Medication info
Medibrex Capsule 100 mg (Celecoxib)

Medibrex Capsule 100 mg (Celecoxib)

Prescription medicationHard capsule
Ingredient · strength
Celecoxib›100mg / 1 capsule
Manufacturer / importer
Intro Biopharma, Co., Ltd.
Appearance
A white capsule filled with a white to pale yellow powder, with blue stripes on the top and bottom.
Packaging
Bottle - 30 capsules/bottle, Bottle - 100 capsules/bottle, Bottle - 500 capsules/bottle
Approval status
Active

MFDS item code 201901049 · Approved 2019.02.20 · Insurance code 052400960

Summary

Main use
Relief of arthritis (such as osteoarthritis and rheumatoid arthritis), acute pain, and primary dysmenorrhea
Who uses it
Adults
Adult dosage
The minimum recommended dose of this medicine should be adjusted according to the patient and may be administered regardless of meals. ○ Adults: 1. Osteoarthritis (degenerative arthritis): Take 200 mg of celecoxib once daily, or divide the dose into 100 mg per dose twice daily. 2. Rheumatoid arthritis: Take 100 mg or 200 mg of celecoxib per dose twice daily. 3. Ankylosing spondylitis (AS): Administer 200 mg of celecoxib once daily, or divide the dose into 100 mg per dose 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 of treatment with 400 mg daily, another treatment method should be considered. 4. Acute pain and primary dysmenorrhea: The initial recommended dose is 400 mg of celecoxib, 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: In patients with moderate hepatic impairment (Child-Pugh Class II), the dose should be reduced to approximately 50% of the recommended daily dose.

Ingredients

Manufacturer
Intro Biopharma, Co., Ltd.

Efficacy & effects

Relief of arthritis (such as osteoarthritis and rheumatoid arthritis), acute pain, and primary dysmenorrhea

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

This medicine is used to relieve symptoms and signs associated with arthritic diseases such as osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. It also effectively relieves acute pain following surgery or tooth extraction. Additionally, it helps in alleviating pain from primary dysmenorrhea. This medication can be utilized to improve various pain and inflammation-related symptoms.

Dosage and Administration

Adult dosage

The minimum recommended dose of this medicine should be adjusted according to the patient and may be administered regardless of meals. ○ Adults: 1. Osteoarthritis (degenerative arthritis): Take 200 mg of celecoxib once daily, or divide the dose into 100 mg per dose twice daily. 2. Rheumatoid arthritis: Take 100 mg or 200 mg of celecoxib per dose twice daily. 3. Ankylosing spondylitis (AS): Administer 200 mg of celecoxib once daily, or divide the dose into 100 mg per dose 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 of treatment with 400 mg daily, another treatment method should be considered. 4. Acute pain and primary dysmenorrhea: The initial recommended dose is 400 mg of celecoxib, 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: In patients with moderate hepatic impairment (Child-Pugh Class II), the dose should be reduced to approximately 50% of the recommended daily dose.

Precautions

This medicine should be consulted with a doctor or pharmacist if the patient regularly consumes more than three glasses of alcohol a day, as it increases the risk of gastrointestinal bleeding. This medication may increase the risk of thrombotic cardiovascular events, thereby elevating the risk of serious cardiovascular diseases such as myocardial infarction or stroke. Therefore, it must be used at the minimum effective dose and for the shortest duration, and medical attention should be sought immediately if cardiovascular symptoms arise. This medication can cause serious adverse reactions such as perforation, ulceration, or bleeding in the gastrointestinal tract, and caution is especially needed for the elderly or patients with a history of gastrointestinal disorders. Symptoms like epigastric pain, indigestion, black stools, or vomiting blood during treatment should be reported to healthcare professionals immediately. This medication should not be administered to specific allergy patients, patients with severe liver or kidney impairment, active peptic ulcer patients, heart failure patients, pregnant women, and nursing mothers. Patients with compromised liver or kidney function, asthmatics, hypertensive patients, the elderly, and diabetics need special caution when taking this medication, and regular check-ups are recommended. Various side effects have been reported with this medication, with common symptoms including indigestion, headache, dizziness, hypertension, cough, itching, and rash. If serious adverse reactions occur, the medication should be stopped immediately and consulted with healthcare professionals. Since this medication is metabolized in the liver, interactions may occur when taken with certain drugs. If the patient is taking other medications, they must inform their healthcare provider. Pregnant women or women who may become pregnant and nursing mothers should not take this medication, as its use during pregnancy may pose risks to the fetus. The safety and efficacy of this medication have not been established in children and adolescents, therefore it is generally not administered to those under 18 years of age. Because the elderly may have reduced liver and kidney function, careful monitoring is necessary when they take this medication. Patients taking this medication for extended periods should undergo regular blood tests and liver and kidney function tests, and if abnormal signs are discovered, they should consult healthcare professionals immediately. In case of overdose, symptoms like nausea, vomiting, and drowsiness may occur, and the patient must receive appropriate treatment at a medical institution immediately. This medication should be stored out of the reach of children and care should be taken as transferring it to other containers may compromise its quality.

Side effects

Gastrointestinal bleeding, cardiovascular thrombotic reactions, myocardial infarction, stroke, upper and lower gastrointestinal perforation, ulcers, bleeding, bronchitis, sinusitis, upper respiratory tract infections, urinary tract infections, pharyngitis, rhinitis, anemia, thrombocytopenia, hypersensitivity, insomnia, anxiety, confused state, 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 disease, duodenal ulcer, esophageal ulcer, intestinal perforation, pancreatitis, elevated liver enzymes, itching, rash, hives, petechial hemorrhage, angioedema, alopecia, blistering dermatitis, peripheral edema, facial edema, influenza-like illness, injury, taste disturbance, albuminuria, cystitis, hematuria, dysuria, frequent urination, kidney stones, incontinence, urinary tract infections, visual disturbances, cataracts, conjunctivitis, eye pain, glaucoma, ocular hemorrhage, retinal artery or vein occlusion, increased serum creatinine, elevated β2-microglobulin, increased NAG, positive for hematuria, positive for proteinuria, renal impairment, acute renal failure, interstitial nephritis, headache, migraine, neuralgia, neuropathy, sensory disturbances, cerebral infarction, aseptic meningitis, ataxia, suicidal tendencies, anosmia, ageusia, back pain, allergy exacerbation, allergic reactions, weakness, chest pain, fluid retention, systemic edema, facial swelling, fatigue, malaise, fever, facial flushing, influenza-like syndrome, pain, peripheral pain, sepsis, sudden death, anaphylactic-like reactions, vasculitis, pulmonary embolism, interstitial pneumonia, hepatitis, liver failure, fulminant hepatitis, hepatic necrosis, cholestasis, cholestatic hepatitis, jaundice, photosensitivity reactions, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms, acute generalized pustular psoriasis, exfoliative dermatitis, generalized blistering fixed drug eruption, fixed drug eruption, menstrual disorders, chest pain, peptic ulcer, hives, anemia, thirst, ulcerative stomatitis, gastritis, allergy, low back pain, hyperlipidemia, diabetes, weight gain, fractures, arthralgia, RA factor positive, herpes zoster, pneumonia, dyspnea, elevated ALT, hearing loss, nausea, constipation, thrombocytopathy, agranulocytosis, aplastic anemia, pancytopenia, leukopenia, eosinophilic fasciitis, contact dermatitis, injection site reactions, skin nodules, auditory loss, ear abnormalities, otalgia, hearing loss, vasculitis, acute renal failure, hyponatremia, tubulointerstitial nephritis, nephrotic syndrome, focal segmental glomerulosclerosis, female infertility, anaphylactic reactions, hallucinations

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 from entering and kept at room temperature between 15 to 30 degrees Celsius. Proper storage will help maintain the medication's efficacy and prevent degradation.

Appearance and packaging

Appearance

A white capsule filled with a white to pale yellow powder, with blue stripes on the top and bottom.

Package unit

Bottle - 30 capsules/bottle, Bottle - 100 capsules/bottle, Bottle - 500 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.