Label: VARDENAFIL tablet, orally disintegrating

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).

How To Get Vardenafil

With a sudden drop in blood pressure, you could get dizzy, faint, or have a heart attack or stroke.Vardenafil hydrochloride orally disintegrating tablets contain phenylalanine which can be harmful to people who have phenylketonuria. Talk to your doctor if you have phenylketonuria.Do not take vardenafil hydrochloride orally disintegrating tablets if you:· Take any medicines called “nitrates” (often used to control chest pain, also known as angina)· Use recreational drugs called “poppers” like amyl nitrate and butyl nitrate.· Take riociguat (Adempas®), a guanulate cyclase stimulator, a medicine that treats pulmonary arterial hypertension and chronic-thromboembolic pulmonary hypertension. 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)].

• Vardenafil is ineffective without sexual arousal.
• It does not protect against sexually transmitted infections.
• Avoid excessive mental or physical exertion while on medication.
• Consult a healthcare professional if unsure about interactions.
• Don't take vardenafil if you've had recent heart attack.
• Use with caution if you have a bleeding disorder.
• Medication may cause a temporary drop in blood pressure.
• Avoid using if you have a known hypersensitivity.
• The pill should be taken as part of a treatment plan.
• Keep track of how you respond to the medication.

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. 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. 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 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.

• Some users may experience mild flickering vision episodes.
• The efficacy of vardenafil varies between individuals.
• The medication is available in various dosage forms.
• Always follow the specific instructions provided.
• Avoid taking vardenafil with high-fat meals to speed absorption.
• Do not take vardenafil if allergic to its ingredients.
• The drug may cause a temporary burning sensation.
• Use caution in patients with a history of priapism.
• Avoid combining vardenafil with certain herbal supplements.
• Consult your doctor about any ongoing health treatments.

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. 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 vardenafil pills attack or stroke. Inform patients that vardenafil hydrochloride orally disintegrating 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 orally disintegrating tablets, with alpha-blockers can lower blood pressure significantly leading to symptomatic hypotension (for example, fainting). 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. Discuss with patients the appropriate use of vardenafil hydrochloride orally disintegrating tablets and its anticipated benefits. 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. Inform 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. Advise patients to contact the prescribing physician if new medications that may interact with vardenafil hydrochloride orally disintegrating tablets are prescribed by another healthcare provider. Inform 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.

What It Contains

Advise 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. 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)]. Inform 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. Vardenafil hydrochloride orally disintegrating tablets are available only in a single strength.

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PATIENT PACKAGE INSERT Vardenafil Hydrochloride (var-DEN-a-fil HYE-droe-KLOR-ide)Orally Disintegrating Tablets, USPRead the Patient Information about vardenafil hydrochloride orally disintegrating tablets before you start taking it and again each time you get a refill. You may also find it helpful to share this information with your partner. This leaflet does not take the place of talking with your doctor. You and your doctor should talk about vardenafil hydrochloride orally disintegrating tablets when you start taking it and at regular checkups. If you do not understand the information, or have questions, talk with your doctor or pharmacist.WHAT IMPORTANT INFORMATION SHOULD YOU KNOW ABOUT VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS?Vardenafil hydrochloride orally disintegrating tablets are not interchangeable with vardenafil film-coated tablets (LEVITRA).Vardenafil hydrochloride orally disintegrating tablets can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. 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)].

Advise 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.

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

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. It should be explained that sexual stimulation is required for an erection to occur after taking vardenafil hydrochloride orally disintegrating tablets.

What should I know about vardenafil before taking it?

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. 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. 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)]. Inform 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. Vardenafil hydrochloride orally disintegrating tablets are available only in a single strength. PATIENT PACKAGE INSERT Vardenafil Hydrochloride (var-DEN-a-fil HYE-droe-KLOR-ide)Orally Disintegrating Tablets, USPRead the Patient Information about vardenafil hydrochloride orally disintegrating tablets before you start taking it and again each time you get a refill. You may also find it helpful to share this information with your partner. This leaflet does not take the place of talking with your doctor. You and your doctor should talk about vardenafil hydrochloride orally disintegrating tablets when you start taking it and at regular checkups. If you do not understand the information, or have questions, talk with your doctor or pharmacist.WHAT IMPORTANT INFORMATION SHOULD YOU KNOW ABOUT VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS?Vardenafil hydrochloride orally disintegrating tablets are not interchangeable with vardenafil film-coated tablets (LEVITRA).Vardenafil hydrochloride orally disintegrating tablets can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines.

5.4 Effects on the Eye

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 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.

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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. 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 vardenafil pills attack or stroke. With a sudden drop in blood pressure, you could get dizzy, faint, or have a heart attack or stroke.Vardenafil hydrochloride orally disintegrating tablets contain phenylalanine which can be harmful to people who have phenylketonuria.

Key Takeaways

Inform patients that vardenafil hydrochloride orally disintegrating 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 orally disintegrating tablets, with alpha-blockers can lower blood pressure significantly leading to symptomatic hypotension (for example, fainting). 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. Discuss with patients the appropriate use of vardenafil hydrochloride orally disintegrating tablets and its anticipated benefits.

Incidence not known

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. Inform 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. Advise patients to contact the prescribing physician if new medications that may interact with vardenafil hydrochloride orally disintegrating tablets are prescribed by another healthcare provider. Inform 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. 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)]. Talk to your doctor if you have phenylketonuria.Do not take vardenafil hydrochloride orally disintegrating tablets if you:· Take any medicines called “nitrates” (often used to control chest pain, also known as angina)· Use recreational drugs called “poppers” like amyl nitrate and butyl nitrate.· Take riociguat (Adempas®), a guanulate cyclase stimulator, a medicine that treats pulmonary arterial hypertension and chronic-thromboembolic pulmonary hypertension.