Agilecox 200 Agimexpharm medicine for osteoarthritis, rheumatoid arthritis (2 blisters x 10 tablets)

NYHA II-IV).

Ischemic heart disease, peripheral artery disease or cerebrovascular disease.

Precautions when using

Effects on the gastrointestinal tract

Complications on the upper and lower digestive tract (perforation, ulcers or bleeding), some cases may lead to death, occurred with patients using Celecoxib. Be cautious when treating patients with high risk of gastrointestinal complications with NSAIDs such as elderly people, patients with cardiovascular diseases, patients taking aspirin, glucocorticoids or other NSAIDs, patients using alcohol, or patients with a history of gastrointestinal diseases such as ulcers, digestive sugar bleeding.

Increased risk of gastrointestinal side effects due to Celecoxib (gastrointestinal ulcer or other digestive tract complications), when Celecoxib is used simultaneously with aspirin (even at low doses).

Simultaneous use nsaid

Should avoid simultaneous use of Celecoxib with an NSAID drug non -aspirin.

Heart impact

The risk of cardiovascular thrombosis: The drug may increase the risk of serious cardiovascular thrombosis, myocardial infarction and stroke, which can lead to death.

This risk may 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, Celecoxib is needed in the lowest daily doses to be effective in the shortest possible time.

Celecoxib is not an alternative to acetylsalicylic acid in preventing obstruction, cardiovascular thrombosis due to lack of platelet function. Because Celecoxib does not inhibit plateletic collection, platelet resistance should not be stopped (for example, acetylsalicylic acid) while using Celecoxib.

Hypertension

Celecoxib may start an increase in hypertension or worsen the inherent hypertension, both of which can increase the risk of cardiovascular events. Caution should be used when using Celecoxib, on hypertension patients. Need to monitor blood pressure closely when starting treatment with Celecoxib as well as during treatment.

Be cautious when using Celecoxib in patients who have been damaged by heart, edema or other conditions may be worse due to fluid and edema, including patients taking diuretics, or at risk of reducing blood volume.

Impact on the liver and kidneys

Celecoxib can be toxic to the kidneys. Clinical trials have shown that Celecoxib has the effects on the kidneys similar to other NSAIDs. Patients with the highest risk of kidney toxicity are those who impaired renal function, heart failure, liver failure and the elderly. Careful monitoring for these patients when treated with Celecoxib. Be careful when starting treatment for dehydration patients. First, it is necessary to rehydration for patients and then start treatment with Celecoxib. Progressive renal disease: Need to closely monitor kidney function in patients with renal disease progressive treatment with Celecoxib.

Some serious liver reaction cases, including hepatitis (some deaths), liver necrosis and liver failure have been reported to Celecoxib. Most of the unwanted effects on the liver are developed within a month after the start of Celecoxib treatment.

CYP2D6 inhibitor: Celecoxib is a medium level of CYP2D6 inhibitor. For drugs metabolized through CYP2D6, it is necessary to reduce the dose of these drugs when starting to use with Celecoxib or increase the dose of these drugs when stopping using Celecoxib.

Hypersensitivity reactions on skin and body

Serious skin reactions, some can lead to death, including flaky dermatitis, Steven-Johnson syndrome and poisoned epidermal necrosis, have been reported but very rare in using Celecoxib. Patients are often at high risk for these events in the early stages of the treatment process, most of these cases occur mainly in the first month of treatment. Celecoxib should be stopped as soon as skin redness appears, mucosal damage or any signs of hypersensitivity.

general

With anti -inflammatory effects, Celecoxib can fade the diagnosis signs, such as fever symptoms in infection diagnosis. Celecoxib simultaneous use with NSAID drugs non -aspirin.

Use with oral anticoagulants

There have been reports on serious bleeding in patients who are concurrently using warfarin or similar substances, including some deaths. Due to a report on increasing prothrombin (INR) time, prothrombin should be monitored in patients who are using Warfarin/Coumarin anticoagulant drugs after starting treatment with Celecoxib or adjusting the dose of these drugs. The simultaneous use of NSAIDs with oral anticoagulants increases the risk of bleeding and needs to be cautious when used. Oral anticoagulants include Warfarin/Coumarin and new oral anticoagulants (such as Apixaban, Dabigatran and Rivaroxaban).

Lactose -containing drugs: Patients with rare genetic disorders in galactose tolerance, Lactose Lapp deficiency. Or Glucose-Galactose absorption disorders should not use this drug.

The ability to drive and operate machinery

Be cautious when taking the drug for people who are driving or operating machinery because the drug can cause headaches, dizziness.

Pregnancy

on animals, the use of prostaglandin synthetic inhibitors increases the risk of miscarriage in the previous and after the embryo. Data from epidemiological studies shows increased risk of spontaneous miscarriage after taking prostaglandin synthetic inhibitors in the early stages of pregnancy. There are no equivalent data on humans. Celecoxib, as well as other prostaglandin synthesis inhibitors, can cause uterus and early aortic ductile, should avoid using Celecoxib in the last 3 months of pregnancy.

In the second or third trimester of pregnancy, NSAIDs including Celecoxib can cause fetal kidney dysfunction that can reduce the volume of amniotic fluid or little amniotic fluid in severe cases. Such effects can occur right after the beginning of treatment and often recover.

Contraindicated using Celecoxib during pregnancy and pregnant women. If women are pregnant during treatment, Celecoxib should be stopped.

Breastfeeding period

Celecoxib is excreted through breast milk breast milk with concentrations equivalent to plasma concentrations. In breastfeeding women using Celecoxib, very few Celecoxibs can be through breast milk. Women who are using Celecoxib should not breastfeed.

Drug interaction

anticoagulant drugs

Anticoagulant should be monitored especially in the first few days after starting or changing the Celecoxib dose in patients using warfarin or other anticoagulants because these patients are at high risk of bleeding complications. Therefore, patients taking oral anticoagulant should be closely monitored Prothrombin Inr, especially in the first few days when starting Celecoxib treatment or changing Celecoxib dose. Bleeding combined with an increase in prothrombin time has been reported, mainly in the elderly, in patients using Celecoxib simultaneously with Warfarin, some patients have died.

Antid for hypertension

NSAID can reduce anti -hypertension effects including Angiotensin (ACEI) and Angiotensin II antagonist (known as Angiotensin, ARB), diuretics and beta receptor blockers. In elderly patients, people with fluid reduced (including diuretics are taking) or kidney damage, simultaneous use of NSAIDs, including selective inhibitors of COX-2, with angiotensin (ACEI), Angiotensin II, or diuretic drugs that can lead to damage to kidney function including acute renal impairment. These effects can often be recovered. Therefore, it is necessary to be cautious when using Celecoxib with these drugs at the same time. Patients need to be compensated enough and monitor the kidney function when starting a combined use regimen as well as periodic control.

In a 28 -day clinical study in stage I and II patients with Lisinopril's control, the use of Celecoxib 200mg x 2 times/day does not cause systolic and diastolic hypertension when compared to the place of placebo use in 24 -hour blood pressure control. In the group of patients using simultaneously with Celecoxib 200mg twice a day, 48% of patients do not respond to Lisinopril on the last visitor (meaning diastolic blood pressure greater than 90mmHg or the center of the center of the school increases more than 10% compared to the original time), for the placebo group this number is 27%. This difference is statistically significant.

CYP2C9 inhibitors

Celecoxib mainly metabolizes through Cytocrom P450 (CYP) 2C9 in the liver. Caution should be used when using Celecoxib in patients who have or suspected poor metabolism through CYP2C9 based on a history with other substrates of CYP2C9 because these patients may have Celecoxib concentration in plasma abnormally high due to reduced metabolic clearance. Should start treatment with the dose equal to the lowest recommended dose.

Concomitance Celecoxib with CYP2C9 inhibitors increases the concentration of celecoxib in plasma. Therefore, Celecoxib should be reduced when used simultaneously with CYP2C9 inhibitors.

Concomitance Celecoxib with CYP2C9 induction substances such as Rifampicin, Carbamazepin and Barbiturate reduces the concentration of plasma Celecoxib. Therefore, it is necessary to increase the dose of Celecoxib when used simultaneously with CYP2C9 induction.

CYP2D6 inhibitors

Clinical pharmacokinetics research and In vitro studies show that although Celecoxib is not a substrate, CYP2D6 inhibitors. Therefore, there may be in vivo interactions with drugs metabolized by CYP2D6.

Simultaneous use of Celecoxib 200mg 2 times a day increases 2.6 times and 1.5 times the concentration of dextromethorphan and metoprolol in plasma (substrates of CYP2D6). This is because Celecoxib inhibits metabolism of substrates of CYP2D6. Therefore, it is necessary to reduce the dose of medications as substrate of CYP2D6 when starting to use Celecoxib simultaneously and need to increase the dose of these drugs when stopping using Celecoxib.

lithium

In healthy objects, plasma lithium concentrations increase by about 17% when used simultaneously lithium and celecoxib. Need to closely monitor patients being treated with lithium when starting or stopping using simultaneously with Celecoxib.

aspirin

Celecoxib does not affect the anti -platelet effect of low -dose aspirin. Because there is no platelet effect, Celecoxib is not an alternative to aspirin in the treatment of cardiovascular disease.

cyclosporin

Because NSAIDs work on the kidney prostaglandin, these drugs may increase the risk of cyclosporin.

fluconazole and ketoconazole

Simultaneously use Fluconazole at a dose of 200mg, 1 time/day doubling the plasma celecoxib concentration due to fluconazole has the effect of inhibiting enzymes to metabolize Celecoxib CYP P450 2C9. Celecoxib should be started at the dose of the recommended dose in patients who are taking drugs that inhibit CYP2C9 as fluconazole. Ketoconazole, a CYP3A4 inhibitor, has no significant celecoxib metabolism inhibitors.

Diuretics

Clinical studies show that in some patients, NSAIDs can reduce the effect of increasing sodium exhaust through the urine of Furosemid and Thiazid by inhibiting the synthesis of kidney prostaglandin.

methotrexate

There are no important clinical and pharmacokinetic interactions between Celecoxib and Methotrexate in clinical research between these two drugs.

Oral contraceptives

In an interactive study, Celecoxib does not have a clinical clear effect with pharmacokinetics of oral contraceptive pills (1mg norethindron 0.035mg ethinyl estradiol).

Other drugs: No clinical interactive reports between Celecoxib and antacids (aluminum and magnesium), Omeprazol, Glibenclamid (Glybid), Phenytoin or Tolbutamid.