Medication info
Newbrex Capsule 200mg (Celecoxib)

Newbrex Capsule 200mg (Celecoxib)

Prescription medicationHard capsuleOral
Ingredient · strength
Celecoxib›200mg / 1 capsule
Manufacturer / importer
Hwail Pharm Co., Ltd.
Appearance
White opaque hard capsule containing a white to yellowish powder
Packaging
30 capsules/bottle, 100 capsules/bottle
Approval status
Active

MFDS item code 201504176 · Approved 2015.06.29 · Insurance code 684501190

Summary

Main use
Relief of joint and spinal inflammation (such as osteoarthritis), 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 administered regardless of meals. ○ Adults 1. Osteoarthritis (degenerative arthritis) Take celecoxib 200 mg once daily, or 100 mg twice daily in divided doses. 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 in divided doses. 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, another treatment should be considered. 4. Acute pain and primary dysmenorrhea The recommended initial 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 as 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
Hwail Pharm Co., Ltd.

Efficacy & effects

Relief of joint and spinal inflammation (such as osteoarthritis), 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 is used to relieve the symptoms and signs of arthritis such as osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. It also reduces acute pain in adults, such as pain that occurs post-surgery or after tooth extraction. Additionally, it effectively alleviates pain associated with primary dysmenorrhea. This drug helps improve various pain and inflammation-related symptoms.

How to take

Adult dose

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 celecoxib 200 mg once daily, or 100 mg twice daily in divided doses. 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 in divided doses. 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, another treatment should be considered. 4. Acute pain and primary dysmenorrhea The recommended initial 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 as 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 increase the risk of gastrointestinal bleeding if taken by individuals who consume alcohol in excess on a daily basis, and should be discussed with a doctor or pharmacist. Those with cardiac or vascular issues or risk factors should use this drug only at the lowest dose and for the shortest duration, as it may cause cardiovascular issues such as myocardial infarction or stroke. Individuals with a history of gastrointestinal ulcers or bleeding should be closely monitored when taking this medication, as the risk of gastrointestinal perforation, ulceration, and bleeding may be increased; any symptoms should prompt immediate medical attention. This medication should not be taken by individuals with allergies to it or who have had hypersensitivity reactions to non-steroidal anti-inflammatory drugs such as aspirin, those with severely impaired liver or kidney function, pregnant or breastfeeding women, or individuals with certain genetic disorders. Individuals with compromised liver or kidney function, asthma, hypertension, heart failure, diabetes, or elderly individuals should use this drug with caution, and regular monitoring may be necessary during treatment. This drug can interact with various medications; therefore, it is essential to inform the doctor or pharmacist of any other medications being taken, especially when used with antihypertensives, anticoagulants, antidepressants, and antibiotics. Pregnant women or those planning pregnancy should avoid this medication as it may affect the fetus, and breastfeeding women should be cautious as it may be transmitted through breast milk. Dizziness or drowsiness may occur while taking this medication, so caution is advised while driving or operating machinery. Those using this medication long-term should undergo regular blood tests and liver and kidney function tests to check for abnormalities, and should stop using the drug and consult medical personnel if any abnormal symptoms appear. In case of overdose, symptoms such as nausea, vomiting, drowsiness, and gastrointestinal bleeding may occur; therefore, strict adherence to the dosage is necessary, and if any unusual symptoms arise, immediate hospital visit is required. Keep out of reach of children, and do not transfer to another container for safety.

Side effects

Gastrointestinal bleeding, cardiovascular thrombotic response, myocardial infarction, stroke, perforation 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 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, injury, taste disturbance, albuminuria, cystitis, hematuria, dysuria, polyuria, kidney stones, 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 N-acetyl-β-D-glucosaminidase (NAG), positive urine hematuria, positive urine protein, renal impairment, 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, bursitis, arthralgia, arthropathy, skeletal anomalies, myalgia, cervical tension, synovitis, tendinitis, myositis, leg cramps, fractures, tendon rupture, pain in various regions, muscle rigidity, decreased hematocrit, increased hemoglobin, petechiae, nosebleeds, thrombocytopathy, agranulocytosis, aplastic anemia, pancytopenia, leukopenia, polyarthritis, contact dermatitis, injection site reactions, skin nodules, headache, leg cramps, tension, sensory impairment, migraine, neuralgia, neuropathy, sensory abnormalities, cerebral infarction, aseptic meningitis, ataxia, suicide, loss of smell, loss of taste, allergy exacerbation, 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, anaphylactic-like reactions, angioedema, insomnia, loss of appetite, increased appetite, depression, neurogenic hypersensitivity, drowsiness, fatal intracranial hemorrhage, hallucinations, exacerbation of epilepsy, upper respiratory tract infection, bronchial spasms, exacerbation of bronchospasms, shortness of breath, laryngitis, pneumonia, nosebleeds, voice disorders, vesicular dermatitis, dermatitis, nail disorders, photosensitive reactions, pruritus, erythematous rash, papular rash, skin diseases, dry skin, increased sweating, erythema multiforme, exfoliative dermatitis, mucous membrane syndrome, toxic epidermal necrolysis, eczema, lipoma, allergic dermatitis, petechiae, dandruff, drug rash, vasculitis, pulmonary embolism, interstitial pneumonia, hepatitis, liver failure, fulminant hepatitis, liver necrosis, cholestasis, cholestatic hepatitis, jaundice, acute renal failure, tubular interstitial nephritis, nephrotic syndrome, minimal change disease, menstrual disorders, female infertility, chest pain, anaphylactic reactions, hallucinations, cerebral hemorrhage

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

Storage

This medication should be stored in a tightly closed container, protected from air and moisture, in a cool place between 15 and 30 degrees Celsius. Storing it this way will maintain the drug's effectiveness and prevent degradation.

Appearance and packaging

Appearance

White opaque hard capsule containing a white to yellowish 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.