Ceutocid 200 Capsule Incepta Treatment of symptoms of osteoarthritis, rheumatoid arthritis (4 blisters x 10 tablets)

pharmacokinetics

absorption:

Celecoxib is quickly absorbed through the gastrointestinal tract. Take Celecoxib with high-fat food that slows down the time to reach the peak plasma concentration compared to drinking at 1 to 2 hours and increases 10-20% of the area under the curve (AUC). Celecoxib can be used simultaneously with food without paying attention to the time of meals.

The peak concentration of plasma is usually at 3 hours after taking a single dose of 200 mg at hunger, and the average is equal to 705 nanogam/ml. The drug concentration in a stable state in plasma is achieved within 5 days; There is no accumulation. In the elderly over 65 years old, the peak concentration in plasma and AUC increased by 40-50%, corresponding to young people; Celecoxib's AUC in a stable state increases by 40 or 180% in mild or medium, corresponding liver failure people, and 40% decrease in chronic kidney failure (glomerular filtration speed of 35-60 ml/min) compared to normal people.

Distribution:

The distribution volume is in a stable state of about 400 liters (about 7.14 liters/kg) so the drug is much distributed into the tissue. At plasma treatment concentrations, 97% of Celecoxib is attached to plasma proteins.

Elimination:

Half of the lifetime eliminates plasma of Celecoxib after drinking is 11 hours, and the clearance coefficient in plasma is about 500 ml/minute. The half -life of the drug lasts for people with renal failure or liver failure. Celecoxib is metabolized in the liver into non -active metabolites by 1Soenzyme CYP450 2C9, Celecoxib excreted about 27% in urine and 57% in feces, less than 3% of the doses were unchanged.

Renal failure: has not been studied and is not recommended for kidney failure. If it is necessary to use Celecoxib for people with severe renal failure, careful monitoring of kidney function. The manufacturer has no special recommendations on adjusting the dose for people with chronic renal failure.

Hepatic failure: Not yet studied. Do not be used for people with severe liver failure. For medium liver failure, the manufacturer recommends a decrease in a dose of about 50%.

What to do when using overdose?

Expression:

Overdose of nonsteroidal anti -inflammatory drugs can cause fleeting, drowsy, nausea, vomiting, and epigastric pain; These manifestations are often recovered with supportive treatment. The gastrointestinal bleeding also occurs. The more rare manifestations are hypertension, acute renal failure, respiratory inhibition and coma. Anaphylactic reactions have been notified to the treatment dose of nonsteroidal anti -inflammatory drugs and may occur during an overdose.

Treatment:

Treatment of nonsteroidal anti -inflammatory drugs including symptomatic and supportive treatment; There is no specific antidote for nonsteroidal anti -inflammatory drugs. In the first 4 hours after overdose, vomiting therapy and/or activated carbon (60-100 g for adults, or 1 to 2 g/kg for children), and/or an osmotic bleach may be helpful to patients who have signed a pathology or have taken a large amount of drugs. It is unknown whether Celecoxib is removed by hemorrhage, but the drug is attached to protein at a high rate of suggesting the use of forced urinary tract measures, urine alkalization, hemorrhage, or blood transfusion may not be effective to eliminate large amounts of Celecoxib from the body.

Need a doctor for advice.

What to do when forgetting 1 dose? It is best to consult a doctor and pharmacist.

Caution when using

digestion:

complications of the upper and lower gastrointestinal tract (perforation, ulcers or bleeding), some deaths, occurred in patients treated with Celecoxib. Caution should be careful when treating patients at high risk of gastrointestinal complications with NSAID drug groups; Elderly, patients use any drugs in the NSAID group or acetylsalicylic acid simultaneously, use glucocorticoids, patients using alcohol, or patients with a history of gastrointestinal diseases, such as ulcers and gastrointestinal bleeding.

The risk of increasing side effects on the gastrointestinal tract (digestive ulcers or other digestive complications), when Celecoxib is used simultaneously with acetylsalicylic acid (even at low doses).

It does not prove that there is clinical difference in terms of safety on the gastrointestinal tract when used simultaneously selective inhibitors of COX-2 and acetylsalicylic acid compared to NSAID + Acetylsalicylic Acid.

Use NSAID simultaneously:

Concomitance Celecoxib and NSAID drugs are not aspirin should be avoided.

Cardiovascular effects:

Increased risk of a serious cardiovascular disease, mainly myocardial infarction, has been recorded in long -term research, placebo control in patients with non -regular gland polyps that are treated with Celecoxib at a dose of 200 mg twice a day and 400 mg 2 times/day.

Celecoxib cardiovascular risks may increase depending on the dosage and use time, recommend the lowest dosage use in the shortest time is still effective. The patient's condition and the level of treatment should be re -evaluated periodically, especially in patients with osteoarthritis.

Patients with significant factors occur in the risk of cardiovascular events (hypertension, diabetes, smoking) should only be treated with Celecoxib after being carefully assessed by the patient. Selective Cox-2 inhibitors are not used to replace acetylsalicylic acid to prevent thrombolytic embolism because of the inefficiency of anti-platelet aggregation. Therefore, the treatment of platelets should not stop.

Keeping water and edema:

As prostaglandin synthesis inhibitors, water retention and edema have been observed in patients using Celecoxib. Therefore, Celecoxib should be used carefully in patients with a history of heart failure, left ventricular dysfunction or hypertension, and in patients with a history of edema from any reason from before, because Prostaglandin inhibitors can lead to impaired renal and water retention. Caution should be prudent for patients taking diuretics or at risk of reducing blood volume.

Hypertension:

As with all NSAIDs, Celecoxib may increase blood pressure or worsen previous hypertension, contributing to the incidence of cardiovascular diseases. Therefore, blood pressure should be closely monitored during the start of treatment with Celecoxib and during treatment.

liver, kidney:

impaired renal function or liver function and especially heart dysfunction is more likely to occur for the elderly and therefore must monitor the appropriate patient condition.

NSAIDS, including Celecoxib, can be toxic to the kidneys. Clinical testing with Celecoxib shows the effect on the kidneys similar to the nsaids for comparison in the test. Patients with the biggest risk for kidney toxicity are those with impaired renal function, heart failure, liver dysfunction, taking diuretics, enzyme inhibitors, Angiotensin II receptor and elderly receptor drugs. These patients should be carefully monitored during treatment with Celecoxib.

Some serious liver reaction cases, including acute hepatitis (have occurred in death), liver necrosis and liver failure (some deaths or liver transplantation), have been reported when using Celecoxib. In the reported cases, most adverse side effects on the liver are detected within a month after the start of Celecoxib treatment.

If during treatment, patients with impaired liver and kidney function as described, medical treatment should be treated and stop considering to stop using Celecoxib.

Inhibition of CYP2D6 enzyme.

Celecoxib inhibits CYP2D6 enzyme, although not a powerful inhibitor, recommends adjusting the dose of drugs metabolized by CYP2D6.

Skin and body hypersensitivity reactions.

Severe skin reaction, can be fatal, including flaky dermatitis, Stevens-Johnson syndrome, and necrotic poisonous epidermis, have been reported although it rarely uses Celecoxib. Patients with the highest risk of adverse adverse reactions are often recorded in the early stages of the treatment process: Most cases of adverse reactions occur in the first month of treatment. Severe hypersensitivity reactions (including anaphylactic reactions, angioedema and rash due to base leukemia and systemic symptoms, or hypersensitivity syndrome), have been reported in patients using Celecoxib. Patients with a history of sulphonamide allergies or any drug allergies may have a risk of skin reaction or serious hypersensitivity reaction. Celecoxib should be stopped when the first symptom appears of the skin rash, mucosal damage, or any hypersensitive signs.

General:

Celecoxib can cover signs of fever and signs of inflammation.

Oral anticoagulants:

In patients treated simultaneously with Warfarin, serious bleeding events, may cause death, have been reported. International standardization time (INR) has been reported. Therefore, closely monitoring in patients with Warfarin/Coumarin anticoagulant medication, especially when starting treatment with Celecoxib or Celecoxib dose is changed. Simultaneous use of anticoagulants with NSAIDs may increase the risk of bleeding. Caution should be careful when coordinating Celecoxib with warfarin or other oral anticoagulants, including new anticoagulants (such as Apixaban, Dabigatran and Rivaroxaban).

Risk of cardiovascular thrombosis:

Non -steroid anti -inflammatory drugs (NSAIDs), non -aspirin, use systemic sugar, 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 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 incidents, it is necessary to use Ceutocid 200 capsule at the lowest daily doses that are effective in the shortest possible time.

excipients:

The drug contains lactose. Patients with rare genetic problems of galactose intolerance, lactase enzyme deficiency or malposive glucose-galactose should not use this drug.

The effect of the drug on the ability to drive and operate machinery

symptoms of unwanted effects are insomnia, dizziness, headache; Therefore, it is necessary to be cautious when driving and operating machinery.

Use drugs for women during pregnancy and lactation

Pregnant women:

So far, there are no complete studies on Celecoxib in pregnant women. Celecoxib should only be used for pregnant women when the benefit is higher than the risk that may occur for fetuses. Do not use Celecoxib in the last 3 months of pregnancy, as Prostaglandin synthesis inhibitors may have a bad effect on the cardiovascular system of the fetus.

breastfeeding women:

Medicinal interaction

metabolism of celecoxib via cytochrom P450 2C9 intermediaries in the liver. Celecoxib simultaneous use with drugs that inhibit this enzyme can affect the pharmacokinetics of Celecoxib, so be careful when using these drugs simultaneously. In addition, Celecoxib also inhibits Cytochrom P450 2D6. Therefore, the interaction between Celecoxib and drugs is metabolized by P450 2D6.

Angiotensin transferring enzyme inhibitors: nonsteroidal anti -inflammatory drugs can reduce the anti -hypertension effect of enzyme inhibitors that transferred angiotensin. Pay attention to this interaction when using Celecoxib simultaneously with angiotensin transfer enzyme inhibitors.

Diuretics: Non -steroid anti -inflammatory drugs can reduce the effect of increasing sodium excretion of Furosemid and Thiazid in some patients, possibly due to prostaglandin synthesis and the risk of renal failure may increase.

Aspirin: Although Celecoxib can be used with low -dose aspirin, simultaneous use of these two nonsteroidal anti -inflammatory drugs can lead to increased gastrointestinal ulcer ratio or other complications, compared to separate Celecoxib. Because of no platelet resistance, Celecoxib is not an aspirin replacement for cardiovascular disease prevention.

Fluconazole: Celecoxib simultaneous use with fluconazole can lead to a significant increase in plasma concentration of Celecoxib. This pharmacokinetic interaction seems by Fluconazole inhibiting Isoenzym P450 2C9 associated with Celecoxib metabolism. Celecoxib should be started with the lowest recommended doses in patients with Fluconazole simultaneously.

Lithi: Celecoxib may reduce lithium renal clearance, which leads to increased lithium levels in plasma. Patients should be closely monitored by lithium and Celecoxib in terms of lithium signs and need to adjust the dose accordingly when starting or stopping Celecoxib.

warfarin: Bleeding complications combined with increased prothrombin time occurred in some patients (mainly the elderly) when using Celecoxib simultaneously with Warfarin. Therefore, it is necessary to monitor blood clotting tests such as prothrombin time, especially in the first few days after starting or changing therapy, because these patients are at high risk of complications of bleeding.