Medication info
Celebrex Capsule 200 mg (Celecoxib)

Celebrex Capsule 200 mg (Celecoxib)

Prescription medicationHard capsuleOral
Ingredient · strength
Celecoxib›200mg / 1 capsule
Manufacturer / importer
Celltrion Pharmaceutical Co., Ltd.
Appearance
White capsule with yellow bands filled with white to pale yellow powder
Packaging
30 capsules/bottle, 100 capsules/bottle
Approval status
Active

MFDS item code 201403889 · Approved 2014.08.20 · Insurance code 693901400

Summary

Main use
Relief of arthritis (e.g., osteoarthritis), acute pain in adults, 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 taken regardless of meals. ○ Adults: 1. Osteoarthritis (degenerative arthritis): The recommended dose is 200 mg of celecoxib per day, taken once daily, or 100 mg per dose twice daily. 2. Rheumatoid arthritis: The recommended dose is 100 mg or 200 mg of celecoxib per dose, taken twice daily. 3. Ankylosing spondylitis (AS): The recommended dose is 200 mg of celecoxib per day, taken once daily, or 100 mg per dose twice daily. If no effect is observed after 6 weeks, the dose may be increased to 400 mg per day. If no effect is observed after 6 weeks of treatment with 400 mg per day, other treatment options should be considered. 4. Acute pain and primary dysmenorrhea: The recommended initial dose is 400 mg of celecoxib per day, with an additional 200 mg on the first day of treatment if needed. From the second day of treatment, the recommended dose, if needed, is 200 mg per dose twice daily. ○ Patients with hepatic impairment: 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
Celltrion Pharmaceutical Co., Ltd.

Efficacy & effects

Relief of arthritis (e.g., osteoarthritis), acute pain in adults, and primary dysmenorrhea

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

This medication helps relieve symptoms and signs of arthritis, such as osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. It also reduces acute pain following surgery or tooth extraction and is used to treat primary dysmenorrhea. Therefore, it is effective in improving various pain and inflammation symptoms.

How to take

Adult dose

The minimum recommended dose of this medicine should be adjusted for each patient, and it may be taken regardless of meals. ○ Adults: 1. Osteoarthritis (degenerative arthritis): The recommended dose is 200 mg of celecoxib per day, taken once daily, or 100 mg per dose twice daily. 2. Rheumatoid arthritis: The recommended dose is 100 mg or 200 mg of celecoxib per dose, taken twice daily. 3. Ankylosing spondylitis (AS): The recommended dose is 200 mg of celecoxib per day, taken once daily, or 100 mg per dose twice daily. If no effect is observed after 6 weeks, the dose may be increased to 400 mg per day. If no effect is observed after 6 weeks of treatment with 400 mg per day, other treatment options should be considered. 4. Acute pain and primary dysmenorrhea: The recommended initial dose is 400 mg of celecoxib per day, with an additional 200 mg on the first day of treatment if needed. From the second day of treatment, the recommended dose, if needed, is 200 mg per dose twice daily. ○ Patients with hepatic impairment: 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 may pose a risk of gastrointestinal bleeding in individuals who regularly consume three or more alcoholic beverages daily; therefore, consultation with a physician or pharmacist is essential. This medication can increase the risk of cardiovascular thrombotic events, myocardial infarction, and stroke; it should be used at the lowest effective dose for the shortest duration necessary, and cardiovascular symptoms should be immediately reported to healthcare personnel. Severe adverse reactions, such as perforation, ulceration, or bleeding in the gastrointestinal tract, can occur, especially in patients with a history of gastrointestinal disease or the elderly; immediate treatment is essential upon any symptoms of gastrointestinal bleeding (epigastric pain, dyspepsia, black stools, hematemesis, etc.). This medication should not be administered to patients with specific allergies, severe hepatic or renal impairment, active peptic ulcer disease, a history of cardiovascular disease, pregnant women, or nursing mothers. Patients with liver impairment, renal impairment, asthma, heart failure, hypertension, edema, the elderly, and those with diabetes should use this medication cautiously and should have regular monitoring of liver and kidney function and cardiovascular status during treatment. This medication can interact with various drugs, so inform healthcare personnel if you are on other medications, especially when used in conjunction with antihypertensives, anticoagulants, diuretics, and antidepressants. Pregnant women or those who may become pregnant should not take this medication, and if pregnancy is confirmed, it should be discontinued immediately. The safety and efficacy of this medication in children and adolescents have not been established, so it is advisable not to use it in individuals under the age of 18. Dizziness or drowsiness may occur during treatment, so avoiding driving or operating machinery is advisable. Long-term use of this medication requires regular blood tests and liver/kidney function monitoring, and any abnormal symptoms should be discussed with a healthcare professional immediately. Overdose may lead to symptoms such as lethargy, drowsiness, nausea, vomiting, and abdominal pain; immediate medical attention is required. This medication should be kept out of reach of children and should not be transferred to another container for safety purposes.

Side effects

Gastrointestinal bleeding, cardiovascular thrombotic reactions, myocardial infarction, stroke, perforations of the upper and lower gastrointestinal tract, ulcers, bleeding, bronchitis, sinusitis, upper respiratory tract infections, urinary tract infections, pharyngitis, rhinitis, anemia, thrombocytopenia, hypersensitivity, insomnia, anxiety, confusion, dizziness, muscle tension, drowsiness, blurred vision, tinnitus, palpitations, congestive heart failure, arrhythmia, tachycardia, hypertension, flushing, cough, vomiting, abdominal pain, diarrhea, dyspepsia, bloating, gastric ulcer, dental diseases, duodenal ulcer, esophageal ulcer, intestinal perforation, pancreatitis, elevated liver enzymes, itching, rash, urticaria, petechial hemorrhage, angioedema, alopecia, blistering dermatitis, peripheral edema, facial swelling, influenza-like illness, damage, taste disorder, 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 kidney failure, interstitial nephritis, headache, leg cramps, tension, sensory reduction, migraine, neuralgia, neuropathy, sensory disturbance, cerebral infarction, aseptic meningitis, ataxia, suicide, anosmia, ageusia, back pain, exacerbation of allergy, allergic reaction, weakness, chest pain, fluid retention, systemic edema, facial swelling, fatigue, lethargy, fever, facial flushing, influenza-like syndrome, pain, peripheral pain, sepsis, sudden death, anaphylactoid reaction, angioedema, insomnia, loss of appetite, increased appetite, depression, neuroexcitation, drowsiness, fatal intracranial hemorrhage, hallucinations, exacerbation of epilepsy, upper respiratory tract infection, herpes simplex, wound infection, gingivitis, herpes simplex, herpes zoster, bacterial infection, fungal infection, soft tissue infection, viral infection, candidiasis, genital candidiasis, otitis media, mastalgia, menopausal symptoms, fibrocystic breast disease, thoracic neoplasm, chest pain, dysmenorrhea, menstrual disorders, vaginal bleeding, vaginitis, prostate disorders, ovarian cysts, hearing loss, ear abnormalities, otalgia, hearing impairment, liver dysfunction, elevated ALT, elevated AST, increased γ-GTP, increased ALP, positive urobilinogen, cholelithiasis, hepatitis, jaundice, liver failure, fulminant hepatitis, hepatic necrosis, increased sodium in the blood, increased potassium in the blood, elevated BUN, elevated CPK, diabetes mellitus, hypercholesterolemia, hyperglycemia, hypokalemia, hyperkalemia, increased NPN, increased creatinine, increased alkaline phosphatase, weight gain, loss of appetite, increased LDH, hypoglycemia, hyponatremia, synovial sac inflammation, arthralgia, arthrosis, skeletal abnormalities, myalgia, cervical tension, synovitis, tendinitis, myositis, fractures, tendon rupture, pain in the back, muscle rigidity, decreased hematocrit, increased hemoglobin, petechial hemorrhage, epistaxis, thrombocytopenic disease, agranulocytosis, aplastic anemia, pancytopenia, leukopenia, borrelia, contact dermatitis, injection site reaction, skin nodules, blurred vision, cataract, conjunctivitis, eye pain, glaucoma, ocular hemorrhage, retinal artery or vein occlusion, acute kidney failure, hyponatremia, tubular interstitial nephritis, nephrotic syndrome, minuscule lesion glomerulonephritis, menstrual disorders, chest pain, anaphylaxis reaction, hallucinations, cerebral hemorrhage, aseptic meningitis, ageusia, anosmia, conjunctivitis, vasculitis, pulmonary embolism, interstitial pneumonia, gastrointestinal bleeding, hepatitis, photosensitivity reaction, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, drug rash, acute generalized exanthematous pustulosis, desquamation dermatitis, generalized fixed drug eruption, fixed drug eruption, acute kidney failure, hyponatremia, tubular interstitial nephritis, nephrotic syndrome, minuscule lesion glomerulonephritis, menstrual disorders, chest pain

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

Storage

This medication should be stored in a tightly sealed container to prevent air and moisture exposure, in a cool place between 15 to 30 degrees Celsius. Storing it this way will help maintain the medication’s efficacy for a longer period.

Appearance and packaging

Appearance

White capsule with yellow bands filled with white to pale yellow powder

Package unit

30 capsules/bottle, 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.

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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.