More info
Active ingredients
Celecoxib
Composition
Celecoxib 200 mg Auxiliary substances: croscarmellose sodium 1.35 mg, magnesium stearate 2.7 mg. The composition of the gelatin capsule: titanium dioxide 1%, iron dye oxide yellow 1%, gelatin to 100%.
Pharmacological effect
NSAIDs. It is a selective inhibitor of COX-2, thereby blocking the formation of inflammatory prostanoids. At therapeutic concentrations in humans, celecoxib does not inhibit COX-1, therefore, it does not affect prostanoids synthesized by activating COX-1. Criteria for determining specificity with respect to COX-2 include no side effects caused by COX-1, especially ulcerative lesions of the stomach and duodenum, serious complications of the upper GI tract (bleeding, perforations, obstruction of the pyloric orifice) and the absence of COX inhibition. -2-dependent platelet aggregation activity.
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 a history of). condition after coronary artery 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 acute phase. heart failure (II – IV functional class according to the NYHA classification). clinically confirmed ischemic heart disease, peripheral arterial diseases and cerebrovascular diseases in the severe stage. hemorrhagic stroke. subarachnoid hemorrhage. pregnancy breastfeeding period (see"Use during pregnancy and breastfeeding"). severe liver failure (Child-Pugh class C) (no experience). severe renal failure (Cl creatinine less than 30 ml / min), progressive kidney disease, confirmed hyperkalemia (no experience with the application). age up to 18 years (no experience of use). lactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome (Dilax preparation contains lactose). With caution: gastrointestinal diseases (peptic ulcer of the stomach or duodenum, ulcerative colitis, Crohn's disease, history of bleeding), Helicobacter pylori infection, simultaneous use with digoxin, anticoagulants (for example, warfarin), antiplatelet agents (eg, acetylsalicylic acrylate, antiaggregants, antiaggregants, antiaggregants, antiaggregants, antiaggregants, antiaggregants, antiaggregants, antiaggregants, antiaggregants, antiaggregants, antiaggregants, antiaggregants, antiaggregants, antiaggregants, antiplatelet agents for oral administration (for example, prednisolone), diuretics, SSRIs (for example, citalopram, fluoxetine, paroxetine, sertraline), CYP2C9 isoenzyme inhibitors, in patients who are slow metabolizers or have suspicion of such a condition, fluid retention and edema, moderate liver function impairment (see “Special Instructions”), history of liver disease, hepatic porphyria, impaired kidney function (Cl creatinine 30–60 ml / min), a significant decrease in BCC (including after surgery), diseases of the cardiovascular system, including ischemic heart disease, arterial hypertension (see “Special Instructions”), cerebrovascular diseases, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, prolonged use of NSAIDs, severe somatic diseases, elderly patients (including receiving diuretics, weakened patients with low body mass), smoking, tuberculosis, alcoholism.
Use during pregnancy and lactation
Experience with celecoxib during pregnancy is insufficient. The potential risk of using Dilax during pregnancy has not been established, but it cannot be ruled out. When using NSAIDs, including celecoxib, due to inhibition of GHG synthesis, some women may develop changes in the ovaries, which can cause complications during pregnancy. When planning a pregnancy or conducting an examination for infertility, consideration should be given to abolishing NSAIDs, including celecoxib.Celecoxib, belonging to the group of inhibitors of GHG synthesis, when used during pregnancy, especially in the third trimester, can cause weakness of labor and premature closure of the ductus arteriosus. The use of inhibitors of GHG synthesis in early pregnancy can adversely affect the course of pregnancy. There are limited data on the excretion of celecoxib in breast milk. Given the potential risk of side effects in the child and the need for celecoxib for the mother, the appropriateness of breastfeeding should be evaluated.
Dosage and administration
Inside, without chewing, drinking water, regardless of the meal. Since the risk of cardiovascular complications may increase with an increase in the dose and duration of the drug Dilax, the minimum effective dose of the drug should be taken as short a course as possible. The maximum recommended daily dose for long-term use is 400 mg. Symptomatic treatment of osteoarthritis. The recommended dose is 200 mg / day in 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. The recommended dose is 200 mg / day in 1 or 2 doses. In some patients, the effectiveness of the use of 400 mg 2 times a day. Treatment of pain and primary dysmenorrhea. The recommended initial dose is 400 mg, followed by, if necessary, receiving 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. Elderly patients. Usually, dose adjustment is not required. However, in patients with a body weight of less than 50 kg, it is better to begin treatment with the minimum recommended dose. Liver dysfunction. In patients with mild hepatic impairment (class A according to the Child-Pugh classification), dose adjustment is not required. In the case of moderate liver failure (Child-Pugh class B), treatment should begin with the minimum recommended dose. Experience with the use of the drug Dilax in patients with severe liver failure (class C according to the Child-Pugh classification) is not (see "Contraindications"). Impaired renal function.In patients with mild to moderate severity of renal failure, dose adjustment is not required. Experience with the use of the drug Dilax in patients with severe renal insufficiency is not (see "Special instructions", "Contraindications"). Simultaneous use with fluconazole. Patients taking fluconazole (an inhibitor of the isoenzyme CYP2C9), Dilax should be taken in the minimum recommended dose. Caution should be exercised when used simultaneously with other inhibitors of the isoenzyme CYP2C9. Slow metabolism of CYP2C9 isoenzyme substrates. In patients who are slow metabolizers or suspected of such a condition, Dilax should be used with caution, since this can lead to high concentrations of celecoxib in plasma. In such patients, the initial recommended dose should be reduced by 2 times.
Side effects
Classification of the incidence of side effects WHO: very often - & # 8805 .1 / 10. often from & # 8805 .1 / 100 to <1/10. Infrequently - from & # 8805 .1 / 1000 to <1/100. rarely from & # 8805. 1/10000 to <1/1000. very rarely from <1/10000. On the part of the cardiovascular system: often - peripheral edema, increased blood pressure, including weighting of the course of arterial hypertension. infrequently - hot flashes, palpitations. rarely - CHF, arrhythmia, tachycardia, ischemic stroke and myocardial infarction. On the part of the digestive system: often - abdominal pain, diarrhea, dyspepsia, flatulence, vomiting. infrequently - diseases of the teeth (post-extraction lune alveolitis). rarely - gastric and duodenal ulcers, ulceration of the esophagus. very rarely - intestinal perforation, pancreatitis. On the part of the nervous system: often - dizziness, insomnia. infrequently - anxiety, increased muscle tone, drowsiness. rarely - confusion (psychosis). Urinary system: often - urinary tract infection. On the part of the respiratory system: often - bronchitis, cough, sinusitis, infections of the upper respiratory tract. infrequently - pharyngitis, rhinitis. On the part of the skin: often - pruritus (including generalized), skin rash. infrequently - urticaria, ecchymosis. rarely - alopecia. From the side of blood-forming organs: infrequently - anemia. rarely - thrombocytopenia. On the part of the senses: infrequently - tinnitus, blurred visual perception. Laboratory indicators: infrequently - increased activity of liver enzymes (includingALT and AST). Allergic reactions: rarely - angioedema. very rarely - bullous eruptions (bullous dermatitis). Other: infrequently - exacerbation of allergic diseases (hypersensitivity), flu-like syndrome, accidental injuries, swelling of the face. According to post-marketing surveillance Allergic reactions: very rarely - anaphylaxis (anaphylactic reactions). On the part of the nervous system: rarely - hallucinations. very rarely - cerebral hemorrhages, aseptic meningitis, loss of taste, loss of smell. From the senses: infrequently - conjunctivitis. From the CCC: rarely - pulmonary embolism. very rarely - vasculitis. On the part of the digestive system: rarely - gastrointestinal bleeding, hepatitis. very rarely - liver failure, fulminant hepatitis, liver necrosis (see "Special instructions", "Effect on the function of the liver"), cholestasis, cholestatic hepatitis, jaundice. For the skin: rarely - photosensitivity reactions. very rarely - Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, drug rash combined with eosinophilia and systemic symptoms (DRESS or hypersensitivity syndrome), acute generalized exanthematic pustus, exfoliative dermatitis. From the urinary system: rarely - acute renal failure (see "Special instructions", subsection "Impact on renal function"), hyponatremia. very rarely - interstitial nephritis, nephrotic syndrome, minimal renal dysfunction. Reproductive system: rarely, menstrual disorders. frequency unknown - decrease in fertility in women * (see. "Use during pregnancy and lactation"). Other: Infrequent - pain in the chest. * Women planning pregnancy were excluded from the study, so they were not taken into account when calculating the frequency of occurrence.
special instructions
Classification of the incidence of side effects WHO: very often - & # 8805 .1 / 10. often from & # 8805 .1 / 100 to <1/10. Infrequently - from & # 8805 .1 / 1000 to <1/100. rarely from & # 8805. 1/10000 to <1/1000. very rarely from <1/10000. On the part of the cardiovascular system: often - peripheral edema, increased blood pressure, including weighting of the course of arterial hypertension. infrequently - hot flashes, palpitations. rarely - CHF, arrhythmia, tachycardia, ischemic stroke and myocardial infarction.On the part of the digestive system: often - abdominal pain, diarrhea, dyspepsia, flatulence, vomiting. infrequently - diseases of the teeth (post-extraction lune alveolitis). rarely - gastric and duodenal ulcers, ulceration of the esophagus. very rarely - intestinal perforation, pancreatitis. On the part of the nervous system: often - dizziness, insomnia. infrequently - anxiety, increased muscle tone, drowsiness. rarely - confusion (psychosis). Urinary system: often - urinary tract infection. On the part of the respiratory system: often - bronchitis, cough, sinusitis, infections of the upper respiratory tract. infrequently - pharyngitis, rhinitis. On the part of the skin: often - pruritus (including generalized), skin rash. infrequently - urticaria, ecchymosis. rarely - alopecia. From the side of blood-forming organs: infrequently - anemia. rarely - thrombocytopenia. On the part of the senses: infrequently - tinnitus, blurred visual perception. Laboratory indicators: infrequently - increased activity of liver enzymes (including ALT and AST). Allergic reactions: rarely - angioedema. very rarely - bullous eruptions (bullous dermatitis). Other: infrequently - exacerbation of allergic diseases (hypersensitivity), flu-like syndrome, accidental injuries, swelling of the face. According to post-marketing surveillance Allergic reactions: very rarely - anaphylaxis (anaphylactic reactions). On the part of the nervous system: rarely - hallucinations. very rarely - cerebral hemorrhages, aseptic meningitis, loss of taste, loss of smell. From the senses: infrequently - conjunctivitis. From the CCC: rarely - pulmonary embolism. very rarely - vasculitis. On the part of the digestive system: rarely - gastrointestinal bleeding, hepatitis. very rarely - liver failure, fulminant hepatitis, liver necrosis (see "Special instructions", "Effect on the function of the liver"), cholestasis, cholestatic hepatitis, jaundice. For the skin: rarely - photosensitivity reactions. very rarely - Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, drug rash combined with eosinophilia and systemic symptoms (DRESS or hypersensitivity syndrome), acute generalized exanthematic pustus, exfoliative dermatitis.From the urinary system: rarely - acute renal failure (see "Special instructions", subsection "Impact on renal function"), hyponatremia. very rarely - interstitial nephritis, nephrotic syndrome, minimal renal dysfunction. Reproductive system: rarely, menstrual disorders. frequency unknown - decrease in fertility in women * (see. "Use during pregnancy and lactation"). Other: Infrequent - pain in the chest. * Women planning pregnancy were excluded from the study, so they were not taken into account when calculating the frequency of occurrence.