Label: VARDENAFIL HYDROCHLORIDE tablet
In the North American trial, vardenafil hydrochloride tablets significantly improved the rates of achieving an erection sufficient for penetration (SEP2) at doses of 5 mg, 10 mg, and 20 mg compared to placebo (65%, 75%, and 80%, respectively, compared to a 52% response in the placebo group at 3 months; p <0.0001). Vardenafil hydrochloride tablets demonstrated a clinically meaningful and statistically significant increase in the overall per-patient rate of maintenance of erection to successful intercourse (SEP3) (51% on 5 mg, 64% on 10 mg, and 65% on 20 mg, respectively, compared to 32% on placebo; p <0.0001) at 3 months in the North American trial. This improvement in mean score was maintained at all doses at 6 months in the North American trial. Vardenafil hydrochloride tablets demonstrated clinically meaningful and statistically significant improvement in erectile function in a prospective, fixed-dose (10 and 20 mg vardenafil hydrochloride tablets), double-blind, placebo-controlled trial of patients with diabetes mellitus (n=439; mean age 57 years, range 33-81; 80% White, 9% Black, 8% Hispanic, and 3% Other). Significant improvements in the EF Domain were shown in this study (EF Domain scores of 17 on 10 mg vardenafil hydrochloride tablets and 19 on 20 mg vardenafil hydrochloride tablets compared to 13 on placebo; p <0.0001). Vardenafil hydrochloride tablets significantly improved the overall per-patient rate of achieving an erection sufficient for penetration (SEP2) (61% on 10 mg and 64% on 20 mg vardenafil hydrochloride tablets compared to 36% on placebo; p <0.0001). Vardenafil hydrochloride tablets demonstrated a clinically meaningful and statistically significant increase in the overall per-patient rate of maintenance of erection to successful intercourse (SEP3) (49% on 10 mg, 54% on 20 mg vardenafil hydrochloride tablets compared to 23% on placebo; p <0.0001).
What special dietary instructions should I follow?
Inform patients that vardenafil hydrochloride tablets are contraindicated in patients who use guanylate cyclase stimulators, such as riociguat. Discuss with patients the potential cardiac risk of sexual activity for patients with preexisting cardiovascular risk factors. Concomitant Use with Drugs which Lower Blood Pressure Inform patients that in some patients concomitant use of PDE5 inhibitors, including vardenafil hydrochloride tablets, with alpha-blockers can lower blood pressure significantly leading to symptomatic hypotension (for example, fainting). Patients prescribed vardenafil hydrochloride tablets who are taking alpha-blockers should be started on the lowest recommended starting dose of vardenafil hydrochloride tablets [see Dosage and Administration (2.4) and Drug Interactions (7)]. Patients should be advised to contact the prescribing physician if other anti-hypertensive drugs or new medications that may interact with vardenafil hydrochloride tablets are prescribed by another healthcare provider.
Before taking vardenafil,
Discuss with patients the appropriate use of vardenafil hydrochloride tablets and its anticipated benefits. Patients should be advised to contact their healthcare provider for dose modification if they are not satisfied with the quality of their sexual performance with vardenafil hydrochloride tablets or in the case of an unwanted effect.
What is vardenafil used for?
Vardenafil hydrochloride tablets demonstrated clinically meaningful and statistically significant improvement in erectile function in a prospective, fixed-dose (10 and 20 mg vardenafil hydrochloride tablets), double-blind, placebo-controlled trial in post-prostatectomy patients (n=427, mean age 60, range 44-77 years; 93% White, 5% Black, 2% Other). Significant improvements in the EF Domain were shown in this study (EF Domain scores of 15 on 10 mg vardenafil hydrochloride tablets and 15 on 20 mg vardenafil hydrochloride tablets compared to 9 on placebo; p <0.0001). Vardenafil hydrochloride tablets significantly improved the overall per-patient rate of achieving an erection sufficient for penetration (SEP2) (47% on 10 mg and 48% on 20 mg vardenafil hydrochloride tablets compared to 22% on placebo; p <0.0001). Vardenafil hydrochloride tablets demonstrated a clinically meaningful and statistically significant increase in the overall per-patient rate of maintenance of erection to successful intercourse (SEP3) (37% on 10 mg, 34% on 20 mg vardenafil hydrochloride tablets compared to 10% on placebo; p <0.0001). 16 HOW SUPPLIED/STORAGE AND HANDLING Vardenafil hydrochloride tablets are formulated as orange, round, tablets embossed with "10" on one side equivalent to 10 mg of vardenafil.NDC 72162-2235-3: 30 Tablets in a BOTTLEStore at 25°C (77°F); excursions permitted within15-30°C (59-86°F) [see USP Controlled Room Temperature].Repackaged/Relabeled by:Bryant Ranch Prepack, Inc.Burbank, CA 91504 Vardenafil hydrochloride tablets are formulated as orange, round, tablets embossed with "10" on one side equivalent to 10 mg of vardenafil. NDC 72162-2235-3: 30 Tablets in a BOTTLE Store at 25°C (77°F); excursions permitted within15-30°C (59-86°F) [see USP Controlled Room Temperature]. 17 PATIENT COUNSELING INFORMATION "See FDA-approved patient labeling (Patient Information)"NitratesInform patients that vardenafil hydrochloride tablets are contraindicated with regular and/or intermittent use of organic nitrates. Patients should be counseled that concomitant use of vardenafil hydrochloride tablets with nitrates could cause blood pressure to suddenly drop to an unsafe level, resulting in dizziness, syncope, or even heart attack or stroke.Guanylate Cyclase (GC) StimulatorsInform patients that vardenafil hydrochloride tablets are contraindicated in patients who use guanylate cyclase stimulators, such as riociguat.CardiovascularDiscuss with patients the potential cardiac risk of sexual activity for patients with preexisting cardiovascular risk factors.Concomitant Use with Drugs which Lower Blood PressureInform patients that in some patients concomitant use of PDE5 inhibitors, including vardenafil hydrochloride tablets, with alpha-blockers can lower blood pressure significantly leading to symptomatic hypotension (for example, fainting).Patients prescribed vardenafil hydrochloride tablets who are taking alpha-blockers should be started on the lowest recommended starting dose of vardenafil hydrochloride tablets [see Dosage and Administration (2.4) and Drug Interactions (7)]. Patients should be advised of the possible occurrence of symptoms related to postural hypotension and appropriate countermeasures. Patients should be advised to contact the prescribing physician if other anti-hypertensive drugs or new medications that may interact with vardenafil hydrochloride tablets are prescribed by another healthcare provider.Recommended AdministrationDiscuss with patients the appropriate use of vardenafil hydrochloride tablets and its anticipated benefits. It should be explained that sexual stimulation is required for an erection to occur after taking vardenafil hydrochloride tablets.
| Product | Dosage | Quantity + Bonus | Price | |
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| Priligy Generic Dapoxetine | 60mg | 10 Pills | 47.63€ 45.36€ | |
| Priligy Generic Dapoxetine | 60mg | 120 + 10 Pills | 341.26€ 325.01€ | |
| Cialis Super Active | 20mg | 60 + 8 Pills | 230.32€ 219.35€ | |
| Kamagra Gold | 50 mg | 120 + 6 Pills | 281.13€ 267.74€ | |
| Cialis Generic | 5mg | 30 + 4 Pills | 53.56€ 51.01€ | |
| Viagra Super Active | 100mg | 60 + 8 Pills | 116.84€ 111.28€ | |
| Cialis Generic | 40mg | 10 Pills | 37.79€ 35.99€ | |
| Priligy Generic Dapoxetine | 60mg | 60 + 8 Pills | 183.06€ 174.34€ | |
| Kamagra Gold | 100 mg | 12 Pills | 55.64€ 52.99€ | |
| Levitra Soft Tabs | 20mg | 60 + 4 Pills | 178.40€ 169.90€ | |
| Viagra Generic | 150mg | 60 + 4 Pills | 111.25€ 105.95€ | |
| Kamagra Gold | 50 mg | 360 + 6 Pills | 713.95€ 679.95€ | |
| Viagra Oral Jelly | 100mg | 21 Sachets | 78.66€ 74.91€ | |
| Viagra Super Active | 100mg | 10 Pills | 28.76€ 27.39€ | |
| Levitra Generic | 60mg | 360 + 10 Pills | 906.69€ 863.51€ |
Vardenafil hydrochloride tablets should be taken approximately 60 minutes before sexual activity. Patients should be counseled lovegra 100 mg regarding the dosing of vardenafil hydrochloride tablets especially regarding the maximum daily dose. Patients should be advised to contact their healthcare provider for dose modification if they are not satisfied with the quality of their sexual performance with vardenafil hydrochloride tablets or in the case of an unwanted effect.PriapismInform patients that there have been rare reports of prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) for vardenafil hydrochloride tablets and this class of compounds.
Usual Geriatric Dose for Erectile Dysfunction
In the North American trial, vardenafil hydrochloride tablets significantly improved the rates of achieving an erection sufficient for penetration (SEP2) at doses of 5 mg, 10 mg, and 20 mg compared to placebo (65%, 75%, and 80%, respectively, compared to a 52% response in the placebo group at 3 months; p <0.0001). Vardenafil hydrochloride tablets demonstrated a clinically meaningful and statistically significant increase in the overall per-patient rate of maintenance of erection to successful intercourse (SEP3) (51% on 5 mg, 64% on 10 mg, and 65% on 20 mg, respectively, compared to 32% on placebo; p <0.0001) at 3 months in the North American trial. This improvement in mean score was maintained at all doses at 6 months in the North American trial. Vardenafil hydrochloride tablets demonstrated clinically meaningful and statistically significant improvement in erectile function in a prospective, fixed-dose (10 and 20 mg vardenafil hydrochloride tablets), double-blind, placebo-controlled trial of patients with diabetes mellitus (n=439; mean age 57 years, range 33-81; 80% White, 9% Black, 8% Hispanic, and 3% Other). Significant improvements in the EF Domain were shown in this study (EF Domain scores of 17 on 10 mg vardenafil hydrochloride tablets and 19 on 20 mg vardenafil hydrochloride tablets compared to 13 on placebo; p <0.0001).
More common
Vardenafil hydrochloride tablets significantly improved the overall per-patient rate of achieving an erection sufficient for penetration (SEP2) (61% on 10 mg and 64% on 20 mg vardenafil hydrochloride tablets compared to 36% on placebo; p <0.0001). Vardenafil hydrochloride tablets demonstrated a clinically meaningful and statistically significant increase in the overall per-patient rate of maintenance of erection to successful intercourse (SEP3) (49% on 10 mg, 54% on 20 mg vardenafil hydrochloride tablets compared to 23% on placebo; p <0.0001). Vardenafil hydrochloride tablets demonstrated clinically meaningful and statistically significant improvement in erectile function in a prospective, fixed-dose (10 and 20 mg vardenafil hydrochloride tablets), double-blind, placebo-controlled trial in post-prostatectomy patients (n=427, mean age 60, range 44-77 years; 93% White, 5% Black, 2% Other). Significant improvements in the EF Domain were shown in this study (EF Domain scores of 15 on 10 mg vardenafil hydrochloride tablets and 15 on 20 mg vardenafil hydrochloride tablets compared to 9 on placebo; p <0.0001). Vardenafil hydrochloride tablets significantly improved the overall per-patient rate of achieving an erection sufficient for penetration (SEP2) (47% on 10 mg and 48% on 20 mg vardenafil hydrochloride tablets compared to 22% on placebo; p <0.0001).
How should I store vardenafil?
Vardenafil hydrochloride tablets demonstrated a clinically meaningful and statistically significant increase in the overall per-patient rate of maintenance of erection to successful intercourse (SEP3) (37% on 10 mg, 34% on 20 mg vardenafil hydrochloride tablets compared to 10% on placebo; p <0.0001). 16 HOW SUPPLIED/STORAGE AND HANDLING Vardenafil hydrochloride tablets are formulated as orange, round, tablets embossed with "10" on one side equivalent to 10 mg of vardenafil.NDC 72162-2235-3: 30 Tablets in a BOTTLEStore at 25°C (77°F); excursions permitted within15-30°C (59-86°F) [see USP Controlled Room Temperature].Repackaged/Relabeled by:Bryant Ranch Prepack, Inc.Burbank, CA 91504 Vardenafil hydrochloride tablets are formulated as orange, round, tablets embossed with "10" on one side equivalent to 10 mg of vardenafil. NDC 72162-2235-3: 30 Tablets in a BOTTLE Store at 25°C (77°F); excursions permitted within15-30°C (59-86°F) [see USP Controlled Room Temperature]. 17 PATIENT COUNSELING INFORMATION "See FDA-approved patient labeling (Patient Information)"NitratesInform patients that vardenafil hydrochloride tablets are contraindicated with regular and/or intermittent use of organic nitrates. Patients should be counseled that concomitant use of vardenafil hydrochloride tablets with nitrates could cause blood pressure to suddenly drop to an unsafe level, resulting in dizziness, syncope, or even heart attack or stroke.Guanylate Cyclase (GC) StimulatorsInform patients that vardenafil hydrochloride tablets are contraindicated in patients who use guanylate cyclase stimulators, such as riociguat.CardiovascularDiscuss with patients the potential cardiac risk of sexual activity for patients with preexisting cardiovascular risk factors.Concomitant Use with Drugs which Lower Blood PressureInform patients that in some patients concomitant use of PDE5 inhibitors, including vardenafil hydrochloride tablets, with alpha-blockers can lower blood pressure significantly leading to symptomatic hypotension (for example, fainting).Patients prescribed vardenafil hydrochloride tablets who are taking alpha-blockers should be started on the lowest recommended starting dose of vardenafil hydrochloride tablets [see Dosage and Administration (2.4) and Drug Interactions (7)]. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.Drug InteractionsAdvise patients to contact the prescribing physician if new medications that may interact with vardenafil hydrochloride tablets are prescribed by another healthcare provider.Sudden Loss of VisionInform patients to stop use of all PDE5 inhibitors, including vardenafil hydrochloride tablets, and seek medical attention in the event of sudden loss of vision in one or both eyes. Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision, including permanent loss of vision, that has been reported rarely post-marketing in temporal association with the use of all PDE5 inhibitors. Physicians should also discuss with patients the increased risk of NAION in individuals who have already experienced NAION in one eye. Physicians should also discuss with patients the increased risk of NAION among the general population in patients with a "crowded" optic disc, although evidence is insufficient to support screening of prospective users of PDE5 inhibitor, including vardenafil hydrochloride tablets, for this uncommon condition [see Warnings and Precautions (5.4)and Adverse Reactions (6.1)] .Sudden Hearing LossAdvise patients to stop taking PDE5 inhibitors, including vardenafil hydrochloride tablets, and seek prompt medical attention in the event of sudden decrease or loss of hearing. These events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to the intake of PDE5 inhibitors, including vardenafil hydrochloride tablets.
- Vardenafil HCl 10mg is effective for most men within 30-60 minutes.
- The duration of effect can last up to 4-5 hours.
- Do not take more than one dose per 24 hours to prevent overdose.
- Vardenafil does not cause an erection without sexual stimulation.
- It’s not a cure for erectile dysfunction but manages symptoms temporarily.
- Men with penile deformities or prior surgeries should consult a doctor before use.
- Side effects are usually mild but consult if they worsen or persist.
- Vardenafil is metabolized in the liver, so dose adjustments may be needed.
- Avoid heavy physical activity immediately after taking the medication.
- Regular check-ups are recommended to monitor health while on vardenafil.
It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [see Adverse Reactions (6)].Sexually Transmitted DiseaseInform patients that vardenafil hydrochloride tablets offer no protection against sexually transmitted diseases.
| Storage Parameter | Recommended Condition | Notes |
|---|---|---|
| Temperature | Below 25°C (77°F) | Store in a cool, dry place |
| Humidity | Avoid excessive moisture | Keep away from water |
| Light exposure | Keep in original container, protect from light | Prevent degradation |
| Shelf life | 2-3 years from manufacturing date | Check expiration date |
Counsel patients that protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), should be considered.
Vardenafil Note
Patients should be advised of the possible occurrence of symptoms related to postural hypotension and appropriate countermeasures. Patients should be advised to contact the prescribing physician if other anti-hypertensive drugs or new medications that may interact with vardenafil hydrochloride tablets are prescribed by another healthcare provider.Recommended AdministrationDiscuss with patients the appropriate use of vardenafil hydrochloride tablets and its anticipated benefits. It should be explained that sexual stimulation is required for an erection to occur after taking vardenafil hydrochloride tablets. Vardenafil hydrochloride tablets should be taken approximately 60 minutes before sexual activity. Patients should be counseled lovegra 100 mg regarding the dosing of vardenafil hydrochloride tablets especially regarding the maximum daily dose.
What should I do if I accidentally take too much vardenafil?
Patients should be advised to contact their healthcare provider for dose modification if they are not satisfied with the quality of their sexual performance with vardenafil hydrochloride tablets or in the case of an unwanted effect.PriapismInform patients that there have been rare reports of prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) for vardenafil hydrochloride tablets and this class of compounds. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.Drug InteractionsAdvise patients to contact the prescribing physician if new medications that may interact with vardenafil hydrochloride tablets are prescribed by another healthcare provider.Sudden Loss of VisionInform patients to stop use of all PDE5 inhibitors, including vardenafil hydrochloride tablets, and seek medical attention in the event of sudden loss of vision in one or both eyes. Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision, including permanent loss of vision, that has been reported rarely post-marketing in temporal association with the use of all PDE5 inhibitors. Physicians should also discuss with patients the increased risk of NAION in individuals who have already experienced NAION in one eye. Physicians should also discuss with patients the increased risk of NAION among the general population in patients with a "crowded" optic disc, although evidence is insufficient to support screening of prospective users of PDE5 inhibitor, including vardenafil hydrochloride tablets, for this uncommon condition [see Warnings and Precautions (5.4)and Adverse Reactions (6.1)] .Sudden Hearing LossAdvise patients to stop taking PDE5 inhibitors, including vardenafil hydrochloride tablets, and seek prompt medical attention in the event of sudden decrease or loss of hearing.
InChI key
These events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to the intake of PDE5 inhibitors, including vardenafil hydrochloride tablets. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [see Adverse Reactions (6)].Sexually Transmitted DiseaseInform patients that vardenafil hydrochloride tablets offer no protection against sexually transmitted diseases. Counsel patients that protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), should be considered. "See FDA-approved patient labeling (Patient Information)" Inform patients that vardenafil hydrochloride tablets are contraindicated with regular and/or intermittent use of organic nitrates. Patients should be counseled that concomitant use of vardenafil hydrochloride tablets with nitrates could cause blood pressure to suddenly drop to an unsafe level, resulting in dizziness, syncope, or even heart attack or stroke. "See FDA-approved patient labeling (Patient Information)" Inform patients that vardenafil hydrochloride tablets are contraindicated with regular and/or intermittent use of organic nitrates. Patients should be counseled that concomitant use of vardenafil hydrochloride tablets with nitrates could cause blood pressure to suddenly drop to an unsafe level, resulting in dizziness, syncope, or even heart attack or stroke.
- Vardenafil 10mg is available by prescription only, ensure your doctor’s approval.
- It is intended for use in adult men diagnosed with erectile dysfunction.
- Be cautious with dosing if you have kidney or liver problems.
- Remember that sexual activity carries health risks for some men.
- Report any adverse effects, especially chest pain or prolonged erections.
- It’s important to discuss your complete medical history before use.
- The medication does not protect against sexually transmitted infections.
- Do not share your medication with others to prevent misuse.
- Use vardenafil only as directed to avoid potential health hazards.
- Pharmacist or doctor can clarify any questions about proper use.
Inform patients that vardenafil hydrochloride tablets are contraindicated in patients who use guanylate cyclase stimulators, such as riociguat.
| 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 |
Discuss with patients the potential cardiac risk of sexual activity for patients with preexisting cardiovascular risk factors. Concomitant Use with Drugs which Lower Blood Pressure Inform patients that in some patients concomitant use of PDE5 inhibitors, including vardenafil hydrochloride tablets, with alpha-blockers can lower blood pressure significantly leading to symptomatic hypotension (for example, fainting). Patients prescribed vardenafil hydrochloride tablets who are taking alpha-blockers should be started on the lowest recommended starting dose of vardenafil hydrochloride tablets [see Dosage and Administration (2.4) and Drug Interactions (7)]. Patients should be advised to contact the prescribing physician if other anti-hypertensive drugs or new medications that may interact with vardenafil hydrochloride tablets are prescribed by another healthcare provider.
- Vardenafil HCl 10mg is available in tablet form, usually taken orally.
- It’s important to follow your doctor’s instructions precisely for effectiveness.
- Do not use vardenafil if you have a known allergy to similar drugs.
- Alcohol can increase side effects, such as dizziness and low blood pressure.
- Men with pre-existing eye conditions should proceed with caution.
- Keep a record of any side effects experienced to inform your doctor.
- Use of vardenafil should be part of a broader approach to managing ED.
- Check for drug interactions with your pharmacist before starting therapy.
- Certain health conditions may require dose adjustments or caution.
- The medication is not intended for use as a performance enhancer.
Discuss with patients the appropriate use of vardenafil hydrochloride tablets and its anticipated benefits.
| Country | Approval Status | Regulatory Body | Notes |
|---|---|---|---|
| USA | Approved (FDA) | FDA | Prescription-only medication |
| European Union | Approved (EMA) | EMA | Prescription medication |
| Canada | Approved | Health Canada | Prescription-only |
| Australia | Approved | TGA | Prescription medication |
Patients should be advised to contact their healthcare provider for dose modification if they are not satisfied with the quality of their sexual performance with vardenafil hydrochloride tablets or in the case of an unwanted effect.
