Levitra pills dispersible 10mg №4

Indications

- Erectile dysfunction (inability to achieve and maintain an erection necessary for sexual intercourse).

Dosage and administration

Drug Levitra ^® OTD is taken orally, regardless of the meal.

The pill is taken immediately after it is removed from the package. The pill should be kept on the tongue until it is completely dissolved and then swallowed without drinking it.

At the beginning of treatment, the recommended dose is 10 mg (approximately 25-60 minutes before sexual contact). The maximum recommended dose is 10 mg 1 time / day.

Sexual stimulation is necessary to ensure an adequate response to treatment. Drug Levitra^® OTD showed its effectiveness when taken 4-5 hours before intercourse.

Dose adjustment in elderly patients (over 65 years) not required.

Have patients with mild hepatic impairment (class A on the Child-Pugh scale) no change in dosage regimen is required. Use of the drug Levitra^® Odt not recommended for patients with moderate liver dysfunction (Child-Pugh class B).

No change in dosage regimen is required. patients with mild (CK> 50-80 ml / min), moderate (CK> 30-50 ml / min) and severe (CK <30 ml / min) impaired renal function.

Adverse effects

When using the drug Levitra^® OTD in recommended doses reported the following adverse reactions (according to the terminology adopted by WHO).

Depending on the incidence, very frequent (≥10%), frequent (≥1% and <10%), infrequent (≥0.1% and <1%) and rare (≥ 0.01% and <0.1%) adverse reactions were identified.

On the part of the immune system: infrequently - allergic edema, angioedema; rarely an allergic reaction.

Nervous system: very often - a headache; often - dizziness; infrequently - a violation of sensitivity, drowsiness, sleep disorders; rarely - fainting, amnesia, convulsions.

Special senses: infrequently - visual impairment, hyperemia of the conjunctiva of the eyeball, color perception, pain in the eyeballs and discomfort in the eyes, photophobia; rarely, increased intraocular pressure, conjunctivitis.

On the part of the organ of hearing and labyrinth disorders: infrequently - ringing in the ears, vertigo.

Since the cardiovascular system: often - vazodilatation; infrequently - palpitations, tachycardia; rarely - angina, myocardial infarction, ventricular tachyarrhythmias, hypotension.

Respiratory: often - nasal congestion; infrequently - shortness of breath, congestion of the paranasal sinuses.

Gastrointestinal: often - dyspepsia; infrequently - nausea, abdominal pain, dry mouth, diarrhea, gastroesophageal reflux disease, gastritis, vomiting, increased transaminase levels.

Skin and Subcutaneous Tissues: infrequently - erythema, rash.

Musculoskeletal system: infrequently - back pain, increased CPK, increased muscle tone and cramps.

From the reproductive system: infrequently - increased erection; rarely priapism.

Other: infrequently - feeling unwell; rarely chest pain.

Cases of myocardial infarction associated with vardenafil and sexual activity have been reported, but it has not been established whether this condition is associated directly with vardenafil, or with sexual activity, or with concomitant diseases, or a combination of these factors. There are rare reports of cases of development of anterior ischemic neuropathy of the optic nerve (PINSS), resulting in visual impairment (including persistent loss of vision), associated in time with taking PDE5 inhibitors, including and drug Levitra^® OTD in patients, many of whom, have concomitant risk factors for the development of this condition, such as: anatomical defect of the optic nerve head, age over 50 years, diabetes, hypertension, coronary heart disease, hyperlipidemia, and smoking. It has not been established whether the development of PINZN is directly related to the use of PDE5 inhibitors, or to the accompanying vascular risk factors and anatomical defects present in the patient, or a combination of these factors, or to other causes.

It is reported cases of visual impairment, including temporary or permanent loss of vision, which are associated in time with the intake of PDE5 inhibitors, including and drug Levitra^® Odt. 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.

There are a few cases of sudden deafness or hearing loss when using drugs from the group of PDE5 inhibitors, including and drug Levitra^® Odt.It is not established whether these cases are directly related to taking Levitra^® Odt, with concomitant risk factors for hearing loss, with a combination of these factors or other causes.

Contraindications

- simultaneous use with nitrates or preparations that are donators of nitric oxide;

- simultaneous use with moderately active or potent inhibitors of CYP3A4, such as Ketoconazole, itraconazole, ritonavir, indinavir, Erythromycin and Clarithromycin;

- children's and teenage age up to 18 years;

- Hypersensitivity to any of the components of the drug.

Safety of Levitra^® OTD has not been studied and, until relevant data have been obtained, its use is not recommended in patients with the following conditions:

- severe abnormal liver function;

- kidney disease in the terminal stage, requiring hemodialysis;

- arterial hypotension (systolic blood pressure at rest less than 90 mm Hg. Art.);

- A recent stroke or myocardial infarction (within the last 6 months);

- unstable angina;

- hereditary degenerative diseases of the retina, for example, retinitis pigmentosa.

WITH caution the drug should be used in patients with anatomical deformation of the penis (curvature, cavernous fibrosis, Peyronie's disease), with diseases predisposing to priapism (sickle cell anemia, multiple myeloma, leukemia). Patients with a tendency to bleeding and with an exacerbation of peptic ulcer disease, the drug should be prescribed only after evaluating the benefit / risk ratio.

Use during pregnancy and lactation

The drug is not indicated for use in women, newborns and children.

Application for violations of the liver

Have patients with mild hepatic impairment (class A on the Child-Pugh scale) no change in dosage regimen is required. Use of the drug Levitra^® Odt not recommended forpatients with moderate liver dysfunction (Child-Pugh class B).

Application for violations of kidney function

No change in dosage regimen is required. patients with mild (CK> 50-80 ml / min), moderate (CK> 30-50 ml / min) and severe (CK <30 ml / min) impaired renal function.

Use in children

Contraindicated in children under 18 years.

Use in elderly patients

Dose adjustment in elderly patients (over 65) not required.

Special notes

Before prescribing drugs used to treat erectile dysfunction, the doctor must assess the state of the cardiovascular system, since there is a risk of developing heart complications during sexual activity. Vardenafil has vasodilating properties, which may be accompanied by a slight or moderate decrease in blood pressure. Patients with obstruction of outflow pathways from the left ventricle, for example, with aortic stenosis, idiopathic hypertrophic subaortic stenosis, may be sensitive to the action of vasodilators, including PDE5 inhibitors.

In men who do not show sexual activity due to concomitant cardiovascular disease, drugs for the treatment of erectile dysfunction should not be used.

When using the drug Levitra^® OTD in therapeutic (10 mg) or supertherapeutic (80 mg) doses prolonged QT interval. The simultaneous use of vardenafil with other drugs that have a similar effect on the QT interval resulted in the summation of the effects on the duration of the QT interval in comparison with taking each of these drugs separately. This should be taken into account when administering Levitra at the same time.^® Odt in patients with a prolonged QT interval in history or patients taking medications that prolong the QT interval. In this regard, the appointment of the drug Levitra^® OTD should be avoided in patients with congenital prolongation of the QT interval and in patients taking class I A antiarrhythmic drugs (quinidine, procainamide) or class III (amiodarone, sotalol).

The safety and effectiveness of vardenafil in combination with other methods of treatment of erectile dysfunction has not been studied, so their combined use is not recommended.

The safety of oral dispersible tablets (10 mg) has not been studied in patients with moderately impaired liver function (Child-Pugh class B), so use in this category of patients is not recommended.

Against the background of the drug Levitra^® OTD and other PDE5 inhibitors have been reported to have transient vision loss and nonarteritis ischemic neuropathy of the optic nerve. When a sudden loss of vision occurs, you must stop taking Levitra^® Odt and urgently consult with your doctor.

Combined therapy with alpha-adrenergic blockers and vardenafil may be accompanied by the development of arterial hypotension with an appropriate clinical picture, since these drugs have a vasodilating effect. The combined appointment of vardenafil and alpha-blockers is permissible only if there are stable blood pressure indices against the background of taking alpha-blockers, while vardenafil should be prescribed in the minimum recommended dose of 5 mg. Patients receiving treatment with alpha-blockers should not use Levitra as an initial dose.^® Odt in the form of tablets dispersed in the mouth (10 mg). Vardenafil should not be taken at the same time with alpha-blockers, with the exception of Tamsulosin or alfuzosin, which can be the same as taking vardenafil. The time interval should be observed between taking vardenafil and other alpha-blockers. In the case of receiving the selected dose of vardenafil, therapy with alpha-blockers should be started with a minimum dose. A gradual increase in the dose of alpha-blockers in patients receiving drugs from the group of PDE5 inhibitors may lead to a further decrease in blood pressure.

Tablets that are dispersed in the mouth, contain 1.8 mg of aspartame, a source of phenylalanine, which should be considered if the patient has phenylketonuria.

Tablets dispersed in the mouth, contain 7.96 mg of sorbitol. Patients with rare hereditary diseases of fructose intolerance should not take this drug.

Additional safety data

The toxic (including reproductive toxicity), genotoxic and carcinogenic effects of vardenafil have not been established.

Influence on ability to drive motor transport and control mechanisms

Before driving vehicles and mechanisms, patients should know how they react to taking Levitra^® Odt.

Overdose

Evaluation of side effects was carried out with the appointment of vardenafil at a dose of up to 120 mg / day.

When prescribing vardenafil in a dose of up to 80 mg 1 time / day and in a dose of up to 40 mg several times a day, no serious adverse reactions were observed. When using doses of vardenafil from 80 mg to 120 mg increases the risk of side effects.

When using vardenafil in a dose of 40 mg 2 times / day, there was marked back pain without signs of toxic action on the muscular and nervous systems.

In cases of overdose, standard maintenance therapy should be performed. Since vardenafil is highly bound to plasma proteins, and only a small amount of the drug is excreted by the kidneys, hemodialysis is unlikely to work.

Drug interaction

Vardenafil is metabolized primarily with the participation of hepatic enzymes of the cytochrome P450 system, namely the 3A4 isoform, as well as with some participation of the 3A5 and 2C9 isoforms. Inhibitors of these enzymes can reduce the clearance of vardenafil.

Cimetidine (400 mg 2 times / day): non-specific inhibitor of cytochrome P450 does not affect the value of AUC and C_max vardenafil (20 mg) with their simultaneous use.

Drug Levitra^® OTD is contraindicated in case of simultaneous use with moderately active or potent inhibitors of CYP3A4, such as ketoconazole, itraconazole, ritonavir, indinavir, erythromycin and clarithromycin. When combined use of the drug Levitra^® OTD with ketoconazole, itraconazole, indinavir and ritonavir (potential CYP3A4 inhibitors) can be expected to significantly increase plasma vardenafil concentrations.

Nitrates, nitric oxide donators: taking vardenafil (10 mg) in the period from 24 h to 1 h, preceding the reception nitroglycerin (0.4 mg sublingually), does not cause an increase in its hypotensive effect when taken in healthy subjects. At a dose of 20 mg 1-4 hours before taking nitrates (0.4 mg sublingually), vardenafil enhances their hypotensive effect, but if vardenafil is prescribed for 24 hours, the hypotensive effect of nitrates does not increase when taken in healthy subjects of middle age.

Nicorarandil It is an activator of potassium channels and contains a nitro group. The presence of a nitrogroup in the nicorandil composition causes a high probability of its interaction with vardenafil.

However, there is not enough information about the potential hypotensive effects of vardenafil while being used with nitrates. In this regard, this combination is contraindicated.

Vardenafil (20 mg) does not change the AUC and C values_max glibenclamide (glyburide in a dose of 3.5 mg) when used together.It has also been shown that the pharmacokinetics of vardenafil do not change when used simultaneously with glibenclamide.

Pharmacokinetic and pharmacodynamic interactions (effects on the prothrombin time and coagulation factors II, VII, X) are not observed when co-administering vardenafil (20 mg) with warfarin (25 mg). Simultaneous use with Warfarin does not change the pharmacokinetics of vardenafil.

No significant pharmacokinetic interaction between vardenafil (20 mg) and nifedipine (30 mg or 60 mg). The combined use of vardenafil and Nifedipine does not lead to significant pharmacodynamic interactions: vardenafil causes an additional decrease in systolic and diastolic blood pressure when measured in the supine position by an average of 5.9 mm Hg. and 5.2 mm Hg. respectively.

Since it is known that alpha blockers cause a decrease in blood pressure, especially postural hypotension and syncope, the question of the interaction of alpha-blockers and vardenafil when used together is carefully studied.

Evaluation of blood pressure and pulse within 10 hours after taking vardenafil at a dosage of 5 mg or 10 mg, administered 4 hours after taking alfuzosin, did not reveal a clinically significant additional reduction of the maximum average blood pressure compared with placebo. One patient experienced a decrease in systolic blood pressure from baseline by more than 30 mm Hg. in standing position after taking vardenafil in a dose of 5 mg. Another patient had a decrease in systolic blood pressure from baseline by more than 30 mm Hg. in standing position after taking vardenafil in a dose of 10 mg. Cases of lowering systolic blood pressure in the standing position below 85 mm Hg. in this case it was not revealed. It was reported about the presence of dizziness in two patients after taking vardenafil in a dose of 5 mg, in one patient - taking 10 mg of vardenafil, and in one - after taking placebo. Since a 4-hour interval between taking doses of vardenafil and alfuzosin was chosen to identify the maximum potential interactions, the time interval between taking the drugs is not required. Cases of fainting in this case and with simultaneous use of vardenafil with tamsulosin or terazosin not identified.

The combined appointment of vardenafil and alpha-blockers is permissible only if there are stable blood pressure indices against the background of taking alpha-blockers, while vardenafil should be prescribed with the minimum recommended dose of 5 mg. However, the drug Levitra^® OTD in the form of tablets dispersed in the oral cavity should not be administered as an initial dose during concurrent therapy with alpha-blockers. Vardenafil should not be taken at the same time with alpha-blockers, with the exception of tamsulosin and alfuzosin, which may be the same as taking Levitra^® Odt. The time interval should be observed between taking vardenafil and other alpha-blockers. With the simultaneous appointment of terazosin and vardenafil, it is necessary to observe the 6-hour interval between the medication.

Simultaneous use digoxin (0.375 mg) and vardenafil (20 mg) every other day for more than 14 days is not accompanied by their interaction.

Single dose antacid (magnesium hydroxide / aluminum hydroxide) does not affect AUC and C_max vardenafil

Bioavailability of vardenafil (20 mg) is also not impaired when it is combined with histamine H blocker.₂-receptors ranitidine (150 mg 2 times / day).

Vardenafil (10 mg and 20 mg) does not affect the duration of bleeding when used as monotherapy and in combination with acetylsalicylic acid in a low dose (2 tab. 81 mg).

Vardenafil (20 mg) does not potentiate the hypotensive effect ethanol (0.5 g / kg body weight), pharmacokinetics of vardenafil is not disturbed.

Acetylsalicylic acid, ACE inhibitors, beta-blockers, diuretics and antidiabetic drugs (sulfonylurea drugs and metformin), weak CYP3A4 inhibitors do not affect the pharmacokinetics of vardenafil.

Terms and conditions of storage

The drug should be stored in its original packaging, out of the reach of children, at a temperature not exceeding 25 ° C.