Levina 20mg Cophavina medicine treats erectile dysfunction (1 blister x 4 tablets)

Dosage form Box of 1 blister x 4 tablets
Specifications Vardenafil

Ingredient

Composition information	Content
Vardenafil	20mg

Uses

indications

Levina drugs are indicated in the following cases:

Treatment of erectile dysfunction. When sexually stimulated, from the ends of the nerves in the cave will release nitric oxid (NO), activate the enzyme Ganylate Cylase, causing increased levels of Guanosin Monophosphate (CGMP) at the cave. This activates smooth muscle relaxation, allowing increased blood flow into the penis.

Due to PDE5 inhibiting effects, enzymes are responsible for causing CGMP divestment in the cave, Vardenafil increases the effects of endogenous NO, released in place in the cave when sexual stimulation.

Dynamic pharmacokinetics

absorption

Vardenafil is quickly absorbed by oral. Because the drug has initial metabolism through the absolute an average of 15%. The peak concentration of plasma is achieved within 30 - 120 minutes. Sediment absorption rate when Vardenafil is used in high -fat meals.

distribution

Vardenafil widely distributed in tissue. 95% Vardenafil and its main metabolites - M1 - attached to plasma proteins. This cohesion is recovery and does not depend on the total concentration of the drug.

Research on healthy volunteers shows that after 90 minutes, no more than 0.00012% of the dose of the drug appears in semen.

transformation

Vardenafil is metabolized in the liver, mainly Cytochrome P450 isoenzymes CYP3A4, such as CYP3A5 and CYP2C ISOFOFof.

In humans, the main metabolites in the M1 circulation are created from the Desethylation process at Vardenafil's Piperazine round and will continue to be metabolized during the sale period of about 4 hours.

In the circulatory system, M1 is in the form of combined with glucuronid (glucuronic acid). M1 metabolites have the same phosphodiesterase properties similar to Vardenafil and the ability to inhibit PDE5 in vitro is about 28% compared to Vardenafil, contributing about 7% of the treatment effect.

Selling waste time of M1 metabolites from 3 to 5 hours, similar to unprocessed drugs.

Elimination

The total clearance rate of Vardenafil is 56L/ hour with the sale time of about 4-5 hours.

Vardenafil is excreted mainly in feces (91 - 95%) and less than the kidneys (2 - 6%). The clearance can be reduced in the elderly and in patients with liver or renal failure.

Before taking Levina 20mg Cophavina medicine treats erectile dysfunction (1 blister x 4 tablets)

How to use

oral tablets. Take the tablet with a glass of water.

Dosage

Common doses: Used for adult men: 1 single tablet (20 mg) oral when needed about 25 - 60 minutes before sexual activity. The drug is effective from 25 minutes to 4-5 hours after drinking. Sexual stimulation is needed to have a natural treatment.

The starting time has the effect of the drug that may slow down if taking the medicine with a fat -rich meal.

The maximum recommended dose is 20 mg, 1 time/day. Drinking is not related to the meal.

Older people over 65 years: Should use lower doses.

Dosage for patients with liver failure: Based on the patient's tolerance, whether to use Levina or not.

Dosage for patients with renal impairment: No dose adjustment in mild, medium or severe kidney failure. For patients with severe renal impairment (creatinine clearance

Not for children under 18 years old.

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 do

do when using overdose? Even with single dose to 80 mg/day or multiple doses of 40 mg/day for 4 weeks are tolerated without causing serious adverse effects. When Vardenafil is used in higher and more frequent doses than the suggested dose: 40 mg films 2 times/day, recorded several severe back pain. However, there is no acknowledgment on muscles or nerves.

In case of overdose, standard support measures should be taken depending on the requirements. Diaphenuria does not increase Vardenafil clearance because the drug is highly connected to serum protein and does not eliminate much through the urine.

In case of 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 doses to compensate for missed dose.

Side Effects

When using the drug, there are common unwanted effects (ADR) such as:

The following unwanted effects have been recorded in patients using Vardenafil. For each frequency group, the unwanted effect is arranged in severity.

Meddra system (Meddra) is very common (≥ 1/10) has not met (not estimated) Translation

Allergic and angioedema Allergic reactions

Sleeping chicken

Faint

Forgot

convulsions

Hemorrhagic Eye

Coloring disorder

eye pain and discomfort

Fear of light

Interior hypertension

Anemia is not due to arteritis (NAON)

visual decline

Dizziness

tachycardia

Agina

Myocardial infarction

A tachycardia on ventricular

Breathing

Sinus congestion

Abdominal pain and digestion

Dry mouth

diarrhea

Stomach esophagus recovery

Gastritis

vomit

Redders

rash

Increase creatine phosphokinase

Increase muscle tone and cramps

muscle pain

Yang Passional pain

The myocardial infarction has been reported temporarily with the use of Vardenafil and sexual activity, but it is impossible to determine the heart attack that is directly related to Vardenafil or with sexual activity, for patient cardiovascular disease or with a combination of these factors.

Previous optic neuropathy is not caused by arteritis causing ischemic anemia that causes vision loss including permanent blindness that has been reported rare in combination with PDE5 inhibitors for a while, including Levina. The majority of these patients have risk factors for the body or the blood vessels to develop Naion, including: over 50 years old, the concave rate for low visual disks ("full disc"), diabetes, hypertension, coronary artery, hyperlipidemia and smoking.

It is not possible to confirm whether these events are directly related to the use of PDE5 inhibitors, to blood vessel risk factors or patient physical defects or combining both of these factors or the participation of other factors.

Visual disorders include visual loss (temporary or permanent) rarely seen after -sales report combined with the use of PDE5 inhibitors for a while, including Levina. It is not possible to confirm whether these events are directly related to the use of PDE5 inhibitors, to blood vessel risk factors or other factors.

Deafness or sudden hearing loss has been reported in small quantities in using PDE5 inhibitors, including Levina.

It is not possible to firmly confirm these events directly related to the use of Levina, to the risk factor that causes hearing loss, combining these factors or participating in other factors.

Notify the doctor with unwanted effects when taking the drug.

Warnings

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

contraindicated

Levina drugs contraindicated in the following cases:

Patients sensitive to any ingredients of the drug. Along with the stimulating drugs Ganyl Cyclase (riociguat)

patients with vision loss one eye with optic neuropathy due to ischemic anemia in the previous area (NAON) related or not the use of previous PDE5 inhibitors. IV). The end of the renal failure must dialysis; Hypotension (blood pressure

Be cautious when using

need to be very careful when taking the drug for patients in the following cases:

Before the beginning of the treatment of erectile dysfunction, physicians must consider the patient's cardiovascular condition, because of sexual activity related to a level of cardiovascular risk, vascular vasodilation can reduce mild and transient blood pressure. Patients with blood flow congestion of the left ventricle such as aortic stenosis or hypertrophic stenosis under the idiopathic aortic valve, may be sensitive to the effects of vasodilators including phosphodiesterase type 5 inhibitors (PDE5). Using anti -arrhythmic drugs in groups such as quinidine, processine or group III such as Amiodarone, Sotalol, anti -arrhythmic drugs or patients with congenital QT should avoid using Levina. It is easy to cause penis pain such as sickle cell anemia, multiple marrow, leukemia. Therefore, it is not recommended for combination treatment. If you suddenly reduce vision, patients should stop using Levina and consult a doctor immediately. Can be used at any time with alfuzosin or tamsulosin. With Terazosin and other alpha blockers, take the way when using Levina simultaneously. Increasing the dose of alpha blockers may be related to further reduction in patients using a PDE5 inhibitor including Levina. Save this interaction with humans.

The effect of the drug on the ability to drive and operate machinery

Do not use the drug when driving and operating machinery.

Use drugs for women during pregnancy and lactation

Do not use this drug for pregnant and lactating women. There are no Vardenafil studies on pregnant and lactating women. There is currently no data on fertility.

Drug interaction

nitrate, nitric oxidant

The hypotension effect of 0.4 mg nitrate is placed under the tongue after using Vardenafil 1 and 4 hours is enhanced by a dose of 20 mg of Levina FCT on healthy middle -aged men. Do not record this effect when using Levina 20 mg 24 hours before using nitroglycerin. However, there is no information on Vardenafil's potential to lower blood pressure when used in combination with nitrates in patients and thus contrary to combining use.

CYP inhibitors

Vardenafil is metabolized mainly through enzymes in the liver through CYP3A4, with the contribution of CYP3A5 and CYP2C -form elements. Therefore, the drug inhibit these enzymes can reduce Vardenafil clearance.

cimetidine (400 mg 2 times/day), is an inhibitor inhibitors of Non -specific Cytochrome P450, which does not work on AUC and CMAX of Vardenafil when used with Levina.

erythromycin (500 mg 3 times/day), a CYP3A4 inhibitor, increasing the AUC of Vardenafil 4 times (300%) and increasing CMAX of Vardenafil 2 times (200%) when used with Levina.

Ketoconazole (200 mg), a strong CYP3A4 inhibitor, increases the AUC of Vardenafil 10 times (900%) and increases CMAX of Vardenafil 4 times (300%) when used with Levina.

indinavir (800 mg 3 times/day), is a HIV protease inhibitor, when used with Levina 10 mg, increasing the AUC of Vardenafil 16 times (1500%) and increasing CMAX of Vardenafil 7 times (600%). After 24 -hour use, the serum concentration of Vardenafil is about 4% of the maximum Vardenafil concentration in the serum (CMAX).

Ritonavir (600 mg 2 times/day), is a HIV Protease inhibitor and strong inhibitor CYP3A4, increasing the cmax of Vardenafil 13 times, and increasing ACO - 24 of Vardenafil 49 times when used with Levina. Ritonavir significantly lasts the half -life of Levina to 25.7 hours.

Alpha blockers

Because single -therapy alpha blockers can reduce blood pressure significantly, especially posture and fainting blood pressure, many interactive studies with Levina have been conducted.

Hypotension in some cases of symptoms, recorded in some significant cases when used in combination with Levina tablets for healthy volunteers with normal normal blood pressure for 14 days or less for high -dose alpha tamsulosin or terazosin.

When Levina 20mg tablets are given in a stable treatment context with Tamsulosin, it does not cause clinical maximum loss of blood pressure on clinically. Use Levina with Tamsulosin or 6 hours after taking Tamsulosin, all appear cases of patients with systolic blood pressure in a vertical position decreasing

Among those treated with terazosin, hypotension (hydrocelinary blood pressure with a vertical posture

3 Research on drug interaction is also conducted with Levina tablets in patients with prostate hypertrophy (BPH) being stable treatment with alpha blockers including alfuzosin, tamsulosin or terazosin.

Take Levina 4 hours after drinking alfuzosin. About the 4 -hour dose selected to suggest maximum interaction possible. There is no maximum maximum medium clinical blood pressure decrease over 10 hours after taking Levina tablets 4 hours after taking alfuzosin. There are cases where patients with decreased systolic blood pressure from the original> 30 mmHg but there are no cases of heart blood pressure collection of vertical posture

The next research in patients with BPH, using levina with tamsulosin 0.4 or 0.8 mg has no cases of centrifugal blood pressure that decreases

When using Levina in combination with Terazosin 5 or 10 mg, causing hypotension in the patient. If using levina 6 hours after using terazosin, there is no case of lowering blood pressure. These results should be used to consider the distance between doses. In both this study and previous research with alfuzosin or terazosin, there was no case of atrial fibrillation.

It should only start treating Levina when the patient has stable treatment with Alpha blockers, which should start at the lowest dose. Levina can be used at any time when used with alfuzosin or tamsulosin. With Terazosin and other alpha blockers, it is necessary to consider the dose division between the drugs when treated with Levina.

In patients taking the optimal dose of Levina, treating with alpha blockers should start at the lowest dose.

Increasing the dose of alpha blockers may be related to further blood pressure loss in patients who are taking PDE5 inhibitors including Levina.

Other drugs

There is no pharmacokinetic interaction when using Levina in patients using 0.375 mg Digoxin, in a stable condition, 14 days away. There is no complications of pharmacokinetic transformation of Vardenafil due to simultaneous use with digoxin.

A single dose of antacids; Magnesium hydroxide/aluminum hydroxide does not change AUC or maximum cmax concentration of Vardenafil.

Concomitance H2 Ranitidine receptor antagonist 150 mg twice a day does not change the bioavailability of Vardenafil 20 mg.

Levina does not affect the bleeding time when used alone or in combination with acetylsalicylic acid (2 x tablets 81mg).

Levina does not cause the hypotension effect of Alcohol at a dose of 0.5 g/kg of weight that is likely to occur. Vardenafil's pharmacokinetics are not affected.

Survey of pharmacokinetic data in the population in phase III research shows that there is no significant effect of acetylsalicylic acid, enzyme inhibitors, beta blockers, CYP3A4 weak inhibitors, diuretics and diabetes treatment drugs, sulfonylumpea and metformin, on the pharmacokinetics of Vardenafil.

When using Levina 20mg simultaneously with Glibenclamide 3.5 mg, Glyburide, the relative bioavailability of glibenclamide is not affected. There is no evidence of Vardenafil's pharmacokinetics that are changed when used with glibenclamide.

There is no pharmacological interaction such as prothrombin and coagulation factors II, VII and X when using Warfarin 25 mg simultaneously with 20 mg Levina tablets. Vardenafil's pharmacokinetics are not affected when used with warfarin.

There is no significant interaction about pharmacokinetic or pharmacokinetic when using Levina simultaneously with Nifedipine 30 or 60 mg. Compared to the placebo, Levina reduces blood pressure by an additional 5.9 mmHg and 5.2 mmHg for systolic and diastolic blood pressure in the lying position, in order).

Storage

Leave a cool place, avoid light, temperature below 30⁰C.

To be out of reach of children, read the user manual carefully before use.

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