Arcoxia 60mg 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, joint spondylitis, rheumatoid arthritis

Ingredient

Composition information	Content
Etoricoxib	60mg

Uses

Indications

Arcoxia 60mg is used for treatment:

Acute and chronic treatment of signs and symptoms of osteoarthritis.

Treatment of joint spondylitis.

Treatment of acute phosphorus arthritis.

Acute and chronic analgesic.

Treatment of prospect of dysmenorrhea.

Pharmacokological

Arcoxia is an non -steroid anti -inflammatory drug (NSAID) with anti -inflammatory, analgesic, and fever in animal models.

Arcoxia is a strong, very selective, very selective, very selective, very selective, very selective, very selective, more active when taken within the scope of clinical dosage. Cycloxygenase has been identified: Cycloxygenase-1 (COX-1) and cyclooxygenase-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 non-selective NSAIDs is often accompanied by stomach damage and platelet inhibition. The COX-2 has been shown in 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 pharmaceutical 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 150mg daily.

Affects the protective activity of the gastric mucosa of COX-1, which is also assessed in a clinical study with gastric biopsy samples collected from the object using Arcoxia 120mg daily to evaluate Prostaglandin synthesis. 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: The cheek flowing time is not affected when using Arcoxia multiple doses of up to 150mg daily for 9 days compared to Placebo. Similarly, bleeding time is not changed in a single dose study with Arcoxia 250 or 500mg. 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 to 150mg. These findings are consistent with the selection of Etoricoxib for COX-2.

pharmacokinetic

absorption

Arcoxia is well absorbed by oral. The oral average is nearly 100%oral. After taking the dose of 120mg once a day until the state is stable, the peak concentration in plasma (average cmax cmax = 3.6mcg/ml) is recorded nearly 1 hour (TMAX) after adults take the drug when hungry. Average AUC 0 - 24 hours is 37.8mcg*hour/ml. Mobile pharmacokinetics of linear arcoxia with clinical dose range.

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

ARCOXIA 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 magnesium/aluminum hydroxide, or antacidic drugs containing calcium carbonate (the ability to neutralize acid approximately 50meq).

Distribution

About 92% of arcoxia dose with protein in human plasma when used within a concentration of 0.05 - 5mcg/ml. The distribution voltage in a sustainable state (VDSS) is about 120L in humans. Arcoxia passes through the placenta in rats and rabbits, and goes through the blood -brain barrier in the rat.

Metabolism

arcoxia is strongly metabolized with

There have been 5 metabolites identified in humans. The main metabolic substance is Arcoxia's 6’-carboxylic acid derivatives formed from oxidation of 6’-hydroxymethyl derivative. These main metabolites manifest or have no active measurable or only active as COX-2 inhibitors. These metabolites do not inhibit COX-1.

Elimination

After an intravenous injection of a single -dose of 25mg of Arcoxia has radioactive for 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 of the Arcoxia is excreted mainly through metabolism, then through the excretion in the kidneys. The concentration of Arcoxia 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 waste duration of about 22 hours. According to estimates, the removal of drugs in plasma is approximately 50ml/min.

Characteristics in patients (special population)

Sex: Pharmacokinetics of Arcoxia in men and women are the same.

Elderly: Pharmacokinetics in the elderly (≥ 65 years old) are similar to young people. No dose adjustment in elderly patients.

Race: Races do not create clinically important effects on the pharmacokinetics of Arcoxia.

Hepatic failure: In patients with mild liver failure (Child-Pugh 5-6 score), Arcoxia dose 60mg once a day with an average AUC higher than 16% higher than healthy objects using the same dose mode. Patients with average liver failure (Child-Pugh 7-9 score) used Arcoxia at a dose of 60mg every 2 days and had average AUC similar to the healthy object of Arcoxia 60mg once a day, the dose of Arcoxia 30mg once a day has not been studied in this population. There is no clinical document or pharmacokinetics when taking drugs in patients with severe liver failure (Child-Pugh> 9).

Kidney failure: ARCOXIA pharmacokinetics of single -dose 120mg in patients with medium - severe renal impairment and patients with end -stage renal disease are undergoing blood decentralization are not significant compared to dynamic pharmacokinetics in healthy subjects. Hematoparoology does not contribute significantly to the elimination of drugs (the clearance of drugs through the appraisal of about 50ml/minute).

Children's patients: Arcoxia's pharmacokinetics in children ( 60kg using Etoricoxib 90mg once daily, it is like a dynamic pharmacology in adults using Etoricoxib 90mg once daily. Arcoxia's safety and effectiveness has not been established in children's patients.

Before taking Arcoxia 60mg 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.

Dosage

conventional dose Arcoxia treat arthritis

Osteoarthritis: The recommended dose is 30mg or 60mg once a day.

rheumatoid arthritis: The suggested dose is 90mg once a day.

Age -adhesive spondylitis: The recommended dose is 90mg every day.

Acute phosphorus arthritis: The suggested dose is 120mg once a day. ARCOXIA 120mg should only be used in acute symptoms, with a maximum treatment time of 8 days.

Normal dosage Arcoxia to relieve pain

Acute pain and prehistoric dysmenorrhea: The recommended dose is 120mg once a day. ARCOXIA 120mg should only be used in acute symptoms, with a maximum treatment time of 8 days.

Chronic pain: The suggested dose is 60mg once a day.

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

Therefore:

Dosage in osteoarthritis does not exceed 60mg per day.

Dosage in rheumatoid arthritis does not exceed 90mg daily.

Dosage in joint inflammation should not exceed 90mg daily.

Dosage in acute leprosy disease should not exceed 120mg every day.

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

Dosage in chronic pain should not exceed 60mg daily.

What to do when overdose?

What to do when forgetting 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.

Side Effects

When using Arcoxia 60mg, you may experience unwanted effects (ADR).

Blood disorders and lymphatic systems

platelet reduction.

immune system disorders

Hypersensitivity reactions, anaphylactic/anaphylactic reactions include shock.

Metabolic and nutrition disorders

Hyperbonemia.

Mental disorders

Anxiety, insomnia, confusion, hallucinations, depression, restlessness.

Nervous system disorders

Disorders of taste, chicken sleep.

visual disorders

blurred vision.

Heart disorders

SECRETING HEART, NURY/DRINKING/BREADING, ASUA, TAPPY HEART.

vascular disorders

Hypertension.

respiratory disorders, chest and mediastinum

Bronchospasm.

Gastrointestinal disorders

Abdominal pain, mouth ulcers, gastrointestinal ulcers include perforation and hemorrhage (mainly in elderly patients), vomiting, diarrhea.

Liver disorders

Hepatitis, jaundice.

Skin and tissue disorders

Thiche, itching, erythema, rash, Stevens-Johnson syndrome, poisoned epidermal necrosis, urticaria.

Warnings

Contraindicated

ARCOXIA 60mg drug is contraindicated in the case of patients with hypersensitivity to the ingredients of Arcoxia 60mg.

Precautions when using

Clinical trials that suggest a group of COX-2 inhibitors may be accompanied by an increased risk of thrombotic events (especially myocardial infarction and stroke), compared to places and some nonsteroidal anti-inflammatory drugs (Naproxen). Because cardiovascular risks can increase according to the dose and time of using COX-2 selective inhibitors, the drug should be used in the shortest time as possible and the lowest daily daily dose. Should re -evaluate the demand for symptom reduction and treatment of patients.

should only use Arcoxia 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 Arcoxia is a member of this group of drugs, it has no effect on inhibiting platelet aggregation, so it is not allowed to stop platelets.

The risk of adverse effects in the stomach (stomach ulcer or other complications in the stomach) increases when using Arcoxia, other COX-2 inhibitors and other nonsteroidal anti-inflammatory drugs (NSAIDs) at the same time as acetylsalicylic acid (even low doses). The relatively difference in stomach and intestines between the regimen of the selective inhibitors of COX-2 + Acetylsalicylic acid compared to NSAIDs and 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 coefficient is estimated

Use in children: Not yet established the safety and effectiveness of Arcoxia in children's patients.

Used in elderly: Pharmacokinetics of drugs in the elderly (≥ 65 years) similar to young people. In clinical trials, the adverse effect rate is higher in elderly patients when compared to younger patients; The relatively differences between the Arcoxia group and the evidence group are the same in the elderly and young people. It is impossible to eliminate more sensitivity in some older people.

The ability to drive and operate machinery

There is no information that suggests Arcoxia affects the ability to drive or operate the machine when the patient is taking the drug.

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 artery.

Breastfeeding period

Arcoxia 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 the side effects of prostaglandin synthetic inhibitors may occur in breastfeeding, depending on the importance of the drug for the mother, decide or stop breastfeeding or stop taking the drug.

Medicinal interaction

Warfarin: In stable objects with chronic Warfarin therapy, Arcoxia 120mg regimen per day is often associated with an increase of about 13% of the international standard chemical ratio in prothrombin time (International Normalized Ratio-inr). It is recommended to regularly check the Inr values when starting or changing 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) representing Arcoxia concentration in plasma. This interaction should be taken into account when using Arcoxia at the same time as Rifampin.

Methotrexate: There are 2 research tests of Arcoxia effects 60, 90 or 120mg once a day in 7 days in patients taking methotrexate dose of 7.5 - 20mg once a week to treat rheumatoid arthritis. Arcoxia dose 60 and 90 mg does not affect methotrexate concentration in plasma (evaluated through AUC) or drug clearance through the kidney. In a test, Arcoxia 120mg 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 120mg increases methotrexate levels in plasma by 28% (evaluated through AUC) and reduces the clearance of methotrexate through the kidney by 13%. Methotrexate toxicity should be monitored when using Arcoxia higher than 90mg daily and methotrexate therapy at the same time.

Diuretics, Angiotensin (ACE) and Angiotensin II (AIIAS): NSAIDs suggested reports include COX-2-selective inhibitors that can reduce the treatment of hypertension of diuretics, ACE inhibitors and Angiotensin II antagonists. This interaction should be paid to using Arcoxia at the same time as these drugs. In some patients with reduced renal function (such as elderly patients or patients with loss of circulatory fluid, including patients using diuretic therapy) are taking nonsteroidal anti-inflammatory drugs, including COX-2 selective inhibitors, simultaneous use of ACE inhibitors or Angiotensin II antagonists can worse renal function worse, including acute renal insufficiency. These effects can often be recovered. Therefore, be careful when combining drugs, especially in the elderly.

Lithium: The non-selective NSAIDs suggesting reports and selective inhibitors can increase lithium concentration in plasma. This interaction should be taken into account for patients to use Arcoxia at the same time as Lithium.

Aspirin: Arcoxia can be used at the same time as low -dose aspirin to prevent cardiovascular disease. In sustainable state, Arcoxia 120mg once a day does not affect the activity of platelet resistance of low -dose aspirin (81mg 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 (see caution at the time of use).

contraceptive pill: Arcoxia 60mg is used at the same time as a 35mcg ethinyl estradiol and 0.5 - 1mg norethindrone in 21 days, increasing the AUC0-24 hours of Ethinyl estradiol in a stable state of up to 37%. The AUC0-24 hours of Ethinyl Estradiol in a sustainable state has increased by 50 - 60% when Arcoxia 120mg 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 tablet with Arcoxia. 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).

Storage

Leave a cool place, avoid light, temperature below 30⁰C.

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