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Levitra is a drug prescribed for the treatment of erectile dysfunction.
Vardenafil is a potent and highly selective PDE5 inhibitor. The inhibitory property of vardenafil on PDE5 is more expressed than on other known PDEs.
Reception of Levitra (Vardenafil) in a dose of 20 mg is able to cause an erection (sufficient for sexual intercourse) already in 15 minutes. A complete response is reached after 25 minutes.
Indications for use
Erectile dysfunction (inability to achieve and maintain an erection necessary for sexual intercourse).
Dosage and administration
The drug is taken orally, regardless of food intake. At the beginning of treatment, the recommended dose is 10 mg (approximately 25-60 minutes before sexual contact). However, Levitra is effective when taken 4-5 hours before sexual intercourse. The maximum frequency is 1 time per day. Depending on the effectiveness and tolerability of treatment, the dose can be increased to 20 mg or reduced to 5 mg per day. The maximum recommended dose is 20 mg once a day. Sexual stimulation is required to provide an adequate response to treatment.
- Hypersensitivity to any of the drug components;
- Simultaneous use with nitrates or drugs that are donors of nitric oxide;
- Concomitant use with moderately active and potent CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, erythromycin, and clarithromycin;
- Medications for the treatment of erectile dysfunction should not be used in men who are contraindicated sexual activity.
The safety of Levitra has not been investigated and, until the relevant data have been obtained, its use is not recommended in patients with the following conditions:
- severe liver dysfunction;
- end-stage kidney diseases requiring hemodialysis;
- arterial hypotension (resting systolic pressure
- unstable angina pectoris;
- hereditary degenerative diseases of the retina, for example, retinitis pigmentosa.
The drug should be used with caution in patients with:
- anatomical deformation of the penis (curvature, cavernous fibrosis, Peyronie’s disease);
- diseases predisposing to priapism (sickle cell anemia, multiple myeloma, leukemia);
- a predisposition to bleeding;
- exacerbation of peptic ulcer.
- Central nervous system and peripheral nervous system: headache; dizziness; drowsiness; anxiety, fainting.
- Cardiovascular system: hot flashes (periodic sudden redness of the face, a sensation of heat); increased blood pressure, decreased blood pressure, orthostatic hypotension; angina pectoris, myocardial ischemia.
- Digestive system: dyspepsia, nausea; change in liver function tests (increased ALT, AST, GGTP).
- Respiratory system: congestive hyperemia of the nasal mucosa (swelling of the mucosa, rhinitis, rhinorrhea); shortness of breath, nosebleeds; laryngeal edema.
- The organ of vision: increased lacrimation, impaired vision (brightness of vision); increased intraocular pressure.
- Dermatological reactions: swelling of the face, photosensitivity.
- Musculoskeletal system: myalgia, back pain, increased CPK; increase muscle tone.
- Reproductive system: prolonged erection or painful erection, priapism.
- Other: hypersensitivity reactions.
In a study in healthy volunteers, a single dose of 120 mg vardenafil per day was tested. Single doses of vardenafil up to 80 mg and multiple doses of up to 40 mg of vardenafil, prescribed once a day for 4 weeks, were tolerated without severe adverse effects.
However, when applying vardenafil at a dose of 40 mg 2 times a day, severe back pain was noted without signs of toxic effects on the muscle and nervous system.
In cases of overdose, standard maintenance therapy should be conducted. Since vardenafil is highly bound to plasma proteins, and only a small amount of the drug is excreted by the kidneys, the effectiveness of hemodialysis is low.
Interaction with other drugs
- Vardenafil is metabolized primarily with the participation of hepatic enzymes of the cytochrome P450 (CYP) system, namely, the ZA4 isoform, as well as with some participation of the CYP3A5 and CYP2C isoforms. Inhibitors of these enzymes may decrease vardenafil clearance.
- Cimetidine (400 mg 2 times a day): this non-specific inhibitor of cytochrome P450 does not affect the value of the PPK and Cpk
indicators of Levitra (20 mg) when used simultaneously.
- Erythromycin (500 mg 3 times a day): this CYP ZA4 inhibitor causes a 4-fold (300%) increase in PPC and a 3-fold (200%) increase in the Cpk of Levitra (5 mg).
- Ketoconazole (200 mg): being a potent inhibitor of CYP ZA4, ketoconazole causes a 10-fold increase (900%) in AUC and a 4-fold increase (300%) Cpk of Levitra (5 mg).
- With the combined use of Levitra (10 mg) and the HIV protease inhibitor indinavir (800 mg 3 times a day), a 16-fold (1500%) increase in AUC and a 7-fold (600%) increase in Max vardenafil are found. 24 hours after administration, the concentration of vardenafil in plasma is approximately 4% of its max indicators.
- Ritonavir (600 mg 2 times a day): increases the Levitra Cmax (5 mg) by 13 times and its total daily Ppk by 49 times.
- Nicorandil is an activator of potassium channels and contains a nitro group. The presence of a nitro group in the composition of nicorandil causes a high probability of its interaction with vardenafil.
- The combined use of Levitra with ketoconazole, itraconazole, indinavir, and ritonavir (potential CYP3A4 inhibitors) provides a significant increase in the concentration of vardenafil in the blood plasma.
Nitrates, nitric oxide donors
Taking Levitra (10 mg) from 24 hours to 1 hour before taking nitroglycerin (0.4 mg sublingually) does not increase its hypotensive effect. At a dose of 20 mg 1-4 hours before the use of nitrates (0.4 mg sublingually), Levitra enhances their hypotensive effect, but if it is prescribed for 24 hours, then the hypotensive effect does not increase.
However, there is insufficient information on the potential antihypertensive effects of vardenafil when used concomitantly with nitrates. In this regard, this combination is contraindicated.