Magrax 90mg Davipharm Treatment Treatment of rheumatoid arthritis (10 blisters x 10 tablets)
Dosage form Box of 10 blisters x 10 tablets
Specifications Etoricoxib
Ingredient
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| Composition information | Content |
| Etoricoxib | 90mg |
Uses
Indications
Magrax medicine are indicated in the following cases:
Pharmacokic
Etoricoxib is a cyclooxygenase inhibitor (COX - 2) selected at therapeutic concentration.
High concentration of COX - 2 at inflamed tissues leading to prostaglandin synthesis is the intermediate substance of pain and inflammation.
In clinical pharmaceutical research, Etoricoxib inhibits COX - 2 depending on the dose without inhibiting COX - 1 at the dose up to 150mg/day.
pharmacokinetic
absorption
Etoricoxib is well absorbed by oral. Absolute bioavailability is approximately 100%. After taking 120mg/time/day to the status of the planet, the peak concentration in plasma (cmax = 3.6ng/ml) is achieved after 1 hour. The area under the concentration curve over time (AUC) is 37.8 Hg. HR/mL. Mobile pharmacokinetics of linear Etoricoxib in the treatment dose range.
Food does not affect Etoricoxib absorption, but affects the absorption rate.
Distribution
about 92% Etoricoxib attaches plasma proteins in the concentration range of 0.05 - 5ng/ml. The integral distribution is about 120l.
Metabolism
The drug is metabolized large with
It seems that CYP3A4 contributes to the transformation of in vivo. In vitro studies show that CYP2D6, CYP2C9, CYP1A2 and CYP2C1 also catalyzed the main metabolism, but their role has not been studied in vivo.
Determined 5 metabolites in humans. The metabolic substance is the derivative 6 - Etoricoxib's carboxylic acid is formed mainly by oxidation for additional coc (Hydroxymethyl.
The main metabolites are not active or inhibited inhibiting COX - 2 weak. No metabolites inhibit COX - 1.
Elimination
After an intravenous single -dose of 25mg Etoricoxib marks radioactive in healthy people, 70% of radioactive activity is found in urine and 20% in feces, mainly in the form of metabolites. Under 2% is found in a constant form.
Etoricoxib elimination is mainly in the form of metabolites by the excretion of the kidney.
Etoricoxib's constant concentration is achieved within 7 days after drinking 120mg once a day, half a lifetime is about 22 hours. Plasma clearance after 1 dose of 25mg intravenously estimates about 50ml/ min.
Before taking Magrax 90mg Davipharm Treatment Treatment of rheumatoid arthritis (10 blisters x 10 tablets)
How to use
Etoricoxib orally and may be shared or without food. The initial effect of the drug can be faster when using Etoricoxib without food. This should be considered when it is necessary to quickly reduce symptoms.
Dosage
Due to Etoricoxib's cardiovascular risk may increase with the dose and exposure time, the shortest daily daily use should be used.
Demand for symptomatic treatment and treatment should be re -evaluated periodically, especially in osteoarthritis patients. Rheumatoid arthritis.
The recommended dose is 60mg x 1 time/day. In some patients who do not decrease symptoms, increasing the dose of 90mg once a day may increase the effectiveness of treatment.When the patient stabilizes clinical, a dose of 60mg/time/day may be appropriate. If not increased treatment effect, should consider other treatment options.
Jerematitis
Dosage for output and joint inflammation should not exceed 90mg/day.
Dosage for acute gout should not exceed 120mg/day, maximum limit of 8 days of treatment.
Dosage for pain after dental surgery should not exceed 90mg/day, maximum limit of 3 days.
What to do when overdose?
In clinical studies, the only dose of 500mg and the repeated dose of 150mg/day for 21 days shows no signs of toxicity.
In case of overdose, it is advisable to conduct common treatments such as removing unprocessed drugs from the gastrointestinal tract, clinical monitoring and supportive treatment if necessary.
Hemolysis does not eliminate Etoricoxib. It is not clear the effectiveness of removing drugs from the body with peritoneal.
What to do when you forget the dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Do not drink twice as prescribed.
Side Effects
Safety records
In clinical trials, Etoricoxib has been assessed for safety in 9,295 individuals, including 6,757 patients with arthritis, output, chronic back pain or spinal stiff inflammation (about 600 patients with arthritis or output for a year or longer).
In clinical studies, unwanted effects are similar in arthritis patients or to treat Etoricoxib for a year or longer.
In a clinical study for acute arthritis caused by gout, patients treated Etoricoxib 120mg x 1 time/day for 8 days.
Data on unwanted effects in this study generally similar to the report in the study combined with arthritis, output and chronic back pain.
In a program on cardiovascular safety results of synthetic data from three controlled tests, 17, 12 patients with arthritis or outps are treated Etoricoxib (60mg or 90mg) for an average period of about 18 months.
In clinical studies on toothache after surgery, including 614 patients with Etoricoxib treatment (90mg or 120mg), data on unwanted effects in these studies is generally similar to reports in the study combined with arthritis, output and chronic back pain.
List of unwanted effects
Risk of cardiovascular thrombosis (see more warning and caution).
The following unwanted effects are reported at a higher rate than the price in clinical trials in patients with arthritis, output, chronic lower back pain or safe joint spondylitis when treated with Etoricoxib 30mg, 60mg or 90mg to recommended doses until 12 weeks.
In the medal program in 3 and a half years: in the study of short -term acute pain within 7 days; or in experience after the drug is marketed.
Agency system
Unwanted effects
Frequency *
Bone bone disease
Common
Gastritis, upper respiratory infection, urinary tract infection
Less
Anemia (mainly related to gastrointestinal bleeding, leukopenia, thrombocytopenia)
Less
immune system disorders Hypersensitivity ++ β Less
Evaluation, anaphylaxis, hypersensitivity including ++
Rare
Supplies/defending water Common
Increase appetite or decrease, weight gain
Less
Mental disorders
worried, depression , mental reduction, hallucinations ++
Less
Confused ++, restless ++
Rare
Dizziness, headache
Common
Intelligence, insomnia, paresthesia, neurasthenia, drowsiness
Less
Blurred conjunctivitis
Less
tinnitus , dizziness
Common
Brushing the chest, arrhythmia ++ Less
Atrial fibrillation, tachycardia ++, congestive heart failure, no specific ECG changes, angina, myocardial infarction §
Common
Vascular disorders
Hypertension
Less
Stimulating, stroke §, Temporary anemia stroke, hypertension ++, vasculitis ++
Common
Less
Bronchospasm
Difficulty breathing, angina
Less
abdominal pain
Very common
constipation, flatulence, gastritis, heartburn/acid reflux, diarrhea, indigestion/discomfort in the epigastric area, nausea, vomiting, esophagitis, mouth ulcers
Common
Abdominal bloating, changing intestinal motility, dry mouth , stomach ulcer - Gut and hemorrhage, irritable bowel syndrome, pancreatitis ++
Less
Increase ALT, increase AST Common
hepatitis ++
Rare
Hepatic failure ++, jaundice ++
Rare
necrotic
Common
Skin edema, itching, rash, erythema ++, urticaria
Less
Stevens-Johnson syndrome, toxic spinal necrosis, fixed spraying ++
Rare
Pain/muscle spasms, muscle and muscle stiffness
Less
proteinuria, increased serum creatinine, renal failure/Renal reduction
Less
Fatigue depression, influenza disease Common
breast anger
Less
Testing Increasing blood urea concentration, increased creatinine phosphokinase, hyperkalemia, increased uric acid Less
blood sodium decreases
Rare
++ This adverse reaction is determined through the monitoring of the post -marketing period. The frequency of the report is estimated based on the highest frequency observed through clinical test data gathered as prescribed and the dose has been approved.
ƚ The frequency portfolio of "rare" has been defined according to the instructions on the summary of the product characteristics (September 2, 2009) based on the estimated 95% confidence range for 0 events given with the number of Etoricoxib treatment subjects in phase data analysis III by dose and indication (n = 15.470).
β sensitivity includes the terms "allergies", "allergies", "hypersensitivity", "hypersensitivity", "too sensitive hypersensitivity", "hypersensitivity reaction" and "Non -specific allergies".
§ Based on the placebo and controlled clinical trial analysis, the selective inhibitors of COX - 2 are related to the risk of serious arterial thrombosis, including myocardial infarction and stroke. The absolute risk of such events may not exceed 1% per year based on existing data (rarely).
The drug can cause other unwanted effects, advising patients to notify unwanted effects when taking the drug.
Warnings
Contraindicated
Stomach ulcers or gastrointestinal bleeding. History of asthma, acute rhinitis, nasal polyps, nerve angiema, urticaria when taking aspirin or nsAID. Pregnant or lactating women. Severe hemorrhage heart failure. Inflammation. Caution in patients with anemia heart disease, kidney failure, cirrhosis, heart failure, left ventricular dysfunction, hypertension, risk of edema, older people, patients dehydration. Heart thrombosis Effects on the gastrointestinal tract Cardiovascular effects Effects on the kidneys Keeping water, edema and hypertension influence on the liver If using the drug, patients have the function of worse organs as described above, should take appropriate management measures and consider stopping Etoricoxib. Proper medical monitoring should be maintained when using Etoricoxib in the elderly and patients with kidney, liver or heart dysfunction. Be cautious when starting treatment with Etoricoxib in dehydration patients. Water compensation should be rehydrated before using Etoricoxib. Serious skin reactions, several fatal cases, including flaky dermatitis, Stevens - Johnson syndrome, and poisoned epidermal necrosis are reported very rare when combining NSAIDs and some COX -2 inhibitors in the process of monitoring after -sales period. Patients with the highest risk of this reaction in the first month of treatment. Serious hypersensitivity reactions (such as hypersensitivity and angioedema) are reported in patients using Etoricoxib. Some selective inhibitors of COX - 2 are associated with an increase in the risk of skin reactions in patients with a history of drug allergies. Etoricoxib should be stopped as soon as the initial signs of the skin rash, mucosal damage, or any signs of hypersensitivity. Etoricoxib can hide other fever and inflammatory symptoms. Be careful when using Etoricoxib simultaneously with warfarin or other oral anticoagulants. Do not use Etoricoxib, as well as any drug products inhibit the synthesis of cyclooxygenase/prostaglandin in women who are trying to get pregnant. To be out of reach of children. Patients with dizziness, dizziness or drowsiness when using Etoricoxib should not drive or operate machinery. Pregnant women There is no clinical data on the use of Etoricoxib during pregnancy. Animal research shows toxicity on fertility. The risk of potential in pregnant women. Etoricoxib, like other prostaglandin synthesis inhibitors, can reduce uterus and arteriosclerosis early in the last 3 months of pregnancy. contraindicated Etoricoxib during pregnancy. If the female patient is pregnant while taking the drug, it is necessary to stop Etoricoxib. breastfeeding women It is unclear whether Etoricoxib has milk in milk. Etoricoxib secretes through milk in mice. Women's patients use Etoricoxib should not breastfeed. Reproduction Etoricoxib, like COX - 2 inhibitors, is not recommended for use in women who are trying to get pregnant. Elderly people No need to adjust the dose for elderly patients. Like other drugs, need to be cautious when used for the elderly. Patients with liver failure Do not use medication for patients with liver failure due to inappropriate dose. Patients with renal failure No dose adjustment for patients with creatinine clearance 230ml/min. Do not use Etoricoxib in patients with creatinine clearance Children Etoricoxib is not contraindicated in children and teenagers under 16 years old. Pharmacological interaction Oral anticoagulants In patients with stable treatment with warfarin, using the daily dosage of Etoricoxib 120mg can lead to an increase of about 13% of prothrombin compared to the international standard ratio (INR). It is necessary to strictly control the INR value when starting with Etoricoxib or when transferred to Etoricoxib treatment. Diuretics, ACE inhibitors and Angiotensin II NSAID anti -anti -drugs can reduce the effectiveness of diuretics and other hypertension drugs. In some patients with renal function damage (such as dehydrated patients or elderly people with kidney damage), sharing ACE inhibitors and Angiotensin II and COX inhibitors can cause more severe kidney damage, which may include acute renal failure, often recovered. These interactions should be considered in patients using Etoricoxib with ACE inhibitors or Angiotensin II. Therefore, be careful when used in combination, especially in the elderly. Should retain water for patients appropriate and consider monitoring of renal function after the beginning of coordination and periodic treatment later. Acetylsalicylic acid In a healthy subject, in a stable state, Etoricoxib 120mg/time/day does not affect the anticoagulant effect of acetyl salicylic acid (81mg/day). Etoricoxib and acetylsalicylic can be used with cardiovascular disease prevention doses (low -dose acetylsalicylic acid). However, using low -dose acetylsalicylic acetylsalicylic acid with Etoricoxib may cause increased gastrointestinal ulcer ratio or other complications compared to using Etoricoxib alone. It is not recommended to share Etoricoxib with acetylsalicylic acid doses above used to prevent cardiovascular disease or with other NSAIDs. cyclosporin and tacrolimus Although there is no interaction studying when used with Etoricoxib, sharing cyclosporin or tacrolimus with any NSAID can increase the toxic effect on the body of cyclosporin or tacrolimus. Kidney function should be monitored when shared with Etoricoxib with cyclosporin or scungrolimus. Pharmacokinetic interaction Etoricoxib effect on the pharmacokinetics of other lithium drugs NSAID reduces lithium excretion through the kidneys and thus increases plasma lithium concentrations. Monitor the lithium tightly and adjust the lithium dose when used with NSAID and when it stops if necessary. methotrexate Two investigating studies of Etoricoxib effects of 60mg, 90mg or 120mg used once a day in 7 days in patients using methotrexate doses once a week from 7.5mg to 20mg exchange with rheumatoid arthritis. Etoricoxib dose 60mg and 90mg does not affect methotrexate concentration in plasma or kidney clearance. In one study, Etoricoxib 120mg has no influence, but in another study, Etoricoxib 120mg increases the concentration of plasma metotrexat to 28% and reduces 13% of the kidney clearance of methotrexate. Should fully check the toxicity related to methotrexate when combining Etoricoxib and Methotrexate. Oral contraceptives commonly used Etoricoxib 60mg with oral contraceptives containing 35 micrograms of ethinyl estradiol (EE) and from 0.5 - 1mg norethindron in 21 days increases 37% ACO - 24 hours in stable state of EE. Use at the same time or 12 hours apart Etoricoxib 120mg and oral contraceptives as above increases the AUC - 24 hours in the stable state of EE by 50 - 60%. The increase in EE concentration should be considered when choosing oral contraceptive pills to be used with Etoricoxib. EE's AUC growth can increase the unwanted effect rate related to oral contraceptive pills such as clogged thrombotic complications in risky women). Hormone replacement treatment (HRT) Shared Etoricoxib 120mg with the replacement treatment of conjugated hormones (0.625mg premarintm) in 28 days increases AUC - 24 hours in stable state of non -conjugate estrogen (41%), Equilin (76%) and 17 B - Estradiol (22%). There is no research with long -lasting Etoricoxib 30mg, 60mg and 90mg. The effect of Etoricoxib 120mg on exposure (AUC0 - 24 hours) on premarin estrogen components is less than half of the observed people when using premarin alone and the dose increases from 0.625 - 1.25mg. Precautions when taking drugs
General caution
Warning about excipients
The ability to drive and operate machinery
Pregnancy and nursing mothers
Other special subjects (elderly, children, allergies)
Drug interaction
Prednison Prednisolon
In drug interactive research, Etoricoxib has no clinically important effects on pharmacokinetics of Prednison Prednisolon.
digoxin
Etoricoxib dose 120mg/time/day for 10 days does not change AUC - 24 hours of plasma or renal excretion in a stable state of digoxin in healthy volunteers. Digoxin's cmax increases about 33%.
This increase is usually not important in most patients. However, patients with high risk of digoxin toxicity should be monitored when used in combination with etoricoxib and digoxin.
Effects of Etoricoxib on metabolic drugs by sulfotransferase
Etoricoxib is an inhibitor of sulfotransferase in humans, especially sultie1, and has shown the effect of increasing the serum concentration of Ethinyl estradiol.
Although the data is limited and clinically, it is still being studied, it is best to be careful when using Etoricoxib with other drugs that are metabolized mainly by sulfotransferase in humans (such as oral salbutamol and minoxidil).
Effects of Etoricoxib on metabolic drugs by ISOENZYM CYP
According to In vitro research, Etoricoxib does not inhibit the P450 (CYP) 1A2, 2C9, 2019, 2D6, 2E1, or 3A4. In a healthy subject, Etoricoxib dose 120mg/day does not change the activity of CYP3A4 in the liver when evaluated by Erythromycin test through breath.
Effects of other drugs on Etoricoxib pharmacokinetics
Etoricoxib's main metabolic path depends on the CYP enzymes. It seems that CYP3A4 contributes to Etoricoxib in Vivo. In vitro research shows that CYP2D6, CYP2C9, CYP1A2 and CYP2C19 can also be a catalyst for the main metabolic path, but their role has not been studied in Vivo.
ketoconazole
When using ketoconazole, a strong CYP3A4 inhibitor, at a dose of 400mg/time/day for 11 days in healthy volunteers, there is no significant influence on any clinical pharmacokinetics for single -dose of Etoricoxib 60mg (up 43% AUC).
voriconazole and miconazole
Shared Etoricoxib and Voriconazole oral or miconazole gel, CYP3A4 strong inhibitors, slightly increasing Etoricoxib exposure, but does not mean clinically based on the published information.
rifampicin
Shared Etoricoxib and Rifampicin, a network induction of CYP enzymes, reducing plasma Etoricoxib levels 65%. This interaction can lead to reproduction of symptoms when using Etoricoxib and Rifampicin.
Although this interactive information shows an increase in Etoricoxib dose, Etoricoxib does not recommend that the dose is higher than the recommended dose above due to no research.
antacids
Etoricoxib's non -dynamic antacids have clinical significance.
Storage
You should store at room temperature, avoid moisture and avoid light. No storage in the bathroom or in the freezer.
You should remember that each drug may have different storage methods. Therefore, you should read carefully storage instructions on the packaging or ask the pharmacist.
Keep pills out of reach of children and pets.
Expiry date: 36 months from the date of manufacture.
Other drugs
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