Table 7: Change from Baseline for the Primary Efficacy Variables in Studies 1 and 2 Vardenafil demonstrated clinically meaningful and statistically significant improvement in erectile function in a prospective, fixed-dose [10 and 20 mg vardenafil film-coated tablets], double-blind, placebo-controlled trial of patients with diabetes mellitus (n=439; mean age 57 years, range 33 to 81; 80% White, 9% Black, 8% Hispanic, and 3% Other).

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Usual Geriatric Dose for:

Significant improvements in the EF Domain were shown in this study (EF Domain scores of 17 on 10 mg vardenafil and 19 on 20 mg vardenafil compared to 13 on placebo; p <0.0001). Vardenafil 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 compared to 36% on placebo; p <0.0001). Vardenafil 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 compared to 23% on placebo; p <0.0001). Vardenafil demonstrated clinically meaningful and statistically significant improvement in erectile function in a prospective, fixed-dose 10 and 20 mg vardenafil film-coated tablets, double-blind, placebo-controlled trial in postprostatectomy patients (n=427, mean age 60, range 44 to 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 and 15 on 20 mg vardenafil compared to 9 on placebo; p <0.0001).

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Vardenafil 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 compared to 22% on placebo; p <0.0001). Vardenafil 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 compared to 10% on placebo; p <0.0001). 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How SuppliedVardenafil hydrochloride orally disintegrating tablets, USP 10 mg are white to off white, round, biconvex tablet debossed with “477” on one side and plain on other side.Vardenafil hydrochloride orally disintegrating tablets, USP are packaged into blister packs and supplied as a 4 tablet unit.1 blister card containing 4 tablets NDC 62332-235-04In addition to the active ingredient, vardenafil, each tablet contains lactose monohydrate, silicified microcrystalline cellulose, crospovidone, colloidal silicon dioxide, aspartame, citric acid monohydrate, NAT Peppermint FL WONF SD #491, sodium stearyl fumarate and magnesium stearate.16.2 Recommended StorageStore vardenafil hydrochloride orally disintegrating tablets, USP at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Vardenafil hydrochloride orally disintegrating tablets, USP are dispensed in blister packs.

5.1 Cardiovascular Effects

Vardenafil hydrochloride orally disintegrating tablets, USP 10 mg are white to off white, round, biconvex tablet debossed with “477” on one side and plain on other side. Vardenafil hydrochloride orally disintegrating tablets, USP are packaged into blister packs and supplied as a 4 tablet unit. Store vardenafil hydrochloride orally disintegrating tablets, USP at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Vardenafil hydrochloride orally disintegrating tablets, USP are dispensed in blister packs. 17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information)Use with Other Formulations of VardenafilInform patients that vardenafil hydrochloride orally disintegrating tablets are not interchangeable with vardenafil film-coated tablets (LEVITRA) as it provides higher systemic exposure.

Does vardenafil interact with foods or drinks?

They should also discuss that the maximum dosage is one vardenafil hydrochloride orally disintegrating tablets tablet per 24 hours.NitratesDiscuss with patients that vardenafil hydrochloride orally disintegrating vardenafil for erectile dysfunction price tablets are contraindicated with regular and/or intermittent use of organic nitrates. Patients should be counseled that concomitant use of vardenafil 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 orally disintegrating 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 orally disintegrating tablets, with alpha-blockers can lower blood pressure significantly leading to symptomatic hypotension (for example, fainting). Patients who are taking alpha-blockers should only use vardenafil hydrochloride orally disintegrating tablets when previous treatment with vardenafil film-coated tablets has been well tolerated [see Dosage and Administration (2) 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 orally disintegrating tablets are prescribed by another healthcare provider.Recommended AdministrationDiscuss with patients the appropriate use of vardenafil hydrochloride orally disintegrating tablets and its anticipated benefits. The patient should tadapox tablets be advised to examine the blister pack before use and not use if blisters are torn, broken, or missing. Vardenafil hydrochloride orally disintegrating tablets, USP 10 mg are white to off white, round, biconvex tablet debossed with “477” on one side and plain on other side. Vardenafil hydrochloride orally disintegrating tablets, USP are packaged into blister packs and supplied as a 4 tablet unit.

Drug Category Potential Interaction Effect
Nitrates Dangerous hypotension Severe decrease in blood pressure
CYP3A4 Inhibitors Increased vardenafil levels Increased side effects
Alpha-blockers Risk of hypotension Dizziness, fainting
Pesticides (e.g., erythromycin) Possible increased plasma levels Enhanced side effects

Store vardenafil hydrochloride orally disintegrating tablets, USP at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Vardenafil hydrochloride orally disintegrating tablets, USP are dispensed in blister packs.

Usual Adult Dose for Erectile Dysfunction

Does vardenafil interact with other medicines (drug interactions)?

17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information)Use with Other Formulations of VardenafilInform patients that vardenafil hydrochloride orally disintegrating tablets are not interchangeable with vardenafil film-coated tablets (LEVITRA) as it provides higher systemic exposure. They should also discuss that the maximum dosage is one vardenafil hydrochloride orally disintegrating tablets tablet per 24 hours.NitratesDiscuss with patients that vardenafil hydrochloride orally disintegrating vardenafil for erectile dysfunction price tablets are contraindicated with regular and/or intermittent use of organic nitrates.

Condition Explanation
Use with Nitrates Can cause severe hypotension
Severe Liver Impairment Metabolism may be impaired, risk of accumulation
Retinitis Pigmentosa Potential risk of worsening vision
Hypotension or Uncontrolled Hypertension Risks of blood pressure fluctuations

Patients should be counseled that concomitant use of vardenafil 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 orally disintegrating 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 orally disintegrating tablets, with alpha-blockers can lower blood pressure significantly leading to symptomatic hypotension (for example, fainting). Patients who are taking alpha-blockers should only use vardenafil hydrochloride orally disintegrating tablets when previous treatment with vardenafil film-coated tablets has been well tolerated [see Dosage and Administration (2) and Drug Interactions (7)].

How To Get Vardenafil

It should be explained that sexual stimulation is required for an erection to occur after taking vardenafil hydrochloride orally disintegrating tablets. Vardenafil hydrochloride orally disintegrating tablets should be taken approximately 60 minutes before sexual activity. Patients should be counseled regarding the dosing of vardenafil hydrochloride orally disintegrating tablets, especially regarding the maximum daily dose. Patients should be advised to contact their healthcare provider if they are not satisfied with the quality of their sexual performance with vardenafil hydrochloride orally disintegrating 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 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 orally disintegrating tablets are prescribed by another healthcare provider.Sudden Loss of VisionInform patients to stop use of all PDE5 inhibitors, including vardenafil hydrochloride orally disintegrating tablets, and seek medical attention in the event of sudden loss of vision in one or both eyes.

Electroanalytical application of carbon based electrodes to the pharmaceuticals

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 postmarketing in temporal association with the use of all PDE5 inhibitors. Physicians should lovegra women 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 orally disintegrating 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 orally disintegrating 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 orally disintegrating 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 orally disintegrating tablets offers no protection against sexually transmitted diseases. Patients should be advised of the possible occurrence of symptoms related to postural hypotension and appropriate countermeasures.

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Tadalafil Tablets

Patients should be advised to contact the prescribing physician if other anti-hypertensive drugs or new medications that may interact with vardenafil hydrochloride orally disintegrating tablets are prescribed by another healthcare provider.Recommended AdministrationDiscuss with patients the appropriate use of vardenafil hydrochloride orally disintegrating tablets and its anticipated benefits. It should be explained that sexual stimulation is required for an erection to occur after taking vardenafil hydrochloride orally disintegrating tablets. Vardenafil hydrochloride orally disintegrating tablets should be taken approximately 60 minutes before sexual activity. Patients should be counseled regarding the dosing of vardenafil hydrochloride orally disintegrating tablets, especially regarding the maximum daily dose.

2.2 Use with Food

Table 7: Change from Baseline for the Primary Efficacy Variables in Studies 1 and 2 Vardenafil demonstrated clinically meaningful and statistically significant improvement in erectile function in a prospective, fixed-dose [10 and 20 mg vardenafil film-coated tablets], double-blind, placebo-controlled trial of patients with diabetes mellitus (n=439; mean age 57 years, range 33 to 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 and 19 on 20 mg vardenafil compared to 13 on placebo; p <0.0001). Vardenafil 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 compared to 36% on placebo; p <0.0001). Vardenafil 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 compared to 23% on placebo; p <0.0001). Vardenafil demonstrated clinically meaningful and statistically significant improvement in erectile function in a prospective, fixed-dose 10 and 20 mg vardenafil film-coated tablets, double-blind, placebo-controlled trial in postprostatectomy patients (n=427, mean age 60, range 44 to 77 years; 93% White, 5% Black, 2% Other).

Consumer Information Use and Disclaimer

Significant improvements in the EF Domain were shown in this study (EF Domain scores of 15 on 10 mg vardenafil and 15 on 20 mg vardenafil compared to 9 on placebo; p <0.0001). Vardenafil 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 compared to 22% on placebo; p <0.0001). Vardenafil 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 compared to 10% on placebo; p <0.0001). 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How SuppliedVardenafil hydrochloride orally disintegrating tablets, USP 10 mg are white to off white, round, biconvex tablet debossed with “477” on one side and plain on other side.Vardenafil hydrochloride orally disintegrating tablets, USP are packaged into blister packs and supplied as a 4 tablet unit.1 blister card containing 4 tablets NDC 62332-235-04In addition to the active ingredient, vardenafil, each tablet contains lactose monohydrate, silicified microcrystalline cellulose, crospovidone, colloidal silicon dioxide, aspartame, citric acid monohydrate, NAT Peppermint FL WONF SD #491, sodium stearyl fumarate and magnesium stearate.16.2 Recommended StorageStore vardenafil hydrochloride orally disintegrating tablets, USP at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Vardenafil hydrochloride orally disintegrating tablets, USP are dispensed in blister packs. The patient should tadapox tablets be advised to examine the blister pack before use and not use if blisters are torn, broken, or missing. Patients should be advised to contact their healthcare provider if they are not satisfied with the quality of their sexual performance with vardenafil hydrochloride orally disintegrating 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 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 orally disintegrating tablets are prescribed by another healthcare provider.Sudden Loss of VisionInform patients to stop use of all PDE5 inhibitors, including vardenafil hydrochloride orally disintegrating 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 postmarketing in temporal association with the use of all PDE5 inhibitors.

  • Vardenafil is part of phosphodiesterase inhibitors.
  • It may interact with certain blood pressure medications.
  • The drug is usually effective within 30 minutes.
  • Store vardenafil in a cool, dry place away from children.

Physicians should lovegra women 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 orally disintegrating 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 orally disintegrating 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 orally disintegrating 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 orally disintegrating tablets offers 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.Dose AdjustmentVardenafil hydrochloride orally disintegrating tablets are available only in a single strength.

Vardenafil (Generic Levitra®) FAQs

Counsel patients that protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), should be considered.Dose AdjustmentVardenafil hydrochloride orally disintegrating tablets are available only in a single strength. Patients who require a different dosage should be prescribed vardenafil film-coated tablets (LEVITRA). See FDA-approved patient labeling (Patient Information) Inform patients that vardenafil hydrochloride orally disintegrating tablets are not interchangeable with vardenafil film-coated tablets (LEVITRA) as it provides higher systemic exposure. They should also discuss that the maximum dosage is one vardenafil hydrochloride orally disintegrating tablets tablet per 24 hours. Discuss with patients that vardenafil hydrochloride orally disintegrating tablets are contraindicated with regular and/or intermittent use of organic nitrates.

Dutasteride

Patients should be counseled that concomitant use of vardenafil with nitrates could cause blood pressure to suddenly drop to an unsafe level, resulting in dizziness, syncope, or even heart attack or stroke. Patients who require a different dosage should be prescribed vardenafil film-coated tablets (LEVITRA). See FDA-approved patient labeling (Patient Information) Inform patients that vardenafil hydrochloride orally disintegrating tablets are not interchangeable with vardenafil film-coated tablets (LEVITRA) as it provides higher systemic exposure. They should also discuss that the maximum dosage is one vardenafil hydrochloride orally disintegrating tablets tablet per 24 hours. Discuss with patients that vardenafil hydrochloride orally disintegrating tablets are contraindicated with regular and/or intermittent use of organic nitrates.

  • Vardenafil can cause dizziness or vision changes.
  • It is contraindicated if you have severe heart conditions.
  • Food, especially high-fat meals, can delay effects.
  • Always follow the prescribed dosage instructions.

Patients should be counseled that concomitant use of vardenafil with nitrates could cause blood pressure to suddenly drop to an unsafe level, resulting in dizziness, syncope, or even heart attack or stroke.

  • Vardenafil can cause temporary vision disturbances.
  • Do not use if you have a recent history of heart attack.
  • It should be used with caution in those with kidney issues.
  • Men with liver problems should seek medical advice.