Medication info

Celebrex Capsule (Celecoxib)

Prescription medicationHard capsuleOralExpired
Ingredient · strength
Celecoxib›200mg / 1 capsule
Manufacturer / importer
Independent Bio Pharmaceutical Co., Ltd.
Appearance
A white opaque hard capsule containing white to slightly yellowish powder.
Packaging
Domestic use - 30 capsules/bottle, Domestic use - 100 capsules/bottle
Approval status
Expired

MFDS item code 201905350 · Approved 2019.07.29

This product's status changed to Expired on 2024.07.29. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Relief of arthritis (osteoarthritis, rheumatoid arthritis, etc.), acute pain, and primary dysmenorrhea
Who takes it
Adults
Adult dose
The minimum recommended dose of this medicine should be adjusted for each patient, and it may be administered with or without food. Osteoarthritis (degenerative arthritis): Administer celecoxib 200 mg once daily or divide the dose into 100 mg twice daily. Rheumatoid arthritis: Administer celecoxib 100 mg or 200 mg twice daily. Ankylosing spondylitis (AS): Administer celecoxib 200 mg once daily or divide the dose into 100 mg twice daily. If no effect is observed after 6 weeks, a dose of up to 400 mg per day may be administered. If no effect is observed after 6 weeks of treatment with 400 mg per day, other treatment options should be considered. Acute pain and primary dysmenorrhea: The recommended initial dose is celecoxib 400 mg, with an additional 200 mg on the first day of treatment if needed. Starting on the second day of treatment, the recommended dose as needed is 200 mg twice daily. For patients with moderate hepatic impairment (Child-Pugh Class II), the dose should be reduced to approximately 50% of the recommended daily dose.

Ingredients

Manufacturer
Independent Bio Pharmaceutical Co., Ltd.

Efficacy & effects

Relief of arthritis (osteoarthritis, rheumatoid arthritis, etc.), acute pain, and primary dysmenorrhea

  • Symptoms of osteoarthritis
  • degenerative arthritis
  • rheumatoid arthritis
  • ankylosing spondylitis
  • acute pain
  • primary dysmenorrhea
View approved original text

This medication helps relieve symptoms and signs of joint-related diseases such as osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. It is also used for relief of acute pain in adults, such as pain occurring after surgery or dental extraction. Additionally, it is effective in alleviating symptoms of primary dysmenorrhea. By relieving these various pain and inflammation symptoms, it helps patients live more comfortably.

How to take

Adult dose

The minimum recommended dose of this medicine should be adjusted for each patient, and it may be administered with or without food. Osteoarthritis (degenerative arthritis): Administer celecoxib 200 mg once daily or divide the dose into 100 mg twice daily. Rheumatoid arthritis: Administer celecoxib 100 mg or 200 mg twice daily. Ankylosing spondylitis (AS): Administer celecoxib 200 mg once daily or divide the dose into 100 mg twice daily. If no effect is observed after 6 weeks, a dose of up to 400 mg per day may be administered. If no effect is observed after 6 weeks of treatment with 400 mg per day, other treatment options should be considered. Acute pain and primary dysmenorrhea: The recommended initial dose is celecoxib 400 mg, with an additional 200 mg on the first day of treatment if needed. Starting on the second day of treatment, the recommended dose as needed is 200 mg twice daily. For patients with moderate hepatic impairment (Child-Pugh Class II), the dose should be reduced to approximately 50% of the recommended daily dose.

Precautions

This medication should be consulted with a physician or pharmacist if taken regularly by individuals who consume more than 3 alcoholic beverages daily, as combining it with alcohol may increase the risk of gastrointestinal bleeding. This medication may increase the risk of serious thrombotic events such as cardiovascular disease, myocardial infarction, and stroke; therefore, it should only be used at the lowest effective dose and for the shortest duration possible. Even in individuals without a history of cardiovascular disease, such symptoms should be monitored closely, and immediate action should be taken if symptoms like chest pain or shortness of breath occur. Additionally, this medication can cause serious gastrointestinal adverse reactions such as gastrointestinal perforation, ulcers, and bleeding. Special caution is required for elderly individuals and those with a history of gastrointestinal disease, and if symptoms such as abdominal pain, dyspepsia, melena, or hematemesis occur, immediate consultation with healthcare professionals is necessary. This medication should not be administered to individuals with specific allergies, severe liver or renal impairment, inflammatory bowel disease, history of heart failure or cardiovascular disease, pregnant or nursing women. Patients with impaired liver or kidney function, hypertension, asthma, diabetes, and elderly patients should use this medication with special caution and should have regular examinations to monitor their condition. During the treatment, various adverse reactions such as headache, dizziness, dyspepsia, vomiting, skin rash, edema, hypertension, etc., may occur, and if symptoms persist or worsen, consultation with a physician is advisable. Moreover, this medication may interact with other medications; it is important to inform healthcare professionals of any other medications being taken, especially when taken with antihypertensives, diuretics, anticoagulants, and antidepressants. Pregnant women or those planning to become pregnant should consult healthcare professionals prior to taking this medication as it may affect the fetus, and it is advisable to avoid use while nursing. This medication has not been established for safety and efficacy in children and adolescents under the age of 18, and its use is not recommended. Dizziness or drowsiness may occur while taking this medication; therefore, driving or operating machinery is not safe. If this medication is taken for an extended period, regular blood tests and liver and kidney function tests should be performed, and if any abnormal findings occur, the medication should be discontinued. In case of overdose, symptoms such as nausea, vomiting, drowsiness, and gastrointestinal bleeding may occur; appropriate medical treatment should be sought immediately. Finally, it is important to store this medication out of the reach of children and to avoid transferring it to other containers.

Side effects

Gastrointestinal bleeding, cardiovascular thrombotic reactions, myocardial infarction, stroke, perforation of the upper and lower gastrointestinal tract, ulcer, bleeding, bronchitis, sinusitis, upper respiratory tract infection, urinary tract infection, pharyngitis, rhinitis, anemia, thrombocytopenia, hypersensitivity, insomnia, anxiety, confusional state, dizziness, muscle hypertonicity, drowsiness, blurred vision, tinnitus, palpitations, congestive heart failure, arrhythmia, tachycardia, hypertension, flushing, cough, vomiting, abdominal pain, diarrhea, dyspepsia, bloating, gastric ulcer, dental disease, duodenal ulcer, esophageal ulcer, intestinal perforation, pancreatitis, elevated liver enzymes, itching, rash, urticaria, petechiae, angioedema, alopecia, blistering dermatitis, peripheral edema, facial edema, influenza-like illness, damage, taste disturbance, albuminuria, cystitis, hematuria, dysuria, polyuria, nephrolithiasis, urinary incontinence, urinary tract infection, blurred vision, cataract, conjunctivitis, eye pain, glaucoma, ocular hemorrhage, retinal artery or vein occlusion, increased serum creatinine, increased β2-microglobulin, increased NAG, positive urine hematuria, positive urine protein, renal dysfunction, acute renal failure, interstitial nephritis, increased serum sodium, increased serum potassium, increased BUN, increased CPK, diabetes, hypercholesterolemia, hyperglycemia, hypokalemia, hyperkalemia, increased NPN, elevated creatinine, increased alkaline phosphatase, weight gain, anorexia, increased LDH, hypoglycemia, hyponatremia, bursitis, arthralgia, arthrosis, skeletal abnormalities, myalgia, cervical dystonia, synovitis, tendinitis, myositis, leg cramps, fractures, tendon rupture, pain in the back, muscle stiffness, decreased hematocrit, increased hemoglobin, petechiae, epistaxis, thrombocytopenic purpura, agranulocytosis, aplastic anemia, pancytopenia, leukopenia, eosinophilic pneumonia, contact dermatitis, injection site reactions, skin nodules, headache, migraine, neuralgia, neuropathy, paresthesia, cerebral infarction, aseptic meningitis, ataxia, suicidality, loss of smell, ageusia, back pain, allergy exacerbation, allergic reactions, asthenia, chest pain, fluid retention, systemic edema, facial edema, fatigue, malaise, fever, facial flushing, influenza-like syndrome, pain, peripheral pain, sepsis, sudden death, anaphylaxis-like reaction, angioedema, anorexia, increased appetite, depression, neuro-irritability, drowsiness, fatal intracranial hemorrhage, hallucinations, epilepsy exacerbation, upper respiratory tract infection, bronchospasm, exacerbation of bronchospasm, dyspnea, laryngitis, pneumonia, epistaxis, voice disorders, vesicular dermatitis, dermatitis, nail diseases, photosensitivity reactions, pruritus, erythematous rash, papular rash, skin diseases, dry skin, increased sweating, erythema multiforme, exfoliative dermatitis, mucous membrane syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, eczema, lipoma, allergic dermatitis, petechiae, dandruff, drug rash with eosinophilia and systemic symptoms, vasculitis, pulmonary embolism, interstitial pneumonia, hepatitis, liver failure, fulminant hepatitis, liver necrosis, cholestasis, cholestatic hepatitis, jaundice, acute renal failure, hyponatremia, tubular interstitial nephritis, nephrotic syndrome, menstrual disorders, female infertility, chest pain, anaphylactic reaction

Not everyone experiences these, and they can vary from person to person.

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is best to maintain the storage temperature between 15 to 30 degrees Celsius. This helps preserve the medication's effectiveness for a longer duration.

Appearance and packaging

Appearance

A white opaque hard capsule containing white to slightly yellowish powder.

Package unit

Domestic use - 30 capsules/bottle, Domestic use - 100 capsules/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.