Dilaxa capsules 200mg, No. 30

• Symptomatic treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis;

• pain syndrome (back pain, musculoskeletal, postoperative and other types of pain);

• treatment of primary dysmenorrhea.

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 taking DilaxaЃ, the minimum effective dose of the drug should be taken in the shortest possible short course. 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 divided 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 divided doses. In some patients, the efficacy of 400 mg 2 times a day was noted.

Treatment of pain syndrome and primary dysmenorrhea. The recommended starting dose is 400 mg, followed by an additional 200 mg as needed on the first day. On the following days, the recommended dose is 200 mg 2 times a day, as needed.

Elderly patients. No dose adjustment is usually required. However, in patients weighing less than 50 kg, it is better to start treatment with the minimum recommended dose.

Liver dysfunction. In patients with mild hepatic impairment (Child-Pugh class A), dose adjustment is not required. In the presence of moderate hepatic impairment (class B according to the Child-Pugh classification), treatment should be started with the minimum recommended dose. There is no experience of using the drug DilaxЃ in patients with severe hepatic impairment (class C according to Child-Pugh classification) (see 'Contraindications').

Impaired renal function. In patients with mild to moderate renal failure, dose adjustment is not required. There is no experience of using DilaxЃ in patients with severe renal failure (see 'Special instructions', 'Contraindications').

Concomitant use with fluconazole. Patients taking fluconazole (an inhibitor of the isoenzyme CYP2C9) should take DilaxaЃ in the minimum recommended dose. Caution should be exercised when used concomitantly with other inhibitors of the CYP2C9 isoenzyme.

Slow metabolism of CYP2C9 isoenzyme substrates. In patients who are slow metabolizers or with suspicion of such a condition, DilaxaЃ should be used with caution, because this can lead to accumulation of celecoxib in high plasma concentrations. In such patients, the initial recommended dose should be reduced by 2 times.

Hard gelatin capsules No. 1, brownish-yellow; the contents of the capsules are white or almost white granular powder.

1 caps. celecoxib 200 mg

Excipients: croscarmellose sodium 1.35 mg, magnesium stearate 2.7 mg.

• Hypersensitivity to celecoxib or any other component of the drug;

• hypersensitivity to other sulfonamide derivatives;

• complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including history);

• condition after coronary artery bypass grafting;

• active erosive and ulcerative lesions of the mucous membrane of the stomach or duodenum, gastric ulcer and duodenal ulcer in the acute stage or gastrointestinal bleeding;

• inflammatory bowel disease (Crohn's disease, ulcerative colitis) in the acute phase;

• heart failure (NYHA functional class II Ц IV);

• clinically proven coronary artery disease, peripheral arterial disease and severe cerebrovascular disease;

• hemorrhagic stroke;

• subarachnoid hemorrhage;

• pregnancy;

• the period of breastfeeding (see 'Application during pregnancy and breastfeeding');

• severe hepatic impairment (Child-Pugh class C) (no experience with use);

• severe renal failure (Cl creatinine less than 30 ml / min), progressive kidney disease, confirmed hyperkalemia (no experience of use);

• age up to 18 years (no experience of use);

• lactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome (DilaxЃ contains lactose).

With care: gastrointestinal diseases (peptic ulcer or duodenal ulcer, ulcerative colitis, Crohn's disease, history of bleeding), the presence of Helicobacter pylori infection, simultaneous use with digoxin, anticoagulants (eg warfarin), antiplatelet agents (eg acetylsalicylic acid), clop for oral administration (eg prednisolone), diuretics, SSRIs (eg citalopram, fluoxetine, paroxetine, sertraline), inhibitors of the CYP2C9 isoenzyme, in patients who are slow metabolizers or suspected of this condition, fluid retention and edema, moderate liver dysfunction severity (see 'Special instructions'), a history of liver disease, hepatic porphyria, impaired renal function (Cl creatinine 30-60 ml / min), a significant decrease in BCC (incl.after surgery), CVS diseases, incl. 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 those receiving diuretics, weakened patients with low body weight), smoking, tuberculosis, alcoholism.alcoholism.alcoholism.

pharmachologic 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 the prostanoids synthesized by COX-1 activation.

Criteria for determining specificity for COX-2 include the absence of side effects due to the action of COX-1, especially gastric and duodenal ulcers, serious complications from the upper gastrointestinal tract (bleeding, perforations, obstruction of the pyloric foramen) and the absence of COX inhibition. -2-dependent platelet aggregation activity.

Side effect

From the side of the cardiovascular system: often - peripheral edema; sometimes - aggravation of the course of arterial hypertension, increased blood pressure, arrhythmia, hot flashes, palpitations, tachycardia; rarely - a manifestation of congestive heart failure, ischemic stroke and myocardial infarction.

From the digestive system: often - abdominal pain, diarrhea, dyspepsia, flatulence, dental diseases (postextraction alveolitis); sometimes vomiting; rarely - stomach and duodenal ulcers, ulceration of the esophagus, intestinal perforation, pancreatitis, increased activity of liver enzymes; there are reports - gastrointestinal bleeding, hepatitis, liver failure.

From the side of the central nervous system and peripheral nervous system: often - dizziness, increased muscle tone, insomnia; sometimes - anxiety, drowsiness; rarely - confusion, hallucinations, aseptic meningitis.

From the urinary system: often - urinary tract infection; there are reports - acute renal failure, interstitial nephritis.

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

Dermatological reactions: often - itching, skin rash; sometimes - alopecia, urticaria; there are reports - photosensitization, skin peeling (including with erythema multiforme and Stevens-Johnson syndrome), toxic epidermal necrolysis, acute generalized exanthematous pustulosis.

From the hematopoietic system: sometimes - anemia, ecchymosis, thrombocytopenia.

From the senses: sometimes - tinnitus, blurred vision; rarely - loss of taste, loss of smell.

On the part of the reproductive system: there are reports - menstrual irregularities.

Allergic reactions: rarely - angioedema, bullous rash; there are reports - anaphylaxis, vasculitis.

On the part of the body as a whole: often - exacerbation of allergic diseases, flu-like syndrome, accidental injuries.

Application during pregnancy and lactation

There have been no adequate and well-controlled studies on the safety of celecoxib during pregnancy, so its use is not recommended.

If necessary, use during lactation should decide on the termination of breastfeeding.

In experimental studies, no toxic effect on the fetus was found; it has been shown that in animals the concentration of celecoxib in breast milk is close to that in plasma.

Application for violations of liver function

Contraindicated in severe liver dysfunction.

Application for impaired renal function

Contraindicated in severe renal impairment.

Use in elderly patients

Elderly patients weighing less than 50 kg or with moderate liver dysfunction, treatment should be started with the minimum recommended dose.

special instructions

It should be used with caution in patients with heart failure and other conditions that predispose to fluid retention. Application in patients with gastric ulcer or duodenal ulcer is possible only in case of complete remission of the disease; in severe renal and hepatic insufficiency - only in exceptional cases.

There is no clinical experience with celecoxib in patients with severe hepatic or renal impairment, as well as in patients under 18 years of age.

Drug interactions

With simultaneous use with drugs that inhibit the activity of the isoenzyme CYP2C9, incl. with fluconazole, a significant increase in plasma celecoxib concentration is possible. Antacids (aluminum and magnesium) reduce the absorption of celecoxib by 10%, which does not cause clinically significant effects. With the simultaneous use of celecoxib with warfarin, the risk of bleeding increases.