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Label: VARDENAFIL tablet, orally disintegrating

Other > vardenafil 10 mg tablet


Vardenafil hydrochloride orally disintegrating tablets should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION.

Further information

Tell your doctor about all other medications you use for erectile dysfunction. This list is not complete and many other drugs may affect vardenafil. This includes prescription and over-the-counter medicines, men enhancement pills vitamins, and herbal products. Not all possible drug interactions are listed here. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Treatment & Diagnosis

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. If you are a consumer or patient please visit this version. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for VARDENAFIL lovegra tablet HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS.VARDENAFIL HYDROCHLORIDE orally disintegrating tabletsInitial U.S. Approval: 2003RECENT MAJOR CHANGESWarnings and Precautions (5.2) 4/2023INDICATIONS AND USAGE• Vardenafil hydrochloride orally disintegrating tablets are phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction. Patients with a “crowded” optic disc may also be at an increased risk of NAION.

(5.4, 6.2)• Sudden Hearing Loss: Patients should stop vardenafil hydrochloride orally disintegrating tablets and seek medical attention in the event of sudden decrease or loss in hearing.

(5.5, 6.2)• Alpha-Blockers: Caution is advised when PDE5 inhibitors are coadministered with alpha-blockers.

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In some patients, concomitant use of these two drug classes can lower blood pressure significantly leading to symptomatic hypotension (for example, fainting).

Ingredient Amount per Tablet Purity Source
Vardenafil Hydrochloride 10 mg 99.9% Pharmacological grade
Lactose Monohydrate 50 mg – Dairy-derived
Microcrystalline Cellulose 20 mg – Plant fiber
Magnesium Stearate 2 mg – Mineral source
Colloidal Silicon Dioxide 1 mg – Silicon dioxide

In patients taking alpha-blockers, do not initiate vardenafil therapy with vardenafil hydrochloride orally disintegrating tablets.

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(1).DOSAGE AND ADMINISTRATION• Vardenafil hydrochloride orally disintegrating tablets are not interchangeable with vardenafil 10 mg film-coated tablets (LEVITRA). Vardenafil hydrochloride orally disintegrating tablets provide higher systemic exposure compared to vardenafil 10 mg film-coated tablets (LEVITRA). (2.1)• Vardenafil hydrochloride orally disintegrating tablets are taken as needed, orally, approximately 60 minutes before sexual activity. (2.1)• The maximum recommended dosing frequency is one tablet per day. (2.1)• Vardenafil hydrochloride orally disintegrating tablets should be placed on the tongue where it will disintegrate.

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(2.1)• Vardenafil hydrochloride orally disintegrating tablets may be taken with or without food. (2.2)DOSAGE FORMS AND STRENGTHS• Vardenafil hydrochloride orally disintegrating tablets 10 mg: White to off white, round, orally disintegrating tablets (not scored) (3)CONTRAINDICATIONSWARNINGS AND PRECAUTIONS• Cardiovascular Effects: Patients should not use vardenafil hydrochloride orally disintegrating tablets if sex is inadvisable due to cardiovascular status. (5.1)• Strong and Moderate CYP3A4 Inhibitors: Do not use vardenafil hydrochloride orally disintegrating tablets in patients taking strong or moderate CYP3A4 inhibitors. (5.2, 7.2)• Risk of Priapism: In the event that an erection lasts more than 4 hours, the patient should seek immediate medical assistance. (5.3)• Effects on the Eye: Patients should stop use of vardenafil hydrochloride orally disintegrating tablets and seek medical attention in the event of sudden loss of vision in one or both eyes, which could be a sign of non arteritic anterior ischemic optic neuropathy (NAION). (2.4, 5.6)• QT Prolongation: Patients with congenital QT syndrome or taking class IA or III antiarrhythmics should avoid using vardenafil hydrochloride orally disintegrating tablets.

2.2 Use with Food

Nitrates are also found in some recreational drugs such as amyl nitrate or nitrite ("poppers"). Tell your doctor if you have ever had: a heart attack, stroke, or congestive heart failure; a heart attack, stroke, or congestive heart failure; long QT syndrome (in you or a family member); long QT syndrome (in you or a family member); a blood cell disorder such as sickle cell anemia, multiple myeloma, or leukemia; a blood cell disorder such as sickle cell anemia, multiple myeloma, or leukemia; an eye disorder such as retinitis pigmentosa (an inherited condition of the eye); an eye disorder such as retinitis pigmentosa (an inherited condition of the eye); a physical deformity of the penis (such as Peyronie's disease); a physical deformity of the penis (such as Peyronie's disease); if you have been told you should not have sexual intercourse for health reasons; or if you have been told you should not have sexual intercourse for health reasons; or liver disease, kidney disease (or if you are on dialysis). liver disease, kidney disease (or if you are on dialysis). Vardenafil can decrease blood flow to the optic nerve of the eye, causing sudden vision loss. This has occurred in a small number of people, most of whom also had heart disease, diabetes, high blood pressure, high cholesterol, or certain pre-existing eye problems, and in those who smoked or were over 50 years old.

Less common

It is not clear whether vardenafil is the actual cause of vision loss. Staxyn (vardenafil disintegrating tablets) may contain phenylalanine. Vardenafil is not approved for use in women, and the effects of vardenafil during pregnancy or in breastfeeding women are unknown. Staxyn (vardenafil disintegrating tablets) should not be used in place of Levitra (vardenafil regular tablets). Avoid medication errors by using only the form and strength your doctor prescribes. (5.7, 12.2)• Phenylketonurics: Each vardenafil hydrochloride orally disintegrating tablet contain 1.403 mg phenylalanine per tablet, which could be harmful for patients with phenylketonuria.

Available Strengths & Forms

Follow all directions on your prescription label and read all medication guides or instruction sheets. Vardenafil can be taken with or without food. Remove an orally disintegrating (Staxyn) tablet from the package only when you are ready buy blue pill to use the medicine. Place the tablet in your mouth and allow it to dissolve without chewing. Swallow several times as the tablet dissolves.

Are you currently using Vardenafil (Levitra, Staxyn)?

Vardenafil is taken only when needed, about 60 minutes before sexual activity. The medicine can help achieve an erection when sexual stimulation occurs. An erection will not occur just by taking a pill. If you receive medical care for heart problems, tell your caregivers when you last took vardenafil. This medicine does not prevent the spread of sexually transmitted diseases such as human immunodeficiency virus (HIV). (5.12)ADVERSE REACTIONSAdverse reactions reported by ≥ 2% of patients treated with vardenafil

hydrochloride orally disintegrating tablets: Headache, flushing, nasal congestion, dyspepsia, dizziness, back pain.

Patient Type Recommended Dose Notes
Adult Men with ED 10 mg 1 hour before activity
Elderly Patients 5-10 mg Adjust based on tolerability
Patients with Liver Impairment 5 mg Lower dose recommended
Use with CYP3A4 inhibitors 5 mg To reduce adverse risk

(6.1)To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals Limited at 1-866-210-9797 or FDA at 1-800-FDA-1088 or

5.8 Hepatic Impairment

You may report side effects to FDA at 1-800-FDA-1088. Some medicines can cause unwanted or dangerous effects when used with vardenafil. Tell your doctor about all your other medicines, especially riociguat (Adempas). Do not take vardenafil if you are also using a nitrate drug for chest pain or heart problems, including nitroglycerin, isosorbide dinitrate, isosorbide mononitrate, and some recreational drugs such as "poppers". Taking vardenafil with a nitrate medicine can cause a sudden and serious decrease in blood pressure.

Medications & Supplements

Call your doctor or seek emergency medical attention if your erection is painful or lasts longer than 4 hours. A prolonged erection (priapism) can damage the penis. Stop using vardenafil and get emergency medical help if you have sudden vision loss. You should not use vardenafil if you are allergic to it, or if you take other medicines to treat pulmonary arterial hypertension, such as riociguat (Adempas). Do not take vardenafil if you are also using a nitrate drug for chest pain or heart problems, including nitroglycerin, isosorbide dinitrate, and isosorbide mononitrate. INTERACTIONS• Vardenafil hydrochloride orally disintegrating tablets can potentiate the hypotensive effects of nitrates, alpha-blockers, and antihypertensives.

Important Notes

Store at room temperature away from moisture and heat. -Initial dose: 10 mg orally once a day, as needed, approximately 60 minutes before sexual activity. Increase to 20 mg or decrease to 5 mg based on efficacy and tolerability.-Maximum dose: 20 mg once a dayPatients on stable alpha blocker therapy:-Initial dose: 5 mg orally once a dayComments:-Sexual stimulation is required for a response to treatment.-A time interval between dosing should be considered when administering this drug concomitantly with alpha-blockers.-Patients taking alpha-blockers should not initiate vardenafil therapy with the orally disintegrating tablet.Use: Erectile dysfunction 65 years or older:-Initial dose: 5 mg orally once a day, as needed, approximately 60 minutes before sexual activityComments: Sexual stimulation is required for a response to treatment.Use: Erectile dysfunction Since vardenafil is used as needed, you are not likely to be on a dosing schedule. Allow 24 hours to pass between doses. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Related treatment guides

Grapefruit and Seville oranges may interact with vardenafil and cause side effects. Avoid consuming grapefruit products and orange marmalades. Drinking alcohol can increase certain side effects of vardenafil. Do not use any other medicine to treat impotence unless your doctor tells you to. Do not use vardenafil with similar medications such as avanafil (Stendra), sildenafil (Viagra), or tadalafil (Cialis). (7.1)• Do not use vardenafil hydrochloride orally disintegrating tablets with moderate or strong CYP3A4 inhibitors as coadministration will result in significant increases in plasma vardenafil concentrations.

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