Celecoxib-Vial (Celecoxib-Vial)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceCelecoxibCelecoxib
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    • Dosage form: & nbsptoapsules
    Composition:

    Composition for 1 capsule 100 mg:

    Active substance: celecoxib 100.00 mg.

    Excipients: lactose anhydrous - 103.33 mg; talcum - 10.00 mg; croscarmellose sodium - 2.67 mg; silicon dioxide colloidal - 2.67 mg; sodium lauryl sulfate - 1.33 mg.

    Composition of cap capsule: color of diamond blue - 0.135%; dye quinoline yellow - 0.624%; dye sunset sunset yellow - 0.194%; titanium dioxide - 1.875%; methyl parahydroxybenzoate - 0.800%; propyl parahydroxybenzoate - 0.200%; sodium lauryl sulfate - 0.100%; gelatin - up to 100,000%.

    Capsule body composition: dye punch [Ponce 4R] - 0.197%; dye sunset yellow - 1.843%, titanium dioxide - 1.741%; methyl parahydroxybenzoate - 0.800%; propyl parahydroxybenzoate - 0.200%; sodium lauryl sulfate - 0.100%; gelatin - up to 100,000%.

    Composition per 1 capsule 200 mg:

    Active substance: celecoxib 200.00 mg.

    Excipients: lactose anhydrous - 86.26 mg; talcum - 14.00 mg; croscarmellose sodium - 3.87 mg; silicon colloidal dioxide - 3.87 mg; sodium lauryl sulfate - 2.00 mg.

    Composition of cap capsule: color of diamond blue 0,195%; titanium dioxide - 2.357%; methyl parahydroxybenzoate - 0.800%; propyl parahydroxybenzoate - 0,200%; sodium lauryl sulfate - 0.100%; gelatin - up to 100,000%.

    Capsule body composition: titanium dioxide - 3,000%; methyl parahydroxybenzoate - 0.800%; propyl parahydroxybenzoate - 0.200%; sodium lauryl sulfate - 0.100%; gelatin - up to 100,000%.

    Description:

    Hard gelatin capsules.

    Dosage of 100 mg: size 2, the lid is green, the body is reddish orange; the contents of the capsules are white or almost white powder.

    Dosage 200 mg: size 1, the lid - blue, the body - almost white; the contents of the capsules are white or almost white powder.

    Pharmacotherapeutic group:NSAIDs
    ATX: & nbsp

    M.01.A.H.01   Celecoxib

    Pharmacodynamics:

    Celecoxib has an anti-inflammatory, analgesic and antipyretic effect, blocking the formation of inflammatory prostaglandins (Pg) mainly due to the inhibition of cyclooxygenase-2 (COX-2). Induction of COX-2 occurs in response to inflammation and leads to the synthesis and accumulation of prostaglandins, in particular prostaglandin E2, while there is an increase in manifestations of inflammation (edema and pain). In therapeutic doses in humans celecoxib significantly does not inhibit cyclooxygenase-1 (COX-1) and does not affect prostaglandins synthesized as a result of COX-1 activation, nor does it affect normal physiological processes associated with COX-1 and that occur in tissues, stomach tissues, intestines and platelets.

    Effect on kidney function

    Celecoxib reduces urinary excretion of PgE2 and 6-keto-PgF1 (metabolite prostacyclin), but does not affect the serum concentration of thromboxane B2 (ThB2) and excretion of 11-dehydro-thromboxane B by the kidneys2, a metabolite of thromboxane (both products of COX-1). Celecoxib does not cause a decrease in the glomerular filtration rate in elderly patients and patients with chronic renal failure (CRF), transiently reduces excretion of sodium. In patients with arthritis, the observed incidence of peripheral edema, arterial hypertension, and cardiac insufficiencycertainty is comparable to that of non-selective COX inhibitors, which have inhibitory activity against COX-1 and COX-2.

    Pharmacokinetics:

    Suction

    When taking an empty stomach celecoxib well absorbed, reaching a maximum concentration (CmOh) in the plasma after about 2-3 hours. FROMmOh in plasma after taking 200 mg - 705 ng / ml. Absolute bioavailability of the drug has not been studied. FROMmOh, and the area under the pharmacokinetic curve "concentration-time" (AUC) is approximately proportional to the dose at the dose range up to 200 mg 2 times a day; when using the drug in higher doses, the degree of increase in CmOh and AUC is less proportionate.

    Effect of food intake

    Taking celecoxib along with fatty foods increases the time to reach CmOh for about 4 hours and increases the total absorption by about 20%.

    Distribution

    The connection with plasma proteins does not depend on the concentration and is about 97%, celecoxib does not bind to red blood cells. The drug penetrates the blood-brain barrier.

    Metabolism

    Celecoxib is metabolized in the liver by hydroxylation, oxidation and partially glucuronidation. Metabolism mainly occurs with the participation of cytochrome P450 CYP2C9. Metabolites found in the blood are not pharmacologically active against COX-1 and COX-2. Cytochrome P450 activity of CYP2C9 is reduced in individuals with genetic polymorphism, such as homozygous for CYP2C9 * 3 polymorphism, which leads to a decrease in the effectiveness of enzymes.

    Excretion

    Celecoxib is metabolized in the liver, excreted in feces and urine in the form of metabolites (57% and 27%, respectively), less than 1% of the accepted dose - in unchanged form. At repeated application the half-life period is 8-12 hours, and the clearance is about 500 ml / min. With repeated applications, equilibrium concentrations in the plasma are reached by day 5. Variability of the main pharmokinetic parameters (AUC, FROMmOh, half-life) is about 30%. The average volume of distribution in the equilibrium state is approximately 500 l / 70 kg in young healthy adults, indicating a wide distribution of celecoxib in the tissue.

    Special patient groups

    Elderly patients

    In patients older than 65 years there is an increase in 1,5-2 times the average values ​​of CmOh, AUC of celecoxib, which is largely due to changes in body weight, rather than age (elderly patients tend to have a lower average body weight than those of younger age, so they, all other things being equal, higher concentrations of celecoxib are achieved). For the same reason, older women usually have a higher plasma concentration of the drug than older men.These features of pharmacokinetics, as a rule, do not require dose adjustment. Nevertheless, in elderly patients with a body weight below 50 kg, treatment with the lowest recommended dose should be started.

    Race

    In representatives of the Negroid race AUC, celecoxib is approximately 40% higher than that of Europeans. The causes and the clinical significance of this fact are not known, therefore it is recommended to start their treatment with the minimum recommended dose.

    Impaired liver function

    Concentrations of celecoxib in plasma in patients with mild degree of hepatic insufficiency (class A according to the Child-Pugh classification) vary slightly. In patients with moderate hepatic impairment (Child-Pugh class B), the concentration of celecoxib in plasma can almost double.

    Impaired renal function

    In elderly patients with a glomerular filtration rate (GFR)> 65 ml / min / 1.73 m2 and in patients with GFR, equal to 35-60 ml / min / 1.73 m2, the pharmacokinetics of celecoxib do not change. There is no significant association between serum creatinine (or creatinine clearance) and celecoxib clearance.

    It is assumed that the presence of severe renal failure does not affect the clearance of celecoxib, since the main way of its elimination is conversion into the liver into inactive metabolites.

    Indications:

    - Symptomatic treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.

    - Pain syndrome (back pain, musculoskeletal, postoperative and other types of pain).

    - Treatment of primary dysmenorrhea.

    It is intended for symptomatic therapy, reducing pain and inflammation at the time of use, the progression of the disease is not affected.

    Contraindications:

    - Hypersensitivity to celecoxib or any other component of the drug.

    - Hypersensitivity to other sulfonamide derivatives.

    - Complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses, and intolerance to acetylsalicylic acid or other NSAIDs (including in the anamnesis).

    - The period after the operation of aortocoronary shunting.

    - Erosive and ulcerative changes in the mucous membrane of the stomach or duodenum, active gastrointestinal bleeding, cerebrovascular or other bleeding,including intracranial hemorrhage or suspicion of it.

    - Hemophilia and other bleeding disorders.

    - Inflammatory bowel disease (Crohn's disease, ulcerative colitis) in the phase of exacerbation.

    - Heart failure (II-IV functional class by classification NYHA).

    - Clinically confirmed ischemic heart disease, peripheral arterial disease and cerebrovascular disease in a pronounced stage.

    - Pregnancy and the period of breastfeeding (see section " pregnancy and during breastfeeding ").

    - Severe hepatic insufficiency (class C according to Child-Pugh classification) (no experience of application).

    - Severe renal failure (QC less than 30 ml / min), progressive kidney disease, confirmed hyperkalemia.

    - Deficiency of lactase, lactose intolerance, glucose-galactose malabsorption.

    - Age under 18 years (no experience of application).

    Carefully:

    Diseases of the gastrointestinal tract (peptic ulcer of the stomach or duodenum, ulcerative colitis, Crohn's disease, history of bleeding), the presence of infection Helicobacter pylori, hepatic porphyria, simultaneous use with digoxin, anticoagulants (for example, warfarin), antiplatelet agents (for example, acetylsalicylic acid, clopidogrel), glucocorticosteroids (GCS) for oral administration (for example, prednisolone), diuretics, selective serotonin reuptake inhibitors (for example, citalopram, fluoxetine, paroxetine, sertraline), inhibitors of isoenzyme CYP2C9, fluid retention and swelling, poor liver function of moderate severity (see section "Special instructions"), diseases of the cardiovascular system, including coronary heart disease, hypertension (see section "Special instructions"), cerebrovascular diseases , dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, smoking, renal dysfunction (Q30-60 ml / min), elderly patients, prolonged use of NSAIDs, severe somatic diseases, tuberculosis, alcoholism, in patients who They are slow metabolizers, or there is a suspicion of this condition, systemic lupus erythematosus or other autoimmune diseases.

    Pregnancy and lactation:

    Experience with celecoxib in pregnancy is not enough. The potential risk of using the drug in pregnancy is not established, but it can not be excluded.

    When using NSAIDs, including celecoxib, due to inhibition of synthesis Pg, some women may develop changes in the ovaries, which can lead to complications during pregnancy. When planning a pregnancy or conducting an infertility survey, you should consider question about the cancellation of celecoxib. Celecoxib, belonging to the group of synthesis inhibitors Pg, when used during pregnancy, especially in the third trimester of pregnancy, may cause weakness in labor and premature closure of the arterial duct. Use of synthesis inhibitors Pg in the early stages of pregnancy can adversely affect the course of pregnancy.

    There are limited data on the excretion of celecoxib with breast milk. Given the potential risk of developing side effects in the child and the need for celecoxib for the mother, the advisability of breastfeeding should be evaluated.

    Dosing and Administration:

    Inside, not liquid, squeezed water, regardless of food intake.

    Since the risk of possible complications from the cardiovascular system may increase with increasing dose and durationreception celecoxib, it should be used as short as possible and at the lowest effective doses. The maximum recommended daily dose for long-term admission is 400 mg.

    Symptomatic treatment of osteoarthritis: the recommended dose is 200 mg per day for 1 or 2 doses.

    Symptomatic treatment of rheumatoid arthritis: the recommended dose is 100 or 200 mg 2 times a day.

    Symptomatic treatment of ankylosing spondylitis: recommended dose is 200 mg per day for 1 or 2 doses.

    Treatment of pain syndrome: the recommended initial dose is 400 mg, followed, if necessary, by taking an additional dose of 200 mg on the first day. In the following days, the recommended dose is 200 mg twice a day, as needed.

    Treatment of primary dysmenorrhea: the recommended initial dose is 400 mg, followed, if necessary, by taking an additional dose of 200 mg on the first day. In the following days, the recommended dose is 200 mg twice a day, as needed.

    Elderly patients: usually do not require dose adjustments. However, in patients with a body weight below 50 kg, treatment should be started with the lowest recommended dose.

    Impaired liver function: in patients with mild hepatic insufficiency (class A according to the Child-Pugh classification) dose adjustment is not required. In the case of a moderate degree of liver failure (class A according to Child-Pugh classification), treatment should begin with the minimum recommended dose. The use of the drug in patients with severe hepatic insufficiency (class C according to the Child-Pugh classification) is contraindicated.

    Impaired renal function: in patients with mild and moderate renal failure, dose adjustment is not required. The use of the drug in patients with severe renal failure is contraindicated.

    Simultaneous use with fluconazole: patients receiving fluconazole (inhibitor of isoenzyme CYP2C9), celecoxib should be used at the minimum recommended dose. Caution should be exercised when used simultaneously with other isoenzyme inhibitors CYP2C9.

    Celecoxib should be used with caution in patients who are slow metabolizers or suspected of such a condition, since this can lead to the accumulation of high concentrations of celecoxib in the blood plasma.In such patients, the initial recommended dose of the drug should be reduced by a factor of 2.

    Side effects:

    On the background of taking celecoxib, the following reactions are possible on the part of organs and systems with the following gradation in frequency: Often - ≥10%; often - ≥1 and <10%; infrequently - ≥0.1 and <1%; rarely - ≥0.01 and <0.1%; rarely - <0,01%.

    From the side of the cardiovascular system: often - peripheral edema; infrequently - worsening of the course of arterial hypertension, increased blood pressure (BP), arrhythmia, sensation of "hot flashes", palpitations, tachycardia; rarely - chronic heart failure, ischemic stroke and myocardial infarction; rarely - Vasculitis.

    From the gastrointestinal tract: often - abdominal pain, diarrhea, dyspepsia, flatulence, dental diseases (postextraction lune alveolitis); infrequently - vomiting; rarely - ulcer of the stomach and duodenum, ulceration of the esophagus, gastrointestinal bleeding; rarely - intestinal perforation, pancreatitis.

    From the nervous system: often - dizziness, insomnia; infrequently - anxiety, increased muscle tone, drowsiness; rarely - confusion (psychosis), hallucinations; very rarely - cerebral hemorrhage, aseptic meningitis,loss of taste, loss of smell.

    From the kidneys and urinary system: often - urinary tract infection; rarely - acute renal failure, hyponatremia; rarely - interstitial nephritis, nephrotic syndrome, impaired renal function.

    From the respiratory system: often - bronchitis, cough, sinusitis, infections of the upper respiratory tract; infrequently - pharyngitis, rhinitis; rarely - pulmonary embolism.

    From the skin: often - skin itching, skin rash; infrequently urticaria, ecchymosis; rarely - alopecia, photosensitivity; rarely - erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash in combination with eosinophilia and systemic symptoms (DRESS or hypersensitivity syndrome), acute generalized exanthematous pustulosis, exfoliative dermatitis.

    From the side of the blood: infrequently - anemia, thrombocytopenia.

    From the sense organs: infrequently - sensation of "noise" in the ears, "indistinctness" of visual perception, conjunctivitis.

    From the immune system: rarely - angioedema, rarely - bullous eruptions; rarely anaphylactic reaction.

    From the hepatobiliary system: infrequently - increased activity "Hepatic" enzymes; rarely - hepatitis; very rarely - hepatic insufficiency, fulminant hepatitis, liver necrosis, cholestasis, cholestatic hepatitis, jaundice.

    From the side of the reproductive system: rarely - violation of the menstrual cycle; frequency unknown - decreased fertility in women.

    Are common: infrequently - exacerbation of allergic diseases, flu-like syndrome, facial edema, chest pain.

    Overdose:

    Clinical experience of overdose is limited. Without clinically significant side effects, single-dose up to 1200 mg and multiple doses up to 1200 mg in 2 divided doses were used. If suspected overdose, appropriate maintenance therapy should be provided. Presumably dialysis is not an effective method of removing the drug from the blood, due to the high (97%) degree of binding of the drug to plasma proteins.

    Interaction:

    Research in vitro showed that celecoxib although it is not a substrate of isoenzyme CYP2D6, but inhibits its activity. Therefore, there is a possibility of drug interaction in vivo with drugs whose metabolism is associated with the isoenzyme CYP2D6.

    Inductors of isoenzyme CYP 2C9: Simultaneous application of inducers CYP 2C9, such as rifampicin, chlorphenamine, promethacin, colestyramine, carbamazepine and barbiturates, can reduce plasma concentrations of celecoxib.

    Warfarin and other anticoagulants (for example, coumarin preparations, sulfonamides): with simultaneous admission, an increase in prothrombin time is possible.

    Fluconazole, ketoconazole: with the simultaneous use of 200 mg of fluconazole, an increase in the concentration of celecoxib in the blood plasma is observed twice a day. This effect is associated with inhibition of celecoxib metabolism by fluconazole via the CYP2C9 isoenzyme.

    Patients receiving fluconazole (inhibitor of the isoenzyme CYP2C9) celecoxib should be used at the lowest recommended dose (see section "Method of administration and dose").

    Ketoconazole (inhibitor of the isoenzyme CYP3A4) does not have a clinically significant effect on the metabolism of celecoxib.

    Angiotensin-converting enzyme (ACE) inhibitors / angiotensin II antagonists: inhibition of prostaglandin synthesis can reduce the antihypertensive effect of ACE inhibitors and / or angiotensin II antagonists. This interaction should be taken into account when using celecoxib in conjunction with ACE inhibitors and / or angiotensin II antagonists. However, there was no significant pharmacodynamic interaction with lisinopril in terms of the effect on blood pressure.

    In elderly patients, dehydrated (including patients receiving diuretics) or in patients with impaired renal function, concurrent use of NSAIDs, including selective COX-2 inhibitors, with ACE inhibitors can lead to impaired renal function, including possible acute renal failure. Usually, these effects are reversible.

    Diuretics: previously known NSAIDs in some patients may reduce the natriuretic effect of furosemide and thiazides by reducing renal synthesis of prostaglandins, this should be borne in mind when using celecoxib.

    Oral contraceptives: there was no clinically significant effect on the pharmacokinetics of the contraceptive combination (1 mg norethisterone / 35 μg ethinyl estradiol).When taking mifepristone, celecoxib can be used 8-12 days after taking mifepristone, since NSAIDs reduce the effect of drugs in this group.

    Lithium: an increase in the concentration of lithium in blood plasma by about 17% was observed with the combined use of lithium and celecoxib. Patients receiving lithium therapy should be carefully monitored when taking or withdrawing celecoxib.

    Other NSAIDs: simultaneous use of celecoxib and other NSAIDs (not containing acetylsalicylic acid) should be avoided.

    Other drugs: there were no clinically significant interactions between celecoxib and antacids (aluminum and magnesium preparations), omeprazole, methotrexate, glibenclamide, phenytoin, or tolbutamide.

    Digoxin: it is possible to increase the level of digoxin in blood plasma when combined with celecoxib.

    Antidiabetic agents for oral administration: possibly increased hypoglycemic effect.

    Joint application with paracetamol increases nephrotoxicity, with methotrexate hepato- and nephrotoxicity. Simultaneous appointment of celecoxib and methotrexate is possible onlywhen using low doses of the latter (monitoring the concentration of methotrexate in blood plasma is necessary).

    Probenecid reduces plasma clearance and volume distribution of celecoxib, increases its concentration in blood plasma and increases the half-life.

    Celecoxib does not affect antiplatelet action acetylsalicylic acid, taken in low doses. Celecoxib has a weak effect on the function of platelets, so it can not be considered as a substitute for acetylsalicylic acid, used to prevent cardiovascular diseases.

    Special instructions:

    Celecoxib, considering the antipyretic effect, may reduce the diagnostic significance of such a symptom as fever, and affect the diagnosis of infection.

    Influence on the cardiovascular system

    Celecoxib, like all coxibs, can increase the risk of serious complications from the cardiovascular system, such as thrombosis, myocardial infarction and stroke, which can lead to death. The risk of these reactions may increase with the dose, the duration 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 celecoxib, it should be used in the least effective doses and as short as possible (at the discretion of the treating physician). The attending physician and the patient should keep in mind the possibility of such complications, even in the absence of previously known symptoms of cardiovascular dysfunction. Patients should be informed of the signs and symptoms of adverse effects on the cardiovascular system and the measures to be taken if they occur.

    With the use of NSAIDs (selective inhibitors of COX-2) in patients after an operation of aortocoronary shunting for the treatment of pain in the first 10-14 days, an increase in the frequency of myocardial infarction and cerebral circulation disorders is possible.

    Due to the weak effect of celecoxib on the function of platelets, it can not be a substitute for acetylsalicylic acid for the prevention of thromboembolism. Also, in connection with this, antiplatelet therapy should not be canceled (for example,acetylsalicylic acid) 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, in patients with hypertension should be used with caution. Monitoring of blood pressure should be performed at the beginning of therapy with celecoxib, and during the course of treatment.

    Effect on the gastrointestinal tract

    In patients who took celecoxib, extremely rare cases of perforation, ulceration and bleeding from the gastrointestinal tractof tract.

    The risk of developing these complications in the treatment of NSAIDs is highest in the elderly, patients with cardiovascular diseases, patients receiving acetylsalicylic acid concurrently, and patients with gastrointestinal tract diseases such as ulcers, bleeding, inflammatory processes in the acute stage and in the anamnesis. Other risk factors for bleeding from the gastrointestinal tract are simultaneous use with oral glucocorticosteroids and anticoagulants, a long period of therapy with NSAIDs, smoking, and alcohol use.Most spontaneous reports of serious side effects on the gastrointestinal tract were related to elderly and debilitated patients.

    Co-administration with warfarin and other anticoagulants

    Serious (some of them fatal) bleeding was reported in patients who received concomitant treatment with warfarin or similar agents. As the prothrombin time has been reported, anticoagulant activity should be monitored after initiation of drug treatment or a change in its dose.

    Fluid retention and swelling

    As with the use of other drugs that inhibit the synthesis of prostaglandins, in a number of patients taking celecoxib, fluid retention and swelling may occur, so caution should be exercised when using this medication in patients with conditions predisposing or worsening due to fluid retention. Patients with a history of heart failure or hypertension should be closely monitored.

    Effect on kidney function

    Long-term use of NSAIDs may lead to papillary necrosis of the kidneys or other impairment of kidney function.It was found that celecoxib is not more toxic than other NSAIDs. Nephrotoxicity is also noted in patients, Pg which play a compensatory role in maintaining renal blood flow. The use of NSAIDs in this group of patients can lead to a dose-related decrease in education Pg and, secondarily, a decrease in renal blood flow, which leads to impaired renal function. The risk of nephrotoxicity is high in patients with initial impairment of kidney function, heart failure, impaired liver function, simultaneously accepting diuretics, ACE inhibitors, ARA II, and elderly patients. Nephrotoxic the effect, as a rule, is reversible with the abolition of therapy with NSAIDs.

    Patients with impaired renal function should be administered with caution. Kidney function should be carefully monitored. Also, care should be taken in patients with dehydration. In such cases, it is advisable to rehydrate, and then begin therapy with the drug Celecoxib.

    Effects on liver function

    Celecoxib should not be used in patients with impaired hepatic function (class C according to the Child-Pugh classification). Celecoxib should be used with caution in the treatment of patients with moderate hepatic impairment and prescribe at the lowest recommended dose.

    In some cases severe liver reactions have been observed, including fulminant hepatitis (sometimes fatal), liver necrosis, liver failure (sometimes with a fatal outcome or the need for liver transplantation). Most of these reactions developed 1 month after the initiation of celecoxib.

    In patients with symptoms and / or laboratory signs of liver dysfunction, more severe liver reactions should be monitored during treatment with the drug. After 2 weeks of using the drug, it is necessary to monitor the indicators of liver function. If signs of liver damage (skin itching, yellowing of the skin, nausea, vomiting, abdominal pain, darkening of the urine, increased activity of the liver transaminases) or systemic manifestations (eg, eosinophilia, skin rash, etc.), it is necessary to cancel the drug and apply to the attending physician.

    Anaphylactic reactions

    When receiving celecoxib, rare cases of anaphylactic reactions and angioedema have been reported.

    A drug Celecoxib, which has antipyretic effect, can reduce the diagnostic value of fever, which makes it difficult to diagnose the infection.

    Serious reactions from the skin

    Very rarely, when taking celecoxib, there were serious reactions from the skin, such as exfoliative dermatitis, syndrome FROMversusensa-Johnson, toxic epidermal necrolysis, some of them fatal. The risk of occurrence of such reactions is higher in patients at the beginning of therapy, in most noted cases such reactions began in the first month of therapy. You should stop taking the drug when skin rash, changes in the mucous membranes, or other signs of hypersensitivity.

    Therapy with glucocorticosteroids (GSK)

    Do not replace the therapy with GCS drug in the treatment of glucocorticosteroid insufficiency. With a sudden discontinuation of the SCS, the syndrome of "withdrawal" develops.

    Influence on the organs of hematopoiesis

    Patients on the background of taking the drug sometimes have anemia. In the presence of symptoms of anemia or hemorrhage, the parameters of hemoglobin and hematocrit should be monitored.The drug in these dosages, as a rule, does not affect the number of platelets, the prothrombin time and activated partial thromboplastin time, and also does not affect platelet aggregation.

    Bronchial asthma in history

    The use of the drug in patients with bronchial asthma, provoked by the intake of NSAIDs, can cause severe bronchospasm, which can be fatal. There is a cross reactivity in the form of bronchospasm between acetylsalicylic acid and other NSAIDs. Such patients should not use the drug Celecoxib.

    Elderly patients

    There are no significant differences in the effectiveness of the drug in elderly patients compared with young volunteers. According to the post-marketing application in elderly patients, spontaneous reports of undesirable effects on the part of the digestive organs with a lethal outcome and the development of acute renal failure were observed more often than in young patients.

    Slow metabolism of isoenzymatic substrates CYP2C9

    Patients with a known slow metabolism of isoenzyme substrates CYP2C9 (on the basis of a genotype or in the anamnesis) or with suspicion on such condition it is necessary to apply a preparation with care. It is recommended to begin therapy with the initial recommended dose, reduced by 2 times.

    The use of the drug may adversely affect female fertility and not is recommended for women planning a pregnancy. Patients with infertility (at Tom number of undergoing examinations) it is recommended to cancel the drug.

    Special information on excipients

    The drug contains lactose, so the drug is contraindicated in patients with lactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome.

    Effect on the ability to drive transp. cf. and fur:

    Care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased concentration and speed of psychomotor reactions, as the drug may cause dizziness and other side effects that may affect these abilities.

    Form release / dosage:

    Capsules, 100 mg and 200 mg.

    Packaging:

    10 capsules per blister PVC / aluminum foil; 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 blisters are placed in a cardboard box together with instructions for use.

    For 60 capsules in a polymer container with a screw cap; one container together with instructions for use in a pack of cardboard.

    Storage conditions:

    At a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-003900
    Date of registration:11.10.2016
    Expiration Date:11.10.2021
    The owner of the registration certificate:VIAL, LLC VIAL, LLC Russia
    Manufacturer: & nbsp
    Representation: & nbspVIAL, LLCVIAL, LLC
    Information update date: & nbsp28.10.2016
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