Active substanceCelecoxibCelecoxib
Similar drugsTo uncover
  • Dilax®
    capsules inwards 
    KRKA-RUS, LLC     Russia
  • Roquoxib-Routeck
    capsules inwards 
    ARS, LLC     Russia
  • Celebrex®
    capsules inwards 
  • Celebrex®
    capsules inwards 
    Pfizer Inc.     USA
  • Celecoxib
    capsules inwards 
    VERTEKS, AO     Russia
  • Celecoxib-Vial
    capsules inwards 
    VIAL, LLC     Russia
  • Dosage form: & nbspCapsules.
    Composition:

    When manufactured at OOO KRKA-RUS, Russia on a capsule of 100 mg:

    Celecoxib substance-granules 132.975 mg [Active substance of substance-granules: Celecoxib 100.00 mg

    Auxiliary substances of granule substance: lactose monohydrate 24.875 mg, sodium lauryl sulfate 4.05 mg, povidoy-KZO 3,375 mg, croscarmellose sodium 0.675 mg]

    Excipients: croscarmellose sodium 0.675 mg, magnesium stearate 1.35 mg

    Hard gelatin capsules № 3

    Housing: titanium dioxide (E171) 2%, gelatin to 100%

    Cap: titanium dioxide (E17 G) 2%, gelatin to 100%

    per capsule 200 mg:

    Celecoxib substance-granules 265.95 mg

    Active Substance Substance-granules:

    Celecoxib 200.00 mg

    Auxiliary substances of granule substance: lactose monohydrate 49.75 mg, sodium lauryl sulfate 8.10 mg, povidoy-KZO 6.75 mg, croscarmellose sodium 1.35 mg]

    Excipients: croscarmellose sodium 1.35 mg, magnesium stearate 2.70 mg

    TveHard gelatin capsules №1

    Housing: titanium dioxide (E171) 1%, iron dye oxide yellow (E172) 1%, gelatin to 100 %

    Cap: titanium dioxide (E171) 1%, iron dye oxide yellow (E172) 1%,

    gelatin up to 100%

    In production at JSC "Krka, dd, Novo mesto", Slovenia

    per capsule 100 mg:

    Active substance:

    Celecoxib 100.00 mg

    Excipients: lactose monohydrate 24.875 mg, sodium lauryl sulfate 4.05 mg, povidone-KZO 3,375 mg, croscarmellose sodium 1.35 mg, magnesium stearate 1.35 mg.

    Hard gelatin capsules № 3

    Housing: titanium dioxide (E171) 2%, gelatin to 100%

    Cap: titanium dioxide (E171) 2%, gelatin to 100%

    per capsule 200 mg:

    Active substance:

    Celecoxib 200.00 mg

    Excipients: lactose monohydrate 49.75 mg, sodium lauryl sulfate 8.10 mg, povidone-K30 6.75 mg, croscarmellose sodium 2.70 mg, magnesium stearate 2.70 mg

    Hard gelatin capsules № 1

    Housing: titanium dioxide (E171) 1%, iron dye oxide yellow (E172) 1%, gelatin 00 %

    Cap: titanium dioxide (P171) 1%, iron dye oxide yellow (E172) 1%, gelatin up to 100%

    Description:

    Capsules 100 mg. Hard gelatin capsules No. 3 in white color (body and lid).

    The contents of the capsules are a granular powder of white or almost white color.

    Capsules 200 mg. Hard gelatin capsules № 1 brownish-yellow color (body and lid).The contents of the capsules are a granular powder of white or almost white color.

    Pharmacotherapeutic group:NSAIDs (non-steroidal anti-inflammatory drug).
    ATX: & nbsp

    M.01.A.H.01   Celecoxib

    Pharmacodynamics:

    Celecoxib has anti-inflammatory, analgesic and antipyretic effects, blocking the formation of inflammatory prostaglandins (Pg) mainly for

    the inhibition of cyclooxygenase-2 (COX-2). Induction of COX-2 occurs in response to inflammation and leads to synthesis and accumulation Pg, first of all PgE2, which causes an increase in inflammation (swelling and pain). In therapeutic doses in humans celecoxib does not significantly inhibit cyclooxygenase-1 (COX-1) and does not affect the concentration Pg, which are synthesized as a result of the activation of COX-1, as well as the normal physiological processes associated with COX-1 and proceeding in the tissues, primarily the stomach, intestines and platelets.

    ATrenal function

    Celecoxib reduces kidney excretion PgE2 and 6-keto-PgFl (metabolite prostacyclin), but does not affect the serum concentration of thromboxane B2 (ThB2) and excretion of 11-dehydro-TxB by the kidneys2, a metabolite of thromboxane (both products of COX-1).

    Celecoxib does not cause a decrease in glomerular filtration rate in elderly patients and patients with chronic renal failure (CRF), transiently reduces excretion of sodium. In patients with arthritis, the incidence of peripheral edema, arterial hypertension, and heart failure was comparable to that of non-selective COX inhibitors inhibitory activity against COX-1 and COX-2. The most pronounced effect was in patients receiving diuretic therapy. However, there was no increase in the incidence of high blood pressure and heart failure, and peripheral edema was mild and passed independently.

    Pharmacokinetics:

    Suction

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

    Effect of food intake

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

    Distribution

    The degree of binding to plasma proteins does not depend on the concentration of celecoxib in the blood plasma and is about 97%. Celecoxib does not bind to red blood cells. Celecoxib penetrates the blood-brain barrier.

    Metabolism

    Celecoxib is metabolized mainly with the participation of the cytochrome P450 isoenzyme (CYP)

    CYP2C9 in the liver by hydroxylation, oxidation and partial glucuronation (see section "Interaction with other drugs"). The resulting metabolites are pharmacologically inactive with respect to COX-1 and C0G-2. Isoenzyme activity CYP2C9 is reduced in patients with genetic polymorphism, such as homozygous for isoenzyme CYP2C9*3 polymorphism, which leads to a decrease in the effectiveness of enzymes.

    Excretion

    Celecoxib is excreted through the intestines and kidneys in the form of metabolites (57% and 27%, respectively), less than 1% of the accepted dose - in unchanged form. With repeated use, the elimination half-life (T1/2) is 8-12 hours, and the clearance is about 500 ml / min. With repeated application, the equilibrium concentrations in the blood plasma are reached by the 5th day of administration. Variability of the main pharmacokinetic parameters (AUC, FROMmOh, T1/2) is about 30%. The average volume of distribution in the equilibrium state is approximately 500 l / 70 kg in young healthy patients, indicating a wide distribution of celecoxib in tissues.

    Pharmacokinetics in selected patient groups

    Elderly patients

    In patients older than 65 years there is an increase in 1,5-2 times the average values ​​of CmOh and AUC, which is more due to changes in body weight, rather than age (in elderly patients, as a rule, a lower average body weight is observed than in younger people, so that, with other conditions being equal, higher concentrations are achieved celecoxib). For the same reason, older women usually have a higher concentration of celecoxib in the blood plasma than older men.These features of pharmacokinetics, as a rule, do not require dose adjustment. However, in elderly patients with a body weight of less than 50 kg, treatment should be started with the minimum recommended dose.

    Pafroma

    Representatives of the Negroid race AUC celecoxib is about 40% higher than that of representatives of the Caucasoid race. The causes and clinical significance of this fact are unknown, therefore, it is recommended to start treatment of people of the Negroid race with the minimum recommended dose.

    Impaired liver function

    Concentrations of celecoxib in blood plasma in patients with mild liver failure (Class A according to the Child-Pugh classification) vary slightly. In patients with moderate hepatic insufficiency (class B according to the Child-Pugh classification), the concentration of celecoxib in the blood plasma can increase almost 2-fold.

    Impaired renal function

    In elderly patients with a glomerular filtration rate (GFR)> 65 ml / min / 1.73 m2, associated with age-related changes, and in patients with GFR of 35-60 ml / min / 1.73 m2, the pharmacokinetics of celecoxib do not change. There is no reliable correlation between serum creatinine concentration (or creatinine clearance (CC)) and the clearance of celecoxib.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.
    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).
    - Condition after aortocoronary bypass surgery.
    - Active erosive and ulcerative lesions of the mucous membrane of the stomach or duodenum, peptic ulcer of the stomach and duodenum in the acute stage or gastrointestinal bleeding.
    - Inflammatory bowel disease (Crohn's disease, ulcerative colitis) in the phase of exacerbation.
    - Heart failure (II-IV functional class according to NYHA classification).
    - Clinically confirmed ischemic heart disease, peripheral arterial disease and cerebrovascular disease in a pronounced stage.
    - Hemorrhagic stroke.
    - Subarachnoid hemorrhage.
    - Pregnancy and the period of breastfeeding (see the section on "Application during 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 (no experience of use).
    - Age under 18 years (no experience of application).
    - Lactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome (Dilax® preparation contains lactose).
    Carefully:
    diseases of the gastrointestinal tract (peptic ulcer of the stomach or duodenum, ulcerative colitis, Crohn's disease, bleeding in the anamnesis), the presence of Helicobacter pylori infection, concomitant 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 the isoenzyme CYP2C9, in patients who are slow metabolizers or are suspected of such a condition, fluid retention and swelling, poor liver function of moderate severity (see section "Special instructions"), liver disease in history, hepatic porphyria, violation kidney function (KK 30-60 ml / min), a significant decrease in the volume of circulating blood (including after surgery), diseases of the cardiovascular system, including coronary heart disease, arterial hypertension (see p Special instructions), cerebrovascular diseases, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, prolonged use of NSAIDs, severe somatic diseases, elderly patients (including those receiving diuretics, weakened low-weight patients), smoking, tuberculosis, alcoholism.
    Pregnancy and lactation:
    The experience with celecoxib in pregnancy is not enough. The potential risk of Dilax® during pregnancy is not established, however, it can not be excluded.
    When using NSAIDs, including celecoxib, due to the inhibition of Pg synthesis, some women may develop changes in the ovaries, which can lead to complications during pregnancy. When planning a pregnancy or conducting an infertility survey, consideration should be given to abolishing NSAIDs, including celecoxib.
    Celecoxib, which belongs to the group of Pg synthesis inhibitors, when used during pregnancy, especially in the third trimester, can cause weakness in labor and premature closure of the ductus arteriosus. The use of Pg synthesis inhibitors in early pregnancy can adversely affect the course of pregnancy. There are limited data on the excretion of celecoxib with breast milk. Considering the potential risk of side effects in the child and the need for celecoxib for the mother, the advisability of breastfeeding should be considered.
    Dosing and Administration:

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

    Since the risk of cardiovascular complications may increase with increasing dose and the duration of administration of the Dilax® preparation, the minimum effective dose of the drug should be taken as short a course as possible. The maximum recommended daily intake for long-term admission is 400 mg.

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

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

    Symptomatic treatment of ankylosing spondylitis: the recommended dose is 200 mg per day in 1 or 2 doses. Some patients noted the effectiveness of 400 mg twice a day.

    Treatment of pain and 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 2 times a day, as needed.

    Older patients: usually no dose adjustment is required.However, in patients with a body weight of less than 50 kg, it is better to start treatment with the minimum recommended dose.

    Impaired liver function: in patients with mild liver failure (Class A Child-Pugh classification), dose adjustment is not required. AT

    If there is a moderate degree of hepatic insufficiency (class B by Child-Pugh classification) treatment should be started with the minimum recommended dose.

    The experience of using Dilax ® in patients with severe severity of liver failure (class C according to the Child-Pugh classification) is not available (see section

    "Contraindications").

    Impaired renal function: in patients with mild and moderate severity of renal failure, dose adjustment is not required. The experience of using Dilax® in patients with severe severity of renal insufficiency is not present (see sections "Special instructions", "Contraindications").

    Simultaneous application with fluconazole: patients receiving fluconazole (inhibitor of isoenzyme CYP2C9), Dilax® should be taken in a minimal recommended dose. Caution should be exercised when used simultaneously with other isoenzyme inhibitors CYP2C9.

    Slow metabolism of isoenzymatic substrates CYP2C9: in patients who are slow metabolizers or suspected of such a condition, Dilax® with caution, as this can lead to the accumulation of celecoxib in high concentrations in the blood plasma. In such patients, the initial recommended dose should be reduced by a factor of 2.

    Side effects:
    Frequency classification development of side effects of the World Health Organization (WHO):
    • Often>1/10
    • often from > 1/100 to <1/10
    • infrequently from > 1/1000 to <1/100
    • rarely from >1/10000 to <1/1000
    • very rarely from <1/10000

    From the cardiovascular system:

    often: peripheral edema, increased blood pressure, including weighting the course of arterial hypertension;

    infrequently: "hot flashes", a feeling of palpitations;

    rarely: chronic heart failure, arrhythmia, tachycardia, ischemic stroke and myocardial infarction.

    From the digestive system:

    often: abdominal pain, diarrhea, indigestion, flatulence, vomiting;

    infrequently: dental disease (postextraction lune alveolitis);

    rarely: gastric and duodenal ulcers, ulceration of the esophagus;

    very rarely: intestinal perforation, pancreatitis.

    From the nervous system:

    often: dizziness, insomnia;

    infrequently: anxiety, increased muscle tone, snotty;

    rarely: confusion (psychosis).

    From the urinary system:

    often: urinary tract infection.

    From the respiratory system:

    often: bronchitis, cough, sinusitis, infections of the upper respiratory tract;

    infrequently: pharyngitis, rhinitis.

    From the skin:

    often: itchy skin (including generalized), skin rash;

    infrequently: urticaria, ecchymosis;

    rarely: alopecia.

    From the hematopoiesis:

    infrequently: anemia;

    pedko: thrombocytopenia.

    From the sense organs:

    infrequently: noise in the ears, blurred vision.

    Laboratory indicators:

    infrequently: increased activity of "hepatic" enzymes (including alanine aminotransferase and aspartate aminotransferase).

    Allergic reactions:

    rarely: angioedema;

    very rarely: bullous eruptions (bullous dermatitis).

    Other:

    infrequently: exacerbation of allergic diseases (hypersensitivity), flu-like syndrome, accidental trauma, edema of the linden.

    According to post-marketing surveillance data

    Allergic reactions:

    very rarely: anaphylaxis (anaphylactic reactions).

    From the nervous system:

    rarely: hallucinations;

    very rarely: cerebral hemorrhage, aseptic meningitis, loss of taste

    sensations, loss of smell.

    From the sense organs:

    infrequently: conjunctivitis.

    From the cardiovascular system:

    rarely: thromboembolism of the pulmonary arteries;

    very rarely: vasculitis.

    From the digestive system:

    rarely: gastrointestinal bleeding, hepatitis;

    very rarely: hepatic insufficiency, fulminant hepatitis, liver necrosis (see section "Special instructions", subsection "Influence on liver function"), cholestasis, cholestatic hepatitis, jaundice.

    From the skin:

    pedko: photosensitivity reaction;

    very rarely: Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, drug rash in combination with eosinophilia and systemic symptoms (DRESS or hypersensitivity syndrome), acute generalized exanthematous pustulosis, exfoliative dermatitis.

    From the urinary system:

    rarely: acute renal failure (see section "Special instructions", subsection

    "Influence on the function of the nights"), hyponatremia;

    very rarely: interstitial nephritis, nephrotic syndrome, minimal renal dysfunction.

    On the part of the reproductive system:

    rarely: violation of the menstrual cycle:

    frequency unknown: decreased fertility in women * (see "Pregnancy and Breastfeeding").

    Other:

    infrequently: chest pain.

    * Women planning pregnancy were excluded from the study, so they were not taken into account when calculating the frequency of occurrence.

    Overdose:Clinical data on overdose are limited. A single dose in a dose of up to 1200 mg and repeated application in a dose of up to 1200 mg twice a day was not accompanied by clinically significant side effects. If suspected of overdosing, supportive therapy should be given. Dialysis is presumably not effective, since the association of celecoxib with plasma proteins is high (97%).
    Interaction:

    Research in vitro showed that celecoxib although it is not a substrate of isoenzyme CYP2D6, on inhibits its activity. Therefore, there is a probability of drug interaction under conditions in vivo with drugs whose metabolism

    Isoenzyme linked CYP2D6.

    Warfarin and other anticoagulants: with simultaneous application, prolongation of prothrombin time is possible.

    Fluconazole, ketoconazole: when 200 mg of fluconazole is applied once a day, the concentration of celecoxib in the blood plasma is increased by a factor of 2, which is associated with inhibition of the metabolism of celecoxib by fluconazole via isoenzyme CYP2C9. Patients receiving fluconazole (inhibitor of isoenzyme CYP2C9), celecoxib should be used at the lowest recommended dose (see section "Method of administration and dose"). Ketoconazole (inhibitor of isoenzyme CYP3A4) does not have a clinically significant effect on the metabolism of celecoxib.

    Angiotensin converting enzyme (ACE inhibitors) / angiotensin II receptor antagonists (APA II): inhibition of synthesis Pg can reduce the antihypertensive effect of ACEI / ARA II. This interaction should be considered when concurrent use of celecoxib with ACEI / ARA II. However, no significant pharmacodynamic interaction with lisinopril was observed with respect to the effect on BP. In elderly patients,in patients with dehydration (including patients receiving diuretic therapy) or in patients with impaired renal function, concurrent use of NSAIDs, including selective COX-2 inhibitors, with an ACEI can lead to impaired renal function, including acute renal failure. Usually, these effects are reversible after the withdrawal of the NSAID.

    Diuretics: NSAIDs in some patients may reduce the natriuretic effect of furosemide and thiazides by reducing renal synthesis Pg. This should be taken into account when using celecoxib.

    Contraceptives for oral administration: celecoxib does not have a clinically significant effect on the pharmacokinetics of the combined contraceptive drug (1 mg norethisterone / 35 μg ethinyl estradiol).

    Lithium: while simultaneous application of lithium salts in a dose of 450 mg twice a day and celecoxib at a dose of 200 mg twice a day, an increase in the concentration of lithium in blood plasma by about 17% was noted. Patients taking lithium drugs should be carefully monitored when celecoxib is used or withdrawn.

    Other NSAIDs: should avoid the simultaneous use of celecoxib and other NSAIDs (not containing acetylsalicylic acid) (increased risk of side effects).

    Other drugs: There were no clinically significant interactions between

    celecoxib and antacids (magnesium / aluminum hydroxide), omeprazole, methotrexate, Glibenclamide, phenytoin, or tolbutamide.

    Celecoxib does not affect the antiplatelet effect of acetylsalicylic acid in low doses. Celecoxib does not have antiaggregant effects on platelets, so they should not replace acetylsalicylic acid in order to prevent cardiovascular diseases.

    In healthy volunteers, NSAIDs have no effect on the pharmacokinetics of digoxin. However, with the simultaneous use of digoxin and indomethacin and ibuprofen in patients, there was an increase in the concentration of digoxin in the blood plasma. This must be taken into account when used simultaneously with other drugs that increase the concentration of digoxin in the blood plasma. There is no information on the interaction of celecoxib and digoxin. Given the other effects of celecoxib on the cardiovascular system, caution should be taken simultaneously with digoxin. In this case, it is recommended to carefully monitor adverse reactions. Celecoxib predominantly metabolized in the liver by isoenzyme CYP2C9. Since barbiturates are inducers of isoenzyme CYP2C9, while concomitant use with celecoxib, there may be a decrease in the concentration of the latter in blood plasma.

    Special instructions:

    Dilax® preparation, which has an antipyretic effect, can reduce the diagnostic significance of fever, which makes diagnosis of the infection difficult.

    Effect on the cardiovascular system

    Celecoxib, like all coxibs, can increase the risk of developing serious cardiovascular complications, such as thrombosis, myocardial infarction and stroke, which can lead to lethal outcome. The risk of these reactions increases with increasing dose, duration of drug intake, as well as in patients with diseases of the cardiovascular system or with risk factors for cardiovascular disease. In order to reduce the risk of these reactions, the Dilax® preparation should be used in minimum effective doses and with the minimum possible short course (at the discretion of the treating physician). The attending physician and the patient should take into account the possibility of developing such complications even in the absence of previously known symptoms of cardiovascular dysfunction.Patients should be informed of the symptoms of serious adverse effects from the cardiovascular system and the measures to be taken if they occur.

    When NSAIDs (selective COX-2 inhibitors) are used in patients after aortocoronary bypass surgery to treat the pain syndrome in the first 10-14 days, an increase in the incidence of myocardial infarction and cerebral circulation disorders is possible.

    Celecoxib has no antiaggregant effect on platelets, so they should not be replaced acetylsalicylic acid with the aim of preventing thromboembolism. Also, therefore, antiplatelet therapy (eg, acetylsalicylic acid) should not be discontinued in patients at risk of developing thromboembolic complications.

    Like all NSAIDs, celecoxib may lead to an increase in blood pressure, which can cause complications from the cardiovascular system. Like other NSAIDs, celecoxib should be used with caution in patients with hypertension. At the beginning and during therapy with celecoxib, BP should be monitored.

    Effect on the digestive system

    In patients who took celecoxib, extremely rare cases of perforation, ulceration, and bleeding from the gastrointestinal tract (GIT) were observed. The risk of these complications in the use of NSAIDs is highest in elderly patients, patients with cardiovascular diseases, in patients receiving acetylsalicylic acid simultaneously, and in patients with gastrointestinal 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 of GCS for oral administration or anticoagulants, long-term therapy with NSAIDs, smoking, and taking ethanol. Most spontaneous reports of serious adverse reactions with a fatal outcome were observed in elderly patients and weakened patients.

    Simultaneous use with warfarin and other anticoagulants

    Serious (some of them fatal) bleeding was reported in patients who simultaneously used celecoxib warfarin or similar means. Given the presence of reports of lengthening of prothrombin time, after the initiation of treatment with Dilax® or with a change in its dose, it is necessary to control the clotting parameters of the blood.

    Fluid retention and swelling

    As with the use of other drugs that inhibit the synthesis Pg, Some patients taking Dilax® may experience fluid retention and swelling, so caution should be exercised when using the drug 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

    NSAIDs, including celecoxib, can have a toxic effect on kidney function. It was found that celecoxib is not more toxic than other NSAIDs.

    Dilax® should be used with caution in patients with impaired renal function, heart failure, impaired liver function, in patients taking diuretics, ACE inhibitors, ARA II, and in elderly patients. It is necessary to closely monitor the kidney function in such patients. Also, care should be taken in patients with dehydration. In such cases it is advisable to conduct per and then start therapy with Dilax®.

    Effects on liver function

    Dilax® should not be used in patients with severe liver failure (class C according to Child-Pugh classification). Patients with moderate hepatic impairment (class B according to Child-Pyo classification) should be treated with caution and at the lowest effective dose. In rare cases severe liver function abnormalities, including fulminant hepatitis (sometimes fatal), liver necrosis and liver failure (sometimes with a fatal outcome or the need for liver transplantation) have been observed. Most of these reactions developed 1 month after the initiation of celecoxib.

    Patients with symptoms and / or signs of liver dysfunction, or those patients who have been diagnosed with liver function abnormalities in the laboratory, should be closely monitored for the development of more severe liver reactions during treatment with Dilax®.

    Anaphylactic reactions

    When taking Dilax®, cases of anaphylactic reactions developed.

    Serious reactions from the skin

    Very rarely, the reception of celecoxib had serious skin reactions, such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, some of which were fatal. The risk of developing such reactions is higher at the beginning of therapy, in most of the reported cases they occurred in the first month of therapy. If skin rash, changes in mucous membranes or other signs of hypersensitivity occur, you should stop taking Dilax®.

    Therapy of GKS

    Do not replace GKS therapy with Dilax® in the treatment of glucocorticosteroid insufficiency.

    Special information on excipients

    The preparation of Dilax® contains lactose, therefore the drug is contraindicated in patients with lactose intolerance, lactase deficiency or glucose-galactose syndrome

    malabsorption.

    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 Dilax® preparation may cause dizziness and other side effects,which can affect these abilities.
    Form release / dosage:Capsules, 100 mg, 200 mg.
    Packaging:
    For 10 capsules and a contour mesh package (blister) made of PVC and aluminum foil.
    1, 2, 3, 4, 5, 6, 9 or 10 contour squares (blisters) together with the instructions for use are placed in a pack of cardboard.
    Storage conditions:At a temperature of no higher than 25 ° C, in the original packaging. Keep out of the reach of children.
    Shelf life:2 years. Do not use the drug after the expiration date.
    Terms of leave from pharmacies:On prescription
    Registration number:LP-002552
    Date of registration:31.07.2014
    Date of cancellation:2019-07-31
    The owner of the registration certificate:KRKA-RUS, LLC KRKA-RUS, LLC Russia
    Manufacturer: & nbsp
    Representation: & nbspKRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO
    Information update date: & nbsp18.10.2015
    Illustrated instructions
      Instructions
      Up