Medication info
Selvix Capsule (Celecoxib)

Selvix Capsule (Celecoxib)

Prescription medicationHard capsuleOral
Ingredient · strength
Celecoxib›200mg / 1 capsule
Manufacturer / importer
Donggu Bio Pharmaceutical Co., Ltd.
Appearance
A capsule filled with powder that is white to off-white.
Packaging
30 capsules/bottle, 100 capsules/bottle
Approval status
Active

MFDS item code 201501279 · Approved 2015.03.12 · Insurance code 657306600

Summary

Main use
Relief of arthritis, ankylosing spondylitis, acute pain in adults, 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 without regard to meals. ○ 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 per day. If no effect is observed after 6 weeks of taking 400 mg per day, other treatment options should be considered. 4. Acute pain and primary dysmenorrhea The recommended initial 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 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
Donggu Bio Pharmaceutical Co., Ltd.

Efficacy & effects

Relief of arthritis, ankylosing spondylitis, acute pain in adults, and primary dysmenorrhea

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

This medication helps relieve symptoms and signs associated with arthritis, such as osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. It also effectively reduces acute pain occurring post-surgery or after tooth extraction, and relieves pain caused by primary dysmenorrhea. It is useful for alleviating various types of pain and inflammation, thereby enhancing the patient's comfort and 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 without regard to meals. ○ 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 per day. If no effect is observed after 6 weeks of taking 400 mg per day, other treatment options should be considered. 4. Acute pain and primary dysmenorrhea The recommended initial 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 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 drug may increase the risk of gastric bleeding when taken frequently by those who consume excessive amounts of alcohol daily, so it should be used only after consulting a doctor or pharmacist. This drug may also elevate the risk of cardiovascular problems such as heart attack or stroke, hence it should only be used at the minimum effective dose and duration, with careful monitoring for any cardiovascular symptoms. Patients with a history of gastric ulcers or bleeding should be particularly cautious as this medication can cause ulcers or bleeding in the stomach; they should seek medical attention immediately if symptoms such as abdominal pain, indigestion, black stools, or vomiting occur. Those who have allergies to this medication or have certain liver, kidney, heart diseases, inflammatory bowel disease, or are pregnant or breastfeeding should not take this medication. Patients with compromised liver or kidney function, asthma, hypertension, heart failure, or diabetes should use this medication with caution and may require regular monitoring during treatment. Dizziness or drowsiness may occur with this medication, so caution should be exercised when driving or operating machinery. This medication is metabolized in the liver, which may lead to drug interactions when taken with certain medications, so it is essential to inform your healthcare provider of any other medications you are taking. Women who are pregnant or planning to become pregnant should avoid this medication as it may affect reproductive ability, and should discontinue use immediately upon confirmation of pregnancy. Safety in children and adolescents has not been established, so it is advisable not to use it in those under 18 years of age. Elderly patients are at higher risk for decreased kidney, liver, and heart function, requiring more careful monitoring during use. Long-term usage of this medication may necessitate blood tests and assessments of liver and kidney function, and any unusual symptoms should prompt immediate discontinuation and consultation with healthcare professionals. Overdose may result in symptoms such as lethargy, nausea, vomiting, and abdominal pain, necessitating immediate emergency care; there is no specific antidote for overdose. This medication should be stored out of reach of children and should not be transferred to other containers for safety.

Side effects

Gastrointestinal bleeding, cardiovascular thrombotic events, myocardial infarction, stroke, perforation of the upper and lower gastrointestinal tract, ulcer, hemorrhage, gastrointestinal bleeding, dyspepsia, diarrhea, irritable bowel syndrome, increased bowel movements, abdominal pain, upper abdominal pain, distension, nausea, constipation, diverticulitis, dysphagia, belching, esophagitis, gastritis, gastrointestinal ulcer, gastroesophageal reflux, gastric discomfort, gastrointestinal disorders, hemorrhoids, hiatal hernia, bloody stools, dry mouth, stomatitis, backache, dental disease, vomiting, exacerbation of gastrointestinal inflammation, angular stomatitis, intestinal obstruction, bowel perforation, hemorrhagic colitis, esophageal perforation, pancreatitis, bowel obstruction, alveolar osteitis after tooth extraction, anastomotic ulcer, melena, glossitis, aphthous stomatitis, oral mucosal vesicle formation, numbness of the mouth, oral pain, headache, dizziness, leg cramps, anxiety, sensory impairment, migraine, neuralgia, neuropathy, sensory abnormalities, cerebral infarction, aseptic meningitis, ataxia, suicide, loss of smell, loss of taste, insomnia, anxiety, delirium, blurred vision, tinnitus, palpitations, congestive heart failure, arrhythmia, tachycardia, hypertension, flushing, cough, itching, rash, urticaria, angioedema, alopecia, vesicular dermatitis, peripheral edema, facial edema, influenza-like illness, injury, anaphylactic reaction, vasculitis, pulmonary embolism, interstitial pneumonia, elevated liver enzymes, hepatitis, liver failure, fulminant hepatitis, liver necrosis, photosensitivity reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms, acute generalized exanthematous pustulosis, exfoliative dermatitis, acute renal failure, hyponatremia, tubulointerstitial nephritis, nephrotic syndrome, minimal change disease, menstrual disorders, female infertility, chest pain, upper respiratory infection, shingles, wound infection, gingivitis, herpes simplex, shingles, bacterial infection, fungal infection, soft tissue infection, viral infection, candidiasis, genital candidiasis, otitis media, hearing loss, ear abnormalities, otalgia, hearing impairment, abnormal liver function, elevated ALT, elevated AST, increased γ-GTP, increased ALP, positive urobilinogen, cholelithiasis, jaundice, increased blood sodium, increased blood potassium, increased BUN, increased CPK, diabetes, hypercholesterolemia, hyperglycemia, hypokalemia, hyperkalemia, increased NPN, increased creatinine, increased alkaline phosphatase, weight gain, loss of appetite, increased LDH, hypoglycemia, hyponatremia, bursitis, arthralgia, arthritis, skeletal abnormalities, myalgia, cervical dystonia, synovitis, tendinitis, myositis, fracture, tendon rupture, pain in the back, muscle stiffness, decreased hematocrit, increased hemoglobin, petechiae, epistaxis, thrombocytopathy, anemia, thrombocytopenia, agranulocytosis, aplastic anemia, pancytopenia, leukopenia, eosinophilic inflammation, contact dermatitis, injection site reaction, skin nodules, taste alteration, albuminuria, cystitis, hematuria, dysuria, polyuria, nephrolithiasis, urinary incontinence, urinary tract infection, blurred vision, cataract, conjunctivitis, eye pain, glaucoma, ocular hemorrhage, retinal artery or vein occlusion, increased blood creatinine, increased β2-microglobulin, increased NAG, positive urine hematuria, positive urine protein, renal impairment, acute renal failure, interstitial nephritis

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, and it is advisable to keep it at room temperature between 15 to 30 degrees Celsius. This helps maintain the medication's efficacy and prevent degradation.

Appearance and packaging

Appearance

A capsule filled with powder that is white to off-white.

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.