Medication info
Celecoxib Capsule 100 Milligrams (Celecoxib)

Celecoxib Capsule 100 Milligrams (Celecoxib)

Prescription medicationHard capsuleOral
Ingredient · strength
Celecoxib›100mg / 1 capsule
Manufacturer / importer
Poonglim Pharmaceutical Co., Ltd.
Appearance
White to off-white powder-filled capsules with a blue line on the top and bottom.
Packaging
30 capsules/bottle, 100 capsules/bottle
Approval status
Active

MFDS item code 201906895 · Approved 2019.09.27 · Insurance code 649002200

Summary

Main use
Relief of joint disorders (such as osteoarthritis and ankylosing spondylitis), 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. ○ Adults 1. Osteoarthritis (degenerative arthritis) Take 200 mg of celecoxib once daily, or 100 mg twice daily. 2. Rheumatoid arthritis Take 100 mg or 200 mg of celecoxib twice daily. 3. Ankylosing spondylitis (AS) Administer 200 mg of celecoxib once daily, or 100 mg twice daily. If no effect is observed after 6 weeks, the dose may be increased to 400 mg daily. If no effect is observed after 6 weeks at 400 mg daily, consider another treatment. 4. Acute pain and primary dysmenorrhea The recommended initial dose is 400 mg of celecoxib; if necessary, an additional 200 mg may be administered on the first day of treatment. From the second day onward, the recommended dose, if needed, is 200 mg twice daily. ○ Patients with hepatic impairment For patients with moderate hepatic impairment (Child-Pugh Class II), reduce the dose to approximately 50% of the recommended daily dose.

Ingredients

Manufacturer
Poonglim Pharmaceutical Co., Ltd.

Efficacy & effects

Relief of joint disorders (such as osteoarthritis and ankylosing spondylitis), acute pain, and primary dysmenorrhea

  • Osteoarthritis
  • degenerative arthritis
  • rheumatoid arthritis
  • ankylosing spondylitis
  • acute pain
  • primary dysmenorrhea
View approved original text

This medication helps relieve symptoms and signs associated with osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. It also alleviates acute pain following surgery or tooth extraction in adults and reduces pain from primary dysmenorrhea. This drug is used to effectively manage various pain and inflammation-related conditions, improving the patient's quality of life.

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. ○ Adults 1. Osteoarthritis (degenerative arthritis) Take 200 mg of celecoxib once daily, or 100 mg twice daily. 2. Rheumatoid arthritis Take 100 mg or 200 mg of celecoxib twice daily. 3. Ankylosing spondylitis (AS) Administer 200 mg of celecoxib once daily, or 100 mg twice daily. If no effect is observed after 6 weeks, the dose may be increased to 400 mg daily. If no effect is observed after 6 weeks at 400 mg daily, consider another treatment. 4. Acute pain and primary dysmenorrhea The recommended initial dose is 400 mg of celecoxib; if necessary, an additional 200 mg may be administered on the first day of treatment. From the second day onward, the recommended dose, if needed, is 200 mg twice daily. ○ Patients with hepatic impairment For patients with moderate hepatic impairment (Child-Pugh Class II), reduce the dose to approximately 50% of the recommended daily dose.

Precautions

Patients who consume large amounts of alcohol daily should consult their physician or pharmacist before taking this medication. There is a risk of gastrointestinal bleeding when using this drug. Caution is required as it may cause clot formation in the heart and blood vessels, leading to serious issues such as myocardial infarction and stroke. This medication should be used at the lowest effective dose for the shortest duration possible. Patients should closely monitor for symptoms of gastrointestinal ulcers or bleeding and consult their doctor immediately if any abnormalities occur. Those with allergies, severe liver or kidney dysfunction, or active gastric ulcers should not take this medication. Patients with weakened liver or kidney function, asthma, heart failure, and hypertension should use it cautiously. Dizziness or drowsiness may occur during treatment, hence driving or operating machinery is not recommended. This medication should not be used by women who are pregnant or breastfeeding, and caution is advised for women planning to conceive. As this drug is metabolized in the liver, it can affect liver function and may interact with other medications, so inform your doctor about any concurrent medications. Regular blood tests and liver and kidney function tests are required during treatment, and immediately consult a doctor if any abnormal symptoms occur. Serious side effects may arise in the gastrointestinal tract, heart, and kidneys, so prescribed doses and durations should be strictly followed. Children and adolescents should not use this drug as safety and efficacy have not been established. Elderly patients may have reduced kidney, liver, and heart function, hence extra caution is necessary during treatment. If symptoms such as skin rash, itching, or fever occur during the course of this medication, stop taking it and consult a doctor immediately. In case of overdose, symptoms such as nausea, vomiting, drowsiness, and lethargy may occur, and appropriate medical treatment should be sought immediately.

Side effects

Gastrointestinal bleeding, cardiovascular thrombotic reaction, myocardial infarction, stroke, perforation of the upper and lower gastrointestinal tract, ulcers, bleeding, bronchitis, sinusitis, upper respiratory infection, urinary tract infection, pharyngitis, rhinitis, anemia, thrombocytopenia, hypersensitivity, insomnia, anxiety, confusional state, dizziness, muscle hypertonia, 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, vesicular dermatitis, peripheral edema, facial edema, influenza-like illness, trauma, headache, leg cramps, hypertonia, sensory decrease, migraine, neuralgia, neuropathy, sensory disturbances, cerebral infarction, aseptic meningitis, ataxia, suicide, loss of smell, loss of taste, back pain, allergy exacerbation, allergic reaction, weakness, chest pain, fluid retention, systemic edema, facial edema, fatigue, lethargy, fever, facial flushing, influenza-like syndrome, pain, peripheral pain, sepsis, sudden death, anaphylactoid reaction, angioedema, loss of appetite, increased appetite, depression, neuroexcitability, drowsiness, fatal intracerebral hemorrhage, hallucinations, exacerbation of epilepsy, upper respiratory infection, bronchospasm, exacerbated bronchospasm, dyspnea, laryngitis, pneumonia, nosebleed, speech disorder, vesicular dermatitis, dermatitis, nail disease, photosensitivity reaction, erythematous rash, maculopapular rash, skin disease, dry skin, increased sweating, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, eczema, lipoma, allergic dermatitis, petechiae, dandruff, drug eruption accompanied by eosinophilia and systemic symptoms, arrhythmia, ventricular hypertrophy, exacerbated hypertension, angina, unstable angina, coronary artery disease, myocardial infarction, heart failure, palpitations, tachycardia, stroke, aortic valve insufficiency, hematoma, sinus bradycardia, syncope, ventricular fibrillation, pulmonary embolism, cerebrovascular accident, peripheral gangrene, thrombophlebitis, vasculitis, deep vein thrombosis, cerebral hemorrhage, monomelic amyotrophy, wound infection, gingivitis, herpes simplex, herpes zoster, bacterial infection, fungal infection, soft tissue infection, viral infection, moniliasis, genital moniliasis, otitis media, mastalgia, menopausal symptoms, fibrocystic breast disease, thoracic neoplasm, dysmenorrhea, menstrual disorders, vaginal bleeding, vaginitis, prostate disorders, ovarian cysts, hearing loss, ear abnormalities, otalgia, hearing impairment, hepatic dysfunction, elevated ALT, elevated AST, increased γ-GTP, increased ALP, positive 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, elevated NPN, increased creatinine, elevated alkaline phosphatase, weight gain, loss of appetite, elevated LDH, hypoglycemia, hyponatremia, synovial sac, arthralgia, arthrosis, skeletal anomalies, myalgia, cervical dystonia, synovitis, tendinitis, myositis, fracture, tendon rupture, pain in the back, muscle rigidity, decreased hematocrit, increased hemoglobin, petechiae, nosebleed, thrombocytopathy, anemia, agranulocytosis, aplastic anemia, pancytopenia, leukopenia, granuloma, contact dermatitis, injection site reaction, skin nodules, dysgeusia, albuminuria, cystitis, hematuria, dysuria, pollakiuria, nephrolithiasis, urinary incontinence, urinary tract infection, visual disturbances, cataract, conjunctivitis, eye pain, glaucoma, ocular hemorrhage, retinal artery or vein occlusion, increased serum creatinine, increased β2-microglobulin, increased NAG, positive urinary hematuria, positive urinary protein, renal dysfunction, acute renal failure, interstitial nephritis, anaphylactic reaction, hallucinations, cerebral hemorrhage, aseptic meningitis, loss of taste, loss of smell, conjunctivitis, vasculitis, pulmonary embolism, interstitial pneumonia, gastrointestinal bleeding, hepatitis, liver failure, fulminant hepatitis, liver necrosis, bile stasis, bile stasis hepatitis, jaundice, photosensitivity reaction, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, drug rash, acute generalized pustular rash, exfoliative dermatitis, acute renal failure, hyponatremia, tubular interstitial nephritis, nephrotic syndrome, minimal change disease

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

Storage

This medication should be stored in a tightly closed container to prevent air exposure, preferably at room temperature between 15 to 30 degrees Celsius. Maintaining proper storage temperature helps preserve the medication's effectiveness safely for a longer time.

Appearance and packaging

Appearance

White to off-white powder-filled capsules with a blue line on the top and bottom.

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.