In patients taking alpha-blockers, do not initiate vardenafil therapy with vardenafil orally disintegrating tablet.
(2.1)Vardenafil orally disintegrating tablet may be taken with or without food. (2.2)DOSAGE FORMS AND STRENGTHSVardenafil orally disintegrating tablet 10 mg: White to off-white, round, biconvex, orally disintegrating tablets (not scored) (3)CONTRAINDICATIONSWARNINGS AND PRECAUTIONSCardiovascular Effects: Patients should not use vardenafil orally disintegrating tablet if sex is inadvisable due to cardiovascular status. (5.1)Strong and Moderate CYP3A4 Inhibitors: Do not use vardenafil orally disintegrating tablet 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 orally disintegrating tablet, 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 orally disintegrating tablet. (5.7, 12.2)Phenylketonurics: Each vardenafil orally disintegrating tablet contains 3.36 mg phenylalanine per tablet, which could be harmful for patients with phenylketonuria.
(5.12)ADVERSE REACTIONSAdverse reactions reported by ≥ 2% of patients treated with vardenafil orally disintegrating tablet: Headache, flushing, nasal congestion, dyspepsia, dizziness, back pain.
| Dosage | Frequency | Onset Time | Duration of Effect | Notes |
|---|---|---|---|---|
| 10 mL (200 mg) | Once 30 minutes before | 30-60 min | Up to 4 hours | Maximum recommended dose |
| 5 mL (100 mg) | As needed | 30 min | 3-4 hours | Consult doctor for tailored dose |
| 15 mL (300 mg) | 24 hours apart | 30-60 min | Up to 4 hours | Do not exceed recommended dose |
(6.1)To report SUSPECTED ADVERSE REACTIONS, contact Macleods Pharma USA, Inc., at 1-888-943-3210 or 1-855-926-3384 or FDA at 1-800-FDA-1088 or INTERACTIONSVardenafil orally disintegrating tablet can potentiate the hypotensive effects of nitrates, alpha-blockers, and antihypertensives.
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Levitra Original | 20mg | 76 + 4 Pills | 344.39€ 327.99€ | |
| Levitra Soft Tabs | 20mg | 90 + 6 Pills | 241.31€ 229.82€ | |
| Levitra Generic | 20mg | 60 + 6 Pills | 131.11€ 124.87€ | |
| Levitra Soft Tabs | 20mg | 360 + 20 Pills | 682.21€ 649.72€ | |
| Levitra Generic | 10mg | 90 + 8 Pills | 150.58€ 143.41€ | |
| Levitra Original | 20mg | 64 + 4 Pills | 298.45€ 284.24€ | |
| Levitra Generic | 40mg | 20 Pills | 67.56€ 64.34€ | |
| Levitra Generic | 60mg | 30 + 2 Pills | 109.43€ 104.22€ | |
| Levitra Soft Tabs | 20mg | 60 + 4 Pills | 178.40€ 169.90€ | |
| Levitra Professional | 20mg | 270 + 6 Pills | 738.98€ 703.79€ | |
| Levitra Professional | 20mg | 30 Pills | 119.12€ 113.45€ | |
| Levitra Professional | 20mg | 60 + 2 Pills | 223.11€ 212.49€ |
(7.1)Do not use vardenafil orally disintegrating tablet with moderate or strong CYP3A4 inhibitors as coadministration will result in significant increases in plasma vardenafil concentrations.
| Ingredient | Concentration | Purpose | Notes |
|---|---|---|---|
| Vardenafil Hydrochloride | 20 mg/mL | Active component for erectile dysfunction relief | Prescribed dose varies |
| Glycerin | 10% | Solvent and base | Enhances absorption |
| Purified Water | Q.S. to 100% | Diluent | Ensures stability |
| Flavoring Agents | - | Improves taste | Commonly mint or berry |
(7.2)USE IN SPECIFIC POPULATIONSSee 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 1/2025 Warnings and Precautions (5.4) 08/2017 Vardenafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction.
You should carry the list with you in case of emergencies. 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 ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for VARDENAFIL ORALLY DISINTEGRATING TABLETS.VARDENAFIL orally disintegrating tabletsInitial U.S. Approval: 2003RECENT MAJOR CHANGESWarnings and Precautions (5.4) 08/2017INDICATIONS AND USAGEVardenafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction.
(1)DOSAGE AND ADMINISTRATIONVardenafil orally disintegrating tablet is not interchangeable with vardenafil 10 mg film-coated tablets (LEVITRA). Vardenafil orally disintegrating tablet provides higher systemic exposure compared to vardenafil 10 mg film-coated tablets (LEVITRA). (2.1)Vardenafil orally disintegrating tablet is 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 orally disintegrating tablet should be placed on the tongue where it will disintegrate. Vardenafil orally disintegrating tablet is not interchangeable with vardenafil 10 mg film-coated tablets (LEVITRA). Vardenafil orally disintegrating tablet is taken as needed, orally, approximately 60 minutes before sexual activity. The maximum recommended dosing frequency is one tablet per day.
Do not take any more doses of vardenafil or similar medications such as sildenafil (Viagra) or tadalafil (Cialis) until you talk to your doctor. Some patients experienced a sudden decrease or loss of hearing after they took vardenafil or other medications that are similar to vardenafil. The hearing loss usually involved only one ear and may not get better. It is not known if the hearing loss was caused by the medication. If you experience a sudden loss of hearing, sometimes with ringing in the ears or dizziness, while you are taking vardenafil, call your doctor immediately.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( or by phone (1-800-332-1088). Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Vardenafil orally disintegrating tablet should be placed on the tongue where it will disintegrate. Vardenafil orally disintegrating tablet may be taken with or without food.
Vardenafil orally disintegrating tablet 10 mg: White to off-white, round, biconvex, orally disintegrating tablets (not scored) (3) Cardiovascular Effects: Patients should not use vardenafil orally disintegrating tablet if sex is inadvisable due to cardiovascular status. Strong and Moderate CYP3A4 Inhibitors: Do not use vardenafil orally disintegrating tablet in patients taking strong or moderate CYP3A4 inhibitors. Risk of Priapism: In the event that an erection lasts more than 4 hours, the patient should seek immediate medical assistance.
Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website for more information. Keep all medication out of sight and reach of children as many containers are not child-resistant. Place the medication in a safe location – one levitra 40 mg online that is up and away and out of their sight and reach. In case of overdose, call the poison control helpline at 1-800-222-1222.
Information is also available online at If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911. Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription. Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. Effects on the Eye: Patients should stop use of vardenafil orally disintegrating tablet, 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).
Sudden Hearing Loss: Patients should stop vardenafil orally disintegrating tablet and seek medical attention in the event of sudden decrease or loss in hearing. Alpha-Blockers: Caution is advised when PDE5 inhibitors are coadministered with alpha-blockers.
If you ever need emergency medical treatment for a heart problem, the health care providers who treat you will need to know when you last took vardenafil. if you have phenylketonuria (PKU, an inherited condition in which a special diet must be followed to prevent damage to your brain that can cause severe intellectual disability), you should know that the rapidly disintegrating tablets are sweetened with aspartame, a source of phenylalanine. if you have fructose intolerance (an inherited condition in which the body lacks the protein needed to break down fructose,[a fruit sugar found in certain sweeteners such as sorbitol]), you should know that the the rapidly disintegrating tablets are sweetened with sorbitol. Tell your doctor if you have fructose intolerance. Talk to your doctor about eating grapefruit or drinking grapefruit juice while taking this medicine.
erection that lasts longer than 4 hours sudden severe loss of vision (see below for more information) changes in color vision (seeing blue tinge on objects, difficulty telling the difference between blue and green, or difficulty seeing at night) swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs Call your doctor if you have any unusual problems while taking this medication. Some patients experienced a sudden loss of some or all of their vision after they took vardenafil or other medications that are similar to vardenafil. The vision loss was permanent in some cases. It is not known if the vision loss was caused by the medication. If you experience a sudden loss of vision while you are taking vardenafil, call your doctor immediately. QT Prolongation: Patients with congenital QT syndrome or taking class IA or III antiarrhythmics should avoid using vardenafil orally disintegrating tablet.
Vardenafil orally disintegrating tablet 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 online levitra pharmacy an increased risk of NAION. (5.4, 6.2)Sudden Hearing Loss: Patients should stop vardenafil orally disintegrating tablet 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. In some patients, concomitant use of these two drug classes can lower blood pressure significantly leading to symptomatic hypotension (for example, fainting). Phenylketonurics: Each vardenafil orally disintegrating tablet contains 3.36 mg phenylalanine per tablet, which could be harmful for patients with phenylketonuria. Adverse reactions reported by ≥ 2% of patients treated with vardenafil orally disintegrating tablet: Headache, flushing, nasal congestion, dyspepsia, dizziness, back pain. To report SUSPECTED ADVERSE REACTIONS, contact Macleods Pharma USA, Inc., at 1-888-943-3210 or 1-855-926-3384 or FDA at 1-800-FDA-1088 or Vardenafil orally disintegrating tablet can potentiate the hypotensive effects of nitrates, alpha-blockers, and antihypertensives.