Cefass 90mg Celogen medicine reduces arthritis, rheumatoid arthritis (3 blisters x 10 tablets)
Dosage form Box of 3 blisters x 10 tablets
Specifications Etoricoxib
Ingredient Dysmenorrhea, joint spondylitis, arthritis, rheumatoid arthritis, osteoarthritis
Ingredient
| Composition information | Content |
| Etoricoxib | 90mg |
Uses
Indications
cefass is indicated in adults and teenagers aged 16 and over to:
It has proven that COX - 2 is mainly responsible for the synthesis of the intermediate substances of Axid Prostanoic causing pain, inflammation and fever. The selective inhibition of COX - 2 due to the use of Etoricoxib has reduced these clinical signs and symptoms, along with reducing toxicity in the digestive tract without having the effect of platelet function.
pharmacokinetic
absorption
Etorieoxib is well absorbed by oral. The oral average is nearly 100%oral. After taking a dose of 90mg once a day until the state is stable, the peak concentration in plasma is recorded nearly 1 hour (TMAX) after the adult object takes the drug when hungry.
Mobile pharmacokinetics of linear Etoricoxib with clinical dose range. Normal meals do not affect clinical significance to the level of absorption of 1 dose of Etoricoxib 90mg. In clinical trials, Etoricoxib is used not related to food.
Distribution
About 92% Etoricoxib attaches to protein in human plasma when used within the concentration of 0.05 - 5 mcg/ml. The distribution voltage is about 120 liters in sustainable state (VDSS). Etoricoxib passes through the placenta in the rats and rabbits, and goes through the blood -brain barrier in the rat.
Metabolism
Etoricoxib is strongly metabolized with
There have been 5 metabolites identified in humans. The main metabolic substance is 6 ' - carboxylic acid's carboxylic acid is formed from 6' - hydroxymethyl derivative oxidation. These main metabolites manifest or without active activity that can be measured or only active as COX - 2 inhibitors. These metabolites are not inhibited COX - 1.
Elimination
After an intravenous injection of a single -dose of 25mg Etoricoxib has radioactive attachment to healthy objects, 70% of radioactive active ingredients are found in urine and 20% in feces, mostly in the form of metabolites. Under 2% of radioactive active ingredients found in non -metabolic drugs.
Most Etoricoxib is excreted mainly through metabolism, then through the excretion in the kidneys. Etoricoxib's concentration in a sustainable state is achieved within 7 days of treatment when taking a dose of 120mg once a day, with accumulated ratios of nearly 2 corresponding to the accumulated sale time of about 22 hours. It is estimated that the removal of drugs in plasma is approximately 50 ml/min.
Before taking Cefass 90mg Celogen medicine reduces arthritis, rheumatoid arthritis (3 blisters x 10 tablets)
How to use
The drug can be taken at hunger or full. Responding to the initial treatment of the drug faster if taking the drug at hunger.
Dosage
Due to the cardiovascular risks and adverse effects of Etoricoxib may increase in dosage and duration of use, need to use the drug in the shortest possible time and with the lowest daily dose effectively. Symptomatic treatment should be re -evaluated periodically, patients with osteoarthritis.
osteoarthritis:
recommended dose is 30mg once a day. If necessary, the dose of 60mg once daily.
rheumatoid arthritis:
The recommended dose is 60mg once a day. If stated, it is necessary to increase to 90mg once a day. When the patient was clinically stable, reducing the dose to 60mg, once a day.
Age -joint spondylitis:
The recommended dose is 60mg once a day. If necessary, the dose can be increased to 90mg once a day. When the patient was clinically stable, reducing the dose to 60mg, once a day.
Acute pain:
For acute pain, Etoricoxib should only be used for acute symptoms.
Acute arthritis caused by gout:
The recommended dose is 120mg once a day. In clinical trials for acute arthritis caused by gout, Etoricoxib is used for 8 days.Pain after surgery due to dental surgery:
recommended dose is 90mg once a day, limited to up to 3 days.
larger dose than the recommended dose has not been studied. So:
Elderly patients
No need to adjust the dose for elderly patients. As with other drugs, caution in elderly patients.
Patients with liver failure
No dose adjustment for patients with creatinine clearance ≥ 30 ml/min. The use of Etoricoxib in patients with creatinine clearance
Children
Contraindicated for children and teenagers under 16 years old.
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 take the patient to the nearest medical facilities for timely treatment.
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 Cefass 90, you may experience unwanted effects (ADR).
Common, ADR> 1/100
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
Contraindicated
Cefass is contraindicated in the following cases:
Precautions when using
Heart thrombotes
Non -steroid anti -inflammatory drugs (NSAIDs), non -aspirin, use systemic sugar, may increase the risk of cardiovascular thrombosis, including myocardial and diverse infarction, which can lead to death.
This risk may appear early in the first few weeks of taking the drug and can increase over time. The risk of cardiovascular thrombosis is recorded mainly at high doses.
Doctors need to periodically evaluate the appearance of cardiovascular events, even if the patient has no previous cardiovascular symptoms. Patients should be warned of symptoms of serious cardiovascular events and need to visit the doctor as soon as they appear.
To minimize the risk of adverse events, Etoricoxib is needed at the first daily dose that is effective in the shortest possible time.
Selective inhibitors of COX - 2 are not used instead of acetylsalicylic acid to prevent cardiovascular disease due to thrombosis because it has no platelet resistance.
Effects on the gastrointestinal tract
complications of the gastrointestinal tract (perforation, ulcer or bleeding (pubs)), some cases leading to death, occurred in patients treated with Etoricoxib. Be cautious when using Etoricoxib in patients with high risk of developing digestive tract complications; Elderly, patients use any other NSAIDs or acetylsalicylic acid or patients with a history of gastrointestinal disease, such as ulcers and gastrointestinal bleeding. There is further increase in the risk of gastrointestinal side effects (gastrointestinal ulcers or other digestive complications) when Etoricoxib is taken simultaneously with acetylsalicylic acid (even at low doses).
affect the kidneys
Prostaglandin kidney can play a roly role in maintaining kidney perfusion. Therefore, in the condition of damaged kidney perfusion, the use of etoricoxib can cause decrease in prostaglandin and reduce kidney blood flow, thus reducing kidney function. Patients with a great risk of this reaction are people with the current function of the kidneys significantly affected, unprocessed heart failure or cirrhosis. Monitoring the kidney function in these patients should be considered.
Keeping water, edema and high blood pressure
As with other drugs known as the synthesis of prostaglandin, water retention, edema and high blood pressure have been observed in patients using Etoricoxib.
All nonsteroidal anti -inflammatory drugs (NSAIDs), including Etoricoxib, can be linked to a new start or recurrent congestion heart failure. Caution should be careful in patients with a history of heart failure, left ventricular dysfunction, or hypertension and patients with edema.
If there is clinical evidence of symptomatic aggravation in these patients, appropriate measures include Etoricoxib suspension should be taken.
Etoricoxib can be linked to many cases of higher and more serious high blood pressure than some other NSAIDs and other COX -2 selective inhibitors, especially at high doses.
Therefore, hypertension should be controlled before treatment with Etoricoxib and especially need to pay attention to monitor blood pressure during treatment with Etoricoxib.
Blood pressure should be monitored within two weeks after the beginning of treatment and periodically. If blood pressure increases significantly, alternative treatment should be considered. .
affect the liver
Increase the concentration of alanin aminotransferase (ALT) and/or Aspartat Aminotransferase (AST) (about three or many upper limits of normal) have been reported in about 1% of patients in clinical trials for treatment with Etoricoxib 30, 60 and 90mg per day for 1 year.
Any patient with symptoms and/or signs that liver dysfunction, or abnormal liver function tests need to be monitored.
If the signs of liver failure occur, or if the abnormal liver function tests are persistent (three upper limits of normal) are detected, the drug should be stopped.
general
If during the treatment process, any of the above -mentioned organ system functions are worse, the appropriate measures that need to be taken and stop the Etoricoxib treatment should be considered.
The appropriate medical monitoring should be maintained when using Etoricoxib in the elderly and in patients with renal impairment, liver, heart dysfunction.Be cautious when used when starting treatment with Etoricoxib in patients with dehydration. Serious skin reaction, some fatal, including flaky dermatitis, Stevens - Johnson syndrome and toxic epidermal necrosis, have been reported very rare when using NSAIDs and some selective inhibitors of COX - 2.
Patients with the highest risk for early reactions during treatment with the beginning of the reactions occurring in most cases in the first month of treatment.
Severe hypersensitivity reactions (such as anaphylactic shock) have been reported in patients using Etoricoxib. Some selective inhibitors of COX - 2 are associated with increased risk of skin allergies in patients with a history of drug allergies.
Stop using Etoricoxib as soon as the skin rash appears, mucosal damage, or any signs of hypersensitivity.
Etoricoxib can hide the signs of fever and inflammation.
Be careful when using Etoricoxib simultaneously with warfarin or other oral anticoagulants.
The use of Etoricoxibs, as with any drug known to inhibit the synthesis of cyclooxygenase/prostaglandin, is not recommended in women who are intended to get pregnant.
Lactose -containing drugs. Patients with rare genetic problems are galactose intolerance, lactase deficiency or glucose - galactose should not be used.
The ability to drive and operate machinery
Patients with dizziness, dizziness or drowsiness while using Etoricoxib should avoid driving or operating machinery.
Pregnancy
Like other drugs that inhibit the synthesis of Prostaglandin, it is necessary to avoid using Etoricoxib in late pregnant women because they can cause early artery.
There are no adequate control studies on pregnant women. Etoricoxib should only be used in the first two quarters of pregnancy if the benefits it gives greater than the risk to the fetus.
Breastfeeding period
Etoricoxib is excreted in mouse milk. It is not known whether it is excreted in breast milk or not. Because there are many drugs excreted in breast milk and because of the possible effects of prostaglandin synthesis inhibitors during breastfeeding, deciding to stop the drug or stop breastfeeding depends on the importance of the drug for the mother.
Medicinal interaction
Oral anticoagulant: In the stable treatment subjects with long -term warfarin, taking Etoricoxib 120mg daily can lead to an increase of about 13% of prothrombin compared to international standard ratio (INR). Therefore, patients who take anticoagulant drugs should be closely monitored in their Prothrombin Inr time, especially in the first days of treatment with Etoricoxib or when the Etoricoxib dose is changed.
Diuretics, ACE inhibitors and Angiotensin II antagonists: NSAIDs can reduce the effects of diuretics and other antihypertensive drugs. In some patients with impaired renal function (for example, patients with dehydration or elderly patients with impaired renal function) simultaneously used an ACE inhibitor or Angiotensin II antagonist and cyclooxygenase inhibitors can lead to further impairment of renal function, which can cause acute renal insufficiency, often recovered. These interactions should be considered in patients using Etoricoxib simultaneously with the enzyme inhibitors or Angiotensin II. Therefore, the combination should be used carefully, especially in the elderly. Patients should be fully compensated and should be considered to monitor kidney function after starting treatment and periodically.
Acetylsalicylic acid: In a healthy person study, in a stable state, oral Etoricoxib 120mg once a day does not affect the anti -platelet aggregation activity of acetylsalicylic acid (81mg once a day). Etoricoxib can be used simultaneously with acetylsalicylic acid at cardiovascular prophylactic doses (low doses of acetylsalicylic acid). However, simultaneous use of low -dose acetylsalicylie acetylsalicy acids with Etoricoxib can lead to an increase in digestive ulcer ratio or other complications compared to the use of alone Etoricoxib. Simultaneous use of Etoricoxib with acetylsalicylic acid doses above the dose for cardiovascular disease or other NSAIDs is not recommended.
Cyclosporin and Tacrolimus: Although this interaction has not been studied with Etoricoxib used with cyclosporin or tacrolimus with any NSAIDs can increase the kidney toxicity of cyclosporin or tacrolimus. Kidney function should be monitored when Etoricoxib and one of these drugs are used in combination.
Effects of Etoricoxib on other drugs of other drugs
Liti: NSAID làm giảm bài tiết liti qua thận và do đó làm tăng nồng độ liti trong huyết tương. If necessary, monitor the concentration of blood liti tight and adjust the dose of liti while using simultaneously with NSAID and after the NSAID stopped.
Methotrexate: There have been two influence studies of Etoricoxib 60, 90 or 120mg once a day x 7 days in patients with methotrexate doses per week 7.5 to 20mg for rheumatoid arthritis. The dose of Etoricoxib 60 and 90mg has no effect on methotrexate concentrations in plasma or kidney clearance. In a study, the dose of Etoricoxib 120mg did not work, but in another study, the Etoricoxib 120mg dose increased 28% of the plasma methotraxat level and reduced 13% of the renal clearance of methotrexate. Full monitoring to prevent methotrexate poisoning is recommended when Etoricoxib and Methotrexate are simultaneously used.
contraceptive pills: 1 dose of Etoricoxib 60mg for concurrent use with 35 microgram ethinyl estradiol (EE) and 0.5 - 1mg norethindron in 21 days increases the stable state of AUC0 - 24 hours of EE 37%. Etoricoxib 120mg is used simultaneously with contraceptives or 12 hours, increasing the stable state of AUC0 - 24 hours of EE 50 - 60%. The increase in this EE concentration should be considered when choosing an oral contraceptive method to use simultaneously with Etoricoxib. This may increase the incidence of side effects related to birth control pills.
Hormonal change therapy (HRT): Use Etoricoxib 120mg with hormone replacement therapy including conjugated estrogen (0.625mg premarintm) in 28 days, increasing the stable state of AUC0 - 24 hours of conjugate estron (41%), Equilin (76%), and 17 - β - Estradiol (22%). Escapes of Etoricoxib (30, 60, and 90mg) long -term use have not been studied. The increase in estrogen levels should be considered when choosing postmenopausal hormone therapy to use with Etoricoxib because it can increase the risk of side effects associated with HRT.
Prednison/Prednisolon: In drug interactive studies, Etoricoxib has no clinical impact on pharmacokinetics of Prednison/Prednisolon.
Digoxin: Use Etoricoxib 120mg once a day for 10 days in healthy volunteers do not change the stable state in AUC0 - 24 hours plasma or the ability to eliminate through the kidney of digoxin. There is an increase in Digoxin's cmax peak concentration (about 33%). Usually this increase is not important for most patients. However, patients with high risk of Digoxin toxicity should be monitored when Etoricoxib and Digoxin are used simultaneously.
The effect of Etoricoxib on drugs metabolized by sulfotransferase: Etoricoxib is an inhibitor of sulfotransferase activity, especially sult1e1, and has been shown to increase the serum concentration of Ethinyl Estradiol. Because the knowledge of the impact of sulfotransferase is incomplete and the clinical consequences for many drugs are still being checked, need to be cautious and closely monitored when using Etoricoxib simultaneously with drugs mainly metabolized by sulfotransferase (e.g. salbutamol and minoxidil).Effects of Etoricoxib on drugs are metabolized by isenzyme CYP
Based on ViO printing studies, Etoricoxib does not inhibit Cytochrom P450 (CYP) 1A2, 2C9, 2C19, 2D6, 2E1 or 3A4. In a healthy study, using Etoricoxib 120mg daily does not change CYP3A4 activity.
Effect of other drugs on Etoricoxib's dynamics: The main path of Etoricoxib metabolism depends on the CYP enzyme. CYP3A4 is involved in Etoricoxib's metabolism in the body. In In vitro study shows that CYP2D6, CYP2C9, CYP2C19 and CYP1A2 can also catalyze the main metabolic path, but their specific role has not been studied in Vivo.
Ketoconazole: Ketoconazole is a strong CYP3A4 inhibitor, researching with ketoconazole 400mg once a day in 11 days in healthy volunteers shows no clinical impact on Etoricoxib's dynamics used at a dose of 60mg.
voriconazole and miconazole: simultaneously use voriconazole oral or miconazole gel, are strong CYP3A4 inhibitors, with Etoricoxib without clinical impact on pharmacokinetics of Etoricoxib.
Rifampicin: simultaneously use Etoricoxib with rifampicin, a powerful induction of the CYP enzyme, reducing 65% of the plasma concentration of Etoricoxib. This interaction can lead to recurrence of symptoms, when Etoricoxib is used with rifampicin. However, the increase in the dose of Etoricoxib has not been studied.
Anti -acid drugs: antacids that do not affect clinical significance to pharmacokinetics of etoricoxib.
Storage
Store in closed packaging, cool dry place, avoid light, at temperatures below 300C.
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