The information provided below corresponds to the official product information from Patient Information Leaflet provided by the manufacturer.
The text does not contain any of medical advices, mode of administration and prescription plans.
Before beginning any treatment, we kindly advise you to consult your healthcare provider.
Generic Levitra. Snovitra
International nonproprietary name: vardenafil
Dosage form: tablets, coated
Each tablet contains 5 mg, 10 mg or 20 mg of Vardenafil
Snovitra generic pharmacological action
Snovitra is a medicine used for the treatment of erectile dysfunction, an inhibitor of phosphodiesterase type 5 (PDE5).
Erection is a hemodynamic process, based on the relaxation of smooth muscles of cavernous tissue of the penis. During sexual stimulation nitric oxide (NO) is released of the nerve endings of cavernous tissue, activating the enzyme guanylate cyclase.This leads to higher amount of cyclic guanosine monophosphate. This results in relaxation of smooth muscles of cavernous tissue, which increases blood flow to the penis. Vardenafil blocks PDE5, and thus increases the amount of cyclic GMP and enhances the vasodilating effect of NO in the cavernous tissue during the sexual stimulation, resulting in the ability to achieve erection sufficient for the sexual intercourse.
After taking Vardenafil tablets is rapidly absorbed from the gastrointestinal tract. Cmax is achieved within 15 minutes, but in most of cases in 60 minutes (from 30 to 120 min). Absolute bioavailability is about 15%.
The clinical effect is observed before achieving Cmax. After oral administration at a dose of 20 mg and 10 mg - Vardenafil generic causes an erection sufficient for penetration and successful completion of sexual intercourse in 34% and 40% of patients with mild to moderate erectile dysfunction, respectively. After 25 min clinical effect occurs in 53% and 50% of patients. The duration of clinical effect is 8-12 hours. Food usually does not affect the effectiveness of Vardenafil generic generic.
When receiving Vardenafil in conjunction with a diet containing high fat (57%), the rate of absorption is decreased.
The average distribution volume of generic Vardenafil is 208 liters, and this demonstrates its good distribution in the tissues.
Binding vardenafil and its major metabolite (M1) to plasma proteins of up to 95%, is reversible and not dependent on the total concentration of the medicine. Nearly of 90% Vardenafil and its main metabolite bind to plasma proteins. Less than 0.00012% were observed in the semen after taking Vardenafil.
Vardenafil is metabolized in the liver with the participation of CYP3A4, CYP3A5 and CYP2C9. The average T1 / 2 vardenafil is 4-5 hours, and Vardenafil metabolite is about 4 hours in the blood contained in the form of glucuronide conjugate (glucuronic acid), which is part of the metabolite M1. Vardenafil metabolite suppresses PDE5 on 28% compared with vardenafil, which corresponds to 7% efficacy.
The total clearance of vardenafil is 56 L / h, half life T1 / 2 -is about 4-5 hours after oral administration of vardenafil. Vardenafil is exceted in the form of metabolites with feces 91-95%, and urine- 2.6%.
Pharmacokinetics in special clinical cases
In healthy older men (≥ 65 years) compared with young (≤ 45 years) hepatic clearance of vardenafil was reduced. The average AUC in the elderly is increased on 52%. However, differences in the effectiveness and safety of the medicine in seniors and young people were not observed.
Patients with mild (CC> 55-80 ml / min) and moderate (QA> 30-50 ml / min) degree of renal dysfunction vardenafil pharmacokinetic parameters were comparable to those in healthy patients. In severely impaired renal function (CC <30 ml / min) AUC was increased on 21% and Cmax was decreased on 23%. In patients on hemodialysis, the pharmacokinetics of vardenafil has not been studied.
Patients with mild and moderate hepatic impairment Vardenafil clearance is reduced in proportion to the degree of the liver's dysfunction. In patients with mild hepatic impairment (class A to Child-Pugh), there is an increase in AUC and Cmax (AUC - at 17%, Cmax - 22%), in moderate degree (class B in Child-Pugh) -- 2.6 times (160%) and 2.3 times (130%), respectively, compared with healthy volunteers.
In patients with severe hepatic impairment (class C by Child-Pugh), the pharmacokinetics of Vardenafil has not been studied.
Vardenafil generic is indicated in erectile dysfunction (inability to achieve and maintain an erection sufficient for sexual intercourse) in men over 18 years of age.
Vardenafil generic Dosage regimen
The medicine is taken orally, regardless of meal. Initial recommended dose is 10 mg 25-60 minutes before sexual intercourse. You can also take Vardenafil generic 4-5 hours to 25 minutes before sexual activity. The maximum frequency of administration - 1 time. Vardenafil generic does not work without sexual stimulation.
Depending on the efficacy and tolerability the dose may be increased up to 20 mg or decreased up to 5 mg. Maximum daily dose is 20 mg.
The corrections of dosing regime in elderly patients is not required.
In patients with moderate hepatic impairment initial dose is 5 mg per day. In the future, depending on the efficacy and tolerability of treatment dose can be increased up to 10 mg and then to 20 mg.
Vardenafil is usually well tolerated and Vardenafil side effects were not significant.
Central nervous system and peripheral nervous system: headache, dizziness, drowsiness, anxiety, fainting.
Cardiovascular system: hot flashes (sudden intermittent facial flushing, sensation of heat), increase in blood pressure, low blood pressure, orthostatic hypotension, angina, cardiac ischemia
Digestive system: dyspepsia, nausea; ≥ 0.1% - <1% - change in liver function tests (increased
Respiratory system: congestive hyperemia of the nasal mucosa (mucosal edema, rhinitis, rhinorrhea) dyspnea, epistaxis; swelling of the larynx.
Vision organs: increased tearing, blurred vision (luminance of view); increased intraocular pressure.
Dermatological reactions: face edema, photosensitivity.
Musculoskeletal system: myalgia, back pain, increased CPK; increase in muscle tonicity
Reproductive system: elongation erection or painful erections, priapism.
Other: hypersensitivity reactions.
There are rare post-marketing reports of cases of anterior ischemic optic neuropathy leading to persistent loss of vision, related with receiving PDE5 inhibitors, including and Vardenafil in patients, especially in patients with risk factors such as an anatomical defect of the optic nerve, age over 50 years, diabetes mellitus, hypertension, coronary artery disease, hyperlipidemia and smoking.
Generic Vardenafil should not be used in the following conditions:
- Simultaneous treatment with nitrates or medicines, which are nitric oxide donators;
- Combination with HIV protease inhibitors such as indinavir or ritonavir;
- Hypersensitivity to any of the medicine ingredients
The product is not intended for use in children and adolescents under the age of 18 years.
Precautions should be used in patients with:
- congenital prolongation of the interval QT
- anatomical deformation of the penis (cavernous fibrosis, Peyronie's disease)
- diseases predisposing to priapism (sickle cell anemia, multiple myeloma, leukemia)
- severe hepatic impairment kidney disease in the terminal stage
- arterial hypertension (systolic blood pressure at rest less than 90 mm Hg)
- recent stroke and myocardial infarction
- unstable angina
- hereditary degenerative diseases of the retina (eg retinitis pigmentosa)
- tendency to bleeding and exacerbation of ulcer disease
- aortic stenosis
- idiopathic hypertrophic subaortal stenosis
The medication is not intended for use in women and newborns.
Application of generic Vardenafil in patients with liver diseases. The medication should be used with caution in patients with liver dysfunction
Use of Vardenafil in patients with renal impairment
Generic Vardenafil should be used with caution in patients with kidney failure.
Prior the indication of Vardenafil (and other medical products used to treat erectile dysfunction), the physician examine assess the patients cardiovascular system, because there is the risk of developing cardiac complications during the sexual activity.
Generic Vardenafil possesses vasodilating properties, which may be accompanied by minor or moderate reduction in blood pressure.
Patients with obstruction aortic stenosis, idiopathic hypertrophic subaortal stenosis, may be sensitive to the action of vasodilators, including PDE5 inhibitors. For those patients in which sexual activity is contraindicated generic Vardenafil and other PDE5 inhibitors should not be taken.
Since Vardenafil in therapeutic doses (10 mg) causes a lengthening of the interval QT, the medicine should not be used in patients with prolongation of the QT interval and those who are taking antiarrhythmics class IA (quinidine, procainamide) or class III (amiodarone, sotalol).
Safety and efficacy of vardenafil in combination with other medications for the treatment of erectile dysfunction was not studied, so their combined use is not recommended.
Safety of Vardenafil has not been investigated and its use is not recommended for the following groups of patients: severe disorders of liver function, kidney disease in the terminal stage, requiring dialysis, hypotension (systolic blood pressure <90 mmHg. Cent.) Generic Vardenafil should not be used in recent stroke or myocardial infarction (within the last 6 months), unstable angina, as well as hereditary retinal degenerative diseases, such as retinitis pigmentosa.
Combined therapy of alpha-adrenergic and vardenafil may be related to the development of arterial hypotension with the appropriate clinical picture, since these medcines have vasodilating effect. Vardenafil should be taken no earlier than 6 hours after administration of alpha-adrenergic blockers, and the dose should not exceed 5 mg.
The dose of generic Cialis should not exceed 5 mg when it is combined with erythromycin, ketoconazole, itraconazole. The dose of ketoconazole and itraconazole at the same time should not exceed 200 mg.
Combination with indinavir and ritonavir is contraindicated.
Since vardenafil has not been applied in patients with a propensity for bleeding in patients with exacerbation of peptic ulcer disease, its function in these cases is possible only after weighting the risk and benefit the ratio of therapy.
Vardenafil generic does not affect the duration of bleeding, as it does not affect the rate, in combination with acetylsalicylic acid.
Vardenafil does not increase platelet aggregation induced by various medicines. Effect of vardenafil and heparin, while the application for the duration of bleeding is not known. Concomitant application of Vardenafil generic and nitrates is contraindicated.
Use in Pediatrics
Vardenafil is not suitable for use in children.
Symptoms: there are known cases receiving Vardenafil in dose of 80 mg 1 time / and 40 mg 1 time / for more than 4 weeks without development of serious adverse reactions. However, at the same time, when generic Vardenafil is used in a dose of 40 mg 2 times daily there was observed a back pain with no signs of toxic effects on muscle and nervous system.
Make sure to inform your doctor about medicines you are currently taking. Vardenafil may interact with the following medicines:
- Alpha-blockers such as doxazosin, prosazin, tamsulosin. Concomitant application may cause lightheadedness, dizziness, fainting.
- Anti-arrhythmic medications such as amiodarone, quinidine, sotalol, procainamide . Concomitant application may of Vardenafil and Anti-arrhythmic medications may lead to QT prolongation and abnormal heart rhythm.
- Certain antibiotics (erythromycin, clarithromycin). These medication can lead to increase of Vardenafil blood levels.
- Antifungals (ketoconazole, itraconazole, miconazole). These medicines may cause the increase of Vardenafil side effects
- Grapefruit juice. Grapefruit juice inhibits liver enzymes and can increase the blood levels of Vardenafil generic.
- Nitrates such as Isosorbide dinitrate, Isosorbide mononitrate, Nitroglycerin spray, Nitroglycerin ointment, Nitroglycerin patches, Nitroglycerin tablets. Patients taking Nitrates and Vardenafil may experience severe drop in blood pressure.
- Protease inhibitors can increase the levels of generic Vardenafil in the blood.
You should store Vardenafil at temperature lower than 30C out of reach of children.
This info corresponds to official PIL provided by legal manufacturer and reviewed by: Dr. Rohit Bansali N.