Dilaxa caps 200 mg x10
Dilaxa caps 200 mg x10
ATX code: M01AH01 (Celecoxib)
Active substance: celecoxib (celecoxib) Rec.INN registered by WHO
Dosage form
DILAX
caps. 200 mg: 10, 20, 30, 40, 50, 60, 90 or 100 pcs.reg. No.: LP-002552 dated 07/31/14 - Valid
Release form, composition and packaging
Hard gelatin capsules No. 1, brownish-yellow in color, the contents of the capsules are granular powder of white or almost white color.
1 caps.
celecoxib 200 mg
Excipients: croscarmellose sodium 1.35 mg, magnesium stearate 2.7 mg.
Composition of the gelatin capsule: titanium dioxide 1%, iron dye yellow oxide 1%, gelatin up to 100%.
Clinical and pharmacological group: NSAIDs. Highly selective COX-2 inhibitor Pharmacotherapeutic group: NSAIDs
Pharmacological action Symptomatic treatment of pain and inflammation in osteoarthritis and rheumatoid arthritis. ICD-10 codes
ICD-10 code Indication
M05 Seropositive rheumatoid arthritis
M15 Polyarthrosis
Dosage regimen
When taken orally for adults, the dose is 200 mg/day in 1-2 doses, if necessary - 200 mg 2 times/day.
Elderly patients weighing less than 50 kg or with moderate liver dysfunction should begin treatment with the minimum recommended dose.
There is no clinical experience with the use of celecoxib in patients with severe hepatic or renal impairment.
Side effect
From the cardiovascular system: often - peripheral edema, sometimes - worsening of arterial hypertension, increased blood pressure, arrhythmia, hot flashes, palpitations, tachycardia, rarely - manifestation of congestive heart failure, ischemic stroke and myocardial infarction.
From the digestive system: often - abdominal pain, diarrhea, dyspepsia, flatulence, dental diseases (post-extraction alveolitis alveolitis), sometimes - vomiting, rarely - gastric and duodenal ulcers, ulceration of the esophagus, intestinal perforation, pancreatitis, increased activity of liver enzymes, available messages - gastrointestinal bleeding, hepatitis, liver failure.
From 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 - skin itching, skin rash, sometimes - alopecia, urticaria, there are reports - photosensitivity, peeling of the skin (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.
From the reproductive system: there are reports of menstrual irregularities.
Allergic reactions: rarely - angioedema, bullous rashes, there are reports - anaphylaxis, vasculitis.
From the body as a whole: often - exacerbation of allergic diseases, flu-like syndrome, accidental injuries.
Contraindications for use Severe renal dysfunction, severe liver dysfunction, history of allergic reactions to acetylsalicylic acid or other NSAIDs, third trimester of pregnancy, lactation (breastfeeding), hypersensitivity to sulfonamides, hypersensitivity to celecoxib.
Use during pregnancy and breastfeeding
Adequate and strictly controlled studies of the safety of celecoxib during pregnancy have not been conducted, so use is not recommended.
If it is necessary to use it during lactation, the issue of stopping breastfeeding should be decided.
Experimental studies have not revealed any toxic effects on the fetus; it has been shown that in animals the concentration of celecoxib in breast milk is close to that in plasma.
Use for liver dysfunction Contraindicated in severe liver dysfunction.
Use for renal impairment Contraindicated in severe renal impairment.
Use in elderly patients
Elderly patients weighing less than 50 kg or with moderate liver dysfunction should begin treatment with the minimum recommended dose.
special instructions
Use with caution in patients with heart failure and other conditions predisposing to fluid retention. Use in patients with gastric or duodenal ulcers is possible only in case of complete remission of the disease; in severe renal and liver failure - only in exceptional cases.
There is no clinical experience with the use of celecoxib in patients with severely impaired liver or kidney function, as well as in patients under 18 years of age.
Drug interactions When used simultaneously with drugs that inhibit the activity of the CYP2C9 isoenzyme, incl. with fluconazole, a significant increase in plasma concentrations of celecoxib is possible. Antacids (aluminum and magnesium) reduce the absorption of celecoxib by 10%, which does not cause clinically significant effects. When celecoxib is used concomitantly with warfarin, the risk of bleeding increases. Storage conditions At a temperature not exceeding 25C, in the original packaging Dispensing conditions Dispensed by prescription, ,
Dilaksa
World Health Organization (WHO) side effect frequency classification:
very often >1/10
often > 1/100 to
uncommon >1/1000 to
rarely from > 1/10000 to
very rarely from
From the nervous system: often: dizziness, increased muscle tone, insomnia; uncommon: anxiety, drowsiness; rarely: confusion.
From the cardiovascular system: often: peripheral edema; uncommon: worsening of arterial hypertension, increased blood pressure (BP), ari, palpitations, tachycardia; rarely: chronic heart failure, ischemic stroke and myocardial infarction.
From the respiratory system: often: bronchitis, cough, pharyngitis, rhinitis, sinusitis, upper respiratory tract infections.
From the digestive system: often: abdominal pain, diarrhea, dyspepsia, flatulence, dental diseases (post-extraction alveolitis); uncommon: vomiting; rarely: gastric and duodenal ulcers, ulceration of the esophagus, intestinal perforation, pancreatitis.
From the hematopoietic organs: uncommon: anemia, ecchymosis, thrombocytopenia.
From the skin: often: skin itching, skin rash; uncommon: alopecia.
From the genitourinary system: often: urinary tract infection.
From the senses: uncommon: tinnitus, blurred vision.
Laboratory indicators: rarely: increased activity of liver enzymes.
Allergic reactions when using the drug: often: exacerbation of allergic diseases; uncommon: urticaria; rarely: angioedema, bullous rashes.
Other: often: influenza-like syndrome, accidental injuries; uncommon: swelling of the face.
According to post-marketing surveillance data, during the treatment period the following were noted:
From the nervous system: hallucinations, loss of taste, loss of smell, aseptic meningitis.
From the senses: conjunctivitis.
From the cardiovascular system: vasculitis, cerebral hemorrhages, pulmonary embolism.
From the digestive system: gastrointestinal bleeding, hepatitis, liver failure, fulminant hepatitis, liver necrosis, cholestasis, cholestatic hepatitis, jaundice.
From the genitourinary system: acute renal failure, interstitial nephritis; nephrotic syndrome, minimal renal dysfunction.
From the skin: photosensitivity reactions, acute generalized exanthematous pustulosis.
From the reproductive system: menstrual irregularities, decreased fertility in women.
Allergic reactions: anaphylaxis, skin peeling (including erythema multiforme and Stevens-Johnson syndrome), toxic epidermal necrolysis, drug rash in combination with eosinophilia and systemic symptoms (DRESS or hypersensitivity syndrome).
Laboratory indicators: hyponatremia.
Other: chest pain.
Clinical data on overdose are limited. A single dose of up to 1200 mg and repeated doses of up to 1200 mg 2 times a day were not accompanied by clinically significant side effects. If an overdose is suspected, maintenance therapy should be carried out. Dialysis is presumably not effective, since the binding of celecoxib to plasma proteins is high (97%).
Dilaxa, 200 mg, capsules, 10 pcs.
Dilaxa®, which has an antipyretic effect, can reduce the diagnostic value of fever, which makes it difficult to diagnose an infection.
Impact on cardiovascular system.
Celecoxib, like all coxibs, may increase the risk of serious cardiovascular complications such as blood clots, myocardial infarction and stroke, which can be fatal. The risk of developing these reactions increases with increasing dose, duration of drug use, and in patients with diseases or risk factors for developing cardiovascular disease. In order to reduce the risk of developing these reactions, Dilaxa® should be used in the minimum effective doses and for the shortest possible short course (at the discretion of the attending physician). The attending physician and 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 cardiovascular adverse effects and the measures to be taken if they occur.
When using NSAIDs (selective COX-2 inhibitors) in patients after coronary artery bypass surgery to treat pain in the first 10–14 days, an increase in the incidence of myocardial infarction and cerebrovascular accidents is possible.
Celecoxib does not have an antiplatelet effect on platelets, so they should not replace acetylsalicylic acid for the prevention of thromboembolism. Also, in this regard, antiplatelet therapy (for example, acetylsalicylic acid) should not be canceled in patients at risk of developing thromboembolic complications.
Like all NSAIDs, celecoxib can lead to an increase in blood pressure, which can cause cardiovascular complications. Like other NSAIDs, celecoxib should be used with caution in patients with hypertension. Blood pressure should be monitored at the beginning and during therapy with celecoxib.
Effect on the digestive system.
Extremely rare cases of perforation, ulceration and bleeding from the gastrointestinal tract have been observed in patients taking celecoxib. The risk of developing these complications when using NSAIDs is highest in elderly patients, patients with cardiovascular diseases, in patients simultaneously receiving acetylsalicylic acid, and in patients with gastrointestinal diseases such as ulcers, bleeding, inflammatory processes in the acute stage and in history. Other risk factors for the development of bleeding from the gastrointestinal tract are the simultaneous use of oral corticosteroids or anticoagulants, long-term therapy with NSAIDs, smoking, and ethanol intake. Most spontaneous reports of serious and fatal adverse reactions occurred in elderly and debilitated patients.
Concomitant use with warfarin and other anticoagulants.
Serious (some fatal) bleeding events have been reported in patients receiving warfarin or similar agents concomitantly with celecoxib. Given the presence of reports of prolongation of PT, after starting treatment with Dilaxa® or when changing its dose, blood clotting parameters should be monitored.
Fluid retention and swelling.
As with other drugs that inhibit PG synthesis, some patients taking Dilaxa may experience fluid retention and edema, so caution should be exercised when using the drug in patients with conditions predisposing or worsened by fluid retention. Patients with a history of heart failure or hypertension should be closely monitored.
Effect on kidney function.
NSAIDs, incl. and celecoxib may have toxic effects on renal function. Celecoxib was found to be no more toxic than other NSAIDs.
Dilaxa® should be used with caution in patients with impaired renal function, heart failure, impaired liver function, in patients taking diuretics, ACE inhibitors, ARB II, and in elderly patients. Renal function should be carefully monitored in such patients. Patients with dehydration should also be careful. In such cases, it is advisable to rehydrate and then begin therapy with Dilaxa®.
Effect on liver function.
Dilaxa® should not be used in patients with severe liver dysfunction (class C according to the Child-Pugh classification). In patients with moderate hepatic impairment (Child-Pugh class B), Dilaxa® should be used with caution and in the minimum effective dose. In rare cases, severe liver dysfunction has occurred, including fulminant hepatitis (sometimes fatal), liver necrosis and liver failure (sometimes fatal or requiring liver transplantation). Most of these reactions occurred 1 month after starting celecoxib.
Patients with symptoms and/or signs of liver dysfunction, or those patients in whom laboratory tests have demonstrated liver dysfunction, should be closely monitored for the development of more severe liver reactions during treatment with Dilaxa.
Anaphylactic reactions.
Cases of anaphylactic reactions have been reported when taking Dilaxa®.
Serious skin reactions.
In extremely rare cases, serious skin reactions such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported with celecoxib, some of which have been fatal. The risk of developing such reactions is higher at the beginning of therapy; in most reported cases they occurred in the first month of therapy. If a skin rash, changes in the mucous membranes or other signs of hypersensitivity appear, you should stop taking Dilaxa®.
GCS therapy.
GCS therapy should not be replaced with Dilaxa® in the treatment of GCS deficiency.
Special information on excipients.
Dilaxa® contains lactose, therefore the drug is contraindicated in patients with lactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome.
Impact on the ability to drive a car and operate machinery.
Care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions, because Dilaxa® may cause dizziness and other side effects that may affect these abilities.
