How does levitra work
Levitra – a drug for the treatment of erectile dysfunction, phosphodiesterase type 5 inhibitor. It is used to treat erectile dysfunction (inability to achieve and maintain an erection necessary for satisfactory sexual intercourse).
Latin name: Levitra / LEVITRA.
Composition and the form: Levitra tablets, coated tablets, for 1, 4,8, or 12 pc. in the package. 1 tablet contains vardenafil Levitra 2.5, 5, 10 or 20 mg (5.926, 11.852 and 23.705 mg of vardenafil hydrochloride trihydrate, respectively).
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Active-active ingredient: Vardenafil / Vardenafil.
Pharmacological properties: Levitra – for the treatment of erectile dysfunction, an inhibitor of phosphodiesterase type 5 (PDE5).
Erection is a hemodynamic process, based on the relaxation of smooth muscles of cavernous bodies and located in its arterioles. During sexual stimulation of the nerve endings of cavernous bodies released nitric oxide (N0), activating the enzyme guanylate cyclase, which leads to higher content in the cavernous bodies of cyclic guanosine monophosphate (cGMP). The result is relaxation of smooth muscles of cavernous bodies, which increases blood flow to the penis. Levitra (vardenafil) blocks PDE5, which is under the influence of the splitting of cGMP, as a result of the action of endogenous NO in the cavernous bodies during sexual stimulation, increases, resulting in the ability to Levitra enhances the natural response to sexual stimulation.
Pharmacokinetics: After oral administration, Levitra is quickly absorbed and starts to act within 15 minutes (the majority of men after 25 minutes), duration of action is 4-5 hours.
Cmax is reached, usually after an average of 60 minutes (from 30 to 120 min). Absolute bioavailability is about 15%. When receiving Levitra (vardenafil) in conjunction with a diet containing large amounts of fat, decreases the rate of absorption: time to achieve Cmax in plasma (Tmax) is increased to 60 min, Cmax, on average reduced by 20% without a significant change in AUC. When receiving Levitra with a normal diet containing no more than 30% fat, vardenafil pharmacokinetic parameters (Cmax, Tmax, AUC) are not changed. Vardenafil and its major metabolite are highly bound to plasma proteins (up to 95%), and this property is reversible and not dependent on the total concentration of the drug. 90 min after administration of oral vardenafil in semen of healthy men found no more than 0.00012% received dose.
Vardenafil is metabolized primarily in the liver with the involvement of isoenzymes of cytochrome P450 – CYP3A4, and CYP3A5 and CYP2C9. The average T1 / 2 vardenafil is 4-5 h, and the main metabolite – about 4 hours total clearance of vardenafil is 56 L / h, terminal T1 / 2 – about 4-5 hours after oral vardenafil in the form of metabolites derived primarily through the intestine – 91-95% of the dose, to a lesser extent, kidney – 2.6% of the dose.
In healthy elderly males (65 years and older) compared with younger (45 years and younger) are not noted a significant reduction in hepatic clearance vardenafil. In men older AUC increased by an average of 52%. In clinical trials, Levitra was not observed differences in the effectiveness and safety between older and younger individuals.
Patients with minor (QA> 55-80 ml / min), moderate (CC> 30-50 ml / min) and severe (CC <30 ml / min) impaired renal function vardenafil pharmacokinetic parameters were comparable with those in healthy subjects. There have not been reliable correlation between QA and the concentration of vardenafil in the plasma (AUC and Cmax).
Patients on hemodialysis, the pharmacokinetics of vardenafil has not been studied. Patients with mild and moderate hepatic impairment Vardenafil clearance is reduced in proportion to the degree of liver function. Compared with healthy men, patients with minor hepatic impairment, may increase in AUC and Cmax 1.2-fold, and at moderate violations of function of the liver – in 2.6 times. Patients with severe hepatic impairment the pharmacokinetics of vardenafil has not been studied.
Indications: Erectile dysfunction (inability to achieve and maintain an erection necessary for satisfactory sexual intercourse).
Dosing and dose: Inside. Levitra can be taken irrespective of meals. Levitra is effective only when a sufficient level of sexual stimulation. Levitra the recommended dose of 10 mg should be taken for 25-60 minutes before intercourse. Levitra duration of action is 4-5 hours. In the absence of positive effect to increase the dose of Levitra 20 mg (diabetes, prostatectomy).
Patients taking other medications or conditions involving reduced metabolism of vardenafil, the dose of Levitra should be 2,5-5 mg. Dose of 5 mg is recommended for older patients (over 65). In the future, depending on the efficacy and tolerability of Levitra dose may be increased to 10 mg.
In patients with moderate hepatic impairment declines vardenafil clearance, so the starting dose of Levitra should be 5 mg / day. In patients with minor hepatic impairment Levitra dosing regime change is not required.
Patients with minor, moderate and severely impaired renal function change the dosage Levitra is not required.
Do not take Levitra more than once a day.
The maximum recommended dose is 20 mg 1 time per day.
Overdose: It is well known cases receiving Levitra in dose of 80 mg per day, which is not accompanied by the development of serious adverse reactions. However, at the same time when used in a dose of 40 mg twice a day there is a pronounced low back pain with no signs of toxic effects on muscle and nervous system.
Treatment: the holding of symptomatic and supportive therapy. Since vardenafil is highly bound to plasma proteins and only a small number Levitra excreted by the kidneys, the effectiveness of hemodialysis is unlikely.
Contraindications: The drug Levitra is not recommended for use in patients: that sexual activity is contraindicated in connection with diseases of the cardiovascular system;
suffered over the last 6 months of myocardial infarction or stroke;
with very low blood pressure (systolic blood pressure at rest below 90 mm Hg. Art.)
uncontrolled rise in blood pressure;
with unstable angina;
with congenital QT interval prolongation;
with aortic stenosis and idiopathic hypertrophic subaortal stenosis;
with severe hepatic insufficiency;
with end-stage renal failure requiring dialysis;
with hereditary retinal degenerative diseases (eg, pigmentary retinopathy);
with anatomical deformation of the penis (curved, cavernous fibrosis, Peyronie’s disease);
diseases predisposing to priapism (sickle-cell anemia, multiple myeloma, leukemia);
with a tendency to bleeding and exacerbation of peptic ulcer;
with hypersensitivity to any component of Levitra;
simultaneously applying nitrates (nitroglycerin, isosorbide dinitrate, isosorbide mononitrate) or drugs that are donators nitric oxide;
simultaneously applying the HIV protease inhibitors such as indinavir or ritonavir.
Levitra is not indicated for women and children under 16 years.
Application of pregnancy and lactation: Levitra is not intended for use in women.
Side effects: Levitra generally well tolerated, side effects, usually slightly or moderately expressed and are transient in nature. When conducting clinical trials of Levitra celebrated adverse reactions were: headache, dizziness, blurred vision, drowsiness, increased muscle tone, dyspepsia, nausea, change in functional “liver” tests, increased GGTP, “tides” of blood to the face, hypertension, syncopal states, myocardial ischemia, epistaxis, rhinitis, dyspnea, anaphylactic reaction (including laryngeal edema), photosensitivity, increased creatine kinase, myalgia, back pain, glaucoma, priapism.
Cautions and precautions:
Due to the fact that sexual activity is associated with a certain degree of fundamental risk, before the appointment of Levitra erectile dysfunction on the need to evaluate the state of the cardiovascular system of the patient. Levitra (vardenafil) is not intended for use in children.
Effects on ability to drive vehicles and management mechanisms: Prior to the appointment of Levitra in patients who are driving a vehicle and work with the mechanisms necessary to clarify their individual reaction to Levitra.
Drug Interactions:
Vardenafil is metabolized primarily in the liver with the involvement of isoenzymes of cytochrome P450, in particular – CYP3A4, as well as with some participation isozymes CYP3A5 and CYP2C9.
Some medicines may affect the metabolism of Levitra, in connection with this, patients should consult with a doctor in case of appointment of a new medicinal product. For example, for patients taking cimetidine, ketoconazole, itraconazole, indinavir or ritonavir, the maximum dose of Levitra is 5 mg. The dose of ketoconazole and itraconazole at the same time should not exceed 200 mg. In an application with the CYP3A4 inhibitor erythromycin did not exceed the recommended maximum dose of Levitra 10 mg / day.
Avoid combined medication Levitra with nitrates (such as nitroglycerin, sodium nitroprusside) or alpha-adrenergic blockers (drugs for the treatment of benign prostatic hyperplasia and / or lowering blood pressure), as well as a joint application with these drugs can lead to a sharp drop in blood pressure and collapse.
Since PDE inhibitors affect the system of nitric oxide / cGMP, PDE5 inhibitors may increase the hypotensive effects of nitrates. Levitra should be no earlier than 6 hours after ingestion of alpha-adrenergic blockers, and the dose should not exceed 5 mg. However, when combined with alpha-blocker tamsulosin, taking medication on time can be the same.
With simultaneous use of Levitra with glyburide, nifedipine, warfarin, and digoxin were observed significant changes in pharmacokinetics.
With simultaneous use of Levitra with warfarin was not observed changes in prothrombin time and clotting factors. With simultaneous use of Levitra with acetylsalicylic acid, antacids, ACE inhibitors (enalapril, captopril), beta-blockers (propranolol, atenolol, metoprolol and others), diuretics, hypoglycemic agents (metformin and sulfonylurea derivatives), as well as with histamine H2-blockers receptors ranitidine and cimetidine pharmacokinetics of vardenafil has not changed.
In studies in humans, while the application Levitra (vardenafil) with acetylsalicylic acid was not observed changes in bleeding time.
In studies on human platelets in vitro demonstrated that monotherapy vardenafilom not inhibit platelet aggregation induced by various platelet agonists.
As the safety and efficacy of combinations of Levitra with other agents for the treatment of erectile function (sildenafil, tadalafil) has not been investigated, the use of such combinations is not recommended.
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