Celeco Capsul

Celecoxib is indicated-

• For the relief of the signs and symptoms of osteoarthritis.
• For the relief of the signs and symptoms of rheumatoid arthritis.
• For the regression and prevention of colorectal adenomatous polyps in patients with familial adenomatous polyposis (FAP).

Celecoxib is a selective cyclooxygenase-2 (COX-2) inhibitor, non-steroidal anti-inflammatory drug (NSAID). It exhibits anti-inflammatory, analgesic and antipyretic properties. The mechanism of action of Celecoxib is believed to be due to the inhibition of prostaglandin synthesis, via the inhibition of cyclooxygenase-2 (COX-2) enzyme. At therapeutic concentration, Celecoxib does not inhibit cyclooxygenase-1 (COX-1) isoenzyme.

Osteoarthritis: The recommended oral dose is 200 mg per day administered as a single dose or as 100 mg twice daily.

Rheumatoid arthritis: The recommended oral dose is 100 to 200 mg twice daily.

Familial adenomatous polyposis (FAP): Usual medical care for FAP patients should be continued while on Celecoxib. To reduce the number of adenomatous colorectal polyps in patients with FAP, the recommended oral dose is 400 mg (2x200 mg capsules) twice daily to be taken with food.

ACE inhibitors: Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE inhibitors. This interaction should be given into consideration in patients taking Celecoxib concomitantly with ACE inhibitors.

Frusemide: NSAIDs can reduce the natriuretic effect of Frusemide and thiazides in some patients.

Aspirin: Celecoxib can be used with low dose Aspirin. However, concomitant administration of Aspirin with Celecoxib may result in an increased rate of gastrointestinal ulceration or similar complications, compared to the use of Celecoxib alone.

Fluconazole: Concomitant administration of Fluconazole at 200 mg qid resulted in a two fold increase in Celecoxib plasma concentration. Celecoxib should be introduced at the lowest recommended dose in patients receiving Fluconazole.

Lithium: Patients on Lithium treatment should be closely monitored when Celecoxib is introduced or withdrawn.

Warfarin: Caution should be used when administering Celecoxib with Warfarin since these patients are at increased risk of bleeding complications.

Co-administration of Celecoxib with aluminium and magnesium-containing antacid should be avoided, because they may reduce the amount of Celecoxib that the body absorbs.

Celecoxib is contraindicated in patients with known hypersensitivity to Celecoxib. It should not be given to patients who have demonstrated allergic type reactions to Sulphonamides (Celecoxib contains a sulphonamide side chain). Celecoxib should not be given to patients who have demonstrated asthma, urticaria or allergic type reactions after taking Aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic like reactions to NSAIDs have been reported in such patients.

Adverse events occurring in ≥2% of patients at recommended doses - Abdominal pain 4.1%, diarrhoea 5.6%, dyspepsia 8.8%, flatulence 2.2%, nausea 3.5%, back pain 2.8%, peripheral oedema 2.1%, accidental injury 2.9%, dizziness 2.0%, headache 15.8%, insomnia 2.3%, pharyngitis 2.3%, rhinitis 2.0%, sinusitis 5.0%, upper respiratory tract infections 8.1%, rash 2.2%. The following adverse events occurred in 0.1-1.9% of patients-

• General: Allergy aggravated, allergic reaction, asthenia, chest pain, oedema generalised, face oedema, fatigue, fever, hot flushes, influenza like symptoms, pain, peripheral pain.
• Gastrointestinal: Constipation, diverticulitis, dysphagia, oesophagitis, gastritis, gastroenteritis, gastro-oesophageal reflux disease, haemorrhoids, hiatal hernia, melaena, dry mouth, stomatitis, tenesmus, tooth disorder, vomiting.
• Cardiovascular: Aggravated hypertension, angina pectoris, coronary artery disease, myocardial infarction.
• Nervous system: Leg cramps, hypertonia, hypoesthesia, migraine, neuralgia, neuropathy, paresthesia, vertigo. Female reproductive system : Breast fibroadenosis, breast neoplasm, breast pain, dysmenorrhoea, menstrual disorder, menorrhagia, vaginitis.
• Male reproductive system: Prostatic disorder.
• Resistance mechanism disorders: Herpes simplex, herpes zoster, bacterial infection, fungal infection, infection of soft tissue, viral infection, moniliasis, moniliasis genital, otitis media.
• Hearing and vestibular: Deafness, ear abnormality, earache, tinnitus.
• Heart rate and rhythm: Palpitation, tachycardia.
• Respiratory: Bronchitis, bronchospasm, bronchospasm aggravated, coughing, dyspnoea, laryngitis, pneumonia.
• Liver and biliary system: Peptic function abnormal, increased AST and ALT.
• Musculoskeletal: Arthralgia, arthrosis, accidental fracture, myalgia, neck stiffness, synovitis, tendinitis.
• Urinary system: Albuminuria, cystitis, dysuria, haematuria, micturition frequency, renal calculus, urinary incontinence, urinary tract infection.
• Metabolic and nutritional: Blood urea nitrogen (BUN), CPK, creatinine, alkaline phosphatase, are increased. Hypercholesterolaemia, hyperglycaemia, hypokalaemia. Bodyweight is also increased.
• Psychiatric: Anorexia, anxiety, increased appetite, depression, nervousness, somnolence.
• Haemic: Anaemia, ecchymosis, epistaxis, thrombocythaemia.
• Skin and appendages: Alopecia, dermatitis, photosensitivity reaction, pruritus, rash erythematous, rash maculopapular, skin disorder, dry skin, increased sweating, urticaria.
• Application site disorders: Cellulitis, contact dermatitis, skin nodule.
• Special senses: Taste perversion.
• Vision: Blurred vision, cataract, conjunctivitis, eye pain, glaucoma.

Celecoxib should be used during pregnancy only if the potential benefit justifies the potential risk to fetus. But in late pregnancy Celecoxib should be avoided because it may cause premature closure of ductus arteriosus. It is not known whether Celecoxib is excreted in human milk. Because many drugs are excreted in human milk and because of potential for serious adverse reactions in nursing infants from Celecoxib, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Celecoxib, at doses up to 200 mg bid, can be administered without regard to timing of meal. Higher doses (400 mg bid) should be administered with food.

Patients should be managed by symptomatic and supportive care following an NSAID overdose. There are no specific antidotes. No information is available regarding the removal of Celecoxib by hemodialysis but based on its high degree of plasma protein binding (>97%) dialysis is unlikely to be useful in overdose. Emesis and/or activated charcoal and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose. Forced diuresis, alkalinization of urine, hemodialysis or hemoperfusion may not be useful due to high protein binding.

Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Geriatric: Dose adjustment in the elderly is not generally necessary. However, for patients of less than 50 kg in body weight, initiate therapy at the lowest recommended dose.

Paediatric: The safety and efficacy of Celecoxib is not established in pediatric patients.

Hepatic insufficiency: Celecoxib capsules should be introduced at a reduced dose in patients with moderate hepatic impairment. The use of Celecoxib in patients with severe hepatic impairment is not recommended.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.