Re-Doo 10mg Reliv treats erectile dysfunction (2 blisters x 2 tablets)

Dosage form Box of 2 blisters x 2 tablets
Specifications Vardenafil

Ingredient

Composition information	Content
Vardenafil	10mg

Uses

indications

re-doo drugs are prescribed in adult men with erectile dysfunction, unable to achieve or maintain an erection of penis enough to satisfy sexual activity. In order for the drug to be effective, there should be an accompanying sexual stimulation.

Pharmacokic

ATC code: G04b E09. Drug group: Drugs to treat erectile dysfunction.

Vardenafil is an oral drug used to improve erectile function in men with erectile dysfunction. In the context of naturally, that is, when sexually stimulated, the drug restores the erectile function by increasing blood flow to the penis.

Oceans are a hemodynamic process. While sexual stimulation, nitric oxide is released. This substance activates Ganylat Cyclase enzyme, resulting in an increase in the concentration of guanosin monophosphate (GMP ring) in the cave. This turns smooth muscle relaxation and increases blood flow into the penis. The GMP ring level is regulated by the biosynthesis speed via cyclase guanylate and the incidence of the divestment via the phosphodiesterase hydrolyzed GMP (PDEs).

Vardenafil is a strong and selective inhibitor on GMP specialized ring enzyme phosphodiesterase type 5 (PDE5), one of the most prominent PDEs in human cave.

Vardenafil increases the effects of endogenous nitric nitric in the cave by inhibiting PDE5. When nitric oxide is released to respond to sexual stimulation, Vardenafil's PDE5 inhibitor increases the GMP level of the cave. Therefore, sexual stimulation is necessary for Vardenafil to promote treatment effects.

In vitro studies show that Vardenafil has a stronger effect on PDE5 than the known phosphodiesterase (> 15 times higher than PDE6,> 130 times higher than PDE1,> 300 times higher than PDE11, and> 1000 times compared to PDE2, PDE3, PDE4, PDE7, PDE8, PDE9 and PDE10).

In a study measuring the change of penis volume (using Rigiscan), Vardenafil 20 mg creates an erection that is thought to be sufficient for intercourse (60% hardness with rigiscan) in some men immediately 15 minutes after taking the drug. The overall response of these subjects with Vardenafil becomes statistically significant, compared to the placebo at the time after taking the drug 25 minutes.

Vardenafil can cause mild and transient blood pressure loss and most cases are not clinically affected. The maximum reduction of systolic blood pressure on average after using 20 mg and 40 mg Vardenafil is 6.9 mmHg and - 3.3 mmHg, compared with the placebo. These effects are suitable for the vasodilation effect of PDE5 inhibitors and may be due to increased GMP levels in blood vessel muscle cells. Use a single dose of multi -dose Vardenafil up to 40 mg without clinical electrocardiogram changes in normal male volunteers.

Pharmacokinetics

absorption

Vardenafil is quickly absorbed. The peak concentration in plasma is reached early for about 15 minutes after drinking in some people. However, 90% cmax is achieved within 30 - 120 minutes (an average of 60 minutes) when taking the drug when hungry. Absolute oral bioavailability is 15%. After taking AUC and CMAX pills of Vardenafil, increasing almost the proportional proportional within the recommended dose range (from 5 - 20 mg).

When taking Vardenafil along with a lot of fat (57%), the absorption rate will decrease with the average increase of TMAX by 1 hour and the average CMAX decrease is 20%. The AUC of Vardenafil is not affected when used with a low -fat 30%diet, the speed and absorption level of Vardenafil (TMAX) CMAX and AUC) are unchanged compared to when used on hunger.

Distribution

Vardenafil's medium stable distribution volume is 208 liters, showing the distribution into tissues.

Vardenafil and metabolites have the main circulating activity (M1) that is heavily connected to plasma proteins (about 95% for Vardenafil or M1). The protein cohesion of Vardenafil and M1, is regardless of the total drug concentration.

Based on the measurement of the medication concentration in the semen of healthy people after taking 90 minutes, no more than 0.00012% of the dose appears in the patient's semen.

Metabolism

Vardenafil is metabolized mainly by liver enzymes through Cytochrom P450 (CYP) in conjunction 3A4 with the contribution of CYP3A5 and CYP2C.

In humans, the main flow metabolites (M1) are due to the reduction of ethyl vardenafil and will be metabolized with the sale time for about 4 hours. Part of M1 in the form of glucuronid in the whole week of body. M1 metabolites have a selective effect on phosphodiesterase similar to Vardenafil and in Vitro has a strong effect on phosphodiesterase type 5 about 28% compared to Vardenafil and the contribution is about 7%.

Elimination

The total clearance of Vardenafil is 56 liters/hour with the final sale time of 4-5 hours. After oral use, Vardenafil is excreted in the form of metabolic mainly in stool (about 91 - 95% of oral dose) and with less than urine (about 2 - 6% of oral dose).

pharmacokinetics in special subjects

Elderly

Vardenafil's liver clearance in the elderly volunteered healthy (65 years and older) was reduced compared to young healthy volunteers (18 - 45 years old). On average, men with AUC have 52% higher and 34% higher CMAX than young men.

Renal failure

In volunteers with mild to medium renal failure (creatinine clearance from 30 - 80 ml/minute), Vardenafil's pharmacokinetics are similar to those with normal kidney function in the control group. In those who volunteer to suffer from severe renal failure (creatinine clearance

People with liver failure

In patients with mild to medium liver failure (Child-Pugh A and B), the Vardenafil clearance is reduced proportional to the level of liver failure. In patients with mild hepatic impairment (Child-Pugh a), AUC and CMAX increased by 17% and 22% respectively compared to healthy controls. In patients with medium liver failure (Child-Pugh B), AUC and CMAX. On average, increased by 160% and 133% compared to healthy controls. Vardenafil pharmacokinetics in patients with severe liver failure (Child-Pugh c) have not been studied.

Before taking Re-Doo 10mg Reliv treats erectile dysfunction (2 blisters x 2 tablets)

How to use

oral medication.

Dosage

used for adults:

recommended dose is 10 mg orally when necessary about 25 - 60 minutes before sexual activity. Depending on the efficiency and ability to tolerate, the dose may be increased to 20 mg or decreased to 5 mg. The maximum recommended dose is 20 mg.

The maximum frequency of drug use is once a day. If the drug is used with a high -fat meal, the beginning of the effect of the drug may be slow.

Special subjects:

Elderly (≥ 65 years)

No dose adjustment for elderly patients. However, it is necessary to consider when increasing the dose to up to 20 mg based on the tolerance of each patient.

People with liver failure

Starting dose of 5 mg should be considered for patients with mild and medium liver failure (Child Pugh A-B). Depending on the efficiency and ability to tolerate, it may increase the dose afterwards, the maximum dose recommended for average liver failure (Child Pugh B) is 10 mg.

Renal failure

No dose adjustment for people with mild to medium.

In people with severe renal failure (creatinine clearance

Children

Do not take medicine for children under 18 years old. There is no indications related to the use of this drug in children.

Used in patients who are taking other drugs.

Use in combination with CYP3A4 inhibitors

When used in combination with CYP3A4 inhibitors such as erythromycin or Clarithromycin, the dose of Vardenafil must not exceed 5 mg.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when using overdose?

When using Vardenafil at a higher doses and more times than the recommended dose (40 mg, 2 times/day), there are reports of severe back pain. This is not related to muscle or nervous toxicity.

Handling: In case of overdose, when needed should apply standard support treatments. Dialyer does not increase the speed of clearance, because Vardenafil is very strong with plasma proteins and does not excrete through urine.

In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.

Side Effects

Side effects are reported in clinical studies are usually fleeting from light to medium levels. The most common side effect occurs in ≥ 10% of patients with headaches.

Side effects are arranged classified by organ systems and frequency listed in the following table:

Classification of disorders by organ system Rō

infections and manifestations

circuit. Scum. Transient anemia.

SECRECTION EYE.

Change of color awareness.

Sore eye pain, discomfort in the eyes, fear of light.

increased glaucoma, increased tear secretion. Visual abnormalities. fast.

Hypertension.

Sinus sinuses.

nosebleeds.

Gastritis.

Gastrointestinal pain and abdominal pain, diarrhea.

vomiting, nausea, dry mouth.

Redders.

rash.

Light sensitivity reactions. Urology Blood.

Penis bleeding, bloody semen has been reported in clinical trials and post -spontaneous marketing data when using PDE5 inhibitors, including Vardenafil.

Use this tablet 20 mg, elderly patients (≥ 65 years old) have a higher frequency of headache and dizziness than young patients (

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

contraindicated re-doo in the following cases:

Hypersensitivity to Vardenafil or any ingredients of the drug.

Use in combination with nitrates or nitric oxide drugs (such as amyl nitrate) in any form.

People who have an vision in one eye due to an anemic antibiotic is anemia (NAOon), regardless of whether it is related to the previous PDE5 inhibitor's exposure.

The recommended person should not be sexually active (severe cardiovascular disease such as unstable angina or severe heart failure III or IV as classified by the New York Heart Association). The following patient subgroups do not have research on safety, so they are contraindicated until more information:

Severe liver failure (Child Pugh C). element. evidence.

Be cautious when using

Before treating erectile dysfunction with drugs, it is necessary to conduct learning about history and examination to diagnose and identify potential causes. Before the beginning of the treatment of erectile dysfunction, the doctor should consider the patient's cardiovascular condition, because there is a level of heart risk related to sexual activity.

Vardenafil has vasodilators, leading to a decrease in mild and transient blood pressure. Patients with left ventricular expressions such as aortic stenosis and hypertrophic stenosis under the idiopathic aortic valve, may be more sensitive to the effects of vasodilators including phosphodiesterase type 5 inhibitors.

Serious cardiovascular events include sudden death, tachycardia, myocardial infarction, ventricular tachycardia, angina and cerebral vascular disorders (including transient anemia and brain hemorrhage) have been reported in cases of temporary combination with Vardenafil. Most patients with these complications are reported to have previous cardiovascular risk factors. However, it is not possible to determine whether the above -mentioned complications are directly related to risk factors, to Vardenafil, to sexual activity or to the combination of these factors or other factors.

Medications to treat erectile dysfunction, should be used in patients with abnormal genitals in the body (such as folding angle, fibrosis or peyronie disease) or in patients with conditions that can lead to penis pain (such as sickle cell anemia, bone marrow or leukemia).

Safety and effectiveness of combining Vardenafil with other erectile dysfunction treatments have not been studied. Hence do not recommend these combinations.

The maximum tolerance of 20 mg can be reduced in the elderly (≥ 65 years).

Use in combination with Alpha inhibitors

The use of a combination of Alpha and Vardenafil inhibitors can lead to symptomatic hypotension in some patients because both are vasodilators. Treatment should only be started with Vardenafil if the patient has stabilized with Alpha inhibitors. In patients stabilizing with Alpha inhibitors, Vardenafil should be started with the lowest starting dose of 5 mg. Vardenafil can be used at any time with tamsulosin or with alfuzosin. For other alpha inhibitors, the medication is needed when used in combination with Vardenafil. In patients who have used the optimal dose of Vardenafil, Alpha inhibitors should be started at the lowest dose. Increasing alpha inhibiting dose can lower blood pressure in patients using Vardenafil.

Use in combination with CYP3A4 inhibitors

Avoid using Vardenafil combining with strong CYP3A4 inhibitors such as otraconazole and ketoconazole (oral form) because of the plasma Vardenafil concentration can reach very high if used combined.

Need to adjust Vardenafil if used in combination with average CYP3A4 inhibitors such as erythromycin and clarithromycin.

Should avoid using grapefruit or grapefruit juice can increase the level of vardenafil in plasma.

affects the distance qt

Single dose of 10 mg and 80 mg Vardenafil has been shown to extend the distance of QT, respectively, 8 milliseconds and 10 milliseconds respectively. And the 10 mg single dose used at the same time with 400 mg gatifloxacin, an active ingredient that has a relative effect on QT, indicates that the effect of QT gap increases 4 milliseconds compared to one of two solo active ingredients. The clinical impact of these QT changes is unknown.

Clinically involved of this finding is not well known and unable to generalize all patients in any case, because it will depend on the risk factors and sensitivity of each individual may appear at any time in any patient. It is best to avoid using drugs that can extend the QT distance, including Vardenafil for patients with related risk factors, such as hypokalemia, congenital QT, used with anti -arrhythmic drugs in group 1A (such as Quinidin, Procainamid) or group III such as Amiodaron, Sotalol.

Effects on vision

Cases of visual abnormalities have been reported spontaneously related to the use of this drug and other PDE5 inhibitors. Patients should be informed that in the case of any sudden visual abnormalities, they should stop taking the drug and consult the doctor immediately.

Effects on bleeding

Platelet studies in humans show that Vardenafil himself has no anticoagulant effect, but at high doses (higher than the dose of treatment) Vardenafil increases the anticoagulant effect of nitric oxide suppliers is sodium nitroprussid. In humans, Vardenafil does not work on bleeding time when used alone or in combination with acetylsalicylic acid. There is no information on the safety of using Vardenafil for patients with progressive bleeding or gastrointestinal ulcers. Therefore, Vardenafil should only be used for these patients after considering the risk of risk and benefits.

Use drugs for women during pregnancy and lactation

The drug is not prescribed for women. There are no studies on this drug in pregnant women.

The effect of the drug on driving and operating machinery

has no research on the ability to drive and use machines.

There have been dizzy and abnormalities in vision in clinical trials with Vardenafil, patients need to know about their body's reaction to the drug, before driving or operating machinery.

Drug interaction

The effect of other drugs on Vardenafil

In vitro studies

Vardenafil is metabolized mainly by liver enzymes through Cytochrom P450 (CYP) in conjunction 3A4 with the contribution of CYP3A5 and CYP2C. Therefore, substances that inhibit these isenzymes can reduce the clearance of Vardenafil.

In vivo studies

Use a combination of HIV Protase Indires Indinavir (800 mg, 3 times daily), a powerful CYP3A4 inhibitor, with Vardenafil (10 mg), increasing the AUC of Vardenafil 16 times and increasing CMAX of Vardenafil is 7 times. At 24 hours, Vardenafil's plasma concentration decreased to about 4% compared to CMAX.

Use a combination of Vardenafil (5 mg) with Ritonavir (600 mg, 2 times daily), increasing the cmax of Vardenafil 13 times and increasing the AUC 2 of Vardenafil 49 times. This interaction is the result of Vardenafil metabolism inhibitors in the liver by Ritonavir, a strong CYP3A4 and CYP2C9 inhibitor. Ritonavir significantly extends Vardenafil's sale time to 25.7 hours.

Use a combination of ketoconazole (200 mg), strong CYP3A4 inhibitor, with Vardenafil (5 mg) increases the AUC of Vardenafil 10 times and increases the cmax of Vardenafil 4 times.

Although specialized interactive studies have not been conducted, other powerful CYP3A4 inhibitors simultaneously (such as iTraconazole) may increase Vardenafil concentration in plasma equivalent to an increase by Ketoconazole. Vardenafil combination should be avoided with strong CYP3A4 inhibitors such as otraconazole and ketoconazole (oral). The use of a combination of vardenafil with otraconazole or ketoconazole in male patients over 75 is contraindicated.

When using Vardenafil (5 mg) in combination with erythromycin (500 mg, 3 times daily), a CYP3A4 inhibitor, increasing the AUC of Vardenafil 4 times and increases C, increasing C,. 3 times. Although there has been no specialized interaction research, the use in combination with Clarithromycin may lead to similar effects on AUC and C,. of Vardenafil. When used in combination with medium CYP3A4 inhibitors such as erythromycin or Clarithromycin, the Vardenafil dose is needed. Cimetidin (400 mg x 2 times/day), is an inhibitor inhibitors of Non -specific, no effect on AUC and CMA of Vardenafil when used in combination with Vardenafil (20 mg) for healthy volunteers.

Grapefruit juice is a weak inhibitor CYP3A4 metabolized in the intestinal wall and can increase low -level Vardenafil concentration in plasma.

The pharmacokinetics of Vardenafil (20 mg) is not affected when used at the same time with H2 Ranitidine antagonism (150 mg x 2 times/day), digoxin, warfarin, glibenclamide, alcohol (maximum alcohol content in the blood is 73 mg/dl) or single dose of antacids (magnesium hydroxide/aluminum hydroxide).

Although interactive studies have not been conducted with all drugs, population pharmacokinetics analysis shows that it does not affect Vardenafil pharmacokinetics when taking the following drugs: Acetylsalicylic acid, ACE inhibitors, Big inhibitors, weak CYP3A4 inhibitors, diuretics and medications for diabetic treatment (sulfonylires and metformins).

The influence of vardenafil on other drugs

There is no data on Vardenafil's interaction with non -specific phosphodiesterase inhibitors like theophylline or dipyridamole.

In vivo studies

There is no potential to cause hypotension of nitroglycerin under the tongue (0.4 mg), when using Vardenafil (10 mg) in different time distance (1 hour to 24 hours) before using nitroglycerin in a study in 18 healthy male subjects.

Vardenafil 20 mg increases the hypotension effect of nitroglycerin under the tongue (0.4 mg) oral 1 hour and 4 hours after using Vardenafil for healthy middle -aged people.

There is no effect on blood pressure when nitroglycerin is used 24 hours after using a single dose of Vardenafil 20 mg. However, there is no information on the ability to increase the hypotension effect of nitrates by Vardenafil in patients and thus contrary to combining.

Nicorandil is a combination of potassium and nitrate activation agents. Due to the nitrate composition, the drug has the potential to cause serious interaction with Vardenafil.

Due to the significant hypotension, especially the posture and fainting of blood pressure and fainting, interactive studies have been done with Vardenafil.

In two interactive studies in healthy volunteers with normal blood pressure after it is required to adjust the alpha tamsulosin or terazosin inhibitors to the high doses, there is a report of lowering blood pressure (in some cases of symptoms) in a large number of patients after use in combination with Vardenafil. Among patients treated with terazosin, blood pressure has been found more often when Vardenafil and Terazosin are used at the same time than when taking the drug 6 hours apart.

Based on the results of interactive studies conducted with Vardenafil in patients with benign prostatic hyperplasia (BPH) are being stable treatment with tamsulosin, terazosin or alfuzosin:

When using Vardenafil at a dose of 5, 10 or 20 mg in the context of stable treatment with Tamsulosin, there is no symptoms of hypotension even though 3/21 subjects treated with Tamsulosin have signs of systolic blood pressure when standing temporarily below 85 mmHg.

When using Vardenafil 5 mg simultaneously with Terazosin 5 or 10 mg, one of 21 patients with posture lowering blood pressure. Do not see hypotension when using Vardenafil 5 mg and terazosin 6 hours apart.

When using Vardenafil at a dose of 5 or 10 mg on the context of stable treatment with alfuzosin compared to placebo, there is no symptoms of hypotension.

Therefore, combining treatment should only be started when the patient has stabilized with Alpha inhibitors. In these patients, Vardenafil should be started with the lowest starting dose of 5 mg. This drug can be used at any time with tamsulosin or alfuzosin. For other Alpha inhibitors, it is necessary to consider using separate when used in combination with Vardenafil.

There is no significant interaction when Warfarin (25 mg), which is metabolized by CYP2C9, or Digoxin (0.375 mg) used in combination with Vardenafil (20 mg). The relative bioavailability of glibenclamid (3.5 mg) is not affected when used simultaneously with Vardenafil (20 mg). In a special study, when using Vardenafil (20 mg) with nifedipine released slowly (30 mg or 60 mg) in patients with hypertension, there is a decrease in systolic blood pressure when lying at 6 mmHg and diastolic blood pressure when lying is 5 mmHg along with an increase in heart rate of 4 times/minute.

When using Vardenafil (20 mg) with alcohol (maximum blood alcohol content of 73 mg/dl), Vardenafil does not increase the effect of alcohol on blood pressure and heart rate and does not change the pharmacokinetics of Vardenafil.

Vardenafil (10 mg) does not increase bleeding time due to acetylsalicylic acid (2x81 mg).

riociguat

Pre -clinical studies show that it reduces additional blood pressure when used in combination with PDE5 inhibitors with riociguat. In clinical studies, Riociguat has been shown to increase the hypotension of PDE5 inhibitors. There is no evidence of clinical beneficial effects of this combination in research objects. Use a combination of riociguat with PDE5 inhibitors, including Vardenafil as contraindicated.

The cavalry of the drug:

Due to the absence of studies on the correlation of the drug, not mixing this drug with other drugs.

Storage

Store at a temperature not exceeding 30 ° C in the original packaging, avoid moisture and avoid light.

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