Xibraz-90 Tablet Aristopharma reduces symptoms of osteoarthritis (2 blisters x 15 tablets)

Dosage form Box of 2 blisters x 15 tablets
Specifications Etoricoxib

Ingredient

Composition informationContent
Etoricoxib90mg

Uses

Indications

Xibraz-90 Tablet is indicated in the following cases:

  • reduce symptoms in cases of osteoarthritis, rheumatoid arthritis , stiff spine, pain and inflammation in acute gout. Through clinical trials, Etoricoxib selectively inhibits the COX-2 dependent and does not inhibit COX-1 at the dose of 150mg daily. This substance does not inhibit the synthesis of prostaglandin and does not work on platelets.

    Cycloxigenase plays an important role in prostaglandin. The two homosexuals have been identified as COX-1 and COX-2. COX-2 is the onset of the enzyme that reduces inflammation and is thought to be the main responsibility in the synthesis of the intermediate substances of this process such as pain, inflammation and fever. COX-2 is also related to ovulation, regulating kidney function and central nervous system function (reducing fever, pain and cognitive function). It may have a role in healing ulcers. Cox-2 is determined in tissues around the gastrointestinal ulcer in humans but evidence of healing effects has not been published.

    pharmacokinetic

    absorption

    Etoricoxib is well absorbed by oral. The absolute bioavailability of the drug is almost 100%. When using the 120mg dose once a day in young people, plasma peak concentration (cmax = 3.6mcg/ml) TMAX is about 1 hour when taking the drug when hungry. The area below the plasma concentration curve (AUC0-24H) is 37.8mcg hours/ml. Pharmacokinetic properties of linear Etoricoxib in the dose range.

    Use with food (high fat meals) has no effect on expanding the absorption of Etoricoxib when taking the dose of 120mg. The absorption rate is affected, resulting in reducing plasma peak concentration by about 36% and increasing TMAX by about 2 hours.

    Distribution

    Etoricoxib is attached to plasma proteins about 92% in the concentration of 0.05 to 5mcg/ml. The distribution voltage in a stable state (VSS) is about 120 liters on humor. Etoricoxib passes through the placenta in mice and rabbits, and through the bloody barrier in the mouse.

    Metabolism

    Etoricoxib is strongly metabolized with less than 1% of the original form found in the urine. The main metabolic path is to form 6′-hydroxymethyl substance due to the catalyst is the CYP430 enzyme system. CYP3A4 is an Etoricoxib conversion agent in vivo. In vitro studies show that CYP2D6, CYP2C9, CYP1A2 and CYP2C19 can also catalyze the main metabolic path, but no In Vivo studies evaluate their role level.

    5 metabolites have been identified on humans. The main metabolic substance is Etoricoxib's 6′-carboxylic acid. These main metabolites have almost no selective inhibition of COX-2 or are very weak. No metabolites inhibit COX-1.

    Elimination

    Etoricoxib elimination takes place almost only by the excretion of the metabolites through the kidneys. When using the 120mg daily dose, Etoricoxib's stable concentration is achieved after 7 days, the cumulative ratio is about 2, the sale time is about 22 hours. Plasma clearance after intravenous injection of 25mg is estimated at about 50ml/min.

    on some patients

    Older people

    Pharmacokinetic properties in the elderly (from 65 years of age) similar to young people.

    Gender

    Pharmacokinetic properties in similar male men in women.

    Reduce liver function

    In patients with mild liver function (Child -Pugh score from 5 to 6 points), using Etoricoxib about 60mg daily for AUC average is 16% higher than healthy people using the same dose. In patients with average liver function reduction (chlid -pugh points from 7 to 9 points) when using Etoricoxib 60mg dose every 2 days for AUC average similar to healthy people, not studying the 30mg dose on this object. There is no clinical data in patients with serious liver function (Child-Pugh ≥ 10).

    Reduce kidney function

    Etoricoxib kinetics when using 120mg in patients with medium to severe renal failure and patients with end -stage renal disease must be significantly different from healthy people. Dialyer kidney contributes negligible to the elimination of Etoricoxib (the clearance of nearly 50ml/minute).

    Children's patients

    There is no study of Etoricoxib's pharmacological properties in children's patients ( 60kg used 90mg daily dose once different from adults used every 90mg daily dose. Etoricoxib's safety and effectiveness in children has not been studied.

  • Before taking Xibraz-90 Tablet Aristopharma reduces symptoms of osteoarthritis (2 blisters x 15 tablets)

    How to use

    Etoricoxib Used orally, can be used with or not with food. The onset of Etoricoxib may be faster if used away from the meal. This should be considered when it is necessary to quickly reduce symptoms.

    Cardiovascular risks can increase according to the dose throughout the use of Etoricoxib, so the lowest dose is effective and in the shortest possible time. Patients need to be treated symptoms and respond well to treatment should be regularly checked, especially in osteoarthritis patients.

    Dosage

    Adults

    osteoarthritis

    The recommended dose is 30mg once a day. Patients who do not respond to this dose may increase the dose to 60mg to increase efficiency. If still does not improve the effectiveness of treatment, consider other treatment options.

    rheumatoid arthritis

    The recommended dose is 90mg once a day.

    Acute gout inflammation

    The recommended dose is 120mg once a day. Etoricoxib is used to reduce symptoms during the outbreak and do not use more than 8 days.

    Stiff spine inflammation

    The recommended dose is 90mg once a day. In the above indications, the higher dosage is not effective or has not been studied.

    Therefore:

  • Do degenerative degenerative dose should not exceed 60mg.

    No need to adjust the dose on the elderly.

    Reduce liver function

    In patients with mild liver function reduction (Chlid -Pugh points from 5 to 6 points), do not exceed the dose of 60mg once a day for any indications. In patients with average liver function (Chlid -Pugh point from 7 to 9 points) should not exceed the dose of 6 mg every 2 days, should consider the dose of 30mg once a day.

    Clinical trials are limited, especially in patients with moderate liver function impairment and thus need to be cautious. There is no clinical data in patients with severe liver function impairment (Chlid-Pugh point is from 10 or more), so it is necessary to contraindicate on these patients.

    Reduce kidney function

    No dose adjustment in patients with creatinine clearance> 30mi/minute. Contraindicated in patients with creatinine clearance below 30ml/min.

    Children's patients

    Contraindicated Etoricoxib in 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? Although there are side effects that have not been reported in most cases, there are still acute allowances due to Etoricoxib overdose. Most common side effects are in accordance with Etoricoxib's clinical records (namely events on the digestive tract, kidney events).

    If the overdose situation occurs, it is necessary to take ordinary measures such as pushing the absorbed pharmaceutical parts from the digestive tract, clinical control, and starting to take supportive measures, if necessary.

    Can not separate Etoricoxib by appraisal measures (hemorrhage), it is unclear whether to separate Etoricoxib by abdominal appraisal measures.

    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 Xibraz-90 Tablet, you may experience unwanted effects (ADR).

    Common
  • Metabolic and nutrition disorders: Keeping water, edema.
  • Nervous system disorders: headache, dizziness.
  • Heart disorders: Brushing the chest.
  • Bloody disorders: Hypertension.
  • Gastrointestinal disorders: Gastrointestinal disorders (namely abdominal pain, heartburn, flatulence), diarrhea, indigestion, abnormalities, nausea.

  • Skin and epidermal disorders: Hematoma.
  • Less

  • Infection and parasitic infection: gastritis, upper respiratory tract infection, urinary tract.
  • Metabolic and nutrition disorders: Increase or decrease appetite, weight gain.
  • Mental disorders: anxiety, depression, awareness.

  • Nervous system disorders: annoying taste, insomnia, drowsiness.
  • visual disorders : blurred vision, lemonitis.

  • Disorders of ear and inner ears: tumor, balance disorders.
  • heart disorders: Atrial fibrosis, congestive heart failure, changes on nonsense electrocardiograms, myocardial infarction.
  • Bloody disorders: Flushing, stroke, transient ischemic attacks.

  • Respiratory, chest, mediastinum disorders: cough, shortness of breath, nosebleeds.
  • Gastrointestinal disorders: Acid reflux, constipation, dry mouth, colitis, irritable bowel syndrome, esophagitis, mouth ulcers, vomiting, gastritis.
  • Skin and epidermal disorders: Peripheral edema, itching, skin burning.
  • Very rare

  • Immune disorders: Hypersensitivity reactions, including angiography, hypersensitivity reactions such as anaphylaxis.
  • Mental disorders: Disorders, hallucinations.

  • Vascular disorders: acute hypertension.
  • Respiratory, chest, mediastinum disorders: bronchospasm.

  • Gastrointestinal disorders: Gastrointestinal ulcers include perforation and gastrointestinal hemorrhage (mainly in the elderly).
  • Hepatitis: Hepatitis.

    Skin and epidermal disorders: urticaria, Stevens-Johnson syndrome.

    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

    Xibraz-90 Tablet contraindicated in the following cases:

  • Hypersensitivity to any ingredients of the drug.
  • Are suffering from gastrointestinal inflammation or gastrointestinal bleeding.
  • Patients with a history of bronchospasm, acute rhinitis or nasal polyps, vasodilic edema, urticaria, allergic reactions when using acetylsalicylic acid or NSAIDs including COX -2 inhibitors (cyclooxygenas -2).

    Pregnant and lactating women.

    Severe liver function reduction (plasma albumin

  • Estimates of creatinine clearance
  • Children and teenagers under 16 years old.
  • Inflammation.
  • NYHA II-IV).

  • Patients with untreated hypertension.
  • Patients are determined to have ischemic heart disease, peripheral artery disease, and/or cerebrovascular disease.

    Precautions when using

    impact on the digestive system

    The above gastrointestinal disorders (such as perforation, inflammation or ulcer - pubs), several such deaths occurred when using Etoricoxib.

    It is necessary to use caution when used to treat patients at high risk in gastrointestinal disorders when using NSAIDs, the elderly, the patient is simultaneously using any other NSAIDs or acetylsalicylic acid or patients with a history of previous gastrointestinal diseases such as ulcers or digestive bleeding.

    When using Etoricoxib simultaneously with acetylsalicylic acid (even if the dose is low), the risk of side effects can be increased on the gastrointestinal tract (gastrointestinal ulcers or other disorders). There are no long-term clinical trials that show any significant differences in the safety of the digestive tract between combination of COX-2 and acetylsalicylic acid inhibitors compared to an NSAIDs and acetylsalicylic acid.

    impact on the cardiovascular system

    Clinical trials show that the selective inhibitors of COX-2 may be related to thrombosis (especially myocardial infarction (MI) and stroke), when compared to Placeboo and a few other NSAIDs. Because the cardiovascular risk of Etoricoxib increases with the dose and time of use, it should be used in the shortest possible time and with the lowest dose effectively. Patients with symptoms treated and responded to drugs should be re -evaluated most often are osteoarthritis patients.

    Patients with significant risks for cardiovascular events (namely hypertension, high blood lipid, diabetes, smoking) should be carefully considered before starting treatment with Etoricoxib.

    Selective inhibitors cannot replace Acetylsalicylic acid in preventing blood vessels because they have no anti-platelet effect. Therefore, anti -platelets should not be used.

    impact on the kidneys

    Prostaglandin in the kidneys plays a clear role in maintaining the activity of the kidney. Therefore, using Etoricoxib can reduce prostaglandin, and then reduce blood flow to the kidneys, thereby leading to renal function. Patients with the highest risk of this problem are patients with renal function in advance, loss of heart failure, or cirrhosis. Need to manage kidney function in this object.

    Keeping water, edema and hypertension.

    For drugs that are determined to prevent prostaglandin synthesis, water retention effects, edema and hypertension of Etoricoxib. All NSAIDs drugs, including Etoricoxib, may be related to recurrence or onset of congested heart failure muscles, need to be concerned about the information about the dose related to Etoricoxib. Be careful in patients with a history of heart failure, left ventricular dysfunction, or hypertension or edema for all causes.

    If there are evidence that the patient's worsening, a number of measures should be taken, including the discontinuation of Etoricoxib.

    Etoricoxib may increase the frequency as well as the severity of hypertension rather than other NSAIDs as well as COX-2 selection, especially with high doses. Therefore, it is necessary to control hypertension before Etoricoxib treatment and regular blood pressure monitor during treatment. Blood pressure control is needed for 2 weeks after the start of treatment with Etoricoxib, and periodically. If there is significant hypertension, there should be some changes in the treatment regimen.

    Effects on the liver

    The increase in Alt liver enzymes (Alanin Aminotransferase) and/or AST (Aspartat Aminotransferase) is about 3 times the maximum allowed amount recorded on more than 1% of the case with clinical Etoricoxib treatment for 1 year at a dose of 30, 60, 90mg per day. Any case with symptoms or signs of liver function impairment, or test results show that the abnormal activity of the liver should be strictly managed. If these signs occur, Etoricoxib is needed. Etoricoxib may obscure the symptoms of fever or other symptoms of inflammation.

    The ability to drive and operate machinery

    There has been no research on the influence of Etoricoxib on the ability to drive and operate machinery. However, patients with dizziness, dizziness, and drowsiness when using Etoricoxib should limit driving and operating machinery.

    Pregnancy

    Similar to other drugs in the selective inhibitor group Cox-2, Etoricoxib are not indicated for pregnant women to prepare for birth.

    There is no clinical data on Etoricoxib exposure on pregnant mothers. Animal studies have shown toxicity. The likelihood of human risk is not clear. As other prostaglandin synthesis inhibitors, etoricoxib can cause an early uterine tone to close the fetal artery in the last 3 months of pregnancy. Contraindicated Etoricoxib on pregnant women. If women are pregnant during treatment with Etoricoxib, they must stop using this drug.

    Breastfeeding period

    It is unknown whether Etoricoxib will be secreted into the milk gland. Etoricoxib has the secretion of the mouse milk glands. The mother is using Etoricoxib not to breastfeed.

    Drug interaction

    Etoricoxib metabolism through cytochrom P450's enzyme system. When used simultaneously with this inhibitor or induction this enzyme can lead to changes in the plasma concentration of Etoricoxib. In addition, In vitro studies show that a few other enzymes can also intermediate the metabolism of Etoricoxib. Rifampicin, a liver enzyme induction can reduce the concentration of Etorieoxib in plasma. Etoricoxib increases the plasma concentration of ethinylelestradiol. Etoricoxib's interaction with other drugs such as oral salbutamol and minoxidil can also occur because these drugs are also specialized in the same enzyme with Etoricoxib.

    NSAIDS drug interaction includes an increase in the impact of oral anticoagulants (namely azapropazon and phenylbutazon) and increases the plasma concentration of lithium, methotrexate, and heart glycosides. The risk of kidney toxicity can be increased if used with medications inhibitors, ciclosporin, tacrolimus, or diuretics. Impact on kidney function can lead to reducing the excretion of some other drugs. It is also possible to supplement diuretics to keep potassium. In addition, it can reduce the anti -hypertension effect of enzyme inhibitors, beta blockers and diuretics. Convulsions may occur if used with quinolones. NSAIDs can increase the effects of phenytoin and sulfonylurea diabetes. Avoid simultaneous use of 2 or more NSAIDs (including aspirin) because it is likely to increase the risk of side effects, especially bleeding or gastrointestinal ulcers.

    Do not use NSAIDs because of the increased risk of drug interactions. The risk of stomach bleeding and ulcers associated with NSAID increases when used with corticosteroids, SSRIs, Snri Venlafaxin, platelet cancellation drugs Clopidogrel and Iloprost, Erlotinib, Sibutramine or possibly alcohol, bishosphate or pentoxifyllin. The risk of poisoning may be increased if zidovudin is used with NSAID drugs. Ritonavir may increase NSAID concentration in plasma. Mifepriston inhibits the synthesis of Prostaglan NSAID or Aspirin can change the effectiveness of Mifepriston.

    Occasionally have an adverse effect when using the NSAID group with Misoprostol, although such a combination is sometimes used to reduce the toxicity of the stomach and intestines.

    Storage

    Store in dry places, avoid light, temperatures below 30 ° C.

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