Celecoxib

Am J Orthop 2002 Aug;31(8):445-51
Efficacy of celecoxib versus ibuprofen in the treatment of acute pain: a multicenter, double-blind, randomized controlled trial in acute ankle sprain
Ekman EF, Fiechtner JJ, Levy S, Fort JG
Southern Orthopaedic Sports Medicine, Providence Hospital Columbia, South Carolina, USA

Ankle sprain is a common acute soft-tissue injury that often results in pain, inflammation, and ecchymosis. In this multicenter, double-blind, randomized parallel-group study, 445 adult patients received celecoxib 400 mg/day, ibuprofen 2,400 mg/day, or placebo for 10 days. Patients had experienced grade 1 or 2 ankle sprains within 48 hours and had moderate to severe ankle pain. Patient's Global Assessment of Ankle Injury responses, given on days 4 and 8, showed that the celecoxib group improved significantly more than the placebo group did, with 67% of the celecoxib group versus 55% of the placebo group improving at day 4 (P < .05). Patient's Assessment of Ankle Pain Visual Analog Scale on Weight Bearing responses, also given on days 4 and 8, showed that celecoxib was as efficacious in the treatment of ankle sprain as the maximum therapeutic dosage of ibuprofen and that, compared with placebo, it reduced pain significantly more (P < .05). The celecoxib group recovered and returned to function earlier (after 5 days) than did either the placebo group (8 days) or the ibuprofen group (6 days); the celecoxib-placebo difference was significant. Celecoxib, a cyclo-oxygenase-2-specific inhibitor with platelet-function-sparing properties, may be useful as a multimodal adjuvant in the treatment of ankle sprain.

GENERIC NAME: celecoxib
BRAND NAME: Celebrex

DRUG CLASS AND MECHANISM: Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) that is used to treat arthritis, pain, menstrual cramps, and colonic polyps. Prostaglandins are chemicals that are important contributors to the inflammation of arthritis that causes the pain, fever, swelling and tenderness. Celecoxib blocks the enzyme that makes prostaglandins (cyclooxygenase 2), resulting in lower concentrations of prostaglandins. As a consequence, inflammation and its accompanying pain, fever, swelling and tenderness are reduced. Celecoxib differs from other NSAIDs in that it causes less inflammation and ulceration of the stomach and intestine (at least with short-term treatment) and does not interfere with the clotting of blood. NSAIDs have been found to prevent the formation and reduce the size of polyps in patients with the genetic disease, familial adenomatous polyposis (FAP). In FAP, patients develop large numbers of polyps in their colons, and the polyps invariably become malignant. The only cure of FAP requires removal of the entire colon. Celecoxib is approved as an adjunctive (secondary) treatment among patients with FAP. The cramping and pain during menstrual periods is due to prostaglandins, and blocking the production of prostaglandins with celecoxib reduces the cramps and pain.

PREPARATIONS: Capsules: 100 mg (white with a blue band), 200 mg (white with a gold band), 400 mg (white with a green band)

STORAGE: Capsules should be stored at 25°C (77°F). It is okay for brief periods in temperatures between 15-30°C (59-86°F).

PRESCRIBED FOR: Celecoxib is used for the relief of pain, fever, swelling, and tenderness caused by osteoarthritis and rheumatoid arthritis . Celecoxib does not prevent the progression of either type of arthritis. It reduces only the symptoms and signs of arthritis. Celecoxib has been approved for patients with familial FAP who have not had their colons removed. Celebrex also is approved for the relief of acute pain and the pain of menstrual cramps (primary dysmenorrhea).

DOSING: The lowest effective dose should be used for each patient. For the management of osteoarthritis, the dose usually is 100 mg twice daily or 200 mg as a single dose. For rheumatoid arthritis, the dose usually is 100 or 200 mg twice daily. For acute pain or menstrual cramps, the dose is 400 mg as a single dose on the first day followed by an additional 200 mg if needed, then 200mg twice daily as needed. For FAP, the recommended dose is 400 mg twice daily.

DRUG INTERACTIONS: Concomitant use of celecoxib with aspirin or other NSAIDs (e.g., ibuprofen, naproxen, etc.) may increase the occurrence of stomach and intestinal ulcers.

Fluconazole (Diflucan) increases the concentration of celecoxib in the body by inhibiting the breakdown of celecoxib in the liver. Therefore, treatment with celecoxib should be initiated at the lowest recommended doses in patients who are taking fluconazole.

Celecoxib increases the concentration of lithium (Eskalith) in the blood by 17%. Therefore, lithium therapy should be closely monitored during and after therapy with celecoxib.

Persons taking the anticoagulant (blood thinner) warfarin (Coumadin) should have their blood tested when initiating or changing celecoxib treatment, particularly in the first few days, for any changes in the effects of the anticoagulant.

Persons who drink more than 3 alcoholic beverages per day may be at increased risk of developing stomach ulcers when taking NSAIDs, and this also may be true with celecoxib.

PREGNANCY: Celecoxib has not been studied in pregnant women. In animal studies, doses that were twice the maximally recommended dose were harmful to the fetus. Celecoxib should only be used in pregnant women when the benefits outweigh the potential risk to the fetus.

NURSING MOTHERS: The use of celecoxib in nursing mothers has not been evaluated.

SIDE EFFECTS: Although stomach and intestinal ulcers occur with the use of celecoxib, their incidence is less than with other NSAIDs in short-term studies.

Celecoxib does not interfere with the function of the blood platelets and, as a result, does not reduce clotting and lead to increased bleeding like other NSAIDs.

The most common adverse effects are headache, abdominal pain, dyspepsia, diarrhea, nausea, flatulence and insomnia. Other side effects include fainting, kidney failure, heart failure, aggravation of hypertension, chest pain, ringing in the ears, deafness, stomach and intestinal ulcers, bleeding, blurred vision, anxiety, photosensitivity, weight gain, water retention, flu-like symptoms, drowsiness and weakness.

Allergic reactions can occur with celecoxib. Individuals who have developed allergic reactions (rash, itching, difficulty breathing) from sulfonamides (e.g., Bactrim), aspirin or other NSAIDs may experience an allergic reaction to celecoxib and should not take celecoxib. Glossary content Copyright © 1996-2002 MedicineNet, Inc. All rights reserved.

Caution! Before starting to take this medicine, it is vital that you should consult your doctor! Do not use it on your own initiative, without medical advice.
Also, you should read carefully important health information about this drug given here:

www.nlm.nih.gov