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Brand Levitra

Brand Levitra
Levitra is intended to increase potency in men and for erectile dysfunction of any nature. Levitra is highly effective from the first dose and regardless of age. The effect of the drug does not decrease over time; on the contrary, more reliable results are provided over and over again.

Brand: Vardenafil

Availability: In Stock
Average Delivery Time: 9 Days
Exp. Date: September 2023
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Brand Levitra 20 mg
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Product description

Pharmacological action of Levitra

Buy Levitra in Canada

The drug for the treatment of erectile dysfunction, PDE5 inhibitor.

Penile erection is a hemodynamic process, which is based on the relaxation of the smooth muscles of the cavernous bodies and the arterioles located in it. During sexual stimulation, nitric oxide (NO) is released from the nerve endings of the corpus cavernosum, which activates the enzyme guanylate cyclase, which leads to an increase in the content of cyclic guanosine monophosphate (cGMP) in the corpus cavernosum. The result is a relaxation of the smooth muscles of the cavernous bodies, which helps to increase blood flow to the penis.

Vardenafil blocks PDE5, under the influence of which the cleavage of cGMP occurs, as a result of which the local action of endogenous NO in the corpus cavernosum during sexual stimulation is enhanced, which determines the ability of Levitra to enhance the response to sexual stimulation.

Pharmacokinetics

Absorption

After oral administration, vardenafil is rapidly absorbed from the gastrointestinal tract. When taken on an empty stomach, Cmax in blood plasma can be reached after 15 minutes, but in 90% of cases, on average, after 60 minutes (from 30 to 120 minutes). The absolute bioavailability is about 15%. In the recommended dose range (5-20 mg), the AUC and Cmax in blood plasma increase in proportion to the dose.

The clinical effect is realized even before reaching Cmax. The onset of action after oral administration at a dose of 20 mg and 10 mg is 10 minutes, which provides an erection sufficient for penetration and successful completion of intercourse in 34% and 40% of patients with mild to moderately mild erectile dysfunction, respectively. After 25 minutes, the effect occurs in 53% and 50% of patients, respectively, which coincides in time with the beginning of the appearance of the drug in the blood and a rapid increase in its concentration. The duration of action is 8-12 hours.

When taken with normal food containing no more than 30% fat, the pharmacokinetic parameters of vardenafil (Cmax, time to reach Cmax, AUC) do not change.

When vardenafil is taken simultaneously with food containing a large amount of fat (57%), the absorption rate decreases with an increase in the time to reach Cmax to 60 minutes, and Cmax in blood plasma decreases on average by 20% without a significant change in AUC.

Distribution

Levitra packaging

The average Vd of vardenafil in the equilibrium state of pharmacokinetic parameters averages 208 liters, which demonstrates its good tissue distribution. The binding of vardenafil and its main metabolite (M1) to blood plasma proteins is up to 95%, is reversible and does not depend on the total concentration of the drug.

Based on the results of measuring the content of vardenafil in the semen of healthy men 90 minutes after administration, it can be assumed that no more than 0.00012% of the dose received can be determined in the semen of patients.

Metabolism

Vardenafil is metabolized in the liver with the participation of mainly CYP3A4, as well as CYP3A5 and CYP2C9. The average T1/2 of vardenafil is 4-5 hours, and M1 is about 4 hours. The blood contains glucuronide in the form of a conjugate (glucuronic acid), which is part of the M1 metabolite. The concentration of the rest of the M1 (non-glucuronic) is 26% of the concentration of the active substance. The selectivity profile for PDE in M1 is similar to that for vardenafil; in vitro, the ability of M1 to suppress PDE5 is 28% compared to vardenafil, which corresponds to 7% of the drug's effectiveness.

Excretion

The total clearance of vardenafil is 56 l / h, the final T1/2 is about 4-5 hours. After oral administration, vardenafil in the form of metabolites is excreted mainly through the intestines - 91-95%, to a lesser extent by the kidneys - 2-6%.

Pharmacokinetics in special clinical situations

In healthy elderly men (≥65 years) compared with young (≤45 years), hepatic clearance of vardenafil is reduced. On average, the AUC in the elderly increases by 52%. However, there are no differences in the effectiveness and safety of the drug in elderly and young patients.

In patients with mild (CC> 55-80 ml / min) and moderate (CC> 30-50 ml / min) degree of impaired renal function, the pharmacokinetic parameters of vardenafil are comparable to those in healthy subjects. In severe renal impairment (CC <30 ml / min), the average AUC increases by 21%, and Cmax decreases by 23%. There is no significant correlation between CC and the concentration of vardenafil in plasma (AUC and Cmax).

In patients on hemodialysis, the pharmacokinetics of vardenafil has not been studied.

In patients with mild to moderate hepatic impairment, the clearance of vardenafil decreases in proportion to the degree of its impairment. With a mild degree of liver failure (class A on the Child-Pugh scale), there is an increase in AUC and Cvalues ​​bymax 1.2 times (AUC - by 17%, Cmax - by 22%), with a moderate degree (class B on the Child-Pugh scale) ) - 2.6 times (160%) and 2.3 times (130%), respectively, compared with healthy volunteers.

In patients with severe hepatic impairment (class C on the Child-Pugh scale), the pharmacokinetics of vardenafil have not been studied.

Indications of the drug Levitra®

  • erectile dysfunction (inability to achieve and maintain an erection, necessary for sexual intercourse).

Levitra dosage regimen

The drug is taken orally, regardless of food intake. The initial recommended dose is 10 mg 25-60 minutes before sexual intercourse. It can also be taken from 4-5 hours to 25 minutes before sexual activity. The maximum frequency of admission is 1 time / day. To be effective, a sufficient level of sexual stimulation is required.

Depending on the effectiveness and tolerability, the dose can be increased to 20 mg or decreased to 5 mg / day. The maximum daily dose is 20 mg.

Correction of the dosage regimen in elderly patients is not required.

In patients with mild hepatic impairment, no dosage adjustment is required. In patients with moderate hepatic impairment, the initial dose is 5 mg per day. In the future, depending on the effectiveness and tolerability of treatment, the dose can be increased to 10 mg and then to 20 mg.

In patients with mild to moderate renal impairment, no dosage adjustment is required


Contraindications to the use of Levitra

  • simultaneous therapy with nitrates or drugs that are donors of nitric oxide;
  • combination with HIV protease inhibitors such as indinavir or ritonavir;
  • hypersensitivity to drug components.

The drug is not intended for use in children and adolescents under the age of 16 years.

It caution should be used within patients with congenital prolongation of the QT interval, with anatomical deformity of the penis (curvature, cavernous fibrosis, Peyronie's disease), with diseases predisposing to priapism (sickle cell anemia, multiple myeloma, leukemia), severe liver dysfunction, end-stage kidney disease, arterial hypotension (systolic pressure at rest less than 90 mm Hg), recent stroke and myocardial infarction, unstable angina pectoris, hereditary degenerative diseases of the retina (eg, retinitis pigmentosa), with a tendency to bleeding and with exacerbation peptic ulcer disease, aortic stenosis and idiopathic hypertrophic subaortic stenosis.

Application during pregnancy and lactation

The drug is not intended for use in women.

Application for violations of liver function

The drug should be used with caution in severe violations of liver function.

In patients with mild hepatic impairment, no dosage adjustment is required. In patients with moderate hepatic impairment, the initial dose is 5 mg per day. Further, depending on the effectiveness and tolerability of treatment, the dose can be increased to 10 mg and then to 20 mg.

Application for impaired renal function

The drug should be used with caution in end-stage renal disease.

In patients with mild and moderate impairment of renal function, no dosage adjustment is required.

Use in children

The drug is not intended for use in children and adolescents under the age of 16 years.

Application in elderly patients

Correction of the dosage regimen in elderly patients is not required.

Special instructions

Before prescribing Levitra® (as well as other drugs used to treat erectile dysfunction), the doctor should assess the state of the cardiovascular system, since there is a risk of developing heart complications during sexual activity.

Vardenafil has vasodilating properties, which may be accompanied by a slight or moderate decrease in blood pressure.

Patients with obstruction of the left ventricular outflow tract, for example, with aortic stenosis, idiopathic hypertrophic subaortic stenosis, may be sensitive to the action of vasodilators, including PDE5 inhibitors.

In men who are not shown sexual activity due to concomitant cardiovascular disease, drugs for the treatment of erectile dysfunction are not prescribed.

Since Levitra® in therapeutic doses (10 mg) causes prolongation of the QT interval, the drug should not be prescribed to patients with congenital prolongation of the QT interval and those taking class IA (quinidine, procainamide) or class III (amiodarone, sotalol) antiarrhythmic drugs.

The safety and efficacy of vardenafil in combination with other drugs for the treatment of erectile dysfunction has not been studied, therefore their combined use is not recommended.

The safety of vardenafil has not been studied and its use is not recommended in the following groups of patients: severe liver dysfunction, end-stage kidney disease requiring hemodialysis, arterial hypotension (systolic pressure at rest <90 mm Hg), recent stroke or myocardial infarction (within the last 6 months), unstable angina pectoris, and hereditary degenerative retinal diseases such as retinitis pigmentosa.

While taking Levitra and other PDE5 inhibitors, cases of transient vision loss and non-arteritis ischemic optic neuropathy have been reported. In the event of a sudden loss of vision, the patient should stop taking Levitra and urgently consult with the attending physician.

Combined therapy with alpha-blockers and vardenafil may be accompanied by the development of arterial hypotension with a corresponding clinical picture, since these drugs have a vasodilating effect. The combined appointment of Levitra and alpha-blockers is permissible only in the presence of stable blood pressure while taking alpha-blockers, while Levitra should be prescribed in the minimum recommended dose of 5 mg. Levitra should not be taken at the same time as alpha-blockers, with the exception of tamsulosin, which may coincide with vardenafil. In the case of taking a selected dose of Levitra, therapy with alpha-blockers should be started at the minimum dose. A gradual increase in the dose of alpha-blockers in patients receiving drugs from the group of PDE5 inhibitors can lead to a further decrease in blood pressure.

The dose of Levitra should not exceed 5 mg when combined with erythromycin, ketoconazole, itraconazole. The dose of ketoconazole and itraconazole should not exceed 200 mg.

The combination with indinavir and ritonavir is contraindicated.

Since vardenafil has not been used in patients with a tendency to bleeding and in patients with exacerbation of peptic ulcer disease, its appointment in these cases is possible only after a careful assessment of the balance of benefits and risks of therapy.

Vardenafil does not affect the duration of bleeding, nor does it affect this indicator when used in combination with acetylsalicylic acid.

Vardenafil does not increase platelet aggregation caused by various drugs. At a concentration higher than the therapeutic one, vardenafil causes a slight increase in the antiplatelet effect of sodium nitroprusside, which is a nitric oxide donor.

The effect of vardenafil and heparin with simultaneous use on the duration of bleeding has not been studied.

The influence of vardenafil on the hypotensive effect of nitrates in patients has not been studied, therefore the combined administration of Levitra and nitrates is contraindicated.

Pediatric use

Vardenafil is not intended for use in children.

Influence on the ability to drive vehicles and control mechanisms

Before prescribing the drug to patients who drive vehicles and work with mechanisms, it is necessary to find out their individual reaction to Levitra.

Overdose

Symptoms: it is known about cases of taking Levitra at a dose of 80 mg 1 time / day and 40 mg 1 time / day for more than 4 weeks without the development of serious adverse reactions. However, at the same time, when used in a dose of 40 mg 2 times / day, severe pain in the lower back is observed without signs of toxic effects on the muscular and nervous system.

Treatment: symptomatic and supportive therapy. Since vardenafil is highly associated with plasma proteins and only a small amount of the drug is excreted by the kidneys, hemodialysis is unlikely to be effective.

Drug Interactions

Vardenafil is metabolized mainly with the participation of hepatic enzymes of the cytochrome P450 system, namely, the isoenzyme CYP3A4, as well as with some participation of isoenzymes CYP3A5 and CYP2C. Inhibitors of these enzymes can reduce the clearance of vardenafil. With the simultaneous use of Levitra with ketoconazole, itraconazole, indinavir and ritonavir (powerful inhibitors of CYP3A4), a significant increase in the plasma concentration of vardenafil can be expected.

With the simultaneous use of cimetidine (400 mg 2 times / day), which is a nonspecific inhibitor of isoenzymes of the cytochrome P450 system, does not affect the value of AUC and Cmax of vardenafil (20 mg).

With simultaneous use with Levitra (5 mg), erythromycin (500 mg 3 times / day), which is an inhibitor of CYP3A4, causes an increase in the AUC of vardenafil by 4 times (300%) and an increase in Cmax of vardenafil by 3 times (200%).

Ketoconazole (200 mg), being a potent inhibitor of CYP3A4, when used simultaneously 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%).

With the simultaneous use of Levitra (10 mg) and the HIV protease inhibitor indinavir (800 mg 3 times / day), there is an increase in vardenafil AUC 16 times (1500%) andCmax vardenafil7 times (600%). 24 hours after administration, the plasma concentration of vardenafil is approximately 4% of its Cmax.

With the simultaneous use of Levitra (5 mg), ritonavir (600 mg 2 times / day) increases the C13 timesmax of vardenafil byand its total daily AUC by 49 times. The interaction is due to the fact that ritonavir, being a potent inhibitor of CYP3A4 and CYP2C9, blocks the hepatic metabolism of vardenafil. Ritonavir significantly prolongs T1/2 vardenafil to 25.7 hours.

In healthy volunteers Levitra® (10 mg) at reception for 24-1 hours prior to administration of nitroglycerine (400 mcg sublingual) does not enhance its hypotensive effect, at a dose of 20 mg of 1- 4 hours before the use of nitrates (400 mcg sublingually) enhances their hypotensive effect, but when administered 24 hours before, the hypotensive effect does not increase.

Vardenafil (20 mg) does not change the AUC and Cmax of glibenclamide (glyburide at a dose of 3.5 mg) when used together and vice versa.

Pharmacokinetic and pharmacodynamic interactions (effects on prothrombin time and coagulation factors II, VII, X) are not observed when vardenafil (20 mg) is combined with warfarin (25 mg).

There is no significant pharmacokinetic interaction between Levitra (20 mg) and nifedipine (30 or 60 mg): vardenafil in the supine position causes an additional decrease in systolic and diastolic blood pressure by an average of 5.9 mm Hg. Art. and 5.2 mm Hg. Art. respectively.

Since it is known that alpha-blockers cause a decrease in blood pressure, especially postural hypotension and fainting, the issue of the interaction of alpha-blockers and Levitra when used together has been carefully studied. Two studies of drug interaction were conducted with the participation of healthy volunteers with normal blood pressure who received the alpha-blockers tamsulosin or terazosin with a rapid increase in doses to the maximum or close to them within 14 days or less. After adding Levitra to the received therapy, arterial hypotension developed in a significant number of study participants. Among people receiving terazosia, arterial hypotension (systolic blood pressure in a standing position below 85 mm Hg) developed more often if Levitra® and terazosin were prescribed in such a way as to achieve coincidence of Cmax in time than in the case, if Cmax diverged in time by 6 hours. These studies may have limited clinical value, since they were conducted with the participation of healthy volunteers, as well as after forced titration of doses (thus, the study participants were not able to achieve stabilization of blood pressure while taking alpha-blockers).

Levitra drug interaction studies were also conducted in patients with benign prostatic hyperplasia (BPH) receiving stable doses of tamsulosin or terazosin. When Levitra was prescribed in doses of 5, 10 or 20 mg to patients receiving stable doses of tamsulosin, no additional decrease in the average blood pressure was observed. With the simultaneous administration of Levitra at a dose of 5 mg and tamsulosin at a dose of 0.4 mg, orthostatic arterial hypotension with a drop in systolic blood pressure below 85 mm Hg was observed in 2 of 21 patients. Art. When taking Levitra at a dose of 5 mg and tamsulosin with a 6-hour interval, orthostatic systolic hypotension with a drop in blood pressure of less than 85 mm Hg. Art. also developed in 2 of 21 patients. In a subsequent study, the simultaneous administration of Levitra at doses of 10 mg and 20 mg and tamsulosin at doses of 0.4 mg and 0.8 mg in cases of orthostatic drop in systolic blood pressure below 85 mm Hg. Art. was not registered. With the simultaneous administration of Levitra at a dose of 5 mg and terazosin at doses of 5 mg or 10 mg, symptomatic postural hypotension was observed in one of 21 patients. When taking Levitra at a dose of 5 mg and terazosin with an interval of 6 hours, there were no cases of a drop in blood pressure. The results obtained should be taken into account when deciding when to prescribe drugs.

The combined appointment of Levitra and alpha-blockers is permissible only in the presence of stable blood pressure while taking alpha-blockers, while Levitra should be prescribed in the minimum recommended dose of 5 mg. You should not take Levitra at the same time with alpha-blockers, with the exception of tamsulosin, which may be taken at the same time as Levitra.

Simultaneous use of digoxin (0.375 mg) and Levitra (20 mg) every other day for more than 14 days is not accompanied by drug interactions.

A single dose of Maalox (antacid, magnesium hydroxide / aluminum hydroxide) does not affect the AUC and Cmax of vardenafil.

The bioavailability of vardenafil (20 mg) is also not impaired when it is combined with histamine Hblockers2receptorranitidine (150 mg 2 times / day) and cimetidine (400 mg 2 times / day).

Levitra® (10 mg and 20 mg) does not affect the duration of bleeding when used as monotherapy and in combination with acetylsalicylic acid in a low dose (2 tablets, 81 mg each).

Levitra® (20 mg) did not potentiate the hypotensive effect of ethanol (0.5 g / kg body weight), the pharmacokinetics of vardenafil is not disturbed.

Acetylsalicylic acid, ACE inhibitors, beta-blockers, diuretics and hypoglycemic drugs (sulfonylurea and metformin), weak CYP3A4 inhibitors do not affect the pharmacokinetics of vardenafil.

Storage conditions of the drug Levitra®

The drug should be stored out of the reach of children, in a dry place at a temperature not exceeding 30 ° C.


Side effect

From the side of the central nervous system and peripheral nervous system: ≥10% - headache; ≥1% - dizziness; ≥0.1% - <1% - drowsiness; ≥0.01% - <0.1% - anxiety, fainting.

From the side of the cardiovascular system: ≥10% - hot flashes (periodic sudden facial flushing, feeling of heat); ≥0.1% - <1% - increased blood pressure, decreased blood pressure, orthostatic hypotension; ≥0.01% - <0.1% - angina pectoris, myocardial ischemia.

From the digestive system: ≥1% - <10% - dyspepsia, nausea; ≥0.1% - <1% - change in liver function tests (increased ALT, AST, GGTP).

From the respiratory system: ≥1% - <10% - congestive hyperemia of the nasal mucosa (edema of the mucous membrane, rhinitis, rhinorrhea); ≥0.1% - <1% - shortness of breath, epistaxis; ≥0.01% - <0.1% - laryngeal edema.

On the part of the organ of vision: ≥0.1% - <1% - increased lacrimation, visual impairment (brightness of vision); ≥0.01% - <0.1% - increased intraocular pressure.

Dermatological reactions: ≥0.1% - <1% - facial edema, photosensitivity.

From the musculoskeletal system: ≥0.1% - <1% - myalgia, back pain, increased CPK; ≥0.01% - <0.1% - increased muscle tone.

From the reproductive system: > 0.01% - <0.1% - lengthening of an erection or painful erection, priapism.

Others: ≥0.01% - <0.1% - hypersensitivity reactions.

There are rare post-marketing reports of cases of the development of anterior ischemic neuropathy of the optic nerve (AICN), leading to visual impairment, including persistent loss of vision, associated in time with the intake of PDE5 inhibitors, incl. and Levitra, in patients, many of whom have concomitant risk factors for the development of this condition, such as anatomical defect of the optic nerve head, age over 50, diabetes mellitus, arterial hypertension, coronary artery disease, hyperlipidemia, and smoking. It has not been established whether the development of PINZN is directly related to the use of PDE5 inhibitors, or to the patient's concomitant vascular risk factors and anatomical defects, or a combination of these factors, or other reasons.

Cases of visual impairment, including temporary or permanent loss of vision, are reported, which are associated in time with the use of PDE5 inhibitors, incl. and Levitra. It has not been established whether these cases are directly related to the use of PDE5 inhibitors, or with concomitant vascular risk factors, or with other causes.