Medication info
Roxocul Tablet (Roxoprofen Sodium Hydrate)

Roxocul Tablet (Roxoprofen Sodium Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Loxoprofen Sodium Hydrate›68.1mg / 1 tablet
Manufacturer / importer
(주)화이트생명과학
Appearance
White round tablets
Packaging
30 tablets/bottle, 600 tablets/bottle
Approval status
Active

MFDS item code 201308925 · Approved 2013.08.21 · Insurance code 625200060

Summary

Main use
Anti-inflammatory and analgesic effects for chronic rheumatic arthritis, osteoarthritis, etc., as well as antipyretic and analgesic effects for acute upper respiratory tract inflammation
Who takes it
Adults
Adult dose
1. For indications 1 and 2 ○ Adults: Administer 60 mg of Roxoprofen Sodium (anhydrous) orally three times a day. In single-dose therapy, administer orally 60-120 mg. 2. For indication 3 ○ Adults: Administer 60 mg of Roxoprofen Sodium (anhydrous) orally. In principle, it can be taken twice daily, with a maximum of 180 mg per day. It is preferable to avoid taking this medication on an empty stomach.

Ingredients

Manufacturer
(주)화이트생명과학

Efficacy & effects

Anti-inflammatory and analgesic effects for chronic rheumatic arthritis, osteoarthritis, etc., as well as antipyretic and analgesic effects for acute upper respiratory tract inflammation

  • Chronic rheumatic arthritis
  • osteoarthritis
  • low back pain
  • periarthritis of the shoulder
  • cervical spondylosis
  • postoperative pain
  • post-trauma pain
  • pain after tooth extraction
  • acute upper respiratory tract infection
  • acute bronchitis
View approved original text

This medication is used to relieve various inflammatory diseases and pain such as chronic rheumatic arthritis, osteoarthritis (degenerative arthritis), low back pain, periarthritis of the shoulder, and cervical spondylosis. It is also effective in reducing inflammation and pain after surgery, trauma, and tooth extraction. Additionally, it helps alleviate fever and pain in infectious diseases, including acute upper respiratory tract infections. For these purposes, this medication is used to reduce discomfort and improve symptoms for patients.

How to take

Adult dose

1. For indications 1 and 2 ○ Adults: Administer 60 mg of Roxoprofen Sodium (anhydrous) orally three times a day. In single-dose therapy, administer orally 60-120 mg. 2. For indication 3 ○ Adults: Administer 60 mg of Roxoprofen Sodium (anhydrous) orally. In principle, it can be taken twice daily, with a maximum of 180 mg per day. It is preferable to avoid taking this medication on an empty stomach.

Precautions

This medication should be discussed with a doctor or pharmacist if taken by individuals who regularly consume more than three glasses of alcohol per day, as it may cause gastrointestinal bleeding. Furthermore, non-steroidal anti-inflammatory drugs (NSAIDs), including this medication, can increase the risk of serious thrombotic reactions such as myocardial infarction or stroke in individuals with cardiovascular issues or risk factors. Therefore, both the doctor and patient should carefully monitor for any symptoms related to the cardiovascular system and report any occurrence immediately. This medication can also affect the gastrointestinal tract, leading to serious issues such as bleeding, ulcers, or perforations in the stomach or intestines. Elderly patients or those with a history of gastrointestinal diseases are at higher risk and should be monitored closely for gastrointestinal symptoms while on this medication. Patients with peptic ulcers, severe blood disorders, liver dysfunction, kidney dysfunction, heart failure, and those allergic to this medication or its components should not take this medication. Additionally, individuals who have had allergic reactions to aspirin or other NSAIDs should not use this medication. Pregnant women in late pregnancy, nursing mothers, and individuals with inflammatory bowel disease should also refrain from taking this medication. Patients with a history of peptic ulcers or liver, kidney, or blood disorders should exercise particular caution when using this medication. If allergic symptoms such as rash, itching, difficulty breathing, or low blood pressure occur during use, the medication should be stopped immediately, and medical help should be sought. Gastrointestinal symptoms may include abdominal pain, nausea, vomiting, diarrhea, or blood in stools; report any of these symptoms immediately. This medication can cause neurological symptoms such as drowsiness, dizziness, or headaches, so caution should be exercised when driving or operating machinery. There may be changes in liver and kidney function, requiring periodic testing, and any unusual symptoms should be reported to healthcare providers immediately. This medication can interact with other NSAIDs or certain medications, so be sure to inform healthcare providers about any other medications being taken. Women who are pregnant or may become pregnant should use this medication with caution and must not take it during late pregnancy. It is also safe to avoid this medication while breastfeeding. Safety in children has not been established, so its use is not recommended in pediatric patients. Elderly patients are at a higher risk of side effects when taking this medication and should be particularly cautious. Finally, this medication should be kept out of reach of children and should not be transferred to another container.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, shock, anaphylactic-like symptoms, gastrointestinal bleeding (hematemesis, melena, blood in stool), shock, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), acute generalized exanthematous pustulosis, liver dysfunction (including jaundice), fulminant hepatitis, acute renal failure, respiratory distress, asthma attacks, interstitial pneumonia, aseptic meningitis

Mild side effects

  • Occasionally may cause rash
  • itching
  • fever
  • abdominal pain
  • gastrointestinal discomfort
  • loss of appetite
  • nausea
  • vomiting
  • diarrhea
  • constipation
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  • chest burning sensation
  • indigestion
  • stomatitis
  • thirst
  • abdominal bloating
  • drowsiness
  • numbness
  • dizziness
  • headache
  • anemia
  • hemolytic anemia
  • leukopenia
  • thrombocytopenia
  • eosinophilia
  • edema
  • chest pain
  • anxiety
  • fatigue
  • palpitations
  • fever
  • resolution
  • abnormal findings on chest X-ray
  • hematuria
  • proteinuria
  • urticaria

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a sealed container. It is essential to maintain a storage temperature between 1 to 30 degrees Celsius to preserve its efficacy and safety over time.

Appearance and packaging

Appearance

White round tablets

Package unit

30 tablets/bottle, 600 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.