International unpatented denomination vardenafil
Dosage form: tablets with coverings
Pharmacologic properties
Pharmacodynamics
Erection of the penis is a haemodynamic process, basing on relaxation of smooth muscles of cavernous bodies and arterioles which are situated in them. During sexual stimulation oxide of nitrogen evolves an activating ferment guanylate ciclase from nervous endings of cavernous bodies, which results in increase of cyclic guanosine monophospate. It results in relaxaion of smooth muscles of cavernous bodies, which favors the increase of blood reflux to the penis.
Blocking a specific phosphodiesterase of the fifth type (PDE5), participating in the disintegration of cGMP, Levitra, thus, favors the intensification of the local action of endogen oxide of nitrogen in cavernous bodies during sexual stimulation. This effect becomes an agent of the ability of Levitra to intensify the reaction to sexual stimulation.
Pharmacokinetics
After an intake Levitra is soaked quickly and starts to act after 15 minutes (in most men after 25 minutes), effective drug duration is 4—5 hours.
Indications to application
Erectile dysfunction (incapacity to reach and retain erection, needed for a sexual intercourse).
Counter indications
Hypersensitivity to any component of Levitra.
Simultaneous intake with nitrates and the preparations which are donators of oxide of nitrogen.
Combination with inhibitors protease HIV, such as indinavir or ritonavir.
Levitra is not indicated for women and children younger than 12 years old.
It should be used with care in patients:
with native prolongation of the interval of OT;
with anatomic deformation of the penis (contortion, cavernous fibrosis, Peironi disease);
with diseases predisposing for priapism (crescent-cell anemia, multiple myeloma, leukemia);
with severe disorders of the liver function. There is no need to change dosage regimen in patients with insignificant disorder of the liver function. In patient with moderate disorder of the liver function the primary dose will be 5 mg. in 24 hours. Further on, in relation to the efficiency and tolerance of the treatment the dose may be increased at most up to10 mg;
with kidney disease in the terminal stage. There is no need to change dosage regimen in patients with insignificant, moderate and severe decrease of the kidney function;
with arterial hypotension (systolic pressure at rest is lower than 90 mm mercury column);
with recently endured insult or myocardial infarction; with instable stenocardia;
with hereditary degenerative retinopathy (for instance pigmented retinitis);
with predisposing to bleeding and aggravation of ulcer disease;
with aortal stenosis and idiopathic hypertrothic subaortal stenosis.
Mode of application and doses
The primary dose is 10 mg.
It is taken 25—60 minutes before a sexual intercourse.
Duration of action of Levitra is 4—5 hours.
Maximum recommended frequency of intake once in 24 hours. In relation to efficiency and tolerance the dose may be increased up to 20 mg or decreased to 5 mg in 24 hours.
Maximum recommended dose is 20 mg once in 24 hours.
A dose of 5 mg is recommended to senior patients (over 65 years old).
A dose of 20 mg is administered in cases of severe ED (diabetes, prostatectomy) when a starting dose of 10 mg shows little efficiency.
Meals and alcoholic beverages do not affect the efficiency of Levitra.
Levitra acts only with a sufficient level of sexual stimulation.
Side effects
Levitra in whole is had well, side effects, as a rule, are insignificantly or moderately expressed and have a transitive character.
The most typical are (1—10%): headache, redness of the face, dyspepsia, nausea, faintness, rhinitis.
Non-typical and rare (0,1—1%): hydrops of the face, photosensitization, aches in the lumbus, arterial hypertension, change of functional “liver” tests, increase of the level of GGTP, increase of the level of creatine kinase, myalgia, drowsiness, dyspnoea, vision disturbance, runny eyes, priapism, anaphylactic reactions (including laryngeal edema), cardiac angina, arterial hypotension, myocardial ischemia, postural hypotension, syncopal states, increase of muscle tonus, nose bleeding, glaucoma.
Overdosing
The cases of an intake of Levitra in a dose of 80 mg. are known, but serious side effects have not developed. But at the same time with an intake of 40 mg. two times in 24 hours there have been witnessed marked pains in the lumbus without any signs of toxic action on the muscular and nervous systems.
Interaction with other medications
A dose of Levitra should not exceed 5 mg. with its combination with erythromycin, ketoconazol, itraconasol. While doses of ketoconazol and itraconasol should not exceed 200 mg. Combinations with indinavir and ritonavir are counter indicated.
Nitrates, donators of oxide of nitrogen: combined administration of Levitra and nitrates is counter indicated because of the hazard of development of arterial hypotension.
Combined therapy of alpha-adrenergic blockers and Levitra may be accompanied by the development of arterial hypotension. Levitra can be taken not earlier than after 6 hours after an intake of alpha-adrenergic blockers, and the dose should not exceed 5 mg. But in coupling with alpha-blocker tamsulosine the intake time of the medications may coincide.
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