Medication info
Celebrex Capsule 400 mg (Celecoxib)

Celebrex Capsule 400 mg (Celecoxib)

Prescription medicationHard capsule
Ingredient · strength
Celecoxib›400mg / 1 capsule
Manufacturer / importer
Viatris
Appearance
A white capsule filled with a white to off-white powder, with green stripes on the top and bottom.
Packaging
30 capsules (10 capsules/blister x 3)
Approval status
Active

MFDS item code 201506677 · Approved 2015.09.22 · Insurance code 073400300

Summary

Main use
Relief of symptoms of acute pain, primary dysmenorrhea, and ankylosing spondylitis
Who uses it
Adults
Adult dosage
The minimum recommended dose of this medicine should be adjusted for each patient and may be administered with or without food. 1. 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 daily may be administered. If no effect is observed after 6 weeks of treatment with 400 mg daily, other treatment options should be considered. 2. Acute pain and primary dysmenorrhea The recommended initial dose is celecoxib 400 mg; if needed, an additional 200 mg may be administered on the first day of treatment. From 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

Importer
Viatris

Efficacy & effects

Relief of symptoms of acute pain, primary dysmenorrhea, and ankylosing spondylitis

  • Symptoms and signs of ankylosing spondylitis
  • acute pain
  • primary dysmenorrhea.
View approved original text

This medication helps alleviate the symptoms and signs of ankylosing spondylitis. It is also used to reduce acute pain in adults, such as pain occurring after surgery or dental extraction. Additionally, it is effective for alleviating discomfort caused by primary dysmenorrhea. It is used to improve various pain and inflammation symptoms.

Dosage and Administration

Adult dosage

The minimum recommended dose of this medicine should be adjusted for each patient and may be administered with or without food. 1. 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 daily may be administered. If no effect is observed after 6 weeks of treatment with 400 mg daily, other treatment options should be considered. 2. Acute pain and primary dysmenorrhea The recommended initial dose is celecoxib 400 mg; if needed, an additional 200 mg may be administered on the first day of treatment. From 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 discussed with a doctor or pharmacist if taken by individuals who regularly consume more than three alcoholic beverages daily, as it increases the risk of gastrointestinal bleeding. Patients with a history or risk factors for cardiovascular diseases should use this medication at the lowest effective dose and for the shortest duration possible due to the potential increased risk of cardiovascular events. Those with a history of gastrointestinal disorders or the elderly should exercise particular caution, as ulcers or bleeding may occur; if symptoms such as abdominal pain or black stools appear, medical consultation is needed immediately. This medication should not be administered to patients with certain allergic reactions, severe liver or kidney impairment, or to women who are pregnant or breastfeeding. Patients with impaired liver or kidney function, hypertension, heart failure, asthma, etc., need careful monitoring when using this medication. Dizziness or drowsiness may occur while taking this medication, so caution is advised when driving or operating machinery. This medication does not affect blood coagulation; however, patients on anticoagulant medications should consult their healthcare provider before use. Regular monitoring of liver and kidney function and blood tests should be conducted during long-term use, and immediate consultation with a doctor is necessary if abnormal symptoms arise. This medication can interact with other drugs, so it is crucial to inform healthcare providers about any other medications currently being taken, especially those metabolized in the liver, which may require dosage adjustments. Women who are pregnant or planning to become pregnant should avoid taking this medication as it may affect reproductive ability. Elderly patients are at a higher risk of decreased kidney and heart function, necessitating closer observation while using this medication. In case of overdose, symptoms such as lethargy, nausea, vomiting, and abdominal pain may occur, requiring immediate appropriate medical treatment. This medication must be kept out of the reach of children, and it is safer not to transfer it to another container.

Side effects

Gastrointestinal bleeding, cardiovascular thrombotic events, myocardial infarction, stroke, upper and lower gastrointestinal perforation, ulcer, bleeding, bronchitis, sinusitis, upper respiratory tract infection, urinary tract infection, 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, angioedema, alopecia, vesicular dermatitis, peripheral edema, facial edema, influenza-like illness, injury, embolitis, contact dermatitis, injection site reaction, skin nodules, taste disturbance, albuminuria, cystitis, hematuria, dysuria, frequency of urination, kidney stones, incontinence, urinary tract infection, blurred vision, cataract, conjunctivitis, eye pain, glaucoma, ocular hemorrhage, retinal artery or vein occlusion, elevated serum creatinine, increased β2-microglobulin, increased NAG, positive urine hematuria, positive urine protein, renal dysfunction, acute renal failure, interstitial nephritis, headache, leg cramps, tension enhancement, sensory dullness, migraine, neuralgia, neuropathy, sensory abnormalities, cerebral infarction, aseptic meningitis, ataxia, suicide, smell loss, taste loss, back pain, allergy exacerbation, allergic reaction, weakness, chest pain, fluid retention, systemic edema, facial swelling, fatigue, lethargy, fever, facial flushing, influenza syndrome, pain, peripheral pain, sepsis, sudden death, anaphylactoid reaction, angioedema, insomnia, decreased appetite, increased appetite, depression, neuro-excitability, drowsiness, fatal intracranial hemorrhage, hallucinations, epilepsy exacerbation, upper respiratory infection, shingles, wound infection, gingivitis, herpes simplex, herpes zoster, bacterial infection, fungal infection, soft tissue infection, viral infection, moniliasis, genital moniliasis, otitis media, breast tenderness, menopausal symptoms, fibrocystic breast disease, thoracic neoplasm, chest pain, dysmenorrhea, menstrual disturbances, 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 urine urobilinogen, cholelithiasis, hepatitis, jaundice, liver failure, fulminant hepatitis, liver necrosis, increased serum sodium, increased serum potassium, elevated BUN, increased CPK, diabetes mellitus, hypercholesterolemia, hyperglycemia, hypokalemia, hyperkalemia, increased NPN, increased creatinine, increased alkaline phosphatase, weight gain, decreased appetite, increased LDH, hypoglycemia, hyponatremia, synovial sac, joint pain, arthropathy, skeletal abnormalities, myalgia, cervical tension, synovitis, tendinitis, myositis, fracture, tendon rupture, pain in various regions, muscle stiffness, decreased hematocrit, increased hemoglobin, petechiae, epistaxis, thrombocythemia, anemia, thrombocytopenia, agranulocytosis, aplastic anemia, pancytopenia, leukopenia, chest pain, anaphylaxis reaction, hallucinations, cerebral hemorrhage, aseptic meningitis, taste loss, smell loss, conjunctivitis, vasculitis, pulmonary embolism, interstitial pneumonia, gastrointestinal bleeding, hepatitis, liver failure, fulminant hepatitis, liver necrosis, bile stasis, bile stasis hepatitis, jaundice, photosensitive reaction, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, drug rash, acute generalized exanthematous pustulosis, exfoliative dermatitis, acute renal failure, hyponatremia, tubular interstitial nephritis, nephrotic syndrome, minimal change nephropathy, menstrual disturbances, female infertility

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

Storage

This medication should be stored in a tightly sealed container that allows for good air circulation, ideally at a temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the effectiveness of the medication for a longer period.

Appearance and packaging

Appearance

A white capsule filled with a white to off-white powder, with green stripes on the top and bottom.

Package unit

30 capsules (10 capsules/blister x 3)

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.