LEVITRA Tablets: Complete Patient Guide & Product Information

What Is LEVITRA?

LEVITRA (vardenafil hydrochloride) is a prescription medication belonging to the phosphodiesterase type 5 (PDE5) inhibitor class. It is primarily indicated for the treatment of erectile dysfunction (ED) in adult men. LEVITRA works by improving blood flow to specific areas of the body when sexual stimulation occurs, helping men achieve and maintain an erection sufficient for sexual activity.

This medication does not cure erectile dysfunction or increase sexual desire. It functions only in the presence of sexual stimulation and addresses the physiological aspect of erectile response. LEVITRA is manufactured by Bayer Pharmaceuticals and is available in various strength formulations as film-coated oral tablets.

Regulatory Classification: Prescription-only medicine (POM)
Active Ingredient: Vardenafil (as hydrochloride trihydrate)
Available Strengths: 5 mg, 10 mg, and 20 mg tablets
Manufacturer: Bayer AG / Licensed generic manufacturers

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How Does LEVITRA Work? Understanding the Mechanism

LEVITRA contains vardenafil, which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. When a man experiences sexual stimulation, nitric oxide is naturally released in the penile tissue. This chemical triggers the production of cyclic guanosine monophosphate (cGMP), which relaxes the smooth muscles in the blood vessels of the penis, allowing increased blood flow.

In men with erectile dysfunction, an enzyme called PDE5 breaks down cGMP too quickly, preventing adequate blood flow. Vardenafil temporarily inhibits PDE5, allowing cGMP levels to remain elevated longer. This results in improved blood flow to the penis during sexual arousal, facilitating the achievement and maintenance of an erection.

Important: LEVITRA requires sexual stimulation to work—it does not cause automatic erections and does not affect sexual desire or libido.

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Therapeutic Indications & Clinical Benefits

Primary Indication

LEVITRA is indicated for the treatment of erectile dysfunction in adult men, defined as the persistent inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.

Key Clinical Benefits

• Improved Erectile Function: Helps men with ED achieve erections firm enough for sexual intercourse when sexually stimulated
• Rapid Onset of Action: Typically begins working within 25-60 minutes after administration
• Flexible Dosing Window: Effective when taken 25 minutes to 4 hours before sexual activity
• Sustained Duration: Effects may last up to 4-5 hours, allowing for spontaneity within that timeframe
• Effective Across ED Causes: Demonstrates efficacy regardless of whether ED stems from psychological, physical, or mixed etiologies
• Tolerability Profile: Generally well-tolerated when used as directed under medical supervision
• Quality of Life Improvement: May enhance confidence and relationship satisfaction when ED is successfully managed

Medical Note: LEVITRA treats the symptoms of erectile dysfunction but does not address underlying causes such as cardiovascular disease, diabetes, hormonal imbalances, or psychological factors. Comprehensive medical evaluation is recommended.

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Usage Instructions & Dosing Guidelines

General Administration

• Route: Oral administration only
• Timing: Take approximately 25-60 minutes before anticipated sexual activity
• Frequency: Do not take more than once in a 24-hour period
• With or Without Food: Can be taken with or without meals, though high-fat meals may delay absorption
• Swallowing: Take the tablet whole with water; do not crush, chew, or split

Standard Dosing Recommendations

Starting Dose: Most patients begin with 10 mg taken as needed, approximately one hour before sexual activity.

Dose Adjustment:

• Based on efficacy and tolerability, the dose may be increased to a maximum of 20 mg or decreased to 5 mg
• Older adults (65+ years) typically start with 5 mg
• Patients with moderate hepatic impairment should not exceed 10 mg

Special Populations:

• Patients with severe renal impairment: Maximum 10 mg
• Concomitant use with certain medications may require dose adjustment

Critical Usage Reminders

⚠️ LEVITRA must be prescribed by a qualified healthcare provider
⚠️ Never exceed the recommended dose
⚠️ Do not combine with other ED medications
⚠️ Sexual stimulation is required for the medication to work

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Possible Side Effects & Adverse Reactions

Like all medications, LEVITRA may cause side effects, though not everyone experiences them. Most side effects are mild to moderate and temporary.

Common Side Effects (May affect up to 1 in 10 people)

• Headache
• Flushing (warmth, redness in face, neck, or chest)
• Nasal congestion or stuffy nose
• Indigestion or dyspepsia
• Dizziness
• Back pain
• Nausea

Less Common Side Effects (May affect up to 1 in 100 people)

• Visual disturbances (color tinge, increased light sensitivity, blurred vision)
• Muscle pain or myalgia
• Increased heart rate or palpitations
• Drowsiness or fatigue
• Rash or skin reactions
• Elevated liver enzymes (detected in blood tests)

Serious Side Effects (Rare but Requiring Immediate Medical Attention)

Seek emergency medical help if you experience:

• Priapism: Erection lasting more than 4 hours (this is a medical emergency that can cause permanent damage)
• Sudden vision loss: Including non-arteritic anterior ischemic optic neuropathy (NAION)
• Sudden hearing loss or decrease: May be accompanied by tinnitus or dizziness
• Severe allergic reactions: Swelling of face, lips, tongue, or throat; difficulty breathing; severe rash
• Chest pain or irregular heartbeat: Particularly during or after sexual activity
• Signs of heart attack or stroke: Sudden numbness, severe dizziness, confusion, trouble speaking

Managing Side Effects

Most mild side effects diminish as your body adjusts to the medication. If side effects persist or become bothersome, consult your healthcare provider about dose adjustment. Never discontinue or modify prescribed treatment without medical guidance.

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Safety Considerations, Precautions & Contraindications

Absolute Contraindications (Do Not Use LEVITRA If:)

❌ You are allergic to vardenafil or any ingredients in LEVITRA
❌ You are taking nitrate medications for chest pain (e.g., nitroglycerin, isosorbide)
❌ You are taking riociguat (for pulmonary hypertension)
❌ You have severe cardiovascular conditions making sexual activity inadvisable
❌ You have experienced stroke or heart attack within the past 6 months
❌ You have severe liver disease or hepatic failure
❌ You have end-stage renal disease requiring dialysis
❌ You have hereditary eye conditions like retinitis pigmentosa
❌ You have experienced sudden vision or hearing loss from previous PDE5 inhibitor use

Use With Caution & Medical Supervision

Cardiovascular Considerations:

• History of heart disease, arrhythmia, or heart failure
• Uncontrolled high or low blood pressure
• Recent cardiac events or procedures
• Sexual activity carries cardiovascular risk—medical assessment required

Anatomical Conditions:

• Peyronie’s disease or penile curvature
• Conditions predisposing to priapism (sickle cell anemia, multiple myeloma, leukemia)

Other Medical Conditions:

• Bleeding disorders or active peptic ulceration
• Moderate liver or kidney impairment
• History of non-arteritic anterior ischemic optic neuropathy (NAION)

Age-Related Precautions

• Elderly patients (65+ years): May require lower starting doses due to decreased drug clearance
• Not indicated for use in children or adolescents under 18 years

Lifestyle Considerations

• Alcohol: Excessive alcohol consumption may impair erectile function and increase side effect risk
• Grapefruit: Grapefruit juice may increase vardenafil blood levels; consumption should be moderate
• Driving & Machinery: If you experience dizziness or visual disturbances, avoid driving or operating machinery

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Drug Interactions & Important Warnings

LEVITRA can interact with numerous medications, potentially causing serious adverse effects or reducing effectiveness.

Critical Drug Interactions

NEVER combine LEVITRA with:

• Nitrates (nitroglycerin, isosorbide mononitrate/dinitrate): May cause dangerous blood pressure drop
• Riociguat (Adempas): Severe hypotension risk
• Recreational drugs containing nitrates (“poppers” like amyl nitrite): Life-threatening interaction

Medications Requiring Dose Adjustment or Caution

Alpha-Blockers (for prostate or blood pressure):

• Doxazosin, tamsulosin, terazosin
• Risk of symptomatic hypotension; must be on stable alpha-blocker therapy before starting LEVITRA

Antifungal Medications:

• Ketoconazole, itraconazole (dose reduction of LEVITRA required)

Antibiotics:

• Erythromycin, clarithromycin (may increase vardenafil levels)

HIV Protease Inhibitors:

• Ritonavir, indinavir, saquinavir (significant dose adjustment necessary)

Other Cardiovascular Medications:

• Antiarrhythmics (Class IA or III)
• Beta-blockers, calcium channel blockers

Medications for Other Conditions:

• Other PDE5 inhibitors (sildenafil, tadalafil)—never combine
• Medications metabolized by CYP3A4 enzyme system

Food & Supplement Interactions

• High-fat meals may delay drug absorption
• Grapefruit and grapefruit juice may increase vardenafil blood concentration
• St. John’s Wort may reduce LEVITRA effectiveness

Always inform your healthcare provider about ALL medications, supplements, and herbal products you use.

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LEVITRA vs. Other ED Medications: Comparison Table

Feature	LEVITRA (Vardenafil)	Viagra (Sildenafil)	Cialis (Tadalafil)	Stendra (Avanafil)
Onset of Action	25-60 minutes	30-60 minutes	30-60 minutes	15-30 minutes
Duration of Effect	4-5 hours	4-6 hours	Up to 36 hours	4-6 hours
Food Interference	Minimal (avoid high-fat)	Moderate (high-fat delays)	Minimal	Minimal
Standard Starting Dose	10 mg	50 mg	10 mg	100 mg
Maximum Dose	20 mg	100 mg	20 mg	200 mg
Frequency	Once per 24 hours	Once per 24 hours	Once daily (low dose) or as needed	Once per 24 hours
Unique Advantage	Fast onset, less food impact	Most studied/established	Longest duration/”weekend pill”	Fastest onset
Effectiveness Rate	80-85%	75-82%	80-85%	80-88%
Generic Available	Yes	Yes	Yes (as of 2018)	Limited availability

Key Distinctions

LEVITRA is often chosen for patients who:

• Prefer relatively rapid onset without the extended duration of tadalafil
• Experience reduced effectiveness with sildenafil
• Want flexibility with meals (less affected by food than sildenafil)
• Have satisfactory response and tolerability profile

Individual Response Varies: The “best” medication differs for each patient based on efficacy, side effect profile, lifestyle factors, and personal preference. Healthcare provider guidance is essential.

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Patient Populations Requiring Special Attention

Who Should Avoid LEVITRA or Use Only Under Strict Supervision?

Patients with cardiovascular conditions:

• Recent heart attack, stroke, or life-threatening arrhythmia
• Coronary artery disease with unstable angina
• Heart failure (NYHA Class 2 or greater within past 6 months)
• Uncontrolled hypertension (BP >170/100) or hypotension (BP <90/50)

Patients with anatomical deformities:

• Significant penile angulation, cavernosal fibrosis, or Peyronie’s disease
• Conditions predisposing to priapism (sickle cell anemia, multiple myeloma, leukemia)

Patients with eye conditions:

• Hereditary degenerative retinal disorders (retinitis pigmentosa)
• History of NAION (non-arteritic anterior ischemic optic neuropathy)
• Severe vision impairment

Patients with hepatic/renal impairment:

• Severe liver disease (Child-Pugh Class C)
• End-stage renal disease requiring dialysis
• Moderate impairment requires dose adjustment

Patients taking contraindicated medications:

• Nitrates, riociguat, or other PDE5 inhibitors
• Strong CYP3A4 inhibitors without appropriate dose modification

Other vulnerable populations:

• Patients with bleeding disorders or active peptic ulcers
• Those with history of prolonged erections (priapism)
• Individuals with severe dehydration

Women & Children

• Not indicated for use in women: Safety and efficacy not established
• Not for pediatric use: Not approved for individuals under 18 years

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Storage, Handling & Shelf-Life Guidelines

Proper Storage Conditions

Temperature: Store at room temperature between 15°C-30°C (59°F-86°F)
Moisture Protection: Keep in original packaging until use; protect from humidity
Light Exposure: Store away from direct sunlight
Location: Keep out of reach of children and pets

Handling Instructions

• Do not remove tablets from blister packaging until immediately before use
• Handle with clean, dry hands
• Do not use if packaging is damaged or compromised
• Check expiration date before each use

Shelf-Life & Expiration

• Typical shelf-life: 2-3 years from manufacturing date when stored properly
• Do not use after expiration date printed on packaging
• Expired medication may be less effective or potentially harmful

Disposal Guidelines

• Do not flush medications down the toilet or pour into drains
• Return unused or expired medication to pharmacy take-back programs
• If no take-back program exists, mix with unpalatable substance (coffee grounds, dirt) in sealed bag before disposing in household trash
• Remove all personal information from prescription packaging before disposal

Environmental Consideration: Pharmaceutical waste can harm aquatic ecosystems—always dispose responsibly.

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Patient FAQs: Common Questions About LEVITRA

1. How long before sexual activity should I take LEVITRA?

Take LEVITRA approximately 25-60 minutes before anticipated sexual activity. The medication typically begins working within this timeframe, though individual response varies. The therapeutic window extends up to 4-5 hours after administration. Plan ahead, as sexual stimulation is required for the medication to work—it does not cause spontaneous erections.

2. Can I take LEVITRA daily or should it be used only when needed?

LEVITRA is designed for “as-needed” use before sexual activity, not as a daily medication. Take it only when you plan to engage in sexual activity, with a maximum of one dose per 24-hour period. Do not take LEVITRA on a schedule or more frequently than prescribed. If you require frequent dosing, discuss alternative treatment approaches with your healthcare provider.

3. What should I do if LEVITRA doesn’t work the first time?

Several factors can affect initial response. Try the medication on 4-6 separate occasions before determining it’s ineffective—response may improve with repeated use. Ensure adequate sexual stimulation, avoid heavy meals and excessive alcohol before use, and take the medication within the recommended timeframe. If it remains ineffective after multiple attempts, consult your healthcare provider about dose adjustment or alternative treatments. Never increase the dose without medical supervision.

4. Is it safe to drink alcohol while using LEVITRA?

Moderate alcohol consumption (1-2 drinks) is generally acceptable, but excessive alcohol can impair erectile function and increase side effect risk, particularly dizziness and low blood pressure. Alcohol independently contributes to erectile dysfunction, potentially reducing LEVITRA’s effectiveness. For best results, limit alcohol intake when planning to use this medication.

5. Can LEVITRA cause dependency or affect natural erections?

No, LEVITRA does not cause physical dependency, and there is no evidence it impairs natural erectile function. It does not alter the body’s normal physiological mechanisms—it temporarily enhances blood flow when needed. However, psychological reliance can develop if patients become concerned about performance without medication. This is a psychological pattern, not pharmacological dependency, and should be discussed with a healthcare provider.

6. What’s the difference between LEVITRA and generic vardenafil?

Generic vardenafil contains the same active ingredient, strength, and dosage form as brand-name LEVITRA, meeting identical quality and safety standards. Both work the same way and have equivalent therapeutic effects. The primary differences are manufacturer, inactive ingredients (which rarely affect function), and cost—generics are typically significantly less expensive. Generic vardenafil provides a cost-effective alternative without compromising efficacy or safety.

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Medical & Prescription Disclaimer

Important Medical Information

This product description is provided for educational and informational purposes only. It does not constitute medical advice and should not replace consultation with a qualified healthcare professional.

Professional Medical Guidance Required

• Prescription Medication: LEVITRA (vardenafil) is available by prescription only and requires evaluation by a licensed physician
• Individual Assessment Necessary: Your healthcare provider must assess your medical history, current medications, and overall health status before prescribing
• Not for Self-Diagnosis: Do not use this information to self-diagnose or self-treat erectile dysfunction
• Comprehensive Evaluation: ED can be a symptom of serious underlying conditions requiring proper medical investigation

Accuracy & Currency of Information

• Information presented reflects current understanding as of publication but is subject to updates as new research emerges
• Always refer to the official prescribing information and patient leaflet provided with your medication
• Regulatory guidelines and product information may vary by country and jurisdiction

Emergency Situations

Seek immediate medical attention if you experience:

• Erection lasting longer than 4 hours (priapism)
• Sudden vision or hearing loss
• Chest pain or irregular heartbeat during sexual activity
• Severe allergic reactions or breathing difficulties

In emergencies, call your local emergency services or go to the nearest emergency department.

Limitation of Liability

The information provided does not cover all possible uses, directions, precautions, drug interactions, or adverse effects. GenericMedsKart and content contributors assume no liability for healthcare decisions made based on this information.

Always consult your physician, pharmacist, or other qualified healthcare provider with any questions regarding medical conditions or medications.

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Medical Accuracy Note: This information is intended for educational purposes and should be verified with current prescribing information and healthcare professionals.