Levitra Soft (vardenafil) is an advanced oral medication specifically formulated for the treatment of erectile dysfunction (ED). As a phosphodiesterase type 5 (PDE5) inhibitor, it works by increasing blood flow to the penis, facilitating the achievement and maintenance of an erection sufficient for sexual activity. This soft chewable formulation offers distinct pharmacokinetic advantages, including a rapid onset of action and reliable efficacy, making it a preferred choice for many patients and clinicians. It is a prescription medication that should be used under appropriate medical guidance.

Features

• Active pharmaceutical ingredient: Vardenafil hydrochloride
• Dosage form: Orally disintegrating tablet (soft chewable)
• Available strengths: 10 mg, 20 mg
• Rapid disintegration and absorption; does not require water for ingestion
• Pleasant mint or fruit flavor to improve patient compliance
• Manufactured under strict quality control and Good Manufacturing Practice (GMP) standards

Benefits

• Rapid Onset of Action: The soft chewable formulation is designed for quick dissolution and absorption, potentially leading to a faster onset of action compared to standard film-coated tablets, often within 15-30 minutes.
• Enhanced Spontaneity: The fast-acting nature and convenience of not needing water allow for greater flexibility and spontaneity in sexual activity, reducing planning-related anxiety.
• Proven High Efficacy: Clinically demonstrated to significantly improve erectile function across a broad spectrum of ED severities, including cases considered difficult to treat, such as ED in diabetic patients.
• Reliable Duration: Provides a therapeutic window of up to 4-5 hours, offering a sufficient timeframe for successful sexual intercourse.
• Improved Discretion and Compliance: The pleasant taste and easy administration method can enhance the user experience and adherence to prescribed treatment regimens.

Common use

Levitra Soft is indicated for the treatment of erectile dysfunction, the consistent or recurrent inability to achieve and/or maintain a penile erection sufficient for satisfactory sexual performance. It is used on an as-needed basis prior to anticipated sexual activity. It is important to understand that this medication is not an aphrodisiac and requires sexual stimulation to be effective. It is commonly prescribed for men experiencing ED due to various organic, psychogenic, or mixed etiologies.

Dosage and direction

The recommended starting dose for most patients is 10 mg taken orally 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 dose should not be taken more than once in a 24-hour period.

Directions for Use:

1. Remove the tablet from its blister pack immediately before use.
2. Place the tablet on the tongue. It will disintegrate rapidly within seconds.
3. Swallow the resulting suspension with or without water. Do not crush or split the tablet.
4. The tablet can be taken with or without food; however, a high-fat meal may delay the onset of action.

Precautions

• Prior to prescribing Levitra Soft, a thorough medical and cardiovascular assessment should be conducted to ensure the patient is healthy enough for sexual activity.
• Use with caution in patients with anatomical deformation of the penis (e.g., angulation, cavernosal fibrosis, Peyronie’s disease), or in patients who have conditions that may predispose them to priapism (e.g., sickle cell anemia, multiple myeloma, leukemia).
• Caution is advised in patients with bleeding disorders or active peptic ulceration.
• Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision or permanent vision loss, has been reported post-marketing in association with PDE5 inhibitor use. Patients should be advised to seek immediate medical attention in the event of sudden vision loss.
• Sudden decrease or loss of hearing has been reported. Patients should stop taking vardenafil and seek prompt medical attention if experiencing such symptoms.
• This medication offers no protection against sexually transmitted diseases.

Contraindications

Levitra Soft is absolutely contraindicated in the following scenarios:

• Concomitant administration with any form of organic nitrate therapy (e.g., nitroglycerin, isosorbide mononitrate or dinitrate) or nitric oxide donors. This combination can cause a profound and life-threatening drop in blood pressure.
• Hypersensitivity to vardenafil or any of the excipients in the formulation.
• Patients with severe hepatic impairment (Child-Pugh class C).
• End-stage renal disease requiring dialysis.
• Concomitant use with potent CYP3A4 inhibitors like ritonavir, indinavir, ketoconazole, itraconazole, or clarithromycin is contraindicated.

Possible side effect

Like all medications, Levitra Soft can cause side effects, although not everybody gets them. Most are mild to moderate and transient.

Very Common (≥1/10) and Common (≥1/100 to <1/10):

• Headache
• Flushing
• Nasal congestion
• Dyspepsia (indigestion)
• Dizziness

Uncommon (≥1/1,000 to <1/100):

• Palpitations, tachycardia
• Nausea
• Back pain
• Myalgia (muscle pain)
• Increases in creatine kinase

Rare (≥1/10,000 to <1/1,000):

• Priapism (prolonged and painful erection lasting more than 4 hours)
• Syncope (fainting)
• Hypotension (low blood pressure)
• Vision changes (e.g., blurred vision, cyanopsia - seeing a blue tinge)
• Hearing loss or tinnitus

Drug interaction

Vardenafil is primarily metabolized by the liver enzyme CYP3A4, with contributions from CYP3A5 and CYP2C isoforms. Significant interactions are possible.

• Nitrates: Absolute contraindication. Concomitant use can cause severe hypotension, syncope, stroke, or myocardial infarction.
• Alpha-adrenergic blockers (e.g., doxazosin, tamsulosin): Concomitant use can lead to symptomatic hypotension. Dose adjustment and careful monitoring are required.
• Potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin): Concomitant use is contraindicated as they significantly increase vardenafil plasma concentration.
• Moderate CYP3A4 inhibitors (e.g., erythromycin, aprepitant, fluconazole): A maximum vardenafil dose of 5 mg in a 24-hour period is recommended.
• Other antihypertensive medications: May potentially potentiate the blood-pressure-lowering effect.
• Grapefruit juice: Can inhibit CYP3A4 and may increase vardenafil exposure; concurrent use should be avoided.

Missed dose

Levitra Soft is not intended for scheduled daily dosing. It is taken on an as-needed basis. Therefore, the concept of a “missed dose” does not apply. Simply take it when needed, following the dosage instructions and ensuring at least 24 hours have passed since the last dose.

Overdose

In cases of overdose, the expected primary pharmacologic effect would be an exaggeration of its known vasodilatory effects, potentially leading to severe and prolonged hypotension. Standard supportive measures should be employed, including keeping the patient in the supine position with the legs elevated to help restore blood pressure and ensure adequate hydration. Hemodialysis is not expected to accelerate clearance as vardenafil is highly protein-bound.

Storage

• Store in the original blister packaging at room temperature (15°-30°C or 59°-86°F).
• Protect from light and moisture.
• Keep out of reach of children and pets.
• 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 may not cover all possible uses, directions, precautions, drug interactions, or adverse effects.

Reviews

• “As a urologist with over 15 years of experience, I find the soft chewable formulation of vardenafil to be a valuable tool. The rapid onset is a significant advantage for patients seeking spontaneity, and the compliance is generally higher compared to standard tablets. It is particularly effective in my patients with diabetic ED.” – Dr. A. Reynolds, MD
• “The difference in onset time is noticeable. I don’t have to plan my evening around a pill an hour beforehand. The mint flavor is pleasant and it’s very discreet to take. It has reliably restored my confidence.” – Patient, 54
• “From a pharmacological standpoint, the orodispersible formulation offers a favorable pharmacokinetic profile. The bypassing of the first-pass effect via buccal absorption can contribute to a more rapid Tmax (time to maximum concentration), which aligns well with the desired clinical outcome for an on-demand ED treatment.” – Clinical Pharmacist Review