Varditra (Vardenafil) – Complete Product Information

Product Name: VARDITRA
Active Ingredient: Vardenafil (as Vardenafil Hydrochloride)
Available Strengths: 10 mg, 20 mg, 40 mg, 60 mg
Dosage Form: Film-coated Oral Tablets
Manufacturer: Healing Pharma India Pvt. Ltd.
Prescription Category: Prescription-Only Medicine (Rx)

What is Varditra?

Varditra is a prescription medication containing vardenafil, which works as a selective inhibitor of phosphodiesterase type 5 (PDE5). This medicine is primarily indicated for adult men experiencing erectile dysfunction (ED), a condition characterized by the inability to achieve or maintain an erection sufficient for satisfactory sexual activity.

Varditra belongs to the same class of medications as other well-known ED treatments and works by increasing blood flow to the penis during sexual stimulation. It’s important to understand that this medication requires sexual stimulation to be effective and does not increase sexual desire.

How Does Varditra Work? (Mechanism of Action)

When a man experiences sexual arousal, the body naturally releases nitric oxide in the penile tissue. This triggers an enzyme that increases levels of a substance called cyclic guanosine monophosphate (cGMP). The cGMP helps relax smooth muscle tissue in the penis, allowing blood vessels to widen and blood flow to increase, which results in an erection.

In men with erectile dysfunction, an enzyme called PDE5 breaks down cGMP too quickly, making it difficult to achieve or maintain an erection. Vardenafil inhibits PDE5, preventing the premature breakdown of cGMP. This allows the natural erectile response to sexual stimulation to occur more effectively.

Key Point: Varditra does not cause an automatic erection. Sexual stimulation is still required for the medication to work effectively.

Approved Uses and Therapeutic Benefits

Varditra is specifically approved for:

• Treatment of Erectile Dysfunction (ED): Helps adult men achieve and maintain erections suitable for sexual activity when sexually stimulated

• Improved Erectile Function: Supports better blood flow to penile tissue during arousal

• Enhanced Confidence: May help reduce performance anxiety associated with ED

• Suitable for Various ED Causes: Can be beneficial for men with ED related to psychological factors, physical conditions, or a combination of both

• Diabetic Neuropathy Support: May be helpful for men experiencing ED related to diabetes-related nerve complications

Important: Varditra treats the symptoms of erectile dysfunction but is not a cure for the underlying condition. It does not protect against sexually transmitted diseases or serve as a contraceptive.

Dosage Guidance and Administration

General Dosing Information

The typical starting dose is 10 mg taken approximately 60 minutes before anticipated sexual activity. Based on effectiveness and tolerability, your healthcare provider may adjust your dose.

Important Administration Guidelines:

• Timing: Take approximately 30-60 minutes before sexual activity • Frequency: Do not take more than one dose per day • With or Without Food: Can be taken with or without meals • Swallowing: Swallow the tablet whole with water; do not crush, chew, or break • Sexual Stimulation Required: The medication will only work when combined with sexual arousal

Dosage Adjustments:

Your doctor may prescribe a different dose based on:

• Your age (those 65 and older may require lower doses)
• Liver or kidney function
• Other medications you’re taking
• Your response to treatment
• Overall health status

Medical Supervision Required: All dosing decisions should be made by a qualified healthcare provider. Never adjust your dose without consulting your doctor.

Potential Side Effects

Like all medications, Varditra may cause side effects, although not everyone experiences them.

Common Side Effects:

• Headache • Flushing (warmth, redness in face, neck, or chest) • Nasal congestion or stuffy nose • Indigestion or upset stomach • Dizziness or lightheadedness • Back pain • Nausea • Vision changes (mild color tinge or blurred vision)

These effects are generally mild and temporary, often subsiding as your body adjusts to the medication.

Serious Side Effects Requiring Immediate Medical Attention:

• Priapism: Erection lasting more than 4 hours (requires emergency treatment) • Sudden vision loss in one or both eyes • Sudden hearing loss or ringing in the ears • Chest pain, irregular heartbeat, or shortness of breath during or after sexual activity • Severe dizziness or fainting • Allergic reactions: Rash, itching, swelling, severe dizziness, difficulty breathing

Emergency Action: If you experience a prolonged erection (priapism) or sudden vision/hearing loss, seek immediate medical care to prevent permanent damage.

Comparison Table: Varditra vs Other ED Medications

Note: All PDE5 inhibitors work similarly but may vary in onset time, duration, and individual response. Your healthcare provider can help determine which medication is most appropriate for your specific needs.

Drug Interactions and Medical Warnings

Contraindicated Medications (DO NOT USE TOGETHER):

Nitrates: Combining vardenafil with nitrates can cause a dangerous drop in blood pressure. These include:

• Nitroglycerin (Nitrostat, Nitro-Dur)
• Isosorbide mononitrate and dinitrate
• Recreational drugs (“poppers”) containing amyl or butyl nitrite

Guanylate Cyclase Stimulators:

• Riociguat (Adempas)
• Vericiguat (Verquvo)

Medications Requiring Dose Adjustment or Caution:

Alpha-Blockers: May cause additive blood pressure lowering (e.g., tamsulosin, alfuzosin, doxazosin)

Antihypertensive Medications: Blood pressure medicines may interact with Varditra

CYP3A4 Inhibitors: Medications like ritonavir and erythromycin significantly increase vardenafil levels and require dose adjustments. These include:

• HIV protease inhibitors (ritonavir, indinavir)
• Certain antibiotics (erythromycin, clarithromycin)
• Antifungal medications (ketoconazole, itraconazole)

Grapefruit Juice: May increase vardenafil levels; avoid consumption while taking this medication

General Warnings:

• Inform your healthcare provider of all medications, supplements, and herbal products you’re taking • Varditra can cause sudden blood pressure decreases • May cause dizziness; avoid driving or operating machinery until you know how it affects you • Limit or avoid alcohol consumption, which may increase side effects • Not for use in women or children

Who Should Avoid or Use Varditra with Caution?

DO NOT USE if you:

• Are taking nitrate medications for chest pain or heart conditions • Are using recreational drugs containing nitrates (“poppers”) • Are taking guanylate cyclase stimulators • Have been advised by your doctor to avoid sexual activity due to heart problems • Are allergic to vardenafil or any ingredients in Varditra • Are a woman or child (not indicated for these populations)

Use with CAUTION and Medical Supervision if you have:

• Cardiovascular conditions: Heart disease, recent heart attack, stroke, irregular heartbeat, or uncontrolled blood pressure • Anatomical penile abnormalities: Peyronie’s disease, angulation, or cavernosal fibrosis • Conditions predisposing to priapism: Sickle cell anemia, multiple myeloma, or leukemia • Bleeding disorders or active peptic ulcers • Severe liver or kidney disease • Retinal disorders or history of vision problems • QT prolongation or family history of Long QT syndrome • Severe hypotension (low blood pressure)

Age Considerations:

Elderly men (65 years and older) may experience higher drug levels and should typically start with a lower dose under medical supervision.

Consult Your Doctor: Always disclose your complete medical history and current medications to ensure Varditra is safe for you.

Proper Storage and Handling Instructions

To maintain the quality and effectiveness of Varditra:

Storage Guidelines:

• Temperature: Store at room temperature between 59°F to 86°F (15°C to 30°C) • Location: Keep in a cool, dry place away from moisture and direct sunlight • Humidity: Protect from excessive moisture • Original Packaging: Keep tablets in their original blister packs until use

Safety Precautions:

• Keep out of reach of children and pets • Do not use tablets if the blister pack is damaged or opened • Do not share your medication with others • Dispose of expired or unused medication properly according to local regulations • Check expiration date before use

Frequently Asked Questions (FAQs)

1. How quickly does Varditra work?

Varditra typically begins working within 30 to 60 minutes after taking the tablet. For optimal results, take it approximately one hour before planned sexual activity. Remember that sexual stimulation is necessary for the medication to work.

2. Can I take Varditra with food?

Yes, Varditra can be taken with or without food. Unlike some ED medications, high-fat meals have minimal effect on vardenafil absorption, though very heavy meals might slightly delay its onset of action.

3. How long do the effects of Varditra last?

The effects of vardenafil typically last approximately 4 to 5 hours. This doesn’t mean you’ll have an erection for this entire period, but rather that you’ll be able to achieve erections more easily during this time frame when sexually stimulated.

4. What should I do if Varditra doesn’t work for me?

If you don’t experience the desired effect, consult your healthcare provider. They may adjust your dose, check for drug interactions, or explore underlying health conditions. Never increase your dose without medical guidance. It may take several attempts to find the optimal dose for you.

5. Can I drink alcohol while taking Varditra?

While there’s no absolute prohibition, it’s recommended to limit alcohol consumption when taking Varditra. Excessive alcohol can increase the risk of side effects like dizziness, lightheadedness, and low blood pressure. Moderate or avoid alcohol for best results and safety.

6. Does Varditra cure erectile dysfunction permanently?

No, Varditra treats the symptoms of erectile dysfunction but does not cure the underlying condition. It works temporarily to help you achieve erections when needed. Addressing lifestyle factors, underlying health conditions, and psychological factors with your healthcare provider may help improve ED in the long term.

Medical and Prescription Disclaimer

Important Safety Information:

This information is provided for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Varditra is a prescription-only medication that must be used under the supervision of a qualified healthcare provider.

Please Note:

• Always consult your physician before starting, stopping, or changing any medication • Individual results may vary based on your health status, age, and other factors • This is not a complete list of all possible side effects, warnings, or interactions • Emergency situations: Seek immediate medical attention for serious side effects • Self-medication is dangerous: Never take this medication without a valid prescription • Not a substitute for professional care: Regular check-ups with your doctor are important

Prescription Requirement:

Varditra contains vardenafil, a potent prescription medication. It should only be obtained with a valid prescription from a licensed healthcare provider after a proper medical evaluation. Online consultations with licensed physicians may be available where permitted by law.

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Disclaimer: This product information is intended for educational purposes and does not replace professional medical advice. Always consult with your healthcare provider for personalized medical guidance. Varditra is a prescription medication that should only be used under proper medical supervision.

References: Information compiled from FDA-approved prescribing information, peer-reviewed medical literature, and official pharmaceutical documentation.