CELCOXX Celecoxib 400mg Capsule 1's

Symptoms: Symptoms following acute NSAID overdose are usually limited to lethargy, drowsiness, nausea, vomiting and epigastric pain, which are generally reversible with supportive care. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose.
Treatment: Patients should be managed by symptomatic and supportive care following an NSAID overdose.

Cardiovascular Thrombotic Events: Chronic use of celecoxib may cause an increased risk of serious adverse cardiovascular thrombotic events, MI and stroke which can be fatal.
All NSAIDs, both COX-2 selective and nonselective, may have a similar risk. Patients with known cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. To minimize the potential risk for an adverse cardiovascular event in patients treated with celecoxib, the lowest effective dose should be used for the shortest duration possible.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.
Gastrointestinal Effects-Risk of GI Ulceration, Bleeding and Perforation: Serious GI toxicity eg, bleeding, ulceration, and perforation of the stomach, small or large intestine, can occur at any time, with or without warning symptoms. In patients treated with NSAIDs, minor upper GI problems, eg dyspepsia, are common and may also occur at any time during NSAID therapy. With longer duration of use of NSAIDs, there is a chance for increasing the likelihood of developing a serious GI event at some time during the course of therapy. However, even short-term therapy is not without risk. Therefore, physicians and patients should remain alert for ulceration and bleeding, even in the absence of previous GI tract symptoms.
NSAIDs should be prescribed with extreme caution in patients with a prior history of ulcer disease or GI bleeding. To minimize the potential risk for an adverse GI event, the lowest effective dose should be used for the shortest possible duration.
Congestive Heart Failure and Edema: Fluid retention and edema have been observed in some patients taking celecoxib. Therefore, celecoxib should be used with caution in patients with fluid retention, hypertension or heart failure.
Hypertension: As with all NSAIDs, celecoxib can lead to the onset of simple hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of cardiovascular events. Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. NSAIDs including celecoxib, should be used with caution in patients with hypertension. Blood pressure should be monitored closely during the initiation of therapy with celecoxib and throughout the course of therapy.
Hepatic Effects: A patient with symptoms and/or signs suggesting liver dysfunction, or in whom an abdominal liver test have occurred, should be monitored carefully for evidence of the development of a more severe hepatic reaction while on therapy with celecoxib. If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (eg, eosinophilia, rash, etc), celecoxib should be discontinued.
Renal Effect: Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. Discontinuation of NSAID therapy is usually followed by recovery to the pre-treatment state.
Caution should be used when initiating treatment with celecoxib in patients with considerable dehydration. It is advisable to rehydrate patients first and then start therapy with celecoxib.
Hematological Effects: Anemia is sometimes seen in patients receiving celecoxib. Patients on long-term treatment with celecoxib should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia or blood loss. Celecoxib does not generally affect platelet counts, prothrombin time (PT), or partial thromboplastin time (PTT), and does not inhibit platelet aggregation at indicated dosages.
Serious Skin Reactions: Patients appear to be at highest risk for serious skin reactions early in the course of therapy. The onset of these events occurring in the majority of the cases within the 1st month of treatment, celecoxib should be discontinued at the 1st appearance of skin rash, mucosal lesions or any other sign of hypersensitivity.
Familial Adenomatous Polyposis (FAP): Treatment with celecoxib in FAP has been shown to reduce the risk of GI cancer or the need for prophylactic colectomy or other FAP-related surgeries. Therefore, the usual care of FAP patients should not be altered because of the concurrent administration of celecoxib.
Use in 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.
Use in lactation: 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.

Use in 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.
Use in lactation: 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 at temperatures not exceeding 30°C. Protect from sunlight and moisture.

Pharmacology: Mechanism of Action: Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic and antipyretic activities. The mechanism of action of celecoxib is believed to be due to inhibition of prostaglandin synthesis, primarily via inhibition of cyclooxygenase-2 (COX-2), and at therapeutic concentrations in humans, celecoxib does not inhibit the cyclooxygenase-1 (COX-1) isoenzyme.
Pharmacokinetics: Absorption: Peak plasma levels of celecoxib occur approximately 3 hrs after an oral dose. Under fasting conditions, both peak plasma levels (C_max) and area under the curve (AUC) are roughly dose proportional up to 200 mg twice daily; at higher doses there are less than proportional increases in C_max and AUC. With multiple dosing, steady-state conditions are reached on or before day 5.
Effect of Food and Antacid: When celecoxib was taken with a high-fat meal, C_max were delayed for about 1-2 hrs with an increase in total absorption (AUC) of 10-20%. Under fasting conditions, at doses >200 mg, there is less than a proportional increase in C_max and AUC, which is thought to be due to the low solubility of the drug in aqueous media. Co-administration of celecoxib with an aluminum- and magnesium-containing antacid resulted in a reduction in plasma celecoxib concentrations with a decrease of 37% in C_max and 10% in AUC.
Celecoxib, at doses up to 200 mg twice daily can be administered without regard to timing of meals. Higher doses (400 mg twice daily) should be administered with food to improve absorption.
Distribution: In healthy subjects, celecoxib is highly protein bound (Yulex97%) within the clinical dose range. The apparent volume of distribution at steady-state (V_ss/F) is approximately 400 L, suggesting extensive distribution into the tissues. Celecoxib is not preferentialy bound to red blood cells.