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Active substance
Vardenafil
Active ingredient: vardenafil (vardenafil)
Rec.INN registered WHO
Dosage Form
LEVITRA®
Tab., cover. film coating is 5 mg: 1, 4 or 20 units.
Composition, structure and packing
The tablets covered with a film cover from light orange to gray-orange, round, biconcave, slightly rough, embossed with “5” on one side and the Bayer Cross trademark – on the other.
1 tab.
vardenafil hydrochloride trihydrate 5,926 mg,
which corresponds to the content of 5 mg vardenafil
Other ingredients: crospovidone – 4.35 mg magnesium stearate – 870 mg, microcrystalline cellulose – 75,419 mg colloidal anhydrous silica – 435 micrograms.
Cover structure: macrogol 400 – 555 mg, Valium – 1.664 mg of titanium dioxide – 455 mg, yellow iron oxide – 92 mg, iron oxide red – 7 g.
1 PC. – Blisters (1) – packs cardboard.
4 things. – Blisters (1) – packs cardboard.
The tablets covered with a film cover from light orange to gray-orange, round, biconcave, slightly rough, embossed with “10” on one side and the Bayer Cross trademark – on the other.
1 tab.
vardenafil hydrochloride trihydrate 11,852 mg,
which corresponds to the content of 10 mg vardenafil
Other ingredients: crospovidone – 6.25 mg magnesium stearate – 1.25 mg, microcrystalline cellulose – 105,023 mg colloidal anhydrous silica – 625 micrograms.
Cover structure: macrogol 400 – 797 mg, Valium – 2.391 mg of titanium dioxide – 653 micrograms of iron oxide yellow – 133 g, iron oxide red – 11 micrograms.
1 PC. – Blisters (1) – packs cardboard.
4 things. – Blisters (1) – packs cardboard.
The tablets covered with a film cover from light orange to gray-orange, round, biconcave, slightly rough, embossed with “20” on one side and the Bayer Cross trademark – on the other.
1 tab.
vardenafil hydrochloride trihydrate 23,705 mg,
which corresponds to the content of 20 mg vardenafil
Other ingredients: crospovidone – 8.85 mg magnesium stearate – 1.77 mg, microcrystalline cellulose – 141,797 mg colloidal anhydrous silica – 885 micrograms.
Cover structure: macrogol 400 – 1.128 mg, Valium – 3.385 mg of titanium dioxide – 925 micrograms of iron oxide yellow – 188 g, iron oxide red – 15 micrograms.
1 PC. – Blisters (1) – packs cardboard.
4 things. – Blisters (1) – packs cardboard.

Indications
– Erectile dysfunction (inability to achieve and maintain an erection necessary for sexual intercourse).
ICD-10 code reading
F52.2 Lack of genital response (psychogenic impotence)
N48.4 Impotence of organic origin

Side effect
From the central and peripheral nervous system: ≥10% – headache; ≥1% – dizziness; ≥0.1% – <1% – lethargy; ≥0.01% – <0.1% – anxiety, fainting.
Cardio-vascular system: ≥10% – tides (periodic sudden reddening of the face, the sensation of heat); ≥0.1% – <1% – increase in blood pressure, reduced blood pressure, orthostatic hypotension; ≥0.01% – <0.1% – angina, myocardial ischemia.
From the digestive system: ≥1% – <10% – indigestion, nausea; ≥0.1% – <1% – change liver function tests (increased ALT, AST, GGT).
The respiratory system: ≥1% – <10% – congestive hyperemia of the nasal mucosa (mucosal edema, rhinitis, rhinorrhea); ≥0.1% – <1% – shortness of breath, nosebleeds; ≥0.01% – <0.1% – swelling of the larynx.
From a sight organ: ≥0.1% – <1% – increased lacrimation, blurred vision (of brightness); ≥0.01% – <0.1% – increased intraocular pressure.
Dermatological reactions: ≥0.1% – <1% – swelling of the face, photosensitivity.
From the musculoskeletal system: ≥0.1% – <1% – myalgia, back pain, increased CPK; ≥0.01% – <0.1% – increase in muscle tone. On the part of the reproductive system:> 0.01% – <0.1% – elongation erection or painful erection,priapism.
Other: ≥0.01% – <0.1% – hypersensitivity reactions.
There are rare post-marketing reports of cases of anterior ischemic optic neuropathy (PINZN), which leads to impaired vision, including permanent loss of vision associated in time with taking PDE5 inhibitors, including and Levitra, patients, many of whom have concomitant risk factors for developing this condition, such as an anatomical defect of the optic nerve, age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia and smoking. Not determined whether the development PINZN connected directly with PDE5 inhibitors or with existing patient associated cardiovascular risk factors and anatomical defect, or a combination of these factors, or other causes.
Reported cases of visual disturbances, including the temporary or permanent loss of vision, which are linked in time with taking PDE5 inhibitors, including and Levitra. Not installed, whether these cases directly with taking PDE5 inhibitors, or with concomitant vascular risk factors, or other causes.

Contraindications
– Simultaneous treatment with nitrates or drugs, which are nitric oxide donators;
– Combination with HIV protease inhibitors such as indinavir, or ritonavir;
– Hypersensitivity to the drug.
The drug is not intended for use in children and adolescents under the age of 16 years.
Caution should be used in patients with congenital prolongation of the interval QT, with anatomical deformation of the penis (contortion, cavernous fibrosis, Peyronie’s disease), diseases predisposing to priapism (sickle-cell anemia, multiple myeloma, leukemia), severe hepatic impairment, kidney disease in the terminal stage, hypotension (systolic pressure at rest less than 90 mmHg), recent stroke and myocardial infarction, unstable angina, hereditary retinal degenerative diseases (such as retinitis pigmentosa), with a tendency to bleeding and aggravation peptic ulcer disease, aortic stenosis and idiopathic hypertrophic subaortal stenosis.
Pregnancy and breast-feeding
The preparation is not intended for use in women.
Application for violations of liver function
With care use in patients with severe hepatic dysfunction.
In patients with severe hepatic slightly nedostatochnostyukorrektsii dosing regimen is required. In patients with moderate hepatic impairment initial dose is 5 mg sutki.Vdalneyshem depending on the efficacy and tolerability of treatment dose can be increased to 10 mg and then 20 mg.
Application for violations of renal function
With care use in patients with kidney disease in the terminal stage.
In patients with severe and moderate only slightly impaired renal function correct dosing regimen is not required

Use in children
The drug is not intended for use in children and adolescents under the age of 16 years.
Use in elderly patients
Correct dosing regimen in elderly patients is not required.
special instructions
Before prescribing the drug Levitra® (and other drugs used to treat erectile dysfunction), the physician should evaluate the state of the cardiovascular system, as there is the risk of cardiac events during sexual activity.

Vardenafil has vasodilator properties, which may be accompanied by minor or moderate decrease in blood pressure.
Patients with obstruction of the outflow tract of the left ventricle such as aortic stenosis, idiopathic hypertrophic subaortal stenosis, can be sensitive to the action of vasodilators, including PDE5 inhibitors.
Men who do not show sexual activity due to concomitant cardiovascular disease, drugs to treat erectile dysfunction is not appointed.
Since Levitra® in therapeutic doses (10 mg) causes elongation of the QT interval, medication should not be prescribed to patients with congenital QT prolongation and those who are taking antiarrhythmics class IA (quinidine, procainamide) or Class III (amiodarone, sotalol).
The safety and efficacy of vardenafil in combination with other drugs to treat erectile dysfunction has not been studied, so their combined use is not recommended.

Safety of vardenafil has not been studied, and its use is not recommended for the following groups of patients: severe liver, kidney disease in the terminal stage, requiring dialysis, hypotension (systolic pressure at rest While taking Levitra and other PDE5 inhibitors have reported cases of transient visual loss and nearteriitnoy ischemic optic neuropathy. In the event of a sudden loss of the patient should stop taking Levitra and immediately consult a physician.

Combined therapy of alpha-blockers and vardenafil may be accompanied by the development of arterial hypotension with the appropriate clinical picture, because these drugs have vasodilating effects. The combined purpose of Levitra and an alpha-blocker is permissible only if the stable performance of BP in patients receiving alpha-blockers, while Levitra should be given to the minimum recommended dose of 5 mg. It should not take Levitra at the same time with an alpha-blocker, with the exception of tamsulosin which reception can coincide in time with the reception of vardenafil. If you receive a dose of Levitra selected alpha-blocker therapy should be started at the minimum dose. The gradual increase in the dose of alpha-blockers to patients receiving drugs from the group of PDE-5 inhibitors may result in further reduction of blood pressure.
Levitra dose should not exceed 5 mg when it is combined with erythromycin, ketoconazole, itraconazole. The dose of ketoconazole and itraconazole thus 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 in patients with acute exacerbation of peptic ulcer disease, its purpose in these cases is possible only after a careful assessment of benefit-risk ratio of the therapy.
Vardenafil does not affect the duration of the bleeding, as it does not affect the rate in the combined use with acetylsalicylic acid.
Vardenafil not enhance platelet aggregation induced by different agents. The above therapeutic concentrations vardenafil causes a slight increase in antiplatelet action of sodium nitroprusside, which is a donor of nitric oxide.
Effect of heparin and vardenafil, while the use of the length of bleeding is not known.
Effect of vardenafil on the hypotensive effect of nitrates in patients not studied, so the combined purpose of Levitra and nitrates is contraindicated.
Use in Pediatrics
Vardenafil is not intended for use in children.
Effects on ability to drive vehicles and management mechanisms
Before prescribing the drug to patients who are driving a vehicle and work with the mechanisms necessary to clarify their individual response to Levitra.

Conditions and terms
The drug should be stored out of reach of children, dry place at temperatures no higher than 30 ° C. Shelf life – 3 years.

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