologic: Seizure, seizure recurrence and transient global amnesia have been reported postmarketing in temporal association with vardenafil.Otologic: Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including vardenafil. In some cases, medical conditions and other factors were reported that may have also played a role in the otologic adverse events.
| Measure | Result | Timeframe | Notes |
|---|---|---|---|
| Erection Success Rate | 70-80% in clinical trials | After 1 Dose | High efficacy reported |
| Patient Satisfaction | 75% reported improvement | After 4 weeks | Based on surveys |
| Onset Time | 30-60 minutes | Post-dose | Rapid onset for most patients |
| Duration of Effect | 4-5 hours | After intake | Provides window for activity |
In many cases, medical follow-up information was limited. It is not possible to determine whether these reported events are related directly to the use of vardenafil, to the patient’s underlying risk factors for hearing loss, a combination of these factors, or to other factors [see Patient Counseling Information (17)]. The following serious adverse reactions with the use of vardenafil hydrochloride orally disintegrating tablets are discussed elsewhere in the labeling: · Cardiovascular effects [see Contraindications (4.1) and Warnings and Precautions (5.1)] · Priapism [see Warnings and Precautions (5.3)] · QT Prolongation [see Warnings and Precautions (5.7)] · Effects on eye [see Warnings and Precautions (5.4)] · Sudden hearing loss [see Warnings and Precautions (5.5)] Because 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. Vardenafil Hydrochloride Orally Disintegrating Tablets: Safety of vardenafil hydrochloride orally disintegrating tablets were evaluated in two identical multi-national, randomized, double-blind, placebo-controlled trials.
| Drug Name | Dose Range | Duration of Action | Onset Time | Special Features |
|---|---|---|---|---|
| Vardenafil | 5-20 mg | 4-5 hours | 30-60 min | Fast onset, good for food timing |
| Sildenafil | 25-100 mg | 4-6 hours | 30-60 min | Well-studied, widespread use |
| Tadalafil | 2.5-20 mg | Up to 36 hours | 30-120 min | Long duration, daily options |
| Avanafil | 50-200 mg | 4-6 hours | 15-30 min | Fastest onset, fewer side effects |
Table 1 below details the most frequently reported adverse reactions.
Proper Use
In humans, vardenafil film-coated tablet alone in doses up to 20 mg does not prolong the bleeding time. Therefore vardenafil hydrochloride orally disintegrating tablets should be administered to sex tablet 100mg these patients after careful benefit-risk assessment. Vardenafil hydrochloride orally disintegrating tablets contain aspartame, a source of phenylalanine which may be harmful for people with phenylketonuria. Phenylketonurics: Each vardenafil hydrochloride orally disintegrating tablet contains 1.403 mg phenylalanine per tablet. Use of vardenafil hydrochloride orally disintegrating tablets offers no protection against sexually transmitted diseases.
How should I store vardenafil?
6 ADVERSE REACTIONS The following serious adverse reactions with the use of vardenafil hydrochloride orally disintegrating tablets are discussed elsewhere in the labeling:· Cardiovascular effects [see Contraindications (4.1) and Warnings and Precautions (5.1)]· Priapism [see Warnings and Precautions (5.3)]· QT Prolongation [see Warnings and Precautions (5.7)]· Effects on eye [see Warnings and Precautions (5.4)]· Sudden hearing loss [see Warnings and Precautions (5.5)]6.1 Clinical Studies 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.Vardenafil Hydrochloride Orally Disintegrating Tablets: Safety of vardenafil hydrochloride orally disintegrating tablets were evaluated in two identical multi-national, randomized, double-blind, placebo-controlled trials. In both pivotal studies, enrollment was stratified so that approximately 50% of patients were ≥65 years old. Approximately 8% (n=29) were ≥75 years old. An integrated analysis of both studies included a total of 355 subjects that received vardenafil hydrochloride orally disintegrating tablets compared to 340 subjects that received placebo (mean age was 61.7, range 21 to 88; 68% White, 5% Black, 6% Asian, 11% Hispanic and 11% Other). The discontinuation rates due to adverse reactions were 1.4% for vardenafil hydrochloride orally disintegrating tablets compared to 0.6% for placebo. Table 1: Adverse drug reactions reported by ≥2% of the patients treated with vardenafil hydrochloride orally disintegrating tablets and more frequent on drug than placebo in controlled trials Adverse drug reactions reported in the vardenafil hydrochloride orally disintegrating tablets placebo controlled trials were comparable to the adverse drug reactions reported in earlier vardenafil film-coated tablets placebo controlled trials.
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