Expiration date: 12/2021

Dosage form 

Capsules 100 mg: 10, 20, 30, 40, 50, 60, 90 or 100 PCs.

Form of issuing, composition

Capsules solid gelatine, No. 3, white color; the contents of capsules - granular powder white, or almost white.

In 1 caps. celecoxib 100mg or 200mg

Excipients: sodium croscarmellose 0.675 mg, magnesium stearate 1.35 mg.

The composition of the gelatin capsules: titanium dioxide 2%, gelatin up to 100%.

Pharmaco-therapeutic group: NSAIDs.

Indications

Symptomatic treatment of pain and inflammation in osteoarthritis and rheumatoid arthritis.

Dosage regimen

The ingestion dose for adults is 200 mg/day in 1-2 reception, if necessary to 200 mg 2 times/day.

Elderly patients weighing less than 50 kg or at moderate impaired liver function treatment should be initiated with the minimum recommended dose.

Clinical experience of celecoxib use in patients with severe hepatic or renal impairment is absent.

Side effect

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

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

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

From the urinary system: often - an infection of the urinary tract; 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 multiform erythema and Stevens-Johnson syndrome), toxic epidermal necrolysis, acute generalized exanthematous pustules.

On the part of the hemopoietic system: sometimes - anemia, ekhimozy, thrombocytopenia.

From the sensory organs: sometimes - tinnitus, blurred vision; rare - loss of taste, loss of smell.

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

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 to use

Severe renal dysfunction, severe disturbances of liver function; allergic reactions to acetylsalicylic acid or other NSAIDs history, III trimester of pregnancy, lactation (breastfeeding); hypersensitivity to sulfonamides, hypersensitivity to celecoxib.

Application in pregnancy and breast-feeding

Adequate and strictly controlled studies of the safety of celecoxib during pregnancy was not carried out, so the use is not recommended.

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

In experimental studies have not found toxic effects on the fetus; it is shown that animals celecoxib concentration in breast milk is similar to that in plasma.

Application for violations of liver function

Is contraindicated in severe violations of liver function.

Application for violations of renal function

Is contraindicated in severe renal impairment.

Use in elderly patients.

Elderly patients weighing less than 50 kg or at moderate impaired liver function treatment should be initiated with the minimum recommended dose.

Special instruction

Caution should be used in patients with heart failure and other conditions predisposing to fluid retention. Use in patients with gastric ulcer or duodenal ulcer in is possible only in case of complete remission of the disease; severe renal and liver failure - only in exceptional cases.

Clinical experience in the use of celecoxib in patients with severe hepatic or renal impairment, as well as in patients under 18 years, is absent.

Drug interaction

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

Dilaxa
(Celecoxib)

    Categories:

  • Brand: KRKA




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