Vardenafil

What is Vardenafil?

• Vardenafil is a phosphodiesterase 5 (PDE5) inhibitor used for the treatment of erectile dysfunction.

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Vardenafil structure

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Vardenafil 3D 1XP0

What are the uses of this medicine?

• Vardenafil hydrochloride is 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. A man who has trouble getting or keeping an erection should see his doctor for help if the condition bothers him.
• Vardenafil hydrochloride tablets may help a man with ED get and keep an erection when he is sexually excited.

How does this medicine work?

• Vardenafil (var den' a fil) is a selective inhibitor of phosphodiesterase type 5 (PDE5), an intracellular enzyme that mediates the breakdown of cyclic guanosine monophosphate (cGMP) inducing smooth muscle relaxation in the corpus cavernosum of the penis and in the pulmonary vasculature where this specific phosphodiesterase is found.
• When a man is sexually stimulated, his body’s normal physical response is to increase blood flow to his penis.
• This results in an erection.
• Vardenafil hydrochloride tablets helps increase blood flow to the penis and may help men with ED get and keep an erection satisfactory for sexual activity.
• Once a man has completed sexual activity, blood flow to his penis decreases, and his erection goes away.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• Take any medicines called “nitrates”
• Take riociguat, a guanylate cyclase stimulator
• Have been told by your healthcare provider to not have sexual activity because of health problems

What drug interactions can this medicine cause?

• Vardenafil hydrochloride can potentiate the hypotensive effects of nitrates, alpha-blockers, and antihypertensives.
• Concomitant use with nitrates and nitric oxide donors in any form is contraindicated.
• Concomitant use with Guanylate Cyclase (GC) Stimulators, such as riociguat is contraindicated.
• The dosage of vardenafil hydrochloride tablets 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.
• 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 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 vardenafil hydrochloride is administered with certain CYP3A4 inhibitors.

Is this medicine FDA approved?

• Vardenafil is effective in prolonging erection and was approved for use in the United States in 2003.

How should this medicine be used?

Recommended dosage:

• For most patients, the recommended starting dose of vardenafil hydrochloride is 10 mg, taken orally, as needed, 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.

Geriatrics:

• A starting dose of 5 mg vardenafil hydrochloride tablets should be considered in patients ≥ 65 years of age

Hepatic Impairment:

• For patients with moderate hepatic impairment (Child-Pugh B), a starting dose of 5 mg vardenafil hydrochloride tablets are recommended.
• The maximum dose in patients with moderate hepatic impairment should not exceed 10 mg.
• Do not use vardenafil hydrochloride tablets in patients with severe hepatic impairment (Child-Pugh C).

Renal Impairment:

• Do not use vardenafil hydrochloride tablets in patients on renal dialysis.

Administration:

• Take vardenafil hydrochloride tablets exactly as your doctor prescribes.
• Do not take more than one vardenafil hydrochloride tablets a day.
• Doses should be taken at least 24 hours apart.
• Some men can only take a low dose of vardenafil hydrochloride tablets because of medical conditions or medicines they take.
• Your doctor will prescribe the dose that is right for you.
• If you are older than 65 or have liver problems, your doctor may start you on a lower dose of vardenafil hydrochloride tablets.
• If you have prostate problems or high blood pressure, for which you take medicines called alpha-blockers, your doctor may start you on a lower dose of vardenafil hydrochloride tablets.
• If you are taking certain other medicines your doctor may prescribe a lower starting dose and limit you to one dose of vardenafil hydrochloride tablets in a 72-hour (3 days) period.
• Take 1 vardenafil hydrochloride tablet about 1 hour (60 minutes) before sexual activity.
• Some form of sexual stimulation is needed for an erection to happen with vardenafil hydrochloride tablets.
• Vardenafil hydrochloride tablets may be taken with or without meals.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Vardenafil hydrochloride tablets 5 mg, 10 mg, 20 mg

This medicine is available in fallowing brand namesː

• Levitra, Staxyn, and Vivanza

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache
• flushing
• stuffy or runny nose
• indigestion
• upset stomach
• dizziness
• back pain

Vardenafil tablets may uncommonly cause:

• An erection that won’t go away (priapism)
• Color vision changes

What special precautions should I follow?

• Patients should not use vardenafil hydrochloride if sex is inadvisable due to cardiovascular status.
• 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. n the event that an erection lasts more than 4 hours, the patient should seek immediate medical assistance.
• Patients should stop use of vardenafil hydrochloride, and seek medical attention in the event of sudden loss of vision in one or both eyes, which could be a sign of nonarteritic anterior ischemic optic neuropathy (NAION). Vardenafil hydrochloride should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION. Patients with a “crowded” optic disc may also be at an increased risk of NAION.
• Patients should stop vardenafil hydrochloride and seek medical attention in the event of sudden decrease or loss in hearing.
• 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 vardenafil hydrochloride is administered with certain CYP3A4 inhibitors.
• Caution is advised when PDE5 inhibitors are co-administered with alpha-blockers. In some patients, concomitant use of these two drug classes can lower blood pressure significantly leading to symptomatic hypotension (for example, fainting).
• Patients with congenital QT syndrome or taking class IA or III antiarrhythmics should avoid using vardenafil hydrochloride.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• severe back pain

Treatment of overdosage:

• In cases of overdose, standard supportive measures should be taken as required.
• Renal dialysis is not expected to accelerate clearance as vardenafil is highly bound to plasma proteins and not significantly eliminated in the urine.

Can this medicine be used in pregnancy?

• Pregnancy Category B vardenafil hydrochloride is not indicated for use in women.
• There are no studies of vardenafil hydrochloride use in pregnant women.

Can this medicine be used in children?

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

What are the active and inactive ingredients in this medicine?

• Active Ingredient: vardenafil hydrochloride trihydrate
• Inactive Ingredients: colloidal silicon dioxide, crospovidone, hypromellose, iron oxide red, iron oxide yellow, polyethylene glycol, microcrystalline cellulose, sodium stearyl fumarate, talc and titanium dioxide.

Who manufactures and distributes this medicine?

Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Oral Solid Dosage Unit Ahmedabad , INDIA

Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ

What should I know about storage and disposal of this medication?

• Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F).
• Keep vardenafil hydrochloride tablets and all medicines out of the reach of children.

PDE 5 inhibitors

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• Tadalafil
• Vardenafil

• Dailymed label info on Vardenafil
• FDA Vardenafil

Vardenafil Resources
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