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Formula
Each capsule contains celecoxib 200 mg and excipients q.s. (lactose monohydrate, croscarmellose sodium, sodium lauryl sulphate, magnesium stearate).
Dosage form
Capsules.
Presentation
Box of 2 blisters x 10 capsules.
Indications
- Treatment of osteoarthritis, rheumatoid arthritis in adults, juvenile rheumatoid athritis in patients 2 years and older, ankylosing spondylitis.
- Relief acute pain, primary dysmenorrhea.
- Adjunctive treatment in familial adenomatous polyposis (FAP).
Contra-indications
- Patients with known hypersensitivity to celecoxib.
- Patients who have demonstrated allergic-type reactions to sulfonamides.
- Patients who have experienced asthma, urticaria or allergic-type reactions after taking aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs).
Precautions
- Patients with historic gastrointestinal ulceration; advanced renal disease; edema, hypertension or heart failure; patients with asthma; pregnant and breast-feeding women; patients under 18 years.
- Dose should be reduced in patients with moderate hepatic impairment. Celecoxib should not be administered in patients with severe hepatic impairment.
Drug interactions
Precautions should be taken when celecoxib is concomitantly used with angiotensin converting enzyme inhibitors, fluconazole, furosemide, thiazides, warfarin. Patients on lithium treatment should be closely monitored when celecoxib is introduced or withdrawn.
Side effects
Gastrointestinal bleeding, dyspepsia, diarrhea, abdominal pain, nausea, back pain, peripheral edema, headache, dizziness, insomnia, rash, pharyngitis.
Inform the physician any side-effect occurs during the therapy.
Dosage and Administration
The lowest dose should be sought for each patient.
- Osteoarthritis: 200 mg once a day or 100 mg twice a day.
- Rheumatoid arthritis: 100 mg - 200 mg twice a day.
Shelf-life
36 months.
Storage
Store in a dry and cool place (<25 degree C). Keep out of reach of children.
Read leaflet carefully before use.
For more information, consult your physician.
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