Vardenafil 5 mg Information
Following multiple dosing for 31 days, similar blood pressure responses were observed on Day 31 as on Day 1.
- The effectiveness of Levitra 5mg depends on individual factors.
- Levitra 5mg is part of a broader ED treatment approach.
- Adhere strictly to your doctor’s prescribed dosage.
- Do not share your medication with others.
- Regular check-ups can help monitor treatment progress.
Vardenafil may add to the blood pressure lowering effects of antihypertensive agents (see PRECAUTIONS, Drug Interactions).
| Use Case | Description | Precaution |
|---|---|---|
| Erectile Dysfunction | Improves blood flow to the penis for erection | Do not combine with nitrates |
| Off-label Uses | Pulmonary hypertension (less common) | Under medical supervision |
| Duration of Effect | Usually lasts around 4-6 hours | Avoid excessive alcohol intake |
A study was conducted in which the blood pressure and heart rate response to 0.4 mg nitroglycerin (NTG) sublingually was evaluated in 18 healthy subjects following pretreatment with LEVITRA 20 mg at various times before NTG administration. LEVITRA 20 mg caused an additional time-related reduction in blood pressure and increase in heart rate in association with NTG administration.
| Attribute | Description | Notes |
|---|---|---|
| Active Ingredient | Vardenafil | PDE5 inhibitor |
| Dosage Form | Tablet | 5mg dosage |
| Manufacturer | Bayer Pharmaceuticals | Approved by FDA |
| Use Duration | Typically effective within 30-60 minutes | Onset of action |
| Typical Course | Taken as needed, not regularly | Consult doctor for guidance |
The blood pressure effects were observed when LEVITRA 20 mg was dosed 1 or 4 hours before NTG and the heart rate effects were observed when 20 mg was dosed 1, 4, or 8 hours before NTG.
Adverse Effects
The tissue concentration of cGMP is regulated by both the rates of synthesis and degradation via phosphodiesterases (PDEs). The most abundant PDE in the human corpus cavernosum is the cGMP-specific phosphodiesterase type 5 (PDE5); therefore, the inhibition of PDE5 enhances erectile function by increasing the amount of cGMP. Because sexual stimulation is required to initiate the local release of nitric oxide, the inhibition of PDE5 has no effect in the absence of sexual stimulation. In vitro studies have shown that vardenafil is a selective inhibitor of PDE5. The inhibitory effect of vardenafil is more selective on PDE5 than for other known phosphodiesterases (>15-fold relative to PDE6, >130-fold relative to PDE1, >300-fold relative to PDE11, and >1,000-fold relative to PDE2, 3, 4, 7, 8, 9, and 10).
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The pharmacokinetics of generic levitra 24 h buy vardenafil are approximately dose proportional over the recommended dose range. Vardenafil is eliminated predominantly by hepatic metabolism, mainly by CYP3A4 and to a minor extent, CYP2C isoforms. Concomitant use with potent CYP3A4 inhibitors such as ritonavir, indinavir, ketoconazole, as well as moderate CYP3A inhibitors such as erythromycin results in significant increases of plasma levels of vardenafil (see PRECAUTIONS, WARNINGS and DOSAGE AND ADMINISTRATION). Mean vardenafil plasma concentrations measured after the administration of a single oral dose of 20 mg to healthy male volunteers are depicted in Figure 1. Figure 1: Plasma Vardenafil Concentration (Mean ± SD) Curve for a Single 20 mg LEVITRA Dose Vardenafil is rapidly absorbed with absolute bioavailability of approximately 15%. Additional blood pressure and heart rate changes were not detected when LEVITRA 20 mg was dosed 24 hours before NTG.
| Tip | Explanation | Benefit |
|---|---|---|
| Take as directed | Follow doctor’s instructions strictly | Maximize efficacy, minimize side effects |
| Avoid heavy meals | Can delay absorption or reduce effectiveness | Ensure quicker onset |
| Limit alcohol consumption | Alcohol can impair effectiveness and increase side effects | Better results |
| Report adverse effects | Contact healthcare provider if side effects occur | Ensures safety |
| Do not share medication | Prescription drugs are personalized | Safety and legal reasons |
Figure 2: Placebo-subtracted point estimates (with 90% CI) of mean maximal blood pressure and heart rate effects of pre-dosing with LEVITRA 20 mg at 24, 8, 4, and 1 hour before 0.4 mg NTG sublingually.
- Levitra 5mg is a PDE5 inhibitor used to treat male erectile issues.
- The medication begins working within 30 minutes for many users.
- Always follow the dosage instructions provided by your healthcare provider.
- Use caution if you have a history of low blood pressure.
- Report any persistent side effects to your doctor promptly.
Because the disease state of patients requiring nitrate therapy is anticipated to increase the likelihood of hypotension, the use of vardenafil by patients on nitrate therapy or on nitric oxide donors is contraindicated (see CONTRAINDICATIONS).
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Levitra Soft Tabs | 20mg | 20 Pills | 74.68€ 71.12€ | |
| Levitra Generic | 60mg | 120 + 8 Pills | 372.33€ 354.60€ | |
| Levitra Generic | 20mg | 360 + 10 Pills | 458.44€ 436.61€ | |
| Levitra Professional | 20mg | 360 + 6 Pills | 914.63€ 871.08€ | |
| Levitra Original | 20mg | 34 + 2 Pills | 188.51€ 179.53€ | |
| Levitra Generic | 10mg | 270 + 10 Pills | 338.09€ 321.99€ | |
| Levitra Generic | 60mg | 90 + 6 Pills | 291.82€ 277.92€ | |
| Levitra Professional | 20mg | 30 Pills | 119.12€ 113.45€ | |
| Levitra Generic | 20mg | 90 + 8 Pills | 180.78€ 172.17€ | |
| Levitra Original | 20mg | 92 + 4 Pills | 406.22€ 386.88€ | |
| Levitra Soft Tabs | 20mg | 270 + 10 Pills | 521.78€ 496.93€ | |
| Levitra Generic | 40mg | 10 Pills | 41.37€ 39.40€ | |
| Levitra Generic | 60mg | 360 + 10 Pills | 906.69€ 863.51€ | |
| Levitra Generic | 10mg | 60 + 6 Pills | 112.98€ 107.60€ |
The effect of 10 mg and 80 mg vardenafil on QT interval was evaluated in a single-dose, double-blind, randomized, placebo- and active-controlled (moxifloxacin 400 mg) crossover study in 59 healthy males (81% White, 12% Black, 7% Hispanic) aged 45-60 years.
Coverage and cost comparison of Levitra vs. Cialis
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Levitra only for the for the indication prescribed. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. LEVITRA- vardenafil hydrochloride tablet, film coated APHENA PHARMA SOLUTIONS - TENNESSEE, INC. LEVITRA® is an oral therapy for the treatment of erectile dysfunction. Vardenafil HCl is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1-f ][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula: Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water.
Which drugs interact with vardenafil?
LEVITRA is formulated as orange, round, film-coated tablets with “BAYER” cross debossed on one side and “2.5”, “5”, “10”, and “20” on the other side corresponding to 2.5 mg, 5 mg, 10 mg, and 20 mg of vardenafil, respectively. Penile erection is a hemodynamic process initiated by the relaxation of smooth muscle in the corpus cavernosum and its associated arterioles. During sexual stimulation, nitric oxide is released from nerve endings and endothelial cells in the corpus cavernosum. Nitric oxide activates the enzyme guanylate cyclase resulting in increased synthesis of cyclic guanosine monophosphate (cGMP) in the smooth muscle cells of the corpus cavernosum. The cGMP in turn triggers smooth muscle relaxation, allowing increased blood flow into the penis, resulting in erection. The QT interval was measured at one hour post dose because this time point approximates the average time of peak vardenafil concentration. The 80 mg dose of LEVITRA (four times the highest recommended dose) was chosen because this dose yields plasma concentrations covering those observed upon co-administration of a low-dose of LEVITRA (5 mg) and 600 mg BID of ritonavir.
Is Levitra or Cialis more effective?
Maximum observed plasma concentrations after a single 20 mg dose in healthy volunteers are usually reached between 30 minutes and 2 hours (median 60 minutes) after oral dosing in the fasted state. Two food-effect studies were conducted which showed that high-fat meals caused a reduction in Cmax by 18%-50%. The mean steady-state volume of distribution (Vss) for vardenafil is 208 L, indicating extensive tissue distribution. Vardenafil and its major circulating metabolite, M1, are highly bound to plasma proteins (about 95% for parent drug and M1). This protein binding is reversible and independent of total drug concentrations.
What are the side effects of vardenafil?
Following a single oral dose of 20 mg vardenafil in healthy volunteers, a mean of 0.00018% of the administered dose was obtained in semen 1.5 hours after dosing. Vardenafil is metabolized predominantly by the hepatic enzyme CYP3A4, with contribution from the CYP3A5 and CYP2C isoforms. The major circulating metabolite, M1, results from desethylation at the piperazine moiety of vardenafil. The plasma concentration of M1 is approximately 26% that of the parent compound. This metabolite shows a phosphodiesterase selectivity profile similar to that of vardenafil and an in vitro inhibitory potency for PDE5 28% of that of vardenafil. Of the CYP3A4 inhibitors that have been studied, ritonavir causes the most significant drug-drug interaction with vardenafil. Table 1 summarizes the effect on mean uncorrected QT and mean corrected QT interval (QTc) with different methods of correction (Fridericia and a linear individual correction method) at one hour post-dose. No single correction method is known to be more valid than the other.
- Common side effects of Levitra 5mg include dizziness and nasal congestion.
- Levitra 5mg does not cure ED but helps achieve an erection.
- Do not take Levitra 5mg if allergic to vardenafil.
- Avoid grapefruit or grapefruit juice when taking Levitra 5mg.
- Levitra 5mg should not be used with other ED medications.
In this study, the mean increase in heart rate associated with a 10 mg dose of LEVITRA compared to placebo was 5 beats/minute and with an 80 mg dose of LEVITRA the mean increase was 6 beats/minute.
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In volunteers with moderate hepatic impairment (Child-Pugh B), the Cmax and AUC following a 10 mg vardenafil dose were increased by 130% and 160%, respectively, compared to healthy control subjects. Consequently, a starting dose of 5 mg is recommended for patients with moderate hepatic impairment, and the maximum dose should not exceed 10 mg (see PRECAUTIONS and DOSAGE AND ADMINISTRATION). Vardenafil has not been evaluated in patients with severe (Child-Pugh C) hepatic impairment. In a clinical pharmacology levitra price cut study of patients with erectile dysfunction, single doses of vardenafil 20 mg caused a mean maximum decrease in supine blood pressure of 7 mmHg systolic and 8 mmHg diastolic (compared to placebo), accompanied by a mean maximum increase of heart rate of 4 beats per minute. The maximum decrease in blood pressure occurred between 1 and 4 hours after dosing. Therapeutic and supratherapeutic doses of vardenafil and the active control moxifloxacin produced similar increases in QTc interval. This study, however, was not designed to make direct statistical comparisons between the drug or the dose levels. The clinical impact of these QTc changes is unknown (see PRECAUTIONS).
- Levitra 5mg should not be used with medications containing nitrates.
- It is important to disclose all health conditions prior to use.
- Levitra 5mg can improve quality of life for ED sufferers.
- Avoid driving or operating heavy machinery if affected by side effects.
- Alcohol and high-fat foods can delay the drug’s effect.
In a separate postmarketing study of 44 healthy volunteers, single doses of 10 mg LEVITRA resulted in a placebo-subtracted mean change from baseline of QTcF (Fridericia correction) of 5 msec (90% CI: 2,8).
Proper Use
Therefore, M1 accounts for approximately 7% of total pharmacologic activity. The total body clearance of vardenafil is 56 L/h, and the terminal half-life of vardenafil and its primary metabolite (M1) is approximately 4-5 hours. After oral administration, vardenafil is excreted as metabolites predominantly in the feces (approximately 91-95% of administered oral dose) and to a lesser extent in the urine (approximately 2-6% of administered oral dose). Pediatrics: Vardenafil trials were not conducted in the pediatric population. Geriatrics: In a healthy volunteer study of elderly males (≥65 years) and younger males (18–45 years), mean Cmax and AUC were 34% and 52% higher, respectively, in the elderly males (see PRECAUTIONS, Geriatric Use and DOSAGE AND ADMINISTRATION).
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Consequently, a lower starting dose of LEVITRA (5 mg) in patients ≥65 years of age should be considered. Renal Insufficiency: In volunteers with mild renal impairment (CLcr = 50-80 ml/min), the pharmacokinetics of vardenafil were similar to those observed in a control group with normal renal function. In the moderate (CLcr = 30-50 ml/min) or severe (CLcr<30 ml/min) renal impairment groups, the AUC of vardenafil was 20–30% higher compared to that observed in a control group with normal renal function (CLcr>80 ml/min). Vardenafil pharmacokinetics have not been evaluated in patients requiring renal dialysis (see PRECAUTIONS, Renal Insufficiency, and DOSAGE AND ADMINISTRATION). Hepatic Insufficiency: In volunteers with mild hepatic impairment (Child-Pugh A), the Cmax and AUC following a 10 mg vardenafil dose were increased by 22% and 17%, respectively, compared to healthy control subjects.
