Levitra Soft (vardenafil) is an orally disintegrating tablet formulation designed for the effective management of erectile dysfunction (ED). This medication belongs to the class of phosphodiesterase type 5 (PDE5) inhibitors, offering a convenient and discreet alternative to traditional film-coated tablets. Its soft tab design allows for rapid dissolution in the mouth without the need for water, facilitating quicker onset of action. Clinically proven to improve erectile function, Levitra Soft works by increasing blood flow to the penis, enabling a natural response to sexual stimulation. It is a preferred option for patients seeking both efficacy and administration convenience.

Features

• Active ingredient: Vardenafil HCl (10mg or 20mg per tablet)
• Formulation: Orally disintegrating tablet (ODT)
• Pharmacological class: Phosphodiesterase type 5 (PDE5) inhibitor
• Administration: Sublingual or buccal placement; dissolves rapidly without water
• Onset of action: As fast as 15-25 minutes post-administration
• Duration of effect: Up to 4-6 hours
• Packaging: Blister packs for stability and portability

Benefits

• Enables the achievement and maintenance of firm erections sufficient for sexual activity.
• Offers a discreet and convenient administration method, independent of water intake, suitable for various settings.
• Provides a rapid onset of action, allowing for more spontaneous sexual activity compared to some other ED treatments.
• Delivers a reliable duration of effect, providing a sufficient window for satisfactory sexual engagement.
• Supports improved sexual confidence and reduces anxiety related to sexual performance.
• Contributes to the enhancement of overall sexual satisfaction for both the individual and their partner.

Common use

Levitra Soft is primarily indicated for the treatment of erectile dysfunction (ED) in adult men. Erectile dysfunction is characterized by the consistent or recurrent inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. The medication is used on an as-needed basis prior to anticipated sexual activity. It is not intended for use by women, children, or adolescents. Its use is predicated on the presence of sexual stimulation; it will not cause an erection spontaneously.

Dosage and direction

The recommended starting dose for most patients is 10 mg, taken approximately 15-60 minutes before sexual activity. Based on efficacy and tolerability, the dose may be increased to a maximum recommended dose of 20 mg or decreased to 5 mg. The dosing frequency should not exceed once per 24-hour period.

Directions for Use:

1. Remove the tablet from the blister pack immediately before use. Do not push the tablet through the foil.
2. Place the tablet on the tongue. It will disintegrate rapidly within seconds.
3. Swallow the resulting particles with saliva. Water is not needed to aid swallowing.
4. The tablet can be taken with or without food. However, consumption with a high-fat meal may delay the onset of action.

Precautions

• Prior to prescribing Levitra Soft, a thorough medical history and physical examination should be conducted to diagnose ED, determine potential underlying causes, and identify appropriate treatment options.
• Cardiovascular Status: Sexual activity carries a potential cardiac risk. Therefore, Levitra Soft should not be used in men for whom sexual activity is inadvisable due to underlying cardiovascular status. Patients with pre-existing cardiovascular disease were not included in clinical trials; therefore, use in these patients is not recommended until appropriate evaluation is completed.
• Prolonged Erection: Patients who experience an erection lasting more than 4 hours (priapism) should seek immediate medical attention. Permanent damage to the penile tissues can occur if priapism is not treated promptly.
• Sudden Vision Loss: Non-arteritic anterior ischemic optic neuropathy (NAION) has been reported rarely post-marketing in connection with PDE5 inhibitor use. It is not possible to determine if these events are related directly to the drug or other factors. Patients who experience a sudden loss of vision should discontinue use and seek immediate medical care.
• Sudden Hearing Loss: Cases of sudden decrease or loss of hearing have been reported. Patients who experience such symptoms should discontinue Levitra Soft and seek prompt medical attention.
• Underlying Medical Conditions: Use with caution in patients with anatomical deformation of the penis (e.g., angulation, cavernosal fibrosis, or Peyronie’s disease), or in patients who have conditions that may predispose them to priapism (e.g., sickle cell anemia, multiple myeloma, or leukemia).
• Renal or Hepatic Impairment: Dose adjustment is recommended for patients with moderate to severe renal impairment and mild to severe hepatic impairment. A starting dose of 5 mg is recommended for patients with moderate hepatic impairment.

Contraindications

Levitra Soft is contraindicated in patients with:

• A known hypersensitivity to vardenafil or any of the tablet’s excipients.
• The concurrent use of organic nitrates or nitric oxide donors (e.g., amyl nitrite “poppers”) in any form, either regularly or intermittently. Concomitant use can lead to a profound and potentially life-threatening drop in blood pressure.
• The concurrent use of guanylate cyclase stimulators, such as riociguat.
• A history of non-arteritic anterior ischemic optic neuropathy (NAION).

Possible side effects

Like all medicines, Levitra Soft can cause side effects, although not everybody gets them. The most common side effects are usually mild to moderate and transient.

Very common (≥1/10):

• Headache

Common (≥1/100 to <1/10):

• Flushing (feeling of warmth in the face, neck, or chest)
• Nasal congestion (stuffy nose)
• Dyspepsia (indigestion)
• Dizziness

Uncommon (≥1/1,000 to <1/100):

• Palpitations
• Tachycardia (increased heart rate)
• Nausea
• Back pain
• Myalgia (muscle pain)
• Increased creatine kinase

Rare (≥1/10,000 to <1/1,000):

• Hypotension (low blood pressure)
• Syncope (fainting)
• Priapism (prolonged and painful erection)
• Visual disturbances (e.g., blurred vision, changes in color vision)
• Tinnitus (ringing in the ears)
• Hearing impairment

Frequency not known:

• Non-arteritic anterior ischemic optic neuropathy (NAION)
• Sudden hearing loss
• Seizures

Drug interaction

The concomitant use of Levitra Soft with other medications can potentiate risks. Key interactions include:

• Nitrates: Concomitant use is contraindicated due to the risk of severe hypotension.
• Alpha-blockers: Concomitant use can potentiate the blood-pressure-lowering effects. This combination should be approached with caution and only when hemodynamic stability has been achieved. A lower starting dose of Levitra Soft (5 mg) should be considered.
• Antihypertensives: Additive effects on blood pressure may occur.
• Potent CYP3A4 Inhibitors: Drugs like ketoconazole, itraconazole, ritonavir, indinavir, atazanavir, and clarithromycin significantly increase vardenafil plasma concentrations. Dose limitations are strict:
  • With ketoconazole, itraconazole, or ritonavir: A maximum dose of 2.5 mg in a 24-hour period.
  • With indinavir or atazanavir: A maximum dose of 2.5 mg in a 24-hour period.
  • With clarithromycin: A maximum dose of 5 mg in a 24-hour period.
• Other PDE5 Inhibitors: Concomitant use with other medications for erectile dysfunction (e.g., sildenafil, tadalafil) is not recommended.

Missed dose

Levitra Soft is not intended for scheduled daily use; it is taken on an as-needed basis. Therefore, the concept of a “missed dose” does not apply. Do not take an extra dose to make up for a missed opportunity. Adhere to the dosing schedule of no more than one dose per 24 hours.

Overdose

In cases of overdose, the expected pharmacologic effects would be an exaggeration of the known dose-related side effects, primarily severe hypotension and syncope. Standard supportive measures should be adopted, including keeping the patient in the supine position with the head lowered to ensure adequate cerebral blood supply. Hemodialysis is not expected to accelerate clearance, as vardenafil is highly protein-bound.

Storage

• Store below 30°C (86°F).
• Keep the tablets in the original blister pack to protect from moisture and light.
• Keep out of the sight and reach of children.
• Do not use after the expiration date printed on the packaging.

Disclaimer

This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or before starting any new treatment. Never disregard professional medical advice or delay in seeking it because of something you have read here. The information provided is not exhaustive and may not cover all possible uses, directions, precautions, interactions, or adverse effects.

Reviews

• “As a urologist with over 15 years of experience, I find the soft tab formulation of vardenafil to be a valuable tool in our arsenal. The rapid disintegration is a significant advantage for patients who dislike swallowing pills or desire more spontaneity. The efficacy profile is consistent with the established vardenafil data.” – Dr. A. Reynolds, MD
• “The switch to Levitra Soft was a game-changer for me. The convenience of not needing water meant I no longer had to plan or excuse myself. It worked reliably within 20 minutes, and the effects lasted for the entire evening. A marked improvement in confidence and experience.” – Verified Patient, 54
• “From a pharmacological standpoint, the orodispersible formulation offers a favorable pharmacokinetic profile with a potentially faster Tmax compared to the standard tablet. This can be particularly beneficial for patient adherence and satisfaction in treating erectile dysfunction.” – Clinical Pharmacist Review