Label: VARDENAFIL HYDROCHLORIDE tablet
These observations should be considered in clinical decisions when prescribing vardenafil hydrochloride tablets to patients with known history of QT prolongation or patients who are taking medications known to prolong the QT interval. Dosage adjustment is necessary in patients with moderate hepatic impairment (Child-Pugh B).
- Vardenafil HCl 10mg is used to treat erectile dysfunction in men.
- It belongs to the phosphodiesterase type 5 inhibitors class.
- Vardenafil enhances blood flow to the penis during arousal.
- The usual recommended dose is 10mg taken about 60 minutes before activity.
- It can be taken with or without food, but high-fat meals may delay effects.
- Common side effects include headache, flushing, and nasal congestion.
- Vardenafil is generally safe when used as prescribed by a doctor.
- Do not combine vardenafil with nitrates or alpha-blockers without medical advice.
- It may cause dizziness or vision changes; avoid driving if affected.
- Store vardenafil in a cool, dry place out of reach of children.
[See Dosage and Administration (2.3) Clinical Pharmacology (12.3) and Use in Specific Populations (8.6)]. Do not use vardenafil hydrochloride 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)].
| Side Effect | Incidence Rate | Severity | Notes |
|---|---|---|---|
| Headache | Common | Mild to moderate | Usually temporary |
| Flushing | Common | Mild | Warm sensation |
| Nasal Congestion | Common | Mild | Sneezing, stuffy nose |
| Dizziness | Less frequent | Mild | When standing up quickly |
The safety and efficacy of vardenafil hydrochloride tablets used in combination with other treatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended.
5.10 Combination with Other Erectile Dysfunction Therapies
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 [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 best pill for ed the otologic adverse events. In many cases, medical follow-up information was limited.
Does vardenafil interact with other medicines (drug interactions)?
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 tablets (vardenafil) 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)] Effects on Eye [see Warnings and Precautions (5.4)] Sudden Hearing Loss [see Warnings and Precautions (5.5)] QT Prolongation [see Warnings and Precautions (5.7)] 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 tablets were administered to over 4430 men (mean age 56, range 18-89 years; 81% White, 6% Black, 2% Asian, 2% Hispanic and 9% Other) during controlled and uncontrolled clinical trials worldwide. Over 2200 patients were treated for 6 months or longer and 880 patients were treated for at least 1 year. In placebo-controlled clinical trials, the discontinuation rate due to adverse events was 3.4% for vardenafil hydrochloride tablets compared to 1.1% for placebo.
What is vardenafil used for?
When vardenafil hydrochloride tablets were taken as recommended in placebo-controlled clinical trials, the following adverse reactions were reported (see Table 1). Back pain was reported in 2.0% of patients treated with vardenafil hydrochloride tablets and 1.7% of patients on placebo. Placebo-controlled trials suggested a dose effect in the incidence of some adverse reactions (headache, flushing, dyspepsia, nausea, and rhinitis) over the 5 mg, 10 mg, and 20 mg doses of vardenafil hydrochloride tablets. All Vardenafil Studies: Vardenafil hydrochloride tablets and vardenafil orally disintegrating tablets have been administered to over 17,000 men (mean age 54.5, range 18–89 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 humans, vardenafil alone in doses up to 20 mg does not prolong the bleeding time. Therefore vardenafil hydrochloride tablets should be administered to these patients after careful benefit-risk assessment. The use of vardenafil hydrochloride tablets offers no protection against sexually transmitted diseases. Counseling of patients about protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), should be considered.
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| Kamagra | 100mg | 84 + 6 Pills | 264.44€ 251.85€ | |
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| Kamagra Gold | 50 mg | 60 + 4 Pills | 171.14€ 162.99€ | |
| Cialis Soft Tabs | 20mg | 20 + 2 Pills | 66.98€ 63.79€ | |
| Kamagra | 100mg | 120 + 6 Pills | 330.74€ 314.99€ | |
| Kamagra Gold | 50 mg | 32 Pills | 103.06€ 98.15€ | |
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| Cialis Soft Tabs | 20mg | 30 + 4 Pills | 87.43€ 83.27€ | |
| Levitra Professional | 20mg | 270 + 6 Pills | 738.98€ 703.79€ | |
| Cialis Generic | 60mg | 120 + 8 Pills | 240.18€ 228.74€ | |
| Viagra Generic | 150mg | 20 Pills | 55.02€ 52.40€ | |
| Kamagra Oral Jelly | 100 mg | 220 + 18 Sachets | 662.24€ 630.70€ |
Phenylalanine can be harmful to patients with phenylketonuria (PKU).
Vardenafil Hydrochloride Market Analysis and Price Projections
These observations should be considered in clinical decisions when prescribing vardenafil hydrochloride tablets to patients with known history of QT prolongation or patients who are taking medications known to prolong the QT interval. Dosage adjustment is necessary in patients with moderate hepatic impairment (Child-Pugh B). [See Dosage and Administration (2.3) Clinical Pharmacology (12.3) and Use in Specific Populations (8.6)]. Do not use vardenafil hydrochloride 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 tablets used in combination with other treatments for erectile dysfunction have not been studied.
Average Pharmacy Cost for VARDENAFIL HCL
Therefore, the use of such combinations is not recommended. In humans, vardenafil alone in doses up to 20 mg does not prolong the bleeding time. Therefore vardenafil hydrochloride tablets should be administered to these patients after careful benefit-risk assessment. The use of vardenafil hydrochloride tablets offers no protection against sexually transmitted diseases. Counseling of patients about protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), should be considered.
Related treatment guides
Phenylalanine can be harmful to patients with phenylketonuria (PKU). 6 ADVERSE REACTIONS The following serious adverse reactions with the use of vardenafil hydrochloride tablets (vardenafil) 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)]Effects on Eye [see Warnings and Precautions (5.4)]Sudden Hearing Loss [see Warnings and Precautions (5.5)]QT Prolongation [see Warnings and Precautions (5.7)]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 tablets were administered to over 4430 men (mean age 56, range 18-89 years; 81% White, 6% Black, 2% Asian, 2% Hispanic and 9% Other) during controlled and uncontrolled clinical trials worldwide. Over 2200 patients were treated for 6 months or longer and 880 patients were treated for at least 1 year.In placebo-controlled clinical trials, the discontinuation rate due to adverse events was 3.4% for vardenafil hydrochloride tablets compared to 1.1% for placebo.When vardenafil hydrochloride tablets were taken as recommended in placebo-controlled clinical trials, the following adverse reactions were reported (see Table 1).Back pain was reported in 2.0% of patients treated with vardenafil hydrochloride tablets and 1.7% of patients on placebo.Placebo-controlled trials suggested a dose effect in the incidence of some adverse reactions (headache, flushing, dyspepsia, nausea, and rhinitis) over the 5 mg, 10 mg, and 20 mg doses of vardenafil hydrochloride tablets.All Vardenafil Studies: Vardenafil hydrochloride tablets and vardenafil orally disintegrating tablets have been administered to over 17,000 men (mean age 54.5, range 18–89 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 hydrochloride tablets and vardenafil orally disintegrating tablets, the discontinuation rate due to adverse events was 1.9% for vardenafil compared to 0.8% for placebo.The following section identifies additional, less frequent adverse reactions (<2%) reported during the clinical development of vardenafil hydrochloride tablets and vardenafil 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 hydrochloride tablets. 6 ADVERSE REACTIONS The following serious adverse reactions with the use of vardenafil hydrochloride tablets (vardenafil) 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)]Effects on Eye [see Warnings and Precautions (5.4)]Sudden Hearing Loss [see Warnings and Precautions (5.5)]QT Prolongation [see Warnings and Precautions (5.7)]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 tablets were administered to over 4430 men (mean age 56, range 18-89 years; 81% White, 6% Black, 2% Asian, 2% Hispanic and 9% Other) during controlled and uncontrolled clinical trials worldwide. Over 2200 patients were treated for 6 months or longer and 880 patients were treated for at least 1 year.In placebo-controlled clinical trials, the discontinuation rate due to adverse events was 3.4% for vardenafil hydrochloride tablets compared to 1.1% for placebo.When vardenafil hydrochloride tablets were taken as recommended in placebo-controlled clinical trials, the following adverse reactions were reported (see Table 1).Back pain was reported in 2.0% of patients treated with vardenafil hydrochloride tablets and 1.7% of patients on placebo.Placebo-controlled trials suggested a dose effect in the incidence of some adverse reactions (headache, flushing, dyspepsia, nausea, and rhinitis) over the 5 mg, 10 mg, and 20 mg doses of vardenafil hydrochloride tablets.All Vardenafil Studies: Vardenafil hydrochloride tablets and vardenafil orally disintegrating tablets have been administered to over 17,000 men (mean age 54.5, range 18–89 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 hydrochloride tablets and vardenafil orally disintegrating tablets, the discontinuation rate due to adverse events was 1.9% for vardenafil compared to 0.8% for placebo.The following section identifies additional, less frequent adverse reactions (<2%) reported during the clinical development of vardenafil hydrochloride tablets and vardenafil 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 hydrochloride tablets.
- Vardenafil 10mg can improve confidence and sexual satisfaction.
- Use it responsibly to avoid dependency or misusage.
- Discuss any allergies to medications with your healthcare provider.
- Always follow the prescribed regimen for optimal results.
- It’s important to inform your doctor about any recent surgeries or health issues.
- Certain foods and beverages may affect the medication’s effectiveness.
- Vardenafil should not be used in combination with recreational drugs.
- Notify your doctor if you experience persistent pain or erection.
- Be aware of potential vision changes, including blurred or blue-tinted vision.
- Store medication safely to prevent accidental ingestion by children.
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 [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 best pill for ed 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)] .
| Drug Class | Interaction Type | Effect | Recommendation |
|---|---|---|---|
| Nitrates | Additive hypotension | Risk of severe low blood pressure | Do not combine |
| CYP3A4 inhibitors | Increased Vardenafil levels | Potential side effects | Adjust dosage if necessary |
| Alpha-blockers | Enhanced hypotensive effect | Dizziness, fainting | Use with caution |
| Alpha-adrenergic agents | Blood pressure changes | Fluctuations in BP | Monitor blood pressure closely |
The following serious adverse reactions with the use of vardenafil hydrochloride tablets (vardenafil) 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)] Effects on Eye [see Warnings and Precautions (5.4)] Sudden Hearing Loss [see Warnings and Precautions (5.5)] QT Prolongation [see Warnings and Precautions (5.7)] 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 dosing information
Vardenafil hydrochloride tablets were administered to over 4430 men (mean age 56, range 18-89 years; 81% White, 6% Black, 2% Asian, 2% Hispanic and 9% Other) during controlled and uncontrolled clinical trials worldwide. Over 2200 patients were treated for 6 months or longer and 880 patients were treated for at least 1 year. In placebo-controlled clinical trials, the discontinuation rate due to adverse events was 3.4% for vardenafil hydrochloride tablets compared to 1.1% for placebo. When vardenafil hydrochloride tablets were taken as recommended in placebo-controlled clinical trials, the following adverse reactions were reported (see Table 1).
Warnings & Precautions
In the placebo-controlled clinical trials for vardenafil hydrochloride tablets and vardenafil orally disintegrating tablets, the discontinuation rate due to adverse events was 1.9% for vardenafil compared to 0.8% for placebo. The following section identifies additional, less frequent adverse reactions (<2%) reported during the clinical development of vardenafil hydrochloride tablets and vardenafil 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 pain Cardiovascular: palpitation, tachycardia, angina pectoris, myocardial infarction, ventricular tachyarrhythmias, hypotension Digestive: nausea, gastrointestinal and abdominal pain, dry mouth, diarrhea, gastroesophageal reflux disease, gastritis, vomiting, increase in transaminases Musculoskeletal: increase in creatine phosphokinase (CPK), increased muscle tone and cramping, myalgia Nervous: paresthesia and dysesthesia, somnolence, sleep disorder, syncope, amnesia, seizure Ophthalmologic: visual disturbance, ocular hyperemia, visual color distortions, eye pain and eye discomfort, photophobia, increase in intraocular pressure, conjunctivitis The following adverse reactions have been identified during post approval use of vardenafil hydrochloride tablets.
What should I know about vardenafil before taking it?
Back pain was reported in 2.0% of patients treated with vardenafil hydrochloride tablets and 1.7% of patients on placebo. Placebo-controlled trials suggested a dose effect in the incidence of some adverse reactions (headache, flushing, dyspepsia, nausea, and rhinitis) over the 5 mg, 10 mg, and 20 mg doses of vardenafil hydrochloride tablets. All Vardenafil Studies: Vardenafil hydrochloride tablets and vardenafil orally disintegrating tablets have been administered to over 17,000 men (mean age 54.5, range 18–89 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 hydrochloride tablets and vardenafil orally disintegrating tablets, the discontinuation rate due to adverse events was 1.9% for vardenafil compared to 0.8% for placebo. The following section identifies additional, less frequent adverse reactions (<2%) reported during the clinical development of vardenafil hydrochloride tablets and vardenafil 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 pain Cardiovascular: palpitation, tachycardia, angina pectoris, myocardial infarction, ventricular tachyarrhythmias, hypotension Digestive: nausea, gastrointestinal and abdominal pain, dry mouth, diarrhea, gastroesophageal reflux disease, gastritis, vomiting, increase in transaminases Musculoskeletal: increase in creatine phosphokinase (CPK), increased muscle tone and cramping, myalgia Nervous: paresthesia and dysesthesia, somnolence, sleep disorder, syncope, amnesia, seizure Ophthalmologic: visual disturbance, ocular hyperemia, visual color distortions, eye pain and eye discomfort, photophobia, increase in intraocular pressure, conjunctivitis The following adverse reactions have been identified during post approval use of vardenafil hydrochloride tablets.