Levitra® (Levitra®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceVardenafilVardenafil
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  • Levitra®
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    Bayer Pharma AG     Germany
  • Levitra® ODT
    pills inwards 
    Bayer Pharma AG     Germany
    • Dosage form: & nbspfilm-coated tablets
    Composition:

    Each tablet contains:

    as active ingredient: vardenafil 5 mg, 10 mg or 20 mg, which is equivalent to the content of active substance in the form of vardenafil hydrochloride trihydrate 5.926 mg or 11.852 mg 23.705 mg, respectively;

    Excipients: crospovidone 4,350 mg, 6,250 mg or 8,850 mg magnesium stearate 0.870 mg, 1.250 mg or 1.770 mg microcrystalline cellulose 75.419 mg 105.023 mg and 141.797 mg colloidal silica 0.435 mg, 0.625 mg or 0.885 mg of macrogol-400 0.555 mg 0.797 mg or 1.128 mg, hypromellose 1.664 mg, 2.391 mg or 3.385 mg Titanium dioxide 0.455 mg, 0.653 mg or 0.925 mg Iron oxide yellow colorant 0.092 mg, 0.133 mg or 0.188 mg iron oxide red colorant 0.007 mg, 0.011 mg or 0.015 mg.

    Description:Round, biconvex tablets, film-coated from light orange to gray-orange, engraved, embossed by: on one side - firm Bayer cross on the other - notation dosage ( "5", "10" or "20" respectively).
    Pharmacotherapeutic group:erectile dysfunction remedy - PDE5-inhibitor
    ATX: & nbsp

    G.04.B.E.09   Vardenafil

    G.04.B.E   Drugs for the treatment of erectile dysfunction

    Pharmacodynamics:

    Erection of the penis is a hemodynamic process, which is based on relaxation of smooth muscles of cavernous bodies and arterioles located in it.

    During sexual stimulation, the nerve endings of the cavernous bodies release nitric oxide (NO), 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 the flow of blood into the penis. The level of cGMP is regulated, on the one hand, by the synthesis of guanylate cyclase, and on the other hand by the cleavage of cGMP by phosphodiesterase hydrolysis (PDE). The most known PDE is cGMP specific phosphodiesterase type 5 (PDE5).

    Blocking PDE5, involved in the cleavage of cGMP, vardenafil thereby promoting local action of endogenous nitric oxide (NO) in cavernous bodies during sexual stimulation. Increasing the level of cGMP by inhibiting PDE5 leads to relaxation of the smooth muscles of the cavernous bodies and an increase in the influx blood in them.

    This effect determines the ability of Levitra® to enhance the natural response to sexual stimulation.

    Vardenafil is a potent and highly selective inhibitor of PDE5 (mean inhibitory concentration relative to PDE5-0.7 nM). The inhibitory activity of vardenafil on PDE5 is more pronounced than that of other known PDEs (15 times more than PDE6, 130 times greater than PDE1, 300 times greater than PDE11 and 1000 times greater than PDE- 2, 3, 4, 7, 8, 9, 10).

    Taking vardenafil at a dose of 20 mg is able to cause an erection (sufficient for penetration) as early as 15 minutes. The full answer is reached in 25 minutes.

    Pharmacokinetics:

    Suction

    After oral administration vardenafil quickly absorbed. When taken on an empty stomach, an early peak of maximum concentration (Cmax) can be achieved after 15 minutes, but in 90% of cases the average maximum concentration is reached after 60 minutes (from 30 to 120 minutes).

    Due to the significant effect of the first passage, the absolute bioavailability is about 15%. In the recommended dose range (5-20 mg), the indicator value "area under the concentration-time ratio curve (AUC) and Cmax increase in proportion to the dose.

    When taking vardenafil simultaneously with food containing a large amount of fat (57%), the rate of absorption decreases with increasing time to reach the maximum concentration (Tmax) up to 60 min, and FROMmax on average, reduced by 20% without a significant change in the AUC. When taken with normal food containing not more than 30% fat, the pharmacokinetic parameters of vardenafil (Cmax, Tmax, PPK) do not change. Based on these data vardenafil can be administered regardless of food intake.

    Distribution

    The average volume of vardenafil distribution in the stable state of pharmacokinetic parameters is 208 liters, which demonstrates its good distribution in tissues. Vardenafil and its main metabolite (M1) bind well to plasma proteins (up to 95%), and this property is reversible and does not depend on the total drug concentration.

    After 90 minutes after taking vardenafil, not more than 0.00012% of the dose obtained can be determined in the sperm of healthy patients.

    Metabolism

    Vardenafil is metabolized predominantly by hepatic enzymes involving the cytochrome CYP3A4 system, as well as CYP3A5 and CYP2C9 isoforms. The mean half-life (T1/2) vardenafil is 4-5 hours, and the main metabolite M1 (formed by de-ethylation of the piperazine part of the molecule) 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 metabolite (non-glucuronic) is 26% of the concentration of the active substance. The selectivity profile for phosphodiesterase in M1 is similar to that of vardenafil; its ability to inhibit PDE5 in vitro is 28% compared with vardenafil, which corresponds to 7% of the effectiveness of the drug.

    Excretion

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

    Patients of advanced age (over 65 years).In healthy elderly men (over 65 years) compared with young men (under 45 years old), the hepatic clearance of vardenafil is reduced. On average, elderly patients taking vardenafil, PPK increases by 52%. However, there are no differences in the efficacy and safety of the drug in elderly and younger patients.

    Renal failure. In patients with mild (creatinine clearance> 50-80 ml / min) and moderate (KK> 30-50 ml / min), the pharmacokinetic indices of vardenafil are comparable with those of healthy men.With severe renal dysfunction (CK <30 ml / min), the average value of the AUC is increased by 21%, and Cmax is reduced by 23%. A significant correlation between creatinine clearance and vardenafil concentration in plasma (AUC and Cmax) is not observed.

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

    Violation of the function of the liver. In patients with mild and moderate impairment of liver function, the clearance of vardenafil decreases in proportion to the degree of impaired hepatic function. With mild degree of hepatic insufficiency (stage A in Child-Pugh), there is an increase in the indices of AUC and Cmax in 1,2 times (PPK by 17%, Cmax on 22%), and at moderate (stage B in Child-Pugh) - in 2,6 (160%) and in 2,3 (130%) times, respectively. In patients with severe impairment of liver function (Child-Pugh Stage C), the pharmacokinetics of vardenafil have not been studied.

    Indications:

    Erectile dysfunction (inability to achieve and maintain the erection necessary for sexual intercourse).

    Contraindications:

    - Hypersensitivity to any of the components of the drug;

    - simultaneous use with nitrates or preparations that are donators of nitric oxide;

    - simultaneous use with moderately active or potent inhibitors of CYP3A4, such as ketoconazole, itraconazole, ritonavir, indinavir, erythromycin and clarithromycin;

    - Drugs for the treatment of erectile dysfunction should not be used in men who are not shown sexual activity (for example, patients with concomitant cardiovascular diseases, such as unstable angina or acute heart failure [Class III or IV according to the classification of the New York Heart Association] );

    - the safety of Levitra® has not been studied and, until the relevant data are obtained, its use is not recommended in patients with the following conditions:

    • severe violations of liver function;
    • kidney disease in the terminal stage requiring hemodialysis;
    • arterial hypotension (systolic pressure at rest <90 mm Hg);
    • 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.

    Carefully:

    In patients with anatomical deformation of the penis (curvature, cavernous fibrosis, Peyronie's disease), with diseases predisposing to priapism (sickle cell anemia, multiple myeloma, leukemia).

    Patients with a tendency to bleeding and exacerbation of peptic ulcer drug should be prescribed only after assessing the benefit-risk relationship.

    Pregnancy and lactation:

    The drug is not indicated for use in women, newborns and children.

    Dosing and Administration:

    The drug is taken inside regardless of food intake.

    At the beginning of treatment, the recommended dose is 10 mg (approximately 25-60 minutes before sexual contact). However, it was shown that the drug Levitra® is also effective when taken 4-5 hours before sexual activity.

    The maximum frequency of taking the drug is 1 time per day. Depending on the effectiveness and tolerability of treatment, the dose can be increased to 20 mg or reduced to 5 mg per day. The maximum recommended dose is 20 mg once a day. To ensure an adequate response to treatment, sexual stimulation is necessary.

    Patients of advanced age (over 65 years)

    Correction of dose in elderly patients is not required.

    Children (up to 18 years)

    The use of Levitra® is not indicated in this age group.

    Impaired liver function

    In patients with a slight impairment of liver function (Child-Pugh stage A), a change in the dosing regimen is not required.In patients with moderate impaired hepatic function (Child-Pugh Stage B), the initial dose is 5 mg per day. In the future, depending on the effectiveness and tolerability of treatment, the dose can be increased, maximally up to 10 mg.

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

    Impaired renal function

    Dosage regimen changes are not required in patients with insignificant (CK> 50-80 ml / min), moderate (CK> 30-50 ml / min) and severe (KC <30 ml / min) decrease in renal function.

    Patients with concomitant administration of CYP3A4 inhibitors

    It may be necessary to adjust the dose of Levitra® film-coated tablets in patients taking certain cytochrome P450 (CYP) 3A4 inhibitors with moderate or severe effects (eg, ketoconazole, itraconazole, erythromycin, clarithromycin, ritonavir and indinavir (see the sections "Special instructions" and "Interaction with other drugs").

    With the joint application of Levitra® with inhibitors of CYP3A4 ketoconazole or itraconazole, their dose should not exceed 200 mg per day. If the dose of ketoconazole or itraconazole exceeds 200 mg per day, Levitra® should not be used.

    When combined with the inhibitors of CYP3A4 erythromycin or clarithromycin, Levitra's dose® should not exceed 5 mg.

    Contraindicated with HIV protease inhibitors, such as indinavir and ritonavir (see the sections "Contraindications", "Special instructions", "Interaction with other drugs").

    Patients with concurrent administration of alpha-blockers.

    In connection with the vasodilating effect of alpha-blockers and vardenafil, the joint administration of tablets coated with a film membrane, Levitra® with alpha-blockers may lead to symptomatic hypotension in some patients. Joint reception can be started only if the patient has a stable condition in the treatment of alpha-blockers (see section "Interaction with other drugs").

    Levitra® can be taken at any time together with alfuzosin or tamsulosin. In the case of joint administration of Levitra with terazosin and other alpha-blockers, the necessary interval between taking Levitra® and these alpha-blockers should be observed (see section "Interaction with other medications").

    For patients already taking the optimal dose of Levitra® tablets coated with a film coat, treatment with alpha-blockers should start at the lowest dose.A gradual increase in the dose of the alpha-blocker may be accompanied by a subsequent decrease in blood pressure in patients taking phosphodiesterase inhibitors (PDE5), including vardenafil.

    Side effects:

    The adverse reactions (HP) reported in connection with the use of Levitra® are given in the table. In each group, undesirable effects are presented in order of decreasing severity. The frequency is defined as "very often (≥1 / 10)", "often (from ≥1 / 100 to <1/10)", "infrequently (from ≥1 / 1,000 to <1/100)", "rarely ( from ≥1 / 10 000 to <1/1 000) "," very rarely (<1/10000) ". HP, which were recorded only during post-marketing observations and whose frequency could not be estimated, are designated as "frequency unknown."

    HP, found in patients in all clinical trials around the world, including those who are considered drug-related in ≥0.1% of patients or rare and serious in their nature.

    System-Organ Class

    Often

    Often

    Infrequently

    Rarely

    >10%

    > 1% and <10%

    > 0.1% and <1%.

    > 0.01% and <0.1%

    Infectious and parasitic diseases

    Conjunctivitis

    Immune system disorders

    Allergic edema and angioedema

    Allergic reactions

    Disorders of the psyche

    Sleep Disorders

    Disturbances from the nervous system

    Headache

    Dizziness

    Paresthesia and dysesthesia

    Drowsiness

    Fainting

    Amnesia

    Convulsions

    Disturbances on the part of the organ of sight

    Visual disturbances

    Hyperemia of the conjunctiva of the eyeball

    Violations of color perception

    Pain in the eyeballs and a feeling of discomfort in the eyes

    Photophobia

    Increased intraocular pressure

    Hearing disorders and labyrinthine disorders

    Ringing in the ears of Vertigo

    Heart Disease

    Palpitation

    Tachycardia

    Angina pectoris

    Myocardial infarction

    Ventricular tachyarrhythmias

    Vascular disorders

    Vasodilation

    Hypotension

    Disturbances from the respiratory system, chest and mediastinal organs

    Nasal congestion

    Dyspnea

    The congestion of the paranasal sinuses

    Disorders from the gastrointestinal tract

    Dyspepsia

    Nausea

    Stomach ache

    Dry mouth

    Diarrhea

    Gastroesophageal reflux disease

    Gastritis

    Vomiting

    Disturbances from the liver and bile ducts

    Increased activity of "liver" transaminases

    Disturbances from the skin and subcutaneous tissues

    Erythema

    Rash

    Disturbances from musculoskeletal and connective tissue

    Backache

    Increase in activity of creatine phosphokinase (CK)

    Increased muscle tone and cramps

    Myalgia

    Violations of the genitals and mammary gland

    Erection enhancement

    Priapism

    General disorders and disorders at the site of administration

    -

    Bad feeling

    Chest pain

    Cases of myocardial infarction associated with vardenafil and with sexual activity have been reported, but it has not been established whether the occurrence of this disease is directly attributable to vardenafil, sexual activity, concomitant diseases, or a combination of these factors.

    There are rare reports of cases of development of anterior ischemic neuropathy of the optic nerve (PINZN) leading to visual impairment (including persistent loss of vision) associated with the administration of PDE5 inhibitors, including Levitra®, in patients, many of whom have coexisting factors risk of developing this condition, such as: an anatomical defect of the optic disc, age over 50 years, diabetes, hypertension, coronary heart disease, hyperlipidemia and smoking.It is not established whether the development of PIAS is directly related to the use of PDE5 inhibitors, to the patient's concomitant vascular risk factors and anatomical defects, a combination of these factors, or other causes. Visually reported cases of visual impairment, including temporary or persistent vision loss, are associated with the administration of PDE5 inhibitors, including Levitra®. It is not established whether these cases are directly related to taking PDE5 inhibitors, or with concomitant vascular risk factors, or with other causes.

    There were a few cases of sudden deafness or hearing loss with the use of drugs from the group of PDE5 inhibitors, including Levitra®. It is not established whether these cases are directly related to Levitra®, concomitant risk factors for hearing loss, a combination of these factors, or other causes.

    Overdose:

    In a study in healthy volunteers, vardenafil was tested in single doses of up to 120 mg per day. One-time doses of vardenafil to 80 mg and multiple doses up to 40 mg of vardenafil, administered once a day for 4 weeks were tolerated without the occurrence of serious adverse side effects.

    However, with the use of vardenafil in a dose of 40 mg 2 times a day, marked pain in the lower back without signs of toxic effects on the muscular and nervous systems.

    In cases of overdose, standard maintenance therapy should be given.

    Because the vardenafil is highly associated with plasma proteins and only a small amount of the drug is excreted by the kidneys, the effectiveness of hemodialysis is unlikely.

    Interaction:

    CYP inhibitors

    Vardenafil is metabolized predominantly with the involvement of hepatic enzymes of the cytochrome P450 (CYP) system, namely the 3A4 isoform, and also with some participation of CYP3A5 and CYP2C isoforms. Inhibitors of these enzymes can reduce the clearance of vardenafil.

    Cimetidine (400 mg twice daily): this nonspecific inhibitor of cytochrome P450 does not affect the values ​​of AUC and Cmax Levitra® (20 mg) with their simultaneous application.

    Erythromycin (500 mg 3 times daily): this CYP 3A4 inhibitor causes a 4-fold (300%) increase in the AUC and a 3-fold (200%) increase in Cmax Levitra® (5 mg)

    Ketoconazole (200 mg): being a potent inhibitor of CYP 3A4, ketoconazole causes a 10-fold increase (900%) of AUC and a 4-fold increase (300%) C max Levitra® (5 mg).

    When combined with Levitra® (10 mg) and an HIV protease inhibitor indinavir (800 mg 3 times daily) there is a 16-fold (1500%) increase in AUC and a 7-fold (600%) increase in Cmax vardenafil. After 24 hours after administration, the concentration of vardenafil in plasma is approximately 4% of its Cmax.

    Ritonavir (600 mg twice daily): increases C 13 times max Levitra® (5 mg) and 49 times its total daily AUC. Interaction is due to the fact that ritonavir, being a potent inhibitor of CYP3A4 and CYP2C9, blocks the hepatic metabolism of Levitra®. Ritonavir considerably extends T1/2 vardenafil (up to 25.7 hours).

    Nicorandil is an activator of potassium channels and contains a nitro group. The presence of a nitro group in the composition of nicorandil causes a high probability of its interaction with vardenafil.

    When combined with Levitra® ketoconazole, itraconazole, indinavir and ritonavir (potential inhibitors-CYP3A4), a significant increase in plasma vardenafil concentration can be expected

    Nitrates, donators of nitric oxide: Taking Levitra® (10 mg) from 24 hours to 1 hour before taking nitroglycerin (0.4 mg sublingually) does not increase its hypotensive effect.At a dose of 20 mg 1-4 hours before the application of nitrates (6.4 mg sublingually), Levitra® enhances their hypotensive effect, but if appointed within 24 hours, then there is no increase in antihypertensive effect.

    However, there is insufficient information about the potential hypotensive effects of vardenafil when used concomitantly with nitrates. In this regard, this combination is contraindicated.

    Other drugs

    The drug Levitra® (20 mg) does not change the parameters of AUC and Cmax glibenclamide (glyburide at a dose of 3.5 mg) when combined.

    It is also shown that the pharmacokinetics of vardenafil does not change when it is used simultaneously with glibenclamide.

    Pharmacokinetic and pharmacodynamic interactions (effects on prothrombin time and coagulation factors II, VII, X) are not observed in the joint application of Levitra® (20 mg) with warfarin (25 mg).

    There was no significant pharmacokinetic interaction between Levitra® (20 mg) and nifedipine (30 or 60 mg). The combined use of Levitra® and nifedipine does not lead to significant pharmacodynamic interaction: the Levitra® drug causes an additional decrease in systolic and diastolic blood pressure (BP) 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 question of the interaction of alpha-adrenoblockers and Levitra® in a joint application was carefully studied.

    Hypotension was reported, in some cases symptomatic in a significant number of subjects after simultaneous reception of Levitra®, film-coated tablets, normotensive volunteers, while simultaneously boosting to high doses of alpha-blockers of tamsulosin or terazosin for 14 days or less.

    When taking Levitra® tablets, film-coated, in doses of 5, 10 and 20 mg on a background of constant therapy tamsulosin There was no clinically significant additional decrease in maximum blood pressure. When Levitra® tablets were coated with a film coating of 5 mg, simultaneously with 0.4 mg of tamsulosin, 2 of 21 patients had systolic pressure in the standing position <85 mm Hg. Art. When Levitra® tablets were coated with a film coat, 6 hours after taking tamsulosin, 2 of 21 patients had systolic pressure in the standing position <85 mm Hg.Art.

    Levitra®, film-coated tablets, 5 mg or 10 mg were administered 4 hours after admission alfuzosin. The four-hour interval was chosen in order to achieve the maximum potential interaction. After taking a dose of vardenafil 4 hours after taking alfuzosin, there was no clinically significant maximum additional decrease in blood pressure within 10 hours after taking vardenafil. One patient experienced a decrease in systolic blood pressure in a standing position compared to baseline by more than 30 mm Hg. Art. after taking vardenafil in a dose of 5 mg. Another patient experienced a decrease in systolic blood pressure in the standing position compared to the baseline by more than 30 mm Hg. after taking vardenafil in a dose of 10 mg. The incidence of systolic blood pressure in the standing position is below 85 mm Hg. Art. in this study was not found. Two patients reported dizziness after taking vardenafil in a dose of 5 mg. One patient noted dizziness after taking 10 mg of vardenafil and one patient reported dizziness after taking a placebo.Based on the results of this study, compliance with the interval between taking alfuzosin and vardenafil is not required.

    Cases of syncope in this study and in earlier studies using tamsulosin or terazosin did not have.

    The combined use of Levitra® and alpha-blockers is acceptable only if there are stable indices of arterial pressure against the background of the use of alpha-adrenoblockers, with the drug Levitra® should be prescribed in the minimum recommended dose of 5 mg.

    Do not take Levitra® at the same time with alpha-blockers except for tamsulosin, which may coincide with Levitra®. Between the use of vardenafil and other alpha-adrenoblockers should observe the time interval. With the simultaneous administration of terazosin and Levitra®, a 6-hour interval between doses should be observed.

    Simultaneous application digoxin (0.375 mg) and Levitra® (20 mg) every other day for more than 14 days are not accompanied by their interaction.

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

    The bioavailability of Levitra® (20 mg) is also not affected by its combination with H antagonists2-recepto ranitidine (150 mg twice daily) and cimetidine (400 mg twice a day).

    Levitra® (10 mg and 20 mg) does not affect the duration of bleeding, when used as a monotherapy and in combination with acetylsalicylic acid in a low dose (2 tablets of 82 mg).

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

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

    Special instructions:

    The drug is taken internally. The drug Levitra® can be taken regardless of food intake. To achieve effective treatment, a sufficient level of sexual stimulation is needed.

    Prior to the appointment of drugs used to treat erectile dysfunction, the doctor must assess the state of the cardiovascular system, since there is a risk of developing complications from the heart during sexual activity.

    Vardenafil has vasodilator properties, which may be accompanied by a slight or moderate decrease in blood pressure. Patients with left ventricular outflow obstruction, for example, with aortic stenosis, idiopathic hypertrophic subaortic stenosis, may be sensitive to the action of vasodilators, including PDE5 inhibitors.

    When levitra® was used in therapeutic (10 mg) and over therapeutic (80 mg) doses, the QT interval was prolonged. Therefore, the appointment of Levitra® should be avoided in patients with congenital prolongation of the QT interval and in patients taking antiarrhythmic drugs of class IA (quinidine, procainamide) or class III (amiodarone, sotalol).

    The safety and efficacy of Levitra® in combination with other treatments for erectile dysfunction have not been studied, and therefore their combined use is not recommended.

    Against the background of taking Levitra ® and other inhibitors of PDE5, cases of transient loss of vision and non-arterial ischemic neuropathy of the optic nerve were recorded. In the event of a sudden loss of vision, you should stop taking Levitra® and consult a doctor immediately.

    Combined therapy with alpha-blockers and Levitra® can be accompanied by the development of arterial hypotension with a corresponding clinical picture, as these drugs have a vasodilating effect. The combined use of vardenafil and alpha-blockers is acceptable only if there are stable indices of arterial pressure when taking alpha-blockers, while Levitra® should be prescribed at the minimum recommended dose of 5 mg. Do not take Levitra® at the same time with alpha-adrenoblockers, with the exception of tamsulosin, which may coincide in time with Levitra®. Between the use of vardenafil and other alpha-adrenoblockers should observe the time interval. In case of taking a selected dose of vardenafil, alpha-blocker therapy should be started with a minimal dose. The gradual increase in the dose of alpha-blockers to patients receiving drugs from the group of PDE5 inhibitors may lead to a further decrease in blood pressure.

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

    Simultaneous reception with indinavir and ritonavir is contraindicated.

    Since Levitra® was not used in patients with a tendency to bleeding and patients with peptic ulcer exacerbation, its appointment in these cases is possible only after a thorough assessment of the benefit-risk relationship.

    Levitra® does not affect the duration of bleeding, nor does it affect this indicator when combined with acetylsalicylic acid.

    Vardenafil does not increase platelet aggregation, caused by various drugs. In a concentration above therapeutic vardenafil causes a slight increase in the antiplatelet effect of sodium nitroprusside, which is a donator of nitric oxide.

    In studies on rats with the combined use of vardenafil and heparin, there was no effect on bleeding time, but the use of this combination in humans has not been studied.

    Safety data from preclinical studies

    There is no toxic (including reproductive toxicity), genotoxic and carcinogenic effects of Levitra®.

    Effect on the ability to drive transp. cf. and fur:

    Before driving vehicles and moving mechanisms, patients should know how they react to taking Levitra®.

    Form release / dosage:

    Tablets, film-coated, 5, 10 and 20 mg.

    Packaging:

    1 or 4 tablets per Al / PP blister.

    For 1 blister in a cardboard pack together with instructions for use.

    Additionally for a dosage of 5 mg: 5 blisters for 4 tablets in a cardboard pack together with instructions for use.

    Storage conditions:

    Store at a temperature not exceeding 30 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:П N015037 / 01
    Date of registration:07.07.2008
    The owner of the registration certificate:Bayer Pharma AGBayer Pharma AG Germany
    Manufacturer: & nbsp
    Representation: & nbspBAYER, AOBAYER, AO
    Information update date: & nbsp13.12.2015
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