Rocla 50 Fremed drugs treat erectile dysfunction (1 blister x 4 tablets)

Dosage form Box of 1 blister x 4 tablets
Specifications Sildenafil

Ingredient

Composition information	Content
Sildenafil	50mg

Uses

indications

Rocla 50 drugs indicated treatment in the following cases:

Sildenafil is used to treat erectile dysfunction, which is the inability to achieve or maintain an erection enough to satisfy sexual activity. Drugs to treat erectile dysfunction.

ATC code: G04b E03.

Sildenafil is in the form of Sildenafil Citrate salt, orally orally to treat erectile dysfunction. Sildenafil has a selective inhibitory effect on Guanosine monophosphate (CGMP -CYCLIC GUANOSINE MONHOSPHATE) - Phosphodiesterase specific type 5 (PDE5).

Mechanism of action

The penis physiological mechanism leads to the release of nitric oxide (NO) in the cave in the process of sexual stimulation.

Then NO activated the Ganylate Cyclase enzyme, this enzyme increases the concentration of CGMP thereby relaxing the blood vessel smooth muscle of the cave and allows blood flow to flow.

Sildenafil has no direct relaxation effect on human isolation, but it increases the effect of NO by inhibiting PDE5, this substance has the effect of decomposing CGMP in the cave.

When stimulating sex, creating a NO release on the spot, Sildenafil's PDE5 inhibitors will increase the amount of CGMP in the cave, the result of smooth muscle relaxation and increase blood flow to the cave.

In the recommended dose, Sildenafil only works when there is an accompanying sexual stimulation.

In vitro studies show that Sildenafil selectively inhibits PDE5.

The effect of Sildenafil selected on PDE5 is stronger than other known phosphodiesterase (10 times higher for PDE6,> 80 times for PDE1,> 700 times for PDE2, PDE3, PDE4 and PDE7-PDE11).

Selective effect on PDE5 is 4,000 times stronger than PDE3, this is very important because PDE3 is an enzyme associated with heart contraction.

Clinical studies

There is no clinical change on the ECG (ECG) of normal volunteers when using Sildenafil single doses up to 100 mg oral.

After using a 100 mg dose, the systolic blood pressure decreased by an average of 8.3 mmHg and the diastolic blood pressure decreased by the average of 5.3 mmHg (measured in the lying position).

The effects on blood pressure on people who are using nitrate more at the same time are also fleeting.

Research on hemodynamics on 14 patients with severe coronary artery disease (> 70% at least 1 coronary artery) is used for a single dose of 100 mg of Siidenafil, which is found that systolic and diastolic blood pressure decreases by 7% and 6% compared to the blood pressure before taking the drug. The average pulmonary systolic blood pressure decreases by 9%.

Sildenafil does not affect the heart supply and does not affect the flow through narrow coronary arteries, and creates improvement (about 13%) in reversing the artery flow stimulated by adenosine (in both narrow arteries and related arteries).

Double clinical clinical trial has a placebo over 144 patients with erectile dysfunction and stable angina. These patients take anti -angina drugs regularly (except for nitrate). They have to work hard to the limit of angina. In patients with a single dose of 100 mg of Sildenafil, the milling time is longer (19.9 seconds; 95%confidence interval: 0.9 - 38.9 seconds) (statistical significance) compared to patients with placebo.

Average effort (adjusted with basic levels) to the limit of angina is 423.6 seconds in Sildenafil users and 403.7 seconds in placebo users.

Randomly blind study, with a placebo (with a change of Sildenafil, up to 100 mg) on 568 men with erectile dysfunction and hypertension.

These patients always have to use at least two anti -hypertension drugs. Sildenafil results improves 71% erection in Sildenafil users compared to 18% in placebo users. Successful intercourse rate in Sildenafil users 62% compared to 26% in placebo users. The rate of unwanted effects in these patients is similar to other patients, as well as not changing in users 3 or more anti -hypertension drugs.

Smart

Differences in distinguishing light and transient colors (blue/green) were discovered in some cases using test Farnsworth - Munsell 100 Hue after 60 minutes when taking a dose of 100 mg, and after 120 minutes there was no proven effect. The main mechanism of distinctive change changes related to PDE6 inhibitors. This enzyme is abundant in the retina. In vitro studies show that Sildenafil inhibits PDE6 10 times less than PDE5. Sildenafil has no influence on the flexibility of vision, contrast sensitivity, retinal electro, pressure in the eyes or measuring pupils.

In a controlled cross -cutting study in patients with gold spot degeneration related to age (n = 9), Sildenafil (single dose of 100 mg) is well tolerated and there is no clinical effect on vision tests (vision flexibility, amsler, distinguishing color, traffic light signals, Humphrey market).

Effectiveness

Sildenafil's effectiveness and safety are assessed in 21 randomly blind clinical trials with placebo over 6 months. Over 3,000 patients with erectile dysfunction (19 - 87 years old) in all forms (organized by the agency, psychological, mixed form) are used for Sildenafil. The effectiveness of Sildenafil is assessed by general review questions, erectile diaries, international IIF (International Index of Erectile Function), and questions for patients' sex partners.

The effect of Sildenafil is the ability to achieve and maintain an erection enough to conduct intercourse. This effect has been shown through all 21 studies and was maintained through extended extended studies (over 1 year). In fixed dose studies, erection improvement rate is 62% (with 25 mg Sildenafil dose), 74% (with 50 mg Sildenafil dose) and 82% (with 100 mg Sildenafil dose) compared to 25% in the placebo group. In addition to improving erection, Sildenafil also improves pleasure, satisfaction when intercourse and general satisfaction.

Through tests that:

In patients with diabetes, Sildenafil's erection improvement rate is 59% compared to 16% in placebo users.

In patients with thorough prostate cutting, this rate is 43% compared to 15% in placebo users.

In patients with spinal injuries, this rate is 83% compared to 12% in placebo users.

Dynamic pharmacokinetics

Sildenafil pharmacokinetics corresponding to the dose in the recommended dose range.

Sildenafil is metabolized in the liver (mainly through Cytochrome P450 3A4) and its metabolites have the same activity as the mother (Sildenafil).

absorption

Sildenafil is quickly absorbed after drinking, with absolute bioavailability of about 41% (ranging from 25% - 63%).

On In vitro, the concentration of 3.5 nm Sildenafil inhibits the PDE5 enzyme of about 50%.

In humans, the maximum free Sildenafil concentration after the single dose of 100 mg is approximately 18 ng/ml or 38 nm.

The maximum concentrations achieved in plasma from 30 - 120 minutes (60 minutes on average) are observed when taking the drug when hungry.

high fat foods reduces Sildenafil's absorption capacity, with an average decrease in TMAX by 60 minutes, and CMAX decreases an average of 29%, on the contrary, the absorption level does not affect significantly (AUC decreased by 11%).

distribution

The average distribution of Sildenafil is 105 I, showing the distribution mainly to tissues.

Sildenafil and the metabolites in its large circulatory round are N-Desmethyl mounted up to 96% to plasma proteins. The attachment to plasma protein does not depend on its total concentration.

transformation

Sildenafil is metabolized mainly by CYP3A4 enzyme (main line) and CYP2C9 (sub -line) in the liver.

The metabolites in the main metabolic ring of Sildenafil are created from the n-demethylation process, and then continue to be metabolized again.

This metabolic substance has a selective activity for phosphodiesterase similar to Sildenafil and on in vitro, selective for PDE5 is approximately 50% of the mother chat.

In healthy volunteers, the plasma concentration of these metabolites is approximately 40% of the mother concentration.

N-Desmethyl metabolites are continued to be metabolized, half-life eliminated about 4 hours.

Elimination

Sildenafil's clearance is 41 I/hour with the last half phase time of 3-5 hours.

After oral or intravenous use, Sildenafil is excreted mainly in the form of metabolites (about 80% of oral doses) and a small part through urine (about 13% of oral dose).

pharmacokinetics in special patients

Older people

On healthy elderly people (aged 65 and older), Sildenafil's clearance decreases, resulting in Sildenafil concentration and N -Desmethyl activity in plasma is about 90% higher than the concentration of these substances in healthy young volunteers (from 18 to 45 years old). Due to the cohesion of Sildenafil on plasma proteins depending on the age, the free concentration of Sildenafil in plasma increased by about 40%.

Renal failure

On people with mild kidney failure (clearine clearance 50 - 80 ml/min) or medium (clearine clearine 30 - 49 ml/min), when using a single dose of Sildenafil (50 mg), there is no change in pharmacokinetics.

On people with severe renal failure (Creatinine clearance ≤ 30 ml/minute), Sildenafil's clearance has been reduced, which has doubled the area under the AUC curve (100%) and CMAX (88%) compared to people at the same age but no kidney failure.

In addition, the values of CMAX and AUC of N-Desmethyl metabolites increase by 200% and 79% in the objects of severe renal failure compared to those with normal kidney function.

People with liver failure

On people with cirrhosis (Child-Pugh A, Child-Pugh B), Sildenafil's clearance is reduced, the result increases AUC (85%) and CMAX (47%) compared to people without liver failure at the same age. Sildenafil's pharmacokinetics in patients with severe liver failure (Child-Pugh C) has not been studied.

Clinical safety data

There is no evidence of the likelihood of cancer in a research on a mice that lasts 24 months using 42 times larger doses (calculated by mg/kg) and nearly 5 times (by mg/m2) compared to the maximum dose recommended on human use (Maximum Recommended Human Dose - MRDH) and another study in the mouse that lasts 18 - 21 months with a dose of 21 times (calculated by Mg/kg) Compared to the maximum dosage in the recommended person.

Seagling tests in bacteria and in vivo are negative.

There is no effect on the movement and morphology of sperm after using a single dose of 100 mg Sildenafil on healthy volunteers.

Before taking Rocla 50 Fremed drugs treat erectile dysfunction (1 blister x 4 tablets)

How to use

Rocla 50 drugs for oral.

Dosage

adults

Most patients are recommended to take a dose of 50 mg when needed, oral before sex about 1 hour.

Based on the tolerance and effect of the drug, the dose may increase to a maximum of 100 mg or decrease to 25 mg. The maximum recommended dose is 100 mg, the maximum number of times is 1 time per day.

Patients with renal failure

Cases of mild or medium renal failure (Creatinine clearance 30 - 80 ml/minute): No dose adjustment.

Cases of severe renal failure (Creatinine clearance

Patients with liver failure

The dose to be used is 25 mg because the clearance of Sildenafil is reduced in these patients (for example, cirrhosis).

Patients taking other drugs

Based on the degree of interaction in patients taking Sildenafil simultaneously with Ritonavir, it should not exceed a maximum single dose of 25 mg Sildenafil within 48 hours.

Patients who are taking drugs inhibit CYP3A4 (eg Erythromycin, Saquinavir, Ketoconazole, Itraconazole), the starting dose should be used as 25 mg.

To limit the risk of posture hypotension during treatment, patients should be stable treatment when taking alpha blockers before starting treatment with Sildenafil.

In addition, it is advisable to consider using lower sildenafil doses at the beginning of treatment.

Children

Do not use Sildenafil for children under 18 years old.

Elderly

No dose adjustment.

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 overdose?

In case of overdose, it is necessary to use appropriate support measures.

Kidney fertilizer does not increase clearance because Sildenafil is strongly connected to plasma proteins and is not eliminated through urine.

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

What to do when forgetting 1 dose?

Side Effects

Overall, unwanted effects are only fleeting, light or medium.

In fixed dose studies, the frequency of some complications increased by the dose.

Studies with fixed dose reflect more closely than the recommended dose regime. The nature of unwanted effects in these studies is similar to that of studies with fixed doses.

The most commonly reported effects are headaches and blushing.

Classification by agency system

nervous system disorders headache dizzy drowsiness epilepsy*, recurrent epilepsy*, fainting eye disorders Light, dizziness, dysliages, eye congestion, dazzling eye edema, swelling of the eyes, dry eyes, eye strain, dazzling, yellow, redness, eye disorders, conjunctival congestion, eye irritation, eye abnormal feeling, eyelid edema breasts Sinuses throat spasms, nasal dryness, nose edema DA

Unwanted erections*, Increase erections

With a larger dose than the recommended dose, the unwanted effects are still the effects listed above, but in general, it will be more encountered.

Through analysis of mesame double blind clinical trials, more than 700 people see any difference between the two groups in terms of heart attack rate and cardiovascular mortality rate. For both groups, the rate of myocardial infarction is 1.1 over 100 people every year, while the cardiovascular mortality rate is 0.3 per 100 people every year.

Notice immediately to the doctor or pharmacist the harmful reactions encountered when using the drug.

Warnings

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

contraindicated

Rocla 50 drugs contraindicated in the following cases:

contraindicated Sildenafil for patients allergies to any ingredients of the drug. Therefore, contraindicated use of Sildenafil for patients who are using nitric oxide suppliers, organic nitrate or organic nitrite in any form, whether regular or interrupted. evidence.

Caution when using

must exploit prehistoric and meticulous clinical examination to diagnose erectile dysfunction, to identify potential causes and determine appropriate treatment.

Because there may be some cardiovascular risks related to sexual activity, the doctor must pay attention to the patient's cardiovascular condition before conducting erectile dysfunction treatment.

Do not use erectile dysfunction drugs in men are recommended not to be sexually active.

Serious cardiovascular events include myocardial infarction, sudden death related to heart disease, ventricular arrhythmia, cerebral hemorrhage and transient ischemic anemia have been reported during the circulation of using Sildenafil to treat erectile dysfunction. Mostly but not all these patients have a history of cardiovascular risk factors. Many of these events were reported in or immediately after sexual activity, and a few events were reported immediately after using Sildenafil without sexual activity. Other events reported from a few hours to several days after using Sildenafil and having sex. It is impossible to identify whether these events are directly related to Sildenafil, sexual activity, patients with cardiovascular disease, a combination of these factors or other factors.

Some clinical trials show that Sildenafil has a systemic vasodilation property that causes fleeting hypotension. For most patients, it has very little or no effect. However, before prescribing, the doctor must pay attention to patients with pathological conditions that may be affected by this effect and especially when there is more sexual activity. Patients who hinder left ventricular flow (e.g. aortic stenosis, hypertrophic cardiomyopathy) or synthetic syndrome of multiple systems are patients with hyperactive hyperplasia, manifested by a serious decline in the ability to control blood pressure automatically, those who need to consider treatment.

Non -artery anemia neuropathy (Naion), a rare disease and is the cause of vision loss or vision loss, is rare in the circulation process when used with phosphodiesterase inhibitors in group 5 (PDE5), including Sildenafil.

Most of these patients have risk factors such as low visual cup ratio compared to visual disks (increased visual discs), over 50 years old, diabetes, hypertension, coronary artery disease, high blood lipids and smoking. An observation study assesses whether the use of PDE5 inhibitors, as a group of drugs, is related to the Naion acute onset. The results suggested that the risk of deion nearly doubled within 5 semi -excreted cycles of PDE5 inhibitors used. Based on the published literature, the annual new incidence of Naion is 2.5 - 11.8 cases per 100,000 men aged ≥ 50 every year in the general population. In case of sudden loss of vision, it is necessary to advise patients to stop using Sildenafil and consult a doctor immediately.

People who have had Naion have a higher risk of deaion recurrence. Therefore, doctors need to discuss with such patients about this risk and whether they are adversely affected if using PDE5 inhibitors. PDE5 inhibitors, including Sildenafil, should be used carefully in these patients and only if the expected benefits are superior to the risk.

Be careful when prescribing Sildenafil for patients who are taking alpha blockers as indicators can lead to symptomic hypotension in sensitive patients. To limit the risk of posture hypotension, patients should treat hemodynamic stability when taking alpha blockers before starting sildenafil therapy. Sildenafil should be considered at low doses. In addition, doctors need to guide patients on what to do in case of symptoms of posture hypotension.

A few patients with pigmentation retinitis have phosphodiesterase gene disorders in the retina, need to be cautious when treating Sildenafil in these patients because there is no safety evidence.

Introeted in vitro studies show that Sildenafil has a influence on the platelet conduction resistance of Sodium Nitropruside (substance for nitric oxide). There is currently no safety information about the use of Sildenafil in patients with blood clotting or acute digestive ulcers, so be cautious in these patients.

Be careful when prescribing erectile dysfunction drugs for patients with deformations of penis anatomy (such as an angle folding penis, cavity fibrosis or Peyronie disease), patients with pathological diseases that cause penis pain (such as sickle cellular anemia, multiple myeloma, leukemia).

There have been reports on prolonged erection and unwanted erection when using Sildenafil after the drug is circulated. In the case of erects that lasted more than 4 hours, patients need medical facilities for immediate treatment. If the erection is not treated immediately, it can lead to the penis tissue destroyed and impossible permanently.

Safety and effectiveness of using Sildenafil combining with other PDE5 inhibitors, medications for pulmonary hypertension containing Sildenafil or other erectile dysfunction drugs that have not been studied, so Sildenafil should not be used with these drugs.

Sudden reduction or loss of hearing has been reported in a small number of cases using PDE5 inhibitors, including Sildenafil in clinical trials and after circulation. Most patients have risk factors for sudden reduction in hearing or loss. The causal relationship between the use of PDE5 inhibitors and the loss or loss of hearing suddenly. Trong trường hợp bị giảm hay mất thính lực đột ngột, bệnh nhân được khuyên nên ngừng uống sildenafil và khám bác sỹ ngay lập tức.

The effect of the drug on driving and operating machinery

There is no evidence of the effect of the drug on the ability to drive and operate machinery.

Dizziness and vision change have been reported in clinical trials with Sildenafil, so patients need to know how they react to Sildenafil before driving or operating machinery.

Using drugs for women during pregnancy and lactation

Do not use Sildenafil for women.

Research on rats and rabbits after taking oral Sildenafil, no evidence of teratogenicity, reduced fertility, or adverse effects for embryo and fetal development.

There are no adequate and appropriate studies on pregnant and lactating women.

Drug interaction

The effect of other drugs on Sildenafil

In vitro studies

Sildenafil is metabolized mainly by Cytochrome P450 (CYP) group 3A4 (main road) and 2C9 (sub -line). Therefore, all the inhibiting agents of these isenzymes can reduce the clearance of Sildenafil and the induction agents of these isenzyme may increase Sildenafil's clearance.

In vivo studies

Pharmacokinetic analysis through clinical test data shows that when using Sildenafil simultaneously with CYP3A4 inhibiting agents (such as ketoconazole, erythromycin, cimetidine) will reduce Sildenafil's clearance.

cimetidine (800 mg), a Cytochrome P450 inhibitor and non -specific inhibitor CYP3A4, when used simultaneously with Sildenafil (50 mg) will increase Sildenafil's concentration in plasma to 56% of healthy volunteers.

erythromycin (500 mg, used 2 times/day for 5 days) is an average inhibitor agent CYP3A4, when used simultaneously with a single dose of 100 mg Sildenafil, increasing the area under the curve (AUC) of Sildenafil up to 182%. In addition, the simultaneous use of a single dose of 100 mg Sildenafil with the protease inhibitors of HIVinavir (1,200 mg used 3 times/day), this is also a CYP3A4 inhibitor, increasing Sildenafil's CMAX to 140% and increasing AUC to 210%. Sildenafil has no effect on the pharmacokinetics of Saquinavir. The more powerful CYP3A4 inhibitors such as ketoconazole and iTraconazole

Single -dose of 100 mg Sildenafil with strong stricthumidios P450 as HIV Ritonavir's Protease inhibitors (500 mg, 2 times/day) increases Sildenafil's CMAX by 300% (4 times) and increases AUC in plasma by 1,000% (11 times).

After 24 hours of taking the drug, Sildenafil's concentration in plasma is still approximately 200 µg/ml compared to 5 ng/mL when using Sildenafil alone. This is consistent with the obvious effect of Ritonavir on the substrates of P450. Sildenafil has no effect on the pharmacokinetics of Ritonavir.

When using Sildenafil at the recommended dose for patients who are treating agents capable of inhibiting CYP3A4, the maximum free Sildenafil concentration in plasma does not exceed 200 nm and well -tolerated. Single dose of antacids (magnesium hydroxide, aluminum hydroxide does not affect the bioavailability of sildenafil.

In a study on healthy male volunteers, the simultaneous use of endothelin and bosentan antagonists (average CYP3A4 touch substance, CYP2C9 and maybe CYP2C19) in a stable state (125 mg, 2 times/day) with Sildenafil in a stable state (80 mg, 3 times/day) leading to the reduction of AUC and CMAX of SIildenfil is 62.6% and 55.4%. Sildenafil increases the AUC and CMAX of Bosentan, respectively 49.8% and 42%. Concentrated with strong CYP3A4 induction substances like Rifampin is expected to reduce sildenafil levels in plasma.

Dynamic pharmacokinetic data in clinical trials shows that the agents inhibit CYP2C9 (such as Tolbutamide, Warfarin), CYP2D6 inhibitors (such as Serotonin Selective Inhibitors, Serotonin, 3 -ring anti -depression drugs), Thiazide diuretics, Angiotensin (ACE) enzyme inhibitors and Calcium channels that do not affect Calci Sildenafil.

On healthy volunteers, there is no influence of azithromycin (500 mg/day for 3 days) to AUC, CMAX, Tmax, Sildenafil's exhaust rate, and its main metabolites.

The influence of Sildenafil on other drugs

In vitro studies

Sildenafil is a weak inhibitor agent of Cytochrome P450 subgroup 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 (IC50> 150 µm).

Because after the recommended dose, the peak concentration of Sildenafil's plasma is approximately 1 µm, so Sildenafil will not change the clearance of the substrates of these ISOENZYMs.

In vivo studies

Sildenafil has been shown to be able to increase the hypotension of acute and chronic nitrate. Therefore, contraindicated use of Sildenafil along with substances for nitric oxide, organic nitrates or organic nitrite in any form, whether regular or interrupted.

In three specific studies on drug interaction, drugs, Alpha Doxazosin (4 mg and 8 mg) and Sildenafil (25 mg, 50 mg or 100 mg) are indicated for patients with prostate healing tumors stable with doxazosin. In these research subjects, the average additional reduction of blood pressure measured in an average back position is 7/7 mmHg, 9/5 mmHg, 8/4 mmHg and the average additional reduction of blood pressure measured in the vertical position is 6/6 mmHg, 11/4 mmHg, 4/5 mmHg. When simultaneously indicated Sildenafil and Doxazosin on patients are being stable treatment with doxazosin, few reports on cases of posture lowering blood pressure. These reports include dizziness and fatigue but not accompanied by fainting. Sildenafil simultaneous indications for patients who are taking alpha blockers can lead to symptomic hypotension in some sensitive patients.

There is no meaning when using simultaneously Sildenafil (50 mg) with Tolbutamide (250 mg) or Warfarin (40 mg) (are substances metabolized by CYP2C9).

Sildenafil (100 mg) does not affect the pharmacokinetics of HIV's protease inhibitors such as Ritonavir and Saquinavir (both of these drugs are the substrate of CYP3A4).

Sildenafil in a stable state (80 mg, 3 times/day) increased 49.8% of Bosentan's AUC and increased by 42% CMAX of Bosentan (125 mg, 2 times/day).

Sildenafil (50 mg) does not increase the time of Aspirin bleeding (150 mg).

Sildenafil (50 mg) does not increase the hypotension effect of alcohol on healthy volunteers with an average maximum concentration of 0.08% (80 mg/dL).

There is no meaning between Sildenafil (100 mg) and amlodipine in hypertension patients (in the back position only lowering 8 mmHg blood pressure for systolic blood pressure and 7 mmHg for diastolic blood pressure).

Analysis based on safety data shows that there is no difference in unwanted effects in patients who use and do not use Sildenafil simultaneously with lowering blood pressure drugs.

Storage

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

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