Levitra: composition and instructions for use of Levitra

Limited use of the drug is possible for the following disorders:

  • injuries and altered conditions of the penis,
  • in the presence of diseases that stimulate long-term erection of the penis, not associated with erotic experiences (myeloma, leukemia),
  • instructions for use of the drug Levitra prescribe limited use of the drug for severe liver pathologies. In these cases, a reduced dosage of the medication is prescribed with mandatory monitoring of the patient's health condition. With normal tolerance, you can use an increased rate,
  • there is no restriction on the use of the drug for pathologies of the genitourinary system, but if side effects and harmful consequences are detected, the drug should be stopped,
  • The use of the drug is not recommended for drivers before a long car trip or when operating various mechanisms that require concentration.

Release form

The drug is produced in the form of round, biconvex tablets in a film shell of a light orange color (sometimes with a grayish tint).

The tablets have an engraving on both sides - a number indicating the dosage of the medicine (“5”, “10” or “20”) and the Bayer brand cross.

Levitra release form

Tablets containing the active ingredient 10 and 20 mg are packaged in blisters of 1 or 4 pieces, which are placed in cardboard packs or sliding “Burgopack” packaging.

For tablets with a dosage of 5 mg, there is another packaging option consisting of 5 blisters, each containing 4 tablets.

is Bayer Pharma AG, D-5I368, Leverkusen, Germany.

Indications for use

Levitra Tabletki is used for the acute stage of erectile dysfunction. In case of weak and short-lived erection, premature ejaculation, and inability to achieve orgasm, the drug can be taken once or used as a course. The instructions for use of the drug Levitra must be strictly followed to avoid negative consequences.

In addition, the beneficial components of the product help strengthen the immune system, increase the body's resistance to viruses and bacteria, and help fight stress and chronic fatigue. The drug can also be taken in the treatment of impotence and the occurrence of obvious symptoms of prostatitis .

Indications and contraindications

The drugs “Levitra”, “Levitra SOFT” and “Levitra ODT” are classified as means of regulating potency.

They are prescribed in the case of erectile dysfunction in men, expressed in the loss of the ability to achieve and maintain an erection at the required level, necessary for normal sexual intercourse.

Levitra tablets cannot be used in the following cases:

  1. Hereditary degenerative pathologies of the retina, for example, retinitis pigmentosa;
  2. Hypersensitivity to any component of the drug;
  3. Stroke or myocardial infarction, after which less than 6 months have passed;
  4. Taking nitric oxide donors or drugs containing nitrates, as well as CYP3A4 inhibitors (Clarithromycin, Ritonavir, Ketoconazole, Erythromycin, Itraconazole, Indinavir);
  5. Arterial hypotension, in which resting blood pressure is less than 90 mmHg;
  6. Drug treatment of erectile dysfunction;
  7. The presence of hemodialysis at the first stage of kidney disease;
  8. The presence of cardiovascular pathologies in a man, such as acute heart failure and unstable angina, as well as diseases in which sexual activity is undesirable;
  9. Serious problems in the liver.

In addition, Levitra tablets are not intended for women, newborns or children.

You should use this product with extreme caution in the following cases:

  • predisposition to priapism, for example, sickle cell anemia, multiple myeloma, leukemia, bleeding tendency;
  • anatomical curvature of the penis, which can occur due to various factors, including Peyronie's disease and cavernous fibrosis;
  • acute form of peptic ulcer.

Effect of the drug

Erectile dysfunction is a common problem today as many men face it.
Those over 40 years of age are especially susceptible. This violation should not be ignored. After all, without proper solution, it can provoke impotence. And this fact definitely scares many men. Therefore, there is no need to bring your health to such a state. Faced with erectile dysfunction, a man begins to look for a solution. Levitra may be suitable for this. These tablets are designed to combat this problem.

Levitra is a drug that is used to treat erectile dysfunction. The tablets will relieve disorders and restore sexual functions. As a result, men who took the drug normalize their response to sexual stimulation.

The drug is considered one of the simplest and most effective medications today. Tablets are available in different dosages. With their help, you can improve sexual desire, potency and increase the duration of sexual intercourse. In addition, the drug is inexpensive, which makes it even more popular.

On pharmacy shelves you can see many drugs that perform the same effect. But a huge number of doctors recommend leaning towards the drug Levitra.

The action of the drug is aimed at blocking a chemical substance that prevents blood from flowing into the genital organ. This leads to the fact that erectile dysfunction disappears. It is worth knowing that the increase in blood flow is due to the release of a chemical when the brain gives a signal. This happens when a man feels sexually aroused.

As a result, all the arteries in the genital organ become full, and pressure appears, which is commonly called an erection. But sometimes phosphodiesterase disrupts this chemical, so there is an outflow. And Levitra blocks it, so blood flow occurs normally.

It is worth remembering that this drug is not aimed at creating an erection, it only strengthens it. This happens by blocking phosphodiesterase and increasing libido. The effect of the drug begins within a third of an hour after a person takes the pill. The effect lasts for 6 hours.

Side effects from using the medicine

The following are the adverse reactions that may occur while using Levitra (reactions are listed in order of decreasing intensity):

  • Conjunctivitis may develop from infections
  • From the psyche and central nervous system: sleep disturbance and headaches;
  • From the visual organs: an increase in IOP and impaired perception of colors and visual acuity, as well as the appearance of conjunctival hyperemia, photophobia, a feeling of discomfort and pain in the eyes;
  • From the hearing system: development of sudden deafness, vertigo, tinnitus;
  • From the immune system: angioedema or allergic edema, as well as other manifestations of allergies;
  • From the cardiovascular system: tachycardia, palpitations, myocardial infarction, angina pectoris, ventricular tachyarrhythmia, hypotension, vasodilation;
  • From the gastrointestinal tract: nausea, diarrhea, vomiting, dyspepsia, abdominal pain, gastroesophageal reflux disease, dry mouth, gastritis;
  • From the respiratory and chest organs: shortness of breath, nasal and paranasal sinus congestion;
  • From the biliary tract and liver: increased transaminase activity;
  • a rash and erythema may appear on the skin (under the skin);
  • From connective and musculoskeletal tissues: increased muscle tone and CK levels, back pain, as well as myalgia;
  • From the genitourinary system: increased erection, priapism;

Common adverse reactions include chest pain and poor health.

Side effects

Levitra is often well tolerated by patients. But still, there are certain side effects. A very small number of men complain of headaches after taking it. For some, side effects include a stuffy nose.

In rare cases, the following side effects occur:

  • swelling;
  • blood from the nose;
  • blurred vision;
  • pain in the lower back.

Overdose

In medical practice, there are cases when the patient took 80 mg of the drug in 24 hours, and the treatment lasted for 30 days. However, no serious complications appeared. But it was found that when the dosage increases, men begin to experience severe lower back pain. But the drug does not have a toxic effect on the body.

How to take Levitra tablets

  1. The medicine is intended for oral administration.
  2. Tablets are taken regardless of meals before sexual contact (25-60 minutes before).
  3. According to the usual dosage regimen, the recommended dosage for the first dose is 10 mg.
  4. Further, based on the tolerability of the drug and the effect it provides, you can increase the daily dose to 20 mg or, conversely, reduce it to 5 mg.
  5. The drug is used maximum once a day.
  6. If there are problems in the functioning of the liver, you should start taking the medicine with a dose of 5 mg. Then you can increase the dosage to a maximum of 10 mg.

What are Generic Levitra tablets

Generic Levitra is a drug intended for the treatment of erectile dysfunction in men .
This is an analogue of the original drug with the same active ingredient, but often in larger quantities. The tablet formula was developed in Germany, where pharmacists studied their effect on the body and came to the conclusion that it was safe and effective. You can take the stimulant to eliminate any erectile dysfunction, ranging from the inability to maintain it to premature ejaculation. According to the American agency of the Ministry of Health FDA, the drug is allowed to be taken for the treatment of impotence and prostatitis (it reduces inflammation), as well as their prevention.

Active ingredient and effect on potency

The main substance of the drug is Vardenafil. It relaxes the muscles of the blood vessels, causing more blood to flow to the pelvic organs. This leads to an erection that persists throughout full sexual intercourse. The pills also delay ejaculation and increase sensitivity. Generic Levitra affects the natural processes of erection formation, therefore it only enhances the response to sexual stimulation. It is important that a man maintains sexual desire during erectile dysfunction, otherwise the stimulant may not work.

Release form and recommended dosage

The drug is produced in the form of orange-yellow round tablets with a film coating. The blister contains 10 pieces. The packaging protects them from exposure to harmful environmental factors, so it is recommended to remove the stimulant immediately before taking it. The sides of the tablets are engraved with the amount of active substance or the trade name of the drug.

Start using generic Levitra with 10 mg per day. If the effect is unsatisfactory (this occurs, for example, with erectile dysfunction due to diabetes or a removed prostate), increase the dose to a maximum of 20 mg. However, researchers and patients noted the absence of overdose symptoms even with a single use of 40 mg of vardenafil. If its effect is too strong, reduce the amount to 5 mg. Doctors advise elderly men over 65 years of age to reduce the dosage to the specified level.

Storage conditions and shelf life of the drug

The product is stored for no longer than 2 years from the date of production in a dry place in the original blister. The air temperature should not exceed 25 C, so do not place the stimulator close to a fireplace, radiator, or heater. Keep it in a dark place to protect it from direct sunlight. Restrict access to the drug to children and pets.

Interaction with other drugs

  • When taken concomitantly with CYP inhibitors, the clearance of vardenafil is likely to decrease.
  • When the drug is combined with erythromycin (in the amount of 1500 mg per day), the AUC increases 4 times and the maximum blood level of Levitra itself (5 mg) increases 3 times.
  • When combined with ketoconazole (200 mg), the AUC increases 10 times and the maximum blood level of Levitra (5 mg) increases 4 times. This involves adjusting the dosages of these drugs.
  • When Levitra and indinavir (an HIV protease inhibitor) are combined in an amount of 2400 mg per day, the AUC increases 16 times and the maximum content of vardenafil in the blood increases 7 times.
  • When used simultaneously with ritonavir (in an amount of 1200 mg per day), the maximum content of Levitra (5 mg) increases 13 times and the total daily AUC value increases 49 times. In addition, there is a significant extension (up to approximately 26 hours) T1/2 of vardenafil.
  • When Levitra is combined with donors and nitrates of nitric oxide, the effect of these drugs increases. If you pause taking them for 24 hours, no such effect is observed.
  • With simultaneous administration of a supratherapeutic dose of vardenafil and sodium nitroprusside, a slight increase in antiplatelet effect occurs.

Course treatment

A course of treatment with Levitra is indicated for patients who have erectile dysfunction. Course treatment with the drug can be carried out several times. In most cases, one course is enough to eliminate the symptoms of sexual dysfunction and normalize erection for a long period of time. The full treatment course takes four weeks, during which a man is recommended to use the drug one capsule per day 20 minutes before the intended sexual contact.

The maximum daily dose of Levitra according to the instructions for use is 20 milligrams. This amount of medicine is indicated for young patients who do not have serious health problems. Older men and patients suffering from chronic liver or kidney diseases should reduce the daily dose of Vardenafil to 10 milligrams, in some cases to 5 milligrams once every 24 hours.

In the absence of contraindications, it is recommended to reduce the dose of the inhibitor to 10 milligrams. The drug accumulates in small quantities in the plasma, and over time it acts actively even when using a minimal dosage. Adjustment of the amount of the active substance is necessary for treatment with vasodilator medications, since Vardenafil has a similar effect.

Alcohol compatibility

Doctors say that the combination of vardenafil and ethanol may not cause any adverse effects in some men, but in some, on the contrary, it can cause a very heavy load on the liver and other organs.

When a sober man takes Levitra, vardenafil has a strong effect on the genitourinary organs and increases blood circulation in the pelvic area.

This, in turn, promotes full and rapid erection and sexual activity.

Vardenafil affects specific areas of the cerebral cortex, as a result of which sexual arousal occurs at the right moment.

When a large amount of ethyl alcohol is present in the body, the breakdown of the active component of the drug by the liver is much slower.

Thus, the effect of the medicine may begin half an hour or an hour later, therefore, an erection simply will not occur at the right time.

Side effects of Levitra and main contraindications

Like any medicine, Levitra has a number of side effects, which vary not only in the frequency of occurrence, but also in the main symptoms - not everyone taking this medicine experiences discomfort even after a positive result.

A large proportion of people, in principle, do not observe any problems with use and consequences, and the most minor manifestations do not require serious treatment or medical intervention.

In particular, statistics have the following data:

  • back pain - 2%
  • headache - 15%
  • facial redness – 11%
  • upset stomach - 4%
  • runny nose - 9%
  • nausea - 2%
  • dizziness - 2%
  • hints of flu - 3%

Levitra

Drug: Levitra®

Active substance: vardenafil ATC code: G04BE09 CFG: Drug used for erectile dysfunction Reg. number: P No. 015037/01 Registration date: 07/07/08 Owner of reg. credential: BAYER HealthCare AG {Germany}

DOSAGE FORM, COMPOSITION AND PACKAGING

Light orange to gray-orange film-coated tablets 1 tab.
vardenafil hydrochloride trihydrate5.926 mg,
which corresponds to the content of vardenafil5 mg

Excipients: crospovidone, magnesium stearate, microcrystalline cellulose, anhydrous colloidal silicon.

Shell composition: macrogol 400, hypromellose, titanium dioxide, yellow iron oxide, red iron oxide.

1 PC. - blisters (1) - cardboard packs. 1 PC. - blisters (2) - cardboard packs. 1 PC. - blisters (3) - cardboard packs. 2 pcs. - blisters (1) - cardboard packs. 2 pcs. - blisters (2) - cardboard packs. 2 pcs. - blisters (3) - cardboard packs. 3 pcs. - blisters (1) - cardboard packs. 3 pcs. - blisters (2) - cardboard packs. 3 pcs. - blisters (3) - cardboard packs. 4 things. - blisters (1) - cardboard packs. 4 things. - blisters (2) - cardboard packs. 4 things. - blisters (3) - cardboard packs.

film-coated tablets , round, biconvex, slightly rough, embossed “10” on one side and the signature Bayer cross on the other.1 tab.
vardenafil hydrochloride trihydrate11.852 mg,
which corresponds to the content of vardenafil10 mg

Excipients: crospovidone, magnesium stearate, microcrystalline cellulose, anhydrous colloidal silicon.

Shell composition: macrogol 400, hypromellose, titanium dioxide, yellow iron oxide, red iron oxide.

1 PC. - blisters (1) - cardboard packs. 1 PC. - blisters (2) - cardboard packs. 1 PC. - blisters (3) - cardboard packs. 2 pcs. - blisters (1) - cardboard packs. 2 pcs. - blisters (2) - cardboard packs. 2 pcs. - blisters (3) - cardboard packs. 3 pcs. - blisters (1) - cardboard packs. 3 pcs. - blisters (2) - cardboard packs. 3 pcs. - blisters (3) - cardboard packs. 4 things. - blisters (1) - cardboard packs. 4 things. - blisters (2) - cardboard packs. 4 things. - blisters (3) - cardboard packs.

film-coated tablets , round, biconvex, slightly rough, embossed “20” on one side and the signature Bayer cross on the other.1 tab.
vardenafil hydrochloride trihydrate23.705 mg,
which corresponds to the content of vardenafil20 mg

Excipients: crospovidone, magnesium stearate, microcrystalline cellulose, anhydrous colloidal silicon.

Shell composition: macrogol 400, hypromellose, titanium dioxide, yellow iron oxide, red iron oxide.

1 PC. - blisters (1) - cardboard packs. 1 PC. - blisters (2) - cardboard packs. 1 PC. - blisters (3) - cardboard packs. 2 pcs. - blisters (1) - cardboard packs. 2 pcs. - blisters (2) - cardboard packs. 2 pcs. - blisters (3) - cardboard packs. 3 pcs. - blisters (1) - cardboard packs. 3 pcs. - blisters (2) - cardboard packs. 3 pcs. - blisters (3) - cardboard packs. 4 things. - blisters (1) - cardboard packs. 4 things. - blisters (2) - cardboard packs. 4 things. - blisters (3) - cardboard packs.

The description of the drug is based on the officially approved instructions for use.

PHARMACHOLOGIC EFFECT

A drug for the treatment of erectile dysfunction, a phosphodiesterase type 5 (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 cavernous bodies, which activates the enzyme guanylate cyclase, which leads to an increase in the content of cyclic guanosine monophosphate (cGMP) in the cavernous bodies. As a result, the smooth muscles of the cavernous bodies relax, which increases blood flow into the penis.

Vardenafil blocks PDE5, under the influence of which cGMP is broken down, as a result of which the local effect of endogenous NO in the cavernous bodies during sexual stimulation is enhanced, which determines Levitra's ability to enhance the response to sexual stimulation.

PHARMACOKINETICS

Suction

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

The clinical effect is realized even before Cmax is reached. 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 sexual intercourse in 34% and 40% of patients with mild and 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 the rapid increase in its concentration. Duration of action - 8-12 hours.

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

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

Distribution

The average Vd of vardenafil in the equilibrium state of pharmacokinetic parameters is on average 208 L, which demonstrates its good distribution in tissues. The binding of vardenafil and its main metabolite (M1) to 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 mainly of 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 a glucuronide in the form of a conjugate (glucuronic acid), which is part of the M1 metabolite. The concentration of the remaining part of M1 (non-glucuronic) is 26% of the concentration of the active substance. The PDE selectivity profile of M1 is similar to that of vardenafil; in vitro, the ability of M1 to suppress PDE5 is 28% compared to vardenafil, which corresponds to 7% of the drug's effectiveness.

Removal

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%, and to a lesser extent by the kidneys - 2-6%.

Pharmacokinetics in special clinical situations

In healthy elderly men (?65 years) compared to young men (?45 years), the hepatic clearance of vardenafil is reduced. On average, 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 (creatinine clearance>55-80 ml/min) and moderate (creatinine clearance>30-50 ml/min) degree of renal impairment, the pharmacokinetic parameters of vardenafil are comparable to those in healthy individuals. With severe renal impairment (creatinine clearance <30 ml/min), the average AUC value increases by 21% and Cmax decreases by 23%. There is no significant correlation between QC and vardenafil plasma concentrations (AUC and Cmax).

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

In patients with mild to moderate hepatic impairment, the clearance of vardenafil is reduced in proportion to the degree of liver impairment. With a mild degree of liver failure (class A on the Child-Pugh scale), there is an increase in AUC and Cmax by 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 to healthy volunteers.

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

INDICATIONS

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

DOSING REGIME

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

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

dosage adjustment is required in elderly patients .

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. Subsequently, 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.

SIDE EFFECT

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

From the cardiovascular system: ?10% - hot flashes (periodic sudden redness of the face, 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 (swelling of the mucous membrane, rhinitis, rhinorrhea); ?0.1%-<1% - shortness of breath, nosebleeds; ?0.01%-<0.1% - laryngeal edema.

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

Dermatological reactions: ?0.1% - <1% - facial swelling, 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% - prolongation of erection or painful erection, priapism.

Other: ?0.01%-<0.1% - hypersensitivity reactions.

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

Cases of visual impairment, including temporary or permanent loss of vision, have been reported that 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 to concomitant vascular risk factors, or to other causes.

CONTRAINDICATIONS

- simultaneous therapy with nitrates or drugs that donor nitric oxide;

- combination with HIV protease inhibitors such as indinavir or ritonavir;

- hypersensitivity to the components of the drug.

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

Use with caution in patients with congenital prolongation of the QT interval, with anatomical deformation 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 renal disease, arterial hypotension (resting systolic pressure less than 90 mmHg), recent stroke and myocardial infarction, unstable angina, hereditary degenerative diseases of the retina (for example, retinitis pigmentosa), with a tendency to bleeding and with exacerbation peptic ulcer, aortic stenosis and idiopathic hypertrophic subaortic stenosis.

PREGNANCY AND LACTATION

The drug is not intended for use in women and newborns.

SPECIAL INSTRUCTIONS

Before prescribing Levitra (as well as other drugs used to treat erectile dysfunction), the doctor should evaluate the condition 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 left ventricular outflow tract obstruction, such as aortic stenosis, idiopathic hypertrophic subaortic stenosis, may be sensitive to the effects of vasodilators, including PDE5 inhibitors.

In men for whom sexual activity is not indicated due to concomitant cardiovascular disease, drugs for the treatment of erectile dysfunction should not be used.

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 antiarrhythmic drugs (amiodarone, sotalol).

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

The safety of vardenafil has not been studied and its use is not recommended in the following patient groups: severe hepatic impairment, end-stage renal disease requiring hemodialysis, hypotension (resting systolic pressure <90 mmHg), recent stroke or myocardial infarction (within the last 6 months), unstable angina, as well as hereditary degenerative diseases of the retina, for example, retinitis pigmentosa.

Combination 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. Vardenafil should be used no earlier than 6 hours after taking alpha-blockers, and its dose should not exceed 5 mg. However, when combined with the alpha blocker tamsulosin, the timing of the drugs may coincide.

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

Combination with indinavir and ritonavir is contraindicated.

Since vardenafil has not been used in patients with a tendency to bleed or in patients with exacerbation of peptic ulcer disease, its use in these cases is possible only after a careful assessment of the benefit-risk ratio 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 enhance platelet aggregation caused by various drugs. At a concentration above the therapeutic level, vardenafil causes a slight increase in the antiplatelet effect of sodium nitroprusside, which is a donor of nitric oxide.

The effect of vardenafil and heparin when used simultaneously on the duration of bleeding has not been studied.

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

Use in pediatrics

Vardenafil is not intended for use in children.

Impact on the ability to drive vehicles and operate machinery

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

OVERDOSE

Symptoms: there are known 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 at a dose of 40 mg 2 times a day, severe lower back pain is observed without signs of toxic effects on the muscular and nervous system.

Treatment: symptomatic and supportive therapy. Since vardenafil is highly bound to 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 primarily with the participation of liver enzymes of the cytochrome P450 system, namely the CYP3A4 isoenzyme, as well as with some participation of the CYP3A5 and CYP2C isoenzymes. Inhibitors of these enzymes may reduce the clearance of vardenafil. With the simultaneous use of Levitra with ketoconazole, itraconazole, indinavir and ritonavir (potent CYP3A4 inhibitors), a significant increase in the plasma concentration of vardenafil can be expected.

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

When used simultaneously 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 the 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 the AUC of vardenafil by 10 times (900%) and the 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 the AUC of vardenafil by 16 times (1500%) and Cmax of vardenafil by 7 times (600%). 24 hours after administration, the plasma concentration of vardenafil is approximately 4% of its Cmax.

With simultaneous use of Levitra (5 mg), ritonavir (600 mg 2 times / day) increases the Cmax of vardenafil by 13 times and 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 the T1/2 half of vardenafil to 25.7 hours.

In healthy volunteers, Levitra (10 mg) when taken 24-1 hour before taking nitroglycerin (400 mcg sublingually) does not increase its hypotensive effect; at a dose of 20 mg 1-4 hours before taking nitrates (400 mcg sublingually) it enhances their hypotensive effect action, but when prescribed 24 hours in advance, 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 causes an additional decrease in systolic and diastolic blood pressure by an average of 5.9 mm Hg in the supine position. Art. and 5.2 mm Hg. Art. respectively.

Since alpha blockers are known to cause a decrease in blood pressure, especially postural hypotension and syncope, the interaction of alpha blockers and Levitra when used together has been carefully studied. In healthy volunteers, adding Levitra at a dose of 10 mg and 20 mg to a previous short course of therapy with alpha-blockers terazosin at a daily dose of 10 mg or tamsulosin at a daily dose of 0.4 mg causes an orthostatic reaction to reduce systolic blood pressure of varying severity: below 85 mm Hg. , by 30 or more mmHg, and also leads to the development of postural hypotension with a corresponding clinical picture. If the drugs are prescribed with a dosing interval of 6 hours, then cases of a decrease in systolic blood pressure below 85 mm Hg. Art. observed less frequently, especially when combined with tamsulosin. When combined with tamsulosin, the average reduction in systolic and diastolic blood pressure during the orthostatic reaction is 8 mm Hg. and 7 mm Hg. accordingly, regardless of the time of taking the drugs. In patients with benign prostatic hyperplasia who received long-term alpha-blockers tamsulosin at a dose of 0.4 mg or terazosin at a dose of 5 mg and 10 mg, Levitra at a dose of 5 mg was prescribed simultaneously with them or with an interval of 6 hours, and in case of an orthostatic reaction, a slight decrease in systolic and diastolic blood pressure (by 6 mm Hg and 3 mm Hg, respectively) regardless of the alpha blocker and the interval between doses. In 3 patients receiving tamsulosin, there was a decrease in systolic blood pressure below 85 mm Hg during the orthostatic response. without clinical manifestations of arterial hypotension. When terazosin and Levitra (5 mg) were taken simultaneously in 5 patients, systolic blood pressure decreased during the orthostatic reaction by 30 or more mmHg, and in 1 patient <85 mmHg. Art., which was accompanied by dizziness. However, if the interval between taking the drugs was 6 hours, then there was no decrease in blood pressure and symptoms of arterial hypotension.

The 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 affected when combined with histamine H2 receptor blockers ranitidine (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 of 81 mg each).

Levitra (20 mg) does not potentiate the hypotensive effect of ethanol (0.5 g/kg body weight), the pharmacokinetics of vardenafil are not affected.

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

CONDITIONS OF VACATION FROM PHARMACIES

The drug is available with a prescription.

CONDITIONS AND DURATION OF STORAGE

The drug should be stored out of the reach of children, in a dry place at a temperature not exceeding 30°C. Shelf life: 3 years.

How long does it take to take Levitra 20 mg?

The manufacturer recommends taking the medication between two hours and one hour before the expected time of sexual activity. The drug takes effect over the next 8-12 hours, so there is no harm in taking the pill in advance. The fact is that some foods can slow down the absorption process. And then the desired effect will occur not in 30-40 minutes, as usual, but in an hour, or even two. Alcohol also affects how long it takes for Levitra to work . Therefore, try to take the pills in advance.

Guarantees and return conditions

Our company has been exchanging and returning all goods without additional conditions for the past thirteen years. This is our strongest guarantee of quality . Thousands of satisfied customers can confirm this.

Doesn’t help, what to do - Guarantees

In some cases, even generic Levitra 20 mg does not help . Let's say right away - if you have problems with penile deformation, it is better not to even take the drug. If they are not there, then you need to figure out what the reason is . The best way is to seek advice from an experienced sex therapist.

If you want to delve into it yourself, start by carefully studying the instructions and analyzing your condition during use. And don’t worry - if something happens, we will change the drug to another one.

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