Each capsule contains: Celecoxib 100 mg
Celecoxib is a non-steroidal anti-inflammatory drug that exhibits anti-inflammatory, analgesic, and antipyretic activities in animal models. The mechanism of action of celecoxib is believed to be due to inhibition of prostaglandin synthesis, primarily via inhibition of cyclooxygenase-2 (COX-2). At therapeutic concentrations in humans, celecoxib does not inhibit the cyclooxygenase-1 (COX-1) isoenzyme.

  1. For relief of the signs and symptoms of osteoarthritis.
  2. For relief of the signs and symptoms of rheumatoid arthritis in adults.

The lowest dose of celecoxib should be sought for each patient.
Osteoarthritis: For relief of the signs and symptoms of osteoarthritis the recommended oral dose is 200 mg per day administered as a single dose or as 100 mg twice per day.
Rheumatoid arthritis: For relief of the signs and symptoms of rheuma toid arthritis the recommended oral dose is 100 to 200 mg twice per day.

The adverse events that occur in > 2% of patients receiving celecoxib from 12 controlled studies conducted in patients with OA or RA that included a placebo and/or a positive control group include abdominal pain, diarrhea, dyspepsia, flatulence, nausea, back pain, peripheral edema, dizziness, headache, insomnia, skin rash etc. The following adverse events occurred in 0.1-1.9% of patients regardless of causality: constipation, gastritis, melena, vomiting, aggravated hypertension, dry mouth, glaucoma, allergic reactions, fever, leg cramps, abnormal hepatic function, pruritus.

Celecoxib is contraindicated in patients with known hypersensitivity to celecoxib.
Celecoxib should not be given to patients who have demonstrated allergic-type reactions to sulfonamides. Celecoxib should not be given to patients who have experienced 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.

Celecoxib metabolism is predominantly mediated via cytochrome P450 2C9 in the liver. Co-administration of celecoxib with drugs that are known to inhibit 2C9 should be done with caution. In vitro studies indicate that celecoxib, although not a substrate, is an inhibitor of cytochrome P450 2D6. Therefore, there is a potential for an in vivo drug interaction with drugs that are metabolized by P450 2D6.
Reports suggest that NSAIDs may diminish the antihypertensive effect of Angiotensin Converting Enzyme (ACE) Inhibitors. This interaction should be given consideration in patients taking celecoxib concomitantly with ACE-inhibitors.
Clinical studies, as well as post marketing observations, have shown that NSAIDs can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis.
Celecoxib can be used with low dose aspirin. However, concomitant administration of aspirin with celecoxib may result in an increased rate of GI ulceration of other complications, compared to use of celecoxib alone. Because of its lack of platelet effects, celecoxib is not a substitute for aspirin for cardiovascular prophylaxis.
Celecoxib should be introduced at the lowest recommended dose in patients receiving fluconazole.
Patients on lithium treatment should be closely monitored when celecoxib is introduced or withdrawn.
In an interaction study of rheumatoid arthritis patients taking methotrexate, celecoxib did not have a significant effect on the pharmacokinetics of methotrexate.
In clinical trials celecoxib did not alter the anticoagulant effect of warfarin as determined by prothrombin time However, caution should be used when administering celecoxib with warfarin since these patients are at increased risk of bleeding complications.
Carcinogenesis, mutagenesis and impairment of fertility in animal studies, celecoxib was not found to be carcinogenic and mutagenic. Also celecoxib did not impair male and female fertility in rats.

General Celecoxib cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to exacerbation of corticosteroid responsive illness. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids. The pharmacological activity of celecoxib in reducing inflammation, and possibly fever, may diminish the utility of these diagnostic signs in detecting infectious complications of presumed noninfectious, painful conditions. Gastrointestinal (GI) Effects Risk of GI Ulceration, Bleeding, and Perforation Serious gastrointestinal toxicity such as bleeding, ulceration and perforation of the stomach, small intestine or large intestine, can occur at any time, with or without warning symptoms, in patients treated with non-steroidal anti-inflammatory drugs (NSAIDs). Minor upper gastrointestinal problems, such as dyspepsia, are common and may also occur at any time during NSAID therapy. NSAIDs should be prescribed with extreme caution in patients with a prior history of ulcer disease or gastrointestinal bleeding. To minimize the potential risk for an adverse GI event, the lowest effective dose should be used for the shortest possible duration. For high risk patients, alternate therapies that do not involve NSAIDs should be considered. Prospective long-term studies required to compare the incidence of serious, clinically significant upper GI adverse events in patients taking celecoxib vs. comparator drugs have not been performed. Studies have shown that patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding and who use NSAIDs, have a greater than 10-fold higher risk for developing a GI bleed than patients with neither of these risk factors. In addition to past history of ulcer diseases, pharmaco-epidemiological studies have identified several other co-therapies or co-morbid conditions that may increase the risk for GI bleeding such as: treatment with oral corticosteroids, treatment with anticoagulants, longer duration of NSAID therapy, smoking, alcoholism, older age, and poor general health status. Anaphylactoid Reactions Anaphylactoid reactions were not reported in patients receiving celecoxib in clinical trials. However, as with NSAIDs in general, anaphylactoid reactions may occur in patients without known prior exposure to celecoxib. Celecoxib should not be given to patients with the aspirin triad. Emergency help should be sought in cases where an anaphylactoid reaction occurs.

Pregnancy: There are no studies in pregnant women. Celecoxib should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In late pregnancy celecoxib should be avoided because it may cause premature closure of the ductus arteriosus. Therefore, use of celecoxib during the third trimester of pregnancy should be avoided.
Labor and delivery The effects of celecoxib on labor and delivery in pregnant women are unknown.
Nursing mothers
It is not known whether celecoxib is excreted in human milk. Because many drugs are excreted in human milk and because of the 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.

Store below 30°C and protect from light and moisture.

COBIX-100 Blister pack of 10 capsules

Cipla Ltd.

Farnoush Darou Teb Co.