Instruction for use: Celebrex

Active substance Celecoxib

ÀÒÕ M01AH01 Celecoxib

Pharmacological group

Non-steroidal anti-inflammatory drug [NSAIDs - Coxiba]

Nosological classification (ICD-10)

M06.9 Other specified rheumatoid arthritis

Rheumatoid arthritis,Pain syndrome in rheumatic diseases, Pain in rheumatoid arthritis, Inflammation in rheumatoid arthritis, Degenerative forms of rheumatoid arthritis, Children's rheumatoid arthritis, Exacerbation of rheumatoid arthritis, Acute articular rheumatism, Rheumatic arthritis, Rheumatic polyarthritis, Rheumatoid arthritis, Rheumatic polyarthritis, Rheumatoid arthritis, Rheumatoid arthritis of active course, Rheumatoid arthritis, Rheumatoid polyarthritis, Acute rheumatoid arthritis, Acute rheumatism

M19.9 Arthrosis, unspecified

Change in brush with osteoarthritis, Osteoarthritis, Osteoarthrosis, Arthrosis of large joints, Pain syndrome in osteoarthritis, Pain syndrome in acute inflammatory diseases of the musculoskeletal system, Pain syndrome in chronic inflammatory diseases of the musculoskeletal system, Deforming arthrosis, Deforming osteoarthritis, Deforming osteoarthritis of joints, Osteoarthritis in the acute stage, Osteoarthritis of large joints, Acute pain syndrome with osteoarthritis, Post-traumatic osteoarthritis, Rheumatic osteoarthritis, Spondylarthrosis, Chronic osteoarthritis

M25.5 Pain in the joint

Arthralgia, Pain syndrome in musculo-articular diseases, Pain syndrome in osteoarthritis, Pain syndrome in osteoarthritis, Pain syndrome in acute inflammatory diseases of the musculoskeletal system, Pain syndrome in chronic inflammatory diseases of the musculoskeletal system, Pain in the joints, Soreness of the joints, Soreness of joints in severe physical exertion, Painful inflammatory joint damage, Painful conditions of the musculoskeletal system, Painful joint conditions, Painful traumatic affection of joints, Pain in the musculoskeletal system, Pain in Shoulder Joints, Pain in the joints, Joint pain, Joint pain with injuries, Musculoskeletal pain, Pain with osteoarthritis, Pain in the pathology of the joints, Pain in rheumatoid arthritis, Pain in chronic degenerative bone diseases, Pain in chronic degenerative joint diseases, Bone-joint pain, Joint pain, Arthritic pain of rheumatic origin, Articular pain syndrome, Joint pain, Rheumatic pain, Rheumatic pains

M45 Ankylosing spondylitis

Ankylosing spondylarthrosis, Marie-Strumpel disease, Ankylosing spondylitis, Pain syndrome in acute inflammatory diseases of the musculoskeletal system, Pain syndrome in chronic inflammatory diseases of the musculoskeletal system, Bechterew's disease, Ankylosing spondylitis, Diseases of the spinal column, Rheumatic spondylitis, Bechterew-Marie-Strumpel disease

M54.5 Pain below the back

Pain in the lower back, Lumbar pain, Lumbalia, Painful conditions of the spinal column, Back pain, Lower Back Pain Syndrome

M54.9 Dorsalgia, unspecified

Pain syndrome with radiculitis, Pain syndrome in the back,Pain with radiculitis, Degenerative changes in the spine, Degenerative and dystrophic disease of the spine and joints, Degenerative disease of the spine, Osteoarthrosis of the spine, Painful lesions of the spine

M79.1 Myalgia

Myofascial pain syndromes ,Pain syndrome in musculo-articular diseases, Pain syndrome in chronic inflammatory diseases of the musculoskeletal system, Pain in the muscles, Tenderness of muscles, Muscular soreness in severe physical exertion, Painful conditions of the musculoskeletal system, Pain in the musculoskeletal system, Pain in the muscles, Pain at rest, Muscle aches, Muscle pain, Musculoskeletal pain, Myalgia, Muscle pain, Muscle pain at rest, Muscle pain, Muscular pain of non-rheumatic origin, Muscle pain of rheumatic origin, Acute muscle pain, Rheumatic pain, Rheumatic pains, Myofascial syndrome, Fibromyalgia

N94.4 Primary dysmenorrhea

Primary functional dysmenorrhea, Pain in primary dysmenorrhea, Primary algodismenorea, Menstrual cramps

R52.9 Unspecified Pain

Pain after cholecystectomy, Pain shooting, Non-malignant pain, Obstetric and gynecological pain, Pain syndrome, Pain in the postoperative period, Pain in the postoperative period after orthopedic surgery, Pain of inflammatory genesis, Pain than cancer genesis, Pain syndrome after diagnostic procedures, Pain after surgery Diagnostic, Pain after surgery, Pain after orthopedic surgery, Pain after injuries, Pain after the removal of hemorrhoids, Pain at the non-rheumatic inflammation of nature, Pain in inflammatory lesions of the peripheral nervous system, Pain in diabetic neuropathy, Pain in acute inflammatory diseases of the musculoskeletal system, Pain when the tendon pathology, Pain smooth muscle spasm, Pain spasm of smooth muscles (renal and biliary colic, intestinal spasms, dysmenorrhea), Pain spasm of smooth muscles of internal organs, Pain spasm of smooth muscles of internal organs (kidney and biliary colic, intestinal spasms, dysmenorrhea), Pain in trauma syndrome, Pain with injuries and after surgical interventions, Pain in chronic inflammatory diseases of the musculoskeletal system, Pain with duodenal ulcer, Pain syndrome in gastric ulcer, Pain syndrome in gastric ulcer and duodenal ulcer, pain, Pain during menstruation, pain syndromes, painful condition, Painful foot fatigue, Sore gums when wearing dentures, Soreness of the cranial nerves exit points, Painful menstrual irregularities, Painful dressings, Painful muscle spasm, Painful teeth growth, Melosalgia, Pain in the area of the surgical wound, Pain in the postoperative period, Pain in the body, Pain after diagnostic procedures, Pain after orthopedic surgery, Pain after surgery, The pains of the flu, Pain in diabetic polyneuropathy, Pain for burns, Pain during sexual intercourse, Pain during diagnostic procedures, Pain during therapeutic procedures, for colds Pain, Pain in sinusitis, Pain in trauma, Pain traumatic, The pain in the postoperative period, Pain after diagnostic procedures, The pain after sclerotherapy, Pain after surgery, postoperative Pain, Pain postoperative and posttraumatic, posttraumatic pain, Pain when swallowing, Pain in infectious and inflammatory diseases of the upper respiratory tract, The pain of burns, The pain in traumatic muscle injury, Pain in trauma, The pain of tooth extraction, The pain of traumatic origin, Pain caused by spasm of smooth muscles, Expressed pain syndrome, Expressed pain syndrome, traumatic origin, Postoperative pain, Post-traumatic pain, Post-traumatic pain syndrome, Torpid pain, Traumatic pain, Traumatic pain, Mild pain, Moderately severe pain, Moderate pain, Polyarthralgia with polymyositis

T88.9 Complication of surgical and medical care, unspecified

Pain in the postoperative period, Pain in the postoperative period after orthopedic surgery, Pain syndrome after diagnostic procedures, Pain after surgery Diagnostic, Pain after surgery, Pain after orthopedic surgery, Pain after the removal of hemorrhoids, Pain in the application of excimer laser, Pain with injuries and after surgical interventions, Pain syndromes in the dental practice, Painful diagnostic intervention, Painful diagnostic manipulations, Painful instrumental diagnostic procedures, Painful instrumental manipulation, Painful treatments, Painful manipulations, Painful dressings, Painful therapeutic interventions, Pain in the area of the surgical wound, Pain in the postoperative period, Pain after diagnostic procedures, Pain after orthopedic surgery, Pain during diagnostic procedures, Pain during therapeutic procedures, Pain in orthopedics, The pain in the postoperative period, Pain after diagnostic procedures, The pain after sclerotherapy, The pain after dental surgery, postoperative Pain, Pain postoperative and posttraumatic, The pain of tooth extraction, Inflammation after surgery or injury, Inflammation after orthopedic surgery, Inflammation after surgery, The inflammatory syndrome after surgery, Festering postoperative fistula, Operating wound, Complications after tooth extraction

Composition

Capsules 1 caps.

active substance:

celecoxib 100 mg/ 200 mg

auxiliary substances: lactose monohydrate - 149.7 / 49.8 mg; sodium lauryl sulfate - 8.1 / 8.1 mg; Povidone K30 - 6.8 / 6.7 mg; croscarmellose sodium - 2.7 / 2.7 mg; magnesium stearate 2.7 / 2.7 mg

shell: titanium dioxide - about 1.7 mg; gelatin - about 58.3 mg

ink for capsules, 100 mg: blue ink SB-6018 (contain shellac 22-27%, ethanol 33-38%, isopropanol 0.5-4%, butanol 4-8%, propylene glycol 3-6% , ammonia water - 1-2%, lacquer aluminum blue FD & C Blue # 2 on the basis of dye indigotine (E132) - 24-28%)

Ink for capsules, 200 mg: yellow ink SB-3002 (contain shellac 22-27%, ethanol 33-38%, isopropanol 3-7%, butanol 4-9%, propylene glycol 3-6%, ammonia water - 1-2%, iron dye oxide yellow (E172) - 18-22%)

Description of dosage form

Capsules, 100 mg: opaque white or almost white, hard gelatinous, marked with white on blue strips: "100" - on one part and "7767" on the other part of the capsule.

Capsules, 200 mg: opaque white or almost white, hard gelatinous, with markings white on yellow strips: "200" - on one part and "7767" on the other part of the capsule.

Contents of the capsules: white or almost white granules.

pharmachologic effect

Pharmacological action - anti-inflammatory, antipyretic, analgesic.

Pharmacodynamics

Celecoxib has an anti-inflammatory, analgesic and antipyretic effect, blocking the formation of inflammatory PG, mainly by inhibiting COX-2. Induction of COX-2 occurs in response to inflammation and leads to the synthesis and accumulation of PG, especially PGE2, with an increase in inflammation (swelling and pain). At therapeutic doses in humans, celecoxib does not significantly inhibit COX-1 and does not affect PG synthesized as a result of activation of COX-1, nor does it affect normal physiological processes associated with COX-1 and that occur in tissues, and primarily in the tissues of the stomach, intestines and platelets.

Influence on kidney function. Celecoxib reduces urinary excretion of PGE2 and 6-keto-PGF1 (prostacyclin metabolite), but does not affect serum thromboxane B2 and urinary excretion of 11-dehydro-thromboxane B2, thromboxane metabolite (both products of COX-1). Celecoxib does not cause a decrease in the glomerular filtration rate (GFR) in elderly patients and individuals with CRF, transiently reduces excretion of sodium. In patients with arthritis, the observed incidence of peripheral edema, arterial hypertension, and heart failure is comparable to that of non-selective COX inhibitors that have inhibitory activity against COX-1 and COX-2. The most pronounced effect was in patients receiving diuretic therapy. Nevertheless, there was no increase in the incidence of increased blood pressure and heart failure, and peripheral edema was mild and passed independently.

Pharmacokinetics

Suction. When taking an empty stomach, celecoxib is well absorbed, Tmax in plasma - about 2-3 hours Cmax in plasma after taking 200 mg - 705 ng / ml. Absolute bioavailability of the drug has not been studied. Cmax and AUC are approximately proportional to the dose taken in the dose range up to 200 mg twice a day; when celecoxib is used at higher doses, the increase in Cmax and AUC is less proportionate.

Influence of food intake. Taking celecoxib along with fatty foods increases Tmax by about 4 hours and increases absorption by about 20%.

Distribution. Binding to plasma proteins does not depend on the concentration and is about 97%, celecoxib does not bind to red blood cells. Celecoxib penetrates through the BBB.

Metabolism. Celecoxib is metabolized in the liver by hydroxylation, oxidation and partially glucuronidation. Metabolism mainly occurs with the participation of cytochrome P450 CYP2C9 (see "Interaction"). Metabolites found in the blood are pharmacologically inactive in relation to COX-1 and COX-2.

The activity of cytochrome P450 CYP2C9 is reduced in persons 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 through the intestine and kidneys in the form of metabolites (57 and 27%, respectively), less than 1% of the dose taken - in unchanged form. With repeated use of T1 / 2 is 8-12 hours, and the clearance is about 500 ml / min. At repeated application Css in plasma it is reached or achieved to 5th day. The variability of the main pharmacokinetic parameters (AUC, Cmax, T1 / 2) is about 30%. The average Vss is approximately 500 l / 70 kg in young healthy adult patients, indicating a wide distribution of celecoxib in the tissue.

Special patient groups

Elderly patients. In patients older than 65 years, an increase in 1.5-2 times the average values of Cmax, AUC celecoxib, which is more due to changes in body weight, rather than age (in elderly patients, as a rule, there is a lower average body weight than in persons of a younger age, so that they, with other conditions being equal, achieve higher concentrations of celecoxib). 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. However, 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 unknown, so treatment of such patients is recommended starting with the minimum recommended dose.

Violation of the function of the liver. Concentrations of celecoxib in blood 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 reduction in GFR> 65 mL / min / 1.73 m2 due to 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 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.

Contraindications

hypersensitivity to celecoxib or any other component of the drug;

known hypersensitivity to sulfonamides;

bronchial asthma, urticaria, or allergic reactions after taking acetylsalicylic acid or other NSAIDs, including other COX-2 inhibitors;

condition after aortocoronary bypass surgery;

peptic ulcer in the acute stage or gastrointestinal bleeding;

inflammatory bowel disease;

heart failure (NYHA II-IV);

clinically confirmed coronary heart disease, peripheral arterial disease and cerebrovascular disease in a pronounced stage;

severe hepatic and renal failure (no experience of use);

pregnancy and lactation (see "Application in pregnancy and lactation");

age to 18 years (no experience of application).

With caution: gastrointestinal diseases (peptic ulcer, bleeding history), presence of Helicobacter pylori infection; joint use with anticoagulants (warfarin), antiplatelet agents (acetylsalicylic acid, clopidogrel), oral GCS (prednisolone), diuretics, SSRIs (citalopram, fluoxetine, paroxetine, sertraline); fluid retention and swelling; violations of the liver function of moderate severity (see "Special instructions"); CAS diseases (see "Special instructions"); cerebrovascular diseases; dyslipidemia / hyperlipidemia; diabetes; diseases of peripheral arteries; simultaneous application with inhibitors of the isoenzyme CYP2S9; patients who are slow metabolizers or are suspected of such a condition; long-term use of NSAIDs; severe physical illness.

pregnancy and lactation

There is insufficient data on the use of celecoxib in pregnant women. The potential risk of using Celebrex® during pregnancy is not established, but can not be ruled out.

In accordance with the mechanism of action, with NSAIDs, including celecoxib, some women may develop ovarian changes, which can lead to complications during pregnancy. Women who plan pregnancy or are undergoing infertility examinations should consider withdrawing NSAIDs, including celecoxib.

Celecoxib, belonging to the group of inhibitors of GHG synthesis, during admission during pregnancy, especially in the third trimester, can cause weakness of uterine contractions and premature closure of the arterial duct in the fetus. The use of inhibitors of GHG synthesis in the early stages of pregnancy can adversely affect the course of pregnancy.

There is limited evidence that celecoxib is excreted in breast milk. Studies have shown that celecoxib is excreted in breast milk at very low concentrations. Nevertheless, taking into account the potential for the development of side effects from celecoxib in the infant fed, the feasibility of abolishing either breastfeeding or taking celecoxib should be evaluated, given the importance of taking Celebrex® for the mother.

Side effects

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

Common: often - exacerbation of allergic diseases, flu-like syndrome, accidental trauma; infrequently - swelling of the face.

From the CCC: often - peripheral edema; infrequently - weighting the course of arterial hypertension, increased blood pressure, arrhythmia, hot flashes, palpitations, tachycardia; rarely - the manifestation of congestive heart failure, ischemic stroke and myocardial infarction.

From the gastrointestinal tract: often - abdominal pain, diarrhea, dyspepsia, flatulence, dental diseases (postextraction lunechke alveolitis); infrequently - vomiting; rarely - gastric and duodenal ulcers, ulceration of the esophagus, intestinal perforation, pancreatitis.

From the nervous system: often - dizziness, increased muscle tone, insomnia; infrequently - anxiety, drowsiness; rarely confusion.

From the kidneys and urinary system: often - infection of the urinary tract.

On the part of the respiratory system: often - bronchitis, cough, pharyngitis, rhinitis, sinusitis, infections of the upper respiratory tract.

From the skin: often - skin itching, skin rash; infrequently - alopecia, hives.

On the part of the blood: infrequently - anemia, ecchymosis, thrombocytopenia.

From the senses: infrequent - noise in the ears, blurred vision.

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

From the hepatobiliary system: rarely - increased activity of liver enzymes.

Side effects revealed in post-marketing observations

From the immune system: anaphylaxis.

From the nervous system: loss of taste, loss of smell, aseptic meningitis, hallucinations.

From the side of the organ of vision: conjunctivitis.

From the side of the vessels: vasculitis, hemorrhage in the brain.

From the digestive tract: gastrointestinal bleeding.

On the part of the hepatobiliary system: hepatitis, hepatic insufficiency, fulminant hepatitis, liver necrosis (see "Special instructions", Impact on liver function), cholestasis, cholestatic hepatitis, jaundice.

On the part of the kidney and urinary system: acute renal failure (see "Special instructions", Impact on kidney function), interstitial nephritis, nephrotic syndrome, minimal renal dysfunction, hyponatremia.

On the part of the skin: photosensitivity reactions, skin peeling (including erythema multiforme and Stevens-Johnson syndrome), toxic epidermal necrolysis, drug rash in combination with eosinophilia and systemic symptoms (DRESS - Drug Reaction (or Rash) with Eosinophilia and Systemic Symptoms - or hypersensitivity syndrome), acute generalized exanthematous pustulosis.

On the part of the reproductive system: violation of the menstrual cycle, decreased fertility in women (see "Application in pregnancy and lactation").

Respiratory, thoracic and mediastinal disorders: embolism of pulmonary arteries.

Systemic disorders: pain in the chest.

Interaction

In vitro studies have shown that celecoxib, although not a substrate of the CYP2D6 isoenzyme, inhibits its activity. Therefore, there is a possibility of drug interaction in vivo with drugs whose metabolism is associated with the isoenzyme CYP2D6.

Warfarin and other anticoagulants: with simultaneous admission, it is possible to increase PV.

Fluconazole, ketoconazole: with the simultaneous use of 200 mg fluconazole, an increase in the concentration of celecoxib in the blood plasma is observed twice a day 2 times. This effect is associated with inhibition of celecoxib metabolism by fluconazole via the CYP2C9 isoenzyme. For patients taking fluconazole (inhibitor of the isoenzyme CYP2C9), celecoxib should be used at the lowest recommended dose (see "Method of administration and dose"). Ketoconazole (an inhibitor of the isoenzyme CYP3A4) does not have a clinically significant effect on the metabolism of celecoxib.

ACE inhibitors / angiotensin II antagonists: inhibition of PG 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 BP.

In elderly patients, dehydrated (including patients receiving diuretic therapy) or in patients with impaired renal function, simultaneous 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 GHG synthesis, 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).

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

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

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

Celecoxib does not affect the antiplatelet effect of acetylsalicylic acid, taken in low doses. Celecoxib has a weak effect on platelet function, so it can not be considered a substitute for acetylsalicylic acid used for the prevention of cardiovascular disease.

Dosing and Administration

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

Because the risk of possible complications from the CCC may increase with increasing dose and duration of Celebrex®, it should be given as short courses 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 twice a day.

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

Treatment of pain syndrome 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 twice a day, as needed.

Special patient groups

Elderly patients. Usually dose adjustment is not required. However, in patients with a body weight below 50 kg, treatment should be started with the lowest recommended dose.

Violation of the function of the liver. In patients with mild liver failure (Class A Child-Pugh classification) dose adjustment is not required, in the case of moderate-grade liver failure (class B according to Child-Pugh classification) treatment should be started with the minimum recommended dose. Experiments with the use of the drug in patients with severe hepatic insufficiency (class C according to the Child-Pugh classification) are not available (see Contraindications).

Impaired renal function. In patients with mild and moderate renal failure, dose adjustment is not required. The experience of using the drug in patients with severe renal failure is not present (see "Contraindications", "Special instructions").

Simultaneous use with fluconazole. For patients taking fluconazole (an inhibitor of the isoenzyme CYP2C9), Celebrex® should be given at the lowest recommended dose. Caution should be exercised when used simultaneously with other inhibitors of the isoenzyme CYP2C9.

Celebrex ® should be used with caution in patients who are slow metabolizers or suspected of such a condition, because 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 half.

Overdose

Clinical experience of overdose is limited. Without clinically significant side effects, single doses up to 1200 mg and multiple doses up to 1200 mg in 2 doses per day were used.

Treatment: it is necessary to provide appropriate maintenance therapy. Presumably dialysis is not an effective method of removing the drug from the blood because of the high degree of binding of the drug to plasma proteins.

special instructions

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

Influence on CAS. Celecoxib, like all coxibs, may increase the risk of serious complications from CVS, 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 CVD and risk factors for such diseases. To reduce the risk of these reactions in patients taking Celebrex®, it should be prescribed at the lowest effective doses and for the shortest possible periods (at the discretion of the treating physician). The attending physician and the patient should bear in mind the possibility of such complications, even in the absence of previously known symptoms of a disturbance of the CAS function. Patients should be informed about the signs and symptoms of adverse effects on CAS and the measures to be taken if they occur.

When using 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 incidence 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 (eg acetylsalicylic acid) should not be abolished 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 CAS. All NSAIDs, incl. and celecoxib, in patients with hypertension should be used with caution. Observation 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 taking celecoxib, extremely rare cases of perforation, ulceration and bleeding from the gastrointestinal tract were observed. The risk of these complications in the treatment of NSAIDs is highest in the elderly, patients with cardiovascular diseases, patients receiving acetylsalicylic acid simultaneously and 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 with oral GCS and anticoagulants, a long period of therapy with NSAIDs, smoking, and alcohol use.

Most spontaneous reports of serious side effects on the gastrointestinal tract related to elderly and weakened patients.

Sharing 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 increase in PT was reported, then after initiation of treatment with Celebrex® or a change in its dose, anticoagulant activity should be monitored.

Fluid retention and swelling. As with other drugs that inhibit the synthesis of PG, a number of patients taking Celebrex® may experience fluid retention and swelling, so caution should be exercised in prescribing this medication to patients with conditions predisposing or worsening due to fluid retention. Patients with a history of heart failure or hypertension should be closely monitored.

Influence on kidney function. NSAIDs, incl. and celecoxib, can have a toxic effect on kidney function. It has been found that celecoxib has no greater toxicity than other NSAIDs. Celebrex® should be used with caution in patients with impaired renal function, heart failure, impaired liver function, and in elderly patients. The function of the kidney 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 impaired hepatic function (class C according to the Child-Pugh classification).

Celebrex® 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 reported, including fulminant hepatitis (sometimes fatal), liver necrosis (sometimes fatal or the need for liver transplantation). Most of these reactions developed 1 month after the initiation of celecoxib.

Patients with symptoms and / or signs of liver dysfunction or those who have a liver function disorder in the laboratory should be closely monitored for the development of heavier liver reactions during treatment with Celebrex®.

Anaphylactic reactions. When taking Celebrex®, cases of anaphylactic reactions were reported.

Serious reactions from the skin. Very rarely, when taking celecoxib, serious skin reactions were observed, such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, some of which were fatal. The risk of occurrence of such reactions in patients at the beginning of therapy is higher, in most noted cases such reactions began in the first month of therapy. Celebrex® should be discontinued if skin rashes, changes in mucous membranes or other signs of hypersensitivity occur.

SCS therapy. Celebrex can not replace GCS or be used as a therapy for GCS deficiency.

Influence on the ability to drive vehicles and work with machinery. The effect of celecoxib on the ability to drive a car and control mechanisms has not been investigated. However, based on the pharmacodynamic properties and general safety profile, it seems unlikely that Celebrex® has such an effect.

Form of issue

Capsules, 100 mg, 200 mg. In the blister (contour mesh packaging) made of PVC / aluminum foil, 10 pcs. 1, 2, 3, 4, 5 or 10 blisters in a cardboard bundle, on the front side of which, in order to control the first opening, a perforated stitch is placed, resembling the outline of semirings; the side surfaces of the pack tightly adhere to the packaging of the preparation.

Conditions of leave from pharmacies

On prescription.

storage Conditions

In a dry place, at a temperature of 15-30 ° C.

Keep out of the reach of children.

Shelf life of Celebrex®

capsule capsule set. 400 mg (1 pc.), Caps. 200 mg (1 pc.) -

capsule capsule set. 400 mg (1 pc.), Caps. 200 mg (5 pcs.) -

capsule capsule set. 400 mg (1 pc.), Caps. 200 mg (9 pcs.) -

capsule capsule set. 400 mg (1 pc.), Caps. 200 mg (13 pcs.) -

capsules 100 mg - 3 years.

capsules 100 mg -

capsules 200 mg - 3 years.

capsules 200 mg -

Do not use after the expiry date printed on the package.