Label: LEVITRA- vardenafil hydrochloride tablet, film coated
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.
Pregnancy, Nursing Mothers and Pediatric Use
Question: Is it possible to identify potential non-responders to oral therapy? Answer: No, it is not possible to identify potential non-responders to a PDE 5 inhibitor such as Cialis, Levitra or Viagra, other than by a trial of these medications in the setting of sexual activity. Patients, who appear to be non-responders to Viagra or Levitra, need to repeat a trial on an empty stomach a few different times before giving up. Cialis absorption and onset of action is not affected by food. The 20-30% who still do not respond generally have ED related to an irreversible physical abnormality due to chronic poor blood flow (often smoking-related) or damaged penile tissue (often diabetes, high cholesterol and after prostate cancer surgery).
Other Interactions
The best option for these patients remains an inflatable penile prosthesis. Question: You said that the PDE5 inhibitors were comparable in efficacy. What about reports that Levitra is more effective than Viagra in treating ED among men with diabetes? Answer: Clinical trial reveals that all three medications have the same success regardless of patient age, underlying medical condition or severity of erectile dysfunction. There is no head-to-head evidence of that, and what literature there is may be misleading. Two food-effect studies were conducted which showed that high-fat meals caused a reduction in Cmax by 18%-50%.Distribution: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.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.Metabolism:Vardenafil is metabolized predominantly by the hepatic enzyme CYP3A4, with contribution from the CYP3A5 and CYP2C isoforms.
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Levitra Generic | 40mg | 60 + 4 Pills | 162.37€ 154.64€ | |
| Levitra Generic | 10mg | 270 + 10 Pills | 338.09€ 321.99€ | |
| Levitra Generic | 40mg | 180 + 10 Pills | 405.06€ 385.77€ | |
| Levitra Generic | 40mg | 270 + 10 Pills | 561.89€ 535.13€ | |
| Levitra Generic | 20mg | 60 + 6 Pills | 131.11€ 124.87€ | |
| Levitra Generic | 10mg | 360 + 10 Pills | 407.94€ 388.51€ | |
| Levitra Generic | 60mg | 10 Pills | 47.42€ 45.16€ | |
| Levitra Generic | 60mg | 120 + 8 Pills | 372.33€ 354.60€ | |
| Levitra Generic | 40mg | 120 + 8 Pills | 302.37€ 287.97€ | |
| Levitra Generic | 10mg | 180 + 10 Pills | 246.74€ 234.99€ | |
| Levitra Generic | 20mg | 90 + 8 Pills | 180.78€ 172.17€ | |
| Levitra Generic | 10mg | 120 + 10 Pills | 178.59€ 170.09€ | |
| Levitra Professional | 20mg | 60 + 2 Pills | 223.11€ 212.49€ | |
| Levitra Generic | 60mg | 90 + 6 Pills | 291.82€ 277.92€ | |
| Levitra Original | 20mg | 8 Pills | 65.05€ 61.95€ |
The major circulating metabolite, M1, results from desethylation at the piperazine moiety of vardenafil.
Tips for Taking Vardenafil and Viagra Effectively
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 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.
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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).PharmacokineticsThe pharmacokinetics of 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 DoseAbsorption:Vardenafil is rapidly absorbed with absolute bioavailability of approximately 15%. The plasma concentration of M1 is approximately 26% that of the parent compound.
| Question | Answer |
|---|---|
| How long does it last? | Up to 4-5 hours, depending on individual factors |
| Can I take it with other medications? | Consult your doctor; some drugs interact adversely |
| Is it safe for everyone? | Not for individuals with certain health issues or on nitrates |
| What should I do if I experience side effects? | Contact your physician immediately |
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.
| Advice | Explanation | Cautionary Notes |
|---|---|---|
| Take on an empty stomach | Food, especially high-fat, delays absorption | Avoid heavy meals before use |
| Avoid alcohol | Can increase side effects | Excessive alcohol can impair effectiveness |
| Follow prescribed dose | To minimize side effects and interactions | Do not double dose in case of missed dose |
Therefore, M1 accounts for approximately 7% of total pharmacologic activity.Excretion: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.
- Levitra 100 mg pills are usually round and blue.
- The medication should be purchased with a prescription.
- It is available in most pharmacies worldwide.
- Generic versions may be less expensive.
- Always check the expiry date before use.
- Do not share medication with others.
- Consult a doctor if you experience prolonged erection.
- Levitra 100 mg does not cure ED permanently.
- Use as part of a comprehensive treatment plan.
- Do not operate heavy machinery after taking.
- Be aware of possible allergic reactions.
- Levitra 100 mg has been studied extensively.
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).Pharmacokinetics in Special PopulationsPediatrics: 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).
Is Vardenafil or Viagra More Effective for You?
Although Viagra, Levitra and Cialis are safe and effective they do, like all medications, have disadvantages. They essentially enhance partial (sexual) erections, rather than initiating them. At best, the response rate among men with advanced ED (for example following radical prostatectomy) is 30%. Fewer than 505 of men with Diabetes will respond. Correct administration of Viagra and Levitra is critical, and if one does not work when taken correctly, no other oral “Viagra like drug” (PDE5 inhibitor like Levitra or Cialis) will either.
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In conclusion, the potencies of Viagra, Levitra and Cialis are broadly similar, but each has unique pharmacological properties related to its molecular structure. Viagra is an exemplary PDE-5 inhibitor that, after 10 years of widespread clinical use, is acknowledged to be effective and particularly well tolerated. Cialis and Levitra are the newer medications and are similar to Viagra in their efficacy and contraindications. The only new attributes of clinical significance are the lack of food interaction and the long duration of action of Cialis. This may translate into greater efficacy of the first dose as well as a return to more spontaneous (normal) initiation of sexual activity (broader window of opportunity). 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.
| Indication | Description | Onset Time | Duration |
|---|---|---|---|
| Erectile Dysfunction | Treats inability to maintain an erection | 30-60 min | Up to 4-5 hours |
| Pulmonary Hypertension | Off-label use in pulmonary blood vessels | N/A | N/A |
| Off-label Uses | Other uses with doctor's approval | Varies | Varies |
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. 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.
- Levitra 100 mg can interact with certain antibiotics.
- Use with caution if you have kidney problems.
- Do not use if you have been advised against sexual activity.
- Consult your healthcare provider before starting.
- Levitra 100 mg is not a remedy for psychological ED causes.
- Be aware of the potential for dizziness or fainting.
- Do not take with high-fat meals for optimal absorption.
- MVP score improves in some men after treatment.
- Not approved as a contraceptive method.
- Avoid driving or operating machinery if affected.
- Use with caution in patients with eye disorders.
- Contact your doctor if you experience chest pain.
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).
Working and benefits of Vardenafil
My belief is that clinical experience will show them to be similar. Data from Six Degrees Survey, October 2001. men who require fast onset or better absorption should avoid fatty meals or take these pills on an empty stomach; start foreplay later in older patients (who may need up to 2 hours to absorb the medicicne); do not give up before making at least 3 attempts at intercourse having at the maximum dose: Viagra 100 mg, Levitra 20mg. Contains inactivated NDC Code(s)NDC Code(s): 43353-323-02, 43353-323-06 If you are a consumer or patient please visit this version. DESCRIPTION LEVITRA® is an oral therapy for the treatment of erectile dysfunction.
What are the most common side effects for Viagra?
This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).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. 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. LEVITRA® is an levitra generic quality 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. CLINICAL PHARMACOLOGY Mechanism of ActionPenile erection is a hemodynamic process initiated by the relaxation of smooth muscle in the corpus cavernosum and its associated arterioles.
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