Siloflam 100 Flamingo medicine for erectile dysfunction (1 blister x 4 tablets)

Be cautious when using

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

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

Cardiovascular risk factors

Before starting any erectile dysfunction, the doctor pays attention to the patient's cardiovascular condition because there may be some cardiovascular risks related to sexual activity. Sildenafil has vasodilator properties, leading to mild and transient hypotension.

Serious cardiovascular events include myocardial infarction, sudden death related to heart disease, ventricular arrhythmia, cerebral hemorrhage and transient ischemic anemia reported during the circulation using Sildenafil to treat erectile dysfunction. Most but not all these patients have a history of cardiovascular risk factors.

Sildenafil increases the hypotension effect of nitrate.

Many of these events are reported in or immediately after sexual activity, and a few events are 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 determine whether these events are directly related to Sildenafil, sexual activity, patients who are cardiovascular disease, a combination of these factors or other factors.

Some clinical trials show that Sildenafil has a systemic vasodilation property that causes transient hypotension. For most patients, it has very little or no effect. However, before prescribing, physicians must pay attention to patients with pathological conditions that may be affected by this effect and especially when they have more sexual activity.

Patients who hinder the left ventricular flow (for example, aortic stenosis, obstructive hypertrophy) or a multi -system syndrome of multiple system atrophy are patients with hyperactive hyperplasia, manifested by a serious decline in the ability to control blood pressure automatically, those who need to consider treatment.

impact on vision

Cases of patients with ischemic optic neuropathy (Naion), a rare condition, related to the use of Sildenafil and other PDE5 inhibitors have been reported.

Most of these patients have risk factors such as low visual cup ratio compared to visual disks ("increased visual disk"), over 50 years old, diabetes, high blood pressure, coronary artery disease, high blood lipids and smoking.

A observation study evaluated whether the recent use of PDE5 inhibitors, like a group of drugs, is involved in the urgency onset of Naion. The results are suggested that the risk of deion has nearly doubled within 5 semi -waste cycles of PDE5 inhibitors used.

Based on the published literature, Naion's annual new incidence is 2.5-11.8 shifts 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.

The person who has been sick in the risk of deaion recurrence increases. So 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.

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

Simultaneous use with alpha blockers

Be careful when prescribing Sildenafil for patients who are taking alpha blockers because they use simultaneously can lead to symptomic hypotension in sensitive patients. This usually happens within 4 hours after using Sildenafil.

To limit the risk of posture hypotension, patients should be treated with hemodynamic stability with alpha blockers before starting sildenafil therapy. Sildenafil treatment should be considered at low doses at a dose of 25 mg. In addition, the doctor should advise patients to do what to do in case of posture hypotension symptoms.

affect bleeding

In vitro studies on human platelets show that Sildenafil has an influence on platelet condenser resistance of sodium nitroprussid (nitric oxid). There is currently no safety information about the use of Sildenafil in patients with clotting disorders or gastrointestinal ulcers at the provincial level, so be cautious in these patients.

Penis pain

Be cautious when prescribing erectile dysfunction drugs, including Sildenafil, for patients with deformation of penis anatomy (such as an angle folding penis, cavity fibrosis or Peyronie), or in patients with diseases that can cause penis pain (such as sickle blood cell anemia, multiple marrow or 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.

Simultaneously used with other PDE5 inhibitors or other erectile dysfunctions

Safety and effectiveness of using Sildenafil combining with other PDE5 inhibitors or medications for pulmonary hypertension (PAH) contains Sildenafil (Revatio) or other non -studied erectile dysfunction drugs, so it should not be combined 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 of these patients have risk factors for sudden reduction in hearing or loss.

There is no cause of causal relationship between the use of PDE5 inhibitors and a sudden reduction or hearing bile. In the event of a sudden reduction of hearing or loss of hearing, the patient is advised to stop taking Sildenafil and see a doctor immediately.

Use simultaneously with ritonavir

Do not use Sildenafil simultaneously with ritonavir.

Women

Sildenafil is not indicated for women.

The ability to drive and operate machinery

Sildenafil may have a slight impact on driving and operating machinery. The dizziness and vision change has been reported in clinical trials with Sildenafil. Therefore, patients need to know how they react to Sildenafil before driving or operating machinery.

Pregnancy

Do not use Sildenafil for women. Research on rats and rabbits after taking oral Sildenafil. No evidence of teratogenicity, reducing fertility, or adverse effects for embryo and fetal development.

breastfeeding period

Do not use Sildenafil for breastfeeding women.

Interactive drug

The effect of other drugs on Sildenafil

In vitro studies:

Sildenafil metabolism takes place mainly by cytochrom P450 (CYP) subgroups form 3a4 (main road) and 2C9 (sub -line). Therefore, all agents that inhibit these subgroups can reduce the clearance of Sildenafil and its stimulating agents that can increase Sildenafil's clearance.

In vivo studies:

Mobile pharmacokinetic analysis through clinical test data shows that when using Sildenafil simultaneously with CYP3A4 inhibitors (such as ketoconazol, erythromycin, cimetidin) will reduce Sildenafil's clearance. Although there is no increase in adverse cases in these patients, it should start at a dose of 25 mg when Sildenafil is simultaneously used with CYP3A4 inhibitors.

cimetidine (800 mg), a Cytochrom P450 inhibitor and non -specific inhibitor CYP3A4, when used simultaneously with Sildenafil (50 mg) will increase the concentration of sildenafil 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 Sildenafil curve (AUC) up to 182%.

In addition, simultaneously using a single dose of 100mg Sildenafil with the protease inhibitor of HIVinavir (1200 mg used 3 times/day), this is also a CYP3A4 inhibitor, increasing Sildenafil's CMAX up to 140% and increasing AUC to 210%. Sildenafil has no effect on Saquinavir's pharmacokinetics.

The more powerful CYP3A4 inhibiting agents such as ketoconazole and iTraconazole will also have greater effects, simultaneous use of a single dose of 100 mg Sildenafil with the protease inhibitor of HIV Ritonavir (500 mg, use 2 times/day), a powerful P450 inhibitor, increasing Sildenafil's CMAX to 300% (folding 4 times) and increasing AUC in soy sauce to 1000% (folding up to 1000% ( 11 times).

The time 24 hours after taking the drug, Sildenafil's concentration in plasma is still approximately 200 ng/ml compared to 5 ng/ml when using Sildenafil alone. This is consistent with the obvious effect of Ritonavir on the substrates of the P450, Sildenafil had no effect on Ritonavir's pharmacokinetics. Based on these pharmacokinetic results, Sildenafil should not be used simultaneously with Ritonavir and in any case, Sildenafil's maximum dose does not exceed 25 mg within 48 hours.

When using Sildenafil at the recommended dose for patients who are being treated with agents that can inhibit CYP3A4, the maximum free Sildenafil concentration in plasma does not exceed 200 nm and are well tolerated.

Single dose of antacids (Magnesi hydroxid, aluminum hydroxid) does not affect the bioavailability of Sildenafil.

In a healthy male volunteer study, the simultaneous use of endothelin and bosentan antagonists, (an average CYP3A4 (average), CYP2C9 and maybe CYP2C19) in a stable state (125 mg, 2 times/day) with Sildenafil in a stable state (80 mg, 3 times/day), resulting in reduction 62.6% and 55.4%. Concentrated with strong CYP3A4 touch substances, like Rifampin, is expected to reduce sildenafil levels in plasma.

Dynamic data in clinical trials shows that CYP2C9 inhibiting agents (such as Tolbutamid, Warfarin, Phenytoin), CYP2D6 inhibitors (such as selective reconfacided inhibitors Serotonin, 3 -ring anti -depressive drugs), ureter, enzyme inhibitors transferring angiotensin (ACE) and cases to Sildenafil's pharmacokinetics.

On healthy men who do not see any influence of azithromycin (500 mg/day for 3 days) to the scope, CMAX, TMAX, Sildenafil's exhaust rate, and its metabolic duration.

Grapefruit juice is a weak inhibitor of CYP3A4 metabolism in the intestinal wall and may increase the Sildenafil concentration in plasma. Nicorandil is a mixture of potassium and nitrate channel activation. Nitrate component can lead to serious interaction between Nicorandil and Sildenafil.

In vitro studies:

Sildenafil is a weak inhibiting factor of Cytocrom P450 subgroups 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 (IC50> 150µm). Because after the recommended dose, the plasma concentration of Sildenafil is approximately 1 µm, so Sildenafil will not change the clearance of the substrates of these isenzymes. There is no data on Sildenafil's interaction and non -specific phosphodiesterase inhibitors like theophylin or dipyridamol.

In vivo studies:

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

SILTHAFIL use for patients who are taking alpha blockers can lead to symptomic hypotension in some sensitive people. This is most likely to happen within 4 hours after using Sildenafil.

In 3 specific studies on interactive drugs of Chen Alpha drugs, the inductance of Doxazosin (4 mg and 8 mg) and Sildenafil (25 mg, 50 g, or 100 mg) are indicated for patients with prostate healing tumors stable with DOXAZOSIN. Observing these researchers, the average additional reduction of blood pressure measured in the back position is 7/7 mmHg, 9/5 mmHg, and 8/4 mmHg and the average additional reduction of measured blood pressure in the vertical position is 6/6 mmHg, 11/4 mmHg, and 4/5 mmHg.

When indicated simultaneously Sildenafil and Doxazosin on patients are being treated stably with doxazosin, few reports on patients with symptomic posture. These reports include dizziness and fatigue, but not fainting.

There is no significant interaction when indicated simultaneously Sildenafil (50 mg) with Tolbutamid (250 mg) or warfarin (40 mg) (substances metabolized by CYP2C9).

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

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 significant interaction between Sildenafil (100 mg) and amlodipine in hypertension patients (in the back position only lower 8 mmHg for systolic blood pressure and 7mmHg for diastolic blood pressure).

Analysis based on safety data indicates that there is no difference in unwanted effects in patients using and not using Sildenafil simultaneously with hypertension medications.

Riociguat: Prelopatic studies show that the effect of lowering the whole body blood pressure when PDE5 inhibitors are combined with riociguat. In clinical studies, Riociguat has been shown to increase the hypotension of PDE5 inhibitors. There is no evidence of the clinical benefits of this combination in the research group. Do not use simultaneously with Riociguat with PDE5 inhibitors, including Sildenafil.