Generic Levitra (Vardenafil): Safety and Efficacy Info, Contraindications, Warnings
Generic Levitra (vardenafil) is a safer ED treatment that followed on the discovery of Viagra. The drug is produced in a pelleted form and is supposed to be taken ca. 60 minutes prior to a supposed time when sexual activity is planned. The timespan of Levitra action is 4 to 6 hours. Generic Levitra is characterized by fewer and milder side events in comparison to those of other ED preparations of the same class.
Levitra is a modern synthetic drug, which is created on the basis of vardenafil. It is made in the shape of tablets containing 5, 10, or 20 mg of active substance.
High effectiveness of the drug is proved by many years of research and clinical practice. Therefore, Levitra fairly occupies a leading position among the medications for treating erectile disorders. The excellent effect is observed in 90% of patients treated with these pills. Levitra assists in the treatment of impotence caused by physiological and psychological factors, as well as factors of other nature. The drug has been used successfully in the treatment of erectile dysfunction that occurred against the background of the development of diabetes.
The main ingredient of the drug is vardenafil that refers to PDE5 inhibitors, i.e. it blocks the activity of a specific enzyme.
Vardenafil promotes the increase of cGMP levels, which leads to the relaxation of the smooth muscles of large vessels in the genitals. The inflow of blood to the penis is enhanced resulting in a powerful natural erection.
Levitra, like other similar drugs, does not affect the male reproductive system if there is no sexual desire or sexual stimulation. The pills are not artificial stimulators and affect only the natural physiological processes.
What You Need to Know before You Buy Generic Levitra Online
Before the prescription of Levitra, just like other medications applied to treat erectile dysfunction, a doctor should estimate the patient’s state of the cardiovascular system because there is a risk of having complications from the heart during sexual activity.
Vasodilator properties of vardenafil may cause a minor or moderate reduction in blood pressure.
Patients who suffer from left ventricle outflow tract obstruction can be sensitive to the action of vasodilators, as well as PDE5 inhibitors.
Drugs applied to treat erectile dysfunction are not prescribed to patients who should abstain from sexual activity because of the concomitant cardiovascular disease.
The intake of Levitra is not advisable to men who suffer from long QT syndrome and take antiarrhythmic drugs of the IA class (quinidine and procainamide), or amiodarone and sotalol because the use of the drug in therapeutic doses (10 mg) results in extension of the QT interval.
The efficacy and safety of vardenafil, when applied with other drugs for the treatment of erectile dysfunction, has not been studied, so it is not advisable to combine Levitra with other drugs.
Vardenafil’s safety has not been studied, and its application is not advisable for the following groups of patients:
- Those who suffer from acute liver failures
- Those who have kidney diseases in the terminal stage
- Those who have hypotension
- Those who have suffered myocardial infarction or stroke within the last 6 months
- Those with hereditary degenerative retinal disorders(for example, retinitis pigmentosa) and unstable angina
There have also been reported cases of ischemic optic neuropathy and transient visual loss. In the case of a sudden loss of vision, the patient should cease using Levitra and consult with a doctor immediately.
Combined therapy of vardenafil and alpha-blockers may cause arterial hypotension because these medications have vasodilating effects. The simultaneous use of Levitra and alpha-blockers is permissible only if the patients’ blood pressure is stable. In this case, the minimum recommended dose of 5 mg should be prescribed. Simultaneous intake of Levitra and an alpha-blocker is not permissible, excluding tamsulosin. If a patient takes Levitra, an alpha-blocker therapy should be received at a minimal dosage. The step-by-step increase in the dosage of alpha-blockers in patients getting medications from the group of PDE5 inhibitors may cause further reduction of blood pressure.
The dosage of Levitra should not be more than 5 mg when it is used with itraconazole, erythromycin, and ketoconazole. In this case, the dosage of ketoconazole and itraconazole should not be more than 200 mg.
The reception of Levitra with ritonavir and indinavir is contraindicated.
Since patients with a tendency to bleeding and peptic ulcer disease have not tried using vardenafil, its intake in these cases is possible only with all the benefits and risks of the treatment are carefully assessed.
The duration of bleeding is not affected by vardenafil because it does not impact the efficacy of acetylsalicylic acid when used at the same time.
The increase of platelet is not influenced by vardenafil. However, it causes a slight increase in the antiplatelet effect of sodium nitroprusside.
Effects of the combined use of vardenafil and heparin on the length of the bleeding are not known.
The impact of vardenafil on the hypotensive effect of nitrates has not been studied, so the combined usage of Levitra and nitrates is contraindicated.
Before prescribing Levitra to patients who are driving a vehicle and work with the mechanisms, it is required to clarify patients’ individual response to Levitra.
Safety and Efficacy
Today, Levitra is a highly efficient and the most potent PDE5 inhibitor for the treatment of erectile dysfunction.
In vitro studies have shown that Levitra, unlike other PDE5 inhibitors, selectively impacts PDE5, the main target for treatment of ED. As it was shown in vitro studies, the effect of Levitra is 10 times stronger than Viagra and 13 times stronger than Cialis. Levitra has less effect than sildenafil on PDE6, isoenzyme contained in the retina, which when blocking causes infringements of color perception. It also has less effect on PDE11 contained in the testes. Thus, Levitra is highly selective with respect to PDE5 and hence is safer. The drug does not inhibit spermatogenesis and does not cause disorders in color vision.
Levitra is available in three dosages, 5, 10, and 20 mg, which is useful for the selection of individual dose for each patient.
Levitra is faster absorbed after oral administration than any other PDE5 inhibitor. In some men, the maximum concentration (Cmax) of the drug in blood plasma is achieved within 15 min after administration. In 90% of cases, Cmax is achieved within 30 min after oral administration and is maintained until the 120th minute. Studies have shown that with a daily intake there is no accumulation of the drug in humans. This is a fundamental difference of Levitra from Cialis.
Unlike Viagra, the efficacy of Levitra in not influenced when taking together with food or alcohol.
In pharmacodynamic studies, Levitra in the dosage of 20 mg caused erection in some men, which was sufficient for the introduction of the penis into the vagina after 15 minutes of its administration. The maximum effect in these men occurred 25 min after administration of the drug.
Generic Levitra and its principal active metabolite (Ml) bind to plasma proteins (from 93.3 to 95.3%), predominantly to serum albumin. Estimation of Levitra in the semen of healthy men 90 minutes after the administration showed that the average content of it is 0.00012% of the administered dose. This means that the drug practically doesn’t accumulate in the sperm and has no inhibitory effect on the spermatogenesis.
Levitra is metabolized in the liver via the enzyme cytochrome P-450. Thus, the use of Levitra together with inhibitors of cytochrome P-450 is contraindicated because of the risk to achieve a very high concentration of the drug in plasma.
The average partial ejection of Levitra is 4-5 hours. Levitra and its metabolites are excreted primarily through the intestine (approximately 91-95% of the administered dose) and in the urine (approximately 2-6% of the administered dose). In patients who are 65 years of old with impaired liver function and advanced renal failure, the ejection of Levitra from the body slows down. Therefore they need to start taking the drug at a dose of 5 mg and increase the dose based on tolerability and safety.
Main North American multicenter study, which was conducted on the basis of 54 research centers in the US and Canada, showed that Levitra in doses of 5, 10, and 20 mg significantly improved erectile function in more than 85% of patients with ED of various etiologies and severity compared to 28% of placebo recipients.
Erectile function was restored in more than 89% of patients with marginally severe ED and 39% of patients with severe erectile dysfunction, compared to 21 and 4%, respectively, in the placebo group.
Types of Generic Levitra
- Levitra Plus. The distinctive feature is that content of vardenafil reaches 400 mg. It might also have such add-ons as vitamins and Ginseng. It is a unique formula that combines both herbal and pharmaceutical elements providing sustainable results. It helps feel the energy boost and great sexual desire. It maintains a stable and long-lasting erection and makes it possible to have several sexual intercourses during several hours. The benefits of this type of generic include: fast response, increase in semen production, harder penis, and the surge of energy. Ginseng, which is an ingredient of the drug, increases metabolic processes and endocrine activity. It also favorably influences central nervous and cardiovascular systems. Levitra Plus is manufactured in different packs from 30 to 360 tablets.
- Levitra Professional. This generic type has shown almost the same effects as the branded Levitra. It is offered in one dosage of 20 mg and packed in different quantities from 10 to 180 tablets.
- Levitra Super Active+. It is produced in the form of soft gelatin capsules and offered in two variants of vardenafil content (20 and 40 mg). It is packed in quantity from 10 to 360 tablets. Doctors recommend using this type of Levitra generic several minutes before sex. The initial dosage is 10 mg. The manufacturer claims that there are no side effects even if you take 80 mg a day. The effective length of the medical action is 4–5 hours.
- Extra Super Levitra. This type of generic has 100 mg of vardenafil and is manufactured in quantities from 10 to 180 tablets in a pack.
- Levitra Extra Dosage. This generic has a larger content of vardenafil and is offered in 40 and 60 mg. There might be from 10 to 180 tablets in a pack.
- Levitra Jelly. It is produced in the form of jelly pills. The content of vardenafil is up to 20 mg. The pack contains 10 to 120 tablets.
- Levitra Soft. This type of generic has 20 mg of vardenafil and is offered in different blister sizes from 10 to 360 pills. It is swallowed easy and has a fast effect. The pill should be put under the tongue until it melts. Patients should use Levitra Soft 1 hour before sex.
- An absolute contraindication for taking Levitra is an individual intolerance to the drug.
- The medication is not prescribed to patients with phenylketonuria.
- It should not be used in patients who are being treated with nitrates.
- Vardenafil is not prescribed to women and children.
- Patients who are contraindicated to have sexual activity should not use the medication, particularly if they recently have had a myocardial infarction or stroke.
- Caution must be exercised when prescribing vardenafil to men suffering from aortic stenosis, left ventricular outflow tract obstruction, idiopathic hypertrophic subaortic stenosis, and long QT syndrome.
- Patients who have a high risk of developing priapism should be cautious when taking Levitra, including me who suffer from anatomical deformation of the penis, cavernous fibrosis, Peyronie’s disease, multiple myeloma, sickle cell disease, and leukemia.
- Caution is advised when using Levitra in patients with reductions in renal and hepatic function, duodenal and stomach ulcer, degenerative diseases of the retina, as well as Crohn’s disease.
Results and Benefits
Since the creation of Levitra, scientists from various countries have had more than a hundred clinical trials. Levitra was tested on men aged from 18 to 90 years of old. Erectile dysfunction in men was caused by a variety of reasons of both organic and psychogenic nature. Men were divided into two groups. The first group received a standard dose of the drug. In the second group, the dose was calculated individually based on the characteristics of the each patient and the disease. In 85% of men in the first group, there was a significant improvement in potency. Among the participants of the second group, the effectiveness of treatment with Levitra reached 92%.
The effect of Levitra starts much earlier than when using other drugs that treat ED. In some patients, the effects of the drug have been noticed even within ten minutes after the application of Levitra. 25 minutes is the longest it might take for the drug to cause a stable.
The most important thing is that Levitra causes much fewer side effects (they occur only in 2% of cases). Medical studies of Levitra by German and British manufacturing companies have shown that Levitra acts in the 50% of cases when Viagra is ineffective. It was also proved that Levitra was effective in 70% of men who have undergone prostate removal and 72% of men with diabetes.
Some of the most recent studies of Levitra were held in the USA. The study included 200 patients suffering from erectile dysfunction aged from 18 to 65 years of old. For one month the first group of patients was taking the drug, and the second group was taking a placebo. 40% of men had moderate erectile dysfunction. 30% of men had a severe ED. While taking 10 mg of Levitra 50 minutes prior to sexual intercourse, patients were able to increase the duration of an erection from 6 to 12 minutes without any side effects. In some cases, men complained about having a flushing in the face and headaches. The test results revealed that thirty-day treatment with Levitra could increase sexual intercourse by several times. All medical studies confirm the great efficacy of the drug.
Warnings and Precautions
- In patients with kidney failures. Levitra should be taken with precaution in men who have kidney diseases in the terminal stage. The individual dosage is not required in patients who suffer from mild and moderate kidney failures.
- In patients with liver failure. In the case of severe hepatic dysfunction, Levitra should be applied with precaution. The individual dosage is not required for men with mild liver failure. The initial dose of 5 mg per day is prescribed to patients with moderate hepatic impairment. Further, the dose can be increased to 10 mg and then 20 mg depending on the efficacy and tolerability of the treatment.
- The application of Levitra in the elderly. The correction of the dosage in elderly patients is not required.
- The application of Levitra in children. The medication is not intended for use in children and adolescents under the age of 16 years old.
Other Drugs and Vardenafil
Vardenafil is metabolized predominantly involving the liver cytochrome P450 enzyme, namely CYP3A4, as well as with some participation of isozymes, CYP3A5 and CYP2S. Inhibitors of these enzymes may reduce vardenafil clearance. Simultaneous use of Levitra with itraconazole, ketoconazole, indinavir, and ritonavir can lead to a significant increase of vardenafil concentrations in plasma.
Simultaneous use of Levitra and cimetidine (400 mg 2 times a day), a non-specific inhibitor of cytochrome P450 isoenzyme system, does not affect vardenafil’s AUC and Cmax.
When Levitra (5 mg) is used together with erythromycin (500 mg 3 times a day), vardenafil’s AUC is increased by 4 times (300%) and vardenafil’s Cmax by 3 times (200%).
Ketoconazole (200 mg), when used with Levitra (5 mg), causes an increase in AUC of vardenafil by 10 times (900%) and Cmax of vardenafil (5 mg) by 4 times (300%).
Simultaneous use of Levitra (10 mg) and the HIV protease inhibitor, indinavir, (800 mg 3 times a day), there is an increase in AUC of vardenafil by 16 times (1,500%) and Cmax of vardenafil by 7 times (600%). 24 hours after intake of vardenafil, its concentration in plasma is about 4% of the Cmax.
Simultaneous application of Levitra (5 mg) and ritonavir (600 mg 2 times a day) enhances Cmax of vardenafil by 13 times, while the daily rate of its total AUC is increased by 49 times. This is because ritonavir blocks hepatic metabolism of vardenafil.
In healthy patients, the application of Levitra (10 mg) 24 hours before administration of nitroglycerine does not enhance its hypotensive effect. The dose of 20 mg 1–4 hours prior to application of nitrate enhances their hypotensive action. However, when taking the drug 24 hours before the application of nitrate, increase in the hypotensive action does not occur.
Vardenafil (20 mg) doesn’t alter the parameters of glibenclamide AUC and Cmax.
Pharmacokinetic and pharmacodynamic interaction is not observed during the simultaneous use of vardenafil (20 mg) and warfarin (25 mg).
There has been no particular pharmacokinetic interaction between nifedipine (30 mg or 60) and Levitra (20 mg).
Since it is known that alpha-blockers cause a decrease in blood pressure, the interaction of alpha-blockers and Levitra when used together was carefully studied. Two studies were conducted on the drug interaction in healthy patients with normal blood pressure who were treated with tamsulosin or terazosin. After adding Levitra to the received therapy, hypotension happened in a significant number of participants of the study. Among those receiving terazosin, hypotension occurred more frequently if Levitra and terazosin were administered so as to reach Cmax coincidence in time than with Cmax 6 hours dispersion.
Studies of Levitra drug interactions were also held in patients with benign prostatic hyperplasia (BPH) receiving stable dosages of tamsulosin or terazosin. When taking Levitra in dosages of 5, 10, or 20 mg in patients who received stable doses of tamsulosin, an extra decrease in blood pressure was not observed.
Combined use of Levitra and an alpha-blocker is permissible only if blood pressure in patients using alpha-blockers is stable. In this case, the minimum recommended dose of 5 mg should be prescribed. It is not advisable to take Levitra in one and the same time with an alpha-blocker, excluding tamsulosin, which reception can coincide with the reception Levitra.
- A single dosage of Maalox doesn’t affect the performance of AUC and Cmax of vardenafil.
- Vardenafil’s (20 mg) bioavailability is also not affected when used together with histamine H2-receptor antagonists and cimetidine.
- Levitra does not impact the duration of bleeding when applied as monotherapy and together with acetylsalicylic acid at a low dose.
- Levitra (20 mg) does not increase ethanol hypotensive effect and doesn’t disturb the pharmacokinetics of vardenafil.
- Aspirin, ACE inhibitors, beta-blockers, diuretics, and hypoglycemic agents (sulfonylureas and metformin) do not affect the pharmacokinetics of vardenafil.
Interactions with Food and Alcohol
Even when drinking moderate amounts of alcohol Levitra shows good results. However, the medication has not been tested for safety after drinking a large amount of alcohol. In the instructions that come with, there are no cautions about taking this medicine with alcohol. When taking Levitra with a moderate amount of alcohol, its efficacy is not reduced.
Levitra works well even after a meal, while fatty foods can slow the absorption of the drug. The most popular feature of Levitra is that there is no need to adjust your diet to use the drug. However, even the action of Levitra may be slowed down by very fatty food.
The results of studies showed that Levitra efficacy was not significantly affected by ingestion, except when having meals high in fat. In this case, the effect of the drug was delayed by one hour.
How to Take Levitra
Levitra is taken orally with or without food. The initial recommended dosage is 10 mg 25–60 minutes prior to sex. It can also be taken in the period from 4–5 hours up to 25 minutes before sexual activity. The maximum frequency of reception is 1 time a day. Sexual arousal is necessary for the efficacy of the drug.
Depending on efficacy and tolerance, the dosage can be increased to 20 mg or reduced to 5 mg a day. The maximum daily dose is 20 mg.
The correction of the dosage in elderly patients is not required.
Generally, the dosage of 20 mg is advisable for patients suffering from severe erectile dysfunction, when an initial dose of 10 mg is inefficient and ineffective.
Overdose Symptoms and First Help
There are cases when Levitra was used in the dose of 80 mg and 40 mg one time a day for more than 4 weeks without causing serious side effects. However, at the same time, when used in a dose of 40 mg two times a day, some patients complain about having lower back pain without signs of toxic effects on the nervous and muscular system.
In the case of overdose, symptomatic and supportive therapy is required. Since vardenafil and, Dialysis efficiency is unlikely to happen because vardenafil bounds to plasma proteins and only a small amount of the medication is released by the kidneys.
Possible Side Effects
Usually, Levitra is well-tolerated by patients. Rare cases of adverse effects in patients treated with vardenafil were reported.
In particular, the following possible side effects were noted:
- Problems with nervous system: sleep disorders, dizziness, memory impairment, drowsiness, fatigue, and headaches.
- Complications with the heart and blood system: angina, vasodilatation, ischemia of the heart muscle, and blood pressure lability.
- Problems with the respiratory system: swelling of the nasal mucosa and rhinitis.
- Complications of the digestive tract: abdominal pain, nausea, vomiting, development of gastroesophageal reflux, and gastritis.
- Vision problems: decreased visual acuity, increased intraocular pressure, photophobia, and disturbance of perception of colors.
- Allergic reactions: angioedema, anaphylactic shock, and bronchospasm.
- Other: back pain and increased muscle tone.
When taking vardenafil, men may have prolonged erections and priapism, which can lead to the damage of the penis tissue and prolonged disturbance of potency.
In some cases, patients who have cardiovascular system diseases might have a heart attack. However, it is not known whether or not the use of Levitra was the cause of this condition.
Some patients may develop visual impairment including the loss of vision (permanent or temporary). However, it is not known yet whether or not the use of vardenafil is the real cause of this condition.
With the development of side effects, including priapism or prolonged erection, patients should consult a doctor.
The drug should be kept out of reach of children in a dry place at temperatures no higher than 30 degrees Celsius. The shelf life of Levitra is 3 years.
- The active ingredient of Levitra is vardenafil.
- 1 pill contains 5 mg, 10 mg, or 20 mg of vardenafil.
- Additional ingredients: crospovidone, magnesium stearate, microcrystalline cellulose, colloidal anhydrous silica, macrogol 400, hypromellose, titanium dioxide (E 171), iron oxide yellow (E 172), and iron oxide red (E 172).
The information uncovered in this article has been compiled with the educational purposes only. The team of authors provides the fact checking before posting any kind of information on this website. But the site’s administration does not guarantee correctness and/or update status of all contents in this article. This article can be taken as a guidance for self-treatment. Only licensed and professional healthcare specialist can diagnose and treat patients considering the personal symptoms in each particular case.