Medication info
Prolox Tablet (Sodium Loxoprofen Hydrate)

Prolox Tablet (Sodium Loxoprofen Hydrate)

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

MFDS item code 201707937 · Approved 2017.11.17 · Insurance code 059600230

Summary

Main use
Anti-inflammatory and analgesic effects for chronic rheumatoid arthritis, osteoarthritis, etc., and fever-reducing and analgesic effects for acute upper respiratory infections
Who takes it
Adults
Adult dose
1. For indications 1 and 2 ○ Adults: Administer 60 mg of sodium loxoprofen (anhydrous) orally 3 times a day. For single dose administration, 60–120 mg is to be taken orally. 2. For indication 3 ○ Adults: Administer 60 mg of sodium loxoprofen (anhydrous) orally. In principle, it can be taken twice a day, with a maximum of 180 mg per day. It is advisable to avoid taking on an empty stomach.

Ingredients

Manufacturer
(주)킴스제약

Efficacy & effects

Anti-inflammatory and analgesic effects for chronic rheumatoid arthritis, osteoarthritis, etc., and fever-reducing and analgesic effects for acute upper respiratory infections

  • Chronic rheumatoid arthritis
  • osteoarthritis
  • low back pain
  • shoulder periarthritis
  • cervical spondylosis
  • post-surgery
  • post-trauma
  • post-tooth extraction
  • acute upper respiratory infection
  • acute bronchitis
View approved original text

This medication provides anti-inflammatory and analgesic effects in various inflammatory diseases such as rheumatoid arthritis, osteoarthritis, low back pain, shoulder periarthritis, and cervical spondylosis. It is also used to relieve pain and inflammation after surgery, trauma, and tooth extraction. Furthermore, it is effective for fever and pain relief in respiratory diseases including acute upper respiratory infections and acute bronchitis. Therefore, this drug is used effectively for improving inflammation, pain, and fever simultaneously.

How to take

Adult dose

1. For indications 1 and 2 ○ Adults: Administer 60 mg of sodium loxoprofen (anhydrous) orally 3 times a day. For single dose administration, 60–120 mg is to be taken orally. 2. For indication 3 ○ Adults: Administer 60 mg of sodium loxoprofen (anhydrous) orally. In principle, it can be taken twice a day, with a maximum of 180 mg per day. It is advisable to avoid taking on an empty stomach.

Precautions

This medication may cause gastric bleeding if consumed by individuals who regularly drink more than three glasses of alcohol per day; therefore, it is essential to consult a doctor or pharmacist. This drug may increase the risk of cardiovascular diseases, so caution is necessary for patients with cardiovascular conditions or risk factors. It may cause serious gastrointestinal adverse reactions such as gastric bleeding, ulcers, and perforations, especially in the elderly, making it more risky. Patients with certain conditions such as peptic ulcers, severe blood disorders, liver impairment, kidney impairment, or heart failure should not take this medication. Patients with a history of hypersensitivity or allergic reactions to aspirin, etc., should also avoid using this drug. Patients with a history of peptic ulcers or issues with liver and kidney function, as well as those with hypertension, should use this medication with caution. This medication may cause various adverse reactions such as skin rashes, urticaria, breathing difficulties, liver impairment, kidney impairment, and gastrointestinal bleeding; hence, it is crucial to stop taking it immediately and consult a doctor if symptoms occur. Regular blood tests and liver and kidney function tests are required during long-term use, with careful monitoring of the patient's condition. The risk of adverse reactions may increase if taken in combination with other non-steroidal anti-inflammatory drugs, so it is advisable not to take them together. It should not be used during late pregnancy due to risks to the fetus and should only be administered at the minimum dose in early or mid-pregnancy if absolutely necessary. Breastfeeding women should not take this medication. Safety in children has not been established, so it is recommended not to use this drug in pediatric patients. Elderly patients are at higher risk for adverse reactions when taking this medication, so special caution is required. This drug should be kept out of reach of children, and transferring it to another container is discouraged as it may affect quality.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria, severe swelling (edema), chest tightness, difficulty breathing, hypotension → severe allergic reactions
  • Gastrointestinal bleeding, ulcers, perforation, hematemesis, melena, hematochezia, shock → serious gastrointestinal adverse reactions
  • Severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa → severe skin adverse reactions
  • Breathing difficulties, asthma attacks, respiratory issues accompanied by cough and fever → respiratory problems
  • Skin or eye issues

Mild side effects

  • Occasionally
  • may cause skin rash
  • itching
  • fever
  • abdominal pain
  • dyspepsia
  • loss of appetite
  • nausea
  • vomiting
  • diarrhea
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  • constipation
  • chest tightness
  • indigestion
  • stomatitis
  • dry mouth
  • abdominal bloating
  • drowsiness
  • numbness
  • dizziness
  • headache
  • anemia
  • hemolytic anemia
  • leukopenia
  • thrombocytopenia
  • eosinophilia
  • swelling
  • chest pain
  • anxiety
  • fatigue
  • palpitations

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

Storage

This medication may be sensitive to air and humidity, so it must be stored in a tightly closed container. The storage temperature should be maintained at room temperature between 1°C and 30°C. This will help maintain the medication's effectiveness for a longer duration.

Appearance and packaging

Appearance

White round tablet

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.