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CELCOXX Celecoxib 400mg Capsule 20's

RXDRUG-DR-XY36564
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Description

Indications/Uses

For the relief of the signs and symptoms of osteoarthritis and rheumatoid arthritis in adults. Management of acute pain in adults especially in postoperative pain. Reduce the number of adenomatous colorectal polyps in familial adenomatous polyposis (FAP), as an adjunct to usual care (eg, endoscopic surveillance surgery). Treatment of dysmenorrhea.

Dosage/Direction for Use

For osteoarthritis and rheumatoid arthritis, the lowest dose of celecoxib should be sought for each patient. These doses can be given without regard to timing of meals.
Osteoarthritis (OA): Recommended Oral Dose: 200 mg/day administered as a single dose or as 100 mg twice daily. If necessary a dose of 200 mg twice daily may be used.
Rheumatoid Arthritis (RA): Recommended Oral Dose: 100-200 mg twice daily.
Juvenile Rheumatoid Arthritis: Patients >25 kg: 100 mg twice daily; ≥10 to ≤25 kg: 50 mg twice daily.
Ankylosing Spondylitis: 200 mg once daily or in 2 divided doses.
Management of Acute Pain and Treatment of Primary Dysmenorrhea: 400 mg initially, followed by an additional 200-mg dose if needed on the 1st day. On the subsequent days, the recommended dose is 200 mg twice daily as needed.
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 twice daily to be taken with food.
Special Populations: Hepatic Insufficient Patients: The daily recommended dose of celecoxib caps in patients with moderate hepatic impairment (Child-Pugh Class B) should be reduced by approximately 50%.

Overdosage

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.

Administration

May be taken with or without food: Dose for OA/RA may be given w/ or w/o meals, but doses for FAP must be given w/ meals.

Contraindications

Patients with known hypersensitivity to celecoxib and those who have demonstrated allergic-type reactions to sulfonamide.
Patients who have experienced asthma, urticaria, or allergic-type reactions after taking acetyl salicylic acid (ASA) or other NSAIDs including other COX-2 specific inhibitors. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients.
Patients with renal impairment associated with CrCl of <30 mL/min.
Patients with severe hepatic impairment (Child-Pugh Class C), heart failure and inflammatory bowel disease.
Patients who have previously had a myocardial infarction (MI) or stroke and in the peri-operative period undergoing cardiac or major vascular surgery.

Warnings

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.

Special Precautions

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 & Lactation

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.

Adverse Reactions

The following adverse drug reactions have been reported during therapy of celecoxib:
Most Common: Gastrointestinal: Abdominal pain, diarrhea, dyspepsia, flatulence, nausea.
Central and Peripheral Nervous System: Dizziness, headache.
Respiratory: Pharyngitis, rhinitis, sinusitis, upper respiratory tract infection.
Others: Back pain, insomnia, rash.
Less Common: Gastrointestinal: Constipation, dysphagia, esophagitis, gastritis, gastroenteritis, gastroesophageal reflux, hemorrhoids, melena, dry mouth, stomatitis, vomiting.
Cardiovascular: Aggravated hypertension, angina pectoris, coronary artery disorder, myocardial infarction, palpitation, tachycardia.
Respiratory: Bronchitis, aggravated bronchospasm, coughing, dyspnea, laryngitis, pneumonia.
Central and Peripheral Nervous System: Leg cramps, hypertonia, hypoesthesia, migraine, neuralgia, neuropathy, paresthesia, vertigo.
Psychiatric: Anorexia, anxiety, increased appetite, depression, nervousness, somnolence.
Reproductive: Breast fibroadenosis, breast neoplasm, breast pain, dysmenorrhea, menstrual disorder, vaginal hemorrhage, vaginitis, prostatic disorder.
Liver and Biliary System: Abnormal hepatic function, increased SGOT.
Musculoskeletal: Arthralgia, bone disorder, myalgia, neck stiffness, tendonitis.
Metabolic and Nutritional: Increased BUN, increased CPK, diabetes mellitus, hypercholesterolemia, hyperglycemia, hypokalemia, NPN increase, increased creatine, inreased alkaline phosphatase, weight increase.
General: Aggravated allergy, allergic reaction, asthenia, chest pain, cyst, generalized edema, face edema, fatigue, fever, hot flushes, influenza-like symptoms, pain, peripheral pain, anemia, ear abnormality, earache, photosensitivity reaction, pruritus, dermatitis, taste perversion, otitis media, blurred vision, eye pain, glaucoma, urinary tract infection (UTI).
Very Rare: Congestive heart failure, pulmonary embolism, vasculitis, cerebrovascular accident, GI bleeding, colitis with bleeding, esophageal perforation, pancreatitis, hepatitis, thrombocytopenia, agranulocytosis, aplastic anemia, pancytopenia, leukopenia, hypoglycemia, hyponatremia, aseptic meningitis, ataxia, acute renal failure, interstitial nephritis, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, anaphylactoid reaction, angioedema.

Drug Interactions

General: Celecoxib metabolism is predominantly mediated via cytochrome P-450 2C9 in the liver. Co-administration of celecoxib with drugs that are known to inhibit 2C9 should be done with caution. Patients who are known or suspected to be P-450 2C9 poor metabolizers based on a previous history should be administered celecoxib with caution as they may have abnormally high plasma levels due to reduced metabolic clearance.
ACE Inhibitors: Reports suggest that NSAID 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.
Furosemide: 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.
Aspirin: Celecoxib can be used with low dose aspirin. However, concomitant administration of aspirin with celecoxib may result in an increased rate of GI ulceration or other complications, compared to use of celecoxib alone. Because of the lack of platelet effects, celecoxib is not a substitute for aspirin for cardiovascular prophylaxis.
Fluconazole: Concomitant administration of fluconazole at 200 mg 4 times daily resulted in a 2-fold increase in celecoxib plasma concentration. This increase is due to the inhibition of celecoxib metabolism via P-450 CYP2C9 by fluconazole. Celecoxib should be introduced at the lowest recommended dose in patients receiving fluconazole.
Lithium: Clinical studies showed that the mean steady-state lithium plasma levels increased approximately 17% in subjects receiving lithium 450 mg twice daily with celecoxib 200 mg twice daily as compared to subjects receiving lithium alone. Patients on lithium treatment should be closely monitored when celecoxib is introduced or withdrawn.
Warfarin: Anticoagulant activity should be monitored, particularly in the 1st few days, after initiating or changing celecoxib therapy in patients receiving warfarin or similar agents, since these patients are at an increased risk of bleeding complications.
Antacid: Co-administration of celecoxib with an aluminum- and magnesium-containing antacid resulted in a reduction in plasma celecoxib concentrations. No dose adjustment is required.
Glucucorticoids: Oral glucucorticoids should be used with caution since they increase the risk of GI side effects eg, ulceration and bleeding. This is especially the case in older (>85 yrs) individuals.

Storage

Store at temperatures not exceeding 30°C. Protect from sunlight and moisture.

Action

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 (Cmax) 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 Cmax 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, Cmax 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 Cmax 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 Cmax 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 (Vss/F) is approximately 400 L, suggesting extensive distribution into the tissues. Celecoxib is not preferentialy bound to red blood cells.

MedsGo Class

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

Features

Brand
Celcoxx
Full Details
Dosage Strength
400mg
Drug Ingredients
  • Celecoxib
Drug Packaging
Capsule 20's
Generic Name
Celecoxib
Dosage Form
Capsule
Registration Number
DR-XY36564
Drug Classification
Prescription Drug (RX)
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