Arcoxia 120mg MSD treatment of osteoarthritis, rheumatoid arthritis (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Etoricoxib
Ingredient Gout, dysmenorrhea, osteoarthritis, joint spondylitis, rheumatoid arthritis

Ingredient

Composition information	Content
Etoricoxib	120mg

Uses

indications

Arcoxia 120mg drugs are indicated in the following cases:

Acute and chronic treatment of signs and symptoms of osteoarthritis (Osteoarthritis (OA) and rheumatoid arthritis (Rheumatoid Arthritis - RA). Arthritis).

Pharmacokic

Arcoxia is an non -steroid anti -inflammatory drug (NSAID) with anti -inflammatory, analgesic and fever -reducing activity in animal models. Arcoxia is a strong, very selective Cycloxygenase-2 (COX-2) inhibitor, which is active when taken within the scope and is higher than the clinical dose range. Cycloxygenase has been identified: Cycloxygenase-1 (COX-1) Cycloxygenase-2 (COX-2).

COX-1 is responsible for normal physiological functions through prostaglandin intermediaries such as protecting the gastric mucosa and platelet aggregation. Cox-1 inhibition due to the same NSAIDs is often accompanied by stomach damage and platelet inhibition.

It has been shown that COX-2 is mainly responsible for the synthesis of the intermediate substances of prostanoic acid that causes 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.

In all clinical studies, Arcoxia has the effect of inhibiting COX-2 depending on the dose of use without inhibiting COX-1 when using the dose up to 150 mg daily.

The effect of protecting the gastric mucosa of COX-1 is also assessed in a clinical study with gastric biopsy samples collected from the object used or Arcoxia 120 mg daily, or Naproxen 500 mg twice a day, or Placebo to assess the aggregate prostaglandin.

Compared to Placebo, Arcoxia does not inhibit prostaglandin synthesis in the stomach. In contrast, Naproxen inhibits the synthesis of prostaglandin in the stomach up to nearly 80% when compared to Placebo. This data proves the selection of Cox-2 of Arcoxia.

Platelet function

Bleeding time is not affected when using Arcoxia multiple doses of up to 150 mg daily for 3 days compared to Placebo. Similarly, bleeding time is not changed in a single dose study with Arcoxia 250 or 500 mg.

In experimental cells living outside the body (EX Vivo), there is no inhibition of arachidonic acid or platelet aggregation due to collagen induction in a stable state with ARCOXIA doses up to 150 mg. These findings are consistent with the selection of Etoricoxib for COX-2.

pharmacokinetics

absorption:

Etoricoxib is well absorbed by oral. The oral average is nearly 100%oral. After taking the dose of 120 mg once a day until it reaches a stable state, the peak concentration in plasma (cmax = 3.6 mcg/ml) is recorded nearly 1 hour after the adults take the drug when hungry. AUC0-24 hours is 37.8 mcg · hours/ml. Mobile pharmacokinetics of linear Etoricoxib with clinical dose range.

Normal meals have no clinical significance to the level or absorption rate of 1 dose of Etoricoxib 120 mg. In clinical trials Etoricoxib are not related to food.

Etoricoxib pharmacokinetics in 12 healthy subjects are the same (equivalent to AUC, CMAX within a difference of 20%) when taking solitary drugs, when used with antacids containing magnesi/aluminum hydroxide, or antacids containing Carbonate (ability to neutralize acid approximately 50 MEQ).

Distribution:

About 92% of the dose of Etoricoxib attached to protein in human plasma when used within the concentration of 0.05 - 5 mcg/ml. The distribution is in a sustainable state (VDSS) about 120 liters in humans. Etoricoxib passed through the placenta in the rats and rabbits and passed through the bloody barrier in the rat.

Metabolism:

Etoricoxib is strongly metabolized with

The main metabolic substance is Etoricoxib's 6’-carboxylic acid derivatives formed from oxidation of 6’-hydroxymethy derivative. These main metabolites manifest or have no active measurable or only active as COX-2 inhibitors. These metabolites do not inhibit COX-1.

Era:

After intravenously an intravenous tent of 25 mg 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 are found in non -metabolic drugs. The majority of Etoricoxib is excreted mainly through metabolism, then through the excretion in the kidney.

Etoricoxib's concentration in a sustainable state is achieved within 7 days of treatment when taking a dose of 120 mg once a day, with accumulated ratios of nearly 2, corresponding to the accumulated waste duration of about 22 hours. It is estimated that the removal of drugs in plasma is approximately 50 ml/min.

Before taking Arcoxia 120mg MSD treatment of osteoarthritis, rheumatoid arthritis (3 blisters x 10 tablets)

How to use

arcoxia is used by oral, can be used or not with food.

Arcoxia 120mg should be used in the shortest possible time and with the lowest daily dose that is effective.

Dosage

osteoarthritis:

The recommended dose for adults is 30 mg or 60 mg once a day.

rheumatoid arthritis:

The recommended dose for adults is 60 mg or 90 mg once a day. The minimum daily dose works every 60 mg.

In some patients, the dose of 90 mg once a day may provide an increase in the benefits of therapy.

A joint vertebrae:

The recommended dose for adults is 60 mg or 90 mg once a day. The minimum daily dose works every 60 mg.

In some patients, the dose of 90 mg once a day may provide an increase in the benefits of therapy.

Acute phosphorus arthritis:

The recommended dose for adults is 120 mg once a day.

should only use Arcoxia 120mg in the acute symptoms, with a maximum treatment time of 8 days.

Acute pain and abnormal dysmenorrhea:

The recommended dose is 120 mg once a day.

Should only use Arcoxia 120mg in a period of acute symptoms, with a maximum treatment time of 8 days.

Pain after dental surgery:

The recommended dose is 90 mg once a day, maximum use for 3 days, some patients may need to use more painkillers.

Doses higher than the recommended dose for each of the above appointments still do not increase the effectiveness of the drug or have not been studied. Hence:

Dose in osteoarthritis does not exceed 60 mg daily.

Dosage in rheumatoid arthritis does not exceed 90 mg daily.

Dosage in joint vertebrae should not exceed 90 mg daily.

Dosage in acute leprosy disease must not exceed 120 mg once a day.

Dosage in acute pain and abolished dysmenorrhea must not exceed 120 mg/day.

Dosage in pain after dental surgery must not exceed 90 mg daily.

Because cardiovascular risks can increase according to the dose and time of using COX-2 selective inhibitors, therefore should take the drug in the shortest possible time and use the lowest daily dosage. It is advisable to re -evaluate the demand for symptoms and respond to patients.

Elderly, gender, race: No need to adjust the arcoxia dose in the elderly or based on gender or race.

Hepatic failure: In patients with mild liver failure (Child-Pugh 5-6 score), the dose should not exceed 60 mg once a day. In patients with average liver failure (Child-Pugh score 7-9), the dose should not be reduced, should not exceed the dose of 60 mg once a day, can also consider the dose of 30 mg once a day. There is no clinical document or pharmacokinetics when taking drugs in patients with severe liver failure (Child-Pugh> 9).

Renal failure: It is not recommended to treat Arcoxia in patients with progressive renal disease (creatinine clearance ratio

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 do

do when using overdose? There have been reports on the use of acute Etoricoxib, but there is no report on adverse effects occurring in most cases of overdose.

The most common adverse effects recorded are in line with the safety characteristics of Etoricoxib (such as the effects on the gastrointestinal tract, on the kidney blood vessels). In case of overdose, reasonable is that it is advisable to apply commonly used support measures, such as removing substances that have not been absorbed from the digestive tract, clinical monitoring and supportive treatment, if necessary.

cannot remove Etoricoxib by blood decomposition, it is not known whether it is possible to use peritoneal fertilizer to remove Etoricoxib.

What to do when forgetting 1 dose?

Not recorded.

Side Effects

When using Arcoxia 120mg, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Nervous system: weakness, fatigue, dizziness, headache.

Digestive system: indigestion, heartburn, nausea.

Liver: increase AST, increase ALT.

cardiovascular system: Hypertension.

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

Arcoxia 120mg contraindications in the following cases:

Hypersensitivity to any ingredient of the drug.

History of asthma, urticaria or allergic reactions after taking aspirin or other nonsteroidal anti -inflammatory drugs (NSAID).

SECRETING HEART (NYHA II - IV).

Patients with high blood pressure with continuous blood pressure increased over 140/90 mmHg and has not been fully controlled.

Ischemic heart disease, peripheral artery disease and/or cerebrovascular disease have been identified (including new patients undergoing coronary graft surgery or blood vessel shaping).

Severe liver dysfunction (serum albumin

Active gastrointestinal ulcers or bleeding (GI) digestion.

Creatinine clearance

Pregnant and lactating women.

Children under 16 years old.

Do not use Arcoxia as a combined therapy with other nonsteroidal anti -inflammatory drugs (NSAID) because there is no sufficient evidence to prove the benefits and adverse side effects may encounter.

Be cautious when used

Risk of cardiovascular thrombosis: nonsteroidal anti -inflammatory drugs (NSAIDs), non -aspirin, body glucose, may increase the risk of cardiovascular thrombosis, including myocardial infarction and stroke, which can lead to death. This risk can 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 need to be warned of symptoms of serious cardiovascular events and need to see a doctor as soon as they appear.

To minimize the risk of adverse events, Arcoxia is needed at the lowest daily doses in the shortest possible time as possible.

Clinical trials that suggest a group of COX-2 inhibitors may be accompanied by an increased risk of thrombotic events (especially myocardial and stroke infarction). Compared to Placebo and some nonsteroidal anti -inflammatory drugs (Naproxen).

should only use Etoricoxib after careful consideration in patients with significant risk factors for cardiovascular events (such as hypertension, hyperlipidemia, diabetes, smoking).

Cox-2 selective inhibitors are not aspirin replacement substitutes in cardiovascular disease because it does not work on platelets. Because Etoricoxib is a member of this drug group, has no effect on inhibiting platelet aggregation, so it is not allowed to stop platelets.

The risk of adverse effects in the stomach - intestines (stomach - intestinal ulcers or other complications in the stomach - intestines) increases when using Etoricoxib, other COX -2 selective inhibitors and other nonsteroidal anti -inflammatory drugs (NSAID) at the same time as acetylsalicylic acid (even at low doses).

The relative difference in stomach safety between the regimen of the selective inhibitors of COX -2 + acetylsalicylic acid compared to NSAID + acetylsalicylic acid has not been fully evaluated in long -term clinical trials.

It is not recommended to use Arcoxia treatment for patients with severe renal disease. Clinical experience in patients with creatinine clearance ratio is estimated

Long -term use NSAID causes kidney necrosis and other kidney damage. Prostaglandin produced in the kidneys may have a role in compensating for the maintenance of kidney perfusion. Therefore, under the conditions of reducing renal perfusion, the use of Arcoxia can reduce the establishment of prostaglandin and reduce blood flow to secondary kidneys and thus reduce kidney function.

Patients with the highest risk of this reaction are those who have decreased kidney function, people with heart failure, or people with significant previous cirrhosis. It is advisable to consider monitoring kidney function in such patients. Like other drugs that inhibit prostaglandin, the discontinuation of arcoxia will lead to restoration of the condition before treatment.

Needs on the beginning of Arcoxia treatment in patients with significant dehydration. Patients should be rehydrated before starting Arcoxia.

As other drugs have the effect of inhibiting prostaglandin synthesis, water retention, edema and hypertension are also recorded in several patients using Arcoxia. This should be taken into account the ability to retain water, edema or hypertension when using Arcoxia for patients already have water retention, hypertension or heart failure. All nonsteroidal anti -inflammatory drugs (NSAID) including Etoricoxib may be related to a new onset or congestive heart failure.

Etoricoxib can coordinate with more frequent and worse hypertension, compared to some NSAIDs and other COX-2 selective inhibitors, especially when taking high doses. Therefore, special attention comes to check blood pressure during treatment with Etoricoxib. If blood pressure increases significantly, other treatments must be considered.

The doctor should know that each patient may develop ulcers/ complications of the gastrointestinal ulcer, regardless of treatment. Despite not rule out the risk of toxicity for the digestive tract when using Arcoxia, the results of the Medal program have shown in patients with Arcoxia therapy, the risk of toxicity for the digestive tract when using Arcoxia 60 mg or 90 mg once a day is noticeable than using DiClofenac 150 mg daily.

In clinical research with Ibuprofen and Naproxen, the risk of gastrointestinal ulcer has been detected through endoscopy patients using Arcoxia 120 g once a day, lower than patients using these unstable NSAIDs.

While the risk of gastrointestinal ulcers detected by lowoscopy in patients with Arcoxia 120 mg, this risk is higher in patients using Placebo. The ulcer/ complications of the gastrointestinal ulcer is recorded in patients with Arcoxia and can occur at any time during the treatment period and there are no warning symptoms.

Patients with a history of perforation, ulcers and gastrointestinal bleeding and patients more than 65 years are known to have a higher risk of these events, regardless of treatment.

About 1% of patients in clinical trials using Arcoxia 30, 60, and 90 mg per day lasting up to 1 year have increased Alanine Arrinotransfern 80 (ALT) and/or Aspartate Aminotransferase (AST) (approximately ≥ 3 times the maximum normal level).

In clinical testing groups using other active ingredients, AST and/or ALT ratios increased in patients using Arcoxia 60 and 90 mg daily, similar to patients using Naproxen 1,000 mg daily, but noticeable lower than the DiClofenac 150 mg daily. The increase in these enzymes has completely cured in patients with Arcoxia therapy, with about half of the patient who increases liver enzymes while still taking the drug.

In clinical trials with control of ARCOXIA 30 mg daily with ibuprofen 2,400 mg daily or Celecoxib 200 mg daily, the rate of ALT or AST increases are the same in groups.

Should test for abnormal liver function assessment in patients with symptoms and/or signs of suggesting liver dysfunction, or in people who have abnormal liver function tests. Arcoxia therapy must be discontinued if the liver function test is constantly abnormal (3 times the maximum maximum level).

Should use Arcoxia carefully in patients who have had acute asthma attacks, urticaria, or previous rhinitis due to induction with salicylate drugs or non -selective cyclooxygenase inhibitors. Because the pathology of these reactions is not well known, the doctor needs to consider the potential benefits of Arcoxia therapy compared to the risks.

When using Etoricoxib in the elderly and in patients with kidney, liver or heart dysfunction, it is necessary to maintain appropriate medical care regime. If these patients have worsened the disease gradually during treatment, they must take appropriate measures, including therapeutic discontinuation.

In after-sales surveillance, it is very rare for serious skin reactions, which some reactions can be fatal, including flaky dermatitis, Stevens-Johnson syndrome and dedicated necrosis occur when using NSAID and some COX-2 inhibitors. These serious side effects may occur without notice. It seems that the patient has the highest risk of these reactions early during treatment: Most cases have a reaction on the first month of treatment.

There have been reports of severe sensitivity reactions (such as anaphylactic reactions) in patients using Etoricoxib. Some selective inhibitors of COX-2 are often in combination with increased risk of skin reactions in patients with a history of allergies.

It is necessary to stop Etoricoxib therapeutic when starting to show signs of skin rash, mucosal lesions or any other signs of hypersensitivity reactions, Arcoxia can cover symptoms of fever, a sign of infection. Doctors should know this problem when taking Arcoxia for patients who are treating infections.

The ability to drive and operate machinery

There is no information to suggest Arcoxia affect the ability to drive or operate the machine when the patient is taking the drug. Patients with dizziness, dizziness, mud sleeping when using Etoricoxib should limit driving and operating machinery.

Pregnancy

like other drugs that inhibit the synthesis of prostaglandin, should avoid using Arcoxia in the last months of pregnancy because it can cause early clitching of arterioscleros.

Research to toxicity on fertility is conducted in rats has proved that there is no evidence of abnormalities in the development of embryos when taking the drug up to 15 mg/kg/day (approximately 1.5 times the dose in 90 mg based on body contact).

In the doses of approximately twice the contact dose in adults (90 mg) based on systemic contact, it is noted that the low rate of cardiovascular deformities and increased abortion after fertilization in rabbits treated with Etoricoxib. No effect on embryo development when the body contact is nearly or inferior to daily doses in humans (90 mg).

However, animal fertility studies are not always predicted in humans. There are no appropriate studies and good control in pregnant women. ARCOXIA should only be used in the first two quarters of pregnancy when the potential benefits are more than possible to the fetus.

Reproduction: Etoricoxib, as well as other COX-2 inhibitors, avoiding for women who are pregnant.

breastfeeding period

Etoricoxib is excreted in mother mouse milk. It is still not known whether this drug will excrete in human milk or not.

Because there are many drugs excreted in human milk and because of the side effects of prostaglandin synthetic inhibitors may occur in breastfeeding, depending on the importance of the mother for the mother, decide or stop breastfeeding or stop taking the drug.

Drug interaction

warfarin:

In stable objects with chronic warfarin therapy, the 120 mg Arcoxia regimen per day is usually associated with an increase of about 13% of the international standard chemical ratio of prothrombin time (International normized ratio - INR). The regular test should be checked at the beginning or change of treatment with Arcoxia, especially in the first few days in patients using warfarin or similar drugs.

rifampin:

Use Arcoxia at the same time as rifampin, a strong induction substance that metabolism through the liver has reduced 65% of the area under the curve (AUC) that shows Etoricoxib concentration in plasma. This interaction should be taken into account when using Arcoxia at the same time as rifampin.

methotrexate:

There are 2 tests for the action of Arcoxia 60, 90 or 120 mg once a day in 7 days in patients taking methotrexate dose of 7.5 - 20 mg once a week to treat rheumatoid arthritis.

Arcoxia dose 60 and 90 mg does not affect methotrexate concentration in plasma (evaluated through AUC) or kidney removal. In a test, Arcoxia 120 mg does not affect the concentration of methotrexate in plasma (evaluated through AUC) or the removal of drugs through the kidney.

In the remaining test, Arcoxia 120 mg increases methotrexate levels in plasma to 28% (evaluated through AUC) and reduces the clearance of methotrexate through the kidney by up to 13%. Methotrexate toxicity should be monitored when using Arcoxia higher than 90 mg daily and using methotrexate therapy at the same time.

Diuretics, Angiotensin (ACE) and Angiotensin II (AIIA):

Suggested reports NSAID including selective inhibitors can reduce the effectiveness of hypertension of diuretics, ACE inhibitors and Angiotensin II antagonists. Should pay attention to this interaction when using Arcoxia at the same time as these drugs.

In some patients with renal function (such as elderly patients or patients with loss of circulatory fluid, including patients using diuretic therapy) taking nonsteroidal anti-inflammatory drugs, including COX-2 inhibitor, simultaneous use These effects can often be recovered. Therefore, be careful when combining drugs, especially the elderly.

Lithi:

Suggested reports of NSAIDs are not selective and COX-2 inhibitors may increase lithium concentration in plasma. This interaction should be taken into account when patients use Arcoxia at the same time as lithium.

aspirin:

Can use Arcoxia at the same time as low -dose aspirin to prevent cardiovascular disease. In sustainable state, Etoricoxib 120 mg once a day does not affect the activity of platelet resistance of low -dose aspirin (81 mg once a day). However, using low -dose aspirin simultaneously with Arcoxia increases the rate of gastrointestinal ulcers or other complications compared to the use of single -treatment Arcoxia.

contraceptive pill:

Arcoxia 60 mg is used at the same time as a contraceptive tablet containing 35 mcg ethinyl estradiol and 0.5-1 mg norethindrone in 21 days has increased the AUC-24 hours of Ethinyl Estradiol in a stable state of up to 37%. The AUC-24 of Ethiny Estradiol in a sustainable state has increased by 50-60% when Arcoxia 120 mg is used at the same time or 12 hours from this type of contraceptive pill.

It is necessary to take into account the increase in Ethinyl estradiol level when choosing a contraceptive pill with Etoricoxib. Increasing exposure to Ethinyl estradiol may increase the proportion of adverse effects that are often associated with using contraceptives (such as venous thrombosis in risky women).

Hormone replacement therapy:

Arcoxia 120 mg is used with hormone replacement therapy containing conjugated estrogen (0.625 mg premarintm) in 28 days, increasing the average AUC-24 hours in the sustainable state of non-conjugate estimates (41%), Equilin (76%) and 17-8-Eestradiol (22%). The impact of the recommended ARCOXIA doses (30, 60 and 90 mg) has not been researched.

The impact of Arcoxia 120 mg on concentration (AUC-24 hours) these estrogen components in premarintm is half less than the observed effect when using a single premarintm and when the drug increases from 0.625 to 1.25 mg.

still do not know the clinical significance of these increase and have no research and a higher dose premarintm coordination regimen with Arcoxia. It is advisable to increase the concentration of estrogen when choosing to replace postmenopausal hormones to use with Arcoxia.

Other drugs in studies on drug interaction. Arcoxia does not have clinically important effects on the dynamics of prednisone/prednisolone or digoxin. Antacids and ketoconazole (1 strong CYP3A4 inhibitor) do not have important effects on the clinical dynamics of Arcoxia.

Storage

Store below 30 degrees Celsius in the original packaging.

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