Levitra

Levitra – medicine for recovery of erectile function, FDE5 inhibitor.

Form of release and structure

Dosage form – tablets, film coated: a round biconvex form, with slightly rough surface, from gray-orange till light orange color, on one party the engraving "5", "10" or "20", is applied on another – a branded bayerovsky cross (1 or 4 pieces in the blister, in a cardboard pack 1 blister).

Active ingredient of Levitra – a vardenafil of a hydrochloride trihydrate, in 1 tablet:

• 5,926 mg that is equivalent to 5 mg of a vardenafil;
• 11,852 mg that is equivalent to 10 mg of a vardenafil;
• 23,705 mg that is equivalent to 20 mg of a vardenafil.

Auxiliary components: magnesium stearate, кросповидон, silicon dioxide colloid anhydrous, cellulose microcrystallic.

In addition as a part of a cover: gipromelloza, macrogoal 400, titanium dioxide, ferrous oxide red, ferrous oxide yellow.

Indications to use

Levitra's use is shown at erectile dysfunction, inability of the man to reach and keep the erection demanded for commission of sexual intercourse.

Contraindications

• Combination with indinaviry, ritonaviry and other inhibitors of HIV proteases;
• Concomitant use of donators of nitrogen oxide or nitrates;
• Age up to 16 years;
• Hypersensitivity to drug components.

Drug is not intended for treatment of women.

With care patients are recommended to apply with anatomically the deformed penis (Peyroni's disease, cavernous fibrosis, a curvature), the inborn lengthening of an interval of QT contributing to a priapism with pathologies (a multiple myeloma, a sickemia, leukemia), the expressed abnormal liver function, an end-stage of a disease of kidneys, arterial hypotension (systolic pressure at rest less than 90 mm of a mercury column), recently had myocardial infarction or a stroke, unstable stenocardia, degenerative hereditary diseases of a retina (including a pigmental retinitis), an aggravation of a peptic ulcer, tendency to bleedings, an idiopathic hypertrophic subaortal and/or aortal stenosis.

Route of administration and dosage

Pill is taken orally irrespective of meal.

Adequate efficiency of drug is reached at the sufficient level of sexual stimulation.

The recommended dosing: 10 mg of 1 times a day, no more than in 5 hours prior to sexual activity, usually in 0,5-1 hour prior to sexual intercourse. The dose can be lowered to 5 mg or is raised, but no more than to 20 mg, depending on individual portability and efficiency of drug.

The mode of dosing does not need correction at the moderated or slightly expressed renal failures, administration of drug by patients of advanced age, an insignificant liver failure.

Patients with a moderate liver failure should begin administration of drug in a dose of 5 mg a day, then it is gradually possible to increase a dose to 10 and 20 mg, considering efficiency and Levitra's portability.

Side effects

Probability of possible emergence of side effects: ≥10% – are frequent, ≥1% – is rare, ≥0,1%-<1% – sometimes:

• Cardiovascular system: often – inflows (feeling of heat, sudden periodic face reddening); sometimes – increase in the arterial pressure (AP), orthostatic hypotension, decrease in the ABP, myocardium ischemia, stenocardia;
• Nervous system: often – a headache; seldom – dizziness; sometimes – alarm, drowsiness, a syncope;
• Alimentary system: sometimes – nausea, dyspepsia, disturbance of functional hepatic tests (increase in alaninaminotranspherase (ALT), aspartate aminotransferase (nuclear heating plant), gamma глутамилтранспептидазы (GGTP));
• Reproductive system: sometimes – a painful erection, lengthening of an erection, a priapism;
• Respiratory system: sometimes – an asthma, a congestive hyperemia of a mucous membrane of a nose (rhinitis, hypostasis mucous, a rhinorrhea), nasal bleeding, throat hypostasis;
• Musculoskeletal system: sometimes – a dorsodynia, a mialgiya, increase in a kreatinfosfokinaza (KFK), increase in a muscle tone;
• Organ of sight: sometimes – disturbance of brightness of sight, the raised slezootdeleniye, increase in intraocular pressure;
• Dermatological reactions: sometimes – a face edema, a photosensitization;
• Others: sometimes – hypersensitivity reactions.

Besides, in post-market researches it is reported about exceptional cases of development of a vision disorder owing to a front ischemic neuropathy of an optic nerve, up to permanent loss of sight. More often the specified states occur at the concurrent factors of risk which are available for patients, such as smoking, the age is more senior than 50 years, anatomic defect of an optic disk, a diabetes mellitus, coronary heart disease, arterial hypertension, a lipidemia. Finally connection between development of a lobby of an ischemic neuropathy of an optic nerve and Levitra's reception is not established.

Special instructions

Purpose of drug has to be made by the doctor after assessment of a condition of cardiovascular system of the patient as during sexual activity the risk of complications from heart increases.

Levitr should not appoint to men with the accompanying pathologies of cardiovascular system at which sexual activity is contraindicated.

Use of a vardenafil has vasodilating effect and can cause insignificant or moderate decrease in the ABP.

At obstruction of outflow tracts from a left ventricle (including an aortal stenosis, an idiopathic hypertrophic subaortal stenosis) the patient can be sensitive to effect of FDE5 inhibitor.

Patients with inborn lengthening of an interval of QT or during reception of quinidine, procaineamide, Amiodaronum, a sotalol and other antiarrhytmic drugs of the class IA and a class III should not appoint drug as reception even of 10 mg of drug causes lengthening of an interval of QT.

Due to the lack of data on therapy effects Levitra is not recommended to be applied at heavy abnormal liver functions, an end-stage of the disease of kidneys (demanding carrying out a hemodialysis), arterial hypotension, the myocardial infarction postponed to the last 6 months or a stroke, unstable stenocardia, hereditary degenerative pathology of a retina (a pigmental retinitis).

At sudden loss of sight administration of drug should be stopped and to see urgently behind consultation the attending physician.

The combination to alpha adrenoblockers can lead to development of arterial hypotension as both drugs have vazodilatiruyushchy effect. This combination is admissible only at the stable ABP against the background of use of alpha adrenoblockers and Levitra's reception in a dose no more than 5 mg.

Reception of a vardenafil can match on time using a tamsulozin, other alpha adrenoblockers should not be accepted along with drug.

At Levitra's reception in the picked-up dose treatment by alpha adrenoblockers needs to be begun with the minimum dose. Gradual increase in a dose of alpha adrenoblockers against the background of therapy by FDE5 inhibitors can cause further decrease in the ABP.

In need of a concomitant use of an itrakonazol, a ketokonazol, erythromycin the dose of a vardenafil should not exceed 5 mg, an itrakonazol and a ketokonazol – 200 mg.

At tendency to bleedings and an aggravation of a peptic ulcer it is recommended to use drug after assessment of a ratio of estimated advantage and potential risk of therapy.

Does not exert impact on duration of bleeding of Levitr both at monotherapy, and in combination with acetylsalicylic acid.

Drug does not strengthen the aggregation of thrombocytes which developed against the background of reception of other means.

Exceeding of a therapeutic dose of a vardenafil leads to insignificant strengthening of antiagregantny effect of Sodium nitroprussidum, being the donator of nitrogen oxide.

Patients whose activity is connected with direct control of vehicles and mechanisms prior to use need to establish extent of individual reaction to effect of drug.

Medicinal interaction

Liver enzymes of system _{of P450 cytochrome} (isoenzymes of CYP3A4, CYP3A5, CYP2C) which inhibitors to a greater or lesser extent can reduce clearance of a vardenafil participate in metabolism of a vardenafil. Therefore at a combination to powerful CYP3A4 inhibitors (итраконазол, кетоконазол, индинавир, ритонавир) vardenafit perhaps substantial increase of level of concentration in a blood plasma.

At simultaneous use of Levitra:

• Cimetidinum (nonspecific inhibitor of isoenzymes of system _{of P450 cytochrome}) in a dose on 400 mg 2 times a day does not influence the maximum indicators of concentration in blood _(Cmax) and AUC of a vardenafil (20 mg);
• Erythromycin (500 mg 3 times a day) by 4 times raises AUC of the vardenafil accepted in a dose of 5 mg and increases _Cmax of a vardenafil by 3 times;
• Ketokonazol (200 mg) causes increase in AUC of a vardenafil (in a dose of 5 mg) by 10 times and _Cmax vardenafit by 4 times;
• Indinavir (inhibitor of HIV proteases) in a dose of 800 mg 3 times a day promotes increase in AUC of a vardenafil (10 mg) by 16 times and _Cmax vardenafit by 7 times (concentration of a vardenafil in plasma in 24 hours after reception decreases to 4% of its _Cmax);
• Ritonavir in a therapeutic dose of 600 mg 2 times a day extends _T1/2 of a vardenafil (5 mg) till 25,7 o'clock, raises _Cmax of a vardenafil by 13 times and its total daily indicator of AUC by 49 times;
• The nitroglycerine in a dose of 0,4 mg accepted sublingual in the period of 24-1 hour after Levitra's reception (10 mg) does not strengthen the hypotensive action;
• Маалокс (an antacid, magnesium hydroxide or aluminum hydroxide) does not exert impact on indicators of AUC and _Cmax of a vardenafil;
• Ranitidine (300 mg a day) and Cimetidinum (800 mg a day) do not influence bioavailability of drug.

The combination of 20 mg of a vardenafil and 3,5 mg of Glyburidum does not exert mutual impact on indicators of AUC and _Cmax.

Pharmakodinamichesky and pharmacokinetic interaction at a combination of 20 mg of a vardenafil is not noted and 25 mg of warfarin.

The concomitant use of 20 mg of Levitra and 60 or 30 mg of nifedipine of considerable pharmacokinetic interaction does not cause.

Hypotensive effect of the ethanol accepted in a dose of 500 mg on 1 kg of weight of the patient does not increase against the background of use of 20 mg of a vardenafil.

There is no medicinal interaction at a combination to digoxin.

Inhibitors of an angiotensin-converting enzyme, acetylsalicylic acid, beta adrenoblockers, hypoglycemic drugs (sulphonylurea, metformin), diuretics, weak CYP3A4 inhibitors do not exert impact on pharmacokinetics of a vardenafil.

Terms and storage conditions

To store in the place, dry, unavailable to children, at a temperature up to 30 °C.

Period of validity – 3 years.