Medication info
Roxofen Tablet (Roxoprofen Sodium)

Roxofen Tablet (Roxoprofen Sodium)

Prescription medicationTablet경구
Ingredient · strength
Loxoprofen Sodium Hydrate›68.1mg / 1 tablet
Manufacturer / importer
대원바이오텍주식회사
Appearance
White round tablets
Packaging
30 tablets/bottle, 500 tablets/bottle
Approval status
Active

MFDS item code 202002380 · Approved 2020.04.06 · Insurance code 057600660

Summary

Main use
Anti-inflammatory and analgesic effects for chronic rheumatoid arthritis and osteoarthritis, as well as antipyretic and analgesic effects for acute upper respiratory tract infections.
Who takes it
Adults
Adult dose
1. For efficacy and effects 1 and 2: Adults: Administer 60 mg of Roxoprofen Sodium (anhydrous) orally three times a day. For single dose therapy: Administer 60-120 mg orally. 2. For efficacy and effect 3: Adults: Administer 60 mg of Roxoprofen Sodium (anhydrous) orally. Generally, can be taken twice a day, with a maximum of 180 mg per day. It is preferable to avoid taking it on an empty stomach.

Ingredients

Manufacturer
대원바이오텍주식회사

Efficacy & effects

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

  • Chronic rheumatoid arthritis
  • osteoarthritis
  • low back pain
  • periarthritis of the shoulder
  • lateral epicondylitis
  • postoperative pain
  • post-traumatic pain
  • pain after tooth extraction
  • acute upper respiratory tract infections
  • acute bronchitis
View approved original text

This drug has anti-inflammatory and analgesic effects for inflammatory diseases such as chronic rheumatoid arthritis, osteoarthritis, low back pain, periarthritis of the shoulder, and lateral epicondylitis. It also helps relieve inflammation and pain following surgery, trauma, or tooth extraction. It is effectively used for fever and pain associated with acute respiratory diseases, including the common cold. This medication is used to improve pain and inflammation associated with various conditions.

How to take

Adult dose

1. For efficacy and effects 1 and 2: Adults: Administer 60 mg of Roxoprofen Sodium (anhydrous) orally three times a day. For single dose therapy: Administer 60-120 mg orally. 2. For efficacy and effect 3: Adults: Administer 60 mg of Roxoprofen Sodium (anhydrous) orally. Generally, can be taken twice a day, with a maximum of 180 mg per day. It is preferable to avoid taking it on an empty stomach.

Precautions

This medication poses a risk of gastrointestinal bleeding for individuals who regularly consume more than three glasses of alcohol daily, so consultation with a physician or pharmacist is essential. This drug may impact the cardiovascular system, increasing the risk of serious cardiovascular diseases such as myocardial infarction or stroke. Patients with cardiovascular diseases or risk factors should be cautious, and any symptoms should be reported to a specialist immediately. This medication can cause serious gastrointestinal reactions such as gastrointestinal bleeding, ulcers, or perforations; therefore, particular caution is required when administering to elderly patients or those with a history of gastrointestinal diseases. If unusual symptoms occur, discontinue use and consult a physician immediately. Patients with a history of peptic ulcers, severe blood disorders, liver dysfunction, kidney dysfunction, heart failure, or allergies to this drug or its ingredients, as well as those allergic to aspirin or other non-steroidal anti-inflammatory drugs should not take this medication. Patients with a history of peptic ulcers, blood disorders, liver dysfunction, kidney dysfunction, heart failure, hypertension, asthma, or elderly patients must be cautious when using this drug and should follow a physician’s instructions closely. This drug may cause allergic reactions including rash, itching, and hives, and in severe cases, anaphylaxis or shock may occur, requiring that the medication be discontinued and a physician consulted if symptoms arise. Gastrointestinal symptoms such as abdominal pain, upper abdominal discomfort, nausea, vomiting, diarrhea, or bloody stools may occur and require immediate treatment in severe cases. This medication may cause central nervous system symptoms like drowsiness, dizziness, or headaches, necessitating caution when driving or operating machinery. It may also affect liver and kidney function, requiring regular monitoring during prolonged use, and treatment should be discontinued if unusual symptoms arise. This drug may interact with other non-steroidal anti-inflammatory drugs, anticoagulants, diuretics, lithium, methotrexate, etc., so any other medications taken must be reported to a physician. It should not be taken in late pregnancy due to potential harm to the fetus, and women who are pregnant or breastfeeding should consult a physician before use. Safety in children has not been established, so use in children should be approached with caution. Elderly patients are at a higher risk of side effects from this medication, necessitating special vigilance when administering it. This medication should be stored out of the reach of children and should not be transferred to another container.

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, hematemesis, melena, gastrointestinal bleeding, abdominal pain, intestinal perforation, severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis), jaundice, fulminant hepatitis, acute renal failure, interstitial nephritis, acute respiratory distress, asthma attacks, aseptic meningitis, severe neurological symptoms (headaches, confusion, etc.), severe.

Mild side effects

  • Occasionally causes rash
  • itching
  • fever
  • drowsiness
  • numbness
  • dizziness
  • headache
  • abdominal pain
  • upper abdominal discomfort
  • loss of appetite
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  • nausea
  • vomiting
  • diarrhea
  • constipation
  • chest discomfort
  • indigestion
  • stomatitis
  • dryness of the mouth
  • abdominal bloating
  • swelling
  • chest pain
  • anxiety
  • fatigue
  • palpitations
  • hematuria
  • proteinuria
  • fever
  • resolution of symptoms
  • abnormal chest X-rays
  • eosinophilia
  • anemia
  • hemolytic anemia
  • leukopenia
  • thrombocytopenia
  • eosinophilia.

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

Storage

This drug should be stored in a tightly sealed container to prevent air or moisture from entering. It is recommended to maintain a storage temperature between 1 degree and 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

White round tablets

Package unit

30 tablets/bottle, 500 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.