Medication info
Acele Capsule 200 mg (Celecoxib)

Acele Capsule 200 mg (Celecoxib)

Prescription medicationHard capsuleOral
Ingredient · strength
Celecoxib›200mg / 1 capsule
Manufacturer / importer
Selbion Co., Ltd.
Appearance
A white capsule filled with a white to light yellow powder
Packaging
30 capsules/bottle, 100 capsules/bottle
Approval status
Active

MFDS item code 201907649 · Approved 2019.10.31

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 according to the patient and may be taken with or without food. ○ Adults: 1. Osteoarthritis (degenerative arthritis): Take celecoxib 200 mg once daily, or 100 mg twice daily. 2. Rheumatoid arthritis: Take celecoxib 100 mg or 200 mg twice daily. 3. Ankylosing spondylitis (AS): Administer celecoxib 200 mg once daily, or 100 mg twice daily. If no effect is observed after 6 weeks, the dose may be increased up to 400 mg daily. If no effect is observed after 6 weeks of treatment with 400 mg daily, other treatment options should be considered. 4. Acute pain and primary dysmenorrhea: The initial recommended dose is celecoxib 400 mg, 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 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
Selbion Co., Ltd.

Efficacy & effects

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

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

This medication helps relieve symptoms of arthritis, such as osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. It also alleviates acute pain that occurs after surgery or tooth extraction and is effective for primary dysmenorrhea. It is used to improve pain and discomfort from these conditions.

How to take

Adult dose

The minimum recommended dose of this medicine should be adjusted according to the patient and may be taken with or without food. ○ Adults: 1. Osteoarthritis (degenerative arthritis): Take celecoxib 200 mg once daily, or 100 mg twice daily. 2. Rheumatoid arthritis: Take celecoxib 100 mg or 200 mg twice daily. 3. Ankylosing spondylitis (AS): Administer celecoxib 200 mg once daily, or 100 mg twice daily. If no effect is observed after 6 weeks, the dose may be increased up to 400 mg daily. If no effect is observed after 6 weeks of treatment with 400 mg daily, other treatment options should be considered. 4. Acute pain and primary dysmenorrhea: The initial recommended dose is celecoxib 400 mg, 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 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 cause gastrointestinal bleeding in individuals who regularly consume more than three alcoholic beverages per day, so it must be used with caution under the guidance of a doctor or pharmacist. This medication may increase the risk of cardiovascular thrombotic events, myocardial infarction, and stroke, so it should be used at the lowest dose and for the shortest duration possible. Serious issues such as perforation, ulceration, or gastrointestinal bleeding can occur, particularly in patients with a history of gastrointestinal disease or the elderly who should be monitored closely. Patients with hypersensitivity or a history of specific allergic reactions to this medication, those with severe liver or kidney disease, and women who are pregnant or nursing should not take this medication. Patients with impaired liver or kidney function, asthma, heart failure, hypertension, or any significant medical history should use this medication with caution and regularly check their status as directed by a physician. During use, adverse symptoms such as dyspepsia, headache, dizziness, hypertension, skin rash, edema, or gastrointestinal bleeding may appear, and patients should consult healthcare providers immediately if such symptoms occur. This medication may affect liver and kidney function, so regular blood tests and assessment of liver and kidney function are necessary. Interactions with other medications may occur, especially when taken with antihypertensives, diuretics, anticoagulants, and antidepressants, so patients should inform their doctor and take precautions. Women who are pregnant or planning to become pregnant should not take this medication, and nursing mothers should avoid it or discontinue breastfeeding. The safety of this medication in pediatric and adolescent patients has not been established, and it should not be used in individuals under 18 years of age. Elderly patients may have reduced kidney and heart function and require closer monitoring when using this medication. Dizziness or drowsiness may occur after taking this medication, so caution is advised when driving or operating machinery. This medication is a non-steroidal anti-inflammatory drug that relieves pain and inflammation but is not a cure, so long-term use should be undertaken according to a doctor’s instruction. In case of overdose, symptoms such as nausea, vomiting, drowsiness, or gastrointestinal bleeding may occur, and immediate medical attention should be sought. This medication should be kept out of the reach of children and should not be transferred to another container for safety.

Side effects

Gastrointestinal bleeding, cardiovascular thrombotic events, myocardial infarction, stroke, perforation of the upper and lower gastrointestinal tracts, ulcers, bleeding, bronchitis, sinusitis, upper respiratory tract infections, urinary tract infections, pharyngitis, rhinitis, anemia, thrombocytopenia, hypersensitivity, insomnia, anxiety, confusion, dizziness, muscle hypertonia, drowsiness, blurred vision, tinnitus, palpitations, congestive heart failure, arrhythmia, tachycardia, hypertension, flushing, cough, vomiting, abdominal pain, diarrhea, indigestion, bloating, gastric ulcer, dental disease, duodenal ulcer, esophageal ulcer, intestinal perforation, pancreatitis, elevated liver enzymes, itching, rash, urticaria, petechiae, angioedema, alopecia, bullous dermatitis, peripheral edema, facial swelling, influenza-like illness, injury, taste disturbance, albuminuria, cystitis, hematuria, dysuria, frequency of urination, nocturia, nephrolithiasis, urinary incontinence, urinary tract infection, blurred vision, cataract, conjunctivitis, eye pain, glaucoma, ocular hemorrhage, retinal artery or vein occlusion, elevated blood creatinine, increased β2-microglobulin, increased NAG, positive urine hematuria, positive urine protein, renal dysfunction, acute renal failure, interstitial nephritis, elevated serum sodium, elevated serum potassium, increased BUN, increased CPK, diabetes mellitus, hypercholesterolemia, hyperglycemia, hypokalemia, hyperkalemia, increased NPN, increased creatinine, increased alkaline phosphatase, weight gain, loss of appetite, increased LDH, hypoglycemia, hyponatremia, synovial cyst, arthralgia, osteoarthritis, skeletal abnormalities, myalgia, cervical tension syndrome, synovitis, tendinitis, myositis, leg cramps, fractures, tendon rupture, pain in the back, muscle rigidity, decreased hematocrit, increased hemoglobin, petechiae, nosebleeds, thrombocytopathy, agranulocytosis, aplastic anemia, pancytopenia, leukopenia, angiolitis, contact dermatitis, injection site reactions, skin nodules, headache, leg cramps, tension increase, sensory decline, migraine, neuralgia, neuropathy, sensory abnormalities, cerebral infarction, aseptic meningitis, ataxia, suicide, anosmia, ageusia, exacerbation of allergies, allergic reactions, 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, insomnia, loss of appetite, increased appetite, depression, neuroexcitability, drowsiness, fatal intracranial hemorrhage, hallucinations, exacerbation of epilepsy, upper respiratory tract infection, herpes zoster, wound infection, gingivitis, herpes simplex, shingles, bacterial infections, fungal infections, soft tissue infections, viral infections, candidiasis, genital candidiasis, otitis media, breast tenderness, menopausal symptoms, fibrocystic disease of the breast, thoracic neoplasm, chest pain, dysmenorrhea, menstrual disorders, vaginal bleeding, vaginitis, prostate disorders, ovarian cysts, hearing loss, ear abnormalities, ear pain, hearing impairment, liver dysfunction, elevated ALT, elevated AST, increased γ-GTP, increased ALP, positive urine urobilinogen, cholelithiasis, hepatitis, jaundice, hepatic failure, fulminant hepatitis, hepatic necrosis, vasculitis, pulmonary embolism, interstitial pneumonia, photosensitivity 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 glomerulonephritis, female infertility, chest pain, thirst, ulcerative stomatitis, gastritis, allergy, low back pain, hyperlipidemia, diabetes, weight gain, fractures, RA factor positive, pneumonia, dyspnea, hearing impairment, nosebleeds, dysphonia, bronchospasm, exacerbated bronchospasm, laryngitis, thrombotic venous thrombosis, deep vein thrombosis, cerebral hemorrhage, ventricular fibrillation, syncope, ventricular hypertrophy, angina, unstable angina, coronary artery disease, myocardial infarction, heart failure, palpitations, tachycardia, stroke, aortic valve insufficiency, hematoma, sinus bradycardia, vasculitis, angioedema, thrombotic venous thrombosis, vasculitis, angioedema

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 exposure, ideally in a cool place between 15 to 30 degrees Celsius. Avoid exposure to direct sunlight and store in a place that is not too hot or too cold.

Appearance and packaging

Appearance

A white capsule filled with a white to light 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.