Vardenafil Tablets
(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.
| Drug Category | Potential Interaction | Effect |
|---|---|---|
| Nitrates | Dangerous hypotension | Severe decrease in blood pressure |
| CYP3A4 Inhibitors | Increased vardenafil levels | Increased side effects |
| Alpha-blockers | Risk of hypotension | Dizziness, fainting |
| Pesticides (e.g., erythromycin) | Possible increased plasma levels | Enhanced side effects |
(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.
Frequently asked questions
For oral dosage form (disintegrating tablets):Adults—10 milligrams (mg) as a single dose, no more than once per day, approximately 1 hour before sexual activity.Children—Use is not recommended. Adults—10 milligrams (mg) as a single dose, no more than once per day, approximately 1 hour before sexual activity. For oral dosage form (tablets):Adults 65 years and older—5 milligrams (mg) as a single dose, no more than once per day, approximately 1 hour before sexual activity. Adults 65 years and older—5 milligrams (mg) as a single dose, no more than once per day, approximately 1 hour before sexual activity. However, the dose is usually not more than 20 mg once per day.
Who should not take vardenafil?
Adults up to 65 years—10 mg as a single dose, no more than once per day, approximately 1 hour before sexual activity. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed. Ask your healthcare professional how you should dispose of any medicine you do not use. (6.1)To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals Limited at 1-866-210-9797 or FDA at 1-800-FDA-1088 or INTERACTIONS• Vardenafil hydrochloride orally disintegrating tablets can potentiate the hypotensive effects of nitrates, alpha-blockers, and antihypertensives.
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(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.
- Vardenafil’s patent protection has expired, leading to generic options.
- Side effects can diminish over time with continued use.
- Do not share medication with others.
- Always check for interactions with other medications.
(7.2)USE IN SPECIFIC POPULATIONSSee 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 7/2025 Warnings and Precautions (5.2) 4/2023 • Vardenafil hydrochloride orally disintegrating tablets are phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction.
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If you already use medicine for high blood pressure (hypertension), vardenafil could make your blood pressure go too low. Call your doctor right away if you have blurred vision, confusion, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, sweating, or unusual tiredness or weakness. This medicine does not protect you against sexually transmitted diseases (including HIV or AIDS). Use protective measures and ask your doctor if you have any questions about this. Do not take other medicines unless they have been discussed with your doctor.
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This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements. Along ed medications with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Check with your doctor immediately if any of the following side effects occur: dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position fast, irregular, pounding, or racing heartbeat or pulse pain or discomfort in the arms, jaw, back, or neck puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. • Vardenafil hydrochloride orally disintegrating tablets are not interchangeable with vardenafil 10 mg film-coated tablets (LEVITRA). • Vardenafil hydrochloride orally disintegrating tablets are taken as needed, orally, approximately 60 minutes before sexual activity.
Dose Adjustments
(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. In some patients, concomitant use of these two drug classes can lower blood pressure significantly leading to symptomatic hypotension (for example, fainting). In patients taking alpha-blockers, do not initiate vardenafil therapy with vardenafil hydrochloride orally disintegrating tablets. (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. • The maximum recommended dosing frequency is one tablet per day. • Vardenafil hydrochloride orally disintegrating tablets should be placed on the tongue where it will disintegrate.
7.3 Effects of Vardenafil on Other Drugs
It is important that you tell all of your doctors that you take vardenafil. If you need emergency medical care for a heart problem, it is important that your doctor knows when you last took vardenafil. Do not use this medicine if you are also using a nitrate medicine for angina or high blood pressure. Some examples of nitrate medicines include nitroglycerin, isosorbide, Imdur®, Nitro-Bid®, Nitro-Dur®, Nitrol® ointment, Nitrolingual® spray, Nitrostat®, and Transderm Nitro®. Some illegal ("street") drugs called "poppers" also contain nitrates such as amyl nitrate and butyl nitrate.
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Do not use this medicine if you also use riociguat (Adempas®). If you experience a prolonged or painful erection for 4 hours or more, contact your doctor right away. This condition may require prompt medical treatment to prevent serious and permanent damage to your penis. If you have a sudden loss of vision in one or both eyes, contact your doctor right away. Check with your doctor right away if you have a sudden decrease in hearing or loss of hearing with dizziness or ringing in the ears. • Vardenafil hydrochloride orally disintegrating tablets may be taken with or without food.
- Vardenafil can cause dizziness or vision changes.
- It is contraindicated if you have severe heart conditions.
- Food, especially high-fat meals, can delay effects.
- Always follow the prescribed dosage instructions.
• Vardenafil hydrochloride orally disintegrating tablets 10 mg: White to off white, round, orally disintegrating tablets (not scored) (3) • Cardiovascular Effects: Patients should not use vardenafil hydrochloride orally disintegrating tablets if sex is inadvisable due to cardiovascular status.
4.2 Guanylate Cyclase (GC) Stimulators
(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. (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.
Drug Interactions
(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). 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. Patients with a “crowded” optic disc may also be at an increased risk of NAION. • Strong and Moderate CYP3A4 Inhibitors: Do not use vardenafil hydrochloride orally disintegrating tablets in patients taking strong or moderate CYP3A4 inhibitors.
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Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: Feeling of warmth and redness of the face, neck, arms, and occasionally, upper chest burning feeling in the chest or stomach burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings feeling of constant movement of self or surroundings increased sensitivity of the eyes to sunlight sores, ulcers, or white spots on the lips or tongue or inside the mouth Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. You may report side effects to the FDA at 1-800-FDA-1088. If you are a consumer or patient please visit this version.
Dosage for people taking certain interacting medications
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 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. (1).DOSAGE AND ADMINISTRATION• Vardenafil hydrochloride orally disintegrating tablets are not interchangeable with vardenafil 10 mg film-coated tablets (LEVITRA). Vardenafil hydrochloride orally vidalista 20mg uk disintegrating tablets provide higher systemic exposure compared to vardenafil 10 mg film-coated tablets (LEVITRA). • Risk of Priapism: In the event that an erection lasts more than 4 hours, the patient should seek immediate medical assistance.
| Condition | Explanation |
|---|---|
| Use with Nitrates | Can cause severe hypotension |
| Severe Liver Impairment | Metabolism may be impaired, risk of accumulation |
| Retinitis Pigmentosa | Potential risk of worsening vision |
| Hypotension or Uncontrolled Hypertension | Risks of blood pressure fluctuations |
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