Valif

Valif, containing the active ingredient Vardenafil, is a prescription medication specifically formulated to address erectile dysfunction (ED) in adult men. As a potent and selective phosphodiesterase type 5 (PDE5) inhibitor, Valif works by increasing blood flow to the penis, facilitating the achievement and maintenance of an erection sufficient for satisfactory sexual activity. It represents a clinically validated therapeutic option for individuals seeking to overcome the physiological challenges associated with ED, thereby improving sexual function and overall quality of life. This medication is intended for use under proper medical supervision and is not indicated for use by women or children.

Features

• Active Pharmaceutical Ingredient: Vardenafil (as Vardenafil Hydrochloride Trihydrate).
• Available Dosage Strengths: 5mg, 10mg, and 20mg film-coated tablets.
• Pharmacological Class: Selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).
• Mechanism of Action: Enhances the effect of nitric oxide by inhibiting PDE5, which is responsible for the degradation of cGMP in the corpus cavernosum.
• Onset of Action: Typically within 25-60 minutes post-administration.
• Duration of Effect: The therapeutic window for efficacy can last up to 4-5 hours.
• Administration: For oral intake, with or without food (though a high-fat meal may delay absorption).
• Prescription Status: Available only with a valid prescription from a licensed healthcare provider.

Benefits

• Facilitates Reliable Erections: Provides a high probability of achieving and sustaining an erection when sexually stimulated, directly targeting the physical aspect of ED.
• Improves Sexual Confidence: Success in sexual performance can significantly reduce anxiety and psychological barriers associated with ED, enhancing self-esteem and relationship satisfaction.
• Offers Dosing Flexibility: Available in multiple strengths allows for personalized treatment plans, enabling physicians to tailor the dose for optimal efficacy and tolerability for each individual.
• Predictable and Rapid Onset: The known pharmacokinetic profile allows for effective planning of sexual activity, contributing to a more natural and spontaneous experience.
• Clinically Proven Efficacy: Supported by robust clinical trial data demonstrating significant improvement in erectile function compared to placebo across various ED severities and etiologies.

Common use

Valif is primarily and exclusively indicated for the treatment of erectile dysfunction (ED) in adult males. Erectile dysfunction is defined as the persistent inability to achieve or maintain an erection sufficient for satisfactory sexual performance. The medication is used on an as-needed basis prior to anticipated sexual activity. It is not an aphrodisiac and requires sexual stimulation to be effective. Valif is used by men whose ED has various underlying causes, including vasculogenic, neurogenic, and psychogenic origins, or a combination thereof. Its use is part of a broader approach to managing ED, which may include psychological counseling and addressing underlying health conditions such as diabetes or hypertension.

Dosage and direction

The recommended starting dose for most patients is 10mg, taken orally approximately 25 to 60 minutes before sexual activity. The dosage may be adjusted based on efficacy and tolerability to a maximum recommended dose of 20mg or down to 5mg.

• Administration: The tablet should be swallowed whole with a glass of water. It can be taken with or without food. However, consumption with a high-fat meal may delay the time until the medication begins to work.
• Dosing Frequency: Valif should not be taken more than once in a 24-hour period.
• Dose Adjustment: For elderly patients (over 65 years), those with hepatic impairment (moderate to severe liver cirrhosis), or those taking certain concomitant medications (e.g., certain alpha-blockers, potent CYP3A4 inhibitors like ketoconazole or ritonavir), a lower starting dose of 5mg is recommended. The maximum dose for these populations may also be limited.
• Renal Impairment: Dose adjustment is not required in patients with mild to moderate renal impairment. Caution is advised in patients with severe renal impairment, and a starting dose of 5mg should be considered.

A healthcare professional must determine the appropriate dosage based on the patient’s health status and other individual factors.

Precautions

• Cardiovascular Status: Sexual activity poses a potential cardiac risk. Valif is not for use in men for whom sexual activity is inadvisable due to underlying cardiovascular status. Patients should be evaluated for cardiovascular health before initiating any treatment for ED.
• Priapism: Prolonged and sometimes painful erections lasting more than 4 hours have been reported infrequently with PDE5 inhibitors. This condition requires immediate medical attention to prevent long-term damage to the penile tissues.
• Sudden Hearing Loss/LVision Loss: There have been post-marketing reports of sudden decrease or loss of hearing, sometimes with tinnitus and dizziness, and sudden vision loss in one or both eyes (NAION). It is not possible to determine if these events are related directly to Valif use. Patients should seek immediate medical attention if these symptoms occur.
• Anatomical Deformities: Men with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie’s disease) or conditions that may predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia) should use Valif with caution.
• Effects on Bleeding: PDE5 inhibitors have been shown to potentiate the antiplatelet effect of nitric oxide. Use with caution in patients with bleeding disorders or active peptic ulceration.
• Use with Other ED Treatments: The safety and efficacy of combinations of Valif with other treatments for ED have not been studied. Therefore, the use of such combinations is not recommended.

Contraindications

Valif is strictly contraindicated in the following patient populations:

• Concomitant Nitrate Therapy: Patients using any form of organic nitrates (e.g., nitroglycerin, isosorbide mononitrate or dinitrate) or nitric oxide donors (e.g., amyl nitrite or “poppers”) either regularly or intermittently. The concomitant use can lead to a dangerous, potentially fatal, drop in blood pressure.
• Concomitant Guanylate Cyclase (GC) Stimulators: Patients using riociguat (Adempas®), as the combination may cause symptomatic hypotension.
• Hypersensitivity: Patients with a known hypersensitivity to Vardenafil or any of the excipients in the Valif formulation.

Possible side effect

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

Very Common (≥1/10):

• Headache

Common (≥1/100 to <1/10):

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

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
• Visual disturbances (blurred vision, changes in color vision)
• Hypersensitivity reactions (including rash, hives)

Frequency Not Known:

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

Drug interaction

Valif is primarily metabolized by the hepatic enzyme CYP3A4, with contributions from CYP3A5 and CYP2C isoforms. Concomitant use with drugs that affect these pathways can alter its plasma concentration.

• Nitrates and GC Stimulators: Absolute contraindication (see Contraindications).
• Potent CYP3A4 Inhibitors: Drugs like ketoconazole, itraconazole, ritonavir, indinavir, atazanavir, and clarithromycin significantly increase Vardenafil plasma levels. A maximum dose of 5mg Valif within a 24-hour period is recommended if co-administration is necessary.
• Moderate CYP3A4 Inhibitors: Drugs like erythromycin and aprepitant may increase Vardenafil exposure. Consider a starting dose of 5mg and careful monitoring.
• Alpha-Blockers: Concomitant use can lead to symptomatic hypotension (dizziness, lightheadedness, fainting). Alpha-blocker therapy should be stable before initiating Valif at the lowest dose (5mg). Dose titration of the alpha-blocker should be done with caution.
• Other Antihypertensives: Valif may add to the blood-pressure-lowering effect of other antihypertensive medications.
• Alcohol: Excessive alcohol consumption (≥5 units) in combination with Valif may increase the potential for orthostatic signs and symptoms, such as increased heart rate, decreased standing blood pressure, dizziness, and headache.

Missed dose

Valif is not intended for regular daily dosing but 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 one. Simply take the next dose when planned before sexual activity, ensuring at least 24 hours have passed since the last dose.

Overdose

In cases of overdose, the expected primary pharmacologic effects would be an extension of its side effects, primarily severe hypotension and syncope.

• Symptoms: Severe headache, pronounced flushing, dizziness, fainting, and potentially prolonged and painful erection (priapism).
• Management: Standard supportive measures should be adopted as required. This includes placing the patient in the supine position with the head low to help restore blood pressure and ensure adequate fluid intake. Renal dialysis is not expected to accelerate clearance as Vardenafil is highly protein-bound. In the event of priapism, immediate medical assistance is mandatory.

Storage

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

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

• “After discussing options with my urologist, we settled on Valif 10mg. The effect is consistent and predictable. It has significantly reduced the performance anxiety I was experiencing and has had a very positive impact on my relationship.” – M.C., 52
• “I found Valif to be effective, but I experienced quite noticeable facial flushing and a stuffy nose. My doctor suggested trying a lower 5mg dose, which provided a good balance of efficacy with fewer side effects for me.” – A.B., 48
• “As a healthcare provider, I appreciate the predictable pharmacokinetic profile of Vardenafil. It allows for effective patient counseling on timing. It’s a valuable tool in our arsenal for treating appropriate patients with ED.” – Dr. E.L., Urologist
• “I tried another medication first but experienced visual side effects. My doctor switched me to Valif, and I have had no such issues. It works well for me with just a minor headache afterward on occasion.” – R.K., 61