16 HOW SUPPLIED/STORAGE AND HANDLING

(5.12)ADVERSE REACTIONSAdverse reactions reported by ≥ 2% of patients treated with vardenafil orally disintegrating tablet: Headache, flushing, nasal congestion, dyspepsia, dizziness, back pain.

Are there OTHER USES for this medicine?

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. Talk to online levitra sale 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.

Pharmaceuticals and personal care products in the environment: what are the big questions?

Place the medication in a safe location – one 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. (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. (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.

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(7.2)USE IN SPECIFIC POPULATIONSSee 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 1/2025 Warnings and Precautions prescription free levitra (5.4) 08/2017 Vardenafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction.

2.1 General

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. 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.

Drug effects

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). 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.

What happens if I miss a dose?

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. 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.

Are you currently using Vardenafil (Levitra, Staxyn)?

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 levitra tablets 5mg taken as needed, orally, approximately 60 minutes before sexual activity. Vardenafil orally disintegrating tablet should be placed on the tongue where it will disintegrate.

Side Effect	Incidence Rate	Severity	Recommended Action	Notes
Headache	Common	Mild	Hydrate and rest	Usually temporary
Flushing	Common	Mild	Cool compress	Usually subsides
Dizziness	Less common	Mild	Sit or lie down temporarily	Be cautious when standing
Nasal Congestion	Rare	Mild	Use of nasal spray if needed	Usually transient

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.

Formulation	Average Cost per Dose	Convenience	Onset Speed	Storage	Notes
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Generic versions	$3 - $7 per dose	Varies	Similar	Varies	Cost-effective alternative

Risk of Priapism: In the event that an erection lasts more than 4 hours, the patient should seek immediate medical assistance. 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.

• Patients should inform their doctor of all medications.
• Interactions with nitrate drugs are dangerous.
• Always consult before combining with other medicines.

QT Prolongation: Patients with congenital QT syndrome or taking class IA or III antiarrhythmics should avoid using vardenafil orally disintegrating tablet.

Erection Scale

(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. (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.

Oral medications

(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). 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 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. 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. Do not use vardenafil orally disintegrating tablet with moderate or strong CYP3A4 inhibitors as coadministration will result in significant increases in plasma vardenafil concentrations. See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

• The safety of liquid Levitra has been studied in clinical trials.
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• Regular check-ups are recommended during use.

Table of Contents FULL PRESCRIBING INFORMATION: CONTENTS*1 INDICATIONS & USAGE2 DOSAGE & ADMINISTRATION2.1 General2.2 Use with Food2.3 Use in Special Populations2.4 Concomitant Medications3 DOSAGE FORMS & STRENGTHS4 CONTRAINDICATIONS4.1 Nitrates4.2 Guanylate Cyclase (GC) Stimulators5 WARNINGS AND PRECAUTIONS5.1 Cardiovascular Effects5.2 Potential for Drug Interactions with Strong or Moderate CYP3A4 Inhibitors5.3 Risk of Priapism5.4 Effects on the Eye5.5 Sudden Hearing Loss5.6 Alpha-Blockers5.7 Congenital or Acquired QT Prolongation5.8 Hepatic Impairment5.9 Renal Impairment5.10 Combination with Other Erectile Dysfunction Therapies5.11 Effects on Bleeding5.12 Phenylketonurics5.13 Fructose Intolerance5.14 Sexually Transmitted Disease6 ADVERSE REACTIONS6.1 Clinical Studies Experience6.2 Postmarketing Experience7 DRUG INTERACTIONS7.1 Potential for Pharmacodynamic Interactions with vardenafil orally disintegrating tablet7.2 Effect of Other Drugs on Vardenafil7.3 Effects of Vardenafil on Other Drugs8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy8.2 Lactation8.4 Pediatric Use8.5 Geriatric Use8.6 Hepatic Impairment8.7 Renal Impairment10 OVERDOSAGE11 DESCRIPTION12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action12.2 Pharmacodynamics12.3 Pharmacokinetics13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis & Mutagenesis & Impairment of Fertility14 CLINICAL STUDIES14.1 Other Vardenafil Clinical Trials Using Film-Coated Tablets16 HOW SUPPLIED/STORAGE AND HANDLING16.1 How Supplied16.2 Recommended Storage17 PATIENT COUNSELING INFORMATION*Sections or subsections omitted from the full prescribing information are not listed.

Future directions in treatment

(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 orally disintegrating tablet. (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.