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Levitra contains the active substance – Vardenafil. Levitra tablets are recognized as one of the most effective and fast-acting drugs to increase and improve male erectile function. This generic drug was first developed was by the Indian company Fortune Health Care. After lengthy experiments and clinical studies, namely, about 8 months, Levitra has been approved and officially launched in 40 countries.
Due to the active substance in the composition of Levitra, the effect is achieved due to the increased and increased blood flow in the region of penile cavernous bodies. This drug does not affect hormones and the level in the blood. It only naturally renews, awakens, strengthens and prolongs an erection. Clinical studies of this drug confirmed that with regular use, penile elasticity increases by 60%. It contributes to an improvement in the quality and duration of sexual intercourse and, as a result, to greater satisfaction of the sexual partner.
An oral administration regardless of food intake. The recommended starting dose is 10 mg. The tablet should be taken 15-25 minutes before sexual intercourse. The effect lasts for about 4-5 hours. To achieve the desired effect with Levitra, adequate sexual stimulation is necessary. Given the effectiveness and tolerability, the dose can be increased to 20 mg or reduced to 5 mg. The maximum recommended dose of Levitra is 20 mg, the frequency of administration is no more than 1 time per day.
There is no need to adjust the dosing regimen in the elderly, patients with renal failure or minor impairment of liver function. In patients with a moderate impaired liver function, vardenafil clearance is reduced, therefore, the initial dose should not exceed 5 mg per day. Given the outcomes, the daily Levitra dose can be increased to 10–20 mg.
- Hypersensitivity to any of the components of the drug;
- Simultaneous use with nitrates or drugs that donate nitric oxide;
- Concomitant use with moderately active or potent CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, erythromycin, and clarithromycin.
- Levitra use is not recommended in patients with the following conditions:
- severe liver dysfunction;
- terminal kidney disease requiring hemodialysis;
- arterial hypotension (CAD at rest less than 90 mm Hg. Art.);
- recent stroke or myocardial infarction (within the last 6 months);
- unstable angina pectoris;
- hereditary degenerative diseases of the retina, such as retinitis pigmentosa;
- children’s age (up to 18 years).
Central and peripheral nervous systems:
- ≥10% – headache;
- ≥1% – dizziness;
- ≥0.1% – <1% – drowsiness;
- ≥0.01% – <0.1% – anxiety, fainting.
- ≥10% – hot flashes (periodic sudden redness of the face, the sensation of heat);
- ≥0.1% – <1% – increased blood pressure, decreased blood pressure, orthostatic hypotension;
- ≥0.01% – <0.1% – angina pectoris, myocardial ischemia.
- ≥1% – <10% – dyspepsia, nausea;
- ≥0.1% – <1% – change in liver function tests.
- ≥1% – <10% – congestive hyperemia of the nasal mucosa (swelling of the mucosa, rhinitis, rhinorrhea);
- ≥0.1% – <1% – shortness of breath, nosebleeds;
- ≥0.01% – <0.1% – laryngeal edema.
Organs of vision:
- ≥0.1% – <1% – increased lacrimation, visual impairment (brightness of vision);
- ≥0.01% – <0.1% – increased intraocular pressure.
Dermatological reactions: ≥0.1% – <1% – facial edema, photosensitivity.
- ≥0.1% – <1% – myalgia, back pain, increased CPK;
- ≥0.01% – <0.1% – increased muscle tone.
Reproductive system: > 0.01% – <0.1% – prolonged erection or painful erection, priapism.
Other: ≥0.01% – <0.1% – hypersensitivity reactions.
There are rare postmarketing reports of cases of anterior ischemic optic neuropathy (CINP). It leads to visual impairment, including persistent loss of vision, associated in time with the use of PDE5 inhibitors, including and Levitra. Many of these patients have concomitant risk factors for the development of this condition, such as an anatomical defect in the optic nerve head, the age over 50 years old, diabetes mellitus, hypertension, coronary artery disease, hyperlipidemia, and smoking.
Reported cases of visual impairment, including temporary or permanent loss of vision, which are associated in time with the intake of PDE5 inhibitors, including Levitra. It has not been established whether these cases are directly related to the intake of PDE5 inhibitors, or to concomitant vascular risk factors, or to other causes.
- The safety and effectiveness of vardenafil in combination with other means to eliminate erectile dysfunction have not been established, therefore, such combinations are not recommended.
- A decrease in vardenafil clearance occurred with the simultaneous use of selective inhibitors of cytochrome P450 CYP 3A4 system enzymes (such as cimetidine, ketoconazole, itraconazole, indinavir, ritonavir, erythromycin).
- The simultaneous administration of vardenafil with blockers of α-adrenergic receptors can cause the development of symptomatic hypotension, therefore Levitra should be used no earlier than 6 hours after their administration.
- Inhibitors of CYP 2C9 (tolbutamide, warfarin), CYP 2D6 (selective inhibitors of serotonin reuptake, tricyclic antidepressants), thiazides and thiazide-like diuretics, loop and potassium-sparing diuretics, ACE inhibitors, calcium receptor antagonists, and calcium, barbiturates) do not affect the pharmacokinetics of vardenafil.
- There was no evidence of a clinically significant interaction of vardenafil with tolbutamide (250 mg) or warfarin (40 mg), which are metabolized by CYP 2C9.
- A single dose of antacid (magnesium/aluminum hydroxide) did not affect the bioavailability of vardenafil.
In a study in healthy volunteers, a single dose of vardenafil was tested, reaching 120 mg per day. Single doses of vardenafil up to 80 mg and multiple doses of up to 40 mg vardenafil, prescribed once a day for 4 weeks, were tolerated without severe adverse reactions. 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.
- Suitable for most men;
- Fast effect – about 20 – 30 minutes;
- Effect duration – up to 12 hours;
- Tablets contribute to increased sexual desire and stimulation of orgasm;
- Penis enlargement during erection;
- The possibility of re-erection within 20 minutes after reaching orgasm.