Medication info

Culprofen Tablet (Dexibuprofen)

Prescription medicationTabletOralApproval withdrawn
Ingredient · strength
Dexibuprofen D.C.›400mg / 1 tablet
Manufacturer / importer
Hanlim Pharmaceutical Co., Ltd.
Appearance
White rectangular film-coated tablet
Packaging
30 tablets per bottle, 300 tablets per bottle
Approval status
Approval withdrawn

MFDS item code 200709336 · Notified 2007.08.08

This product's status changed to Approval withdrawn on 2024.03.06. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Joint diseases (arthritis, etc.), inflammation following trauma or surgery, adjunctive treatment of infections
Who takes it
Adults
Adult dose
Adults: Administer 400 mg per dose orally 2~3 times daily as dexibuprofen. Do not exceed 1,200 mg of dexibuprofen per day.

Ingredients

Manufacturer
Hanlim Pharmaceutical Co., Ltd.

Efficacy & effects

Joint diseases (arthritis, etc.), inflammation following trauma or surgery, adjunctive treatment of infections

  • Chronic multi-joint arthritis
  • rheumatoid arthritis
  • osteoarthritis
  • ankylosing spondylitis
  • painful swelling
  • inflammation
  • pain
  • and fever after trauma and surgery
View approved original text

This medication is used for chronic inflammatory diseases such as chronic multi-joint arthritis, rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis. It also helps relieve painful swelling and inflammation following trauma or surgery. Additionally, it plays a supportive role in the treatment of infections accompanied by inflammation, pain, and fever. It is effectively used for various inflammatory diseases and pain relief.

How to take

Adult dose

Adults: Administer 400 mg per dose orally 2~3 times daily as dexibuprofen. Do not exceed 1,200 mg of dexibuprofen per day.

Precautions

This medication carries a risk of gastrointestinal bleeding in individuals who regularly consume more than 3 alcoholic beverages per day; therefore, consultation with a doctor or pharmacist is essential. This medication may affect the cardiovascular system and increase the risk of myocardial infarction or stroke, so particular caution is needed for individuals with cardiovascular diseases or risk factors. This medication can cause severe gastrointestinal problems like gastrointestinal bleeding, ulcers, or perforation, thus older adults or individuals with a history of gastrointestinal conditions should take it with extra caution. Individuals with gastrointestinal ulcers or bleeding, severe blood disorders, liver disease, kidney disease, heart failure, or high blood pressure should not take this medication. Combining this medication with aspirin or other non-steroidal anti-inflammatory drugs can increase the risk of serious side effects, so it is advisable not to take them together. During the course of this medication, breastfeeding should be discontinued or discussed with a doctor, and caution is required while driving or operating machinery as dizziness or fatigue may occur. Individuals with a history of blood disorders, liver disease, kidney disease, hypertension, heart failure, as well as elderly patients, children, pregnant women, and alcoholics should consult an expert before taking this medication. If symptoms of shock, severe skin rash, gastrointestinal bleeding, liver dysfunction, kidney dysfunction, or neurological disturbances appear during the course of this medication, it should be discontinued immediately and a doctor consulted. This medication should be taken for the shortest duration and at the lowest effective dose; long-term use requires regular blood tests and monitoring of liver and kidney functions. After the 20th week of pregnancy, it may affect the fetal kidney function, so the duration and dosage should be minimized, and the amniotic fluid condition should be monitored if necessary. In case of overdose, even without symptoms, it is crucial to visit a medical institution quickly for appropriate treatment. This medication should be stored in a cool, dry place out of reach of children and in a sealed container to prevent exposure to air and moisture; avoid transferring to another container.

Side effects

  • Gastrointestinal bleeding
  • cardiovascular thrombotic events
  • myocardial infarction
  • stroke
  • bleeding from the stomach or intestines
  • ulcers
  • perforations
  • dizziness
  • fatigue
  • headaches
Show 113 more
  • shock
  • aplastic anemia
  • hemolytic anemia
  • granulocytopenia
  • leukopenia
  • agranulocytosis
  • pancytopenia
  • thrombocytopenia
  • impaired platelet function
  • eosinophilia
  • dyspepsia
  • abdominal distension
  • heartburn
  • epigastric pain
  • diarrhea
  • constipation
  • loss of appetite
  • nausea
  • vomiting
  • abdominal pain
  • gastric discomfort
  • esophagitis
  • esophageal stricture
  • exacerbation of diverticulitis
  • nonspecific hemorrhagic colitis
  • ulcerative colitis
  • Crohn's disease
  • peptic ulcer
  • gastrointestinal bleeding
  • perforation
  • bloody stools
  • gastritis
  • pancreatitis
  • thirst
  • stomatitis
  • erythema multiforme
  • systemic lupus erythematosus
  • hair loss
  • angioedema
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • eosinophilia
  • drug rash with systemic symptoms
  • rash
  • urticaria
  • itching
  • purpura
  • asthma attacks
  • eczema
  • anaphylactic reactions
  • photosensitivity reactions
  • jaundice
  • elevated ALT
  • elevated AST
  • elevated ALP
  • liver dysfunction
  • hepatitis
  • rhinitis
  • bronchospasm
  • acute pneumonia
  • neglect
  • cancer invasion
  • hearing loss
  • tinnitus
  • taste disturbances
  • fatigue
  • drowsiness
  • headaches
  • dizziness
  • anxiety
  • agitation
  • confusion
  • depression
  • aseptic meningitis
  • psychiatric disturbances
  • restlessness
  • excitement
  • sense of direction impairment
  • reversible toxic myopathy
  • low blood pressure
  • high blood pressure
  • palpitations
  • acute renal failure
  • oliguria
  • hematuria
  • proteinuria
  • elevated BUN
  • elevated serum creatinine
  • hyperkalemia
  • decreased urine output
  • generalized edema
  • shortness of breath
  • lethargy
  • renal papillary necrosis
  • nephrotic syndrome
  • interstitial nephritis
  • peripheral edema
  • acute pulmonary edema
  • fluid retention
  • decreased reproductive capacity in women
  • periorbital edema
  • fatigue
  • fever
  • nosebleeds
  • exacerbation of inflammation
  • crying
  • facial swelling
  • dyspepsia
  • itching
  • anaphylactic shock
  • rash
  • diarrhea
  • vomiting

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

Storage

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture and should be kept at room temperature between 1 degrees and 30 degrees Celsius. This will help maintain the effectiveness and safety of the medication.

Appearance and packaging

Appearance

White rectangular film-coated tablet

Package unit

30 tablets per bottle, 300 tablets per 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.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.