Viagra 100mg viatris drugs treat erectile dysfunction (1 blister x 1 tablet)
Dosage form Box of 1 blister x 1 tablet
Specifications Sildenafil
Ingredient
| Composition information | Content |
| Sildenafil | 100mg |
Uses
indications
Viagra drugs are indicated in the following cases:
Pharmacy
Sildenafil has a selective inhibitory effect Guanosin Monophosphate (CGMP - Cyclic Guanosine Monophat) phosphodiesterase specific type 5.
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 the release of 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.
pharmacokinetic
corresponds to the dose in the recommended dose range.
absorption
Sildenafil is quickly absorbed after drinking, with absolute bioavailability of about 41%on average. The maximum concentration achieved in plasma from 30 - 120 minutes.
Distribution
Sildenafil's average drug distribution (VSS) is 105L, the distribution focuses on tissues, 96% into plasma proteins.
Metabolism
Sildenafil is metabolized mainly by CYP3A4 (main roads) and CYP2C9 (sub -line) in the liver.
Elimination
Sildenafil's total clearance is 41L/h with half phase time of 3-5 hours, Sildenafil is eliminated mainly through feces in the form of metabolites (about 80% of oral dose) and a small part in urine (about 13% of oral dose).
Before taking Viagra 100mg viatris drugs treat erectile dysfunction (1 blister x 1 tablet)
How to use
Sildenafil tablets are used by oral, drink before sex about 1 hour.
Dosage
Adults
Most patients are recommended to take the dose of 50mg when needed, take about 1 hour before sex.
Based on the tolerance and effect of the drug, the dose may increase to a maximum of 100mg or decrease to 25mg. The maximum recommended dose is 100mg, the maximum number of times is 1 time per day.
For patients with renal failure
Cases of mild or medium renal failure (Creatinine clearance = 30 - 80ml/minute), do not need to adjust the dose.
Cases of severe renal failure (Creatinine clearance
For patients with liver failure
The dose to be used is 25mg because of Sildenafil's clearance reduced in these patients (for example, cirrhosis).
For patients who are taking other drugs
Based on the degree of interaction in diseases using Sildenafil simultaneously with Ritonavir (seeing the interaction section with other drugs and drug interactions), it should not exceed a maximum single dose of 25mg of Sildenafil within 48 hours.
Patients who are taking drugs that inhibit CYP3A4 (e.g. Erythromycin, Saquinavir, Ketoconazole, Itraconazole), the starting dose should be used as 25mg (see interactive items with other drugs and drug interactions).
To limit the risk of posture hypotension during treatment, patients should be treated stably when using α cancellation drugs before starting treatment with sildenafil. In addition, it is advisable to consider using lower sildenafil doses at the beginning of the treatment (see the warning and prudent section especially when using, interacting with other drugs and drug interactions).
Children
Do not use Sildenafil for children under 18 years old.
Old people
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? In case of overdose, requires appropriate support measures.
Kidney fertilizer does not increase the clearance because Sildenafil is strongly attached to plasma proteins and is not eliminated through the urine.
What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.
Side Effects
When using Viagra, you may experience unwanted effects (ADR).
Common, ADR> 1/100
Uncommon, 1/1000 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
Viagra drugs contraindicated in the following cases:
Precautions when using
must exploit the history and clinical examination meticulously to diagnose erectile dysfunction, to identify the potential causes and determine the appropriate treatment.
Because there may be some cardiovascular risks related to sexual activity, the physician 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 reported during circulation using Sildenafil to treat erectile dysfunction.
Most but not all these patients have a history of cardiovascular risk factors. 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.
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 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 suggested that the risk of deion nearly doubled within 5 semi -excreted cycles of PDES inhibitors used. Based on the published literature, Naion's annual incidence is 2.5 - 11.8 cases over 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.
Be cautious when prescribing Sildenafil for patients who are taking α sympathetic drugs because of indications that can lead to symptomic hypotension in sensitive patients (see interactive items with other drugs and other forms of interactions).
To limit the risk of posture hypotension, patients should treat hemodynamic stability when using α cancellation drugs before starting Sildenafil therapy. Sildenafil should be considered at low doses (see the dose section and the method of use). In addition, the doctor should advise patients to do what to do in case of posture hypotension symptoms.
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.
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 acute blood clotting or digestive ulcers, so be cautious in these patients.
Be careful when prescribing erectile dysfunction agents for patients with deformity on penis anatomy (such as an angle folding penis, cavity fibrosis, or Peyronie disease), patients with diseases that can cause penis anemia (such as sickle cell anemia, multiple marrow disease, 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, pulmonary arterial medications (PAH) contains Sildenafil (Revatio) or other non -researched erectile dysfunction drugs, so it should not be combined with these drugs.
Sudden reduction or loss of hearing has reported on 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. In the event of a sudden reduction or loss of hearing, the patient is advised to stop taking Sildenafil and see a doctor immediately.
The ability to drive and operate machinery
There has been no specific research on the impact of driving and operating 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.
Pregnancy
There are no complete and appropriate studies in pregnant women. Do not use sildenafil for pregnant women.
Breastfeeding period
There are no complete and appropriate studies in breastfeeding women. Do not use sildenafil for breastfeeding women.
Drug interaction
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 inhibiting agents (such as ketoconazole, erythromycin, cimetidin) will reduce Sildenafil's clearance.
cimetidin (800mg), a Cytochrom P450 inhibitor and non -specific inhibitor CYP3A4, when used simultaneously with Sildenafil (50mg) will increase Sildenafil's concentration in plasma to 56% of healthy volunteers.
erythromycin (500mg, use 2 times/day for 5 days) is a medium inhibitor agent CYP3A4, when used simultaneously with a single dose of 100mg Sildenafil, increasing the area under the Sildenafil curve (AUC) up to 182%. In addition, the simultaneous use of a single dose of 100mg Sildenafil with the protease inhibitor of HIVinavir (1200mg 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 (see the dose section and the method of use). The more powerful CYP3A4 inhibitors such as Ketoconazole and Itraconazole will also have greater effects.
Self -use of 100mg Sildenafil single -dose with HIV Ritonavir Protease inhibitors (500mg, use 2 times/day), a strong P450 inhibitor, increasing Sildenafil's CMAX up to 300% (4 times) and increased AUC in plasma up to 1000% (11 times higher). 24 hours after taking the drug, the concentration of sildenafil in plasma is still approximately 200ng/ml compared to 5ng/ml when using Sildenafil alone. This is consistent with the obvious effect of Ritonavir on the substrates of P450. Sildenafil did not have any effect on the pharmacokinetics of Ritonavir (see the dose section and the method of use).
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 200Nm and well tolerated. Single dose of antacids (magnesium hydroxid, aluminum hydroxid) does not affect the bioavailability of Sildenafil.
In a study on healthy male volunteers, the simultaneous use of endothelin and bosentan antagonists, (a CYP3A4 induction (medium), CYP2C9 and maybe CYP2C19) in a stable state (125mg, 2 times/day) with Sildenafil in a stable state (80mg, 3 times/day) leading to reduction 62.6% and 55.4%. Sildenafil increases the AUC and CMAX of Bosentan, respectively 49.8% and 42%. Concentrated with strong CYP3A4 touch substances, like Rifampin, is expected to reduce sildenafil levels in plasma.
Due to pharmacokinetic material in clinical trials shows that CYP2C9 inhibiting agents (such as Tolbutamid, Warfarin), CYP2D6 inhibitors (such as Serotonin Selective Rehabilitation Inhibitors, 3 -ring anti -depression drugs), enzyme inhibitors transferring angiotensin (ACE) and cases Sildenafil's dynamics.
On healthy men who volunteered, there was no effect of azithromycin (500mg/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 inhibiting agent of Cytocrom P450 subgroups 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 (IC 50> 150µm).
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 nitrates. So contraindicated use of Sildenafil along with substances for nitric oxidation, organic nitrates or organic nitrite in any form, whether regular or interrupted (see contraindications).
In 3 specific studies on drug interaction - drugs, α cancellation drugs doxazosin (4mg and 8mg) and sildenafil (25mg, 50mg, or 100mg) are indicated for patients with prostate healing tumors stable with Doxazosin. Observing these research objects, the average additional reduction of blood pressure measured in the back position is 7/7mmHg, 9/5mmHg, and 8/4mmHg respectively and the average additional reduction of blood pressure due to the vertical position is 6/6mmHg, 11/4mmHG, and 4/5mmHG.
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. Sildenafil simultaneous indications for patients who are taking α cancel drugs can lead to symptomic hypotension in some sensitive patients (see the dose sections and methods of use and warning and caution, especially when used).
There is no significant interaction when indicated simultaneously Sildenafil (50mg) with Tolbutamid (250mg) or Warfarin (40mg) (are substances metabolized by CYP2C9).
Sildenafil (100mg) does not affect the pharmacokinetics of HIV's protease inhibitors such as Ritonavir and Saquinavir (both of these drugs are the substrate of CYP3A4) (see above, the effect of other drugs on Sildenafil).
Sildenafil in a stable state (80mg, 3 times/day) increased 49.8% of Bosentan's AUC and increased by 42% CMAX of Bosentan (125mg, 2 times/day) (see the above section, the effect of other drugs on Sildenafil).
Sildenafil (50mg) does not increase the time of Aspirin bleeding (150mg).
Sildenafil (50mg) does not increase the hypotension effect of alcohol on healthy volunteers with an average maximum concentration of 0.08% (80mg/dl).
There is no meaning between Sildenafil (100mg) and amlodipine in hypertension patients (in the back position only lowering 8mmHg blood pressure for systolic blood pressure and 7mmHg 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.
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