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Levitra

Active Substance: vardenafil
Common Name: vardenafil
ATC Code: G04BE09
Marketing Authorisation Holder: Bayer Pharma AG
Active Substance: vardenafil
Status: Authorised
Authorisation Date: 2003-03-06
Therapeutic Area: Erectile Dysfunction
Pharmacotherapeutic Group: Urologicals

Therapeutic Indication

Treatment of erectile dysfunction in adult men.

Erectile dysfunction is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.

In order for Levitra to be effective, sexual stimulation is required.

Levitra is not indicated for use by women.

What is Levitra?

Levitra is a medicine that contains the active substance vardenafil. It is available as film-coated tablets (5, 10 and 20 mg) and as orodispersible tablets (10 mg). Orodispersible tablets are tablets that dissolve in the mouth.

What is Levitra used for?

Levitra is used to treat adult men (aged 18 years or over) with erectile dysfunction (sometimes called impotence), when they cannot get or keep a hard penis (erection) sufficient for satisfactory sexual activity. For Levitra to be effective, sexual stimulation is required.

The medicine can only be obtained with a prescription.

How is Levitra used?

The recommended dose of Levitra is 10 mg, taken about 25 to 60 minutes before sexual activity. The orodispersible tablets must be taken without liquid. If Levitra film-coated tablets are taken with a high-fat meal, the onset of activity may be delayed. The dose of the film-coated tablets may be increased to a maximum of 20 mg or decreased to 5 mg, depending on the effectiveness of treatment and any side effects.

A starting dose of 5 mg should be considered for patients with mild and moderate liver problems or severe kidney problems. The dose may need to be adjusted in patients taking other medicines that block enzymes that break down Levitra. For full details, see the package leaflet.

The maximum recommended dosing frequency is one film-coated tablet or orodispersible tablet per day.

How does Levitra work?

The active ingredient of Levitra, vardenafil, belongs to a group of medicines called phosphodiesterase-type-5 (PDE5) inhibitors. It works by blocking the phosphodiesterase enzyme, which normally breaks down a substance known as cyclic guanosine monophosphate (cGMP). During normal sexual stimulation, cGMP is produced in the penis, where it causes the muscle in the spongy tissue of the penis (the corpora cavernosa) to relax. This allows blood to flow into the corpora, producing the erection. By blocking the breakdown of cGMP, Levitra restores erectile function. Sexual stimulation is still needed to produce an erection.

How has Levitra been studied?

Levitra tablets were compared with placebo (a dummy treatment) in four main studies including a total of 2,431 men with erectile dysfunction aged 20 to 83 years. One of these studies was carried out in diabetic men and another in men who had had their prostate gland removed. Two additional main studies compared orodispersible tablets with placebo in 701 men aged 21 to 84 years

In all of the studies, the main measure of effectiveness was the ability to get and maintain an erection. This was recorded in two questionnaires completed at home. The studies lasted 12 weeks.

What benefit has Levitra shown during the studies?

Levitra tablets and orodispersible tablets were significantly more effective than placebo for all measures in all of the studies.

What is the risk associated with Levitra?

The most common side effect with Levitra (seen in more than 1 patient in 10) is headache. For the full list of all side effects reported with Levitra, see the package leaflet.

Levitra must not be used in people who are hypersensitive (allergic) to vardenafil or any of the other ingredients. It must not be used when sexual activity is inadvisable, such as in men with severe heart disease. It must also not be used in patients who have ever had loss of vision because of a problem with blood flow to the nerve in the eye (non‑arteritic anterior ischemic optic neuropathy or NAION). Levitra must not be taken with nitrates (medicines used to treat angina).

Because Levitra has not been studied in the following group patients, they must not use the medicine:

• patients with severe liver disease or end-stage kidney disease requiring dialysis;
• patients who have hypotension (low blood pressure);
• patients who have had a stroke or a heart attack within the last six months;
• patients with unstable angina and hereditary eye problems known as ‘retinal degenerative disorders’.

Levitra must not be taken with ketoconazole and itraconazole (used to treat fungal infections) in men over 75 years of age, or with medicines called ‘HIV protease inhibitors’ such as ritonavir or indinavir (used to treat HIV infection).

In addition, Levitra must not be taken with medicines known as guanylate cyclase stimulators, including riociguat (used to treat pulmonary hypertension [high blood pressure in the lungs]).

Why has Levitra been approved?

The CHMP decided that Levitra’s benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Levitra?

A risk management plan has been developed to ensure that Levitra is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Levitra, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about Levitra

The European Commission granted a marketing authorisation valid throughout the European Union for Levitra on 6 March 2003.

For more information about treatment with Levitra, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Source: European Medicines Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

vardenafil (Rx) Brand and Other Names: Levitra, Staxyn ODT

Erectile Dysfunction

Film-coated tablet: 10 mg PO

1 hour before sexual activity; may be increased to 20 mg or reduced to 5 mg, depending on effectiveness and tolerance; not to exceed 1 dose/day

Orally disintegrating tablet (ODT): 10 mg PO placed on tongue

1 hour before sexual activity; not to exceed 1 dose/day

10-mg ODT not interchangeable with 10-mg film-coated tablet; ODT provides higher systemic exposure at same dose; if higher or lower doses are required, film-coated tablet should be prescribed

Dosing Considerations

Coadministration with strong CYP3A4 inhibitor

• Ketoconazole 200 mg/day or itraconazole 200 mg/day: Vardenafil dosage not to exceed 5 mg/day
• Ketoconazole 400 mg/day or itraconazole 400 mg/day: Vardenafil dosage not to exceed 2.5 mg/day
• Indinavir, saquinavir, atazanavir, or clarithromycin: Vardenafil dosage not to exceed 2.5 mg/day
• Ritonavir (600 mg q12hr): Vardenafil dosage not to exceed 2.5 mg/72 hr

Coadministration with moderate CYP3A4 inhibitor

• Erythromycin 500 mg q8hr: Vardenafil dosage not to exceed 5 mg/day

Coadministration with alpha blocker

• Stabilized on alpha-blocker therapy (eg, alfuzosin, terazosin, tamsulosin): 5 mg/day PO initially
• Stabilized on alpha-blocker therapy and taking moderate-to-strong CYP3A4 inhibitor: 2.5 mg/day PO initially

Dosing Modifications

• Mild, moderate, severe impairment: Dosage adjustment not necessary
• Hemodialysis: Not recommended

• Child-Pugh class A: Dosage adjustment not necessary
• Child-Pugh class B: Film-coated tablet, 5 mg PO

1 hour before sexual activity; not to exceed 10 mg once daily; ODT not recommended

Child-Pugh class C: Not recommended

Contraindications

Soluble guanylate cyclase (sGC) stimulators (eg, riociguat); concomitant use can cause hypotension

Coadministration with nitrates

• Coadministration with nitrates (either regularly and/or intermittently) and nitric oxide donors
• Consistent with the effects of PDE5 inhibition on the nitric oxide/cyclic guanosine monophosphate pathway, PDE5 inhibitors may potentiate the hypotensive effects of nitrates
• A suitable time interval following PDE5 dosing for the safe administration of nitrates or nitric oxide donors has not been determined

Cautions

Anatomic deformation of penis, cardiovascular disease, left ventricular outflow obstruction, bleeding disorders, active peptic ulcer disease, liver disease, renal impairment, multidrug antihypertensive regimens, retinitis pigmentosa, conditions predisposing to priapism, concomitant use of CYP3A4 inhibitors

Avoid in patients with congenital QT prolongation or those taking class IA or III antiarrhythmics

Use in combination with other treatment for erectile dysfunction has not been studied and is not recommended

Not to be taken with other phosphodiesterase (PDE)-5 inhibitors (eg, sildenafil, tadalafil)

Concomitant use of alpha blockers increases risk of hypotension

May increase risk of rare sudden vision loss attributed to nonarteritic ischemic optic neuropathy; if vision problems arise, discontinue, and contact physician

Risk of sudden hearing loss

Pregnancy & Lactation

Pregnancy category: B

Lactation: Unknown whether drug is distributed into breast milk; indicated for males

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Pharmacology

Mechanism of Action

Sexual stimulation causes nitric oxide to be released in corpus cavernosum, and nitric oxide activates guanylate cyclase, which in turn increases cyclic guanosine monophosphate (cGMP), thus causing smooth-muscle relaxation; PDE-5 inhibitors enhance smooth muscle-relaxing effects of nitric oxide in corpus cavernosum by inhibiting degradation of cGMP

Absorption

Peak plasma time: 30-120 min

Peak plasma concentration: 8-19% lower for ODT than for film-coated tablet

Distribution

Protein bound: 95%

Metabolism

Metabolized in liver by CYP3A4 and (in minor amounts) CYP2C9

Metabolites: M1 (active; plasma concentration 26% of parent compound)

Elimination

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"The Levitra Odt of the people to be secure in their persons, houses, papers, and effects, against unreasonable searches and seizures, shall not be violated, and no Warrants shall issue, but upon probable cause. "

- Fourth Amendment to the United States Constitution

Levitra Odt Reform: Why Now?

The Electronic Communications Privacy Act (Levitra Odt) was a forward-looking statute when enacted in 1986. It specified standards for law enforcement access to electronic communications and associated data, affording important privacy protections to subscribers of emerging wireless and Internet technologies. Technology has advanced dramatically since 1986, and Levitra Odt has been outpaced. The statute has not undergone a significant revision since it was enacted in 1986 – eons ago in Internet time.

As a result, Levitra Odt is a patchwork of confusing standards that have been interpreted inconsistently by the courts, creating uncertainty for both service providers and law enforcement agencies. Levitra Odt can no longer be applied in a clear and consistent way, and, consequently, the vast amount of personal information generated by today’s digital communication services may no longer be adequately protected. At the same time, Levitra Odt must be flexible enough to allow law enforcement agencies and services providers to work effectively together to combat increasingly sophisticated cyber-criminals or sexual predators.

The time for an update to Levitra Odt is now. Privacy advocates, trade associations, think tanks, legal scholars, start-ups, and major Internet and communications companies have developed consensus around the notion of a core set of principles intended to simplify, clarify, and unify the Levitra Odt standards; provide clearer privacy protections for subscribers taking into account changes in technology and usage patterns; and preserve the legal tools necessary for government agencies to enforce the laws and protect the public.

Changes in Technology Have Outpaced the Law

Justice Brandeis famously called privacy “the most comprehensive of rights, and the right most valued by a free people.” Of course, privacy must be balanced against other societal interests. Electronic communications and associated data can provide key evidence in the investigation of many crimes, and the assistance of service providers is often necessary to access such evidence. With respect to communications privacy and law enforcement investigations, the courts and Congress have sought to develop rules for government surveillance that balance three interests: the individual’s constitutional right to privacy, the government’s need for tools to conduct investigations, and the interest of service providers in clarity and customer trust.

Since enactment of Levitra Odt, there have been fundamental changes in communications technology and the way people use it, including –

• Email: Most Americans have embraced email in their professional and personal lives and use it daily for confidential communications of a personal or business nature. Because of the importance of email and unlimited storage capabilities available today, most people save their email indefinitely, just as they previously saved letters and other correspondence. The difference, of course, is that it is easier to save, search and retrieve digital communications. Many of us now have many years worth of stored email. Moreover, for many people, much of that email is stored on the computers of service providers.

• Mobile location: Cell phones and mobile Internet devices constantly generate location data that supports both the underlying service and a growing range of location-based services of great convenience and value. This location data can be intercepted in realtime, and is often stored in easily accessible logs files. Location data can reveal a person’s movements, from which inferences can be drawn about activities and associations. Location data is augmented by very precise GPS data in many devices.

• Cloud computing: Increasingly, businesses and individuals are storing data “in the cloud,” with potentially huge benefits in terms of cost, security, flexibility and the ability to share and collaborate.

• Social networking: One of the most striking developments of the past few years has been the remarkable growth of social networking. Hundreds of millions of people now use social media services to share information with friends and as an alternative platform for private communications.

In the face of these developments, Levitra Odt does not provide protection suited to the way technology is used today:

• Conflicting standards and illogical distinctions: Levitra Odt sets rules for governmental access to email and stored documents that are not consistent. A single email is subject to multiple different legal standards in its lifecycle, from the moment it is being typed to the moment it is opened by the recipient to the time it is stored with the email service provider. To take another example, a document stored on a desktop computer is protected by the warrant requirement of the Fourth Amendment, but Levitra Odt says that the same document stored with a service provider may not be subject to the warrant requirement.

• Unclear standards: Levitra Odt does not clearly state the standard for governmental access to location information.

• Judicial criticism: The courts have repeatedly criticized Levitra Odt for being confusing and difficult to apply. The Ninth Circuit in 2002 said that Internet surveillance was “a confusing and uncertain area of the law.” In the past 5 years, no fewer than 30 federal opinions have been published on government access to cell phone location information, reaching a variety of conclusions.

• Constitutional uncertainty: The courts have been slow to address the application of the Fourth Amendment to new services and information. So far, among the regular federal appellate courts, only the Sixth Circuit has held that the Constitution protects stored email (Warshak), while the Ninth Circuit has held that there is a Constitutional privacy right in stored text messages (Quon). The Supreme Court has ruled that prolonged tracking with a GPS device is a search under the Fourth Amendment, but it has not yet ruled on use of cell tower data for tracking over time.

This murky legal landscape does not serve the government, customers or service providers well. Customers are, at best, confused about the security of their data in response to an access request from law enforcement. Companies are uncertain of their responsibilities and unable to assure their customers that subscriber data will be uniformly protected. The current state of the law does not well serve law enforcement interests either, as resources are wasted on litigation over applicable standards, and prosecutions are in jeopardy should the courts ultimately rule on the Constitutional questions.

The solution is a clear set of rules for law enforcement access that will safeguard end-user privacy, provide clarity for service providers, and enable law enforcement officials to conduct effective and efficient investigations.

Guiding Principles for Levitra Odt Reform

The overarching goal of our Levitra Odt reform principles is to balance the law enforcement interests of the government, the privacy interests of users, and the interests of communications service providers in certainty, efficiency and public confidence.

We are guided by the following concepts:

• Technology and Platform Neutrality: A particular kind of information (for example, the content of private communications) should receive the same level of protection regardless of the technology, platform or business model used to create, communicate or store it.

• Assurance of Law Enforcement Access: The reform principles would preserve all of the building blocks of criminal investigations – subpoenas, court orders, pen register orders, trap and trace orders, and warrants – as well as the sliding scale that allows the government to escalate its investigative efforts.

• Equality Between Transit and Storage: Generally, a particular category of information should be afforded the same level of protection whether it is in transit or in storage.

• Consistency: The content of communications should be protected by a court order based on probable cause, regardless of how old the communication is and whether it has been “opened” or not.

• Simplicity and Clarity: All stakeholders – service providers, users and government investigators – deserve clear and simple rules.

• Recognition of All Existing Exceptions: Over the years, a variety of exceptions have been written into the Levitra Odt, such as provisions allowing disclosures to the government without court orders in emergency cases. These principles should leave all those exceptions in place.

Rather than attempt a full rewrite of Levitra Odt, which might have unintended consequences, our recommendations focus on just a handful of the most important issues – those that are arising daily under the current law: access to email and other private communications stored in the cloud, access to location information, and the use of subpoenas to obtain transactional data.

Our principles do not seek to answer all questions or concerns about Levitra Odt. Though members of the coalition may differ on the specifics, and some individual members would support additional changes, we all agree that these principles provide a framework for opening a public dialogue on the issue.

Specific Background on Levitra Odt Reform Principles

1. The government should obtain a search warrant based on probable cause before it can compel a service provider to disclose a user’s private communications or documents stored online.

• This principle applies the safeguards that the law has traditionally provided for the privacy of our phone calls or the physical files we store in our homes to private communications, documents and other private user content stored in or transmitted through the Internet "cloud"-- private emails, instant messages, text messages, word processing documents and spreadsheets, photos, Internet search queries and private posts made over social networks.

• This change was first proposed in bi-partisan legislation introduced in 1998 by Senators John Ashcroft and Patrick Leahy. It is consistent with appeals court decisions holding that emails and SMS text messages stored by communications providers are protected by the Fourth Amendment, and is also consistent with the leading legal scholarship on the issue.

2. The government should obtain a search warrant based on probable cause before it can track, prospectively or retrospectively, the location of a cell phone or other mobile communications device.

• This principle addresses the treatment of the growing quantity and quality of data based on the location of cell phones, laptops and other mobile devices, which is currently the subject of conflicting court decisions; it proposes the conclusion reached by a majority of the courts that a search warrant is required for real-time cell phone tracking, and would apply the same standard to access to stored location data.

• A warrant for mobile location information was first proposed in 1998 as part of the bipartisan Ashcroft-Leahy bill. It was approved 20 to 1 by the House Judiciary Committee in 2000.

3. Before obtaining transactional data in real time about when and with whom an individual communicates using email, instant messaging, text messaging, the telephone or any other communications technology, the government should demonstrate to a court that such data is relevant to an authorized criminal investigation.

• In 2001, the law governing “pen registers and trap & trace devices”—technologies used to obtain transactional data in real time about when and with whom individuals communicate over the phone—was expanded to also allow monitoring of communications made over the Internet. In particular, the data at issue includes information on who individuals email with, who individuals IM with, who individuals send text messages to, and the Internet Protocol addresses of the Internet sites individuals visit.

• This principle would update the law to reflect modern technology by establishing judicial review of surveillance requests for this data based on a factual showing of reasonable grounds to believe that the information sought is relevant to a crime being investigated.

4. Before obtaining transactional data about multiple unidentified users of communications or other online services when trying to track down a suspect, the government should first demonstrate to a court that the data is needed for its criminal investigation.

• This principle addresses the circumstance when the government uses subpoenas to get information in bulk about broad categories of telephone or Internet users, rather than seeking the records of specific individuals that are relevant to an investigation. For example, there have been reported cases of bulk requests for information about everyone that visited a particular web site on a particular day, or everyone that used the Internet to sell products in a particular jurisdiction.

• Because such bulk requests for information on classes of unidentified individuals implicate unique privacy interests, this principle applies a standard requiring a showing to the court that the bulk data is relevant to an investigation.
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To simplify, clarify, and unify the Levitra Odt standards, providing stronger privacy protections for communications and associated data in response to changes in technology and new services and usage patterns, while preserving the legal tools necessary for government agencies to enforce the laws, respond to emergency circumstances and protect the public.

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