Key Ingredients in Levitra Professional 20mg
Figure 1: Placebo-subtracted point estimates (with 90% CI) of mean maximal blood pressure and heart rate effects of pre-dosing with vardenafil 20 mg at 24, 8, 4, and 1 hour before 0.4 mg NTG sublingually
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LEVITRA is formulated as orange, round, film-coated tablets with “BAYER” cross debossed on one side and “5”, “10”, and “20” on the other side corresponding to 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. 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 (4.1)].
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Levitra Generic | 60mg | 20 Pills | 81.30€ 77.43€ | |
| Levitra Soft Tabs | 20mg | 10 Pills | 52.27€ 49.78€ | |
| Levitra Generic | 20mg | 10 Pills | 31.49€ 29.99€ | |
| Levitra Generic | 40mg | 360 + 10 Pills | 704.99€ 671.42€ | |
| Levitra Original | 20mg | 92 + 4 Pills | 406.22€ 386.88€ | |
| Levitra Soft Tabs | 20mg | 20 Pills | 74.68€ 71.12€ | |
| Levitra Generic | 20mg | 90 + 8 Pills | 180.78€ 172.17€ | |
| Levitra Professional | 20mg | 20 Pills | 101.00€ 96.19€ | |
| Levitra Soft Tabs | 20mg | 270 + 10 Pills | 521.78€ 496.93€ | |
| Levitra Professional | 20mg | 180 + 4 Pills | 502.31€ 478.39€ | |
| Levitra Generic | 10mg | 360 + 10 Pills | 407.94€ 388.51€ | |
| Levitra Professional | 20mg | 270 + 6 Pills | 738.98€ 703.79€ | |
| Levitra Generic | 40mg | 30 + 2 Pills | 93.58€ 89.12€ |
Three clinical pharmacology studies were conducted in patients with benign prostatic hyperplasia (BPH) on stable-dose alpha-blocker treatment, consisting of alfuzosin, tamsulosin or terazosin.
| Feature | Description |
|---|---|
| Drug Name | Levitra Professional 20mg |
| Active Ingredient | Vardenafil |
| Dosage Strength | 20 milligrams |
| Form | Tablet |
| Manufacturer | Bayer Healthcare |
Study 1: This study was designed to evaluate the effect of 5 mg vardenafil compared to placebo when administered to BPH patients on
6. Adverse Reactions/Side Effects
In male volunteers with CLcr = 50-80 ml/min, the pharmacokinetics of vardenafil were similar to those observed in a control group with CLcr >80 mL/min. In male volunteers with CLcr = 30-50 mL/min or CLcr<30 mL/min, the AUC of vardenafil was 20–30% higher compared to that observed in a control group with CLcr>80 mL/min. [See Dosage and Administration (2.3) and Warnings and Precautions (5.9).] The maximum dose of LEVITRA for which human data are available is a single 120 mg dose administered to healthy male volunteers. The majority of these subjects experienced reversible back pain/myalgia and/or “abnormal vision.” Single doses up to 80 mg vardenafil and multiple doses up to 40 mg vardenafil administered once daily over 4 weeks were tolerated without producing serious adverse side effects. When 40 mg of vardenafil was administered twice daily, cases of severe back pain were observed.
5.8 Hepatic Impairment
No muscle or neurological toxicity was identified. In cases of overdose, standard supportive measures should be taken as required. Renal dialysis is not expected to accelerate clearance as vardenafil is highly bound to plasma proteins and is not significantly eliminated in the urine. LEVITRA (vardenafil hydrochloride) is administered orally 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. chronic alpha-blocker therapy in two separate cohorts: tamsulosin 0.4 mg daily (cohort 1, n=21) and terazosin 5 or 10 mg daily (cohort 2, n=21).
- Be aware that individual responses to Levitra vary; some may need adjustment.
- Combining with certain recreational drugs can be dangerous.
- Do not use beyond the recommended duration without consulting a healthcare provider.
The design was a randomized, double blind, cross-over study with four treatments: vardenafil 5 mg or placebo administered simultaneously with the alpha-blocker and vardenafil 5 mg or placebo administered 6 hours after the alpha-blocker.
| Contraindication | Explanation |
|---|---|
| Nitrate Medications | Risk of severe hypotension |
| Severe Heart Conditions | Increased risk during cardiovascular events |
| Allergies to Vardenafil | Potential allergic reactions |
| Liver or Kidney Disease | Dose adjustment may be required |
Blood pressure and pulse were evaluated over the 6-hour interval after vardenafil dosing.
How To Get Vardenafil
Vardenafil may add to the blood pressure lowering effects of antihypertensive agents [see Drug Interactions (7)]. 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. 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. Additional blood pressure and heart rate changes were not detected when LEVITRA 20 mg was dosed 24 hours before NTG. For blood pressure (BP) results see Table 2.
¿Qué debo evitar mientras utilizo vardenafil?
In these patients whose hypertension was controlled with nifedipine, LEVITRA 20 mg produced mean additional supine systolic/diastolic blood pressure reductions of 6/5 mmHg compared to placebo. Upon administration of 10 mg of LEVITRA with 800 mg TID indinavir, the Cmax and AUC of indinavir were reduced by 40% and 30%, respectively. Aspirin: LEVITRA (10 mg and 20 mg) did not potentiate the increase in bleeding time caused by aspirin (two 81 mg tablets). Other interactions: LEVITRA had no effect on the pharmacodynamics of glyburide (glucose and insulin concentrations) and warfarin (prothrombin time or other pharmacodynamic parameters). LEVITRA is not indicated for use in women.
12.1 Levitra Mechanism of Action
There are no studies of LEVITRA use in pregnant women. No evidence of specific potential for teratogenicity, embryotoxicity or fetotoxicity was observed in rats and rabbits that received vardenafil at up to 18 mg/kg/day during organogenesis. This dose is approximately 100 fold (rat) and 29 fold (rabbit) greater than the AUC values for unbound vardenafil and its major metabolite in humans given the maximum recommended human dose (MRHD) of 20 mg. In the rat pre-and postnatal development study, the NOAEL (no observed adverse effect level) for maternal toxicity was 8 mg/kg/day. Retarded physical development of pups in the absence of maternal effects was observed following maternal exposure to 1 and 8 mg/kg possibly due to vasodilatation and/or secretion of the drug into milk. One patient after simultaneous treatment with 5 mg vardenafil and 10 mg terazosin exhibited symptomatic hypotension with standing blood
- Levitra Professional 20mg offers an option for men with specific ED needs.
- The medication does not increase libido but enhances erectile response.
- It should be used as part of a comprehensive treatment plan.
pressure of 80/60 mmHg occurring one hour after administration and subsequent mild dizziness and moderate lightheadedness lasting for 6 hours.
16. How is Levitra supplied
However, due to increased vardenafil concentrations in the elderly, a starting dose of 5 mg LEVITRA should be considered in patients ≥65 years of age [see Clinical Pharmacology (12.3)]. Dosage adjustment is necessary in patients with moderate hepatic impairment. Do not use LEVITRA in patients with severe hepatic impairment (Child-Pugh C). Vardenafil has not been evaluated in this patient population. A starting dose of 5 mg is recommended in patients with moderate hepatic impairment (Child-Pugh B) and the maximum dose should not exceed 10 mg.
Serious side effects
In volunteers with moderate hepatic impairment, the Cmax and AUC following a 10 mg vardenafil dose were increased by 130% and 160%, respectively, compared to healthy control subjects. [See Warnings and Precautions (5.8) and Dosage and Administration (2.3).] 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. No dosage adjustment is necessary in patients with mild hepatic impairment. Do not use LEVITRA levitra shipping in patients on renal dialysis as vardenafil has not been evaluated in such patients. No dosage adjustment is necessary in patients with creatinine clearance (CLcr) of 30–80 mL/min. For vardenafil and placebo, five and two patients, respectively, experienced a decrease in standing systolic blood pressure (SBP) of >30 mmHg following simultaneous administration of terazosin. Hypotension was not observed when vardenafil 5 mg and terazosin were administered 6 hours apart.
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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). Following simultaneous administration of vardenafil 5 mg and tamsulosin, two patients had a standing SBP of <85 mmHg.
Overdose/Missed Dose
The number of living pups born to rats exposed pre- and postnatally was reduced at 60 mg/kg/day. Based on the results of the pre- and postnatal study, the developmental NOAEL is less than 1 mg/kg/day. Based on plasma exposures in the rat developmental toxicity study, 1 mg/kg/day in the pregnant rat is estimated to produce total AUC values for unbound vardenafil and its major metabolite comparable to the human AUC at the MRHD of 20 mg. It is not known if vardenafil is excreted in human breast milk. Vardenafil was secreted into the milk of lactating rats at concentrations approximately 10-fold greater than found in the plasma.
Adverse Reactions/Side Effects
Following a single oral dose of 3 mg/kg, 3.3% of the administered dose was excreted into the milk within 24 hours. LEVITRA is not indicated for use in pediatric patients. Safety and efficacy have not been established in this population. Elderly males 65 years of age and older have higher vardenafil plasma concentrations than younger males (18 – 45 years), mean Cmax and AUC were 34% and 52% higher, respectively. Phase 3 clinical trials included more than 834 elderly patients, and no differences in safety or effectiveness of LEVITRA 5, 10, or 20 mg were noted when these elderly patients were compared to younger patients.