Vardenafil

Vardenafil
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]

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Overview

Vardenafil is a Phosphodiesterase 5 Inhibitor that is FDA approved for the {{{indicationType}}} of treatment of erectile dysfunction]. Common adverse reactions include Flushing, Dizziness, Headache, Rhinitis.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

erectile dysfunction

• General Dose Information

• Recommended starting dosage: 10 mg PO approximately 60 minutes before sexual activity.

• The dose may be increased to a maximum recommended dose of 20 mg or decreased to 5 mg based on efficacy and side effects.
• The maximum recommended dosing frequency is once per day. Sexual stimulation is required for a response to treatment.

• Use with Food

• LEVITRA can be taken with or without food.

• Use in Specific Populations

• Geriatrics: A starting dose of 5 mg LEVITRA should be considered in patients ≥ 65 years of age [see Use in Specific Populations (8.5)].

• Hepatic Impairment

• For patients with moderate hepatic impairment (Child-Pugh B)

• Starting dosage: 5 mg
• Maximum dosage: ≤ 10 mg.

• Do not use LEVITRA in patients with severe hepatic impairment (Child-Pugh C) [see Warnings and Precautions (5.8), Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

• Renal Impairment: Do not use LEVITRA in patients on renal dialysis [see Warnings and Precautions (5.9), Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

• Concomitant Medications

• Nitrates: Concomitant use with nitrates and nitric oxide donors in any form is contraindicated [see Contraindications (4.1)].

• CYP3A4 Inhibitors: The dosage of LEVITRA may require adjustment in patients receiving potent CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, atazanavir, and clarithromycin as well as in other patients receiving moderate CYP3A4 inhibitors such as erythromycin [see Drug Interactions (7.2)].

• For ritonavir, a single dose of 2.5 mg LEVITRA should not be exceeded in a 72-hour period.
• For indinavir, saquinavir, atazanavir, ketoconazole 400 mg daily,
• For itraconazole: 400 mg daily
• For clarithromycin: ≤ 2.5 mg PO qd.
• For ketoconazole: 200 mg/day
• For itraconazole: 200 mg/day
• For erythromycin: ≤5 mg PO qd

• Alpha-Blockers: In those patients who are stable on alpha-blocker therapy, phosphodiesterase type 5 (PDE5) inhibitors should be initiated at the lowest recommended starting dose. Concomitant treatment should be initiated only if the patient is stable on his alpha-blocker therapy. Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure in patients taking a phosphodiesterase (PDE5) inhibitor including vardenafil. In those patients who are stable on alpha-blocker therapy, LEVITRA should be initiated at a dose of 5 mg (2.5 mg when used concomitantly with certain CYP3A4 inhibitors). [See Warnings and Precautions (5.6) and Drug Interactions (7.1).]

• A time interval between dosing should be considered when Levitra is prescribed concomitantly with alpha-blocker therapy [see Clinical Pharmacology (12.2)].

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Vardenafil in adult patients.

Non–Guideline-Supported Use

Benign prostatic hyperplasia - Lower urinary tract symptoms

• Dosing information

• 10 mg/day 18281145, 22510238

Pulmonary hypertension

• Dosing information

• 5 mg PO qd for the first 4 weeks, then 5 mg PO bid 21471085, 19549620

Secondary Raynaud's phenomenon

• Dosing information

• 10 mg PO bid 23426043

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

LEVITRA is not indicated for use in pediatric patients. Safety and efficacy have not been established in this population.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Vardenafil in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Vardenafil in pediatric patients.

Contraindications

Nitrates

Administration of LEVITRA with nitrates (either regularly and/or intermittently) and nitric oxide donors is contraindicated [see Clinical Pharmacology (12.2)]. Consistent with the effects of PDE5 inhibition on the nitric oxide/cyclic guanosine monophosphate pathway, PDE5 inhibitors, including LEVITRA, may potentiate the hypotensive effects of nitrates. A suitable time interval following dosing of LEVITRA for the safe administration of nitrates or nitric oxide donors has not been determined.

Warnings

The evaluation of erectile dysfunction should include a medical assessment, a determination of potential underlying causes and the identification of appropriate treatment. Before prescribing LEVITRA, it is important to note the following:

Cardiovascular Effects

General

Physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Therefore, treatment for erectile dysfunction, including LEVITRA, should not be used in men for whom sexual activity is not recommended because of their underlying cardiovascular status. There are no controlled clinical data on the safety or efficacy of vardenafil 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.

Left Ventricular Outflow Obstruction

Patients with left ventricular outflow obstruction, (for example, aortic stenosis and idiopathic hypertrophic sub aortic stenosis) can be sensitive to the action of vasodilators including PDE5 inhibitors.

Blood Pressure Effects

LEVITRA has systemic vasodilatory properties that resulted in transient decreases in supine blood pressure in healthy volunteers (mean maximum decrease of 7 mmHg systolic and 8 mmHg diastolic) [see Clinical Pharmacology (12.2)]. While this normally would be expected to be of little consequence in most patients, prior to prescribing LEVITRA, physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects.

Potential for Drug Interactions with Potent or Moderate CYP3A4 Inhibitors

Concomitant administration with potent CYP3A4 inhibitors (such as ritonavir, indinavir, ketoconazole) or moderate CYP3A4 inhibitors (such as erythromycin) increases plasma concentrations of vardenafil. Dosage adjustment is necessary when LEVITRA is administered with certain CYP3A4 inhibitors [see Dosage and Administration (2.4), Drug Interactions (7.2)]. Long-term safety information is not available on the concomitant administration of vardenafil with HIV protease inhibitors.

Risk of Priapism

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. 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. LEVITRA should 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).

Effects on the Eye

Physicians should advise patients to stop use of all phosphodiesterase type 5 (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 rare condition and 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. Based on published literature, the annual incidence of NAION is 2.5–11.8 cases per 100,000 in males aged ≥50. An observational study evaluated whether recent use of PDE5 inhibitors, as a class, was associated with acute onset of NAION. The results suggest an approximate 2 fold increase in the risk of NAION within 5 half-lives of PDE5 inhibitor use. From this information, 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 (6.2)]. Physicians should consider whether their patients with underlying NAION risk factors could be adversely affected by use of PDE5 inhibitors. Individuals who have already experienced NAION are at increased risk of NAION recurrence. Therefore, PDE5 inhibitors, including LEVITRA, should be used with caution in these patients and only when the anticipated benefits outweigh the risks. Individuals with “crowded” optic disc are also considered at greater risk for NAION compared to the general population, however, evidence is insufficient to support screening of prospective users of PDE5 inhibitors, including LEVITRA, for this uncommon condition. LEVITRA has not been evaluated in patients with known hereditary degenerative retinal disorders, including retinitis pigmentosa, therefore its use is not recommended until further information is available in those patients.

Sudden Hearing Loss

Physicians should advise patients to stop taking all 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 vardenafil. 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 (6.2)].

Alpha-Blockers

Caution is advised when PDE5 inhibitors are co-administered with alpha-blockers. 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 leading to symptomatic hypotension (for example, fainting) [see Drug Interactions (7.1) and Clinical Pharmacology (12.2)]. 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.

• 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 (2.4)].

• 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.

Congenital or Acquired QT Prolongation

In a study of the effect of LEVITRA on QT interval in 59 healthy males [see Clinical Pharmacology (12.2)], therapeutic (10 mg) and supratherapeutic (80 mg) doses of vardenafil 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 (12.2)]. 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. Patients taking Class 1A (for example. quinidine, procainamide) or Class III (for example, amiodarone, sotalol) antiarrhythmic medications or those with congenital QT prolongation, should avoid using LEVITRA.

Hepatic Impairment

Dosage adjustment is necessary in patients with moderate hepatic impairment (Child-Pugh B). Do not use LEVITRA in patients with severe (Child-Pugh C) hepatic impairment. [See Dosage and Administration (2.3) Clinical Pharmacology (12.3)] and Use in Specific Populations (8.6).] 5.9 Renal Impairment Do not use LEVITRA in patients on renal dialysis, as vardenafil has not been evaluated in this population [see Dosage and Administration (2.3) and Use in Specific Populations (8.7)].

Combination with Other Erectile Dysfunction Therapies

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.

Effects on Bleeding

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. LEVITRA 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.

Sexually Transmitted Disease

The use of LEVITRA 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.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Vardenafil Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Vardenafil Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Vardenafil Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Vardenafil in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Vardenafil in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Vardenafil during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Vardenafil in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Vardenafil in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Vardenafil in geriatric settings.

Gender

There is no FDA guidance on the use of Vardenafil with respect to specific gender populations.

Race

There is no FDA guidance on the use of Vardenafil with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Vardenafil in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Vardenafil in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Vardenafil in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Vardenafil in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Vardenafil Administration in the drug label.

Monitoring

There is limited information regarding Vardenafil Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Vardenafil and IV administrations.

Overdosage

There is limited information regarding Vardenafil overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Vardenafil Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Vardenafil Mechanism of Action in the drug label.

Structure

There is limited information regarding Vardenafil Structure in the drug label.

Pharmacodynamics

There is limited information regarding Vardenafil Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Vardenafil Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Vardenafil Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Vardenafil Clinical Studies in the drug label.

How Supplied

There is limited information regarding Vardenafil How Supplied in the drug label.

Storage

There is limited information regarding Vardenafil Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Vardenafil Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Vardenafil interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Vardenafil Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Vardenafil Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.