Medication info

Roxfense Tablet (Roxoprofen Sodium Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Loxoprofen Sodium Hydrate›68.1mg / 1 tablet
Manufacturer / importer
한국넬슨제약(주)
Appearance
White to yellowish round tablets
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201901961 · Approved 2019.03.30 · Insurance code 656702030

Summary

Main use
Anti-inflammatory and analgesic effects for chronic rheumatoid arthritis and osteoarthritis, and antipyretic and analgesic effects for acute upper respiratory infections
Who takes it
Adults
Adult dose
1. For indications 1 and 2: Adults should administer 60 mg of Roxoprofen Sodium (anhydrous) orally three times a day. For a one-time dose, 60–120 mg can be taken orally. 2. For indication 3: Adults should administer 60 mg of Roxoprofen Sodium (anhydrous) orally. In principle, it can be taken twice a day, with a maximum daily dose of 180 mg. It is advisable to avoid taking it on an empty stomach.

Ingredients

Manufacturer
한국넬슨제약(주)

Efficacy & effects

Anti-inflammatory and analgesic effects for chronic rheumatoid arthritis and osteoarthritis, and antipyretic and analgesic effects for acute upper respiratory infections

  • Chronic rheumatoid arthritis
  • osteoarthritis
  • low back pain
  • shoulder periarthritis
  • cervical radiculopathy
  • postoperative pain
  • post-traumatic pain
  • post-extraction pain
  • acute upper respiratory infections
  • acute bronchitis
View approved original text

This medication is effective for reducing inflammation and pain associated with inflammatory diseases such as chronic rheumatoid arthritis, osteoarthritis, low back pain, shoulder periarthritis, and cervical radiculopathy. It is also used to relieve inflammation and pain that occur after surgery, trauma, or tooth extraction. The drug provides antipyretic and analgesic effects in acute inflammatory diseases such as acute upper respiratory infections, thereby alleviating fever and pain symptoms. This medication can be used for various inflammatory diseases along with pain and fever symptoms.

How to take

Adult dose

1. For indications 1 and 2: Adults should administer 60 mg of Roxoprofen Sodium (anhydrous) orally three times a day. For a one-time dose, 60–120 mg can be taken orally. 2. For indication 3: Adults should administer 60 mg of Roxoprofen Sodium (anhydrous) orally. In principle, it can be taken twice a day, with a maximum daily dose of 180 mg. It is advisable to avoid taking it on an empty stomach.

Precautions

This medication should be consulted with a doctor or pharmacist before taking, especially for those who regularly consume three or more alcoholic drinks daily, as it may cause gastrointestinal bleeding. This drug may increase the risk of cardiovascular disease, so individuals with a risk of heart disease or stroke should be particularly cautious. During treatment, closely monitor for any cardiovascular symptoms; if any symptoms occur, immediate medical attention is necessary. There is a risk of serious gastrointestinal problems such as bleeding, ulcers, and perforation with this medication. Special care must be taken in older patients or those on prolonged treatment as the risks may increase, thus monitoring gastrointestinal symptoms is essential. Individuals with a history of peptic ulcers, severe blood disorders, liver dysfunction, kidney dysfunction, congestive heart failure, or those allergic to this drug or its components should not take it. Also, individuals who have had allergic reactions to aspirin or other non-steroidal anti-inflammatory drugs, pregnant women in late pregnancy, nursing mothers, and patients with inflammatory bowel disease should not use this drug. Patients with a history of peptic ulcer disease, liver, kidney, or blood disorders, asthmatic patients, hypertensive patients, and the elderly should use caution when taking this medication. Additionally, women in the early or middle stages of pregnancy should seek a doctor’s advice before taking it. If any unusual symptoms like rash, itching, breathing difficulty, abdominal pain, blood in stool, dizziness, liver function abnormalities, renal function abnormalities, or skin rashes occur while taking this medication, stop taking it immediately and consult a doctor. Taking this drug with other non-steroidal anti-inflammatory medications may increase the risk of side effects, so they should not be taken together. Caution is advised as this drug may interact with some diabetes medications, antibiotics, blood pressure medications, diuretics, anticoagulants, lithium, chemotherapy agents, etc.; inform your doctor or pharmacist of all medications you are taking. This medication should not be taken especially during late pregnancy, and it is also considered unsafe during breastfeeding. The safety for children has not been established, and caution is necessary for the elderly due to a higher risk of side effects. Keep this medication out of reach of children, and do not transfer it to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, shock, anaphylactic-like symptoms, peptic ulcer, perforation, hematemesis, melena, shock, severe skin adverse reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis), skin and mucosal syndrome, acute generalized exanthematous pustulosis, fever, difficulty breathing, asthma attacks, liver dysfunction (including jaundice), fulminant hepatitis, acute renal failure, nephrotic syndrome, interstitial nephritis

Mild side effects

  • Rash
  • itching
  • fever
  • abdominal pain
  • gastrointestinal discomfort
  • loss of appetite
  • nausea
  • vomiting
  • diarrhea
  • constipation
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  • chest burning
  • indigestion
  • stomatitis
  • dry mouth
  • abdominal bloating
  • drowsiness
  • numbness
  • dizziness
  • headache
  • anemia
  • hemolytic anemia
  • leukopenia
  • thrombocytopenia
  • eosinophilia
  • edema
  • chest pain
  • anxiety
  • weakness
  • palpitations

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

Storage

This medication is sensitive to air and moisture, so it should be stored in a tightly sealed container. Additionally, it is important to store the drug at room temperature that is not too hot or too cold.

Appearance and packaging

Appearance

White to yellowish round tablets

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.