Temptcure-100 gracure 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
Temptcure-100 drug is indicated in the following cases:
Sildenafil is used to treat erectile dysfunction, which is the inability to achieve or maintain enough erection to satisfy sexual activity.
Sildenafil only works when there is an accompanying sexual stimulation.
Pharmacological
Temptcure-100 contains Sildenafil in the form of citrate salt, oral to treat erectile dysfunction. Sildenafil has a selective inhibitory effect on Guanosin Monophosphate Round (CGMP- Cyclic Guuan Monophosphate) - Phosphodiesterase specific phosphoderase 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, this enzyme increases the concentration of CGMP, thereby relaxing the blood vessel smooth muscle of the cave and allows the 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 sexual stimulation creates 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 accompanied by sexual stimulation. In vitro studies show that Sildenafil selectively inhibits PDE5, the effect of Sildenafil selected on PDE5 is stronger than the other known phosphodiesterase (10 times 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 a enzyme related to the contraction of the heart.
Dynamic pharmacokinetics
Sildenafil pharmacokinetics corresponding to the dose in the recommended dose range. Sildenafil is metabolized in the liver (mainly through Cytochrom P450 3A4) and its metabolites have the same activity as the mother.
absorption:
Sildenafil is quickly absorbed after drinking, with an absolute amount of an average of about 41%(ranging from 25 - 63%) on in vitro, the concentration of 3.5 nm Sildenafil inhibits the PDE5 enzyme of about 50%.
On humans, the maximum free Sildenafil concentration after using a single dose of 100 mg is approximately 18 ng/ml or 38 Nm. The maximum concentrations achieved in plasma from 30 - 120 minutes (on average 60 minutes) are observed when taking the drug when hungry.
High fat foods reduce Sildenafil's absorption capacity, with an average time for TMAX's average reduction of 60 minutes, and CMAX decreased by an average of 29%, on the contrary, the absorption level does not affect significantly (the area below the curve decreased by 11%).
Distribution:
Sildenafil's average drug distribution (VSS) is 105 l, which focuses 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 mainly by CYP3A4 (main roads) and CYP2C9 (sub -line) in the liver. The metabolites in the main metabolism 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 in PDE5 approximately 50% of the mother. In healthy volunteers, the plasma concentration of metabolites is approximately 40% of the mother concentration. N-Desmethyl metabolites are metabolized again, with a half-life of 4 hours.
Era:
The total clearance of Sildenafil is 41 l/h with the last half phase time of 3-5 hours. After oral or intravenous use, Sildenafil is excreted mainly in the form of metabolic (about 80% of oral dose) and a small part through the urine (about 13% of oral dose).
Before taking Temptcure-100 gracure treatment for erectile dysfunction (1 blister x 4 tablets)
How to use
Take oral use.
Dosage
for adults:
Most patients are recommended to take a dose of 50 mg when needed, oral before sex about 1 hour.
Based on the intake and effect of the drug, it may increase to a maximum of 100 mg or decrease to 5 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/min), 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 25 mg because Sildenafil's clearance is reduced in these patients (for example, cirrhosis).
For patients who are 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 25mg of Sildenafil within 48 hours.
Patients who are taking drugs that inhibit CYP3A4 (for example, 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 treated stably when using α cancellation drugs before starting treatment with Sildenafil. In addition, it is advisable to consider using lower doses of Sildenafil at the beginning of treatment.
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?
In case of an overdose, requires appropriate support measures. Kidney fertilizer does not increase clearance because Sildenafil is strongly attached to plasma proteins and is not eliminated through urine.
What to do when forgetting 1 dose?
Not recorded.
Side Effects
When using Temptcure-100 drug, you may experience unwanted effects (ADR).
Common, ADR> 1/100
Digestive system: Nausea, indigestion.
Uncommon, 1/1000 Digestive system: gastroesophageal reflux, vomiting, upper abdominal pain, dry mouth. DA: rash. Muscle and connective tissue system: muscle pain, pain. 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
Temptcure-100 drug contraindicated in the following cases:
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 associated with sexual activity, physicians must pay attention to the patient's cardiovascular condition before the treatment of erectile dysfunction.
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 the 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 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 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 (e.g. aortic stenosis, obstructive hypertrophy) or suffer from syndrome of multiple systems Atrophy are patients with hyperactive hyperplasia, manifested by a serious decline in the ability to control blood pressure automatically, those who need to be very considerate when treated.
Nanon anemia neuropathy (nanon), a rare disease and is the cause of vision loss or vision loss, is reported rare during circulation 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 PDE5 inhibitors used. Based on the published idea, the annual new incidence of Naion 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. People who have had Naion's disease are at higher risk of increased Naion recurrence. 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 and can lead to symptomic hypotension in sensitive patients. To limit the risk of posture hypotension, patients should treat hemodynamic stability when using α sympathetic drugs before starting sildenafil therapy. Sildenafil should be considered at low doses. 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 deformations of penis anatomy (such as angle folding penis, caves fibrosis or Peyronie disease), patients with pathological diseases that cause penis anemia (such as sickle cell anemia, pulp pain, 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 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. 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 effects of driving and operating machinery. The phenomenon of dizziness and vision change has been reported in clinical trials with Sildenafil, so patients need to know how they react to Sildenafil before driving or operating machinery.
Pregnancy
Do not use Sildenafil for women. Research on mice and rabbits after using oral Sildenafil, no evidence of teratogenicity, fertility, or adverse effects for embryo and fetal development. There are no complete and appropriate studies on pregnant women.
Lactation period
Do not use Sildenafil for women. There are no adequate and appropriate studies on 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
Dynamic analysis through clinical test data shows that when using Sildenafil simultaneously with CYP3A4 inhibiting agents (such as ketoconazol, erythromycin, cimetidin) will reduce Sildenafil's clearance.
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, the simultaneous use of a single dose of 100 mg Sildenafil with the protease inhibitor of HIVinavir (1200 mg used 3 times/day), this is also a CYP3A4 inhibitor agent, increasing Sildenafil's CMAX to 140% and increasing AUC to 200%. Sildenafil has no effect on Saquinavir's pharmacokinetics. The more powerful CYP3A4 inhibitors such as Ketoconazole and Itraconazole will also have greater effects.
Single -dose of 100 mg Sildenafil with HIV Ritonavir (500 mg, use 2 times/day), a powerful P450 inhibitor, increasing Sildenafil's CMAX up to 300% (4 times) and increasing AUC in plasma up to 1000% (11 times higher).
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 clear impact of Ritonavir on the substrates of P450.
Sildenafil did not have this effect on Ritonavir's pharmacokinetics. When using Sildenafil at the recommended dose for patients who are treating agents that can inhibit CYP3A4, the maximum free Sildenafil concentration in plasma does not exceed 200 nm 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 (an average CYP3A4 touch substance, CYP2C9 and maybe CYPOC19) in a stable state (125 mg, 2 times/day) with Sildenafil in a stable state (80 mg, 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.
Dynamic pharmacokinetic data in clinical trials shows that CYP2C9 inhibitors (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 (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 inhibiting agent of Cytocrom P450 subgroups 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 (IC50> 150 μm).
Because after the recommended dose, the peak concentration of Sildenafil is approximately 1m, so Sildenafil will not change the clearance of the enzyme substrates.
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 it is frequent or interrupted.
In three specific studies on drug interaction - drugs, DOXAZOSIN (4 mg and 8mg) and Sildenafil (25 mg, 50 mg, or 100 mg) are indicated for patients with prostate healing tumors with stable treatment with doxazosin. Observing these research objects, the average additional reduction of blood pressure measured in the back position is 7/7 mmHg, 9/5 mmHg and 8/4 mmHg respectively 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. Sildenafil indications for patients who are using α cancel α can lead to symptomic hypotension in some sensitive patients.
There is no meaning 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 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 antihypertensive drugs.
Storage
Store in a cool dry place, at a temperature not exceeding 30 ° C. Avoid light.
Other drugs
- BUSCOPAN AMPOULES 20MG/ML
- GLIBENCLAMIDE 5MG TABLETS BP
- IBUCALM 400MG TABLETS
- PARIET 20MG TABLETS
- PRIMOLUT N
- RHINATHIOL SYRUP 250MG/5ML
Disclaimer
Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Popular Keywords
- metformin obat apa
- alahan panjang
- glimepiride obat apa
- takikardia adalah
- erau ernie
- pradiabetes
- besar88
- atrofi adalah
- kutu anjing
- trakeostomi
- mayzent pi
- enbrel auto injector not working
- enbrel interactions
- lenvima life expectancy
- leqvio pi
- what is lenvima
- lenvima pi
- empagliflozin-linagliptin
- encourage foundation for enbrel
- qulipta drug interactions