Levitra is a PDE5 inhibitor; drug for the treatment of erectile dysfunction.
Release form and composition
Levitra dosage form - tablets: round, biconvex, from light orange to gray-orange, slightly rough, with a Bayer branded cross on one side and embossed ("5", "10" or "20") - on the other (on 1 or 4 pieces in blisters, 1 blister in carton packs).
The active ingredient of the drug is vardenafil (in the form of trihydrate hydrochloride). In 1 tablet - 5, 10 or 20 mg.
Auxiliary components: magnesium stearate, crospovidone, microcrystalline cellulose, anhydrous colloidal silicon dioxide.
The composition of the shell: hypromellose, titanium dioxide, macrogol 400, iron dyes yellow oxide and iron red oxide.
Indications for use
Levitra is used for erectile dysfunction (inability to achieve and maintain an erection sufficient for sexual intercourse).
- Combination with HIV protease inhibitors such as ritonavir or indinavir;
- The period of treatment with nitrates or drugs that are nitric oxide donors;
- Hypersensitivity to the drug.
The drug is not intended for use in women, children and adolescents under the age of 16 years.
Levitra should be taken with extreme caution in the following cases:
- Congenital prolongation of the QT interval;
- Anatomical deformation of the penis (cavernous fibrosis, curvature, Peyronie's disease);
- Diseases predisposing to priapism (leukemia, multiple myeloma, sickle cell anemia);
- Kidney disease in the terminal stage;
- Impaired liver function;
- Tendency to bleed;
- Aggravation of peptic ulcer disease;
- Hypotension (systolic pressure at rest does not reach the level of 90 mm Hg);
- Unstable Angina;
- Aortic stenosis and idiopathic hypertrophic subaortic stenosis;
- A recent myocardial infarction or stroke;
- Hereditary degenerative diseases of the retina (for example, retinitis pigmentosa).
Dosing and Administration
Levitra should be taken orally once a day. Eating does not affect the effectiveness of the drug.
The initial recommended dose is 10 mg. The optimal time for taking the pill is 25-60 minutes before sexual intercourse, but it can be taken 4-5 hours before sexual activity.
If necessary, taking into account the effectiveness and tolerability of vardenafil, the dose can be reduced to 5 mg or increased to 20 mg.
The maximum permissible daily dose is 20 mg.
To achieve the greatest effectiveness, a sufficient level of sexual stimulation is necessary.
The initial dose for patients with moderate hepatic insufficiency is 5 mg. Depending on the effectiveness and tolerability of the drug, it can be increased to 10 mg and then to 20 mg.
Elderly patients, patients with slightly severe liver failure, slightly and moderately severe renal impairment do not require dose adjustment.
- Central and peripheral nervous system: very often - headache; often - dizziness; sometimes drowsiness; very rarely - fainting, anxiety;
- Cardiovascular system: very often - hot flashes (intermittent sudden sensation of heat and redness of the face); sometimes - orthostatic hypotension, a decrease or increase in blood pressure; very rarely - myocardial ischemia, angina pectoris;
- The digestive system: often - nausea, dyspepsia; sometimes changes in liver function tests (increased alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltranspeptidase);
- Respiratory system: often - congestive hyperemia of the nasal mucosa (rhinorrhea, rhinitis, mucosal edema); sometimes - nosebleeds, shortness of breath; very rarely - laryngeal edema;
- Musculoskeletal system: sometimes - back pain, myalgia, increased creatine phosphokinase; very rarely - increased muscle tone;
- Organ of vision: sometimes - violation of the brightness of vision, increased tearing; very rarely, increased intraocular pressure;
- The reproductive system: rarely - painful erection, prolongation of erection, priapism;
- Dermatological reactions: sometimes - photosensitivity, swelling of the face;
- Other: very rarely - hypersensitivity reactions.
In the post-marketing practice, there are rare reports of cases of development of anterior ischemic optic neuropathy, resulting in visual impairment (including persistent loss of vision), which coincide in time with the intake of PDE5 inhibitor, including Levitra. Many of the patients had concomitant risk factors, such as an anatomical defect of the optic nerve head, coronary heart disease, arterial hypertension, hyperlipidemia, diabetes, over 50 years of age, smoking. Whether the development of this phenomenon is directly related to the intake of the PDE5 inhibitor, either with the accompanying anatomical defects or vascular risk factors present in the patient, or with a combination of such factors, or with any other causes, has not been reliably established.
Also reported cases of visual impairment, including persistent or temporary loss of it, which coincided in time with taking PDE5 inhibitors, including Levitra, however, the causal connection with their use has not been proven.
Before prescribing Levitra (as well as any other drug for treating erectile dysfunction), it is necessary to assess the state of the cardiovascular system, since There is a risk of complications during sexual activity.
Patients diagnosed with obstruction of the outflow tract from the left ventricle, for example, idiopathic hypertrophic subaortic stenosis or aortic stenosis, may be sensitive to the action of Levitra.
The drug is not prescribed to men who are contraindicated for sexual activity due to the presence of concomitant cardiovascular disease.
Vardenafil has a vasodilating property, which may be accompanied by a slight or moderate decrease in blood pressure.
To determine the effect of vardenafil on patients driving vehicles or working in industries that require reaction speed and concentration, it is necessary to find out their individual response to Levitra.
Since Levitra causes lengthening of the QT interval at doses of doses, it cannot be prescribed not only to patients with congenital lengthening of the QT interval, but also in the case of treatment with antiarrhythmic drugs of class IA (procainamide, quinidine) or class III (amiodarone, sotalol).
It is not recommended to prescribe vardenafil in combination with other drugs for the treatment of erectile dysfunction, since the safety and efficacy of such combinations have not been studied.
Taking vardenafil during alpha-blocker therapy can lead to the development of arterial hypotension with an appropriate clinical picture, which is due to the vasodilating effect of these drugs. The prescription of Levitra to patients receiving alpha-adrenergic blockers is possible only in the case of stable blood pressure indicators, while vardenafil should be taken in a minimum dose of 5 mg. If alpha-blockers are prescribed to patients who have already selected the dose of vardenafil, these agents should be prescribed in the minimum dose. It is not recommended to take Levitra with alpha-blocker (with the exception of tamsulosin) at the same time.
If ketoconazole, erythromycin or itraconazole is used, the dose of vardenafil should not exceed 5 mg. The maximum permissible dose of itraconazole and ketoconazole is 200 mg.
The combination of this drug with ritonavir and indinavir is contraindicated.
Terms and conditions of storage
Store at a temperature not exceeding 30 ° C in a dry place inaccessible to children.
Shelf life - 3 years.