Vardenafil Tablets
Article em En MEDLINE ID: mdl-31525574 It is often reported that falsified medicines have harmful effects on patients both Japan and abroad. These statements have not been evaluated by the Food and Drug Administration (FDA). Compounded products are not FDA-approved and are not intended to diagnose, treat, cure, or prevent any disease. The information provided is for educational purposes only and should not be considered medical advice. Always consult with your healthcare provider before starting any new treatment.
- Vardenafil efficacy depends on proper dosage and timing.
- It is generally safe when used as directed.
- Patients should avoid heavy meals before intake.
- Follow-up with your healthcare provider regularly.
Use as directed by your healthcare provider. This medicine is usually taken only when needed before sexual activity, and not more than once per day. Do not change your dose or take extra doses, even if it does not work the first time. Your healthcare provider will decide the right dose and how long you should use it.
| Study/Source | Sample Size | Success Rate | Notes |
|---|---|---|---|
| Clinical Trial A | 150 men | 80% | Significant improvement in erectile function |
| Clinical Trial B | 200 men | 75% | Better outcomes with 10 mg dose compared to placebo |
| Real-world Reports | 300 patients | 78% | Effective in various age groups and conditions |
Vardenafil helps treat ED by relaxing blood vessels and improving blood flow to the penis during sexual stimulation. It does this by blocking an enzyme called PDE5, which helps keep a natural chemical signal (cGMP) working longer so blood vessels stay more open. It does not cause an erection by itself, so sexual vardenafil oral arousal is still needed. Many people notice an effect within about 30 to 60 minutes, and the benefit may last for several hours; this varies from person to person and may be affected by food and alcohol.
6.2 Postmarketing Experience
In this study, we purchased vardenafil tablets on the internet and investigated their quality and authenticity using visual observations, authenticity investigations, non-destructive tests (handheld NIR and Raman spectroscopy), and quality analyses (active ingredient content and tablet dissolution rate). We used genuine 20-mg Levitra tablets that were sold in Japan and tablets from Bayer AG (Germany) as controls. In April 2015, we obtained 28 samples from 15 websites on the internet. Our authenticity investigations revealed that 11 (40%) were genuine products and 17 (60%) were falsified products. Handheld NIR and Raman results revealed that the falsified products had different spectra to the genuine products.
What is priapism and what should I do if it happens?
Principal component analysis of the NIR and Raman spectra showed variation among the falsified products. The 11 genuine products were of good quality, and the 17 falsified products were of poor quality. The falsified products contained sildenafil (the active ingredient of Viagra) or tadalafil (the active ingredient of Cialis) instead of vardenafil. Our results show that falsified Vardenafil tablets are sold on the internet and that it is important to prevent illegal internet sales and increase consumer awareness of the presence of falsified medicines. Applies to the following strengths: 2.5 mg; 5 mg; 10 mg; 20 mg Initial dose: 10 mg orally once a day, as needed, approximately 60 minutes before sexual activity. Do not use if you take any nitrate medicine for chest pain (such as nitroglycerin tablets/spray/patch, isosorbide mononitrate, or isosorbide dinitrate) because your blood pressure can drop to a dangerous level.
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Cialis Soft Tabs | 20mg | 20 + 2 Pills | 66.98€ 63.79€ | |
| Levitra Generic | 20mg | 360 + 10 Pills | 458.44€ 436.61€ | |
| Cialis Professional | 40mg | 20 Pills | 110.24€ 104.99€ | |
| Kamagra Gold | 100 mg | 32 Pills | 121.24€ 115.47€ | |
| Cialis Professional | 40mg | 180 + 4 Pills | 618.23€ 588.79€ | |
| Cialis Generic | 60mg | 90 + 6 Pills | 196.67€ 187.30€ | |
| Cialis Generic | 40mg | 180 + 10 Pills | 277.29€ 264.09€ | |
| Kamagra Effervescent Tablets | 100 mg | 14 Pills | 51.61€ 49.15€ | |
| Levitra Soft Tabs | 20mg | 10 Pills | 52.27€ 49.78€ | |
| Viagra Generic | 25mg | 20 Pills | 37.74€ 35.94€ | |
| Viagra Generic | 100mg | 120 + 6 Pills | 149.50€ 142.38€ | |
| Cialis Super Active | 20mg | 180 + 20 Pills | 521.59€ 496.75€ | |
| Cialis Generic | 20mg | 180 + 10 Pills | 254.09€ 241.99€ | |
| Viagra Generic | 100mg | 270 + 10 Pills | 270.47€ 257.59€ | |
| Kamagra Soft Tabs | 100mg | 84 + 4 Pills | 233.05€ 221.95€ | |
| Cialis Generic | 60mg | 180 + 10 Pills | 313.11€ 298.20€ |
Do not use if you take riociguat (Adempas) for pulmonary hypertension because it can cause severe low blood pressure.
4.2 Guanylate Cyclase (GC) Stimulators
Increase to 20 mg or decrease to 5 mg based on efficacy and tolerability. Maximum dose: 20 mg once a day Initial dose: 5 mg orally once a day Sexual stimulation is required for a response to treatment. A time interval between dosing should be considered when administering this drug concomitantly with alpha-blockers. Patients taking alpha-blockers should not initiate vardenafil therapy with the orally disintegrating tablet. Initial dose: 5 mg orally once a day, as needed, approximately 60 minutes before sexual activity Comments: Sexual stimulation is required for a response to treatment.
Dosage for people taking certain interacting medications
CrCl: ed gel 30 to 80 mL/min: No adjustment recommended. Comment: The orally disintegrating tablet (brand Staxyn) can be used in patients with mild, moderate or severe renal impairment. Mild hepatic dysfunction (Child-Pugh A): No adjustment recommended. Moderate hepatic dysfunction (Child-Pugh B): 5 mg orally once a day, as needed, approximately 60 minutes before sexual activity. The maximum dose should not exceed 10 mg. Do not use if you have had an allergic reaction to vardenafil or any ingredient in the tablet.
| Dosage (mg) | Typical Usage | Onset of Action | Duration of Effect |
|---|---|---|---|
| 10 | Mild to moderate ED | 30-60 minutes | Up to 4 hours |
| 20 | Moderate to severe ED | 30-60 minutes | Up to 4-5 hours |
| 5 | Lower dose for less side effects | 30-60 minutes | Up to 4 hours |
| 25 | Off-label use, clinical trials | 30-60 minutes | Up to 4 hours |
Do not use if your healthcare provider has told you not to have sexual activity because of a heart problem. Do not use if you have certain serious heart conditions (such as recent heart attack or stroke, uncontrolled irregular heartbeat, or very low or very high blood pressure) unless your prescriber says it is safe.
Further information
Patients should stop use of PDE5 inhibitors, including this drug, and seek medical attention in the event of sudden loss of vision in one or both eyes, and decrease or loss of hearing. Symptoms related to postural hypotension may occur, appropriate countermeasures are recommended. Contact the prescribing physician if other antihypertensive drugs or new medications that may interact with this drug are prescribed by another healthcare provider. Patients should contact their healthcare provider for dose modification if they are not satisfied with the quality of their sexual performance with this drug, or in the case of an unwanted side effect. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Not for use in women or in children under 18. This medication may interact with: (1) Nitrates (nitroglycerin, Imdur, Isordil) and nitrite “poppers” (amyl nitrite): SEVERE—do not combine; can cause life-threatening low blood pressure. (3) Alpha-blockers used for prostate or blood pressure problems (tamsulosin/Flomax, doxazosin/Cardura, terazosin/Hytrin): MODERATE to SEVERE—may cause dizziness or fainting; your prescriber may adjust doses and separate timing.
- Vardenafil may cause nasal congestion or upset stomach.
- Use caution when operating machinery after dosing.
- It is not a cure but helps manage erectile dysfunction symptoms.
- Regular medical checkups are recommended during use.
(4) Strong CYP3A4 inhibitors that raise vardenafil levels (ketoconazole, itraconazole, ritonavir, cobicistat, clarithromycin): MODERATE to SEVERE—higher risk of side effects; dose changes or avoidance may be needed.
What should I know about storage and disposal of this medication?
The dose is taken 1 hour before sexual activity. Do not take your medication more often than directed. Side effects that you should report to your care team as soon as possible: Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision Sudden vision loss in one or both eyes Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome): This list may not describe all possible side effects. Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Keep in the original blister package until time of use.
Usual Adult Dose for:
Throw away any unused medication after the expiration date. We found up to 60% of Levitra products sold online were falsified. The falsified products contained sildenafil or tadalafil instead of vardenafil. Handheld NIR and Raman could discriminate between genuine and falsified products. It is often reported that falsified medicines have harmful effects on patients both Japan and abroad. (5) Other ED medicines (sildenafil/Viagra, tadalafil/Cialis, avanafil/Stendra) or ED injections/suppositories: MODERATE—do not combine unless specifically directed.
| Parameter | Value | Notes |
|---|---|---|
| Absorption Time | 30-60 minutes | Peak plasma concentration reached during this time |
| Half-life | 4-5 hours | Duration of drug activity |
| Bioavailability | Approximately 15% | Oral absorption efficiency |
| Metabolism | Via CYP3A4 enzyme | Liver processing of drug |
(6) Blood pressure medicines and alcohol: MODERATE—can increase lightheadedness; limit alcohol and stand up slowly. (7) Grapefruit or grapefruit juice: MODERATE—may increase side effects; avoid or limit and ask your pharmacist.
What special precautions should I follow?
Severe hepatic dysfunction (Child-Pugh C): Use should be avoided. Comment: The orally disintegrating tablets should not be used in patients with moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic dysfunction. The dose may be increased to a maximum recommended dose of 20 mg or decreased to 5 mg based on efficacy and side effects. If taking potent or moderate inhibitors of CYP450 3A4, the dose should be adjusted as follows: Ritonavir: No more than 2.5 mg in a 72-hour period Indinavir, saquinavir, atazanavir, ketoconazole 400 mg daily, itraconazole 400 mg daily, clarithromycin: No more than 2.5 mg in a 24-hour period Ketoconazole 200 mg daily, itraconazole 200 mg daily, erythromycin: No more than 5 mg in a 24-hour period Safety and efficacy have not been established in patients younger than 18 years. This drug is not indicated for use in pediatric patients.
What should I know about vardenafil before taking it?
This drug can be taken with or without food. The 10 mg orally disintegrating tablet (ODT) provides higher systemic exposure and is not interchangeable with the 10 mg film-coated tablets. The ODT tablet should be taken without liquid and immediately upon removal from the blister. Patients who require a lower or higher dose than 10 mg should be prescribed the film-coated tablets. Patients treated with alpha-blockers, who have previously used vardenafil film-coated tablets, may be switched to ODT tablets at the advice of their healthcare provider. Always tell your healthcare provider about all prescription drugs, over-the-counter medicines, vitamins, and herbal products you use. Common (up to about 1 in 10 people): headache, flushing (warm/red face), stuffy or runny nose, indigestion or upset stomach, dizziness. Less common: nausea, back pain, muscle aches, trouble sleeping, fast heartbeat, rash.
- Vardenafil is effective for up to 4-5 hours.
- Do not use if allergic to vardenafil or similar drugs.
- Overdose symptoms may include prolonged erections.
- Medical advice is essential for any severe side effects.
Uncommon but important: changes in vision (blurred vision, sensitivity to light) or hearing problems (ringing, sudden hearing loss). Rare but serious—get emergency help right away: chest pain, fainting, signs of an allergic reaction (hives, swelling of face/lips/tongue/throat, trouble breathing), or an erection lasting more than 4 hours (priapism), which can cause permanent damage if not treated quickly.
- Vardenafil’s patent protection has expired, leading to generic options.
- Side effects can diminish over time with continued use.
- Do not share medication with others.
- Always check for interactions with other medications.