Medication info

Dirole 400 mg (Dexibuprofen)

Prescription medicationTablet경구Expired
Ingredient · strength
Dexibuprofen›400mg / 1 tablet
Manufacturer / importer
(주)서흥
Appearance
White, rectangular film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Expired

MFDS item code 200709555 · Notified 2007.08.17

This product's status changed to Expired on 2024.04.01. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of chronic polyarthritis and rheumatoid arthritis (arthritis, ankylosing spondylitis) and relief of inflammation and pain.
Who takes it
Adults
Adult dose
As dexibuprofen, take 400 mg orally 2 to 3 times a day. However, do not exceed 1,200 mg per day as dexibuprofen.

Ingredients

Manufacturer
(주)서흥

Efficacy & effects

Treatment of chronic polyarthritis and rheumatoid arthritis (arthritis, ankylosing spondylitis) and relief of inflammation and pain.

  • Chronic polyarthritis
  • rheumatoid arthritis
  • arthritis
  • ankylosing spondylitis
  • painful swelling
  • inflammation
  • pain
  • fever
View approved original text

This medication is effective for inflammatory joint diseases such as chronic polyarthritis, rheumatoid arthritis, arthritis, and ankylosing spondylitis. It also helps reduce painful swelling and inflammation resulting from trauma or surgery, and assists in the treatment of infections accompanied by inflammation, pain, and fever. This drug is used to improve various inflammation-related symptoms.

How to take

Adult dose

As dexibuprofen, take 400 mg orally 2 to 3 times a day. However, do not exceed 1,200 mg per day as dexibuprofen.

Precautions

This medication can pose a risk of gastric bleeding if taken by individuals who regularly consume more than 3 alcoholic beverages daily; therefore, it is essential to consult a physician or pharmacist. It may affect the cardiovascular system, increasing the risk of myocardial infarction, stroke, etc., so special caution is needed for patients with cardiovascular diseases or risk factors. As a non-steroidal anti-inflammatory drug, this medication can cause serious adverse reactions such as gastric bleeding, ulcers, and perforation, and the risk may be greater for the elderly or those taking it over an extended period. Individuals with a history of gastrointestinal ulcers or bleeding, severe liver disease, kidney disease, heart failure, or hypertension should not take this medication, and those with allergies or asthma history should also avoid it. It is preferable to avoid using this medication concurrently with aspirin or other non-steroidal anti-inflammatory drugs, and caution is needed due to the potential for increased side effects from interactions with specific medications. During treatment, it is recommended to stop breastfeeding or discontinue medication, as dizziness or fatigue may occur, requiring caution when driving or operating machinery. Individuals with a history of blood abnormalities, liver disease, kidney disease, hypertension, heart failure, the elderly, children, and pregnant women should consult healthcare professionals prior to use. If symptoms such as shock, severe skin rashes, gastrointestinal bleeding, liver dysfunction, kidney problems, or neurological symptoms appear during treatment, discontinue immediately and consult a physician. Long-term use requires regular blood tests and liver and kidney function checks, and it should be used at the minimum effective dose for as short a duration as possible. After 20 weeks of pregnancy, there is a risk of fetal kidney dysfunction and oligohydramnios, so it should be used with caution, and immediate medical attention is required in case of overdose. Keep this medication out of reach of children, store it away from direct sunlight, and keep it in a cool, dry place.

Side effects and when to seek care immediately

Serious side effects

  • Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor → severe allergic reactions
  • Severe rash with high fever, blisters, skin peeling, mucosal pain in mouth/eyes → severe skin reactions
  • Asthma attacks, breathing difficulties accompanied by cough and fever → respiratory issues
  • Yellowing of the skin or eyes (jaundice), extreme lethargy → liver issues (jaundice)
  • Sudden and severe headaches, thunderclap headaches

Mild side effects

  • Dyspepsia
  • abdominal bloating
  • heartburn
  • diarrhea
  • constipation
  • loss of appetite
  • nausea
  • vomiting
  • abdominal pain
  • gastric discomfort
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  • thirst
  • stomatitis
  • rash
  • itching
  • blood pressure changes
  • palpitations
  • dizziness
  • drowsiness
  • fatigue
  • anxiety
  • restlessness
  • confusion
  • depression
  • mental disorders
  • nervousness
  • excitement
  • spatial disorientation
  • forgetfulness
  • tinnitus
  • auditory impairment
  • dysgeusia
  • periorbital swelling
  • malaise
  • fever
  • nosebleeds
  • exacerbation of inflammation

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

Storage

This medication may be sensitive to air and moisture, so it must be stored in a sealed container. Additionally, it is advisable to keep it at room temperature (between 1 and 30 degrees Celsius), ensuring it is not stored in excessively high or low temperatures.

Appearance and packaging

Appearance

White, rectangular film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/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.