Celebrex
Use during pregnancy and breastfeeding
There are insufficient data on the use of celecoxib in pregnant women.
The potential risk of using Celebrex during fluctuating periods has not been established but cannot be excluded. According to the mechanism of action, when using NSAIDs, including celecoxib, some women may develop changes in the ovaries, which can cause complications during pregnancy. In women who are planning pregnancy or undergoing evaluation for infertility, discontinuation of NSAIDs, including celecoxib, should be considered.
Celecoxib, which belongs to the group of prostaglandin synthesis inhibitors, when taken during pregnancy, especially in the third trimester, can cause weakness of uterine contractions and premature closure of the ductus arteriosus. The use of prostaglandin synthesis inhibitors in the early stages of pregnancy can negatively affect the course of pregnancy.
There is limited evidence that celecoxib is excreted in breast milk. Studies have shown that celecoxib is excreted into breast milk in very low concentrations. However, given the potential for side effects from celecoxib in a nursing infant, the advisability of stopping either breastfeeding or taking celecoxib should be assessed, given the importance of taking Celebrex® for the mother.
Use for liver dysfunction
In patients with mild hepatic impairment (class A according to the Child-Pugh classification), no dose adjustment is required. In case of moderate liver failure (class A according to the Child-Pugh classification), treatment should begin with the minimum recommended dose. There is no experience with the use of the drug in patients with severe liver failure (class C according to the Child-Pugh classification) (see section “Contraindications”).
Use for renal impairment
In patients with mild to moderate renal failure, no dose adjustment is required. There is no experience with the use of the drug in patients with severe renal failure (see sections “Special instructions”, “Contraindications”).
Use in children
Contraindicated in children under 18 years of age
special instructions
Celebrex, given its antipyretic effect, can reduce the diagnostic significance of a symptom such as fever and affect the diagnosis of infection.
Effect on the cardiovascular system
Celecoxib, like all coxibs, may increase the risk of serious cardiovascular events such as blood clots, myocardial infarction, and stroke, which can be fatal. The risk of these reactions may increase with the dose, duration of use of the drug, as well as in patients with diseases of the cardiovascular system and risk factors for such diseases. To reduce the risk of these reactions in patients taking Celebrex®, it should be used in the lowest effective doses and for the shortest possible periods (at the discretion of the attending physician). The attending physician and patient should be aware of the possibility of such complications occurring even in the absence of previously known symptoms of impaired cardiovascular function. Patients should be informed of the signs and symptoms of adverse cardiovascular effects and measures to take if they occur.
When using NSAIDs (selective COX-2 inhibitors) in patients after coronary artery bypass surgery for the treatment of pain in the first 10-14 days, an increase in the incidence of myocardial infarction and cerebrovascular accidents is possible.
Due to the weak effect of celecoxib on platelet function, it cannot be a substitute for acetylsalicylic acid for the prevention of thromboembolism. Also, in this regard, antiplatelet therapy (for example, acetylsalicylic acid) should not be discontinued in patients at risk of developing thromboembolic complications.
Like all NSAIDs, celecoxib can lead to an increase in blood pressure, which can also cause complications from the cardiovascular system. All NSAIDs, including celecoxib, should be used with caution in patients with arterial hypertension. Monitoring of blood pressure should be carried out at the beginning of therapy with celecoxib, as well as during the course of treatment.
Effect on the gastrointestinal tract
Extremely rare cases of perforation, ulceration and bleeding from the gastrointestinal tract have been observed in patients taking celecoxib. The risk of developing these complications during treatment with NSAIDs is highest in older people, patients with cardiovascular diseases, patients simultaneously receiving acetylsalicylic acid, and patients with diseases of the gastrointestinal tract such as ulcers, bleeding, inflammatory processes in the acute stage and in history. Other risk factors for the development of bleeding from the gastrointestinal tract are simultaneous use with oral corticosteroids and anticoagulants, a long period of NSAID therapy, smoking, and alcohol consumption. Most spontaneous reports of serious gastrointestinal side effects were in elderly and debilitated patients.
Combined use with warfarin and other anticoagulants
Serious (some fatal) bleeding has been reported in patients receiving concomitant treatment with warfarin or similar agents. Since an increase in prothrombin time has been reported, anticoagulant activity should be monitored after initiation of treatment with Celebrex® or a change in its dose.
Fluid retention and swelling
As with other drugs that inhibit prostaglandin synthesis, some patients taking Celebrex® may experience fluid retention and edema, so caution should be exercised when using this drug in patients with conditions predisposing or worsened by fluid retention. Patients with a history of heart failure or hypertension should be closely monitored.
Effect on kidney function
NSAIDs, including celecoxib, may have toxic effects on renal function. Celecoxib was found to be no more toxic than other NSAIDs. Celebrex® should be used with caution in patients with impaired renal function, heart failure, impaired liver function and in elderly patients. Renal function in such patients should be carefully monitored.
Caution should be exercised when using Celebrex® in patients with dehydration. In such cases, it is advisable to first rehydrate and then begin therapy with Celebrex®.
Effect on liver function
Celebrex® should not be used in patients with severe hepatic impairment (Child-Pyotr class C). Celebrex® should be used with caution in the treatment of patients with moderate hepatic impairment and should be prescribed at the lowest recommended dose.
In some cases, severe liver reactions have been observed, including fulminant hepatitis (sometimes fatal), liver necrosis, liver failure (sometimes fatal or the need for liver transplantation). Most of these reactions occurred 1 month after starting celecoxib.
Patients with symptoms and/or signs of hepatic impairment, or those patients in whom laboratory tests have demonstrated hepatic impairment, should be closely monitored for the development of more severe hepatic reactions during treatment with Celebrex®.
Anaphylactic reactions
Cases of anaphylactic reactions have been reported while taking Celebrex®.
Serious skin reactions
In extremely rare cases, serious skin reactions such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported with celecoxib, some of which have been fatal. The risk of such reactions occurring is higher in patients at the beginning of therapy; in most reported cases, such reactions began in the first month of therapy. Stop taking Celebrex if you experience skin rash, changes in mucous membranes, or other signs of hypersensitivity.
Glucocorticosteroid therapy
Celebrex® cannot replace glucocorticosteroids or be used as therapy for glucocorticosteroid deficiency.
Impact on the ability to drive a car and operate machinery
The effect of celecoxib on the ability to drive a car and operate machinery has not been studied. However, based on the pharmacodynamic properties and overall safety profile, it appears unlikely that Celebrex® has such an effect.
Celebrex®
Celebrex®, given its antipyretic effect, can reduce the diagnostic significance of a symptom such as fever and affect the diagnosis of infection. Cardiovascular effects
Celecoxib, like all coxibs, may increase the risk of serious cardiovascular complications such as blood clots, myocardial infarction and stroke, which can be fatal. The risk of these reactions may increase with the dose, duration of use of the drug, as well as in patients with diseases of the cardiovascular system and risk factors for such diseases. To reduce the risk of these reactions in patients taking Celebrex®, it should be used in the lowest effective doses and for the shortest possible short course (at the discretion of the treating physician). The attending physician and patient should be aware of the possibility of such complications occurring even in the absence of previously known symptoms of impaired cardiovascular function. Patients should be informed of the signs and symptoms of adverse cardiovascular effects and measures to take if they occur.
When using NSAIDs (selective COX-2 inhibitors) in patients after coronary artery bypass surgery for the treatment of pain in the first 10-14 days, an increase in the incidence of myocardial infarction and cerebrovascular accidents is possible.
Due to the weak effect of celecoxib on platelet function, it cannot be a substitute for acetylsalicylic acid for the prevention of thromboembolism. Also, in this regard, antiplatelet therapy (for example, acetylsalicylic acid) should not be discontinued in patients at risk of developing thromboembolic complications.
Like all NSAIDs, celecoxib can lead to an increase in blood pressure, which can also cause complications from the cardiovascular system. All NSAIDs, including celecoxib, should be used with caution in patients with arterial hypertension. Monitoring of blood pressure should be carried out at the beginning of therapy with celecoxib, as well as during the course of treatment.
Effect on the gastrointestinal tract
Extremely rare cases of gastrointestinal perforation, ulceration, and bleeding have occurred in patients taking celecoxib. The risk of developing these complications during treatment with NSAIDs is highest in the elderly, patients with cardiovascular disease, patients concomitantly receiving acetylsalicylic acid, and patients with gastrointestinal diseases such as ulcers.
bleeding, inflammatory processes in the acute stage and in history. Other risk factors for the development of bleeding from the gastrointestinal tract are simultaneous use with oral glucocorticosteroids and anticoagulants, a long period of NSAID therapy, smoking, and alcohol consumption. Most spontaneous reports of serious gastrointestinal side effects were in elderly and debilitated patients.
Combined use with oral anticoagulants
When NSAIDs are used simultaneously with oral anticoagulants, the risk of bleeding increases. Caution is advised when using these drugs together. Oral anticoagulants include warfarin, coumarin anticoagulants, and direct oral anticoagulants (eg, apixaban, dabigatran, and rivaroxaban). Serious (some fatal) bleeding has been reported in patients receiving concomitant treatment with warfarin or similar agents. Since an increase in prothrombin time (international prothrombin time (IPT)) has been reported, anticoagulant activity and/or MH0 should be monitored in patients receiving concomitant therapy with oral anticoagulants after initiating treatment with Celebrex® or changing its dose. Fluid retention and swelling
As with other drugs that inhibit prostaglandin synthesis, some patients taking Celebrex® may experience fluid retention and edema, so caution should be exercised when using this drug in patients with conditions predisposing or worsened by fluid retention. Patients with a history of heart failure or hypertension should be closely monitored.
Effect on kidney function
NSAIDs, including celecoxib, may have toxic effects on renal function. Celecoxib was found to be no more toxic than other NSAIDs. Celebrex should be used with caution in patients with impaired renal function, heart failure, impaired liver function and in elderly patients. Renal function in such patients should be carefully monitored (see section "Dosage and Administration"). Caution should be exercised when using Celebrex® in patients with dehydration. In such cases, it is advisable to first rehydrate and then begin therapy with Celebrex®.
Effect on liver function
Celebrex® should not be used in patients with severe hepatic impairment (Child-Pugh class C). Celebrex® should be used with caution when treating patients with moderate hepatic impairment and the initial recommended dose of the drug should be reduced by half (see section "Dosage and Administration").
Severe liver reactions have occurred in some cases, including fulminant hepatitis (sometimes fatal), liver necrosis, and liver failure (sometimes fatal or requiring liver transplantation). Most of these reactions developed one month after starting celecoxib.
Patients with symptoms and/or signs of hepatic impairment, or those patients in whom laboratory tests have demonstrated hepatic impairment, should be closely monitored for the development of more severe hepatic reactions during treatment with Celebrex®.
Anaphylactic reactions
Cases of anaphylactic reactions have been reported while taking Celebrex® (see section "Contraindications").
Serious skin reactions
In extremely rare cases, serious skin reactions such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported with celecoxib, some of which have been fatal. The risk of such reactions occurring is higher in patients at the beginning of therapy; in most reported cases, such reactions began in the first month of therapy. Stop taking Celebrex if you experience skin rash, changes in mucous membranes, or other signs of hypersensitivity.
Glucocorticosteroid therapy
Celebrex® cannot replace glucocorticosteroids or be used as therapy for glucocorticosteroid deficiency.
Inhibition of the function of the
CYP2D6
Celecoxib has been found to be a moderate inhibitor of the CYP2D6 isoenzyme. During the period of initiation of therapy with celecoxib, the dose of drugs metabolized by the CYP2D6 isoenzyme should be reduced, and after completion of treatment with celecoxib, the dose of these drugs should be increased (see section “Interaction with other drugs”).
