Erecfil-100 Sildenafil Citrate treatment for erectile dysfunction (1 blister x 4 tablets)

Dosage form Box of 1 blister x 4 tablets
Specifications Sildenafil

Ingredient

Composition information	Content
Sildenafil	100mg

Uses

indications

Erecfil - 100 is indicated in the following cases:

Treatment of erectile dysfunction, which is the inability to achieve or maintain an erection enough to satisfy sexual activity.

Sildenafil only works when there is an accompanying sexual stimulation. Sildenafil has a selective inhibitory effect on Guanosin Monophosphate ring (CGMP -CYCLIC GUANOSINE MONHOSPHATE) - Phosphodiesterase specific phosphodiesterase 5 (PDE5).

Mechanism of action:

The penis physiological mechanism leads to the release of nitric oxid (NO) in the cave in the process of sexual stimulation. Then NO activated the Ganylat Cyclase yeast, which 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.

Dynamic pharmacokinetics

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

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 the person about 50%. In humans, the maximum free Sildenafil shall be after using a single dose of 100 mg is approximately 18 ng/ml or 38 nm.

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

Food with high fat content reduces Sildenafil's absorption capacity, with an average time for TMAX's average reduction of 60 minutes, and CMAX decreases an average of 29%, on the contrary, the absorption level does not affect significantly (the area below the curve decreases by 11%).

Drug distribution

Sildenafil's average drug distribution (VSS) is 105 l, focusing on 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.

Sildenafil's concentration in semen of healthy volunteers after taking 90 minutes is less than 0.0002% of the dose of use (average 188 ng).

Metabolism

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

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

The metabolites in the main metabolic ring of Sildenafil generated from the n-Desmethyl process, and then continued to be metabolized again. These metabolites have a selective activity for PDE similar to Sildenafil and on Vitro selective for PDE5 approximately 50% of the mother substance.

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

Metabolic N - Desmethyl is metabolized again, with a half -life of 4 hours.

Eliminate drugs

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

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

pharmacokinetics in special patients:

Older people

On healthy elderly people aged 65 and over: 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 renal failure (clearinine clearance 50 - 80 ml/minute or average of creatinine 30 - 49 ml/minute): when using a single dose of Sildenafil (50 mg), there is no change in pharmacokinetic.

On people with severe renal failure (creatinine clearance

People with liver failure

In people with cirrhosis (Child-Pugh A, Child-Pugh B), Sildenafil's clearance is reduced, the result increases the area under the AUC curve (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.

Before taking Erecfil-100 Sildenafil Citrate treatment for erectile dysfunction (1 blister x 4 tablets)

How to use

Sildenafil tablets are used by oral.

Dosage

for adults:

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

Based on the tolerance and effect of the drug, the dose may increase to a maximum of 100 mg. The maximum recommended dose is 100 mg, the maximum number of times is once a day.

For 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

For patients with liver failure: Do not use erecfil - 100

For children: Do not use Sildenafil for children under 18 years old.

For the elderly: No need to adjust the dose.

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?

Overdose:

Research on volunteers taking single dose of 800 mg Sildenafil shows that unwanted effects in this dose are similar to low doses, but the frequency is encountered and the level increases.

Management:

In case of an overdose, requires appropriate support measures. Kidney fertilizer does not increase the clearance because Sidenafil is strongly attached to plasma proteins and is not eliminated through the urine.

What to do when forgetting a dose?

Side Effects

When using Erecfil - 100, you may experience unwanted effects (ADR).

Very common, ADR> 1/10

Nervous system: headache.

Common, 1/100

Nervous system: Dizziness.

Eyes: blurred vision, disorder, evidence of green.

blood vessel system: hot burning, flushing.

Respiratory system: stuffy nose.

Digestive system: Nausea, indigestion.

Uncommon, 1/1000

Respiratory system: rhinitis, nosebleeds, sinus blockage.

Nervous system: Sleep.

Eye: eye pain, fear of light, dizziness, color disorder, eye congestion, dazzling.

Heart: tachycardia, brushing chest.

Hemotic blood system: Hypotension.

Digestive system: gastroesophageal reflux, vomiting, upper abdominal pain, dry mouth.

Skin and subcutaneous tissue system: rash.

Muscle system and connective tissue: muscle pain, headache.

Body: Hypersensitivity, hot feeling.

Rare, ADR

Nervous system: epilepsy, recurrent epilepsy, fainting.

eyes: eye edema, swelling of the eyes, dry eyes, eye fatigue, eye -catching, yellowish, redness, eye disorders, conjunctival congestion, itchy eye, abnormal sensation in the face, eyelid edema.

Respiratory system: anhydrous throat, dry nose, nose edema.

Digestive system: Reduce tactile mouth.

Genital and breast system: Unwanted erection.

Body: itching.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

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

Contraindicated

Erecfil - 100 contraindications in the following cases:

When using drugs that provide nitric oxyd, nitrite and organic nitrate, such as glyceryl trinitrate (nitroglycerin), sodium nitroprussid, amyl nitrite.

Concomitance the use of PDE5 inhibitors such as Sildenafil with Ganylat Cyclase stimulants such as riociguat is contraindicated due to lower blood pressure symptoms.

In men should not intercourse due to cardiovascular risk factors. Severe liver failure (impaired liver function).

Severe kidney failure.

Hypotenosis (low blood pressure).

Stroke or heart incident recently.

genetic retinal degeneration disorders (including genetic disorders of retinal phosphodiesterose).

Patients with one -eyed vision loss due to ischemic optic neuropathy in the area before the artery causes (NAON).

Be cautious when using

need to diagnose erectile dysfunction based on disease biography and actual health check to determine the potential cause before consideration of drug treatment.

Cardiovascular risk factors:

Before starting any treatment of erectile dysfunction, the doctor needs to consider the patient's cardiovascular condition due to the risk of heart disease associated with sexual activity. Sildenafil has a gradual vasodilation, so it reduces mild and transient blood pressure. Before prescribing Sildenafil, the doctor should carefully consider whether the patient with certain potential conditions may be adversely affected by the vasodilation effects of the drug, especially when combined with sexual activity.

Patients who are sensitive to vasodilators include people with left ventricular congestion (for example, aortic stenosis, congestion cardiomyopathy), those with rare syndrome of multi -system atrophic manifestations such as serious impaired blood pressure control function.

Sildenafil increases the hypotension effect of nitrate.

Serious cardiovascular events include myocardial infarction, sudden death related to heart disease, ventricular arrhythmia, cerebral hemorrhage, transient ischemia, hypertension and hypotension are reported during the treatment of erectile dysfunction with Sildenafil.

Penis pain:

Outstanding dysfunction treatments, including Sildenafil, should be used cautiously in patients with anatomical deformation of the penis (such as folding, fibrosis or Peyronie disease), or in patients with diseases that can cause penis pain (such as sickle cell anemia, root canal pain or leukemia).

Simultaneously used with other PDE5 inhibitors or other erectile dysfunction treatments:

Safety and effectiveness of combining Sildenafil with other PDE5 inhibitors or pulmonary hypertension treatments (PAH) contains Sildenafil or other non -studied erectile dysfunction treatments, so these coordinates are not advised.

Salon influence:

Cases of patients with neuropathy ischemic anemia before not due to artery causes (Naion), a rare condition, related to the use of Sildenafil and other PDE5 inhibitors have been reported. In case of any sudden eye problems, patients need to stop using the drug and ask for advice immediately.

Use simultaneously with ritonavir:

Do not use Sildenafil simultaneously with ritonavir.

Use simultaneously with alpha blockers:

Be careful when using Sildenafil with Alpha blockers simultaneously can lead to symptomic hypotension in some sensitive patients. This usually happens within 4 hours after using Sildenafil. In order to limit puppet muscle lowering posture, patients should treat hemodynamic stability when taking alpha blockers before starting therapy with Sildenafil. Should consider the beginning of treatment at the dose of 25 mg.

affect bleeding:

In vitro studies on human platelets show that Sildenafil has an effect on the anti -condensation of sodium nitroprussid. There is no safety information on using Sildenafil for patients with bleeding disorders or peptic ulcer. So only use Sildenafil for these patients after careful assessment of benefits - risks.

Erecfil-100 tablets contain lactose:

Do not use drugs for people with rare genetic problems of galactose intolerance, lactase lactase deficiency or Glucose - Galactose.

The ability to drive and operate machinery

This drug can cause dizziness or visual changes, be careful when participating in activities that need crystalline such as driving or using machines.

Pregnancy

Do not take medicine for women.

Breastfeeding period

Do not take medicine for women.

Interaction

Sildenafil increases the effects of antihypertensive drugs. This drug also increases the effect of lowering the hypotension of nitrates, such as isosorbid dinitrate (ISORLIL), Isosorbid Mononitrate (IMDUR, ISNO, Monoket), Nitroglycerin (Nitro-Dur, Transderm-Nito) are vasodilators, often used to treat angina.

Patients who are using nitrate must not use Sildenafil.

cimetidin (tagamet), erythromycin, ketoconazole (Nizoral), Itraconazole (Sportanox) and Mibefradil significantly increase the amount of Sildenafil in the body. Careful monitoring patients should take these drugs if using Sildenafil.

Rifampin can reduce Sildenafil's blood concentration and reduce efficiency.

Storage

Store in a cool dry place, at temperatures below 30 ° C. Avoid light.

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