Storage and Handling of Your Tablets

The use of LEVITRA offers no protection against sexually transmitted diseases.

• Levitra 20 mg helps men achieve and maintain an erection.
• 4 tablets in each pack make dosing straightforward.
• Take one tablet with a glass of water, about 30 minutes before sex.
• Avoid heavy meals and alcohol when using Levitra.
• Do not take more than one tablet daily.
• Check for possible drug interactions with your doctor.
• Levitra 20 mg is not recommended for women.
• Store in a dry, cool place away from sunlight.
• Talk to a healthcare professional if you experience adverse effects.
• Do not share your medication with others.
• Always complete your prescribed course of treatment.

Counseling of patients about protective

How To Get Vardenafil

Vardenafil has not been administered to patients with bleeding disorders or significant active peptic ulceration. Therefore LEVITRA should be administered to these patients after careful benefit-risk assessment. Treatment for erectile dysfunction should generally be used with caution by patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie’s disease) or by patients who have conditions that may predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia). The safety and efficacy of LEVITRA used in combination with other treatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended.

Does vardenafil interact with other medicines (drug interactions)?

Physicians should discuss with patients the contraindication of LEVITRA with regular and/or intermittent use of organic nitrates. Patients should be counseled that concomitant use of LEVITRA 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 inform their patients that in some patients concomitant use of PDE5 inhibitors, including LEVITRA, with alpha-blockers can lower blood pressure significantly leading to symptomatic hypotension (e.g., fainting). Patients prescribed LEVITRA who are taking alpha-blockers should be started on the lowest recommended starting dose of LEVITRA (see Drug Interactions and DOSAGE AND ADMINISTRATION). Patients should be advised of the possible occurrence of symptoms related to postural hypotension and appropriate countermeasures. measures necessary to guard against sexually transmitted diseases, including the Human

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Immunodeficiency Virus (HIV), should be considered.

What Side Effects Can You Expect From These Medications?

Phosphodiesterase Type 5 (PDE5) inhibitors, including LEVITRA, and alpha-adrenergic blocking agents are both vasodilators with blood-pressure lowering effects. When vasodilators are used in combination, an additive effect on blood pressure may be anticipated. In some patients, concomitant use of these two drug classes can lower blood pressure significantly (see PRECAUTIONS,Drug Interactions) leading to symptomatic hypotension (e.g., fainting). Consideration should be given to the following: Patients should be stable on alpha-blocker therapy prior to initiating a PDE5 inhibitor. Patients who demonstrate hemodynamic instability on alpha-blocker therapy alone are at increased risk of symptomatic hypotension with concomitant use of PDE5 inhibitors.

Does vardenafil interact with foods or drinks?

In those patients who are stable on alpha-blocker therapy, PDE5 inhibitors should be initiated at the lowest recommended starting dose (see DOSAGE and ADMINISTRATION). In those patients already taking an optimized dose of PDE5 inhibitor, alpha-blocker therapy should be initiated at the lowest dose. Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure in patients taking a PDE5 inhibitor. Safety of combined use of PDE5 inhibitors and alpha-blockers may be affected by other variables, including intravascular volume depletion and other anti-hypertensive drugs. In volunteers with moderate impairment (Child-Pugh B), the Cmax and AUC following a 10 mg vardenafil dose were increased 130% and 160%, respectively, compared to healthy control subjects. Physicians should inform patients that there have been

• Levitra 20 mg enhances blood flow for stronger erections.
• Comes in a small pack of four tablets, easy for travel.
• Take with water, 30 minutes before planned intimate activity.
• Do not take more than one tablet per day to avoid side effects.
• Avoid fatty meals and alcohol to maximize effectiveness.
• Check with your doctor about potential drug interactions.
• Not suitable for use by women or children.
• Store away from direct sunlight and humidity.
• Contact a healthcare professional if adverse reactions occur.
• Always follow the dosing instructions provided.
• Keep Levitra 20 mg in a secure place to prevent misuse.

rare reports of prolonged erections greater than 4 hours

Side Effects

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 LEVITRA or in the case of an unwanted effect. Patients should be advised to contact the prescribing physician if new medications that may interact with LEVITRA are prescribed by another healthcare provider. Physicians should advise patients to stop use of all PDE5 inhibitors, including LEVITRA, 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. It is not possible to determine whether these events were related directly to the use of PDE5 inhibitors or to other factors. and priapism (painful erections greater than 6 hours

• Levitra 20 mg is a prescription medication for erectile dysfunction.
• Each box contains 4 tablets of Levitra 20 mg.
• Levitra 20 mg works by increasing blood flow to the penis.
• Typical dosage is one tablet taken about an hour before activity.
• Do not exceed one Levitra 20 mg tablet per 24 hours.
• Take Levitra with water; avoid using it with high-fat meals.
• Common side effects include headaches and flushing.
• Levitra 20 mg should be used under medical supervision.
• It is not suitable for individuals with heart conditions.
• Levitra 20 mg may interact with certain blood pressure medicines.
• Store Levitra tablets in a cool, dry place away from children.

in duration) for LEVITRA and this class of compounds.

Levitra general information

Concomitant administration with ritonavir or indinavir substantially increases plasma concentrations of vardenafil. Because ritonavir prolongs LEVITRA elimination half-life (5 to 6-fold), no more than a single 2.5 mg dose of LEVITRA should be taken in a 72-hour period by patients also taking ritonavir. Patients taking indinavir, saquinavir, atazanavir or other potent CYP3A4 inhibitors such as clarithromycin, ketoconazole 400 mg daily, or itraconazole 400 mg daily should not exceed a dose of LEVITRA 2.5 mg once daily. For patients taking ketoconazole 200 mg daily or itraconazole 200 mg daily, a single dose of 5 mg LEVITRA should not be exceeded in a 24-hour period (see PRECAUTIONS,Drug Interactions and DOSAGE AND ADMINISTRATION). There have been rare reports of prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) for this class of compounds, including vardenafil.

When should Levitra not be used?

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. There are no controlled clinical data on the safety or efficacy of LEVITRA in the following patients; and therefore its use is not recommended until further information is available. unstable angina; hypotension (resting systolic blood pressure of <90 mmHg); uncontrolled hypertension (>170/110 mmHg); recent history of stroke, life-threatening arrhythmia, or myocardial infarction (within the last 6 months); severe cardiac failure known hereditary degenerative retinal disorders, including retinitis pigmentosa The evaluation of erectile dysfunction should include a determination of potential underlying causes, a medical assessment, and the identification of appropriate treatment. Before prescribing LEVITRA, it is important to note the following: Caution is advised when PDE5 inhibitors are co-administered with alpha-blockers. In vitro studies: Studies in human

Brand vs. Generic

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 (see POST-MARKETING EXPERIENCE, Ophthalmologic). Physicians should advise patients to stop taking PDE5 inhibitors, including LEVITRA, 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 LEVITRA. 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). Physicians should discuss with patients the potential cardiac risk of sexual activity for patients with preexisting cardiovascular risk factors. liver microsomes showed that vardenafil is metabolized

Parameter	Value	Notes
Absorption Rate	Fast	Starts within 30-60 minutes
Peak Plasma Concentration	1.0-2.0 hours	Max nivel around 60 mins
Half-life	Approximately 4-5 hours	Duration of effect
Metabolism	Liver (CYP3A4 enzyme)	Requires caution with interacting drugs

primarily by cytochrome P450 (CYP) isoforms 3A4/5, and to a lesser degree by CYP2C9.

Condition	Caution Level	Details
Heart disease	High	Consult cardiologist before use
Using nitrate medications	Absolute	Do not take together
Liver impairment	Moderate	Adjust dosage accordingly
History of Priapism	High	Avoid use, seek medical advice

Therefore, inhibitors of these enzymes are expected to

Vardenafil (Generic Levitra®) FAQs

Consequently, a starting dose of 5 mg is recommended for patients with moderate hepatic impairment and the maximum dose should not exceed 10 mg (see CLINICAL PHARMACOLOGY,Pharmacokinetics in Special Populations, and DOSAGE AND ADMINISTRATION). Vardenafil has not been evaluated in patients with severe hepatic impairment (Child-Pugh C). Congenital or Acquired QT generic levitra 20 Prolongation: In a study of the effect of LEVITRA on QT interval in 59 healthy males (see CLINICAL PHARMACOLOGY,Electrophysiology), therapeutic (10 mg) and supratherapeutic (80 mg) doses of LEVITRA and the active control moxifloxacin (400 mg) produced similar increases in QTc interval. A postmarketing study evaluating the effect of combining LEVITRA with another drug of comparable QT effect showed an additive QT effect when compared with either drug alone (see CLINICAL PHARMACOLOGY,Electrophysiology). These observations should be considered in clinical decisions when prescribing LEVITRA to patients with known history of QT prolongation or patients who are taking medications known to prolong the QT interval.

How long does 20mg of Levitra last?

amiodarone, sotalol) antiarrhythmic medications or those with congenital QT prolongation, should avoid using LEVITRA. In patients with moderate (CLcr = 30-50 ml/min) to severe (CLcr<30 ml/min) renal impairment, the AUC of vardenafil was 20 – 30% higher compared to that observed in a control group with normal renal function (CLcr>80 ml/min) (see CLINICAL PHARMACOLOGY, Pharmacokinetics in Special Populations). Vardenafil pharmacokinetics have not been evaluated in patients requiring renal dialysis. General: In humans, vardenafil alone in doses up to 20 mg does not prolong the bleeding time. There is no clinical evidence of any additive prolongation of the bleeding time when vardenafil is administered with aspirin. reduce vardenafil clearance (see WARNINGS and DOSAGE AND ADMINISTRATION).

How Vardenafil and Viagra Work

Patients should be advised to contact the prescribing physician if other anti-hypertensive drugs or new medications that may interact with LEVITRA are prescribed by another healthcare provider. Physicians should discuss with patients the appropriate use of LEVITRA and its anticipated benefits. It should be explained that sexual stimulation is required for an erection to occur after taking LEVITRA. LEVITRA should be taken approximately 60 minutes before sexual activity. Patients levitra 100 mg should be counseled regarding the dosing of LEVITRA.