Medication info
Proloxofen Tablets (Loxoprofen Sodium Hydrate)

Proloxofen Tablets (Loxoprofen Sodium Hydrate)

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

MFDS item code 201901014 · Approved 2019.02.19 · Insurance code 670501340

Summary

Main use
Anti-inflammatory and analgesic effects for chronic rheumatoid arthritis, osteoarthritis, and antipyretic analgesic effects for acute upper respiratory tract inflammation
Who takes it
Adults
Adult dose
1. For indications 1 and 2: Adults: 60 mg of loxoprofen sodium (anhydrous) orally three times a day. For single dosing, take 60-120 mg orally. 2. For indication 3: Adults: 60 mg of loxoprofen sodium (anhydrous) orally. In principle, it can be administered twice a day, with a maximum of 180 mg per day. It is preferable to avoid taking it on an empty stomach.

Ingredients

Manufacturer
(주)보령바이오파마

Efficacy & effects

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

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

This medicine exerts anti-inflammatory and analgesic effects in various inflammatory diseases such as chronic rheumatoid arthritis, osteoarthritis, low back pain, periarthritis of the shoulder, and cervical spondylosis. It is also used to relieve inflammation and pain after surgery, trauma, or dental extraction. Additionally, it helps reduce fever and pain associated with acute upper respiratory infections and bronchitis. Thus, it is effective in reducing inflammation and improving pain and fever in several conditions and situations.

How to take

Adult dose

1. For indications 1 and 2: Adults: 60 mg of loxoprofen sodium (anhydrous) orally three times a day. For single dosing, take 60-120 mg orally. 2. For indication 3: Adults: 60 mg of loxoprofen sodium (anhydrous) orally. In principle, it can be administered 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 may cause gastric bleeding if taken by individuals who regularly consume more than three glasses of alcohol daily; consultation with a doctor or pharmacist is essential. Caution is needed as the risk of serious cardiovascular diseases, such as myocardial infarction or stroke, may increase when using this medication by those with heart or vascular issues or risk factors. This medication can cause severe problems such as gastrointestinal bleeding, ulcers, and perforation, and the risks may be greater in older adults. Patients with a history of peptic ulcers, severe blood disorders, liver or kidney diseases, heart failure, hypersensitivity, those in late pregnancy, nursing mothers, or those with specific inflammatory bowel diseases should avoid using this medication. Patients with a past history of peptic ulcers, blood disorders, liver, or kidney diseases need careful monitoring when using this medication. If symptoms of hypersensitivity such as rash, itching, hives, or difficulty breathing occur while taking this medication, immediate discontinuation and consultation with a doctor is necessary. Gastrointestinal symptoms such as abdominal pain, nausea, vomiting, or diarrhea may occur, and immediate treatment is required in case of severe bleeding symptoms. Psychological symptoms such as drowsiness, dizziness, or headache can occasionally occur, necessitating caution when driving or operating machinery. Regular check-ups are needed during prolonged use due to potential liver dysfunction or kidney impairment. This medication should not be taken with other non-steroidal anti-inflammatory drugs due to an increased risk of side effects. Interactions may occur with specific blood pressure medications, diuretics, anticoagulants, antibiotics, antidepressants, etc., so inform your healthcare provider of any other medications you are taking. It is unsafe to use this medication during late pregnancy and should be used cautiously at the minimum dose during early or mid-pregnancy under a doctor's guidance. It is safer not to take this medication while breastfeeding. It is preferable not to use this medication in children as its safety has not been established. Elderly individuals are at higher risk for side effects; therefore, careful monitoring is needed when using this medication. This medication should be stored out of reach of children and should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema, facial swelling, periorbital swelling, oral swelling), chest tightness, difficulty breathing, shock, anaphylactic symptoms, peptic ulcer, gastrointestinal bleeding (hematemesis, melena, blood in stool), severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, mucocutaneous syndrome, erythema multiforme, acute generalized exanthematous pustulosis, DRESS syndrome), jaundice, liver dysfunction (fulminant hepatitis, liver necrosis

Mild side effects

  • Occasional rash
  • itching
  • fever
  • drowsiness
  • numbness
  • dizziness
  • headache
  • abdominal pain
  • discomfort in the upper stomach
  • loss of appetite
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  • nausea
  • vomiting
  • diarrhea
  • constipation
  • chest discomfort
  • indigestion
  • stomatitis
  • dryness
  • abdominal bloating
  • hematuria
  • proteinuria
  • swelling
  • chest pain
  • anxiety
  • fatigue
  • palpitations

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

Storage

This medication must be stored in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Light pink round tablet

Package unit

500 tablets/bottle, 30 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.