12 CLINICAL PHARMACOLOGY

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.

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

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 flibanserin should talk about vardenafil hydrochloride orally disintegrating tablets when you start taking it and at regular checkups.

Tadalafil Tablets

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. 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. (See “Who Should Not Take Vardenafil Hydrochloride Orally Disintegrating Tablets?”)Tell all your healthcare providers that you take vardenafil hydrochloride orally disintegrating tablets. If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took vardenafil hydrochloride orally disintegrating tablets.WHAT ARE VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS?Vardenafil hydrochloride orally disintegrating tablets are a prescription medicine taken by mouth for the treatment of erectile dysfunction (ED) in men.ED is a condition where the penis does not harden and expand when a man is sexually excited, or when he cannot keep an erection. 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.

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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. 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 20 mg vardenafil 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 attack or stroke.

• Vardenafil may cause nasal congestion or upset stomach.
• Use caution when operating machinery after dosing.
• It is not a cure but helps manage erectile dysfunction symptoms.
• Regular medical checkups are recommended during use.

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.

Clinical Information

Incidence not known

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.

• Vardenafil is used to treat erectile dysfunction in men.
• It works by increasing blood flow to the penis.
• Vardenafil is marketed under the brand name Levitra.
• The drug typically takes effect within 25-60 minutes.

Advise patients to contact the prescribing physician if new medications that may interact with vardenafil hydrochloride orally disintegrating tablets sex pills for women are prescribed by another healthcare provider.

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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)].

UK Registered Pharmacy

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 sex pills for women 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.

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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. 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. 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. 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.

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A man who has trouble getting or keeping an erection should see his doctor for help if the condition bothers him. Vardenafil hydrochloride orally disintegrating tablets may help a man with ED get and keep an erection when he is sexually excited.Vardenafil hydrochloride orally disintegrating tablets does not:· Cure ED.· Increase a man’s sexual desire.· Protect a man or his partner from sexually transmitted diseases, including HIV. Speak to your doctor about ways to guard against sexually transmitted diseases.· Serve as a male form of birth control.Vardenafil hydrochloride orally disintegrating tablets are only for men with ED.

Dosage for people taking certain interacting medications

You may also find it helpful to share this information with your partner.

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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 20 mg vardenafil 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.

Visual disturbances

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. 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. This leaflet does not take the place of talking with your doctor. You and your doctor flibanserin should talk about vardenafil hydrochloride orally disintegrating tablets when you start taking it and at regular checkups.

• Vardenafil is available by prescription only.
• Common side effects include headache and flushing.
• It should be taken on an empty stomach for best results.
• Do not combine vardenafil with nitrates.

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. 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. (See “Who Should Not Take Vardenafil Hydrochloride Orally Disintegrating Tablets?”)Tell all your healthcare providers that you take vardenafil hydrochloride orally disintegrating tablets. If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took vardenafil hydrochloride orally disintegrating tablets.WHAT ARE VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS?Vardenafil hydrochloride orally disintegrating tablets are a prescription medicine taken by mouth for the treatment of erectile dysfunction (ED) in men.ED is a condition where the penis does not harden and expand when a man is sexually excited, or when he cannot keep an erection.

• Vardenafil is a selective inhibitor of PDE5 enzyme.
• It is classified as a prescription medication.
• Online purchases should be approached with caution.
• Always disclose your health history to your doctor.

A man who has trouble getting or keeping an erection should see his doctor for help if the condition bothers him. Vardenafil hydrochloride orally disintegrating tablets may help a man with ED get and keep an erection when he is sexually excited.Vardenafil hydrochloride orally disintegrating tablets does not:· Cure ED.· Increase a man’s sexual desire.· Protect a man or his partner from sexually transmitted diseases, including HIV.

Brand Name	Price per Pack	Dosage Options	Over-the-counter (OTC)	Prescription Required
Levitra	$40-$60	5, 10, 20 mg	No	Yes
Vardenafil Generic	$10-$25	5, 10, 20 mg	No	Yes
Other Brands	Varies	5-20 mg	No	Yes

Speak to your doctor about ways to guard against sexually transmitted diseases.· Serve as a male form of birth control.Vardenafil hydrochloride orally disintegrating tablets are only for men with ED.

Is my consultation and order confidential?

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.

Dosage for people with kidney disease

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.