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STAXYN (VARDENAFIL): PATIENT COUNSELING INFORMATION
Use with Other Formulations of Vardenafil
Physicians should inform patients that Staxyn (Vardenafil) is not interchangeable with vardenafil film-coated tablets (Levitra) as it provides higher systemic exposure. They should also discuss that the maximum dosage is one Staxyn tablet per 24 hours.
Doctors should discuss with patients the contraindication of Staxyn (Vardenafil) tablets 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.
Physicians should 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
Physicians should inform their patients that in some patients concomitant use of PDE5 inhibitors, including Vardenafil Hydrochloride (Staxyn), with alpha-blockers can lower blood pressure significantly leading to symptomatic hypotension (for example, fainting). Patients who are taking alpha-blockers should only use Staxyn when previous treatment with vardenafil film-coated tablets has been well tolerated. 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 (Staxyn) tablets are prescribed by another healthcare provider.
Physicians should discuss with patients the appropriate use of Staxyn and its anticipated benefits. It should be explained that sexual stimulation is required for an erection to occur after taking Staxyn (Vardenafil HCl). This medication should be taken approximately 60 minutes before sexual activity. Patients should be counseled regarding the dosing of Staxyn, 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 Staxyn (Vardenafil HCl) tablets or in the case of an unwanted effect.
Physicians should 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. In the event that an erection persists longer than 4 hours, the patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.
Patients should be advised to contact the prescribing physician if new medications that may interact with Vardenafil (Staxyn) are prescribed by another healthcare provider.
Physicians should advise patients to stop use of all PDE5 inhibitors, including Staxyn, 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 were related directly to the use of PDE5 inhibitors or to other factors. Physicians should also discuss with patients the increased risk of NAION in individuals who have already experienced NAION in one eye, including whether such individuals could be adversely affected by use of vasodilators such as PDE5 inhibitors.
Sudden Hearing Loss
healthcare providers should advise patients to stop taking PDE5 inhibitors, including Vardenafil (Staxyn) 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 Staxyn. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors.
Sexually Transmitted Disease
The use of Staxyn 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.
Staxyn (Vardenafil Hydrochloride) is available only in a single strength. Patients who require a different dosage should be prescribed vardenafil film-coated tablets (Levitra).
Manufactured and distributed by Bayer, GlaxoSmithKline, Merck pharmaceutical companies and their divisions.
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