Cenoxib-200 Celogen Pharma treatments for osteoarthritis, rheumatoid arthritis (4 blisters x 10 tablets)

Dosage form Box of 4 blisters x 10 tablets
Specifications Celecoxib
Ingredient Dysmenorrhea, osteoarthritis, arthritis, rheumatoid arthritis, adolescent arthritis

Ingredient

Composition information	Content
Celecoxib	200mg

Uses

indications

cenoxib 200 drugs are indicated in the following cases:

Treatment of symptoms of osteoarthritis in adults. Cycloxygenase - 2 (COX - 2), has anti -inflammatory, analgesic, fever -reducing effects. The mechanism of action of Celecoxib is considered to inhibit the synthesis of prostaglandin, mainly through the effect of inhibiting isenzyme cyclooxygenase - 2 (COX - 2), resulting in a reduction in the formation of prostaglandin.

Different from the majority of nonsteroidal anti -inflammatory drugs before, Celecoxib does not inhibit isenzyme cyclooxygenase -1 (COX - 1) with human treatment concentrations. COX - 1 is a structural enzyme available in almost all tissues, large and platelet leukocytes. COX - 1 involved in thrombosis (such as promoting platelets to stop exercising) to maintain the protective mucosa fence of the stomach and kidney function (such as maintaining kidney perfusion).

Due to not inhibiting COX - 1, Celecoxib is less likely to cause side effects (for example, for platelets of the gastric mucosa), but may cause side effects in the kidneys similar to non -selective non -steroid anti -inflammatory drugs.

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 of 65 peaks in plasma and AUC increased by 40 and 50%, respectively, compared to young people; AUC of Celecoxib 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 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 concentration, 97% Celecoxib is attached to plasma proteins.

Era:

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 converted in the liver into non -active metabolites by isenzyme CYP4502C9.

Celecoxib eliminates about 27% in urine and 57% in feces, less than 3% of the doses are eliminated unchanged.

Before taking Cenoxib-200 Celogen Pharma treatments for osteoarthritis, rheumatoid arthritis (4 blisters x 10 tablets)

How to use

oral medication 01 times or divided into 2 times equal, all have the same effect in the treatment of bone - joint degeneration.

For rheumatoid arthritis, the dose should be divided evenly into 2 times. The dose is up to 200 mg/ time, taken 2 times a day, can be taken without paying attention to the meal; Higher doses (ie 400 mg/ time, 2 times a day) must be taken at meals (along with food) to improve absorption.

Dosage

adults:

To treat bone - joint degeneration, the dose must be adjusted according to the needs and response of each patient, finding the lowest dose that is effective.

Bone degeneration - joints:

Normal dose: 200 mg/ day orally or divided into 2 equal doses.

Doses higher than 200 mg/ day (such as 200 mg/ 1 dose, 2 times a day) is not more effective.

rheumatoid arthritis in adults:

Normal dose: 100 - 200 mg/ time 2 times a day, higher doses (400 mg x 2 times/ day) does not work better than the dose of 100 - 200 mg x 2 times/ day.

Pain in general and economic system:

The usual dosage in adults: 400 mg oral 1 time, followed by 200 mg if necessary, in the first day.

To continue analgesic, can give a dose of 200 mg orally twice a day, if necessary.

Elderly:

Over 65: No dose adjustment, although the concentration of drugs in plasma. However, for the elderly with a body weight of less than 50 kg, the lowest recommended dose must be used at the beginning of treatment.

kidney failure:

has not been researched 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 kidney failure.

liver failure:

has not been studied. According to the manufacturer, not for patients with severe liver failure. For medium liver failure, the manufacturer recommends a dose reduction of about 50%.

What to do when overdose?

Overdose

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.

How to handle

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 useful for patients who have manifested pathology or have taken a large amount of drugs.

It is unknown whether Celecoxib is equal to the hemorrhage, but the drug is attached to the 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.

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. Do not drink twice as prescribed.

Side Effects

When using Cenoxib 200, you may experience unwanted effects (ADR).

The unwanted effect of Celecoxib at the common doses is generally light and related to the digestive tract. The unwanted effects that make the most medication stop include: indigestion, abdominal pain. About 7.1% of patients using Celecoxib must stop taking the drug because of unwanted effects compared to 6.1% of patients who use Placebo to stop.

Risk of cardiovascular thrombosis (see more cautious use).

Common, ADR> 1/100

Digestive: abdominal pain, diarrhea, indigestion, flatulence, nausea.

Respiratory: Sore throat, rhinitis, sinusitis, upper respiratory infection.

Central nervous system: Insomnia, dizziness, headache.

DA: Ban. general: back pain, peripheral edema.

Rare, ADR

Cardiovascular: fainting, congestive heart failure, ventricular vibration, pulmonary disease, stroke, peripheral mail, thrombosis, vasculitis.

digestive: intestinal obstruction, perforation, gastrointestinal bleeding, bleeding colitis, esophagus, pancreatitis, bowel obstruction. liver: gallstones, hepatitis, jaundice, liver failure. Hematology: reduces platelet amount, granulocytosis, non -regenerated anemia, reduces all bloody, leukopenia.

Metabolism: Hemorrhage reduction.

Central nervous system: loss of air conditioning, paranoia, suicide. kidney: Acute renal failure, interstitial nephritis. skin: Diverse erythema, peeling dermatitis, Stevens - Johnson syndrome.

General: infection, sudden death, anaphylactic reaction, angioedema.

Instructions on how to handle ADR

If there is a toxic manifestation of kidneys while treating Celecoxib, it is necessary to stop the drug, usually the kidney function will return to the level before treatment after stopping the drug.

Liver test may increase (3 times the normal level at high limit). This increase can progress, or unchanged or temporarily temporarily for a while when continuing treatment. But if there is a heavy expression of hepatitis (jaundice, manifestation of liver failure ...) must stop immediately.

In general, when used in normal and short doses, Celecoxib tolerates well.

Notice immediately to the doctor when encountering unwanted effects of the drug.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Cenoxib 200 drugs, contraindicated in the following cases:

Hypersensitivity to Celecoxib, Sulfonamid, or any ingredients of the drug (excipients: sodium crosscarmello, lactose, sodium lamuryl sulphat, PVP K - 30, Magnesi Stearat, Pure Water, Yellow Hard/ Red Collects No. 1).

Severe heart failure.

Severe renal failure (Creatinine clearance coefficient below 30 ml/min). Severe liver failure.

Inflammation (Crohn's disease, ulcerative colitis).

History of asthma, urticaria, or other allergic reactions after taking aspirin or other nonsteroidal anti -inflammatory drugs. There have been reports on severe, sometimes lethal reactions, with nonsteroidal anti -inflammatory drugs in these patients.

Pregnant women or are intending to get pregnant, unless using effective contraception. When having stomach ulcers or gastrointestinal bleeding.

Be cautious when using

be careful to use Celecoxib for people with a history of peptic ulcer, or gastrointestinal bleeding, although the drug is considered not to cause digestive tract complications due to selective inhibition of COX - 2.

Be careful to use Celecoxib for people with a history of asthma, allergies when taking aspirin or an nonsteroidal anti -inflammatory drug because anaphylaxis may occur. Be careful to use Celecoxib for the elderly, weakened because it is easy to cause gastrointestinal bleeding and often the renal function is impaired due to age.

Celecoxib can be toxic to the kidneys, especially when maintaining the blood flow through the kidneys, it requires the support of the kidney prostaglandin. People with high risk include people with heart failure, kidney failure or liver failure, need to be very careful to use Celecoxib for these patients. Caution should be carefully used for Celecoxib for people with edema, water retention (such as heart failure, kidney) because of drugs that cause fluid stasis, worse disease.

Be careful when using Celecoxib for people with foreign cell loss (due to strong diuretics), it is necessary to treat dehydration before using Celecoxib.

Monitor the risk of cardiovascular complications (myocardial infarction, myocardial anemia). This risk may increase with the dose and over time of exposure, so it is necessary to use in the shortest time and the lowest daily dosage but still effective. Celecoxib has no intrinsic activity of platelet resistance and thus not protects the complications due to myocardial ischemia, especially if the high dose is prolonged (400 - 800 mg/ day).

Like all other NSAIDs, using Celecoxib can lead to hypertension, potentially worse in patients with high blood pressure, or contribute to increased cardiovascular disease. Therefore, it is necessary to closely monitor blood pressure before and during Celecoxib treatment.

Hypersensitivity reactions on the skin: Some serious hypersensitivity reactions, one of which can cause death such as flaking dermatitis, Stevens - Johnson syndrome, epidermal necrosis has been reported when using Celecoxib. Some hypersensitivity reports such as angioedema, rash with eosinophilia have also been reported, especially in patients with a history of allergies to sulfonamid or allergies to Celecoxib may increase the severity of hypersensitivity reactions. Celecoxib should be discontinued when there is a sign of allergies such as skin rash, mucosal damage or any signs of hypersensitivity symptoms.

Using Celecoxib may not detect fever or other inflammatory signs.

In patients treated simultaneously with oral anticoagulant drugs (such as warfarin ...) can increase the risk of serious bleeding, which can lead to deaths. Prothrombin (INR) time extended when used simultaneously with Celecoxib has been reported, so it is necessary to closely monitor in patients using oral anticoagulants such as Warfarin/ Coumarin, which may need to change the Celecoxib dose. The simultaneous use of NSAIDs with anticoagulant drugs increases the risk of bleeding, so it is necessary to be cautious when combining Celecoxib with oral anticoagulants.

In Cenoxib 200 uses lactose, so it is necessary to be careful to use for patients without sugar, galactose or Lactose Lapp.

In Cenoxib 200 contains a small amount of sodium so there is no need to adjust the diet containing sodium when using Cenoxib 200.

Heart 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 a doctor as soon as this symptom appears.

To reduce the risk of adverse events, Cenoxib 200 is needed at the lowest daily daily dose in the shortest possible time.

The ability to drive and operate machinery

The drug can cause adverse reactions such as insomnia, dizziness, headache, so it should be cautious when participating in driving and operating machinery.

Pregnancy

so far, there has been no adequate studies on Celecoxib in pregnant women. Celecoxib should only be used for pregnant women when the benefits are higher than the risk that may occur for the fetus. Do not use Celecoxib in the last 3 months of pregnancy, because the prostaglandin synthetic inhibitors have a bad effect on the cardiovascular system of the fetus.

Breastfeeding period

It is unknown whether Celecoxib is distributed into breast milk or not. Because Celecoxib may have serious unwanted effects in breastfed children, consider gums/ harms or stop breastfeeding, or stop using Celecoxib.

Model interaction

: metabolism of Celecoxib via cytochrom P4502C9 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. Celecoxib also inhibits Cytochrom P4502D6. Therefore, the interaction between Celecoxib and drugs is metabolized by P4502D6.

Angiotensin transfer enzyme inhibitors: Non -steroid anti -inflammatory drugs can reduce the anti -hypertension effect of angiotensin transfer enzyme inhibitors, pay attention to this interaction when using Celecoxib simultaneously with angiotensin transferred 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 doses of aspirin, simultaneous use of these two nonsteroidal anti -inflammatory drugs can lead to an increase in the rate of gastrointestinal ulcers or other complications, compared to using 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 the isenzyme CYP4502C9 associated with the metabolism of Celecoxib. Celecoxib should be started with the lowest recommended doses in patients with Fluconazole simultaneously.

Lithi: Celecoxib may reduce lithium renal clearance, which leads to an increase in lithium levels in plasma, need to closely monitor patients with simultaneous lithium and celecoxib about 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 risk of high bleeding complications.

Cyclosporin and Tacrolimus: Concomplifying nsalds with cyclosporin or tacrolimus may increase the toxic effect on the kidneys of cyclosporin or tacrolimus. Therefore, it is necessary to closely monitor kidney function when using Celecoxib with cyclosporin, tacrolimus.

Anticoagulant: Anticoagulant activities should be closely monitored in the first few days after starting treatment or changes in Celecoxib doses in patients using warfarin or other anticoagulants due to the risk of bleeding complications. It is necessary to closely monitor prothrombin (INR) for a few days when starting with Celecoxib or when changing the Celecoxib dose in patients using anticoagulants due to the risk of bleeding.

Storage

Store in closed packaging, temperatures below 30 ° C, avoiding light, temperatures below 30 ° C. To be out of reach of children.

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