Celeborg 200 mg 20 capsules

Celeborg 200 mg 20 capsules

Composition:

Each hard gelatin capsule (size 0) contains:
Active ingredient: Celecoxib 200 mg.
Excipients: lactose monohydrate, croscarmellose sodium, povidone k25, sodium lauryl sulfate, magnesium stearate, colloidal silicon dioxide.

Description:

Selective cyclooxygenase-2 (COX-2) inhibitor, a non-steroidal anti-inflammatory drug (NSAID).
Possesses anti-inflammatory, analgesic, and antipyretic properties.
Used for the symptomatic treatment of inflammatory and degenerative joint and spinal diseases.

Indications for Use:

Symptomatic treatment in adults:

• Osteoarthritis.
• Rheumatoid arthritis.
• Ankylosing spondylitis.
  The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient's overall risk.

Dosage and Administration:

• Administration: With or without food.
  Capsules should be swallowed whole with water.
• Dosage: Treatment should be initiated at the lowest effective dose for the shortest possible duration.
• Osteoarthritis: 200 mg once daily or 100 mg twice daily.
  If symptoms are insufficiently relieved, the dose may be increased to 200 mg twice daily.
• Rheumatoid arthritis: 100-200 mg twice daily.
• Ankylosing spondylitis: 200 mg once daily or 100 mg twice daily.
  If symptoms are insufficiently relieved, the dose may be increased to 400 mg daily (in one or two doses).
• Maximum daily dose for all indications is 400 mg.
• Special Populations: Elderly patients should start at the lowest dose.
  In patients with moderate hepatic impairment (cirrhosis, albumin 25-35 g/l), the dose should be halved.
  Use with caution in patients who are known or suspected to be CYP2C9 poor metabolizers (reduce dose to half the lowest recommended dose). 

Contraindications:

• Hypersensitivity to celecoxib, sulfonamides, or any excipient.
• History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
• Active peptic ulcer or gastrointestinal bleeding.
• Severe hepatic impairment (serum albumin <25 g/l, Child-Pugh score ≥10).
• Severe renal impairment (creatinine clearance <30 ml/min).
• Inflammatory bowel disease (Crohn's disease, ulcerative colitis).
• Congestive heart failure (NYHA class II-IV).
• Established ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease.
• Post-coronary artery bypass graft (CABG) surgery period.
• Pregnancy, lactation, women of childbearing potential not using effective contraception.
• Age under 18 years.

Precautions:

• Cardiovascular Risk: Increases the risk of serious thrombotic events (myocardial infarction, stroke), especially with long-term use and high doses.
  Use with caution in patients with risk factors (hypertension, hyperlipidemia, diabetes, smoking).
• Gastrointestinal Risk: Can cause serious GI complications (ulceration, bleeding, perforation), sometimes without warning symptoms.
  Risk is higher in the elderly, patients with a history of ulcers, and those taking corticosteroids, anticoagulants, other NSAIDs, or alcohol.
• Fluid Retention and Edema: May worsen congestive heart failure, hypertension, and cause edema.
• Hepatic and Renal Effects: Monitor function in patients with impairments.
  Cases of severe hepatitis, hepatic failure, and renal toxicity have been reported.
• Skin Reactions: Serious skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) are possible.
  Discontinue immediately at the first appearance of rash or signs of hypersensitivity.
• Other: Contains lactose.
  Contraindicated in lactose intolerance, lactase deficiency, glucose-galactose malabsorption.
  May mask signs of infection.
  May impair female fertility (reversible).

Side Effects:

• Common: Dyspepsia, diarrhea, abdominal pain, flatulence; dizziness, headache; peripheral edema; hypertension; rash, pruritus; sinusitis, upper respiratory tract infection, urinary tract infection.
• Uncommon: Anemia, insomnia, anxiety, somnolence, paresthesia, blurred vision, tinnitus, allergy aggravated, gastritis, increased hepatic enzymes, hyperkalemia, increased blood creatinine and urea, leg cramps.
• Rare: GI ulcer, bleeding, perforation; leukopenia, thrombocytopenia; hypertension aggravated, cardiac failure; hepatitis, hepatic failure; interstitial nephritis, acute renal failure; bronchospasm; anaphylactoid reactions, angioedema, serious skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Frequency not known: Pancytopenia, aseptic meningitis, pancreatitis.

Pregnancy and Lactation:

• Contraindicated during pregnancy.
  May cause fetal malformations (based on animal studies).
  Pregnancy must be excluded and reliable contraception ensured in women of childbearing potential before starting therapy.
• Contraindicated during breastfeeding.
  Celecoxib passes into breast milk.
  Breastfeeding should be discontinued during treatment.

Storage Conditions:

Store in a dry place at a temperature not exceeding 30°C.
Keep out of reach of children.

Packaging:

Carton box containing 2 blister strips of 10 capsules each, and a package leaflet.